Medwrite Portfolio_20 Surgery Sample Articles

OBES SURG100. Himsworth HP. Diabetes mellitus: its differentiation into insulin- syndrome for Asian Indians and recommendations for physical sensitive and insulin-insensitive types. Lancet. 1936;i:127–30. activity, medical and surgical management. J Assoc Physicians of India. 2009;57:163–70.101. National Institutes of Health Consensus Development Panel. 104. Razak F, Anand SS, Shannon H, et al. Defining obesity cut points in Gastrointestinal surgery for severe obesity. Ann Intern Med. a multiethnic population. Circulation. 2007;115:2111–8. 1991;115:956–61. 105. Janssen I, Katzmarzyk PT, Ross R. Body mass index, waist circumference, and health risk: evidence in support of current102. IFSO Editorial. Statement on patient selection for bariatric National Institutes of Health guidelines. Arch Intern Med. surgery. Obes Surg. 1997;7(1):41. 2002;162:2074–9.103. Misra A, Chowbey P, Makkar BM, et al. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic

Surgery for Obesity and Related Diseases 4 (2008) 174 –185 Review articleStudies of Swedish adjustable gastric band and Lap-Band: systematic review and meta-analysis Scott A. Cunneen, M.D.a,*, Edward Phillips, M.D.a, George Fielding, M.D.,b, Deirdre Banel, B.S.c, Rhonda Estok, R.N., B.S.N.c, Kyle Fahrbach, Ph.D.c, Isabella Sledge, M.D., M.P.H.c aCedars Sinai Medical Center, Los Angeles, California; bDepartment of Surgery, New York University Medical Center, New York, New York; cUnited BioSource Corporation, Medford, Massachusetts Received July 16, 2007; revised October 7, 2007; accepted October 19, 2007Abstract Background: This is the first systematic review and meta-analysis of the large body of dataKeywords: describing the Swedish adjustable gastric band (SAGB) and Lap-Band (LB). Methods: A systematic review was performed that included screening of studies published in any language (January 1, 1998 through April 30, 2006) identified through MEDLINE, Current Contents, or the Cochrane Library. Studies with Ն10 SAGB or LB patients reporting Ն30-day efficacy or safety outcomes were eligible for review; the data were extracted from the accepted studies. A weighted means analysis and random-effects meta-analysis of efficacy outcomes of interest were conducted. Results: A total of 4592 bariatric surgery studies met the initial criteria. Of these studies, 129 (28,980 patients) were accepted (33 SAGB and 104 LB studies); most had a retrospective single- center design. For 4273 patients (36 treatment groups) in 33 SAGB studies and 24,707 patients (111 groups) in 104 LB studies, the mean baseline age (39.1– 40.2 yr), body mass index (43.8 – 45.3 kg/m2), and gender (women 79.2– 82.5%) were similar. A laparoscopic technique was used in Ն88% and a pars flaccida technique in Ն41% of both groups. Early mortality was equivalent for SAGB/LB (Յ.1%). The 3-year mean SAGB and LB excess weight loss (56.36% and 50.20%, respectively) and body mass index reduction (Ϫ11.99 and Ϫ11.81 kg/m2, respectively) from baseline were statistically significant (P Ͻ.05), as was the resolution of diabetes (61.45% and 60.29%, respectively) and hypertension (62.95% and 43.58%, respectively). Although scant and inconsistently reported data precluded direct statistical comparisons, the complication rates for the 2 devices appeared comparable. In 8 directly comparative studies, meta-analysis found a signifi- cantly greater absolute weight loss (P Ͻ.05) with the SAGB at 2 years (48.4 versus 41.9 kg, mean difference Ϫ4.84, 95% confidence interval Ϫ9.47 to Ϫ0.22), although no difference was found in the percentage of excess weight loss or change in body mass index. Conclusion: In a systematic review of the published world SAGB and LB data, at 1, 2, and 3 years, the weight loss, resolution of diabetes and hypertension, and complications appeared comparable. (Surg Obes Relat Dis 2008;4:174 –185.) © 2008 American Society for Metabolic and Bariatric Surgery. All rights reserved. Morbid obesity; Laparoscopic adjustable gastric band; LAGB; Swedish adjustable gastric band; Lap-Band; Weight; Systematic review; Meta-analysisThis work was supported by Ethicon Endo-Surgery, a Johnson & Johnson Company, Cincinnati, Ohio Presented at the 24th Annual Meeting of the American Society for Cedars Sinai Medical Center, 8635 West Third Street, Suite 795W, LosBariatric Surgery, June 11–16, 2007, San Diego, California Angeles, CA 90048. *Reprint requests: Scott A. Cunneen, M.D., Center for Weight Loss, E-mail: [email protected]/08/$ – see front matter © 2008 American Society for Metabolic and Bariatric Surgery. All rights reserved.doi:10.1016/j.soard.2007.10.016

S. A. Cunneen et al. / Surgery for Obesity and Related Diseases 4 (2008) 174 –185 175 At the outset of the 21st century, bariatric surgery is the studies to identify and meta-analytically compare the SAGBbest available therapy [1–5] for the global epidemic of and LB outcomes [40]. A broad electronic search was per-morbid obesity (body mass index [BMI] Ն40 or Ն35 kg/m2 formed using PubMed accessing MEDLINE, Current Con-in the presence of high-risk co-morbidities) [6 –9]. Im- tents, and the Cochrane Library, with cutoff dates of Janu-planted in Ͼ100,000 procedures [10], laparoscopic adjust- ary 1, 1998 through April 30, 2006. The following searchable gastric banding (LAGB), a restrictive operation [11], is terms were used: Obesity/surgery [MeSH] OR gastroplasty1 of several weight-loss operations (i.e., LAGB, vertical OR bariatric OR gastric banding, with the delimitation:banded gastroplasty, gastric bypass, biliopancreatic diver- human, 1998 –2006. Manual supplementary referencesion/duodenal switch) to have demonstrated efficacy char- checks of the accepted studies and reviews within the past 2acterized by clinically meaningful (Ն50%) excess weight years were also performed.loss and co-morbidity reduction in the short (1–3 yr) andintermediate (Ն3– 8 yr) terms [12–17]. LAGB also carries Screeningthe benefits of minimal invasiveness [18], is associated witha premier perioperative safety record [12,19 –23], is fre- Two levels of screening were applied (i.e., abstracts forquently selected by patients [24], and has the lowest mor- all retrieved studies and full-text review for accepted stud-tality (Ͻ.05%) of the bariatric procedures [14,21,22]. ies). The acceptance requirements included studies of any design on Ն10 patients who had undergone SAGB or LB LAGB patients benefit from swift operative times of implantation and reporting extractable outcomes of interest.30 – 60 minutes [25], minimal postoperative pain, a brief The bands must have been placed laparoscopically in Ն85%hospital stay, and a relatively rapid recovery involving min- of patients. The efficacy outcomes (i.e., percentage of ex-imal scarring. The hallmark of the LAGB procedure is an cess weight loss, change in BMI, and reduction in absoluteadjustability that facilitates individualized, modifiable, ex- weight) were extracted at the 1-, 2-, 3-, and 5-year points,ternal band restriction such that short-term changes in nu- and at the latest point at which Ն50% of the population hadtritional requirements (e.g., pregnancy, illness) can be ac- follow-up data available. Both early and late safety datacommodated [13,26,27]. The LAGB procedure is also (i.e., mortality and band/port/other complications) were re-reversible, allowing restoration of essentially normal gas- quired to be extractable by band type. Kin study data (mul-trointestinal anatomy and function or conversion to an al- tiple publications using the same study population) wereternate bariatric procedure [28 –32]. The long-term out- counted only once, as part of the accepted study tabulation.comes (Ͼ8 –10 yr) of LAGB, similar to those of other All accepted studies were identified with a Centre for Evi-bariatric procedures, remain to be demonstrated [15]. dence-Based Medicine (Oxford, UK) level of evidence from I to IV, with I being the best/most complete. Of the several gastric bands available globally, the 2most often implanted are the Swedish adjustable gastric Statistical analysisband (SAGB, Obtech Medical Sarl, Le Locle, Switzerlandand Ethicon Endo-Surgery, Cincinnati, OH) and the Lap- The efficacy outcomes of interest were synthesized usingBand (LB; Allergan Medical, Irvine, CA). The SAGB and meta-analytic pooling of the SAGB and LB results. Meta-adjustable gastric banding were introduced in the mid-1980s analyses of all efficacy outcomes were conducted using aby Hallberg and Forsell [33] and Kuzmak [34], respectively, random-effects model. The efficacy outcomes included bothand have been consistently reported on in medical publica- raw mean before and after changes (e.g., absolute weighttions since then. The LB and SAGB were first implanted loss) and proportions (e.g., response rates) [41– 43]. Bayes-laparoscopically in 1993, reported on in 1995 by Belachew ian meta-analyses were also conducted for select outcomeset al. [35] and Catona et al. [36] and in 1996 by Forsell and to ascertain the robustness of the results. Heterogeneity wasHellers [37] and Klaiber et al. [38], and are currently the assessed using Cochrane’s Q statistic. Zeroes were not as-most used and widely studied bands. The SAGB is an sumed when not mentioned; rather, the data were treated asinvestigational device in the United States as of July 7, missing and were not included in the analyses. Zeroes were2007. The present study sought to assess the efficacy and imputed for mortality calculations if all patients had beensafety of LAGB as a therapeutic strategy and to compare the followed up and accounted for.SAGB and LB in terms of weight loss, co-morbidity im-provement, and complications using a systematic review For studies in which SAGB and LB were studied side-and meta-analysis of the world data. by-side and directly compared, a meta-analysis was con- ducted for the mean before and after change differences (forMethods continuous outcomes) and odds ratios (for binary out- comes). A positive difference in the before and afterSources changes denoted a greater decrease in a continuous outcome measure in question. An odds ratio of Ͻ1 denoted that a In July 7, 2003, a prospective protocol was developed to given binary outcome occurred more frequently. The meta-undertake a systematic review [39] of the published medical analytic mean values and weighted mean differences with

176 S. A. Cunneen et al. / Surgery for Obesity and Related Diseases 4 (2008) 174 –185Table 1Study characteristicsStudy characteristic Total SAGB Lap-Band Direct comparison studies kt n kt n kt n kt nTotal 129 147 28,980 33 36 4,273 104 111 24,707 8 17 1,696Study locationEurope 83 95 18,416 25 27 3,601 64 68 14,815 6 13 1,304North America 23 25 5,039 — — — 23 25 5,039 — — —Other* 23 27 5,525 8 9 672 17 18 4,853 2 4 392Study designRCT 8 12 478 4 6 209 5 6 269 1 2 180Nonrandomized comparative study 27 35 3,626 10 11 748 22 24 2,878 5 10 528Single-arm study 93 99 24,832 19 19 3,316 76 80 21,516 2 5 988Case control 11 44 — — —11 44 — — —Prospective 46 55 6,640 14 17 1,447 35 38 5,193 3 7 1,040Retrospective 83 92 22,340 19 19 2,826 69 73 19,514 5 10 656Evidence level†I 58 520 2 3 130 4 5 390 1 2 180II 16 19 1,108 7 9 489 10 10 619 1 2 156III 31 36 4,665 7 7 400 27 29 4,265 3 6 320IV 77 84 22,687 17 17 3,254 63 67 19,433 3 7 1,040Institutional settingSingle 114 130 21,801 30 33 3,827 91 97 17,974 7 15 1,516Multicenter 15 17 7,179 3 3 446 13 14 6,733 1 2 180Mean follow-up (mo)Ͻ24 44 51 4,645 12 13 1,002 34 38 3,643 2 5 98824–35 36 40 6,280 10 11 1,165 29 29 5,115 3 6 365Ͼ36 36 41 14,687 9 10 2,045 29 31 12,642 2 4 291NR 13 15 3,368 2 2 61 12 13 3,307 1 2 52 SAGB ϭ Swedish adjustable gastric band; k ϭ number of studies; t ϭ number of treatment groups; n ϭ number of patients; RCT ϭ randomized controlledtrial; NR ϭ not reported. * Australia, Egypt, Israel, Saudi Arabia, and Singapore. † Level of evidence according to Center of Evidence Based Medicine.95% confidence intervals (CIs), were computed. For calcu- Study characteristicslating the weight loss and co-morbidity outcomes, the latestpoint at which Ն50% patient follow-up data were available The accepted studies included 83 European studieswas used. Early (Ͻ30 d) and late (Ն30 d) complications (18,416 patients), 22 North American studies (5039 pa-were summarized by band type and whether the pars flac- tients), and 24 studies from other locations (Australia,cida technique was used. Calculations were performed us- Egypt, Israel, Saudi Arabia, Singapore; Table 1). Most stud-ing Statistical Analysis Systems software, version 8.1 (SAS ies were retrospective case series conducted at single cen-Institute, Cary, NC) and Statistical Package for Social Sci- ters. Of the studies reporting a median (or mean) follow-upences, version 13.0 (SPSS, Chicago, IL). time, 44 reported Ͻ2 years of follow-up, 36 studies reported 2–3 years, 36 reported Ͼ3 years of follow-up, and 13 didResults not report on the length of follow-up. SAGB was repre- sented in 36 treatment groups (4273 patients) in 33 studiesScreening outcomes and LB in 111 treatment groups (24,707 patients) in 104 studies. Of the complete catalogue of SAGB and LB citationsidentified (n ϭ 4594), level 1 screening rejected 2740 stud- Patient characteristicsies. Of the remaining 1854 studies, 1549 were rejected inthe level 2 screening. Of the 305 remaining studies, 176 The baseline demographics were comparable. The meanwere kin studies for which the data were counted only once age, percentage of women, and mean BMI was 39.1 andin amalgamation with the overlapping data of the 129 “ac- 40.2 years, 79.2% and 82.5%, and 43.8 and 45.3 kg/m2 forcepted studies” (28,980 patients), all of which were fully the SAGB and LB groups). Most patients met the Nationalextracted and eligible for meta-analysis (see the Appendix Institutes of Health [6] criteria for weight loss surgery. Theof Accepted Studies). percentages of patients with co-morbidities at baseline were more varied (e.g., 24% of 1083 SAGB patients had hyper-

S. A. Cunneen et al. / Surgery for Obesity and Related Diseases 4 (2008) 174 –185 177tension in the 8 treatment arms reporting this characteristic findings; the numbers of patients available at each point forcompared with 37% of 3664 LB patients in 28 treatment the sensitivity analysis were not substantively reduced. Tooarms). Too few treatment arms reported on the SAGB base- few studies and heterogeneity of the SAGB and LB per-line co-morbidities to draw meaningful conclusions about centage of excess weight loss and BMI data precludedpatient differences between the groups. In studies providing meta-analytic comparison of these variables. The weightbaseline co-morbidity data, rarely was improvement or res- loss results from the meta-analyses using Bayesian methodolution reported at follow-up. Also, the follow-up duration was not substantively different from the results using avaried widely (range 1–98 mo). random effects meta-analysis. A subset of 8 studies (1696 patients) directly compared Co-morbid diseaseSAGB and LB [44 –51], of which only 1 was a randomizedcomparison [51]. Of the 6 European studies and 2 from For the specific co-morbidities of obesity and their re-other countries, 3 presented their 3-year results. The sponse to LAGB, the number of studies available for eitherSAGB/LB patient baseline demographics were similar to band was somewhat low and the definitions used of changesthose of the primary accepted studies. in categorical outcomes (e.g., resolved, improved, resolved/ improved, unchanged, worsened) were often inconsistent,Technique and hospitalization unclear, or not stated. The time frames for improvement were also inconsistently described; only the results for a The vast majority of SAGB and LB patients underwent change from baseline for type 2 diabetes and hypertensionlaparoscopic band placement (87.9% and 98.8%, respec- included a meaningful number of studies for reporting thetively), with a similar (1.1% and 2.0%) rate of conversion to meta-analysis (Table 3).an open procedure. The pars flaccida technique was used in16 of 36 SAGB and 28 of 111 LB groups. The investigators Two SAGB and 14 LB studies reported a statisticallyoften did not explicitly state the technique used, and the significant resolution of diabetes (P Ͻ.05) in 61.5% of 117accrual years for many cohorts were broad and included SAGB patients and 60.3% of 249 LB patients at 2 years forboth the pars flaccida and the perigastric techniques. The those who had diabetes at baseline. Significant reductions inmean length of hospital stay was not significantly different insulin (Ϫ67.87 and Ϫ70.04 pmol/L, respectively) and fast-between the groups. ing blood glucose (Ϫ0.89 and Ϫ0.63 mmol/L, respectively) provided laboratory substantiation of the clinical outcomesWeight loss in the SAGB and LB studies. Patients also had high rates of hypertension resolution at 2 years— 62.95% of patients in 5 Significant weight reduction (P Ͻ.05) was observed in SAGB treatment arms (228 patients) and 43.6% in 12 LBthe SAGB and LB groups independently when computa- treatment arms (488 patients)—an improvement that per-tions using either simple weighted pooling of the estimates sisted for Ͼ2 years in 42.9% of SAGB patients. No LBof all studies or meta-analytic computations of the mean studies reported the results for hypertension after 2 years.change were performed (Table 2). At a follow-up of 1, 2, The small number of studies precluded a meta-analyticand 3 years, the bands demonstrated steady weight loss, comparison of the changes in co-morbidities.reaching 56.36% (95% CI 48.14 – 64.58%) and 50.20%(95% CI 43.36 –57.0%) excess weight loss in the SAGB and ComplicationsLB groups at 3 years, respectively. In the subset of com-parative studies, a meta-analytic comparison at 2 years and Early mortality was equivalent for both devices (.1%),at the last point at which Ն50% of patients had follow-up and late mortality was comparable (SAGB .2% versus LBdata available showed a statistically significant (P Ͻ.05) .1%). The incidence of early and late complications wasmean difference in absolute weight loss (weighted mean: low. Overall, the complication rates for the SAGB and LBSAGB, Ϫ48.38 versus LB, Ϫ41.9; weighted mean differ- appeared similar (Table 4), although a statistical compari-ence: Ϫ4.84, 95% CI Ϫ9.47 to Ϫ0.22); at the last point son of the complications was not possible owing to thereported, however, the weight loss measures varied widely, widespread inconsistency in data reporting. For all studiesfrom 4 to 36 months. describing complications, the frequency of late slippage or migration (4.0% and 6.2% for SAGB and LB, respectively) The change in BMI was consistent and statistically sig- and pouch dilation (1.7% and 5.1% for SAGB and LB,nificant (P Ͻ.05) from the baseline value for both SAGB respectively) was lower for SAGB. When the analysis con-and LB, independently, at all points (3 yr Ϫ11.99, 95% CI trolled for the use of the pars flaccida technique, the differ-Ϫ15.20 to Ϫ8.77 and Ϫ11.81, 95% CI Ϫ13.16 to Ϫ10.47, ences in the complication rates were reduced (from 4.3% torespectively). These results were corroborated by a sensi- 2.6% for SAGB and 6.9% to 3.1% for LB). Few othertivity analysis of only those SAGB studies with weight loss differences in SAGB and LB morbidity were apparent, anddata at all points (data not shown). An upward bias of the all were highly variable in the direction and magnitude ofweight loss results because of selective dropout of patients the difference. The number of studies reporting additionalwith weight loss failure did not appear to contribute to the

178 S. A. Cunneen et al. / Surgery for Obesity and Related Diseases 4 (2008) 174 –185Table 2Total weight loss outcomesOutcome SAGB Lap-Band t (n) Weighted mean Mean change (95% CI) t (n) Weighted mean Mean change (95% CI)Absolute weight (kg) 20 (1235) Ϫ46.04 Ϫ40.35 (Ϫ48.91,Ϫ31.79)† 34 (2436) Ϫ33.66 Ϫ30.14 (Ϫ34.54,Ϫ25.74)† Last follow-up* (yr) 10 (877) Ϫ39.22 Ϫ41.30 (Ϫ50.55,Ϫ32.05)† 26 (1541) Ϫ29.12 Ϫ28.95 (Ϫ31.87,Ϫ26.03)† 1 Ϫ49.08 Ϫ44.98 (Ϫ57.18,Ϫ32.79)† 15 (803) Ϫ33.21 Ϫ34.17 (Ϫ39.71,Ϫ28.64)† 2 9 (387) Ϫ51.79 Ϫ49.89 (Ϫ64.18,Ϫ35.61)† Ϫ33.93 Ϫ37.25 (Ϫ50.20,Ϫ24.31)† 3 4 (323) — — 7 (501) Ϫ24.07 — 5 — 2 (123) Ϫ12.25 Ϫ12.30 (Ϫ14.48,Ϫ10.13)† Ϫ10.22 (Ϫ11.08,Ϫ9.37)†BMI (kg/m2) 26 (2459) Ϫ9.89 Ϫ11.90 (Ϫ14.42,Ϫ9.38)† 61 (8217) Ϫ11.05 Ϫ10.11 (Ϫ10.76,Ϫ9.46)† Last follow-up* 16 (2778) Ϫ11.51 Ϫ13.69 (Ϫ16.94,Ϫ10.44)† 51 (7804) Ϫ10.75 Ϫ11.32 (Ϫ12.10,Ϫ10.54)† 1 13 (2164) Ϫ11.10 Ϫ11.99 (Ϫ15.20,Ϫ8.77)† 37 (4275) Ϫ11.67 Ϫ11.81 (Ϫ13.16,Ϫ10.47)† 2 Ϫ13.02 — 25 (4495) Ϫ13.00 3 6 (1560) Ϫ11.32 Ϫ9.21 (Ϫ15.22,Ϫ3.20)† 5 2 (190) 55.28 55.62 (50.04,61.21)† 4 (249) 38.83 44.48 (37.35,51.61)† 43.57 (39.98,47.15)†%EWL 12 (2221) 46.49 49.98 (45.86,54.10)† 47 (6251) 43.90 42.97 (40.39,45.56)† Last follow-up* 9 (1943) 52.63 56.36 (48.14,64.58)† 45 (6204) 42.44 48.14 (43.26,53.01)† 1 6 (1657) 56.71 — 32 (3540) 50.38 50.20 (43.36,57.04)† 2 6 (1560) 19 (1659) 54.13 39.76 (27.52,52.00)† 3 2 (190) 51.14 5 6 (823)Meta-analysis Comparative studies only WMD (95% CI) t (n) Weighted mean t (n) Weighted mean Absolute weight (kg) 3 (101) Ϫ50.4 3 (147) Ϫ44.07 Ϫ4.82 (Ϫ9.36, Ϫ0.27)‡ Last follow-up* 3 (127) Ϫ41.32 3 (157) Ϫ44.22 2.50 (Ϫ1.73, 6.74) 1 3 (101) Ϫ48.38 3 (134) Ϫ41.9 Ϫ4.84 (Ϫ9.47, Ϫ0.22)‡ 2 2 (70) Ϫ52.34 2 (112) Ϫ45.96 — 3BMI (kg/m2) 2 (115) Ϫ13.32 2 (123) Ϫ11.1 — Last follow-up* 2 (130) Ϫ9.76 2 (124) Ϫ10.02 — 1 2 (115) Ϫ12.59 2 (109) Ϫ13.12 — 2 1 (84) Ϫ13.40 1 (88) Ϫ11.6 — 3%EWL 2 (672) 51.88 3 (167) 51.24 — Last follow-up* 2 (677) 45.04 3 (168) 48.24 — 1 1 (84) 55.00 1 (87) 63 — 2 1 (84) 65.00 1 (88) 54 — 3 SAGB ϭ Swedish adjustable gastric band; t ϭ number of treatment groups; n ϭ number of patients evaluated; CI ϭ confidence interval; BMI ϭ bodymass index; %EWL ϭ percentage of excess weight loss; WMD ϭ weighted mean difference (mean difference in pooled groups from comparison studiesonly). * Last follow-up available with Ն50% of patients followed up. † P Ͻ.001; significant mean effect. ‡ Significant mean effect.band-related, port-related, or other complications was low, commonly used LAGBs. The study designs varied andas were the rates of absolute events, rendering the clinical ranged from randomized controlled clinical trials to single-significance of these data uncertain. center retrospective reviews. In the subset of 8 studies reporting both SAGB and LB The most consistently and well-described data among theresults, odds ratios were computed for specific complica- accepted studies were the weight loss measures. Both bandstions, none of which reached statistical significance in favor consistently evidenced statistically significant (P Ͻ.05) andof either band. durable, safe, weight loss (approximately 50% excess weight loss) at 3 years.Discussion The resolution of diabetes and hypertension was sig- This is the first systematic review of the world data (4595 nificant for both devices and appeared to parallel weightcitations) to encompass cumulative studies of the 2 most loss at 2 years. As has been shown, the improvement and/or resolution of co-morbidities correlates with even

S. A. Cunneen et al. / Surgery for Obesity and Related Diseases 4 (2008) 174 –185 179Table 3Resolution of co-morbiditiesCo-morbidity SAGB Lap-Band t (n) Mean (95% CI) t (n) Mean (95% CI)Diabetes 2 (117) 61.45 (52.11, 70.78) 14 (249) 60.29 (44.75, 75.83)†‡ Resolved* — — 13 (436) 83.24 (71.55, 94.93)†‡ Resolved or improved — — 13 (436) 35.99 (18.92, 53.06)†‡ Improved — — 9 (245) 16.37 (6.05, 26.69)†‡ Unchanged — — 2 (54) 22.35 (0.00, 52.10)§ Worsened Diabetes measure 4 (133) Ϫ67.87 (Ϫ101.14, Ϫ34.60)† 4 (107) Ϫ70.04 (Ϫ102.79, Ϫ37.28)†‡ Insulin (pmol/L) — — 3 (99) Ϫ0.37 (Ϫ0.83, 0.09)§ HbA1c (%) 5 (143) Ϫ0.89 (Ϫ1.41, Ϫ0.37)† 3 (97) Ϫ0.63 (Ϫ0.98, Ϫ0.29)‡ Fasting glucose (mmol/L) 5 (228) 62.95 (41.18, 84.72)† 12 (488) 43.58 (30.21, 56.95)†‡Hypertension 1 (235) 74.89 (69.35, 80.44) 11 (942) 70.35 (55.26, 85.43)†‡ Resolved* 1 (235) 74.89 (69.35, 80.44) 11 (942) 41.36 (33.80, 48.91)†‡ Resolved or improved Improved SAGB ϭ Swedish adjustable gastric band; t ϭ number of treatment groups reporting characteristic; n ϭ number of patients evaluated; CI ϭ confidenceinterval; HbA1c ϭ hemoglobin A1c. * Discontinued treatment or, for diabetes improvement, reduced treatment. † P Ͻ.001 for test of heterogeneity of outcome. ‡ Statistically significant pre- vs. postoperative difference within surgery category. § P Ͻ.01 for test of heterogeneity of outcome.modest reductions (10 –15%) of weight after bariatric bearing on the development of long-term complications,surgery [17,52,53]. and requires additional study. Although not comparable statistically, the meta-analysis findings for both bands were The common complications recorded for LAGB in- in agreement with the most-cited banding data identifyingcluded gastric prolapse or slippage, pouch dilatation, ero- LAGB, in general, as a safe bariatric procedure. The SAGBsion, and device breakage. The complication profiles for was originally designed for implantation using the parsSAGB and LB appeared quite comparable. Very few serious flaccida pathway. This is a technique that has yielded lowearly complications were associated with either band, in rates of long-term complications with the SAGB, and, ascontrast to other bariatric operations. Both devices demon- evidenced in this meta-analysis, has resulted in LB morbid-strated minimal long-term complication and failure rates, as ity outcomes also significantly improved compared withevidenced by similar durable weight loss. those achieved using the perigastric approach [57]. In the 129 studies accepted for systematic review, the The subset of 8 studies that directly compared SAGB andless well-known co-morbidities were either absent from the LB [44 –51] included the prospective comparison of short-population or poorly documented. Future studies should term SAGB/LB weight loss and complications by Ponson etclearly define the characteristics of change in co-morbid al. [47], which found no statistically significant differencesdiseases measured and the time frames in which the data between these bands, and the prospective, randomized com-were recorded. Descriptions of postoperative management parison of early SAGB/LB results by Suter et al. [51], whichwere limited, lacked standardization, and primarily com- also found no difference in weight loss, food tolerance, orprised only the short or intermediate term. Only a few quality of life at 18 months and “identical” rates of latestudies followed up patients for Ն6 –10 years and captured morbidity and reoperation. Each of the SAGB/LB compar-information on meaningful numbers of patients at those ative studies independently concluded band comparability.extended points [21,23,54 –56]. Only 8 studies were identi-fied that were designed to directly compare the SAGB and The statistically significant findings in this meta-analysisLB performances. Meta-analytic comparisons would be for weight loss, resolution of co-morbidities, and mortalitygreatly strengthened by the availability of more SAGB with respect to LAGB as a surgical approach to morbidstudies and more comparative studies of SAGB and LB with obesity corroborate those of prominent systematic reviewsintermediate-term (3–10 yr) and truly long-term (Ն10 yr, as of bariatric outcomes, such as Fielding et al. [12], O’Briendefined by O’Brien et al. [15]) follow-up for Ն50% of et al. [15], Fried et al. [58], and Chapman et al. [14].patients. Moreover, the outcomes for banding at 3 years in the present study (laparoscopic implantation for Ն88%; per- Both SAGB and LB achieve weight loss and satiety by centage of excess weight loss Ն50%; BMI reductionrestriction. The SAGB has been, since its inception, engi- Ն11.81 kg/m2; diabetes and hypertension resolution ofneered for “low-pressure” restriction, which could have a

180 S. A. Cunneen et al. / Surgery for Obesity and Related Diseases 4 (2008) 174 –185Table 4ComplicationsComplication SAGB Lap-Band Total Pars flaccida Total Pars flaccida t n/N %t n/N %t n/N %t n/N %MortalityEarly 24 4/3,825 0.1 12 4/1,990 0.2 66 15/14,518 0.1 21 4/5,585 0.1Late 21 6/3,596 0.2 10 5/1,841 0.3 54 14/10,056 0.1 17 1/3,317 0.0Band relatedErosionEarly 5 0/1,740 0.0 3 0/1,061 0.0 19 4/4,972 0.1 9 3/2,944 0.1Late 10 23/2,141 1.1 5 20/1,386 1.4 30 140/10,840 1.3 10 42/3,500 1.2LeakageEarly —— — —— —1 4/63 6.3 — — —Late 1 2/625 0.3 — — —5 6/415 1.4 2 1/237 0.4Slippage/migrationEarly 10 8/2,301 0.3 4 4/1,411 0.3 35 66/8,945 0.7 10 41/2,800 1.5Late 13 118/2,966 4.0 5 35/1,370 2.6 55 813/13,113 6.2 12 96/3,064 3.1Port relatedLeakageEarly 1 0/824 0.0 1 0/824 0.0 8 0/2,868 0.0 2 0/101 0.0Late 2 19/914 2.1 2 19/914 2.1 16 87/4,331 2.0 5 18/824 2.2Tubing ruptureEarly 1 0/34 0.0 1 0/34 0.0 9 35/3,954 0.9 6 35/2,404 1.5Late 4 9/618 1.5 2 2/249 0.8 11 85/4,627 1.8 7 37/2,199 1.7DislocationEarly 4 0/1,004 0.0 4 0/1,004 0.0 14 26/2941 0.9 7 8/1,390 0.6Late 10 69/2,781 2.5 6 20/1,359 1.5 27 150/4,920 3.0 7 14/935 1.5OtherEsophagealdilationEarly 2 2/230 0.9 2 2/230 0.9 3 0/1,504 0.0 3 0/1,504 0.0Late 3 11/1,026 1.1 1 2/90 2.2 11 91/5,583 1.6 4 16/1,754 0.9Pouch dilationEarly 8 7/863 0.8 4 4/215 1.9 22 51/3,002 1.7 3 0/224 0.0Late 11 19/1,122 1.7 5 8/430 1.9 32 222/4,372 5.1 6 28/759 3.7Stomal stenosisEarly —— — —— — 11 57/3,687 1.5 4 47/2,924 1.6Late 1 1/26 3.8 — — — 8 104/3,143 3.3 1 0/1,014 0.0 SAGB ϭ Swedish adjustable gastric band; t ϭ number of treatment groups; n ϭ number of patients with outcome; N ϭ number of patients evaluated;% ϭ percentage of patients with complication.Ն60.29 and Ն43.58%, respectively; early mortality rate Acknowledgment.1%) were clinically meaningful relative to the outcomesbenchmarks established in medical studies, such as Buch- We would like to acknowledge Jane Buchwald, M.A.wald et al. [17,59] and Maggard et al. [60], using the more and Roy Kulick, M.D. for their substantial contributions tostringent standard of meta-analysis. Although in this sys- the development of this report.tematic review and meta-analysis of SAGB and LB, onlyabsolute weight loss was appropriate for direct statistical Referencescomparison within a small subset of studies, the findings forLAGB as a device class are powerful, demonstrating its [1] North American Association for the Study of Obesity and Nationalsafety and statistically and clinically significant efficacy for Heart, Lung, and Blood Institute. The practical guide: identification,the short to early-intermediate term. evaluation, and treatment of overweight and obesity in adults. Pub- lication No. 00-4084. Bethesda: National Institutes of Health; 2000.Disclosures [2] National Institutes of Health and National Heart, Lung, and Blood The authors have no commercial associations that might Institute. Clinical guidelines on the identification, evaluation, andbe a conflict of interest in relation to this article. treatment of overweight and obesity in adults: the evidence report. Publication No. 98-4083. Bethesda: National Institutes of Health; 1998.

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S. A. Cunneen et al. / Surgery for Obesity and Related Diseases 4 (2008) 174 –185 183[30] Doherty C, Maher JW, Heitshusen DS. Long-term data indicate a and laparoscopic adjustable silicone gastric banding. Obes Surg progressive loss in efficacy of adjustable silicone gastric banding for 2000;10:214 –9. the surgical treatment of morbid obesity. Surgery 2002;132:724 –7. [53] Holeczy P, Novak P, Kralova A. 30% complications with adjustable gastric banding: what did we do wrong?. Obes Surg 2001;11:748 –[31] Dukhno O, Ovnat A, Levy I. Our experience with 250 laparoscopic 51. adjustable silicone gastric bandings. Surg Endosc 2003;17:601–2. [54] Holloway JA, Forney GA, Gould DE. The Lap-Band is an effective tool for weight loss even in the United States. Am J Surg 2004;188:[32] Elakkary E, Elhorr A, Aziz F, Gazayerli MM, Silva YJ. Do support 659 – 62. groups play a role in weight loss after laparoscopic adjustable gastric [55] Horchner R, Tuinebreijer MW, Kelder PH. Quality-of-life assess- banding? Obes Surg 2006;16:331– 4. ment of morbidly obese patients who have undergone a Lap-Band operation: 2-year follow-up study. Is the MOS SF-36 a useful[33] Elias B, Staudt JP, Van Vyne E. The technical approach in banding instrument to measure quality of life in morbidly obese patients? to avoid pouch dilatation. Obes Surg 2001;11:311– 4. Obes Surg 2001;11:212– 8. [56] Horchner R, Tuinebreijer W, Kelder H. Eating patterns in morbidly[34] Evans JD, Scott MH, Brown AS, Rogers J. Laparoscopic adjustable obese patients before and after a gastric restrictive operation. Obes gastric banding for the treatment of morbid obesity. Am J Surg Surg 2002;12:108 –12. 2002;184:97–102. [57] Iordache N, Vizeteu R, Iorgulescu A, Zmeu B, Iordache M. Lapa- roscopic adjustable gastric-banding treatment for morbid obesity:[35] Favretti F, Cadiere GB, Segato G, Himpens J, De Luca M, Busetto our first year experience. Chirurgia (Bucur) 2003;98:135– 42. L. 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OBES SURGDOI 10.1007/s11695-012-0634-z REVIEWA Review of Unmet Needs in Obesity ManagementN. Nguyen & J. K. Champion & J. Ponce &B. Quebbemann & E. Patterson & B. Pham & W. Raum &J. N. Buchwald & G. Segato & F. Favretti# Springer Science+Business Media, LLC 2012Abstract The prevalence of obesity continues to escalate in super obese patients (BMI>60), the morbidly obese adoles-the USA; however, there is no consensus regarding the cent, and obese patients requiring weight reduction in prep-optimal therapy for obesity. For the vast majority of severely aration for other procedures, such as orthopedic, transplant,obese patients, conventional medical therapies (i.e., diet, or vascular surgeries. In these circumstances, there is a needexercise, behavioral counseling) often fail over the long for an effective but less invasive treatment to bridge the gapterm. Existing pharmacotherapy adjunctive to behavioral between medical and surgical therapy. This review exam-therapy has limited effectiveness and an imperfect safety ines current treatment outcomes, identifies prominent areasrecord. In contrast, bariatric surgery has a high degree of of unmet clinical needs, and provides an overview of twoweight loss efficacy, yet only a small fraction of the quali- minimally invasive “temporary procedures for weight loss”fying obese population undergoes these procedures because that may eventually address some of the unmet needs inof the associated perioperative risks and potential late com- obesity management.plications. In addition, the role of bariatric surgery is unclearin certain patient populations, such as patients with lower Keywords Bariatric surgery . Obesity . Endoscopy . Weightbody mass index (BMI, 30–35 kg/m2), the high-risk super- loss . Intragastric balloonN. Nguyen (*) B. PhamDivision of GI Surgery, UCLA Division of Gastroenterology/Hepatology,University of California Irvine Medical Center, Torrance, CA, USA333 City Bldg. West, Suite 850,Orange, CA 92868, USA W. Raume-mail: [email protected] Weight Management Institute, Legacy Good Samaritan Hospital, Portland, OR, USAJ. K. ChampionNorthside Hospital, J. N. BuchwaldAtlanta, GA, USA Division of Scientific Writing, Medwrite, LLC, Maiden Rock, WI, USAJ. PonceHamilton Medical Center, G. Segato : F. FavrettiDalton, GA, USA Department of Surgery, Regional Hospital,B. Quebbemann Vicenza, ItalyN.E.W. Program, Center for Advanced Laparoscopic Surgery, Inc.,Newport Beach, CA, USAE. Patterson : W. RaumOregon Weight Loss Surgery, LLC,Portland, OR, USA

OBES SURGIntroduction obesity is rising at a faster rate in women than men, partic- ularly for non-Hispanic White women [8]. Based on theMedical therapies are used for the treatment of obesity 2006–2008 Behavioral Risk Factor Surveillance Systemthroughout the spectrum of the disease, from mild to ex- data, Blacks and Hispanics have a 51 and 21 %, respective-treme obesity, whereas bariatric surgery has been offered for ly, higher prevalence of obesity than Whites [9]. A highpatients with extreme obesity. Medical therapies can be level of obesity in socioeconomically disadvantaged andeffective, yet their efficacy diminishes with long-term minority communities contributes to the further escalationfollow-up. In contrast, bariatric surgery is a highly effective of obesity prevalence [10]. Obesity is on its way to overtak-therapy for the treatment of morbid obesity, but can be ing tobacco use as the main cause of preventable death inassociated with certain perioperative risks and late compli- the USA [1].cations. Currently, the only available surgical therapy ap-proved for the treatment of mild obesity (class I) is the The prevalence of obese children and adolescents is alsolaparoscopic adjustable gastric band (Lap-Band®), approved an emerging crisis. Obesity in children is often gauged byin February 2011 by the Food and Drug Administration the sex- and age-specific ≥95th percentile BMI cutpoint of(FDA) for use in patients with a body mass index (BMI)≥ the pediatric growth charts [11]. Between 2003 and 2006,30 kg/m2 with one or more comorbid conditions. Decreas- the prevalence of obesity in children was approximatelying the gap between medical and surgical therapy requires 12.4 % for children 2–5 years old and 17 % for those 7–refinement of existing therapies and/or development of new 11 years [7]. Between 1999 and 2006, the prevalence oftechnologies. The current review analyzes the trends in the high BMI in children and adolescent plateaued, but in-obesity epidemic, examines the outcomes of current treat- creased for boys age 6–19 years between 2007 and 2008ments of obesity, identifies prominent areas of unmet clin- [12]. In addition, overweight children typically progress toical need in obesity therapy, and provides an overview of an obese adolescents and adults [13]. The prevalence of obeseevolving class of therapy, “temporary procedures for weight children is higher in socioeconomically depressed areasloss,” that may eventually fulfill some of the unmet clinical [14]. In certain southern states, such as Louisiana, the prev-needs. alence of obesity in children and adolescents rose from 5.6 to 30.8 %, a fivefold increase over a 35-year period [15].Prevalence of Obesity Burgeoning DiseaseDespite the call to action for over a decade in the USA, Already pandemic, the prevalence of obesity may be grosslyEurope, and other industrialized nations [1, 2], the obesity underestimated [16]. The degree of obesity is commonlyepidemic continues to increase. Developing countries, such defined by a ratio of weight to height—the BMI. The 1991as India, China, South Africa, Argentina, Guatemala, and NIH Consensus Statement characterized the morbidity andthe Pacific Islands, are also increasingly affected by obesity mortality risk of obesity as directly proportional to BMI[3]. The National Institutes of Health (NIH) and World classes [17]. This straightforward relationship has beenHealth Organization (WHO) have reported an average in- challenged by insights from bariatric/metabolic surgery thatcrease in the BMI prevalence for overweight and obesity by point to a more complex risk landscape.approximately 0.3–0.8 % points yearly over the past threedecades [4, 5]. The world prevalence of overweight adults is Findings regarding the neurohormonal mechanisms un-estimated at >1.6 billion, with >400 million considered derlying obesity, particularly in relation to treatment of typeobese. The WHO predicts that >2.3 billion adults will be 2 diabetes mellitus (T2DM) and metabolic syndrome, sug-overweight, with more than 700 million obese individuals gest that even individuals in the lowest obesity classes (classworldwide by 2015 [6]. I), and in the overweight category, may be at risk for development of metabolic disease and may benefit from In the USA, more than two thirds of adults and one third weight loss [18, 19]. The risk threshold for morbidity andof children/adolescents are considered overweight or obese, mortality associated with obesity exists particularly at lowera prevalence that has more than doubled since the 1970s. BMIs in certain genetic groups (e.g., Asian Indians) [20,The projected prevalence of overweight individuals is 74.7 21]. Furthermore, just as measurement of visceral adiposity% by 2015 [4]. Greater than one third of US adults is offers a better depiction of lipotoxicity than BMI alone [22],currently obese [7] and 5.9 % (~15 million) are morbidly evaluating metabolic status using a composite measure ofobese [8] with a BMI≥40. The prevalence of obesity has BMI, waist-to-hip ratio, gender, genetic ethnicity, and met-increased in both males and females of all ages, racial/ethnic abolic markers may be of greater value in risk stratificationgroups, and educational levels. The National Health and of obesity [22, 23]. There is broad movement by medicalNutrition Examination Survey found that age-adjusted and government bodies worldwide to reevaluate obesity and overweight prevalence. An Asian Indian Consensus Group

OBES SURGrecently reclassified the threshold for medical and surgical category. Six studies had no change in BMI. Interventionstreatment of obesity with comorbidities to be 25 and 32.5, with <6 months’ duration had higher failure rates. Therespectively, while, the WHO, International Diabetes Fed- review of 23 distinct DEB approaches lacked sufficienteration, and American Heart Association/National Heart, follow-up to determine whether the weight loss was main-Lung, and Blood Institute redefined metabolic syndrome, tained [43]. Similarly, in a head-to-head comparison of DEBmandating waist circumference to be an integral feature to and bariatric surgery in the morbidly obese, clinically sig-its diagnosis [23–26]. A recent large-scale comparison study nificant weight loss and comorbidity improvements wereof calculated BMI and obesity as measured by dual energy seen with both interventions at 1 year, but no long-termX-ray absorptiometry showed substantial underdiagnosis of follow-up was reported [43].global obesity [27]. Evidence regarding the intricate inter-action between weight, fat cells, fat distribution, genes, and A systematic review of randomized controlled trials ofobesity’s comorbidities, as well as utilization of more pre- weight loss using very low calorie diets (VLCDs) with 12–cise measurement technologies is altering the way we define 36-month follow-up reported significant weight loss rangingobesity and the risks of obesity. between 3.5 and 13.4 kg, but long-term weight loss data were not available [44]. In a systematic review of majorGoals of Weight Loss weight loss programs in the USA, 15–25 % of weight loss was seen over the short term (3–6 months), but <9 % ofPrevention of weight gain alone may be considered a good patients were able to maintain their weight loss at 1 yearoutcome in obesity management for certain patients. One [45]. Several large-scale trials of lifestyle intervention dem-kilogram of weight gain increases diabetes risk by 4.5–9.0 onstrated weight loss efficacy, particularly in patients with% and cardiovascular risk by 3.1 % [28, 29]. Although impaired glucose tolerance; however, weight loss main-attainment of ideal body weight is a level of success rarely tained over short and medium terms was small, approxi-achieved in practice, the primary motive for obese patients is mately 4 kg (mean 4 % body weight) [46–49]. Studies ofmarked weight loss and its maintenance. In the majority of DEB interventions with long-term follow-up, in which sig-patients, weight reduction significantly reduces obesity- nificant major weight loss (up to 100 lbs) was attained in therelated comorbidity [30, 31], increases life expectancy short term, employed very intensive behavioral interven-[32–34], and improves quality of life (QoL) [35, 36]. Weight tions (e.g., residential nursing programs; weight loss camps;loss sufficient to improve or resolve comorbidities is depen- outpatient courses featuring weekly meetings, mid-weekdent on individual metabolic factors, but is reported by the phone calls, and close staff follow-up) that were costly andCDC to be in the range of 5–15 % EWL [1]. Obesity access-prohibitive options for the majority of obese individ-comorbidities, including T2DM, cardiovascular disease, hy- uals. Most DEB patients regained 34–41 % of their weightpertension, dyslipidemia, degenerative joint disease, and lost at 1–5 years of follow-up [50, 51]. A permanent behav-obstructive sleep apnea (OSA) have been shown to signifi- ioral weight management program that extends short-termcantly improve with even modest weight loss [37]. weight loss success is needed.Outcomes of Current Treatments for Obesity Pharmacologic TherapyDiet, Exercise, Behavioral Modification (DEB) A race is underway to develop drugs that will effectively treat obesity. Criteria currently used by the US FDA for theThe CDC advises assessment of weight by BMI category efficacy of appetite-suppressing drugs is the demonstrationand, if needed, gradual weight loss of 1–2 lbs/week until the of statistically significant weight loss of 5 % better than theweight is within the target healthy BMI zone (18.5–24.9) placebo group based on a randomized, double-blind,[38]. The optimal diet for lifelong prevention of obesity and placebo-controlled clinical trial [52]. The criterion of weightits comorbidities features fiber-rich, fat-reduced, and low- loss success with medication defined by the European Com-density carbohydrates combined with a 30–60-min daily mittee on Proprietary Medicinal Products is a statisticalexercise [39]. While evidence exists that safe weight loss decrease of 10 % of body weight from baseline [53].occurs via DEB, it is typically maintained for only 1–5 years[40, 41]. In a 2007 review of studies of DEB interventions At this time, patients unable to lose weight with DEB alonefor obesity, 23 therapeutic studies were compared, most of who have a BMI≥30 or ≥27 in the presence of a comorbiditywhich ran for <6 months [42]. Fifteen studies had statisti- are eligible for drug treatment [54]. The FDA approved sibutr-cally significant reduction in BMI, though without sufficient amine (a serotonin-norepinephrine reuptake inhibitor) andreduction to move patients from the obese to the overweight orlistat (a lipase inhibitor) as adjunctive weight loss therapycategory, or from the overweight into the healthy weight in the USA [55, 56]. Rimonabant is also approved in the UK for weight loss and weight loss maintenance. The short-term success rate of these drugs is typically 5–10 % body weight

OBES SURGloss from baseline [57]. Side effects vary, ranging from the Comprehensive Obesity Managementloose stools and flatulence associated with orlistat to psychi-atric disturbances associated with sibutramine due to its action The 5–15 % body weight loss at which comorbidities im-on the central nervous system. Sibutramine was removed from prove or resolve represents success for some patients [65].the European market because of a significant number of Weight loss combined with comorbidity improvement, safe-reported adverse events (e.g., tachycardia, hypertension, ty of therapy, QoL, and treatment accessibility is increas-arrhythmias) [58] and, recently, removed from the US market ingly viewed as an inseparable composite—comprehensiveas well. A large number of anti-obesity drugs are in preclinical obesity management—a more precise means of evaluatingand clinical development. obesity treatment (Table 1).Bariatric Surgery Psychosocial efficacy has gained recognition as an essen- tial measure of obesity treatment, wherein the patient’s per-Long-term outcomes after bariatric surgery are better than that ception of success in treatment is at least equal in importanceof DEB or DEB plus pharmacotherapy. In addition, bariatric to the clinician’s interpretation [66]. The “perceptual” patient-surgery achieves extensive comorbidity improvements that identified nature of QoL has slowed its acceptance as a requi-are superior to those achieved by DEB owing to possible site element of bariatric outcome reporting; QoL data, how-mechanisms involved with surgical alteration of the gastroin- ever, are increasingly employed as standard measures oftestinal tract [59]. A 2004 meta-analysis of the world bariatric efficacy [67]. The majority of patients who have lost signifi-surgery data found that following bariatric surgery, medical cant weight report improvement in QoL and psychosocialconditions resolved or significantly improved, respectively, in functioning after a lifetime of psychologic strain, difficulty76.8 and 86.0 % for T2DM, 61.7 and 78.5 % for hypertension, in obtaining employment, and societal stigmatization.and 85.7 and 83.6 % for sleep apnea [30]. In studies compar-ing bariatric surgery vs DEB (a randomized controlled trial Evidence demonstrates that the best outcomes for safety,and a cohort study), weight loss was shown to be significantly efficacy, and quality of care occur within a comprehensivegreater with bariatric surgery [60, 61]. high-volume center with a multidisciplinary team [68]. The While bariatric surgery has a low perioperative risk pro- Table 1 Parameters to gauge success in obesity management across allfile, the potential long-term complications are an area of therapiesconcern. Perioperative complications for laparoscopic gas-tric bypass include major complications such as pulmonary Measures of comprehensive obesity managementembolism, gastrointestinal leak, bowel obstruction, stricture,and bleeding. Reoperation may be required for the manage- Medical efficacyment of some of these complications. Late complications Weight lossinclude persistent nausea and vomiting, marginal ulcera- Imp/Res T2DMtions, internal hernia, and nutritional deficiency [1]. Lapa- Imp/Res hypertensionroscopic gastric bypass procedures carry an overall Imp/Res OSAcomplication rate of 3.2 to 16 % and 30-day readmission Imp/Res depressionrate of 4.3 to 6.6 % [62]. Imp/Res DJD Imp/Res dyslipidemia Survival is significantly enhanced in morbidly obese Imp nutritionpatients undergoing bariatric surgery [63]. A recent meta- Psychosocial efficacyanalysis of 44,022 patients who underwent gastric bypass or Imp quality of lifebanding procedures (eight trials, n014,052 undergoing sur- Decreased stigmatizationgery, 29,970 controls) indicated that bariatric surgery mark- Imp employment statusedly reduced global, cardiovascular, and all-cause mortality. Imp relationships/social statusIn addition, the perioperative mortality improved. In a national Safetyaudit of 19 academic medical centers, Nguyen et al. reported a Complications30-day mortality of 0.4 % in 1,049 patients who underwent Side effectsgastric bypass [62]. In a 2007 study of an obesity surgery Mortalitymortality risk score for gastric bypass (based on BMI, male Accessibility of therapysex, hypertension, risk of pulmonary embolus, and patient Physical proximityage), low-, intermediate-, and high-risk patient mortality risk Affordable out-of-pocket costswere 0.31, 1.39, and 7.56 %, respectively [64]. Thus, the low, Insurance coverage (acceptance/denial)but not inconsequential risk associated with bariatric surgeryrequires careful patient and procedural selection. Imp improvement, Res resolution, T2DM type 2 diabetes mellitus, OSA obstructive sleep apnea, DJD degenerative joint disease

OBES SURG“Bariatric Surgery Center of Excellence” (BSCOE) concept systematic review and meta-analysis of mortality in bariatrichas been developed by the American Society for Metabolic surgery from 1990 to 2006 (N085,048) found total mortal-and Bariatric Surgery (ASMBS) and the American College ity to be 0.28 % in 475 treatment arms [33]. In a Clevelandof Surgeons Bariatric Surgery Center Network [69]. Initial Clinic study of barriers to therapy, 45 % of morbidly obesedata from the ASMBS (August 2005 to May 2007; 66,339 patients reported that they were extremely concerned aboutbariatric surgeries) showed equivalent or more favorable the risk of death and complications of bariatric surgery [73].outcomes than in currently reported non-BSCOE findings Although the mortality rate associated with bariatric surgery[70]. is low, the fear of bariatric surgery is still a major limiting factor for acceptance of bariatric procedures.Unmet Clinical Needs Adults, BMI > 60There is no long-term clinical success with DEB or drug The super-super obese are at a 5–10 times higher risk oftreatment at this time. In effect, a noninvasive DEB and/or premature death due to exorbitant body weight and comor-pharmacologic therapy represents the most glaring unmet bidities [74]. While bariatric surgery is the best option forneed in obesity management. In the absence of DEB/drug weight reduction, super-super obesity is an independent risksolutions, the only barometer against which to identify and factor for higher perioperative morbidity and mortality [75].evaluate other key unmet needs is bariatric surgery. In a Veteran’s Affairs study of 856 men and women under- going bariatric surgery, 36 % of whom were superobese, 30 Despite bariatric surgery’s proven efficacy in managing of 54 deaths were in the superobese group and had 30-, 90-,obesity, its utilization in patients that meet the NIH guide- and 1-year mortality rates of 2, 3.6, and 5.2 %, respectivelylines (BMI ≥35) in the USA is <1 % (approximately [76]. Perioperative risk in patients undergoing nonbariatric220,000 procedures/year); thus, currently available bariatric as well as bariatric surgery is also increased in super-supersurgery treatments excluded approximately 99 % of quali- obesity; special considerations, particularly with respect tofied patients [71]. However, the recent expansion of the anesthesia (e.g., pre-oxygenation and operating table posi-indication for Lap-Band use to patients with BMI≥30 in tioning; careful intraoperative ventilation and pharmacolog-the USA will potentially broadens the scope of bariatric ic monitoring), are mandatory [77]. Traditional operativesurgery to several million more Americans. Still, the role techniques and equipment may require some minor modifi-of bariatric surgery is not clearly defined in certain popula- cations [78]. Superobesity is also associated with a relative-tions including patients with lower BMI [30–35], the high- ly high percentage of short- and long-term complicationsrisk super-super obese patients (BMI>60), the morbidly [78]. An alternative strategy for the management of theobese adolescent, and the obese patient requiring weight super-super obese is a stepwise approach with preoperativereduction in preparation for other procedures, such as ortho- weight reduction. There is a distinct role for low-risk inter-pedic, transplant, or vascular surgeries. vention that will induce weight loss and, hence, lower the operative risks for the superobese prior to bariatric, or other,Adults, BMI 30–35 surgery [79].The BMI 30–35 demographic (obesity class I) currently Adolescent, BMI≥40represents a large population of unaddressed need. Abdom-inal obesity (waist circumference>35 in.) increases the risk Adolescent obesity prevalence, currently 16.9 % in theof heart failure and increases high blood pressure, T2DM, USA, has increased dramatically since the 1970s with thelow-density lipoprotein cholesterol, OSA, stroke, osteoar- metabolic syndrome, alone, increasing by 8.6 % in a 1-yearthritis, cancers, and mortality from all causes. A patient span (2001–2002). In obese children and adolescents, earlywhose BMI is at the upper end of the overweight range onset T2DM, metabolic syndrome, hypertension, dyslipide-may be at risk for development of the metabolic syndrome mia, nonalcoholic fatty liver disease, and other comorbid-and other high-risk comorbidities. ities are prevalent [80] and on the rise [81]. In addition to the burden of comorbidities, another reason for intervention in Even if bariatric surgery is available for this patient the extremely obese in this age group is their severe psy-population, some patients are fearful of the perioperative chosocial stress. Depression, high-risk behaviors, and lowand long-term risks of bariatric surgery. In a recent study, the self-esteem plague this demographic; a survey of obeseLongitudinal Assessment of Bariatric Surgery (LABS) youth demonstrated QoL scores significantly below non-reported the outcomes of 4,776 bariatric surgery patients obese youth and comparable to those diagnosed with cancer(i.e., bypass and band procedures) at 10 US COE hospitals [82]. To avoid its progression, adolescent obesity is an areaand found the 30-day mortality to be 0.3 %, equivalent to orless than the risk of gallbladder surgery [72]. Similarly, a

OBES SURGof unmet need that requires family-oriented behavioral ther- needed surgical procedures following clinically meaningfulapy in addition to effective surgical or minimally invasive weight loss of >10 %, comprise a significant area of unmetintervention. need. Patients preparing to undergo vascular, orthopedic, or transplant procedures are at markedly increased risk if they Bariatric surgery, particularly malabsorptive procedures are also obese or morbidly obese.such as biliopancreatic diversion with duodenal switch, canprovide good weight loss results, improve quality of life, Patients preparing for transplant, or to become donors forand prolong survival for youths suffering from superobesity transplant who are also obese, are similarly candidates forassociated with metabolic syndromes, including those with effective, minimally invasive weight loss treatment to bridgerare genetic disorders (e.g., Prader–Willi syndrome) [83]. the gap between medical and surgical therapy. Severe obe-Because of the potential for perioperative and late compli- sity makes surgical exposure difficult, whereas weight losscations, surgical therapy has been reserved for the severely can improve exposure, reducing operating room time andobese adolescent [84]; in addition, data for bariatric surgery the risk of iatrogenic injuries or poor outcomes due toin adolescents are scarce. In a study of 61 adolescents who limited exposure. In transplantation, performing a vascularunderwent gastric bypass (mean age 17 years and a mean anastomosis or ureteral implant can be much more difficultBMI 60), BMI decreased 37 % at 1 year with improved or in obesity and may result in a poor outcome requiring aresolved cardiovascular risk factors. This study underscores revision of an anastomosis, or even loss of the transplantthe importance of timing of bariatric surgery for treatment of with an impaired blood supply. Limited exposure alsoextremely obese adolescents, as there appears to be a corre- makes anterior lumbar fusions difficult. Knee replacementslation between “late” (very high BMI) referral for surgery can be threatened by excess weight bearing in the earlyand inability to reverse comorbidities [85]. In a randomized recovery period.study of morbidly obese adolescents (n025) undergoinggastric banding vs medical interventions (n025), 84 % of Reducing the Therapeutic Gap: Evolving Strategiesband patients vs 12 % in the medical group lost >50 %EWL. At baseline, 36 % of patients in the band group and There is no single successful therapy for obesity; a variety of40 % of patients in the medical therapy group had metabolic novel strategies are needed to treat the spectrum of obesitysyndrome; at 2-year follow-up, metabolic syndrome had classes. The US Clinical Trials website lists >800 currentresolved in 100 % of patients in the band group vs 22 % trials for obesity. Many of these novel, hybrid therapies arein the medical therapy group [84]. These key studies show- under study to address the above unmet need group ofing a positive response of adolescent obesity to bariatric patients. A promising new therapeutic class of obesity ther-surgery suggest an important role for bariatric surgery in apy is “temporary procedures for weight loss” (TPW), aanswering this demographic’s unmet need; yet, the risks class that bridges medical and surgical therapies.associated with surgery warrant even less invasivealternatives. The rationale underlying TPW intervention is not tempo- rary weight loss, but rather, reversible, nonsurgical (or min- Despite the low efficacy of DEB and proven efficacy of imally invasive surgical) therapy that yields effective weightbariatric surgery in managing adolescent obesity, a 2010 loss. TPW may target one or multiple weight loss mecha-study of physicians’ attitudes shows that nearly 50 % of nisms (e.g., restriction, malabsorption, hormonal) and mayphysicians surveyed would never refer an obese adolescent be applied as transitional or stand-alone therapy. Whilefor surgery and would only consider such a therapy for those distinguished by its intended transience as an intervention,≥18 years [86]. Despite worldwide calls to action against the TPW concept shares certain characteristics with otherchild and adolescent obesity, including the “Let’s Move” emerging, minimally invasive weight loss therapies or sur-campaign of Michelle Obama in the USA, no “complete” gical approaches (i.e., forms of endoluminal procedure). Thesolutions exist for the morbidly obese adolescent: Diet and 2009 ASMBS Position Statement on Emerging Endosurgi-behavioral efforts are insufficient and bariatric surgery is not cal Interventions for Treatment of Obesity suggests that thewell-accepted. The unmet need of adolescent obesity must evolving therapeutic class offers a potential means of im-be weighed against the risk associated with bariatric surgery. proving outcomes and patients’ lives; however, as with allThere is a need for a less invasive weight loss procedure in therapies, these must undergo rigorous safety and efficacythis patient population. trials [87].Obese Adults Requiring Weight Loss Prior Within bariatric surgery, there is a movement toward lessto Other Procedures invasive procedures for high-risk and lower BMI patients who suffer from obesity-related comorbidities [88]. As withObese, or high-risk obese, who have failed standard medical laparoscopy in bariatric surgery, whereby significant reduc-or DEB therapy, yet who would be better candidates for tions in morbidity, pain, and length of hospital stay were

OBES SURGachieved, the still less invasive and reversible TPW may Temporary Procedures for Weight Lossfurther reduce barriers to physician referral and patientacceptance. TPW include several versions of intragastric balloon (IB) and endobarriers/endosleeves. There are other TPW in theA Role for Temporary Treatments to Aid Permanent Weight developmental stage with minimal clinical data that will notLoss be discussed in this section. Each of these therapies fulfills most or all criteria summarized in Table 2.Bariatric surgery has the intent of permanence (thoughreversibility is sometimes possible); TPW represents a Intragastric Balloonsnew therapeutic class that offers transient interventionand may be less invasive than bariatric surgery. Tempo- The mechanism of IB therapy is thought to be restriction by arary procedures for weight loss are designed to be space-occupying device, similar to that of a gastric bezoar thatreversed at a clinically appropriate time without perma- simulates fullness and/or satiety during the term of treatmentnently altering the gastrointestinal tract. If proven safe of 6 months. In the 1980s, early IBs had high complicationand effective, this weight loss therapy may be of value and failure rates (e.g., the Garren Edwards gastric bubble [92])as a low-risk procedure performed as a “bridge to due to structural and placement problems. Focusing on thesurgery” for high-risk individuals or as a freestanding intrinsic possibilities of a simple device that does not alter thetherapy in patients with lower BMI. gastrointestinal tract and that is reversible, a safe and effective evolution of the original IBs was pursued [93]. The resulting The areas of unmet need identified represent objectives modern IBs are inserted into the stomach under direct visionthat may be addressed by TPW (Table 2). The TPW can and inflated with a saline/methylene blue solution, or air, andserve as a bridge to bariatric surgery or to obtain weight loss deflated for removal with specialized needles and snares. Theprior to necessary orthopedic or vascular operations. Preop- therapy is reversible and potentially repeatable for serial treat-erative weight loss can result in shorter operative times and ment. Complications include nausea, vomiting, gastric ulcer-lower surgical complication rates [89]. The minimal inva- ation and erosion, spontaneous deflation, and occasionally,siveness of TPW may reduce the fear that often prohibits bowel obstruction [94].patients from undergoing weight loss interventions [90].TPW may be a cost-effective means of weight loss and Trial data for contemporary IBs between 2004 and 2010preoperative risk reduction [91]. have been detailed elsewhere [95]. Summary findings includeTable 2 Optimal features of Aims of temporary procedures for weight loss (TPW)temporary procedures for weightloss Addresses underserved demographics (adults with BMI 28–40; adults with BMI>50; adolescents with BMI≥ 40; adults with obstructive sleep apnea with BMI≥35) Employs a protocol with indications/contraindications for treating underserved obese patients Safe Minimally invasive No permanent alteration of the gastrointestinal tract Reversible Effective in the short/medium term; a bridge to other surgery, or other weight loss therapy, or weight maintenance Facilitates modest to moderate weight loss (~10 to 30 % EWL) Decreases some/all comorbidities significantly Minimizes patient fear of possible subsequent surgery (e.g., bariatric, vascular, orthopedic) Accessible Insurable/reimbursable (lower cost than bariatric surgery) Accessible financially: markedly lower out-of-pocket costs than bariatric surgery Accessible geographically Can be performed by an endoscopist, gastroenterologist, bariatric surgeon Supported within comprehensive obesity management program Stimulus to behavior modification Performed and followed long term in a bariatric center

OBES SURGthe observation that current IBs are safe intra- and postopera- and were successfully removed. At 3 months, %EWL wastively [90], with a very low mortality of 0.1 % by meta- 22–23.6 %. In a recent randomized controlled trial of DJBSanalysis (2 deaths in 3,429 procedures) [94]; IBs are effective vs VLCD, as a bridge to surgery, the %EWL for DJBS wasin achieving between 10 and 48 % EWL [96] as well as 22 vs 5 % for diet [103].comorbidity reduction as a precursor to bariatric surgery[90], equal to or superior in weight reduction vs sham proce- Endosleeves are in an early developmental phase and showdure and diet [93], and potentially effective as a freestanding promise as TWPs and as models for the study of the neuroen-weight loss procedure (in one study, 25 % of patients retained docrine milieu. DJBSs may prove more effective for improve-≥90 % of their BMI reduction at 1 year [90]), although up to ment of T2DM and other comorbidities than for weight loss;75 % of IB patients experienced some weight regain within 6– longer-term results with the DJBS are not yet available [104].30 months [90]. While first-stage IB therapy reduced the riskof intraoperative complications and conversion to open sur- Conclusiongery in the superobese, it did not demonstrate an additiveeffect on the total weight loss in a trial of IB followed by In 2011, while approaches to weight loss via diet, exercise,laparoscopic gastric banding vs gastric banding alone [97]. and behavior modification with or without pharmacologicAside from achieving comorbidity improvement to optimize support are sometimes successful in the short term, availablepreoperative readiness, weight loss from IB treatment resulted data indicate that they do not last beyond 6 months to 1 year.in clinically improved or resolved OSA [98]. In addition, IB Adherence to a diet and exercise program is lower thantherapy of ≤6 months with weight loss of 10–20 % was shown adherence to a surgical therapy that reinforces complianceto significantly increase fecundity in obese women [99]. The through anatomic alteration. While bariatric surgery haspersistence of weight loss and comorbidity improvement been shown to be successful over the long term, there isachieved with IB therapy requires longer follow-up. still a perioperative and long-term risk profile associated with bariatric surgery. Temporary procedures for weight loss Several IBs have been approved for use in Europe, Japan, may offer a lower risk profile and possibly diminish theand countries in South America and Asia. Certain IB models long-term risks associated with bariatric procedures.have been in human use extensively in Europe, where theyhave demonstrated effectiveness as a bridge to surgery. In Many individuals who qualify for bariatric surgery areItaly, for example, patients with BMI≥30 are governmen- afraid of its associated risks or do not have access to thetally approved for IB treatment and practitioners are reim- therapy and represent an area of unmet need in obesity man-bursed for the procedure. An additional application of the IB agement. Treatment-seeking adults with a BMI 30–35, adultsis the “balloon test,” a strategy that has been used to stratify with a BMI>60, obese adolescents, and obese adults requiringpatients for the most appropriate bariatric procedure [100]. weight reduction prior to other procedures constitute additionalIB technology is evolving, and new designs for IB structure major areas of unmet need. Temporary procedures for weightand insertion/removal are in preclinical trial in the USA. loss represent an emerging therapeutic class that may play an important role in the obesity management armamentarium.Endosleeves Acknowledgments We wish to thank Paul Fabbrini of Telecue, Inc. forThe duodenojejunal bypass sleeve (DJBS) is an investiga- recording the panel discussion among the authors that inspired this review.tional TWP whose probable mechanism is malabsorptionwithin the proximal small intestine combined with delayed Disclosures N. Nguyen and B. Pham have consulting agreementsgastric emptying and early satiety [101]. The procedure with ReShape. J. Ponce, B. Quebbemann, E. Patterson, and F. Favrettiinvolves endoluminal placement of a flexible nutrient- have been investigators for ReShape; W. Raum and G. Segato haveimpermeable, plastic barrier into the duodenum. The DJBS been co-investigators for ReShape. J.K. Champion received an hono-is positioned within the duodenal bulb and extended to the rarium to participate in the development of this work. J.N. Buchwaldjejunum [95], where it excludes the proximal intestine from has a consulting research writing agreement with ReShape. Thealimentary flow, simulating the effects of the Roux-en-Y authors thank ReShape Medical Corporation for financial support togastric bypass [102]. Complications include oropharyngeal develop this work.tears and esophageal mucosal tears, bloating, upper gastro-intestinal bleeds, and sleeve migration. References The procedure is completely reversible, and its efficacy 1. The Surgeon General's call to action to prevent and decreasehas been examined in rodent and porcine models with overweight and obesity/Office of Disease Prevention and Healthsignificant weight loss and improvement in glucose metab- Promotion; Centers for Disease Control and Prevention, Nationalolism [102] and in small pilot studies in humans [101]. Most Institutes of Health. [Rockville, MD]: U.S. Dept. of Health andDJBS devices in human trials remained in place for 3 months Human Services, Public Health Service, Office of the Surgeon General; Washington, D.C., 2001.

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Surgery for Obesity and Related Diseases 7 (2011) 23–32 Original articleAdjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial Martin Fried, M.D., Ph.D.a,b,*, Karin Dolezalova, M.D.a, Petra Sramkova, M.D.a,c aOB Klinika a.s., Prague, Czech Republic bFirst Faculty of Medicine, Charles University, Prague, Czech Republic cEndocrinology Institute, Prague, Czech Republic Received April 18, 2010; accepted September 25, 2010Abstract Background: The intended purpose of gastrogastric imbrication sutures in laparoscopic adjustableKeywords: gastric banding is to reduce band-related complications; however, evidence demonstrating imbri- cation suture utility has been lacking. A 3-year randomized controlled trial on the safety and efficacy of laparoscopic adjustable gastric banding with and without imbrication sutures was undertaken. We performed a prospective investigation of the outcomes using the Swedish adjustable gastric band (SAGB) with and without imbrication sutures. Methods: From January to September 2006, 100 patients undergoing SAGB placement were randomized to group 1 (n ϭ 50, Ն2 imbrication sutures) or group 2 (n ϭ 50, no imbrication sutures). The SAGB was implanted in both groups using a standardized pars flaccida technique. The mean operative time, hospitalization time, percentage of excess weight loss, body mass index, band fill volume, and complications were recorded. The Fisher exact test for categorical data, the independent samples t test for continuous data, and the paired t test to assess the body mass index reduction were performed. All tests were 2-tailed, and statistical significance was set at P Ͻ.05. Results: The mean operative time was 75 Ϯ 7 minutes (range 50 –92) and 48 Ϯ 4 minutes (range 32–75) for groups 1 and 2, respectively (P Ͻ.001). The mean hospitalization time was 26 Ϯ 12 hours (range 20 –96) and 23 Ϯ 9 hours (range 20 – 48) for groups 1 and 2, respectively (P Ͻ.17). The 3-year percentage of excess weight loss was 55.7% Ϯ 3.4% and 58.1% Ϯ 4.1% for groups 1 and 2, respectively (95% confidence interval Ϫ4.0% to Ϫ.8%, P Ͻ.01). The body mass index at 3 years was 34.0 Ϯ 5.8 kg/m2 and 30.3 Ϯ 6.4 kg/m2 (range 1.2– 6.2) for groups 1 and 2, respectively (P Ͻ.01). The fill volume at 3 years was 3.6 Ϯ 1.2 mL (range 1.0 –5.5) and 4.5 Ϯ 0.5 mL (range .0 –5.0) for groups 1 and 2, respectively (P Ͻ.01). Finally, slippage occurred in 1 patient (2.2%) and 1 patient (2.0%) and migration in 1 patient (2.2%) and 1 patient (2.0%) in groups 1 and 2, respectively (P ϭ NS). No patient died in either group. Conclusion: The results of our randomized controlled trial have demonstrated that SAGB com- bined with a conservative approach to band adjustments and limited retrogastric dissection is effective and safe with and without imbrication sutures. Not using imbrication sutures results in significant benefits in operative speed with comparable clinical weight loss and intermediate term safety. These randomized controlled trial data suggest that imbrication sutures are not indispensable to laparoscopic adjustable gastric banding and their use can be left to the surgeon’s discretion. (Surg Obes Relat Dis 2011;7:23–32.) © 2011 American Society for Metabolic and Bariatric Surgery. All rights reserved. Bariatric surgery; Imbrication sutures; Swedish adjustable gastric banding; SAGB; Pars flaccida; Band adjust- ment; Plication Supported by a grant from Ethicon Endo-Surgery. *Correspondence: Martin Fried, M.D., Ph.D., OB Klinika a.s., Pod Krejcarkem 975, 13000 Prague 3, Czech Republic. E-mail: [email protected]/11/$ – see front matter © 2011 American Society for Metabolic and Bariatric Surgery. All rights reserved.doi:10.1016/j.soard.2010.09.018

24 M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32 Laparoscopic adjustable gastric banding has proved to be Frering and Fontaumard [47] retrospectively reviewed slip-a very effective treatment of moderate to morbid obesity page with and without imbrication sutures in 3584 patientsand its co-morbidities [1– 6] and has remained the safest in whom the band had been placed using the pars flaccidabariatric surgical option [7–12]. It is the most commonly technique. They reported a 3% slippage rate with imbricationperformed bariatric procedure worldwide [13]. The laparo- sutures versus 1% without imbrication sutures (P Ͻ.0001) [47].scopic band originated in the early 1980s as a nonadjustable Lantsberg et al. [30] retrospectively compared their initialgastric band [14,15]. An adjustable band was then devel- implantation technique with imbrication sutures in 784 pa-oped and placed using an open technique [16], with nonad- tients with their newer technique without imbrication su-justable bands placed laparoscopically in the early 1990s tures in 1494 patients. They reported a 24% slippage rate[16,17]. Finally, laparoscopically placed adjustable banding and 1.8% erosion rate with imbrication sutures versus awas performed in the mid-1990s [18 –20]. Thus, the band, 5.5% slippage rate and .2% erosion rate without imbricationimplantation technique, and follow-up regimen have under- sutures [30]. Shashidhar et al. [31], in a questionnaire-basedgone continuous modifications to simplify the procedure study of 29 British surgeons, investigated slippage related toand enhance safety [21]. The primary targets for improve- imbrication suture use and the pars flaccida technique and ament have been the reduction of long-term morbidity and variety of bands. For 6990 bands placed with imbricationincreased treatment efficacy. Special emphasis has been sutures, the slippage rate was .5–12% compared with aplaced on reducing the incidence of band slippage followed slippage rate of 1.0 –2.5% for 1370 bands without imbrica-by gastric prolapse with pouch enlargement. The latter com- tion sutures. In their study, 90% of the slippages occurredplication has had an incidence of 1.4 –24% in series Ͼ1000 after band inflation [31]. The results from these observa-[22,23] and can lead to potentially serious outcomes, in- tional studies suggest a neutral role, at best, for the use ofcluding acute renal failure and gastric pouch ischemia. imbrication sutures, in contrast to the predominant historical assumption of imbrication suture utility. Complications have been minimized by the widespreadadoption of the pars flaccida placement technique, coupled Since 1996, in our own clinical experience using nowith high positioning, just below the esophagogastric junc- imbrication sutures, we have consistently recorded long-tion. This approach enhances secure anchoring of the band term, successful (Ͼ60%) excess weight loss, with a 3.1%around the stomach, particularly in the band’s posterior rate of band slippage/pouch dilation. The uncertainty re-aspect. This technique, with its use of distinct anatomic garding the ramifications of the suture-fixation portion oflandmarks and standardized steps, has been extensively the SAGB operation, coupled with the paucity of controlledtested and shown to decrease the incidence of complications studies of imbrication sutures, motivated us to prospectively[24 –29]. In contrast, although band plication with gastro- investigate whether the SAGB outcomes, in general, wouldgastric tunneling, or “imbrication,” sutures has also become differ with the use of imbrication sutures versus no imbri-common practice [30] and has been referred to in several cation sutures. To our knowledge, this is the first random-studies evaluating the overall safety and effectiveness of ized controlled trial (RCT) to investigate this question.laparoscopic adjustable gastric banding, the current studieshave not contained enough data to demonstrate the effec- Methodstiveness of imbrication sutures in stabilizing the band andminimizing adverse events compared with nonimbrication The ethics committee approved the RCT study protocol.sutures [31]. As a technical step intended to secure the band, The trial was conducted under the “good clinical practices”the placement of imbrication sutures first appeared in re- and the Declaration of Helsinki to ensure the patients’ports describing the original silicone band models [18,19]. welfare and the ethical conduct of the study. All patientsIn 1997, Forsell and Hellers [18] reported on a reoperation provided informed consent before enrollment in the trial.needed because of breakage of imbrication sutures. Subse-quently, however, the use of imbrication sutures was re- Participant recruitmentported as one of several solutions to the high complicationrates necessitating reversal or conversion [32–34]. Numer- The participants were initially recruited as they came toous series followed that incorporated imbrication sutures as the hospital seeking treatment of morbid obesity. They werea standard step in the evolving technique of band implan- assessed for eligibility in person or by telephone by thetation [35–39], with some reporting diminished rates of nursing staff. The patients were prospectively evaluated forslippage with imbrication sutures [40 – 43] and a few report- study eligibility during a 9-month period by a multidisci-ing reduced slippage without imbrication sutures [44,45]. plinary medical team (bariatric surgeons, psychologist, in-Steffen et al. [46] reported no difference in slippage rates ternist– obesitologists, gastroenterologists, and dietitians),with or without imbrication sutures. according to the hospital’s standard operating procedures. Recently, several abstracts were presented delineating Inclusion criteriacomparative evaluations of laparoscopic adjustable gastricbanding slippage relative to the use of imbrication sutures. The eligible patients met the standard National Institutes of Health, International Federation for the Surgery of Obe-

M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32 25sity–European Chapter, and European Association for cm) in the peritoneal layer medial to the right crus. TheStudy of Obesity indication criteria for bariatric surgery as blunt dissector was passed retrogastrically through thisa primary operation (not a repeat operation) [48,49]. All opening at the gastroesophageal junction and brought up atmale and female patients were required to be morbidly the opposite side (angle of His), where the previous limitedobese (body mass index [BMI] Ն40 kg/m2 or Ն35 kg/m2 dissection had been performed. This maneuver facilitatedwith Ն2 co-morbidities), to be 18 – 65 years old on the day creation of a narrow (5-mm) retrogastric tunnel as wide asof surgery, to have a history of documented weight loss the blunt dissector.failure, and to be committed to the significant lifestylechanges needed for long-term success with the SAGB. During retrogastric dissection, meticulous attention was given to the creation of a very narrow retrogastric tunnelExclusion criteria before the introduction of the laparoscopic adjustable gas- tric band, a critical factor in minimizing the risk of slippage/ The patients who had congenital or acquired anomalies pouch dilation.of the gastrointestinal tract; inflammatory disease; cirrhosis;severe cardiopulmonary disease; gastrointestinal bleeding Next, the band was pulled back by the blunt dissectordisorders; intestinal telangiectasia; esophageal dysmotility, through the narrowly dissected retrogastric region from thereflux, or Barrett’s esophagus; chronic pancreatitis; or a angle of His to the lesser curvature. Despite this, it wasterminal illness were not admitted to the study. Patients with possible to pull the SAGB without significant friction, be-a history of impaired mental status were excluded, as were cause the band dilated adjacent tissue as it was pulled. Withpatients who had undergone previous bariatric surgery, this “minimal dissection” technique, at the end of the pro-were pregnant, or desired a different bariatric procedure. cedure, the retrogastric tissue firmly holds the entire retro- gastric part of the band throughout the postoperative course.Study intervention Finally, the buckle was closed, with the band in place. All patients underwent implantation with the Swedish Treatment group 1 (imbrication sutures)adjustable gastric band (distributed under the tradenameSAGB Quickclose, Obtech, Switzerland, or REALIZE Ad- In the patients assigned to group 1, a plication wasjustable Gastric Band, Ethicon Endo-Surgery, Cincinnati, performed from the anterior fundus distal to the band to theOH) using standard patient preparation and abdominal ac- anterior gastric pouch using 2 or 3 permanent sutures. Thiscess technique [35], followed by standard SAGB dissection created a loose gastric tunnel to accommodate eventualprocedures. inflation of the band. Dissection was begun at the angle of His. Limited de- Treatment group 2 (no imbrication sutures)tachment of the adherent peritoneal layer at the left dia-phragmatic crus and gastric fundus was performed with the In patients assigned to group 2, the same steps wereelectrocautery hook, and subsequently, by gentle blunt dis- followed, except that no gastrogastric imbrication suturessection, resulting in an approximately 1-cm opening of the were placed.peritoneal reflection. The extent of the dissection was justsufficient to accommodate the tip of the dissector (distrib- Follow-up programuted under the tradenames Goldfinger Blunt Dissector, Ob-tech, and REALIZE Endoscopic Dissector, Ethicon Endo- The indicated lifestyle behavior modification practicesSurgery) and pass it from the lesser curvature at a later stage were the same for both groups after band implantation. Bothin the procedure. More extensive dissection (as usually groups complied with the same conservative postoperativeperformed during Nissen fundoplication or for hiatal hernia adjustment strategy, which stipulated that, before any ad-repair) can contribute to the loss of the retrogastric circum- justment, the patient had undergone detailed nutritional,ferential support of the band and, thus, inappropriate posi- psychological, and bariatric counseling. This behavioral in-tioning of the band. tervention sought to frequently influence the eating attitudes and habits of the patients, rather than automatically apply- The next dissection began at the pars flaccida of the ing band restriction for continued weight loss. The band fillgastrohepatic ligament at the lesser curvature. The pars was increased only if the rate of weight loss had decreasedflaccida area was opened at its midpoint, and the right to Ͻ2 kg/mo during the first postoperative year and afterdiaphragmatic crus was exposed. The calibration bougie repeated failure of the multidisciplinary approach efforts towas extended into the stomach such that both the abdominal restart an appropriate weight loss rate (Ն2 kg/mo).portion of the esophagus and gastroesophageal junctionwere clearly identified. At this anatomic landmark (i.e., a Using this protocol, a maximum of 2-mL increments oftriangle created by the right crus, abdominal portion of the band fill volume at a time was permitted during the first oresophagus, and the gastroesophageal junction), gentle, lim- second adjustment. Thereafter, a maximum of 1 mL at aited dissection was done, providing an opening (usually Ͻ1 time was allowed. A minimum of 6 – 8 weeks between adjustments was required. The patients did not routinely

26 M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32undergo upper gastrointestinal imaging series after band parameters drew an envelope from the box and were as-adjustments. signed to either group 1 or 2. The patients were not blinded to their treatment once allocated to a study group.Study objective Statistical analysis The trial was designed to assess the role of imbricationsutures in SAGB system effectiveness up to the study end- Continuous variables are reported as the mean Ϯ stan-point. The primary effectiveness null hypothesis took the dard deviation, range, and 95% confidence intervals (CI).following form: H0: ␮ϩimbrication sutures Ϫ ␮Ϫimbrication sutures ϭ Categorical variables are reported as the number and per-0, where ␮ϩimbrication sutures represented the mean percentage centage. The demographic data and comparative outcomesof excess weight loss (%EWL) for patients receiving were analyzed using Fisher’s exact test for categorical dataSAGB implanted with 2–3 imbrication sutures (group 1), (contingency tables) and the independent samples t test forand ␮Ϫimbrication sutures represents the mean %EWL for pa- continuous data. A paired t test was used to assess a signif-tients receiving SAGB implanted without imbrication sutures icant reduction in the mean %EWL from baseline. All tests(group 2). The null hypothesis posited no significant differ- were 2-tailed, and statistical significance was set at P Ͻ.05.ences between the 2 groups. For the secondary effectiveness The calculations were performed using the Statistical Pack-endpoints, all null hypotheses followed a similar construction. age for Social Sciences statistical software, version 16.0 (SPSS, Chicago, IL).Primary and secondary outcomes and data collection Results The primary effectiveness endpoint of the present studywas the mean %EWL, calculated as the difference from The study participants were recruited from January tobaseline and the 3-year postoperative weight divided by the September 2006. Participant flow is shown in Fig. 1. Of thedifference in the baseline and ideal body weight (i.e., upper original 171 patients assessed for eligibility, 32 refusedlimit value of the medium-frame range on the Metropolitan participation, and 139 underwent the clinical assessment. OfLife Insurance Tables) multiplied by 100. The weight data the 139 patients, 39 were excluded (3 had a BMI Ͻ35were collected preoperatively, on the day of surgery, and at kg/m2, 5 did not meet the psychological criteria, 24 under-6 weeks and 3, 6, 12, 18, 24, and 36 months postoperatively. went a different bariatric procedure, and 7 had undergone a previous bariatric procedure). Thus, 100 patients met the The secondary endpoints included the mean operating eligibility requirements. Of these, 50 were randomly allo-time (calculated as the interval from the first incision to the cated to receive the SAGB with imbrication sutures (grouplast skin incision closure), duration of hospitalization, 1) and 50 to receive the SAGB without imbrication sutureschange in BMI, perioperative and longer term complica- (group 2). In group 1, 2 patients withdrew from the studytions (i.e., band slippage/pouch dilation, migration/erosion, preoperatively without receiving the allocated intervention.and port-related complications), and mean SAGB fill vol- In the postoperative period, 3 patients were lost to follow-upume. (2 at 12 months and 1 at 17 months). In group 2, 1 patient withdrew from the study preoperatively, and 1 was lost toSample size follow-up, with no reason identified. Thus, in groups 1 and 2, 45 patients (90%) and 48 patients (96%), respectively, The estimation of the sample size was determined by the received the intervention and completed the RCT, providingprojected weight loss at 3 years after band implantation. The data for analysis through the 3-year endpoint.SAGB efficacy data were set as the mean estimate of 50%EWL [3]. Clinical significance was set at a mean difference The baseline patient demographics are listed in Table 1.of 10%. To achieve 80% power in detecting such a differ- No significant preoperative differences in age, male/femaleence using a 2-sided test at the .05 level, 45 patients per ratio, weight, excess body weight, or BMI were apparenttreatment group were required. This sample size was also between the 2 groups.deemed sufficient to detect a 5% difference in complicationrates between the 2 groups. The primary null hypothesis was rejected, because the difference between the 2 groups in %EWL at 3 years was We scheduled interim analyses of the trail data at 6 statistically significant; however, clinical significance wasmonths to assess the safety of the intervention. not established (i.e., the mean difference was Ͻ5%). Other statistically significant differences between the 2 groupsRandomization were found in operative time, 3-year BMI, and band fill volume. The participant allocation sequence was developed byrandom computer generation of a set of odd and even Operative time and hospital staynumbers corresponding to the treatment associated withboth study groups (1 and 2). The generated numbers were All bands were placed laparoscopically, with an averagesealed in envelopes and placed in a box. The patients who operative time of 75 Ϯ 7 minutes (range 50 –92) and 48 Ϯhad agreed to undergo SAGB surgery within the study

M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32 27Fig. 1. Flow chart of participants.4 minutes (range 32–75) for groups 1 and 2, respectively 3.4% and 58.1% Ϯ 4.1% (95% CI Ϫ4.0 to Ϫ0.8; P Ͻ.01),(P Ͻ.001). The operative time for group 2 was significantly indicating a statistically significant difference favoringshorter (27 minutes) than that for group 1. The mean hos- group 2 (Table 3). Also, a significant difference in the meanpital stay for group 1 was 26 Ϯ 12 hours (range 20 –96) and BMI at 3 years was seen between groups 1 and 2 (34.0 Ϯwas 23 Ϯ 9 hours (range 20 – 48) for group 2, with no 5.8 and 30.3 Ϯ 6.4 kg/m2, respectively; 95% CI 1.2– 6.2;significant difference between the 2 groups in hospital re- P Ͻ.01). Although the difference in BMI might not havecovery time (P Ͻ.17; Table 2). been clinically relevant, both groups experienced a clin- ically significant reduction in BMI relative to the baselineWeight loss measures (i.e., group 1 decreased from 41.9 Ϯ 5.2 kg/m2 to 34.0 Ϯ 5.8 kg/m2 [mean change Ϫ7.9, P Ͻ.001]; and At 3 years after SAGB surgery, group 1 had achieved a group 2 from 40.6 Ϯ 6.4 kg/m2 to 30.3 Ϯ 6.4 kg/m2mean weight of 94.1 Ϯ 19.3 kg (mean change from baseline [mean change Ϫ10.3, P Ͻ.001]).Ϫ29.5 kg). At 3 years, the mean weight for group 2 was86.6 Ϯ 17.9 kg (Ϫ29.1; 95% CI Ϫ0.2 to 15.2; P ϭ .06). At Band fills1 and 2 years after SAGB surgery, the mean %EWL ingroups 1 and 2 was 28.4% and 31.9% and 53.5% and Most patients attended all required postoperative office54.5%, respectively. At 3 years, the %EWL was 55.7% Ϯ visits for weight and band adjustment evaluation. In group

28 M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32Table 1 Table 3Baseline patient characteristics Percentage of excess weight loss at 1, 2, and 3 yearsCharacteristic Group 1 Group 2 P Variable Group 1 Group 2 (no 95% CI P (imbrication (no imbrication value (imbrication imbrication value sutures; n ϭ 50) sutures; n ϭ 50) .42 sutures; sutures; n ϭ 45 n ϭ 48 [96%])Age (yr) 45.9 Ϯ 8.5 .64 [90%]) Mean Ϯ SD 47.4 Ϯ 10.0 30.5–58.4 Range 29.0–57.0 .06 At 1 yr 28.4 31.9 Ͻ.01 37 (74) Mean %EWL 15.0 16.0 Ϫ4.0 to Ϫ.8Gender (n) 40 (80) 13 (26) .35 Mean weight Women 10 (20) loss (kg) 53.5 54.5 Men 115.7 Ϯ 19.9 .27 28.3 27.3 123.6 Ϯ 21.8 82.9–179.1 At 2 yrWeight (kg) 85.0–185.4 Mean %EWL 55.7 Ϯ 3.4 58.1 Ϯ 4.1 Mean Ϯ SD 50.1 Ϯ 15.3 Mean weight 52.1–67.0 53.2–65.2 Range 52.9 Ϯ 14.7 24.3–125.4 loss (kg) 29.5 29.1 26.4–128.5Excess body weight (kg) 40.6 Ϯ 6.4 At 3 yr Mean Ϯ SD 41.9 Ϯ 5.2 36.0–54.9 Mean %EWL Range 35.1–55.7 Ϯ SD RangeBMI (kg/m2) Mean weight Mean Ϯ SD loss (kg) RangeBMI ϭ body mass index.1, the patients received an average of 3 band fills during the %EWL ϭ percentage of excess weight loss; CI ϭ confidence interval3-year study period, with a mean band fill volume of 3.6 Ϯ (difference between mean values).1.2 mL (range 1.0 –5.5). Group 2 patients received an av-erage of 4 fills during the study period, with a greater mean P values calculated using 2-sided independent samples t test.fill volume of 4.5 Ϯ 0.5 mL (range 0 –5.0; P Ͻ.01). In group 2, 1 patient experienced band slippage (2.0%) atMid- to longer term complications 14 months, which resolved after temporary deflation of the band. After repeated nutritionist, psychologist, and bariatric No patient died during the trial. The perioperative com- surgeon educational and behavioral interventions, it wasplications were minor in both groups. possible to successfully readjust this patient’s band. An- other patient experienced band migration (2.0%) at 19 In group 1, 1 patient experienced band slippage (2.2%) at months after surgery, necessitating endoscopic removal and22 months and underwent successful revision. Another pa- conversion to biliopancreatic diversion (Scopinaro). Notient experienced band migration (2.2%) at 30 months after pouch dilation occurred in group 2. One port-related com-surgery. This patient subsequently underwent endoscopic plication occurred (2.1%) and 1 port infection, which ne-band removal, with conversion to biliopancreatic diversion cessitated temporary port removal (Table 4). No statistically(Scopinaro). No pouch dilation occurred during the study significant differences were found between the 2 groups inperiod in group 1. Three port-related complications oc- the incidence or severity of complications.curred (6.7%), including 2 port flips and 1 port infection,requiring temporary port removal (Table 4). Interim analysisTable 2 In December 2006, preliminary statistical analysis of theOperative time and hospital stay trial data showed no statistically significant differences be- tween the 2 groups in any safety parameter. Therefore, fromVariable Group 1 Group 2 (no P value January 2007, we continued with no imbrication sutures (imbrication imbrication applied in any patient undergoing SAGB Quickclose im- sutures; n ϭ 48) sutures; n ϭ 49) plantation at our institution (1100 patients up to December 2009) using the same method as before the study started.Operative time* (min) 75 Ϯ 7 48 Ϯ 4 Ͻ.001† This included Ͼ400 patients in whom the REALIZE C- Mean Ϯ SD 50–92 32–75 Ͻ.17 band was implanted from August 2008. The present RCT Range and its ongoing statistical comparison were carried to com- 95% CI 73.0–77.0 47.0–49.2 pletion at 3 years.Hospital stay (hr) 26 Ϯ 12 23 Ϯ 9 Discussion Mean Ϯ SD 20–96 20–48 Range This is the first RCT of the effectiveness and safety of the 95% CI 22.5–29.5 20.4–25.6 use of imbrication sutures in SAGB Quickclose or REALIZE adjustable gastric band. Our findings have corroborated theSD ϭ standard deviation; CI ϭ confidence interval (of the mean).* Skin to skin closure.† Statistically significant.

M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32 29Table 4 Group 1 (imbrication Follow-up Group 2 (no imbrication Follow-up P valueLate complications sutures; n ϭ 45 [90%]) (mo) sutures; n ϭ 48 [96%]) (mo) .99Complication 22 1 (2.0) 14 .99 30 1 (2.0) 19 —Slippage (n) 1 (2.2) — 0 — .23Migration (n) 1 (2.2) — 0 — .35Erosion (n) 0 — 1 (2.1) — .23Reoperation (n) 2 (4.4) — 0 — .99Port-related (n) 3 (6.7) — 1 (2.1) — 2 (4.4) Flip 1 (2.2) InfectionData in parentheses are percentages.observational data suggesting the use of imbrication sutures particularly if the sutures “bite” the entire thickness of thedoes not result in clinically superior weight loss or lower gastric wall, creating microtrauma and potential microchan-complication rates. Patients implanted with the SAGB nels for infection to travel from inside the stomach towardQuickclose or REALIZE adjustable gastric band without the implanted band.imbrication sutures experienced a significantly shorter op-erative time than the patients implanted with imbrication The low rate of SAGB Quickclose or REALIZE adjust-sutures (Table 2), without compromising safety, as demon- able gastric band complications without imbrication suturesstrated by their low rate of perioperative and long-term found in the present trial could also have been associatedmorbidity, comparable to that of patients implanted with with the very conservative band adjustment algorithm fol-imbrication sutures. The patients without imbrication su- lowed at our institution. The protocol (described in thetures also achieved effective, consistent weight loss equiv- “Methods” section) resulted in adequate weight loss withalent to that of the patients with imbrication sutures in the minimal band adjustments (i.e., a band left completelyfirst 2 postoperative years and slightly, although not statis- empty) in approximately 30 – 40% of our patients at 12tically significant, better at 3 years. The weight loss rate and months after surgery. At 2 years after band implantation,incidence of complications without imbrication sutures ob- Ͼ20% of patients continued to experience excellent weightserved in the present study were comparable to those re- loss results without any band adjustment using this conser-ported with imbrication sutures [3,50 –52]. These findings vative and gentle adjustment algorithm, a practice thatsuggest that the use of imbrication sutures in gastric banding might be particularly effective in band patients withoutcan be left to the surgeon’s discretion. imbrication sutures. Our experience with a minimal incidence of slippage One limitation of the present study was the interaction ofwithout the use of imbrication sutures contrasts with those the treatment under investigation with the specific postop-reported by other centers, in which a greater incidence of erative adjustment algorithm and limited retrogastric dissec-slippage and migration were observed using imbrication tion technique. The generalization of our findings for thesutures. From 1986 to 1993, we implanted nonadjustable no-imbrication suture group might be limited without ad-bands with no imbrication sutures and using an open tech- herence to both the surgical technique and postoperativenique. This also resulted in low rates of slippage [53]. We band adjustment algorithm we used. To our knowledge, nobegan using the laparoscopic technique in 1993 and contin- other RCTs have compared the use and none use of imbri-ued performing most procedures with nonadjustable bands, cation sutures in SAGB to date; additional controlled stud-with minimal slippage [54]. From 1996 on, we transitioned ies would be of value.to laparoscopically implanted SAGBs, placed consistentlyusing the pars flaccida technique, maintaining our practice Conclusionof no imbrication sutures in most patients. This resulted inno change in our overall complication rate, including the The findings of the present RCT have demonstrated thatincidence of slippage, or long-term weight loss. a conservative approach to band adjustments coupled with conservative/limited retrogastric dissection at placement Moreover, at endoscopy, we observed that band migra- without imbrication sutures will result in the significanttion (erosion) was often noted with the posterior band benefit of a shorter operative time while maintaining clinical“backbone” seen first inside the stomach, leading us to weight loss and intermediate-term safety comparable to thatspeculate that the anterior gastric wall, held in place by with imbrication sutures.imbrication sutures covering the band and the posteriorband “backbone,” might be the inaugural points of band We would like to state, however, that the decision to notmigration in imbrication suture-fixed bands. Also, imbrica- use imbrication sutures is not consistent with current labeltion sutures, themselves, might facilitate band migration, indications for the REALIZE adjustable gastric band.

30 M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32Acknowledgments [16] Hallberg D, Forsell P. Ballongband vid behandling av massiv over- vikt [Balloon band for treatment of massive obesity]. Svensk Kirurgi We would like to thank Jane N. Buchwald, Chief Bari- 1985;43:106.atric/Metabolic Surgery Writer and Director of MedicalWriting and Publications, Medwrite Medical Communica- [17] Broadbent R, Tracey M, Harrington P. Laparoscopic gastric banding:tions, Maiden Rock, WI, for substantial research and writing a preliminary report. Obes Surg 1993;3:63–7.assistance in the development of our report; RNDr. Ing. K.Chroust, Ph.D., Institute of Biostatistics and Analysis, Ka- [18] Forsell P, Hellers G. The Swedish adjustable gastric banding (SAGB) formenice, Czech Republic, for performing the initial statisti- morbid obesity: 9-year experience and a 4-year follow up of patientscal analyses; Tim W. McGlennon, Principal, M3, Maiden operated with a new adjustable band. Obes Surg 1997;7:345–51.Rock, Wisconsin, for statistical consultation; and M.Frankova, D.S., for her work in data capture and collection. [19] Belachew M, Legrand MJ, Defechereux TH, et al. Laparoscopic adjustable silicone gastric banding in the treatment of morbid obesity:Disclosures a preliminary report. Surg Endosc 1994;8:1354 – 6. M. Fried is a consultant for Ethicon Endo-Surgery, Cin- [20] Catona A, La Manna L, Forsell P. The Swedish adjustable gastriccinnati, Ohio. band: laparoscopic technique and preliminary results. Obes Surg 1994;10:15–21.References [21] Buchwald H, Buchwald JN. Evolution of surgery for morbid obesity, [1] Dixon JB, O’Brien PE, Playfair J, et al. Adjustable gastric banding In: Pitombo C, Jones KB, Higa KD, Pareja JC, editors. Obesity and conventional therapy for type 2 diabetes: a randomized controlled surgery: principles and practice. New York: McGraw-Hill Medical; trial. JAMA 2008;299:316 –23. 2007. p. 3–14. [2] Fielding GA, Ren CJ. 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M. Fried et al. / Surgery for Obesity and Related Diseases 7 (2011) 23–32 31[37] Watkins B, Ahroni J, Michaelson R, et al. Laparoscopic adjustable [47] Frering V, Fontaumard E. Does stitching band increase slipping? gastric banding in an ambulatory surgery center. Surg Obes Relat Dis (abstract). Surg Obes Relat Dis 2008;4:289 –311. 2008;4:S56 – 62. [48] National Institutes of Health, National Heart, Lung and Blood Insti-[38] Mittermair RP, Obermüller S, Perathoner A, et al. Results and com- tute (NHLBA) in cooperation with the National Institute of Diabetes plications after Swedish adjustable gastric banding—10 years’ expe- and Digestive and Kidney Diseases (NIDDKD). Clinical Guidelines rience. Obes Surg 2009;19:1636 – 41. on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: the Evidence Report. Bethesda: National Institutes[39] Weiner RA. Gastric banding: surgical and technical aspects. Chirurg of Health; 1998. 2005;76:678 – 88. 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Obes Surg 1996;7:22–5.[46] Steffen R, Biertho L, Ricklin T, et al. Laparoscopic Swedish adjustable gastric banding: a five-year prospective study. Obes Surg 2003;13;404–11. Editorial commentComment on: Adjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial Since its earliest descriptions, the procedural steps of lapa- band slippage rate of 2.0 –2.2% is testament to their depth ofroscopic adjustable gastric banding (LAGB) have undergone experience. Most importantly, they can conclude that, inseveral modifications, each designed to further minimize the their hands, the use of ISs does not significantly result inassociated complications such as slippage and erosion. By superior weight loss or lower complication rates. They alsoavoiding perigastric dissection and instead using pars flaccida appropriately conclude that the use of ISs should be at thedissection with minimal posterior dissection, randomized pro- surgeon’s discretion.spective studies have shown that the incidence of band slip-page (gastric prolapse) can be significantly reduced [1]. The As with many randomized, prospective trials, before wide-results have since been validated in multiple large volume and spread acceptance of the conclusions can be adopted intometa-analysis studies [2]. practice, further validation by other multiple, large-volume, prospective studies would be helpful. Certainly, avoiding un- An additional method thought to reduce the risk of postop- necessary sutures, such as ISs, in the stomach has some po-erative band complications has included the use of strategically tential advantages. For instance, as many bariatric surgeons areplaced anterior gastrogastric imbrication sutures (ISs) [3– 6]. aware, reoperation or revision after adjustable gastric bandingHowever, until this excellent report by Fried et al., the use of has been considered a high-risk procedure, in part because theISs as an independent variable affecting the short- and long- takedown of the ISs has been associated with an elevated riskterm outcomes has not been scientifically challenged in a of gastric injury and leak, sometimes requiring meticulousprospective randomized fashion. Although once thought to be dissection, wedge resection, or oversewing [7]. Revisional sur-a mandatory key step in LAGB, as the authors point out, gery after laparoscopic adjustable gastric banding performedbanding with and without ISs has led to conflicting published without ISs would theoretically reduce that same risk andresults. Therefore, a randomized prospective study was clearly perhaps make those procedures safer for the patient, shouldindicated. they be needed. The authors are to be congratulated for completing this In addition to the gastrogastric ISs, some surgeons per-very clearly defined randomized trial that was sufficiently forming LAGB have advocated an additional IS on thepowered to detect a difference between performing adjust- stomach, placed just 2 cm distal to the band’s location,able gastric banding with and without ISs. Their overall suturing together the lesser curve to the greater curve of the

OBES SURGDOI 10.1007/s11695-013-0937-8 ORIGINAL CONTRIBUTIONSEarly Experience with the Incisionless Operating Platform™(IOP) for the Treatment of ObesityThe Primary Obesity Surgery Endolumenal (POSE) ProcedureJ. C. Espinós & R. Turró & A. Mata & M. Cruz &M. da Costa & V. Villa & J. N. Buchwald & J. Turró# Springer Science+Business Media New York 2013Abstract Conclusions At 6-month follow-up of a prospective caseBackground We report our initial experience and 6-month series, the POSE procedure appeared to provide safe andoutcomes in a single center using the per-oral Incisionless effective weight loss without the scarring, pain, and recoveryOperating Platform™ (IOP) (USGI Medical) to place issues of open and laparoscopic bariatric surgery. Long-termtransmural plications in the gastric fundus and distal body follow-up and further study are required.using specialized suture anchors (the Primary Obesity Sur-gery Endolumenal [POSE] procedure). Keywords Obesity . Primary Obesity Surgery EndolumenalMethods A prospective observational study was undertaken (POSE) . Incisionless Operating Platform (IOP) . Weight losswith institutional Ethics Board approval in a private hospitalin Barcelona, Spain. Indicated patients were WHO obesity Introductionclass I–II, or III, where patients refused a surgical approach.Results Between February 28, 2011 and March 23, 2012, Although bariatric surgery is more effective in achievingthe POSE procedure was successfully performed in 45 pa- durable weight loss than conventional therapy (i.e., diet, ex-tients: 75.6 % female; mean age 43.4±9.2 SD (range 21.0– ercise, pharmacotherapy) [1–5], there is an urgent need for64.0). At baseline: mean absolute weight (AW, kg), 100.8± less-invasive solutions for the world’s >1.6 billion overweight12.9 (75.5–132.5); body mass index (BMI, kg/m2), 36.7± adults and >400 million obese patients [6]. Bariatric surgery3.8 (28.1–46.6). A mean 8.2 suture-anchor plications were carries a low rate of operative mortality (0.1–0.4 %, restrictiveplaced in the fundus, 3.0 along the distal body wall. Mean procedures and gastric bypass) [7, 8], yet is not withoutoperative time, 69.2±26.6 min (32.0–126.0); patients were perioperative risk, the possibility of long-term complicationsdischarged in <24 h. Six-month mean AW was 87.0±10.3 (e.g., for bleeding, leak, wound infection, anastomotic stric-(68.0–111.5); BMI decreased 5.8 to 31.3±3.3 (25.1–38.6) ture, marginal ulcer, bowel obstruction, and device-related(p<0.001); EWL was 49.4 %; TBWL, 15.5 %. No mortality events), and the need for reoperation. In addition, the majorityor operative morbidity. Minor postoperative side effects of patients who qualify by National Institutes of Health (NIH)resolved with treatment by discharge. Patients reported less guidelines for bariatric surgery are unable to receive it due tohunger and earlier satiety post procedure. Liquid intake issues involving cost and accessibility, inadequate insurance,began 12 h post procedure with full solids by 6 weeks. and/or fear of surgery [9, 10].J. CV.ilElasp:iJn.óTsu(r*ró) : R. Turró : A. Mata : M. Cruz : M. da Costa : From within the milieu of natural orifice translumenalV. endoscopic surgery (NOTES), a gastroendoscopic approach that saw its first human trials within the last decade [11], theUnidad de Endoscopia, Centro Médico Teknon, Vilana, 12, minimally invasive Incisionless Operating Platform™ (USGI Medical, San Clemente, CA, USA) was developed;08022 Barcelona, Spain its clinical use has been previously described [12–15]. The IOP devices have had Food and Drug Administration (FDA)e-mail: [email protected] 510(k) clearance since 2006 and have attained the CE MarkJ. N. BuchwaldDivision of Scientific Research Writing, Medwrite MedicalCommunications, Maiden Rock, WI, USA

OBES SURG(since 2010) for use in approximating GI tissue without Endpoints, Data Collectionopen or laparoscopic incisions and are employed to carryout procedures such as endolumenal cholecystectomy [16], Safety endpoints analyzed were minor and major complica-closure of gastrotomies [17], repair of gastro-gastric fistulae tions. Operative time and duration of hospital stay were[18], transgastric appendectomy [15], and the ROSE proce- recorded. The primary effectiveness endpoint was weightdure (Repair of Surgery, Endolumenal), an approach for loss at 6 months expressed as mean change from baseline intreating weight regain post bariatric surgery (e.g., after grad- absolute weight (AW) and BMI. In addition, percentageual gastric pouch and stoma enlargement following Roux- excess weight loss (%EWL), and percentage total bodyen-Y gastric bypass [19–23]). The IOP is also in early trials weight loss (%TBWL) were calculated. Percentage EWLas the platform of access devices that facilitate the novel was calculated using a constant BMI of 25 kg/m2 to determinePrimary Obesity Surgery Endolumenal (POSE) procedure, ideal body weight (IBW): %EWL=(baseline AW−6-monthan approach that may provide a means of weight reduction AW)/(baseline AW−IBW)×100; %TBWL was calculated as:as effective as bariatric surgery, yet with even greater safety. %TBWL=(baseline AW−6-month AW)/(baseline AW)×100.POSE has been performed successfully by both surgeonsand gastroenterologists in North America, Europe, and the PatientsMiddle East; to our knowledge, this study provides the firstformal English-language presentation of outcome data. Patients who considered undergoing the POSE procedure underwent an informed consent process concluding with their In the POSE procedure, stomach tissue is plicated in 8–9 signing of the Ethics Board-approved consent form. To partic-locations in the fundus and in 3–4 in the distal body using ipate in the study, patients needed to present with a BMI in thespecialized suture anchors. The plicated areas mechanically class I or II obesity range (World Health Organization [WHO]and physiologically restrict contact of ingested food with the [32]), or in the WHO class III range but be unwilling to undergofull surface area of the stomach. It is hypothesized that the a surgical procedure. As the procedure is new, patients with aanchored plications may more rapidly activate gastric stretch BMI between 30 and 40 were felt to be the best candidates toreceptors in response to food, partially defunctionalizing the provide the probable best outcomes for these lower- to mid-fundus by limiting its ability to accommodate a meal [24–26]. range BMI patients while reserving standard bariatric proce-Additional distal plications are expected to slow antral mill dures for patients with a BMI >40. Patients were required to becontractions and delay complete gastric emptying, thereby >20 years of age and able to return to the hospital for all follow-reducing hunger and initiating earlier and prolonged satiety up visits. Nutritional evaluation and psychological screening[27, 28]. By these — and perhaps other — mechanisms, provided confirmation of patients’ ability and willingness toPOSE may facilitate durable weight loss and comorbidity comply with the post-procedure diet and exercise program.improvement while not precluding other interventions. Patients paid independently for their procedures with no USGI financial support provided for either the patient or clinician. Between February 28, 2011 and March 16, 2012 in ourinstitution, the Centro Médico Teknon (Barcelona, Spain), Patients were excluded if they were non-ambulatory orwe performed the POSE procedure in a series of patients had significant mobility impairment; if they had a knownwith an initial mean body mass index (BMI, kg/m2) of 36.7. and untreated hormonal or genetic cause for obesity; or, ifWe present our experience to date and 6-month outcomes they had work hours, family obligations, or transportationwith the POSE procedure. issues that could interfere with their return for all scheduled evaluations.Methods Endoscopic EquipmentStudy The incisionless, flexible endosurgical TransPort® EndoscopicIn 2011, our endoscopic group in the Centro Médico Teknon Access Device (USGI Medical) provides a stable platformundertook a clinical study of the POSE procedure. The through which to work in the operative site. The TransPortstudy was of a prospective, single-center, non-comparative has four working ports that deploy an endoscope and threeobservational design. The study protocol and case report specialized instruments: the g-Prox EZ® Endoscopic Grasper, aform stipulate good clinical practices (GCPs) as defined in flexible shaft with a jawed gripper for mobilizing and approx-ISO EN 14155–1 and −2 [29, 30]. All patients were asked to imating a tissue fold; the g-Lix™ Tissue Grasper, a flexibleprovide written informed consent prior to surgery in accord probe with a distal helical tip designed to assist the g-Prox inwith Teknon Ethics Board requirements and GCP guidelines capturing target tissue (Fig. 1a); and the g-Cath EZ™ Sutureoutlining patient protections stipulated by the Declaration of Anchor Delivery Catheter, a catheter system with a needle at itsHelsinki [31]. distal tip that, after advancement through the lumen of the

OBES SURGFig. 1 a Incisionless Operating Platform™ with TransPort® Endo- Prior to intubation of the Transport, a standard gastros-scopic Access Device; b g-Cath EZ™ Suture Anchors; c schematic of copy was routinely performed to aspirate any accumulationanchors holding plicated tissue permitting serosal approximation. of fluid, as well as to verify that the pathology of the anatomy was not irregular. The shape of the fundus wasgProx, penetrates the mobilized target tissue, installs a pair of noted, as this may affect the number of suture anchorspre-loaded Suture Anchors™, and cinches the anchored tissue placed. The TransPort was inserted transorally and advancedfold (Fig. 1b). The mesh suture anchors (pledgets) were into the stomach. Visualization was achieved through thedesigned to distribute holding forces across the plication con- TransPort with a small-diameter endoscope.tact points in order to reduce the tissue trauma often associatedwith sutures, thereby facilitating postoperative healing and Suture-anchor plications were placed in the fundus andincreasing procedure durability. distal body with the intent of reducing fundal accommoda- tion and inducing antral dysmotility following meal con-Surgical Technique sumption. To achieve each plication, target tissue was grasped with the g-Lix and pulled and guided into the jawsThe POSE procedure was conducted in the operating room of the g-Prox. The g-Prox jaws were closed. After insertionusing general anesthesia. of the g-Cath system through the g-Prox lumen, the g-Cath needle tip was advanced through the tissue fold and a suture anchor deployed on each side of the tissue fold to approx- imate it; the suture anchors were cinched to an appropriate tension. The proximal end of the suture was cut, leaving the cinched anchor pair holding the apposed tissue (Fig. 1c). After the first 15 cases, a technical improvement was by made by cutting the sutures using the g-Prox instead of an external scissors; this resulted in shortening the operative time by 20 min in the ensuing cases. The g-Cath system facilitated creation of secure plications without the chal- lenge of endoscopic knot tying and the associated potential tissue trauma. Generally, 8–9 plications in the fundus proved sufficient to reduce the surface area significantly. The orientation of the g-Prox influenced alignment of the tissue fold once the g-Cath needle was deployed. When the needle passed from anterior to posterior, the fold was created at a medial to lateral angle; the second pair of suture anchors was placed approximately 2–3 cm from the previous pair, creating and continuing a tissue ridge. This approach appeared to be the quickest method of setting up subsequent anchor placements and providing visual confirmation of fundal surface reduc- tion. After placing four suture anchors, the tissue ridge routinely extended to the lateral limit of the fundus; a second row, anterior to the first row, was then started and completed using four suture anchors. More anchors may be necessary to achieve a complete reduction; however, the two tissue ridges appeared to confer the greatest fundal surface con- traction using the fewest sutures. Following placement of the fundal tissue anchors, we ensured that the apex of the fundus was pulled down to the same level as the gastro- esophageal junction. With the aim of disrupting the gastric antral mill, 3–4 additional plications were placed in the distal body, creating a tissue ridge near the mouth of the antrum opposite the angular incisure. After creation of a tissue ridge in the distal body, the instruments and TransPort were removed, and anesthesia withdrawn. A standard gastroscope was routinely

OBES SURGused following the procedure to view the plications and Table 1 Patient baseline characteristics Valueverify that there was no bleeding. The CO2 was aspirated Characteristic Mean±SD (rangea)and the stomach collapsed prior to final extubation. N = 45Postoperative Care Age (years) 43.4±9.2 (21.0–64.0)In the first 4 weeks post procedure, patients were placed on a Height (m) 1.7±0.1 (1.5–1.8)customized, calorie-restricted diet (per day: 800 calories, min- AW (kg) 100.8±12.9 (75.5–132.5)imum 50–70 g protein, maximum 30 g fat, ≥64 oz fluids) that BMI (kg/m2) 36.7±3.8 (28.1–46.6)transitioned from liquid to pureed foods, to soft solids, and IBWb (kg) 68.7±5.8 (59.0–81.0)then full solids in the sixth week. In the sixth week, patients EWc (kg) 32.1±10.7 (8.3–60.3)were counseled to maintain their daily diet at 1,200 calories. Gender, N (%)Walking exercise (10–15 min 2–3 times/day) was encouraged Male 11 (24.4)in the first 4 postoperative weeks, with instructions to increase Female 34 (75.6)exercise in the fifth week to an investigator-approved aerobic BMI by WHO class, N (%)regimen of 35–45 min 5 times/week. Class Id (30.0–<35) 15 (33.3) Class II (≥35.0–<40) 24 (53.3) Because this procedure was new to us, we preferred a Class III (≥40.0) 6 (13.4)rigorous and cautious follow up schedule: Follow-up visitswere performed at 1, 2, and 3 weeks, and at 1, 2, 3, 4, 5, and AW absolute weight, BMI body mass index, IBW ideal body weight, EW6 months. Upper GI series were not performed as a rule. excess weight, WHO World Health Organization weight classificationsStatistical Analysis a Range=min–maxStatistical analyses were performed using SAS® software v. b IBW (kg)=height (m)2 ×25 kg/m21.9 (SAS, Cary, NC). Patient baseline characteristics andperioperative outcomes were summarized; continuous pa- c EW (kg)=AW (kg) – IBW (kg). (Determination of EW for this studyrameters were reported as number of non-missing observa- was based on an “ideal” body weight [IBW] equivalent to a BMI oftions (N), mean, standard deviation (SD), and range. 25 kg/m2 – the cut-off point that defines overweight in the currentCategorical parameters, both at baseline and postoperative- WHO classification)ly, were reported as count and percentage. Continuous out-come variables were generally reported as mean, SD, and d Two patients had BMI <30 (i.e., 28.1 and 29.9 kg/m2 )range. Mean change values at 6 months in AW and BMIwere calculated along with corresponding 95 % confidence baseline BMI was 36.8. There were 15 patients with classintervals (CIs) for mean differences. Also, 95 % CIs were I obesity (33.3 %), 24 patients with class II obesity (53.3 %),calculated for mean %EWL and mean %TBWL at 6 months, and six patients with class III obesity (13.4 %).as well as for subgroup %TBWL means at 1, 3, and6 months. Measures of change from baseline were analyzed Operative Outcomesusing paired-samples t-tests. Between-group comparisons(i.e., %TBWL subgroup analyses) were carried out using All POSE cases were performed by experienced endoscopistsanalysis of variance (ANOVA) for independent samples. with no intraoperative adverse events, no conversions or failedScatter diagrams and correlation analysis were used to ex- procedures, and no postoperative re-hospitalizations. Theplore %TBWL and %EWL relationships with baseline BMI. mean number of total suture anchors placed was 11.3±1.1Statistical significance was set at p<0.05. (8–14) (Table 2). The mean operative time was 69.2 ± 26.6 min. Following the procedure, 100 % of patients reported less hunger and earlier satiety. All patients were discharged between 12 and 24 h. Weight OutcomesResults Postoperative weight outcomes were available in 80.0 % (27/34) of protocol-compliant patients at the 6-month timeBaseline Patient Characteristics point. Paired samples t-tests indicated that obesity parame- ters were significantly reduced (Table 3). Mean AW (kg)As shown in Table 1, the majority of patients were female was 87.0±10.3 compared to 103.3±13.1 at baseline, a(75.6 %). The mean age was 43.4±9.2 years (21–64). Mean within-patient mean change of −16.3±7.1 (95 % CI, −19.1 toAW was 100.8±12.9 kg (75.5–132.5); height, 1.7±0.1 m −13.5; p<0.001). Percentage TBWL was 15.5±6.1 (95 % CI,(1.5–1.8); and BMI, 36.7±3.8 (28.1–46.6). The median 13.1 to 17.9). BMI was 31.3±3.3 relative to a baseline measure

OBES SURGTable 2 Perioperative outcomes Value TBWL at 6 months. Also, 75 % (6/8) of BMI<35 patients,Characteristic Mean±SD (range) and 89.5 % (17/19) of BMI≥35 patients experienced greater (N = 45) than 25 % EWL over the same period. POSE patient 6-monthProcedure duration, min %TBWL and %EWL correlated at r =0.83 (p <0.001).Number of anchors, fundus 69.2±26.6 (32.0–126.0) Overall, %TBWL and %EWL correlated at a mean r=0.69Number of anchors, distal body 8.2±1.1 (5.0–10.0) (range: 0.61–0.83) across follow-up time points. GenerallyNumber of additional anchors 3.0±0.5 (2.0–5.0) speaking, both BMI subgroups trended upward along percent-Total number of anchors 0.0±0.2 (0.0–1.0) age weight-loss outcome measures. 11.3±1.1 (8.0–14.0) Complicationsof 37.2±3.9, a mean change of −5.8±2.5 (95 % CI, There was no mortality in the series and only two minor−6.8 to −4.8; p<0.001); %EWL was 49.4±21.5 (95 % CI, adverse events as defined by the American Society for Gastro-40.9 to 57.9). intestinal Endoscopy (ASGE) [33]. Post POSE, there was one case of low-grade fever that resolved with oral antibiotic Subgroup analyses of weight loss (i.e., %TBWL) by treatment and another patient who returned to the hospital ongender, age, and BMI at 1, 3, and 6 months following POSE the second postoperative day with chest pain; complicationsare presented in Table 4. Due to the relatively small number from the procedure and cardiovascular issues were ruled outof class III patients (n=6) in the study, patients were divided and the patient was sent home. Minor postoperative side effectsinto two BMI groups: class I obesity (30.0 to <35.0) vs. included sore throat, stomach pain, nausea, and chest painclass II (≥35 to 40) and above. Analyses indicated that there (Table 5). There were three cases of vomiting that resolvedwere no significant differences in weight-loss outcomes within the first 12 h with no requirement of additional hospitalbetween males and females, age groups (i.e., <40, ≥40 to stay. One patient was discharged on the second postoperative<50, ≥50 years), or between BMI groups (i.e., BMI <35.0, day for her personal convenience, not due to medical necessity.BMI ≥35.0) across time points. There was no device-related morbidity. Scatter diagrams and correlation analyses were used to Discussionfurther examine the relationship between baseline BMI andthe efficacy of the POSE procedure as measured by %TBWL Current study results demonstrate the clinical safety andand %EWL at 6 months. Percentage TBWL and EWL corre- effectiveness of the POSE procedure for primary weightlated with baseline BMI at r=0.29 (p=0.14), and r=0.23 (p= loss in a small cohort of obese patients. In addition to0.25), respectively. Although the relationship between base- achieving significant weight loss with no major complica-line BMI and weight outcome was not statistically significant, tions, POSE required just over an hour of procedural time,several interesting observations were noted—particularly with incurred no incisions or scars, and resulted in a fast recoveryregard to patients with BMI<35 vs. those with BMI≥35. time and brief hospital stay.Seventy-five percent (6/8) of BMI<35 patients, and 95 %(18/19) of BMI≥35 patients experienced greater than 5 %Table 3 Mean weight loss at 6 monthsParameter Mean±SD (range) Mean change±SD 95 % CI p valuea (N = 27) <0.001AW (kg) 87.0±10.3 (68.0–111.5) −16.3 ± 7.1 −19.1, −13.5b <0.001BMI (kg/m2) 31.3±3.3 (25.1–38.6) −5.8 ± 2.5 −6.8, −4.8b __EWLc (%) 49.4±21.5 (13.7–98.4) __ 40.9, 57.9d __TBWLe (%) 15.5±6.1 (2.4–24.5) __ 13.1, 17.9‡AW absolute weight, BMI body mass index, EWL excess weight loss, IBW ideal body weight, TBWL total body weight lossa Paired samples t-test assessing change from baselineb 95 % CI of mean differencec 95 % CI of the meand EWL (%)=(AW change [kg]/(baseline AW [kg]−IBW [kg]))×100e TBWL (%)=(AW change [kg]/baseline AW [kg])×100

OBES SURGTable 4 Total body weight loss by month and subgroup There was no mortality in the current study, whereas, ≥30-day mortality in all categories of bariatric surgery (fromMonth N Mean±SD (range) 95% CIa p valueb purely restrictive to malabsorptive-restrictive to purelyParameter (%) malabsorptive procedures [34]) is 0.1 % to 0.28 % according to meta-analysis [35]. In the POSE cohort, there were noMonth 1 (0.0 %) major perioperative complications, only minor compli- cations that cleared rapidly, while the overall complication rateTBWL by gender for restrictive and malabsorptive-restrictive bariatric procedures has been estimated at 1.1 % to 2.7 % [36].Females 32 8.1±2.4 (4.4–14.3) 7.2–8.9 0.09 8.4–10.4 0.93 Although current POSE findings at 6-month follow-upMales 11 9.4±1.5 (6.4–11.4) 0.90 are preliminary and based on a small cohort, POSE appeared 7.4–9.4 0.12 equally effective for both sexes and for all age and BMITBWL by age (years) 6.7–9.7 0.75 groups studied. In relation to the recent interest in bariatric 7.2–10.0 0.22 treatment for low-BMI patients, both BMI groups (baseline<40 16 8.4±1.9 (5.3–11.4) 0.14 <35 and ≥35) trended upward along percentage weight-loss 6.6–10.1 0.99 outcome. However, lower-BMI POSE patients appeared to≥40 to <50 15 8.2±2.7 (4.4–14.3) 7.7–9.2 0.24 experience relatively higher %EWL than higher-BMI pa- tients; conversely, low-BMI patients demonstrated slightly ≥50 12 8.6±2.2 (5.1–11.4) 10.8–14.3 lower %TBWL over time than their higher-BMI counter-TBWL by BMI (kg/m2) 13.0–17.1 parts. These seemingly contradictory results are due to the choice of outcome measure.<35.0 13 8.3±2.8 (4.4–14.3) 10.2–15.3 10.8–17.1 Several measures of weight loss have been employed in≥35.0 30 8.4±2.0 (5.3–11.4) 11.1–14.8 the scientific literature, rendering comparison of outcomes within and across bariatric methodologies challenging. Re-Month 3 9.4–14.5 ports of medical/nonsurgical therapies typically present ac- 12.0–15.5 tual weight loss or %TBWL; whereas, weight-loss resultsTBWL by gender for primary bariatric surgical procedures are mainly reported 11.4–17.5 as %EWL. Further, %EWL has been reported in the litera-Females 29 12.6±4.6 (4.0–20.3) 14.6–22.4 ture using two different methods [37]. The EWL calculation reported most frequently utilizes the Metropolitan LifeMales 10 15.1±2.9 (9.3–19.7) 12.0–19.1 Tables (MLT) to determine ideal body weight; whereas, 8.7–22.0 the second method uses a constant BMI of 25. In the currentTBWL by age (years) 10.6–20.7 study, the second measure of EWL was employed, as some have suggested it is a more accurate representation of ideal<40 15 12.8±4.6 (4.1–20.3) 7.7–19.0 body weight due to the narrow and outdated range of an- 13.6–19.2 thropometric measurements upon which the MLT classifica-≥40 to <50 13 14.0±5.2 (4.0–19.9) tions are based [37–39]. Practitioners in the emerging area of endoscopic bariatric procedures, such as the ASGE and≥50 11 12.9±2.7 (7.3–16.1) the American Society for Metabolic and Bariatric SurgeryTBWL by BMI (kg/m2) (ASMBS) Task Force, are discussing the most apt measure- ment(s) with which to compare weight-loss effectiveness<35.0 12 11.9±4.0 (4.0–17.6) across endoscopic procedures and in relation to bariatric and non-interventional approaches [40].≥35.0 27 13.8±4.4 (4.1–20.3) In the current study, the mean 6-month POSE TBWL wasMonth 6 15.5 %, which is significantly better than the minimum 5.0 % TBWL threshold recommended for achievement of weight-TBWL by gender related comorbidity resolution [39] and congruent with the approximately 15.0–25.0 % TBWL seen in systematicallyFemales 20 14.5±6.4 (2.4–24.5) reviewed analyses of patients following very low-calorie diet and exercise programs for <6 months (although fewer thanMales 7 18.5±4.2 (11.6–23.2) 9.0 % of the diet and exercise regimen patients maintained this weight loss at 1 year) [41, 42]. Using the MLT calculation ofTBWL by age (years) EWL for POSE at 6 months—40.0 %—POSE results were<40 11 15.6±5.3 (7.8–23.7)≥40 to <50 8 15.3±8.0 (2.4–24.5) ≥50 8 15.6±6.1 (4.5–21.4)TBWL by BMI (kg/m2)<35.0 8 13.3±6.7 (2.4–21.0)≥35.0 19 16.4±5.8 (4.5–24.5)TBWL total body weight loss, BMI body mass indexa 95% CI of the meanb Analysis of variance (ANOVA) for independent samplesTable 5 Postoperative Complication N (%)complications (N = 45) Fever 1 (2.2) Sore throat 5 (11.1) Stomach pain 15 (33.3) Nausea 6 (13.3) Vomiting 3 (6.7) Chest pain 2 (4.4)

OBES SURGcomparable to the 1-year laparoscopic adjustable gastric Fig. 3 Endoscopic view of suture anchor stability at 6 months follow-banding mean EWL of 42.6 % reported by recent meta- ing POSE.analysis using the MLT standard [43]. At 6-month follow-up, more than 80.0 % of POSE patients had achieved ≥25 % complications: gastric perforation, pneumoperitoneum requir-EWL, and the overall POSE patient mean EWL as calculated ing percutaneous intervention [45], device migration, obstruc-by either metric (MLT [40.0 %] or BMI 25 as ideal end point tion, bleeding [46, 47]).[49.4 %]) far exceeded the minimum 1-year goal of 25.0 %EWL recommended for endoscopic bariatric therapies by the The TERIS procedure and the POSE procedure using theASGE/ASMBS Task Force [40]. Patients in the current POSE IOP differ in several important respects. The TERIS is ancohort who have reached the 9- and 12-month time points implant-based procedure, with plastic anchors placed nearhave continued their weight-loss trend with no complications. the cardia to create an internal restriction similar to a gastric band. The TERIS devices acquire tissue via suction, which There are several other new endoscopic procedures for has been found to provide tissue plications of inconsistentshort- and long-term primary weight loss that take different size and depth. The POSE procedure using the IOP is notmechanical approaches, ranging from gastric-volume reduc- implant-based, and instead uses sutures and pledgets totion (e.g., the EndoCinch, Bard, Murray Hill, NJ; and TERIS, secure durable folds in gastric tissue. The IOP acquiresBaroSense, Redwood, CA) to exposure of the jejunum to tissue using a grasper with a long, 33-mm jaw that allowspartly digested nutrients (EndoBarrier, GI Dynamics, Lexing- full-thickness bites to be secured under direct visualization.ton, MA). In initial studies, these procedures have shown The POSE procedure itself is not thought to be restrictive in19.9–46.0 % EWL at 6 months to 1 year [44]. Early trials of its mechanism of action, and involves plicating the fundusTERIS and Endo Barrier resulted in the following major and distal gastrum of patients to induce a physiological response: earlier fullness and prolonged satiety. FurtherFig. 2 Endoscopic view of fundal and distal body plications immedi- investigation of these endoscopic devices and proceduresately post POSE. is required. More study is required to understand the mechanisms of action involved in POSE weight loss using the method of multiple individual tissue plications. The safest and most effective locations for gastric anchor placement in POSE are still being refined. Also unknown is the minimum number of suture anchors that would provide maximum weight-loss effectiveness in the fundus and distal body. A weight-loss approach such as the POSE procedure depends for its success upon creating the most favorable conditions for GI wound healing. GI tissue healing follow- ing suturing requires incorporation of the muscular, serosal, and submucosal layers to trigger an inflammatory response sufficient to promote early proliferation of collagen at the plication site [48, 49]. The snowshoe-shaped suture anchors deployed through the g-Cath appear to be an attractive

OBES SURGoption relative to traditional suturing to achieve tissue appo- Referencessition. When sutures are cinched across gastric tissue folds toform plications, overtightening may cut through tissues, pre- 1. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versuscipitating wound dehiscence [50]. As demonstrated in a short- intensive medical therapy in obese patients with diabetes. N Engl Jterm preclinical study comparing four suture anchor designs Med. 2012;366(17):1567–76.used to make full-thickness gastric plications, the expandablesuture anchors provided what appeared to be a firm, non- 2. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgerydamaging amount of compression, pliant in response to the versus conventional medical therapy for type 2 diabetes. N Engl Jinflammatory process that facilitated durable tissue remodel- Med. 2012;366(17):1577–85.ing [51]. In the current study, Fig. 2 shows an endoscopic viewof fundal and distal body plications immediately post POSE; 3. Kissane NA, Pratt JS. Medical and surgical treatment of obesity.Fig. 3 shows suture-anchor stability at the 6-month post- Best Pract Res Clin Anaesthesiol. 2011;25(1):11–25.POSE study end point. 4. Karlsson J, Taft C, Ryden A, et al. Ten-year trends in health related The POSE procedure can be performed by a well-trained quality of life after surgical and conventional treatment for severeendoscopist or bariatric surgeon. As with bariatric surgical obesity: the SOS intervention study. Int J Obes. 2007;31:1248–61.procedures, POSE should be undertaken within a supportive,comprehensive, obesity management program, and should be 5. Dixon JB, Strauss BJ, Laurie C, et al. Changes in body compositionviewed as a tool for weight loss and stimulus to behavior with weight loss: obese subjects randomized to surgical and medicalmodification rather than as an independent solution to obesity. programs. Obesity (Silver Spring, MD). 2007;15:1187–98. A weakness of this study was that it was conducted on a 6. World Health Organization. Obesity and overweight—fact sheetsmall patient series without a control group. Although data No. 311. 2006. Accessible at: http://www.who.int/mediacentre/on comorbidities and quality of life were collected through- factsheets/fs311/en/index.html. Accessed September 25, 2012.out the study, they were not collected uniformly and, thus,could not be appropriately analyzed and described as part of 7. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: athe 6-month findings; follow-up reports should include the- systematic review and meta-analysis. JAMA. 2004;292(14):1724–37.se data. As POSE is thought to have a significant impact onhunger and satiety, objective evaluations of these parameters 8. Nguyen NT, Silver M, Robinson M, et al. Result of a national auditwould be of value in future investigations. of bariatric surgery performed at academic centers: a 2004 University Health System Consortium Benchmarking Project. To our knowledge, this is the first peer-reviewed publi- Arch Surg. 2006;141:445–9.cation of POSE weight-loss outcomes in obese patients.Initial results are encouraging. Marked weight loss with 9. Gastrointestinal Surgery for Severe Obesity. NIH ConsensusPOSE with only minor perioperative side effects compares Statement. 1991;9(1):1–20.favorably with outcomes of restrictive bariatric surgical pro-cedures while providing a better safety profile over the short 10. Martin M, Beekley A, Kjorstad R, et al. Socioeconomic disparitiesterm. POSE may also provide a novel means of early inter- in eligibility and access to bariatric surgery: a national population-vention in overweight patients’ progression into obesity and based analysis. Surg Obes Relat Dis. 2010;6(1):8–15.increasing comorbid illness. Long-term follow-up of thisseries and additional rigorous studies of POSE for weight 11. Rattner D, Kalloo A, SAGES/ASGE Working Group on Naturalloss are required to evaluate its safety, effectiveness, and Orifice Translumenal Endoscopic Surgery. ASGE/SAGES Workingpatient acceptance. Group on Natural Orifice Translumenal Endoscopic Surgery: 2005. Surg Endosc. 2006;20:329–33.Acknowledgments We thank Dror Rom, PhD, Prosoft Software,LLC (Wayne, PA), for performing the statistical analysis, and T.W. 12. Swanstrom LL, Kozarek R, Pasricha PJ, et al. Development of aMcGlennon, M3, LLC (Maiden Rock, WI) for statistical consultation. new access device for transgastric surgery. J Gastrointest Surg.We also thank Maribel Sanchez for nutritional consultation during the 2005;9:1129–36. discussion 1136–7.study, Marta Lasaosa for administration, Sandra Andres for endoscopicnursing, Dr. Monica Prat for psychiatric consultation, and Sonia Oliva 13. Bardaro SJ, Swanström L. Development of advanced endoscopesfor psychological evaluation. for Natural Orifice Transluminal Endoscopic Surgery (NOTES). Minim Invasive Ther Allied Technol. 2006;15(6):378–83.Disclosure The clinical study at the Teknon site was not financiallysupported and was conducted independently by Teknon’s physicians. 14. Mellinger JD, MacFadyen BV, Kozarek RA, et al. Initial experi-Manuscript development was supported by USGI Medical, USA. J.N. ence with a novel endoscopic device allowing intragastric manip-Buchwald is the director and chief scientific research writer at ulation and plication. Surg Endosc. 2007;21(6):1002–5.Medwrite LLC, a CRO under contract with USGI. Manuscript devel-opment was supported by USGI Medical, Inc. 15. Horgan S, Thompson K, Talamini M, et al. Clinical experience with a multifunctional, flexible surgery system for endolumenal, single port and NOTES procedures. Surg Endosc. 2011;25(2):586–92. 16. Swanstrom LL, Dunst C, Whiteford M, Hungness E, Soper NJ. Initial experience with NOTES transgastric cholecystectomy. Surg Endosc. 2008;Apr Suppl:S034. 17. Sclabas G, Swain P, Swanstrom LL. Endolumenal therapy for gastrotomy closure in natural orifice transenteric surgery (NOTES). Surg Innovation. 2006;13(1):23–30. 18. Raman SR, Holover S, Garber S. Endolumenal revision obesity surgery results in weight loss and closure of gastric-gastric fistula. Surg Obes Relat Dis. 2011;7:304–8. 19. Ryou M, Swanstrom L, Mullady D, et al. Gastric pouch and stoma reduction using a novel endosurgical operating platform. Surg Obes Relat Dis. 2008;6:358–62. 20. Ryou M, Mullady DK, Lautz DB, et al. 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OBES SURGDOI 10.1007/s11695-011-0400-7 TECHNICAL INNOVATIONLaparoscopic Reinforced Sleeve Gastrectomy: Early Resultsand ComplicationsLuigi Angrisani & Pier Paolo Cutolo & Jane N. Buchwald & Tim W. McGlennon &Gabriella Nosso & Francesco Persico & Brunella Capaldo & Silvia Savastano# Springer Science+Business Media, LLC 2011Abstract appropriate. The paired t test was used to assess change fromBackground Sleeve gastrectomy (SG) was pioneered as a two- baseline; bivariate analyses and logistic regression were usedstage intervention for super and super-super obesity to minimize to identify preoperative patient characteristics predictive ofmorbidity and mortality; it is employed increasingly as a suboptimal weight loss.primary procedure. Early outcomes and integrity of laparoscopic Results Mean operative time was 105 min (95–180), andSG (LSG) against leak using a technique incorporating gastric mean hospitalization was 5.6 days (1–14). There was notransection-line reinforcement were studied. mortality. There were 6 (5.0%) complications: 1 intraoperativeMethods Between 2003 and 2009, 121 patients underwent leak, 1 stricture, 1 trocar-site bleed, 1 renal failure, and 2LSG (16, two-stage; 105, primary). Of the patients, 66% were wound infections. There were no postoperative staple-linewomen, mean age 38.8±10.9 (15.0–64.0), and body mass leaks. Following 15 concomitant hiatal hernia operations, 3index (BMI, kg/m2) 48.7±9.3 (33.7–74.8). Bovine pericardi- (20%) recurred: 1 revised to RYGB and 2 in standby. Twoum (Peri-Strips Dry [PSD]) was used to reinforce the staple post-LSG hiatal hernias of the two-stage series requiredline. Parametric and nonparametric tests were used, as revisions because of symptoms. BMI decreased 24.7% at 6 months (n=55) to 37.5±9.3 (22.2–58.1); %EWL was 48.1L. Angrisani : P. P. Cutolo : F. Persico ±19.3 (15.5–98.9). Twelve-month BMI (n=41) was 38.4± 10.5 (19.3–62.3); %EWL was 51.7±25.0 (8.9–123.3). Forty-General and Laparoscopic Surgery Unit, eight-month BMI (n=13) was 35.6±6.8 (24.9–47.5); %EWLSan Giovanni Bosco Hospital, was 61.1±12.2 (43.9–82.1) (p<0.001). Preoperative BMINaples, Italy was predictive of >70% of patients who experienced <50% EWL at 6 months. At 2 weeks, 100% of type 2 diabetesJ. N. Buchwald patients (n=23) were off medication (mean HbA1C, 5.9±Division of Scientific Writing, 0.5%; glycemia, 90.0±19.9 mg/dL (p<0.01) at 3 months).Medwrite Medical Communications, Conclusions Laparoscopic PSD-reinforced LSG as a stagedMaiden Rock, WI, USA or definitive procedure is safe and effective in the short term and provides rapid type 2 diabetes mellitus reductionT. W. McGlennon with a very low rate of complications.Statistical Analysis and Quality of Life Assessment,McGlennon MotiMetrics, Keywords Bariatric surgery . Laparoscopic . SleeveMaiden Rock, WI, USA gastrectomy . Morbid obesity . Staple-line reinforcement . Buttress material . Gastric leakG. Nosso : B. Capaldo : S. Savastano IntroductionDepartment of Molecular and Clinical Endocrinologyand Oncology, Federico II Medical School, University of Naples, Sleeve gastrectomy (SG) was approved as a primaryNaples, Italy bariatric procedure in 2009 by the American Society forL. Angrisani (*)General and Laparoscopic Surgery Unit, San Giovanni BoscoHospital, University Federico II, Medical School,via F.M. Briganti 255,80144 Naples, Italye-mail: [email protected]

OBES SURGMetabolic and Bariatric Surgery. The operation, performed and 2006 as part of a planned, two-stage approach foropen or laparoscopically (LSG), constitutes the gastric super-obese patients, and from 2007 to 2009, as a primaryportion of the biliopancreatic diversion with duodenal procedure, independent of BMI, to be revised and com-switch (BPD/DS) [1]. SG was pioneered during the past pleted if necessary. Early efficacy outcomes and thedecade as the first operation of a two-stage intervention for integrity of LSG against leak using a technique incorporat-super and super-super obesity (body mass index [BMI, ing gastric transection-line reinforcement were studied.kg/m2] >50 and >60 [2]) and/or high operative risk as astrategy to minimize morbidity and mortality [3–7]. SG has Methodsbeen employed increasingly, since 2006, as a stand-alone,primary procedure [8–12], sometimes requiring “comple- Institutional Review and Study Designtion” with a second operation due to inadequate weight loss[13, 14]. The study was reviewed and approved by the institutional review board of San Giovanni Bosco Hospital, Naples, A systematic review of the literature by Brethauer et al. Italy. Adherence to the ethical conduct standards of thereported short- and intermediate-term outcomes in 2,570 Declaration of Helsinki ensured patients' welfare [27]. TheSG patients with mean overall excess weight loss (EWL) of study was retrospective, using prospectively collected data.55.4% (range 33.0–85.0; summarized in 1,662 patients,);46.9% (33.0–61.4; n=821) for SG performed within a Patient Eligibility, Informed Consent, and Preparationstaged approach; and 60.4% (36.0–85.0; n=1, 749) whenintended as a definitive procedure [15]. In the same review, Patients seen at the hospital for treatment of their morbidthe majority of patients with comorbid illness (n=754) obesity underwent a multidisciplinary evaluation to consid-experienced comorbidity improvement or resolution; >70% er the option of bariatric surgery [28]. Eligible patients metof patients experienced improved or resolved type 2 the International Federation for the Surgery of Obesitydiabetes mellitus (T2DM). The efficacy of SG appears to (IFSO), the European Association for the Study of Obesityextend to morbidly obese patients (BMI≥40, or ≥35 with (EASO), and the National Institutes of Health (NIH)two or more comorbidities [2]) with average operative risk indications for bariatric procedure eligibility [29, 30].[16, 17] and to certain lower-BMI populations with severe Patients in the super obese and super-super obese categoriesadiposity and/or high risk [18]. SG effectiveness as a who qualified for LSG as a primary procedure wereprimary procedure is comparable to other approved bari- informed that they were at greater risk of requiring aatric procedures through the intermediate term [19–22], second procedure if adequate weight loss was not attainedalthough long-term follow-up data with which to evaluate it through LSG alone. Informed consent was obtained fromare still needed [1, 23]. all patients. Each patient underwent comprehensive medical evaluation. Prior to surgery, antibiotic prophylaxis and Use of SG is on the rise; in a recent survey of metabolic/ venous stasis prophylaxis were instituted.bariatric surgery worldwide, no SGs/LSGs were reportedperformed in 2003, whereas they represented 5.4% (0.3% Surgical TechniqueSG, 5.1% LSG) of bariatric procedures reported in 2008[24]. LSG has been described as one of the most rapid and Venous stasis prophylaxis was performed by externalleast difficult of bariatric procedures to perform [25]. The pneumatic compression (SCD™ Compression Sleeves;complication rate for SG is reasonably low, mean 9.4% Covidien, Mansfield, MA) at time of surgery, with(0–23.8) in high-risk or staged patients, and 6.2% (0–21.7) administration of low molecular heparin for a period ofin primary procedures; leak is the most frequently reported 20 days postoperatively and early patient mobilization thecomplication, 2.2%, followed by bleeding, 1.2%, and day after surgery. Under general anesthesia, the patient wasstricture, 0.6%, with low mortality, 0.19% [15]. Leak may placed in reverse Trendelenburg lithotomic position, armsbe related to too small a calibration of the sleeve segment, and legs abducted, with the surgeon positioned between theor to imperfect closure of the gastric transection line. patient's legs, the first assistant on the patient's left, and theAlthough the overall leak rate is not high, due to the camera operator, on the right. Closed CO2 pneumoperito-extensive resection that characterizes SG, in the context of a neum was induced by subcostal Veress needle insertion inproximal stricture, a persistent leak may result in total the left upper quadrant. Five trocars (T) were positioned:gastrectomy as the sole surgical option [1]. At our (T1) a 10-mm trocar approximately 20 cm below theinstitution, we applied our experience in a prior randomized xyphoid process in the midline for a 30° camera system,trial of staple-line reinforcement in Roux-en-Y gastric (T2) a 10-mm trocar in the subcostal region on the leftbypass (RYGB) for bleeding reduction [26] toward thegoal of minimizing leak in SG. In a consecutive series ofmorbidly obese patients, we performed LSG between 2003

OBES SURGanterior axillary line, (T3) a 5-mm trocar 2 cm below the staple line and facilitate tissue remodeling. The buttressedxyphoid process for liver retraction, (T4) a 5-mm trocar on transection line was reinforced with titanium clips to obtainthe left mid-clavicular line and transverse umbilical line, perfect hemostasis; the nonbuttressed transection line wasand (T5) a 10–12-mm trocar (for Ethicon Endo-Surgery reinforced with a manual, running, absorbable, polydiox-[EES] staplers) or a 10–15-mm trocar (for Covidien anone seroserosal suture.staplers) on the right mid-clavicular line and transverseumbilical line. The calibrating bougie was replaced by a nasogastric tube positioned in the distal stomach to perform the The gastrocolic ligament attached to the stomach was methylene blue dye test for determination of staple-lineopened, beginning 10–12 cm from the pylorus toward the integrity. A clean sponge was placed along the transectionlower pole of the spleen. The gastric greater curvature was line, the bowel clamp was placed distal to the suture line,freed up to the cardioesophageal junction close to the and the reduced stomach was inflated with 60–80 cc ofstomach with the use of a vessel-sealing device (Ultracision methylene fluid; the swab and the transection line wereHarmonic Scalpel®, EES, Cincinnati, OH; LigaSure®, inspected for the presence of methylene blue dye. Follow-Covidien, Mansfield, MA) sparing the gastroepiploic ing a negative test, the resected stomach was removedvessels. Meticulous dissection was performed at the angle through the T5 trocar in a specimen bag, usually withoutof His with full mobilization of the gastric fundus. Large fat elongating the incision, and a left subcostal drain waspads of Belsey were resected to provide a clean field for placed. The 10-mm trocar access sites were closed with astomach resection. The esophageal hiatus was carefully suture passer (Endoclose®, Covidien, Norwalk, CT) withinspected for a hiatal hernia (HH). In the instance of a 2–0 absorbable vicryl suture. The 5-mm trocars were onlyhernia, the esophagus was encircled, and the diaphragmatic inspected for bleeding.crura were completely dissected to the mediastinal space.The gastric herniation was reduced into the abdomen. Outcomes and Data CollectionReconstruction was performed using nonabsorbable(0 Ethibond) interrupted sutures reinforced with a 1″×1″ Data collection was facilitated using Microsoft Excel®pledget of bovine pericardium with collagen matrix (Peri- 2008 (version 12.2.5, Redmond, WA). Operative time andStrips Dry® [PSD] with Veritas® Collagen Matrix Staple duration of hospital stay were recorded. Effectiveness endLine Reinforcement, Synovis Surgical Innovations, St. points included mean BMI change from baseline atPaul, MN), calibrated on a 40 French orogastric bougie. 6 months; mean %EWL at 6 months and trends in BMIMobilization of the stomach continued with inferior and %EWL (noted to 48 months); %EWL is calculated asdissection of the greater curvature toward the antrum up the difference in baseline and postsurgery weight dividedto 3–5 cm from the pylorus. Serosal attachments of the by the difference in baseline and ideal body weight (i.e.,posterior gastric wall to the pancreatic capsule were divided upper limit value of the medium-frame range on theuntil visualization of the caudate lobe of the liver was Metropolitan Life Insurance Tables [31]) multiplied byobtained. The final surgical preparation was a mobilized 100; and metabolic outcomes in diabetic patients at 2 weeksstomach tethered at the celiac axis. and 3 months. Safety end points were perioperative and long-term complications. Data were scheduled to be The anesthesiologist inserted a 40 French orogastric collected preoperatively, on the day of surgery, and atcalibrating bougie directed toward the pylorus along the postoperative visits at 2 weeks, every 3 months for the firstgastric lesser curvature. The stomach was resected with the postoperative year, at 1 year, and at a minimum, yearlylinear stapler parallel to the orogastric tube along the lesser thereafter.curve, starting 3–5 cm from the pylorus. The antrum waspartially resected by firing 3–5 green endoscopic linear Statistical Analysisstapler cartridges (ETS Flex® 4.1, EES; Echelon 60®, EES;Endo GIA 60® 4.8, Covidien) from the right-sided trocar The SPSS® software package (version 17, SPSS [IBM],(T5). As the muscular layer of the stomach is thicker, the Chicago, IL) was used to perform all statistical analyses.staple line at the level of the antrum is reinforced with Continuous demographic variables were reported as mean,seroserosal running sutures rather than staples. After standard deviation (SD), and range; categorical variablespassing by the level of the angular incisure, the gastric were reported as number and percentage. Concomitantcorpus and fundus were transected with 4–5 cartridges of surgical procedures and complications were also reported asthe 45-mm linear stapler or 3–4 cartridges of the 60-mm number and percentage. Continuous outcome variablesstapler, depending on their availability in the operating were generally reported as mean, SD, range, mean change,room (Endo GIA Universal®, Autosuture, Norwalk, CT; and percentage change. Ninety-five percent confidenceEndopath ETS®, EES; Echelon 60®, EES), and using intervals (CIs) were calculated for weight-loss outcomemultiple blue cartridges loaded with PSD to reinforce the

OBES SURGdata. Fisher's exact test was used to investigate relationships Table 1 Preoperative patient characteristicsbetween categorical variables. Between-group comparisonsalong continuous measures were carried out by means of Characteristic Value, mean±SD (range), N=121parametric and nonparametric tests, as appropriate (i.e.,independent samples t test or analysis of variance Age (years) 38.8±10.9 (15.0–64.0)[ANOVA]; Mann–Whitney U test or Kruskal–Wallis test). Height (m) 1.7±0.1 (1.5–2.0)Measures of change from baseline were analyzed using Absolute weight (kg)either the paired samples t test or the Wilcoxon signed-rank Excess body weight (kg) 134.6±29.0 (80.0–200.0)test. In addition, bivariate unadjusted analyses were Ideal body weight (kg) 74.1±26.8 (26.3–130.5)performed to identify preoperative characteristics associated BMI (kg/m2)with suboptimal weight loss; logistic regression was applied ASA score 60.6±5.4 (50.5–77.6)in the development of the predictive model. Statistical Number of comorbidities 48.7±9.3 (33.7–74.8)significance was set at p<0.05. Gender (N, %) Male 3.6±0.6 (2.0–4.0)Results Female 1.0±1.2 (0.0–4.0) Comorbidities (N, %)One hundred twenty-one patients qualified to receive LSG. Hypertension 41 (34.5)Sixteen patients (from January 2003 to December 2006) OSA 78 (65.5)underwent LSG as part of a staged bariatric procedure. T2DMFrom 2007 to 2009, 105 patients were operated on with the Hyperlipidemia 43 (36.1)intent of performing LSG as a primary procedure. One Arthroses 30 (25.2)patient who had undergone laparotomic intragastric balloon Celiac disease 23 (19.3)(IB) positioning with antral rupture, bleeding, and perfora- GERD 17 (14.3)tion in 2005 was explored laparoscopically with the intent 5 (4.2)of performing LSG in 2009; however, due to the poor 1 (0.8)quality of the tissue noted during gastric preparation, the 1 (0.8)operation performed was RYGB with gastrectomy of theremnant stomach. A second patient, intended for staged BMI body mass index, ASA American Society of AnesthesiologistsLSG 8 months after gastric band removal, presented with (physical status classification score), OSA obstructive sleep apnea,scar tissue and a difficult gastric preparation resulting in T2DM type 2 diabetes mellitus, GERD gastrointestinal esophagealmultiple positive intraoperative methylene blue tests at the reflux diseaselevel of the incisura angularis corresponding to the firstbuttressed transection line. After several failed attempts at Percentage ideal body weight and excess body weight determined bystaple-line repair with gastrogastric seroserosal sutures, this the Metropolitan Weight Tables for Life Insurance, 1983patient was converted to RYGB with distal gastrectomy. to IB positioning. After removal of the IB at 6 months, meanPatient Characteristics weight was 146.66±29.12 kg; mean BMI was 53.28± 10.03 kg/m2. The LSG procedure was performed after IB removal at 49±75 weeks. Only 18/32 IB patients were admitted to surgery within 16 weeks after BIB removal, as most of their weight loss was regained before the time of LSG surgery.Baseline characteristics of intent-to-treat patients are shown in Operative Time, Concomitant Procedures, and HospitalTable 1. Sixty-six percent of patients were women. The mean Stayage was 38.8±10.9 (15.0–64.0). Mean absolute weight was134.6±29.0 kg (80.0–200.0), mean BMI 48.7±9.3 (33.7– Mean operative time was 105 min (95–180). Among 3274.8), and mean excess body weight 74.1±26.8 kg (26.3– concomitant procedures, 8 (25%) were cholecystectomies,130.5). In operative risk assessment, American Society of 1 (3.1%) omentectomy, 1 (3.1%) biliointestinal bypassAnesthesiologists (ASA) physical status score [32] was mean restoration, 7 (22%) umbilical hernia repairs, and 15 (47%)3.6±0.6 (2.0–4.0). Hypertension was the most prominent HH reductions with cruroplasty (Table 2). One patientcomorbid illness (43, 36.1%), followed by obstructive sleep underwent both the omentectomy and biliointestinal bypassapnea (OSA; 30, 25.2%), T2DM (23, 19.3%), and hyperlip- restoration. The biliointestinal bypass restoration consistedidemia (17, 14.3%). of closure of the biliointestinal anastomosis with a linear stapler (60-mm ENDO GIA), cholecystectomy, closure of Prior to LSG, as a first-step in weight reduction, 32 patients ileo-ileal anastomosis (T-L), and a restoration of intestinal(mean weight, 167.37±31.94 kg; mean BMI, 60.91± continuity with a new ileo-ileal anastomosis, followed by11.83 kg/m2; mean EW, 125.69%±49.17) were submitted

OBES SURGTable 2 Concomitant procedures and complications in 121 patients with collagen matrix (PSD), was revised to an RYGB. Two patients of the two-stage series developed HH followingConcomitant procedure N (%) LSG; one was revised 14 months postsurgery to RYGB, and the other, who received to a BPD/DS 5 months after theCholecystectomy 8 (6.7) sleeve, underwent cruroplasty and fundectomy 38 monthsOmentectomy 1 (0.8) after the second stage because of untreatable symptoms. InBiliointestinal bypass restoration 1 (0.8) this case, in a 50-year-old woman with a preoperative BMIUmbilical hernia repair 7 (5.8) of 78 kg/m2, HH was not clearly recognized during herHiatal hernia reduction and cruroplasty 15 (12.6) LSG procedure, and a complete fundectomy was difficult toComplication N (%) achieve at that time; thus, during the revisional cruroplastyIntraoperative leak 1 (0.8) (at which time the patient had a BMI of 27 kg/m2), a re-Stricture 1 (0.8) resection of the fundus was performed to control her refluxExtraluminal bleeding (trocar site) 1 (0.8) symptoms (Fig. 1). The fundectomy was performed withAcute renal failure 1 (0.8) the use of reinforced 45-mm blue cartridges close to a 40 FrWound infection 2 (1.7) gastric bougie. The assistant surgeon exposed the fundusPostoperative leak 0 (0.0) using posterolateral traction while the surgeon applied traction on the sleeved stomach with the left hand, andsleeve gastrectomy. The omentectomy in this patient transected the stomach with the linear stapler in the rightresulted in the complete excision of the omentum close to hand, as close to the 40 Fr gastric bougie as possible.its emergence from the transverse colon. Mean postopera-tive time in hospital was 5.6 days (1–14). Weight LossMortality, Leak Rate, and Complications In the follow-up of 55 patients at the postoperative 6-month point, BMI decreased 24.7% to 37.5±9.3 (range 22.2–58.1)There was no perioperative or postoperative mortality in the representing a significant change of −12.3 from baselineseries. In one case of intraoperative leak (0.8%) at the level (p<0.001). Total group %EWL at 6 months was 48.1±19.3of the incisura angularis corresponding to the first but- (15.5–98.9) (Table 3). In the subgroup analysis of %EWL attressed transection line, suture repair was not successful; 6 months, there were no significant differences betweenafter repeating the methylene dye test with two positive males and females, age groups (<33, ≥33–<43, ≥43 years),results, the procedure was converted to an RYGB. There or comorbidity group (comorbidity presence vs. not present);were no postoperative leaks in the series. Overall compli- however, a significant difference was found between BMIcations (6, 5.0%) included one stricture, treated with subgroups (<40, ≥40–<50, ≥50; p<0.001). Nonparametricendoscopic dilation; one extraluminal bleed at the trocar ANOVA followed by independent Mann–Whitney U testssite, treated with a blood transfusion; one acute renal failure1 week after surgery, treated in the intensive care unit Fig. 1 Laparoscopic sleeve gastrectomy and hiatal hernia. Pts(patient discharged after 10 days); and two wound patients, BPD/DS biliopancreatic diversion/duodenal switch, RYGBinfections, managed with drainage and antibiotics (Table 2). Roux-en-Y gastric bypass The patient who developed stricture postoperatively hada gastric band removed 8 months prior to the planned LSG;the stricture developed before the gastric angle at the levelof the last unbuttressed staple line. The patient withpostoperative bleeding experienced a decrease of hemoglo-bin concentration from 14.5 to 11.0 mg/dL within the first24 postoperative hours; there was no blood drainagethrough the drainage tube positioned close to the excisionline. A CT contrast study in POD1 showed a largeproperitoneal blood collection near the left side trocar site.This acute bleeding was treated with blood cell unittransfusion and resolved within 48 h. Of the 15 patients operated concomitantly for HH, three(20%) recurred; one of these, who had also previouslyreceived crural repair by interrupted nonabsorbable suturesthat was reinforced with a pledget of bovine pericardium

OBES SURGTable 3 Total and subgroup weight loss at 6 monthsTotal group Value N=55 Mean ± SD (range) Mean change (% change) 95% CI p valueaAbsolute weight (kg) 103.0±26.8 (59.6–165.9) −33.9 (24.8) −37.7–−30.2b <0.001BMI (kg/m2) 37.5±9.3 (22.2–58.1) −12.3 (24.7) −13.6–−11.0b <0.001 48.1±19.3 (15.5–98.9) – 42.9–53.3c –EWL (%) N Mean ± SD (range) 95% CIc p value NSdSubgroups 37 48.1±20.2 (15.5–98.9) 41.4–54.8 18 48.1±17.8 (17.4–82.6) 39.2–57.0 NSeEWL (%), by gender 18 53.3±21.8 (15.5–87.6) 42.5–64.1 <0.001e Females 16 45.2±19.6 (20.8–98.9) 34.8–55.6 Males 21 45.9±16.7 (17.4–71.6) 38.3–53.5 NSdEWL (%), by age (years) 12 63.3±20.5 (29.4–98.9) 50.3–76.3 15 54.7±11.7 (29.4–70.3) 48.2–61.2 <33 28 38.0±16.5 (15.5–86.9) 31.6–44.4 ≥33–<43 ≥43 29 46.2±19.9 (15.5–98.9) 38.6–53.8EWL (%), by BMI 26 50.2±18.7 (20.8–87.6) 42.7–57.8 <40 ≥40–<50 ≥50EWL (%), by comorbidity Present Not presentBMI body mass index, EWL excess weight loss, CI confidence intervala Paired samples t test assessing change from baselineb 95% CI of mean differencec 95% CI of the meand Independent samples Mann–Whitney U teste Kruskal–Wallis one-way ANOVArevealed significant differences between the lowest and variance in %EWL and, as a lone predictor, was found tohighest BMI groups, and also between the mid-range BMI correctly classify >70% of patients who experienced <50%and highest BMI groups, but no statistically significant EWL at 6 months. (At 3 years, preoperative BMI accounteddifference between the lowest and the mid-range BMI for 72.3% of the variance in %EWL, n=11.) Figure 3bgroups (Table 3). Figure 2 presents mean BMI and %EWL presents results of logistic regression analysis in the form offollowing LSG with respect to time from 1 to 48 months. At a probability curve. As BMI remained the only significant12 months (n=41), BMI was 38.4±10.5 (19.3–62.3) with predictor (odds ratio=1.13, 95% CI 1.05–1.21, p<0.001) in51.7±25.0 (8.9–123.3) %EWL; at 24 months (n=23), BMI the multivariate model, its beta coefficient and associatedwas 37.5±7.5 (24.7–49.7) with 53.1±16.6 (25.3–84.5) % constant were used to develop the equation characterizingEWL; at 36 months (n=11), BMI was 35.5±8.8 (25.9–51.9) the likelihood of suboptimal weight loss (%EWL <50 atwith 63.9±14.0 (35.2–81.0) %EWL; and at 48 months (n= 6 months) as a function of preoperative BMI.13), BMI was 35.6±6.8 (24.9–47.5) with 61.1±12.2 (43.9–82.1) %EWL. Diabetes Subgroup Analysis Table 4 presents the bivariate analysis results investigat- Two weeks following LSG, 100% of preoperative T2DMing preoperative clinical variables and their potential value patients (n=23, mean preoperative T2DM duration 3.7 yearsin predicting suboptimal weight loss at 6 months. Pre- [range 1–10]) were in remission and off all medical therapy.sleeve BMI was the only significant predictor in the Mean glycosylated hemoglobin (HbA1C, %) in the diabeticbivariate analysis; however, patient ASA score and pres- subgroup was 6.5±0.8, reduced from a baseline HbA1C ofence of T2DM trended toward significance and were, 7.6±1.6 (p<0.01); mean glycemic level (mg/dL) was 90.6±therefore, incorporated into the multivariate model. 22.4, reduced from 133.9±29.6 (p<0.01). Three-monthFigure 3a depicts the results of bivariate correlation analysis data (Table 5) confirmed and reinforced 2-week results:of %EWL and BMI at 6 months (Pearson r=−0.58; p< 100% of patients remained off diabetic medication; HbA1C0.001). Preoperative BMI accounted for 33.6% of the

OBES SURG addition, at 3 months, diabetic subgroup BMI decreased 70 18.7% from baseline (p<0.01) with a mean %EWL of 70 %EWL BMI 37.2±11.7 (18.8–53.1), which was not significantly differ- ent from %EWL of the nondiabetic subgroup (34.1±13.0 60 60 [16.0–66.5]). 50 50BMI Discussion %EWL 40 40 San Giovanni Bosco Hospital, Naples, has steadily increased its annual use of the LSG procedure since 2002; this is 30 30 consonant with increased performance of SG in Italy, and globally [24, 33]. We began performing LSG as the first step 20 20 of a two-stage procedure (BPD-DS) in super-obese patients (1/62 cases in 2002, 4/74 [2003], 6/100 [2004], 3/100 N=119 N=85 N=56 N=55 N=41 N=23 N=11 N=13 [2005], 3/97 [2006]). Considering the minimal morbidity and complications experienced by our patients, combined with 0 1 3 6 12 24 36 48 satisfactory weight loss, in 2007, we began offering LSG as Time (months) a definitive procedure for the treatment of mild obesity as well, extending this procedure to a larger number of patientsFig. 2 Body mass index (BMI) and percentage excess weight loss (% (15/102 [2007], 19/96 [2008], 67/110 [2009], 148/169EWL) with respect to time following laparoscopic sleeve gastrectomy [2010]).was 5.9±0.5, a decrease of 22.4% from baseline (p<0.001); In the current study, our early findings of 48.1% andand mean glycemic level, 90.0±19.9, a decrease of 32.8% 51.7% EWL at 6 and 12 months, respectively, are in thefrom baseline (p<0.01). Cholesterol and triglyceride reduc- range of the mean EWL, 55.4%, reported in the systematiction in the T2DM subgroup trended toward significance. In review of 2,570 SG patients (36 studies, 3–60 month follow-up) by Brethauer et al. [15], and 60.7% in a large international questionnaire-based consensus review (repre- senting 14,776 SG patients, 12-month follow-up) by Gagner et al. [34]. Other approved bariatric procedures realize a weight-loss zenith at 2–4 years with some weight regain at 3–5 years. In the only >5-year SG series withTable 4 Bivariate analysis of preoperative clinical variables with respect to weight loss following sleeve gastrectomy at 6 monthsVariable <50% EWL (N=29) ≥50% EWL (N=26) p valueAge 39.5 ± 10.5 38.1 ± 11.3 NSaMale sex 9 (31.0%) 9 (34.6%) NSbBMI 54.2 ± 8.8 45.0 ± 8.2 <0.001aASA score 3.6 ± 0.6 3.4 ± 0.7 NSa (0.16)Number of comorbidities 1.2 ± 1.4 0.9 ± 1.2 NSaComorbidity Hypertension 12 (41.4%) 12 (46.2%) NSb OSA 9 (31.0%) 6 (23.1%) NSb T2DM 8 (27.6%) 3 (11.5%) NSb (0.13) Hyperlipidemia 5 (17.2%) 2 (7.7%) NSbEWL excess weight loss, BMI body mass index, ASA American Society of Anesthesiologists (physical status classification score), OSA obstructivesleep apnea, T2DM type 2 diabetes mellitusData are expressed as mean ± SD for continuous variables, and N (%) for categorical variablesa Mann–Whitney U testb Fisher's exact test

OBES SURGa useful in aiding patients to visualize their likelihood of requiring a second operation, and may promote realistic r = –0.58 weight-loss expectations. For example, a patient with a pre- p < 0.001 LSG BMI of 48.5 would have a 50% chance of experiencing a 6-month outcome of <50% EWL, whereas Pre-operative BMI a pre-LSG BMI of 69 would predict a 90% chance of <50% EWL at 6 months. This finding may be due to the fact thatb the patients with a higher preoperative BMI were initially subjected to temporary IB treatment which resulted inFig. 3 a Scatter plot and regression line depicting inverse relationship substantial weight loss prior to undergoing LSG.between preoperative body mass index (BMI) and percentage excessweight loss (%EWL) following laparoscopic sleeve gastrectomy at Rapid improvement of T2DM following the primarily6 months. b Probability curve characterizing likelihood of patient with restrictive SG typically occurs within weeks of surgery,a given preoperative BMI experiencing %EWL <50 6 months similar to that following primarily malabsorptive proce-following laparoscopic sleeve gastrectomy. For example, a patient dures. In the current study, mean HbA1C, glycemia, andwith a pre-sleeve BMI of 48.5 is predicted to have a 50% chance of triglyceride levels were reduced to within normativeexperiencing a 6-month weight-loss outcome of <50% EWL, whereas reference ranges at 3 months after surgery, and 100% ofa patient with a pre-sleeve BMI of 69 is predicted to have a 90% the T2DM subgroup no longer required T2DM medication.chance of experiencing a 6-month weight-loss outcome of <50% EWL The percentage of those in whom T2DM resolved was superior to resolution observed in the majority of SGcomplete follow-up (n=26), a 2010 study by Bohdjalian et reports, which ranges from 14% to 100% [5–7, 36–45].al., 3-year EWL was 60%, and 55% at 5 years [35].Although only a small number of LSG patients in our study There was no mortality in our series. In two recenthad reached 3-year (63.9% EWL) and 4-year (61.1% EWL) reviews of LSG (n=3,510), mortality ranged from 0.17% tofollow-up, their weight loss suggests a similar trend. 0.24% [15, 46]. The overall complication rate ranges from 0% to 24% (mean 9.4% high-risk/staged, 6.2% primary In our series, the lowest BMI group (<40) experienced [15]) in the SG literature; complications in the current studythe greatest %EWL, significantly more than the highest were low, 5.0%. Hiatal hernia, sometimes with gastro-BMI group (≥50). When treated as a continuous variable, esophageal reflux disease (GERD), is a frequent occurrencecorrelation and logistic regression analyses demonstrated in the obese (15% incidence symptomatic HH in BMI >35that preoperative BMI was predictive of suboptimal weight [47]), and in most instances, bariatric surgery successfullyloss. This analysis, and resultant probability curve, may be treats the hernia (restoring cardioesophageal competence [48, 49]), obesity, and GERD [50]. In our series of 15 patients with HH operated concomitantly with LSG, three (20%) recurred, one was revised to RYGB, and two await reoperation. Of patients who developed HH postoperatively (patients of the two-stage series), one was revised 14 months postsurgery to RYGB, and the other, who received a BPD/ DS 5 months after the sleeve, underwent cruroplasty and fundectomy 38 months after the second stage because of untreatable symptoms. In the super-super obese patients undergoing LSG, it may be very difficult to recognize a crural defect, and especially considering the aim of this “salvage operation,” it might not be indicated to perform complex and risky esophageal dissection. In the case of a 50-year-old woman with a preoperative BMI of 78 kg/m2, during her LSG procedure, HH was not clearly recognized, and a complete fundectomy was not attempted at that time. SG can improve or ameliorate symptoms of preoperative GERD in 40% to 85% of patients if there is successful crural repair [51]. In the authors' experience, “trans-hiatal sleeve migration” with crural dehiscence carries severe GERD symptom recur- rence. When HH cannot be satisfactorily repaired at time of LSG, conversion to RYGB should be considered. In