Sleeve gastrectomy: 5-year outcomes of a single institution

Transcription

1 Surgery for Obesity and Related Diseases 9 (2013) Original article Sleeve gastrectomy: 5-year outcomes of a single institution Logan Rawlins, M.D. a, *, Melissa P. Rawlins, M.P.A., P.A.-C. b, Carey C. Brown, M.D., F.A.C.S. b, David L. Schumacher, M.D., F.A.C.S. b a Department of Surgery, Wright State University, Dayton, Ohio b Kettering Bariatric Surgery, Kettering Sycamore Hospital, Miamisburg, Ohio Received May 31, 2012; accepted August 28, 2012 Abstract Keywords: Background: Laparoscopic sleeve gastrectomy (SG) is the most recent bariatric surgical procedure to gain universal acceptance by providers and payers. Long-term clinical data on outcomes is limited at this time. Methods: We retrospectively examined 5-year outcomes (weight loss, complications, and resolution of co-morbid conditions) of patients undergoing SG at our institution. Results: Our initial SG was performed in 2005, and we operated on 55 consecutive patients who are 5 years out from surgery. Six patients were excluded from the long-term results. Four patients underwent conversion to a duodenal switch, and 2 patients died in the first year outside the perioperative period. Average starting body mass index was 65 kg/m 2. Five-year average percent excess weight loss was 86% (range 50% 103%). Percentage of co-morbidities resolved: hypertension (95%), type 2 diabetes mellitus (100%), hyperlipidemia (100%), and obstructive sleep apnea (100%). Gastroesophageal reflux disease (GERD) was resolved in 53%, and new GERD symptoms developed in 11% of patients. There was 1 staple line leak (1.9%), no strictures, no gastrointestinal bleeding, and no perioperative deaths. Conclusion: In this study, SG is a well-tolerated and effective bariatric surgical procedure with good long-term weight loss and resolution of co-morbid medical conditions. (Surg Obes Relat Dis 2013;9:21-25.) Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery. Laparoscopic sleeve gastrectomy; Five year; Long-term; Weight loss; Outcomes; Medicare Laparoscopic sleeve gastrectomy (SG) is the most recent bariatric surgical procedure to gain universal acceptance by providers and payers. However, long-term clinical data on outcomes are limited at this time. We initially offered SG as part of a staged duodenal switch procedure for super morbidly obese patients and have since initiated SG as a stand-alone procedure secondary to promising success rates. This is consistent with other published reports of this evolution [1 3]. Controversies exist regarding surgical technique, including site of initial transection, staple cartridge choice, bougie size, staple line reinforcement, and method for intraoperative leak test [4]. SG is slow to become * Correspondence: Logan Rawlins, M.D., Kettering Sycamore Bariatric Surgery, 4000 Miamisburg Centerville Road, Suite 210, Miamisburg, OH rawlinml@yahoo.com universally covered by all insurance payers despite promising short-term outcomes. We sought to review our results of patients who were 5 years out from surgery and describe the key variations in surgical technique unique to our practice. Methods We performed a retrospective chart review of patients who underwent SG starting in 2005 and report our 5-year clinical outcomes (weight loss, complications, and resolution of co-morbid conditions). All patients consented preoperatively to the collection of data in a prospective database, which was analyzed retrospectively. The study was submitted to the hospital institutional review board for approval before analysis of data. The diagnosis of arterial hypertension was defined by a blood pressure 4120/80 mm Hg and was considered /13/$ see front matter Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.

2 22 L. Rawlins et al. / Surgery for Obesity and Related Diseases 9 (2013) resolved when vital signs normalized off medication. Type 2 diabetes was diagnosed by fasting blood glucose 4126 mg/dl or glycated hemoglobin 46 g/dl and requiring medication for control. Resolution was discontinuation of antiglycemic medications with these laboratory values reversed. Hyperlipidemia was defined as having a total cholesterol 4200 mg/dl, triglycerides 4150 mg/dl, or both, and was considered resolved when these values were normal without medication. The diagnosis of obstructive sleep apnea was made by a sleep study and treated with nighttime continuous positive airway pressure (CPAP). Resolution was confirmed by repeat sleep study off CPAP. Gastroesophageal reflux disease (GERD) was diagnosed by patient report. GERD was resolved if patients symptomatically tolerated withdrawal of medication 3 months after surgery. Our surgical technique started with taking down the greater curvature of the stomach and short gastric vessels with an ultrasonic dissector. An upper endoscopy was performed to rule out any gastric abnormality, and the tip of the scope was left in the first portion of the duodenum. Vertical transection of the stomach was accomplished with 5 6 firings of a 60-mm linear stapler (Ethicon Endo-Surgery, Echelon Flex, Cincinnati,OH).Thefirstfiringwasinitiated 3 cm from the pylorus, measured with a grasper. The 26.4F endoscope (8.8 mm in diameter) was used as the bougie, and each of the staple fires were taken closely against the scope, with the exception of the firing opposite to the incisura, at which the width is widened by a few unmeasured mm to prevent stenosis in this location. Three green staple loads (open staple height 4.1 mm) were used near the antrum, followed by 3 blue loads (3.5 mm) closer to the angle of His. More recently, we have added black loads (4.4 mm) and gold loads (3.8 mm); however, these products were not available in Transition between staple load sizes was determined by the operating surgeon based on intraoperative qualitative anatomical assessment of stomach thickness. No buttress material was used. A Vicryl suture was placed at each crossing staple line, and the entire staple line from the incisura to the antrum was imbricated with a running Vicryl suture. An air leak test was performed as the endoscope was withdrawn. The staple line was then covered with fibrin sealant, and a drain was left for a period of 1 week. Results We started performing SG in 2005 and have 55 patients who are 5 years out from surgery. This encompasses operating dates from January 2005 to December As of October 2011, we have performed a total of 276 SG procedures, although only patients who are 5 years out from surgery were included in this study. No patients were lost to follow-up. Six patients were excluded from the data; 4 were converted to duodenal switch at 2 years, and 2 died outside the perioperative period in the first year after surgery. One died from ischemic colitis, and the other committed suicide. Average starting body mass index Fig. 1. Sleeve gastrectomy long-term (5-year) weight loss. (BMI) was 65 kg/m 2 (range ). Five-year average weight loss results (with range) are as follows: percent excess weight loss (%EWL): 86% (range ); BMI reduction: 35 kg/m 2 (range ); percent excess BMI loss (%EBMIL): 91% (range ); percent weight loss (%WL): 53% (range ); kg lost: 95 kg (range ). Average %EWL at each yearly follow-up interval was as follows: 1 year: 56%; 2 year: 70%; 3 year: 77%; 4 year: 81% (Fig. 1). Seventy percent (n ¼ 37) of the study participants were female. Patients ages ranged from years old, with an average age of 44. Only 1 patient was 65 years or older. Fourteen of the patients were Medicare beneficiaries; the sole 65-year-old patient was one of them. There was no statistical difference in the 5-year %EWL between Medicare and non-medicare beneficiaries (84.9 versus 86.1%; P ¼.74). There was complete or near-complete resolution of comorbidities in most patients, including hypertension, type 2 diabetes mellitus, hyperlipidemia, and obstructive sleep apnea (Table 1). The only exception was GERD, which was resolved in 53% (8/15) of patients. New GERD symptoms developed in 11% (6/53) of all patients or 16% (6/38) of those without preexisting GERD. Regarding complications directly related to SG, there was 1 staple line leak (1.9%) at the angle of His, no strictures, no gastrointestinal bleeding, and no perioperative deaths. There were no conversions to an open procedure. Table 1 Sleeve gastrectomy 5-year resolution of co-morbidity Co-morbidity Resolved, % n Hypertension 95 41/43 Type 2 diabetes mellitus /19 Hyperlipidemia /23 Obstructive sleep apnea /23 Gastroesophageal reflux 53 8/15

3 Sleeve Gastrectomy: 5-Year Outcomes / Surgery for Obesity and Related Diseases 9 (2013) Discussion The most recent compilation of data regarding SG was collected and published in 2011 by Deitel et al. [5]. The mean %EWL at 5 years was 60%; however, this comprised only 4 studies with long-term data. Those studies, by Santoro [6], Weiner et al. [7], Bohdjalian et al. [8], and Himpens et al. [9], as well as those published more recently by D Hondt et al. [10], Serela et al. [11], and Strain et al. [12], are summarized in Table 2. Our cohort of patients had a much higher starting BMI compared with other published reports [5]. Initially, SG was not intended as a stand-alone procedure, but rather as a part of a staged duodenal switch for super morbidly obese patients. When patients did not require a second stage procedure after successful weight loss and resolution of comorbidities, we transitioned to performing this procedure in lower BMI patients. We have only 1 patient 465 years old included in this data. Anecdotally, we believe that older patients were more likely to have diabetes, and given that little was known on the antidiabetic effect of sleeve gastrectomy at the time, these patients were steered toward gastric bypass. As we learn more about the success of SG in diabetic patients and have an expanding group of older patients seeking bariatric surgery, we have performed this procedure more commonly in the past few years within this group. In respect to Medicare beneficiaries, most of whom were eligible based on disability instead of age, there was no difference in weight loss results compared with non-medicare beneficiaries. Our reported weight loss results are much higher than the other published data [5 12]. The reason for this is multifactorial. The most easily quantifiable variable is surgical technique. We begin our transection 3 cm from the pylorus, which is closer than many other published reports (2 8 cm) [4]. We also use a 26.4F endoscope (8.8 mm in diameter) as the bougie, creating a very tight sleeve, which is the smallest reported in the literature. We believe that this added restriction is necessary to aid the patient in modifying his or her eating habits. Other surgeons do not make the sleeve as tight because of concerns for narrowing the incisura or making the sleeve too small and developing a stricture. This has previously been reported to lead to a higher rate of leaks [13]. We have not found this to be true in our patients. Moreover, we have not had to perform dilations, stricturoplasty, or conversion to gastric bypass in any of these patients. Smaller bougie size is important to improve weight loss results and resolution of co-morbidities. This has been previously demonstrated by Atkins et al. [14], who found superior weight loss with a 40F versus 50F bougie at 4 years follow-up. In addition to surgical technique, we use other selection and management factors that we feel make a difference in weight loss, although these factors are more difficult to quantify. The patients we steer toward SG are large-volume eaters. Large-volume eaters are, theoretically, more likely to have improved weight loss with a restrictive procedure. The SG is low maintenance for these patients compared with an adjustable gastric band and has few malabsorptive effects [15]. We also use dieticians and exercise physiologists in the preoperative and postoperative management of all our patients. They are required to see these ancillary providers before surgery, in the hospital, and postoperatively at 1-week, 1-month, and 3-month intervals for the first year. They may continue to use these services at their discretion thereafter. GERD was the one co-morbidity for which there was only moderate patient improvement. Resolution occurred in only 53% (8/15) of patients, and new GERD symptoms developed in 16% (6/38) of those without preexisting GERD. This is consistent with other published reports, which have indicated that SG may be refluxogenic [6]. Mechanisms that have been postulated to account for this finding include concomitant presence of a hiatal hernia, dissection of the phrenoesophageal ligament, intact or incompetent pylorus with a narrow gastric tube, intrathoracic sleeve migration, narrowing at the incisura, or fundus regrowth ( neostomach ) [9,16 17]. Some surgeons consider a hiatal hernia or preexisting GERD to be a contraindication to SG, but we do not necessarily share that sentiment [18]. Patients with new GERD are worked up with a contrasted upper gastrointestinal series and endoscopy to rule out ulcer, stricture, sleeve migration, and Table 2 Sleeve gastrectomy 45-year weight loss literature Article Follow-up, yr n %EWL BMI (kg/m 2 ) reduction Initial BMI Weiner et al. (2007) [7] 5 8 NA Santoro (2007) [6] 5 NA 55 NA NA Himpens et al. (2010) [9] Bohdjalian et al. (2010) [8] D Hondt et al. (2011) [10] 5/6 27/23 71/56 NA 39.3 Sarela et al. (2011) [11] Strain et al. (2011) [12] Present study (2012) %EWL ¼ percent excess weight loss; BMI ¼ body mass index; NA ¼ not available.

4 24 L. Rawlins et al. / Surgery for Obesity and Related Diseases 9 (2013) neofundus. No abnormal findings were discovered in any of our patients, and they were all treated successfully with proton pump inhibitors. The single sleeve leak we experienced occurred high near the gastroesophageal junction. The leak was identified on postoperative day 3 and was treated conservatively with the drain left at the time of surgery and parenteral nutrition for 6 weeks. No stents were used. A splenic abscess was identified 1 year later and was treated with an open splenectomy. We believe this complication was related to latent infection from the leak in conjunction with splenic infarction. However, this complication presented quite late, so the true cause may be unknown. The 4 patients converted to a duodenal switch deserve some special attention. All were super-super morbidly obese (BMI: 106, 81, 76, and 73) at the time of initial surgery, and all lost significant weight before revision (BMI reduction of 34, 32, 39, and 32, respectively). At the time of revision at 2 years, the %EWL for those 4 patients was 41/55/55/68%, and at 5 years total follow-up, they settled at a %EWL of 67/ 76/92/94%, respectively. Although all 4 patients still had a BMI above 35 before conversion, only 1 had a %EWL of o50. Patients considered for conversion were those whose BMI had stabilized 435 and had persistent comorbid conditions. We did not expect patients to do so well with stand-alone SG, and our very low rate of conversion (7%) is a testament to the efficacy of this procedure as a standard bariatric operation. It may be thought that our exclusion of these 4 conversions adds bias to the study, but rather we feel the opposite, as the data are cleaner in regard to interpreting the long-term results of SG by itself. In fact, with the inclusion of those 4 patients %EWL at 5 years, the %EWL of 86% that we report did not change. In this study, we report a 100% 5-year follow-up of 49 patients after sleeve gastrectomy. This is difficult to attain. Our practice is diligent about auditing patients who do not follow-up and calling them to reestablish care. Given that this study was following only 49 specific patients 5 years out made this task somewhat easier. Of the 49, 32 had followed up with us every year for 5 years. Of the remaining 17, there was some missing data for the 4- and 5-year time points. Of the 17, 10 were still in town, and these patients were scheduled for office follow-up, their charts updated, and their data collected and recorded. The remaining 7 patients were no longer in town but were all able to be reached by phone, and their weights were based on self-reports. These 7 patients are our most unverified data, because we did not directly record it, which could be seen as a limitation of the study. Our study is further limited by its retrospective nature and small sample size. Although this data was not obtained from a prospective trial, every patient included had adequate follow-up for reporting purposes. Despite reporting 5-year outcome data on only 49 patients, this represents the largest cohort in the published literature to date. Conclusion In our experience, SG is an effective bariatric surgical procedure with good long-term (5 year) weight loss (86% EWL) and resolution of co-morbid medical conditions with a low and acceptable safety profile. Disclosure The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Silecchia G, Rizzello M, Casella G, Fioriti M, Soricelli E, Basso N. Two-stage laparoscopic biliopancreatic diversion with duodenal switch as treatment of high-risk super-obese patients: analysis of complications. Surg Endosc 2009;23: [2] Moy J, Pomp A, Dakin G, Parikh M, Gagner M. Laparoscopic sleeve gastrectomy for morbid obesity. Am J Surg 2008;196:e56 9. [3] Iannelli A, Schneck AS, Dahman M, Negri C, Gugenhim J. Two-step laparoscopic duodenal switch for superobesity: a feasibility study. Surg Endosc 2009;23: [4] Rosenthal RJ. International Sleeve Gastrectomy Expert Panel. International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of 412,000 cases. Surg Obes Relat Dis 2012;8:8 19. [5] Deitel M, Gagner M, Erickson AL, Crosby RD. Third International Summit: current status of sleeve gastrectomy. Surg Obes Relat Dis 2011;7: [6] Santoro S. Technical aspects in sleeve gastrectomy. Obes Surg 2007; 17: [7] Weiner RA, Weiner S, Pomhoff I, Jacobi C, Makarewicz W, Weigand G. Laparoscopic sleeve Gastrectomy influence of sleeve size and resected gastric volume. Obes Surg 2007;17: [8] Bohdjalian A, Langer FB, Shakeri-Leidenmuhler S, et al. Sleeve Gastrectomy as sole and definitive bariatric procedure: 5-year results for weight loss and ghrelin. Obes Surg 2010;20: [9] Himpens J, Dobbeleir J, Peeters G. Longterm results of laparoscopic sleeve gastrectomy for obesity. Ann Surg 2010;252: [10] D Hondt M, Vanneste S, Pottel H, Devriendt D, Van Rooy F, Vansteenkiste F. Laparoscopic sleeve gastrectomy as a single-stage procedure for the treatment of morbid obesity and the resulting quality of life, resolution of comorbidities, food tolerance, and 6-year weight loss. Surg Endosc 2011;25: [11] Sarela AI, Dexter SP, O Kane M, Menon A, McMahon MJ. Longterm follow-up after laparoscopic sleeve gastrectomy: 8 9 -year results. Surg Obes Relat Dis 2012;8: [12] Strain GW, Saif T, Gagner M, Rossidis M, Dakin G, Pomp A. Crosssectional review of effects of laparoscopic sleeve gastrectomy at 1, 3, and 5 years. Surg Obes Relat Dis 2011;7: [13] Gagner M. Leaks after sleeve gastrectomy are associated with smaller bougies: prevention and treatment strategies. Surg Laparosc Endosc Percutan Tech 2010;20: [14] Atkins ER, Preen DB, Jarman C, Cohen LD. Improved obesity reduction and co-morbidity resolution in patients treated with 40- French bougie versus 50-French bougie four years after laparoscopic sleeve gastrectomy. Analysis of 294 patients. Obes Surg 2012;22: [15] Gehrer S, Kern B, Peters T, Christoffel-Courtin C, Peterli R. Fewer nutrient deficiencies ater laparoscopic sleeve gastrectomy (LSG) than after laparoscopic Roux-Y-gastric bypass (LRYGB) a prospective study. Obes Surg 2010;20:

5 Sleeve Gastrectomy: 5-Year Outcomes / Surgery for Obesity and Related Diseases 9 (2013) [16] Baumann T, Grueneberger J, Pache G, et al. Three-dimensional stomach analysis with computed tomography after laparoscopic sleeve gastrectomy: sleeve dilation and thoracic migration. Surg Endosc 2011;25: [17] Braghetto I, Lanzarini E, Korn O, Valladares H, Molina JC, Henriquez A. Manometric changes of the lower esophageal sphincter after sleeve Gastrectomy in obese patients. Obes Surg 2010;20: [18] Kakoulidis TP, Karringer A, Gloaguen T, Arvidsson D. Initial results with sleeve gastrectomy for patients with class I obesity (BMI kg/m2). Surg Obes Relat Dis 2009;5:425 8.