Treatment of massive super-obesity with laparoscopic adjustable gastric banding

Surgery for Obesity and Related Diseases 2 (2006) 37– 40

Original article

Treatment of massive super-obesity with laparoscopic adjustable gastric banding Jonathan A. Myers, M.D.*, Sharfi Sarker, M.D., Vafa Shayani, M.D. Department of Surgery, Loyola University Medical Center, Maywood, Illinois Manuscript received June 21, 2005; revised September 14, 2005; accepted September 29, 2005

Abstract

Background: Controversy exists concerning the optimal treatment of patients with massive superobesity (body mass index ⬎60 kg/m2). The ideal surgical operation must balance optimal weight loss with minimal morbidity and mortality. We report our results for this patient population undergoing laparoscopic adjustable gastric banding (LAGB). Methods: We performed a retrospective review of all consecutive patients undergoing LAGB at our institution. Patients with a preoperative body mass index ⬎60 kg/m2 were identified and their charts were reviewed. Weight loss data were collected when the patients returned for band adjustments. All band adjustments were patient driven and performed under fluoroscopic guidance. Results: Between November 2001 and October 2004, 352 patients underwent LAGB. Of these, 53 had a preoperative body mass index ⬎60 kg/m2 (15%). The mean absolute weight and body mass index was 186.6 kg (range 139.6 –250.6) and 66 kg/m2 (range 60.0 –79.8), respectively. The average follow-up was 12.5 months (range 1.3–31). The most prevalent co-morbidities were obstructive sleep apnea (64%), hypertension (42%), and diabetes mellitus (42%). Postoperative complications included one band removal for chronic obstruction, one band revision for slippage, and one nonfatal pulmonary embolism. The mean percentage of excess weight loss was 15% (⫺1.1 to 27.4) with ⬍6 months of follow-up, 28.1% (range 1.9 – 44.5) with 6 –12 months of follow-up, 35.1% (range 8.8 – 84.9) with 12–18 months of follow-up, and 42.9% (range 15.7– 80.1) with ⬎18 months of follow-up. Compared with our cohort of nonmassive super-obese patients, massive super-obese patients required a longer period of follow-up to accomplish a similar percentage of excess weight loss. Conclusion: LAGB is an appropriate surgical option for the treatment of massive super-obesity. The procedure can be performed with minimal morbidity and mortality and leads to promising medium-term weight loss. Longer term follow-up of massive super-obese patients is necessary and may demonstrate even more successful results. © 2006 American Society for Bariatric Surgery. All rights reserved.

Keywords:

Laparoscopic adjustable gastric banding; Massive super-obesity

Bariatric surgery remains a challenging field because of the high incidence of associated morbidity and mortality. Patients who are morbidly obese (body mass index [BMI] ⬎40 kg/m2) often present with multiple medical, surgical,

Presented at the 22nd Annual Meeting of the American Society for Bariatric Surgery, Orlando, Florida, June 26 –July 1, 2005 *Reprint requests: Jonathan A. Myers, M.D., Department of Surgery, Loyola University Medical Center, 2160 South First Avenue, Maywood, IL 60513.

and anesthetic risks. As we continue to accumulate more experience in this field, the need to categorize and risk stratify extremely obese patients further has been recognized [1]. Patients who have a BMI ⬎50 kg/m2 are classified as super-obese and those with a BMI ⬎60 kg/m2 are considered to be super super-obese (massive super-obesity) [2– 4]. Surgical treatment for these patients is an important consideration, because no other weight reduction therapy appears to be effective. In addition to our concerns about the safety of operating on this patient population, controversy

1550-7289/06/$ – see front matter © 2006 American Society for Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2005.09.015

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J.A. Myers et al. / Surgery for Obesity and Related Diseases 2 (2006) 37– 40

Table 1 Co-morbidities Obstructive sleep apnea Hypertension Arthritis Gastroesophageal reflux Hypercholesterolemia Asthma Diabetes mellitus Depression Urinary incontinence Hypothyroid Coronary artery disease

64% 42% 42% 28% 23% 21% 19% 17% 6% 6% 2%

exists regarding the best method to achieve optimal weight loss. Surgical options include biliopancreatic diversion (BPD), Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), 2-stage BPD, 2-stage RYGB, and even LAGB coupled with preoperative gastric balloon therapy [ 3–10]. The ideal surgical operation must balance optimal weight loss with minimal morbidity and mortality. Few reports are available that have established recommendations on the ideal operation for weight loss for the super-obese population, and even fewer have offered guidelines for dealing with the massively super-obese population. We report our results for the massive super-obese patient population undergoing LAGB at our institution. Methods We performed a retrospective review of all consecutive patients undergoing LAGB at our institution. All procedures consisted of laparoscopic placement of a gastric band (LapBand System, Inamed Health, Santa Barbara, CA) around the proximal stomach. The 10-cm band was used in all patients operated on before April 2004. After this date, the 11-cm VG band was released and used in all subsequent patients in this study. Patients with a preoperative BMI ⬎60 kg/m2 were identified as massively super-obese and their charts were reviewed. Weight loss data were obtained at subsequent follow-up visits for band adjustment. Excess weight was defined as the difference between the actual weight and the ideal body weight (using a BMI of 25 kg/m2) before surgery. All band adjustments were patient driven and performed under fluoroscopic guidance. Results Between November 2001 and October 2004, 352 patients underwent LAGB. Of these, 53 patients had a preoperative BMI ⬎60 kg/m2 (15%). The mean absolute weight and BMI was 186.6 kg (range 139.6 –250.6) and 66 kg/m2 (range 60.0 –79.8), respectively. Of the 53 patients, 34 (64%) were women, and the average age was 39.7 years (range 22–58). The mean follow-up was 12.5 months (range 1.3–31). The

most prevalent co-morbidities are listed in Table 1. The average operative time was 84 minutes (range 40 –240). The mean length of hospital stay was 2.7 days (range 1–18, median 1). Four patients had extended hospital stays secondary to postoperative obstruction from edema that resolved with conservative measures. These patients underwent surgery before April 2004 and had the 10-cm band placed. Postoperative complications included one band removal for chronic obstruction (1.9%), one band revision for slip (1.9%), and one nonfatal pulmonary embolism (1.9%). The mean percentage of excess weight loss (EWL) was 15% (range ⫺1.1 to 27.4) with ⬍6 months of follow-up, 28.1% (range 1.9 – 44.5) with 6 –12 months of follow-up, 35.1% (range 8.8 – 84.9) with 12–18 months of follow-up, and 42.9% (range 15.7– 80.1) with ⬎18 months of follow-up. This corresponded to an average weight and BMI of 169.4 kg (range 140.9 –231.8) and 59.8 kg/m2 (range 50.9 –73.1) with ⬍6 months of follow-up, 162.4 kg (range 132.7–199.1) and 55.0 kg/m2 (range 48.1– 61.9) with 6 –12 months of follow-up, 143.8 kg (range 104.1–181.8) and 52.5 kg/m2 (range 30.3– 68.5) with 12–18 months of follow-up, and 131.3 kg (range 102.3–172.7) and 47.3 kg/m2 (range 33.3– 57.5) with ⬎18 months of follow-up, respectively. The breakdown of patients with ⬍25% EWL, 25–50% EWL, and ⬎50% EWL for each follow-up period is listed in Table 2. Comparatively, of the remaining 299 patients with a BMI ⬍60 kg/m2, 236 (79%) were women, with a mean age of 42.2 years (range 18 –72). The average operating time was 65 minutes (range 30 –280), with a mean length of stay of 1.7 days (range 1–13). The mean operative time was the only statistically significant difference among the variables of age, operative time, and length of stay (P ⬍.0001, MannWhitney rank sum test). The mean %EWL was 20.9% (range ⫺5.6 to 50.8) with ⬍6 months of follow-up, 35.7% (range ⫺2.1 to 82) with 6 –12 months of follow-up, 44.9% (range 0 –102.9) with 12–18 months of follow-up, and 51.7% (range 0 –99.2) with ⬎18 months of follow-up. The ⬍6 month category achieved the only statistically significant %EWL difference between the ⬍60 kg/m2 BMI and ⬎60 kg/m2 BMI groups (P ⫽ .04, t test). The operative complications in this group included 2 band removals for nontolerance (0.67%), 15 laparoscopic revisions or removal for band slippage (5.0%), 3 nonfatal pulmonary emboli

Table 2 Percentage of excess weight loss per follow-up period EWL (%)

⬍25% 25–50% ⬎50%

Follow-up (%) ⬍6 mo

6–12 mo

12–18 mo

⬎18 mo

71 29 0

30 70 0

50 25 25

17 50 33

EWL ⫽ excess weight loss.

J.A. Myers et al. / Surgery for Obesity and Related Diseases 2 (2006) 37– 40

(1.0%), and 1 death from postoperative myocardial infarction (0.33%). Discussion Much scrutiny has centered around the variety of surgical procedures available to treat morbid obesity. The increased technical demands of the operation and the greater rate of co-morbid illness among massively superobese patients result in greater risk to the patient. The safety of the procedure should be paramount; thus, we chose to focus on this aspect rather than on more rapid or extensive weight loss exhibited by some other procedures. LAGB provides a safe alternative to RYGB and BPD in that the absence of suture lines and anastomoses eliminates the risk of anastomotic leaks with the subsequent devastating consequences. When comparing LAGB to BPD and RYGB, Dolan et al. [5] found patients undergoing BPD had significantly more complications (56.5% versus 8.7%) and had a significantly longer hospital stay (8 days for laparoscopic BPD versus 1 day for LAGB). Complications after BPD included anastomotic leak, bleeding, and wound-related problems (11 of 23 patients had open BPD). In our study, in-hospital complications were isolated to postoperative obstruction secondary to edema, and late complications were limited to one laparoscopic revision for band slippage and one port replacement for leakage in the system. The early complication rate after RYGB was also greater in the comparison of RYGB and LAGB (10% versus 2.8%) by Mongol et al. [6]. Additionally, the early complications for LAGB were usually less severe and more amenable to medical or laparoscopic intervention. The incidence of bleeding complications was greater with RYGB and necessitated laparotomy for treatment. The late complication rate was also greater in the LAGB group (26% versus 15.3%), but most of these complications were from band slippages (82%). However, 92% of these slippages were in patients who had undergone band placement using the perigastric technique. Subsequently, most institutions, including that of Mongol et al. [6], have changed to the pars flaccida technique and have reported a much lower incidence of band slippage complications (28.7% versus 4.7%). When reviewing our data, we did not find any statistically significant differences in the complication rates of patients with a preoperative BMI ⬎60 kg/m2 and those with a preoperative BMI ⬍60 kg/m2. Admittedly, it is difficult to assess the safety of a procedure within a small series such as this; however, our findings, coupled with the aforementioned series, provide additional support. At our institution, all patients before April 2004 received the 10-cm gastric band, regardless of their BMI. Since the introduction of the 11-cm VG band in the United States, we have used the larger band in patients with a greater BMI and have eliminated the problem of

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postoperative obstruction. Because of the short follow-up of patients with the VG band, more time is needed to evaluate the effect of the use of the larger band on the weight loss amount and rate of band slippage in the massively super-obese population. In addition to the safety of a bariatric procedure, it is essential to evaluate the efficacy of the operation with regard to the amount and rapidity of weight loss. In a study comparing RYGB and LAGB in super-obese patients, gastric bypass afforded a 63% EWL versus 41% EWL at 1 year and 73% EWL versus 46% at 2 years [6]. Similarly, a comparison of BPD and LAGB demonstrated a 64.4% versus 48.4% EWL between the groups [5]. It has been shown that weight loss is slower and more gradual with LAGB than many other bariatric procedures. The average EWL after RYGB has been reported to range from 60% to 80%, often within the first postoperative year [11]. A general consensus is emerging that after 2–3 years, the difference in the amount of weight loss between LAGB and gastric bypass in the morbidly obese population is not statistically significant and tends to be within 50 – 60% EWL [12,13]. Other studies of LAGB in the massive super-obese population have supported these data, with 5-year results of 61% EWL [4]. Our weight loss data, although from limited follow-up, have demonstrated a trend toward these endpoints. Although the only statistically significant difference in the %EWL between the ⬍60 kg/m2 BMI and ⬎60 kg/m2 BMI groups was seen in patients with ⬍6 months of followup, it is likely that with a larger sample size, statistical significance would be noted across all timeframes. Thus, it is apparent that in the massively super-obese population, additional time may be needed to achieve similar weight loss results.

Conclusion LAGB is an appropriate surgical option for treatment of massive super-obesity. The procedure can be performed with minimal morbidity and mortality and leads to promising medium-term weight loss. Compared with our cohort of patients with a BMI ⬍60 kg/m2, massive super-obese patients took longer to accomplish a similar %EWL. Longer term follow-up is necessary for this cohort of patients and may demonstrate even more successful results. Additional investigation into co-morbidity and quality-of-life data will provide further insight as to the efficacy of this procedure in this patient population.

References [1] Bloomston M, Zervos EE, Camps MA, Goode SE, Rosemurgy AS. Outcome following bariatric surgery in super versus morbidly obese patients: does weight matter? Obes Surg 1997;7:414 –19.

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[2] Standards Committee, American Society for Bariatric Surgery. Guidelines for reporting results in bariatric surgery. Obes Surg 1997; 7:521–2. [3] Weiner R, Gutberlet H, Bockhorn H. Preparation of extremely obese patients for laparoscopic gastric banding by gastric-balloon therapy. Obes Surg 1999;9:261– 4. [4] Fielding GA. Laparoscopic adjustable gastric banding for massive superobesity (⬎60 body mass index kg/m2). Surg Endosc 2003;17: 1541–5. [5] Dolan K, Hatzifotis M, Newbury L, Fielding G. A comparison of laparoscopic adjustable gastric banding and biliopancreatic diversion in superobesity. Obes Surg 2004;14:165–9. [6] Mongol P, Chosidow D, Marmuse JP. Laparoscopic gastric bypass versus laparoscopic adjustable gastric banding in the super-obese: a comparative study of 290 patients. Obes Surg 2005;15:76 – 81. [7] Mittermair RP, Aigner F, Nehoda H. Results and complications after laparoscopic adjustable gastric banding in super-obese patients, using the Swedish band. Obes Surg 2004;14:1327–30.

[8] Angrisani L, Furbetta F, Doldi SB, et al. Results of the Italian Multicenter Study on 239 super-obese patients treated by adjustable gastric banding. Obes Surg 2002;12:846 –50. [9] Busetto L, Segato G, De Luca M, et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg 2004;14:671– 6. [10] Regan JP, Inabnet WB, Gagner M, Pomp P. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg 2003;13:861– 4. [11] Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux-en-Y— 500 patients: technique and results, with 3– 60-month follow-up. Obes Surg 2000;10:233–9. [12] Chapman AE, Kiroff G, Game P, et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery 2004;135:326 –51. [13] Zinzindohoue F, Chevallier JM, Douard R, et al. Laparoscopic gastric banding: a minimally invasive surgical treatment for morbid obesity. Ann Surg 2003;237:1–9.

Editorial Comment The authors present their intermediate term results with adjustable gastric banding in patients with body mass index (BMI) ⬎ 60. There is no doubt that this group of patients can be challenging to manage and may be at higher risk for complications and mortality; but BMI alone may not tell the entire story. Central versus peripheral fat distribution and the severity of associated comorbidities may be predictive of technical difficulty and risks, respectively. The simplicity and relative safety of gastric banding make it an attractive option for these patients. As these results demonstrate, weight loss is slow and may not reach levels commonly associated with success, with 50% of patients experiencing ⬍ 25% excess weight loss (EWL) at 12 to 18 months (reduced to 17% beyond 18 months) and only 33% achieving ⬎ 50% EWL. Although longer-term follow-up may reveal continued weight loss, most patients likely will not attain 50% EWL. But if there is significant resolution of comorbidities, then just how important is this arbitrary cutoff for “success”? Toward this end, reports such as this should contain data

on resolution of comorbidities to allow for better evaluation of outcomes. Other approaches to this problem include staged procedures with sleeve gastrectomy as the first stage or preoperative weight loss with very low calorie diets (VLCD). Perhaps banding as a first stage and progression to bypass or biliopancreatic diversion (BPD) in patients who lose some, but not enough, weight or do not resolve comorbidities will be a useful strategy. Further study of treatment for this extreme form of the disease may require multicenter efforts to compare outcomes of various options in a controlled fashion. New approaches for decreasing preoperative risk should be sought; these may include endoscopic approaches, such as the intragastric balloon and others currently in development. Careful evaluation of these strategies will help us offer the tremendous benefits of massive weight loss while reducing risk. Marc Bessler, M.D. New York Presbyterian Center for Obesity Surgery Columbia Presbyterian Medical Center New York, New York