© Springer Science+Business Media New York 2015
Stacy A. Brethauer, Philip R. Schauer and Bruce D. Schirmer (eds.)Minimally Invasive Bariatric Surgery10.1007/978-1-4939-1637-5_2323 Laparoscopic Adjustable Gastric Banding: Controversies
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Department of Surgery, New York University, 530 First Avenue, Suite 105, New York, NY 10016, USA
Keywords
Bariatric surgeryLaparoscopic adjustable gastric bandingBand revisionBariatric surgery is a blessing for morbidly obese people. Nothing else really works. All the currently available bariatric procedures work to varying degrees and all have their problems. I currently perform all these procedures, and my patients have reaped the rewards of surgery and suffered the tribulations that can go with them—leaks after bypass and sleeve, band slips and erosions, malnutrition after BPD, weight regain, and failure after all of them. In the main though, most patients do well and are happy. Patients play an important role in the selection of their operation and the risks and benefits of all procedures should be explained to help them make this sometimes difficult decision.
Laparoscopic adjustable gastric banding (LAGB) has been a successful choice for the treatment of morbid obesity by many bariatric surgeons around the world, since its introduction in 1994. After its approval in 2001 in the USA by the Food and Drug Administration (FDA), the use of the lap band increased and has given patients an alternative treatment to the Roux-en-Y gastric bypass (RYGBP) and more recently the sleeve gastrectomy. The LAGB does not involve any bowel anastomosis, staple line complications, or risk of leaks. It is also adjustable and easily removable, both characteristics that are appealing to patients considering bariatric surgery. After its introduction to the USA in 2001, LAGB had similar popularity to that achieved in Australia and Europe, rivaling gastric bypass as the most common bariatric operation. In recent years though, that popularity has somewhat declined, particularly with the increasing interest in sleeve gastrectomy. Several factors have influenced that change, some real, some due to different perceptions of the value of gastric banding.
The Main Controversy: Should We Still Do the Band?
Obesity is currently the second largest cause of preventable death in the USA and a devastating disease, with its incidence and associated complications rising exponentially every year. There are more morbidly obese people in the USA than the total population of Australia. There are more in India than the total population of the USA. It’s overwhelming. Surgery is currently the most effective proven treatment to control this epidemic, yet so few people who need it come for it.
LAGB surgery, and its postoperative management, as it is done today, bears very little resemblance to how it was done 10 years ago. Successful modification in the technique of band implantation, especially use of the pars flaccida technique, and hiatal hernia repair/cruroplasty at the initial operation, has substantially reduced the need for reoperation after band placement [1, 2]. Changes in band technology, especially use of wider, lower pressure bands result in further reductions. We understand that the band works primarily by controlling hunger and increasing feelings of satiety, rather than as a punitive, restrictive procedure [3, 4]. We have modified our adjustment strategies accordingly, aiming to keep patients in the “Green Zone,” as described by Dixon and O’Brien. We teach patients to eat slowly, telling them that they can’t live with a band as if they don’t have one. With all this, long-term patient satisfaction has matched the reduction in need for band revision and removal, compared to patients who had their bands inserted in the late 1990s and early 2000s.
The LAGB delivers satisfactory weight loss, provided the band is adjusted properly. The percentage excess weight loss (%EWL) after LAGB has been reported at 55 % after 5 years [5]. Lanthaler et al. report %EWL of 64 % out to 10 years [6]. O’Brien reviewed 3,227 patients treated by laparoscopic adjustable gastric band placement between September 1994 and December 2011 [7]. Seven hundred fourteen patients had completed at least 10 years of follow-up. Follow-up was intact in 78 % of those beyond 10 years. There was no perioperative mortality for the primary placement or for any revisional procedures. There was a mean of 47.0 % EWL (n = 714; 95 % CI = 1.3) for all patients who were at or beyond 10-year follow-up. The band was explanted in 5.6 %. In Weichman et al.’s recent study of 2,909 patients from New York, %EWL after 6 years was 47 % [8]. The %EWL 3 years after surgery was 52.9 %, which was sustained thereafter to 47 % at 6 years. In multivariate models, increased number of office visits, younger age, female gender, and Caucasian race were significantly associated with a higher maximum %EWL. Of these patients, 363 (12.2 %) experienced one or more complications. The most common complications were band slip (4.5 %) and port-related problems (3.3 %). Other complications were rare. Only 7 patients (0.2 %) had band erosion. Eleven patients (0.4 %) underwent reoperation for weight gain. A total of 10 deaths (0.34 %) occurred during the study period. Three patients died within 30 days of surgery. Two of these deaths (0.06 %) were related to surgery, and 1 resulted from a motor vehicle accident. Seven patients died of causes unrelated to surgery during the course of the study. LAGB is a safe procedure with few early or late complications. Mortality is very rare.
In 2003, Weiner published data on 984 LAGB patients, including 100 patients with over 8-year follow-up, for whom he had 90 % follow-up [9]. They had 59 % EWL, and their body mass index (BMI) fell from 47 to 32 kg/m2. He showed that it is an effective treatment.
If one reviews the literature concerning longer follow-up of LAGB, it seems that one can expect about 50 % EWL out to 10 years, with 50 % of patients achieving 50 % EWL, with very low risk to the patient.
We often hear that the gastric bypass (RYGB) is the “gold standard” for bariatric surgery. There is actually very little long-term data for gastric bypass. The best 10-year follow-up is from Kelvin Higa [10]. A total of 242 patients underwent RYGB surgery from February 1998 to April 1999. The office follow-up rate was 33 % at 2 years and only 7 % at 10 years. An additional 19 % had telephone follow-up at 10 years. The mean excess weight loss was 57 % at 10 years. Only 67 % of patients had 50 % EWL. Furthermore, 86 (35 %) had ≥1 complication during follow-up. The internal hernia rate was 16 %, and the gastrojejunal stenosis rate was 4.9 %. Of the 242 patients, 136 (51 %) had nutritional testing at least once after postoperative year 1. Of these 136 patients, only 24 (18 %) had remained nutritionally intact during follow-up. The weight loss is not that dissimilar to LAGB patients, there is a high long-term complication rate, and most patients had nutritional deficiencies. What’s more, this is in the 26 % with documented follow-up.
Himpens et al. reviewed 126 consecutive patients treated with RYGB between January 1, 2001, and December 31, 2002 [11]. Seventy-seven patients (61.1 %) were available for evaluation after 9.4 ± 0.6 years. Initial BMI was 40.3 ± 7.5 kg/m2. There was no postoperative mortality. Some 9 % of the patients suffered from internal herniation, despite the closure of potential hernia sites. With time, the patients regained weight; percentage of excess BMI lost was 56.2 ± 29.3 %, down from a maximum of 88.0 ± 29.6 % at 2.0 years. RYGB was effective for diabetes control in 85.7 % of the affected patients, but, surprisingly, 27.9 % developed new-onset diabetes.
Long-term data for the sleeve tells a similar story. Himpens has published his data on 53 patients who had laparoscopic sleeve gastrectomy between November 2001 and October 2002 [12]. There were 41 patients in follow-up, and 11 received an additional malabsorptive procedure at a later stage because of weight regain. In the 30 patients receiving only sleeve gastrectomy, there was a 3-year %EWL of 77.5 % and 6+ year %EWL of 53.3 %. The differences between the third and sixth postoperative year were statistically significant in both groups. New gastroesophageal reflux complaints appeared in 21 % of patients.
In another study, Sarela found, in 20 patients out to 9 years, that 3 were lost and 4 converted to another procedure [13]. Of the remaining 13 patients, 55 % had 50 % EWL.
Surgery for massive super obesity is a formidable challenge. No existing open or laparoscopic procedure reduces mean BMI below 30 from a starting point above 55. Eid and Schauer recently presented a group of 74 super obese patients, with a mean BMI of 66 (43–90) having sleeve gastrectomy between January 2002 and February 2004, with a mean 6-year follow-up [14]. Mean EWL at 72, 84, and 96 months after LSG was 52 %, 43 %, and 46 %, respectively, with an overall EWL of 48 %. The mean BMI decreased from 66 (43–90) to 46 kg/m2 (22–73).
Years ago, I presented a group of 76 super obese patients, with a mean BMI of 69 (60–104) having had LAGB [15]. Five patients had a BMI > 100 kg/m2. BMI fell from 69 ± 6.2 to 49 ± 7.73 at 1 year to 37 ± 4.45 at 3 years and this was maintained at 4 and 5 years. BMI in 13 patients with >5-year follow-up was 35.09 ± 5.3 kg/m2 (27–44).
Weight loss with LAGB in this group of massive super obese patients was similar to all other surgical techniques. In total contrast, Marmuses’s group from France has just published very disappointing results in a group of 35 men (18.8 %) and 151 women (81.2 %), with a mean BMI of 55.06 kg/m2 (range: 50–74.4) who had LAGB between September 1995 and December 2007 [16]. The mean follow-up was 112.5 months with a minimum of 28 months and a maximum of 172 months. The follow-up rate was maintained at 89 % at 10 years. At 10 years there was a band removal rate of 52.2 % (47 of 90 patients), a failure rate of 22 % (7 of 33 patients) of those who still had their band in place, and a median BMI of 43.43 kg/m2. No one really knows why there is such disparity in reported outcomes with the band. It may be due to a preference to remove bands rather than revise them when there is reflux or variations in follow-up.
Weiner performed 937 sleeves between October 2001 and December 2010, with 0.4 % mortality [17]. Of the 937 patients, 17 (1.8 %) experienced staple line leakage. From 2005 to 2010, 106 secondary procedures were performed. Insufficient weight loss or weight regain was the indication in 88 cases. Sixteen (15 %) patients had severe gastroesophageal reflux which was resolved by RYGB.
In conclusion, long-term data for LAGB, sleeve, and RYGB demonstrates a remarkable similarity—about 50 % EWL—and a substantial need for reoperation.
This then leaves patients with a choice. Many patients base that choice on safety, if there is a similar benefit. In 2004, Ren et al. asked 469 consecutive patients what was the reason for their choice of operation [18]. Safety of the operation (43 %) was the highest rated factor in choosing LAGB. RYGB was preferred due to “lack of a foreign body,” “inability to cheat,” and “dumping.” Duodenal switch (BPD/DS) was selected in 11 % of patients, primarily because of “durability of the weight loss” (51 %).
Patients care about safety. The one indisputable feature that separates the LAGB from other procedures is its safety with operative mortality in the order of 1/2,000. Nguyen et al. recently reviewed 10,151 bands admitted in University Healthcare Consortium (UHC) hospitals between January 2007 and December 2009 [19]. There was a mean length of stay of 1.2 days and 3 deaths (0.03 %).
Chakraverty et al. performed a search of all comparative studies of LAGB and other procedures and found five level one randomized controlled trials [20]. Their conclusion was that LAGB delivered satisfactory weight loss and was much safer, with fewer complications and shorter stay, and thus may be preferable to patients. Gould reviewed 32,509 bariatric procedures, of which 58 % were laparoscopic RYGB and 21 % LAGB. Mortality was 0.09 % vs. 0.02 % (P < 0.05) and inpatient complications 4 % vs. 1.6 % (P < 0.1) [21]. Finks, reviewing the Michigan Bariatric Collaboration data of 25,469 patients found that 644 patients had a serious complication and that sleeve was 2.46 times and RYGB 3.58 times as likely as LAGB to have a complication [22]. In a review of 322 super obese patients, Parikh found that 27 patients had a major complication. LAGB had 4.7 % and RYGB 11.3 % [23].
If one was to apply mortality rates of 0.02 % and 0.3 % to the 23 million people in the USA with a BMI over 35, the difference is 4,500 dead people after surgery with a band, compared to 70,000 after a bypass. It is the fear of death after bypass or sleeve that prevents so many people from coming for bariatric surgery.
Saunders et al. reviewed 2,823 consecutive bariatric patients. Of these 165 (5.8 %) patients required 184 (6.5 %) readmissions within 30 days of their operation [24]. LAGB had the lowest patient readmission rate of 3.1 % compared to RYGB 7.3 %. LAGB decreased the odds for readmission. The same authors then assessed 1-year readmission rates for 1,939 patients and found that LAGB was 12.7 % and RYGB 24 % [25].
The issue with band vs. sleeve is slightly different. There is a similar safety differential as with a bypass. The real problem is leak after the sleeve, a complication that typically has a very protracted recovery, unlike anything seen after LAGB and only rarely after bypass. In published literature up to 2012, leak rates range from 0 to 2.5 %. Aurora reviewed 4,888 sleeve patients, with a leak rate of 2.4 %, most of which happened after discharge [26]. Weiner showed a leak rate of 1.8 % in 937 patients [15]. Sakran showed 44 (1.5 leaks in 2,834 patients, all but 1 after discharge [27]. The leaks had a median closure of 40 days (1–270 days).
What a patient has to be told, quite simply, is that if you have a sleeve, based on current data, the chance of dying after a sleeve is five times that of a band. The patient will have a 1/40 chance of a leak, which takes an average of 40 days to close. You also have a 1/5 chance of needing a conversion to another procedure by 5 years. After all that, the weight loss at 5 years is the same as with a well-adjusted band.
Follow-Up
Given that it’s much safer and delivers similar weight loss long term as a bypass or a sleeve, why is there controversy about using the band? The answer lies in the need for a high level of long-term maintenance and the need for band revision. Long-term follow-up is the weak point of all bariatric operations. With the band, far more than the other procedures, it determines success or failure. In 2004, Shen et al. reviewed 216 LAGB and 139 RYGB operations performed between October 2000 and September 2002 [28]. Of these patients, 186 LAGB patients and 115 RYGBP patients were available for 1-year follow-up. Of the LAGB patients, 130 (70 %) returned 6 or less times in the first year and achieved 42 % EWL, and 56 patients (30 %) returned more than 6 times and had 50 % EWL (P = 0.005). Overall %EWL after RYGBP was 66.1 %. Some 53 patients (46 %) returned 3 or less times in the first year, achieving 66.1 % EWL. A further 62 patients (54 %) returned more than 3 times after surgery and achieved 67.6 % EWL (P = NS). They showed that patient follow-up plays a significant role in the amount of weight lost after LAGB, but not after RYGBP. It still holds true today. Patient motivation and surgeon commitment for long-term follow-up is critical for successful weight loss after LAGB surgery.
This is the key to the whole issue of band vs. other procedures. A successful outcome after LAGB requires a substantial input from patient and surgeon. An unadjusted band won’t work. There needs to be relatively open access to the surgeon and their team. Patients need to be able to come in if they are hungry or have a problem. This open-door policy is somewhat at odds with the traditional surgical model, as is the long-term follow-up. At NYU, we see patients once a month for the first 18 months, and then in reducing intervals after that. We see them yearly after 5 years. We have peripheral clinics to make access easier. Adjustments are done by the surgeons and by practice extenders such as RNs, PAs, and NPs. It’s a lot of work. It’s probably the main issue facing bariatric surgeons who wish to do LAGB surgery. With the newer bands, modern surgical techniques, and understanding of the Green Zone, more and more patients are doing well, with fewer problems. Eventually there is a very large patient load. One simply needs to decide if one wants it. The payoff is the low morbidity, low risk, effective surgery one can offer our patients. But if you want successful outcomes, you have to do the work. If this is daunting or cannot be accommodated into practice, then it’s probably best not to do LAGB surgery.