Reoperations for Long-Term Complications Following Laparoscopic Adjustable Gastric Banding: Analysis of Incidence and Causality

Background: Laparoscopic adjustable gastric banding (LAGB) gained popularity in the early 2000s as a purely restrictive procedure with modest weight loss. The potential for complications requiring reoperation has since become evident. A retrospective review was performed to determine the incidence of long-term complications and predictive factors requiring surgical reintervention after LAGB. Methods: Institutional review board approval was obtained, and a retrospective review of 200 consecutive patients undergoing LAGB over a period of six years was conducted at a single institution with American Society of Metabolic and Bariatric Surgery Center of Excellence designation. Data were collected on patient characteristics, comorbid conditions and complications requiring reintervention. Statistical analysis was performed using SPSS Statistics software (IBM Corp., Armonk, NY). Results: Of the 200 patients, 176 (90.7%) were female with an average age of 53.6 years and preoperative body mass index (BMI) of 44.2 kg/m2. The average follow-up was 46 months. Complications occurred in 55 (28.4%) patients with band slippage/prolapse as the most common need for reoperation. Younger age, lack of comorbidities and diet/exercise compliance were associated with reintervention. Conclusions: LAGB has a high rate of reoperation secondary to complications associated with younger age. Alternative bariatric procedures may be more appropriate in these patients who have fewer comorbid conditions and are motivated to improve his or her health.


Introduction
The disease of obesity and its related comorbid conditions represent the most significant public health threat of our time [1]. Weight loss surgery has been proven to be the most effective and consistent treatment for patients seeking long-term weight loss and has demonstrated a significant impact on patient longevity [2,3]. Currently, several types of procedures are employed that vary in the degree of restriction and malabsorption [4]. The laparoscopic adjustable gastric band (LAGB) obtained FDA approval in the United States in 2001. Over the past 18 years, it has been utilized as a purely restrictive procedure for the treatment of obesity with reasonable weight loss results [5][6][7]. With more indwelling LAGBs, the potential for longterm complications requiring surgical intervention has become evident [8][9][10][11][12]. Predictive factors of these complications and reoperative rates have not fully been determined in the American patient population. The specific aims of this study are to provide clinicians and patients with incidence rates of long-term complications and predictive factors requiring surgical reintervention after LAGB.

Materials And Methods
Institutional review board (IRB) approval to conduct the study was obtained at a university affiliated tertiary care center with an American Society of Metabolic

Results
A total of 200 patients were studied with a mean follow-up of 46 months (range = 2-109) ( Table  1). Of all participants, six (3%) patients did not have 12-month data available and were considered lost to follow-up and excluded from the study. Noted in the series were three deaths, none of which occurred within the 12-month initial operative period and none were associated with band complications.      For the 55 patients undergoing reintervention, 25 (46%) underwent an alternative bariatric procedure ( Table 6). These patients tended to have a lower preoperative weight (117.7 vs. 125.71, p = 0.083). There was no statistical significance between preoperative BMI and 12month %EWL. There was no statistical difference in comorbidities, sex or exercise/diet compliance between these groups ( Table 7). The average time to conversion to an alternative bariatric procedure was 55.5 (range = 25.8-87.5) months. The majority of these patients (21) underwent conversion to a LRYGB, while only four patients had an LSG.

Discussion
LAGB is known to provide moderate weight loss with an excellent perioperative safety profile [5][6][7]. Early studies revealed short-term superiority with the LAGB in regards to weight reduction (43-78 %EWL at three years), remission of diabetes and other obesity-related comorbidities compared with medical therapy alone [13][14][15]. Perioperative mortality was found to be <0.05% in these studies [15]. Despite this, as more data became available, LABG showed poor long-term efficacy. Ten-year data from Froylich et al. revealed no improvement in comorbidities and worsening of GERD-related symptoms; 59.4% of the patients had their band removed, and 30% of those went on to have an alternative bariatric procedure [16]. With other studies reporting high rates of reintervention between 19.2% and 33.1%, bariatric procedures with more durable weight loss outcomes were advocated [8,9,17].
In our study, long-term complications from LAGB leading to surgical reintervention occurred with significant frequency, with more than 28.4% of the patients requiring surgery within a 46month average follow-up. The most common reason for reintervention was band slippage or prolapse followed closely by weight loss failures. Less common were band intolerances, port/tubing complications and band erosions. Causes for reintervention appear consistent with reported literature; however, direct comparison is hampered by variability in reporting of complications in these studies [8,9,26]. Of the patients who experienced weight loss failure, 84% (n = 16) underwent an alternative bariatric procedure compared with 33% (n = 8) of band slippage/prolapse patients. Only one patient with band intolerance underwent an alternative procedure for severe GERD associated with the LAGB. Of those undergoing an alternative bariatric procedure, 84% (n = 21) elected for LRYGB compared with the LSG (n = 4). While difficult to quantify, there appeared to be a bias towards conversion to LRYGB due to concern of trading one restrictive procedure (LAGB) for another (LSG). Given equivocal two-year %EWL, which is evident in newer literature, this is likely an unfounded concern [24,25].
Overall, patients in this study experiencing band complications requiring reintervention were younger, had a higher preoperative weight and less comorbidities (lower rates of DM, HTN and HLD). At 12 months, these patients tended to have a lower %EWL and were statistically significantly more compliant with prescribed diet and exercise routines. Of this reintervention group, those with a lower %EWL at 12 months were more likely to undergo a conversion to an alternative bariatric procedure. These data suggest that in younger, healthier patients who are motivated about weight loss, LAGB may not be the ideal initial procedure as it is associated with higher reintervention rates over time. As 45.5% of this population underwent an alternative bariatric procedure, an LRYGB or LSG may be more satisfactory to meet these patients' longterm weight loss goals.
The limitations of our study include its retrospective nature without randomization or a control group. Some patients were lost to follow-up and may have presented to outside institutions for complication care and therefore could not be accounted. Additionally, no data regarding quality of life or weight loss satisfaction were collected. These factors may also influence a patient's decision when choosing a bariatric procedure.

Conclusions
Although LAGB is not as common as it was a short time ago, the procedure is still performed today and most practicing bariatric surgeons will encounter patients with indwelling bands.
Clinicians caring for these patients should be aware of the complications necessitating reoperation and the patient characteristics associated with these complications. LAGB is associated with high long-term complication rates, and our study suggests that alternative bariatric procedures may be more appropriate in younger patients with fewer comorbid conditions who are motivated to lose weight. While LAGB may still have a limited role in a select subset of patients, given the high frequency of potential complications, it should not be presented as the only option within a bariatric program. Our findings may guide clinicians and patients in utilizing alternative bariatric and metabolic procedures which have been shown to have superior efficacy with much lower rates of surgical reintervention.

Additional Information Disclosures
Human subjects: Consent was obtained by all participants in this study. Summa Health Institutional Review Board issued approval 12010. Institutional Review Board (IRB) approval to conduct the study was obtained at a university affiliated tertiary care center with an American Society of Metabolic and Bariatric Surgery (ASMBS) Center of Excellence designation and subsequent Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) accreditation. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.