eTable 1. Baseline Characteristics and 30-Day Major Adverse Outcomes of Patients Undergoing Gastric Bypass After Failed Gastric Banding
eTable 2. Baseline Characteristics and 30-Day Major Adverse Outcomes According to BMI Quartile Distribution and to Sex
Thereaux J, Veyrie N, Barsamian C, Corigliano N, Beauchet A, Poitou C, Oppert J, Czernichow S, Bouillot J. Similar Postoperative Safety Between Primary and Revisional Gastric Bypass for Failed Gastric Banding. JAMA Surg. 2014;149(8):780-786. doi:10.1001/jamasurg.2014.625
Adjustable gastric bands are widely used because of low postoperative morbidity, but their long-term results are poor, often leading to revisional surgery.
To assess the safety of revisional procedures by comparing the 30-day outcomes of primary gastric bypass vs revisions following failed adjustable gastric banding.
Design, Setting, and Participants
Retrospective review using logistic regression models to compute odds ratios (95% CIs) across preoperative body mass index (calculated as weight in kilograms divided by height in meters squared) quartiles to evaluate the risk for major adverse outcomes at 30 days (death, venous thromboembolism, reinterventions, and failure to be discharged). The prospective database of a single university surgical center in Paris, France, was queried for clinical and other relevant data among all patients undergoing primary or revisional laparoscopic gastric bypass between January 1, 2004, and June 30, 2013.
Main Outcomes and Measures
The primary outcome was a comparison between 30-day outcomes of primary gastric bypass and procedures following failed adjustable gastric banding.
In total, 831 patients had a primary procedure (group 1), and 177 patients had a secondary procedure after failed adjustable gastric banding (group 2). Overall, 78.7% of patients were female, the mean (SD) patient age was 42.6 (11.6) years, the mean (SD) body mass index was 47.6 (7.6), and mortality at 30 days was 0.5%. The rates of major adverse outcomes were similar in group 1 (7.8%) and group 2 (8.5%) (P = .77). In multivariate analyses, odds ratios for major adverse outcomes across preoperative body mass index quartiles (<42, 42-46, >46 to 52, and >52) were 1.00, 0.39 (95% CI, 0.20-0.77; P = .006), 0.55 (95% CI, 0.30-1.02; P = .06), and 0.50 (95% CI, 0.27-0.94; P = .03), respectively.
Conclusions and Relevance
The 30-day major adverse outcome rates were similar for primary gastric bypass and for procedures following failed adjustable gastric banding. Long-term comparative studies are required to better understand the quadratic relationship between body mass index and early postoperative outcomes.
Morbid obesity and associated coexisting conditions are of increasing concern in Western countries. In a 2011 report by the National Center for Health Statistics, 34.4% of the US population had obesity, with 6.0% having morbid obesity.1 In France, 15% of adults were reported to have had obesity in 2012, with 4.3% having a body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) exceeding 35.2 The number of laparoscopic bariatric procedures performed has been steadily increasing, with 7154 procedures performed in 2005 and 36 322 procedures performed in 2012 in France.3
Three procedures that are most frequently used for the treatment of morbid obesity are laparoscopic adjustable gastric banding (LAGB), laparoscopic gastric bypass (LGBP), and laparoscopic sleeve gastrectomy. Gastric bypass was first described in 1967 by laparotomy,4 and the intervention was first performed in 1994 by laparoscopy.5 Gastric bypass has since become the procedure of choice for bariatric surgery, particularly following improvements in early postoperative outcomes. Initially, LAGB was widely performed because its morbidity and mortality are close to zero and because it yields good early outcomes in terms of excess weight loss (EWL).6,7 However, some studies8- 12 have reported poor long-term results and a high frequency of complications with this procedure. Himpens et al11 found that 12 years after the procedure 60% of gastric bands had been removed. Laparoscopic adjustable gastric banding may be unsuccessful for various reasons, including band erosion, band slippage, difficulty in eating, gastroesophageal reflux disease, gastroesophageal dilation with pseudoachalasia, and other minor mechanical complications,8 as well as insufficient weight loss (particularly in patients with a BMI >50).13
Given the high failure rate of LAGB, the best conversion procedure choice remains unclear in terms of early and long-term results. Conversion from a band to an LGBP is a technically demanding procedure and can be performed in 2 steps (particularly in cases of intragastric band migration) or as a single-step procedure. In France, conversion from LAGB to another bariatric procedure increased by 3-fold from 2009 to 2012, indicating a major challenge for the next decade, especially because of preoperative difficulties and potentially higher postoperative major adverse outcomes (MAOs).3 A few small observational studies14- 18 have assessed the feasibility of LGBP following failed LAGB in terms of early morbidity and mortality and have reported good results. However, a recent large population-based study19 reported a higher frequency of early MAOs for LGBP procedures after failed LAGB than for primary LGBP, with more gastrointestinal complications.
In 2009, the Longitudinal Assessment of Bariatric Surgery Consortium20 reported a significantly lower frequency of MAOs (including death, percutaneous or endoscopic interventions or repeat surgery, venous thromboembolism, and failure to be discharged) at 30 days after primary LAGB than after primary LGBP. Surprisingly, preoperative BMI had a quadratic relationship with 30-day MAOs, with a BMI of 53 being associated with the lowest frequency of MAOs.20 In 2010, the consortium found a greater incidence of 30-day MAOs for revisional bariatric surgery, with 42 patients undergoing undetermined revisional surgery after failed LAGB.21
We aimed to compare the postoperative safety between LGBP as a first-line treatment and after failed LAGB. Furthermore, in the large expert single-center cohort of 1008 patients, we identified risk factors for 30-day MAOs.
The study was approved by our local ethics committee at Ambroise Paré University Hospital, Boulogne-Billancourt, France. During their hospital admission, patients provided oral informed consent for study participation. Data were prospectively collected in an electronic database that was registered with the French national data protection agency (Comité National Informatique et Liberté).
We included all consecutive patients 18 years or older undergoing LGBP as a primary treatment or following failed LAGB between January 1, 2004, and June 30, 2013, at a single high-volume university hospital bariatric center at Ambroise Paré University Hospital. All LGBPs performed because of failed sleeve gastrectomy, vertical banded gastroplasty, or loop gastric bypass (mini–gastric bypass) were excluded. Bariatric surgery was offered to patients in accord with French guidelines for bariatric surgery,22 which are similar to those from the National Institutes of Health.23 Briefly, all patients with a maximum BMI of 40 or higher or a BMI of 35 or higher with at least 1 severe coexisting condition (cardiovascular disease, hypertension, obstructive sleep apnea syndrome, type 2 diabetes mellitus, dyslipidemia, nonalcoholic steatohepatitis, or osteoarticular disorders) were eligible for inclusion. Each patient was evaluated and followed up for at least 6 months at a university nutrition department before surgery (at Pitié-Salpêtrière Hospital [Paris, France] or at Ambroise Paré University Hospital), and the indication for bariatric surgery was endorsed by a multidisciplinary team (J.T., N.V., C.B., N.C., C.P., J.-M.O., S.C., and J.-L.B.).
Hypertension was defined as a blood pressure exceeding 140 mm Hg (systolic) or 90 mm Hg (diastolic) or the use of antihypertensive medication. Diabetes mellitus was defined as a fasting glucose level exceeding 126 mg/dL (to convert glucose level to millimoles per liter, multiply by 0.0555) on at least 2 different occasions or the use of antidiabetic medication. Dyslipidemia was defined as a total cholesterol level exceeding 220 mg/dL, a serum high-density lipoprotein cholesterol level exceeding 39 mg/dL, a triglycerides level exceeding 150 mg/dL, or the use of lipid-lowering medication (to convert cholesterol level to millimoles per liter, multiply by 0.0259; to convert triglycerides level to millimoles per liter, multiply by 0.0113). All study participants underwent a nocturnal polygram, and obstructive sleep apnea syndrome was defined as an apnea-hypopnea index (the number of apnea or hypopnea events per hour of sleep) exceeding 10 events per hour or the use of nocturnal continuous positive airway pressure.
Laparoscopic gastric bypass has been the gold standard procedure for bariatric surgery at the Department of General, Digestive, and Metabolic Surgery at Ambroise Paré University Hospital since 2004. Therefore, LGBP was offered as a first-line treatment (except for marginal cases) to all patients for whom primary bariatric surgery was indicated and to all patients requiring surgery for the conversion of failed gastric banding. By a 1-step or 2-step procedure, gastric banding can be converted to LGBP (patients were generally referred to the Department of General, Digestive, and Metabolic Surgery after band removal, mostly because of gastroesophageal dilation and band slippage). In cases of LAGB conversion to LGBP in a single-step procedure, systematic endoscopy and upper gastrointestinal series were performed to assess any band erosion and gastroesophageal dilation, which can rule out the possibility of band conversion in a single-step procedure. All bands were emptied 2 months before the revision procedure.
We have used a standardized surgical technique for LGBP since 2004. Operations were initially performed by one of us (J.-L.B.) and subsequently by 3 others (J.T., N.V., and N.C.).
A composite end point of MAOs at 30 days was used as described in a previous study.20 This end point included death, venous thromboembolism, percutaneous or endoscopic interventions or repeat surgery, and failure to be discharged from the hospital.20
Percentage of EWL was calculated according to the theoretical baseline weight corresponding to a BMI of 25 and using the following formula: 100 × [(Baseline Weight − Follow-up Weight) ÷ by Baseline Excess Weight]. We used χ2 test for categorical variables and t test or Kruskal-Wallis test as appropriate. Baseline characteristics were described across quartiles of preoperative BMI in men and women separately. Univariate and multivariate analyses were performed using logistic regression models, and 95% CIs were calculated for the risk for 30-day MAOs. All factors with P < .20 in univariate analyses were retained for the multivariate models. All analyses were performed with statistical software (SAS version 9.2; SAS Institute). The significance threshold was set at P = .05.
Between January 1, 2004, and June 30, 2013, a total of 1008 patients with obesity underwent LGBP as a primary procedure (group 1, comprising 831 patients [82.4%]) or after failed LAGB (group 2, comprising 177 patients [17.6%]). In total, 793 of these patients (78.7%) were female, the overall mean (SD) patient age was 42.6 (11.6) years, and the mean (SD) preoperative BMI was 47.6 (7.6). The mean (SD) preoperative BMI (47.8 [7.4] in group 1 vs 46.5 [8.5] in group 2, P = .03) and the proportion of women (76.9% in group 1 vs 87.0% in group 2, P = .003) differed significantly between the 2 groups. The frequencies of preoperative type 2 diabetes mellitus (36.9% vs 26.6%, P = .009), obstructive sleep apnea syndrome (57.4% vs 47.5%, P = .02), dyslipidemia (34.8% vs 22.6%, P = .003), and gastroesophageal reflux disease (31.8% vs 24.3%, P = .05) were significantly higher in group 1 than in group 2 (Table 1).
In group 2, the principal reasons for failed LAGB were failure to lose excess weight (41.7%) and esophageal dilation (30.9%). The mean (SD) maximum percentage of EWL before the revisional procedure was 49.6% (25.3%), and the mean (SD) interval between LAGB and LGBP was 7.5 (2.9) years. In group 2, no differences in baseline characteristics and coexisting conditions were observed between patients undergoing 1-step vs 2-step procedures except for age at the time of LGBP (mean [SD] age, 44.2 [10.0] vs 41.5 [10.6] years; P = .05) and BMI before gastric banding (mean [SD], 48.4 [9.1] vs 46.1 [7.9]; P = .04) (eTable 1 in the Supplement).
The 30-day mortality rate was 0.5%, the rate of repeat surgery was 6.2%, and 80 patients (7.9%) reached the composite end point of 30-day MAOs, with no significant difference between the 2 groups (Table 2). The principal reasons for repeat surgery were small-intestine occlusion (45.2%), intra-abdominal or intraluminal hemorrhage (19.4%), and gastrojejunal anastomosis fistula (17.7%). In group 2, no difference in 30-day MAOs was found between the 1-step vs 2-step procedures (7.6% vs 10.2%, P = .57) (eTable 1 in the Supplement). After 1 month, the mean (SD) weight loss was 13.4 (4.8) kg for group 1 and 10.9 (4.7) kg for group 2 (P < .001).
In univariate analyses, the factors predictive of 30-day MAOs were male sex and BMI. In multivariate analyses, the only factor predictive of 30-day MAOs was male sex (odds ratio, 1.92; 95% CI, 1.26-3.20; P = .01) regardless of age and LAGB history. In multivariate analyses, odds ratios for MAOs across preoperative BMI quartiles (<42, 42-46, >46 to 52, and >52) were 1.00, 0.39 (95% CI, 0.20-0.77; P = .006), 0.55 (95% CI, 0.30-1.02; P = .06), and 0.50 (95% CI, 0.27-0.94; P = .03), respectively (Table 3). Body mass index had a quadratic relationship with 30-day MAO occurrence among women, with the highest rate (11.6%) for the first quartile and the lowest rate (4.0%) for the second quartile (P = .02). No such relationship as a function of BMI distribution was observed for men (P = .84) (eTable 2 in the Supplement).
Following the first description of open surgery gastric bypass by Mason and Ito4 in 1967, bariatric surgery has become increasingly popular, particularly since the development of laparoscopy5 and the alarming increase in obesity prevalence worldwide.24 Furthermore, strong evidence suggests that bariatric surgery is superior to conventional therapy for weight loss, cardiovascular risk factor management, and overall mortality reduction.25- 29
In Europe, LAGB was widely performed in the 1990s but is no longer the most frequently performed bariatric procedure because of the high frequency of long-term complications and the intermediate long-term weight loss benefit. The mean (SD) interval between LAGB and LGBP in our study was 7.5 (2.9) years, a figure similar to that reported in previous studies.15,30,31 Since its initial approval by the Food and Drug Administration in 2001, the frequency of LAGB procedures increased by 3-fold from 2004 to 2007 in the United States,32 and Worni et al19 recently reaffirmed the broad indications for LAGB in the US population. However, the outcomes of LAGB are disappointing. The percentage of EWL varies considerably from 47.1% to 35% at 10 years in patients with bands still in place.33,34 These results are far from those expected with LGBP.27 Furthermore, gastric banding is associated with a high rate of late complications, requiring repeat surgery for 60% of patients within 12 years according to Cadière et al31 and for 40% of patients according to O’Brien et al33 during his first 10 years of experience. The most frequent reasons for band explantation are intragastric migration, pouch dilation, and band slippage, leading to rapid weight regain.35
The poor long-term results of LAGB, the large number of gastric band implantations performed in Europe and the United States, the rapid increase in the obesity epidemic, and the interval of a few years between LAGB and LGBP suggest that the number of conversions of LAGB to other bariatric procedures will sharply grow in the next few years, particularly in the United States. Therefore, all physicians may be confronted with the challenging problem of determining the best conversion procedure in terms of early and long-term outcomes.
To date, this study is the largest single-center prospective study comparing early MAOs between primary LGBP and LGBP after failed LAGB. Since publication in 2002 of the reoperative experience by Gagner et al,36 small studies17,18,30,31,35 have assessed the feasibility of converting gastric banding to LGBP and have reported major complication rates of 13.4% to 30.6%. Only the study by Worni et al19 compared early adverse outcomes between primary LGBP and subsequent gastric banding failure in a large population-based investigation. They found that patients who underwent LGBP after gastric banding failure experienced significantly higher rates of postoperative complications, repeat surgery, and further interventions, leading to higher hospital charges. However, their study had several limitations such as the exclusion of 2-step procedures for LGBP and the absence of preoperative data, which might be potential sources of statistical confusion bias.
We assessed risk factors for 30-day MAOs using a composite end point definition similar to that described in a previous large cohort study20 of 4776 patients undergoing bariatric surgery. Because the distribution of BMI among patients differs between the United States and Europe, we chose to use cutoff points different from those used in the study by the Longitudinal Assessment of Bariatric Surgery Consortium20 of perioperative safety.20 Risk factors for early morbidity and mortality after primary LGBP have been widely assessed, but only the consortium study20 and our study report a quadratic relationship between BMI and 30-day MAOs. In a validated37 scoring system for postoperative mortality risk, DeMaria et al38 found that only BMI and a history of deep vein thrombosis or pulmonary embolism were significantly associated with mortality regardless of age, sex, and hypertension status in patients undergoing LGBP. Other studies have found that older age39,40 and male sex39,40 were associated with mortality, as were a history of obstructive sleep apnea syndrome,39 ischemic or congestive heart disease,39,40 pulmonary hypertension,40 and liver disease.40 The risk factors for 30-day MAOs reported by the consortium authors were a history of deep vein thrombosis or pulmonary embolism, impaired functional status, obstructive sleep apnea syndrome, and extreme BMI values20; they also found a quadratic relationship between BMI and 30-day MAOs, with the lowest risk for a BMI of 53. In our multivariate analyses, we found that male sex was a significant risk factor for 30-day MAOs. However, conversion of failed gastric banding and a history of ischemic heart disease or deep vein thrombosis or pulmonary embolism were not found to be risk factors for 30-day MAOs herein. We observed a quadratic relationship between BMI and 30-day MAOs, with the highest risk for the extreme quartiles. To better understand this relationship, we analyzed men and women separately. This association was observed among women, while no such association was found among men. However, this sex difference may be explained by the smaller sample size for men in our study. These results suggest a complex interplay between the effects of BMI and patient sex on 30-day MAOs.
In our study, the conversion of failed gastric banding was not identified as a risk factor for 30-day MAOs. Patients undergoing 1-step or 2-step procedures did not differ in terms of baseline characteristics at the time of LGBP except for age (eTable 1 in the Supplement).
An alternative revision for failed LAGB is laparoscopic sleeve gastrectomy. Despite the feasibility of converting failed gastric banding to laparoscopic sleeve gastrectomy,14,16,41,42 the International Sleeve Gastrectomy Expert Panel Consensus in 2012 concluded that LGBP should be the procedure of choice for cases of failure of adjustable gastric banding.43 However, a recent systematic review demonstrated fewer postoperative complications after laparoscopic sleeve gastrectomy than after LGBP as a revisional procedure for failed gastric banding.44
Except for a few specific cases, no consensus has emerged concerning the best bariatric procedure for the primary management of morbid obesity. Given the poor long-term results of LAGB, the number of patients with failed gastric banding who are eligible for revisional surgery will increase in the future. Our data suggest that the 30-day MAO rates are similar for primary gastric bypass and for procedures following failed adjustable gastric banding.
Accepted for Publication: January 15, 2014.
Corresponding Author: Jérémie Thereaux, MD, Department of General, Digestive, and Metabolic Surgery, Ambroise Paré University Hospital, Versailles Saint-Quentin University, Assistance Publique–Hôpitaux de Paris, 9 Ave Charles de Gaulle, 92100 Boulogne-Billancourt, France (firstname.lastname@example.org).
Published Online: June 18, 2014. doi:10.1001/jamasurg.2014.625.
Author Contributions: Dr Thereaux had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Thereaux, Corigliano, Czernichow.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Thereaux, Poitou.
Critical revision of the manuscript for important intellectual content: Veyrie, Barsamian, Corigliano, Beauchet, Poitou, Oppert, Czernichow, Bouillot.
Statistical analysis: Thereaux, Beauchet.
Administrative, technical, or material support: Veyrie.
Study supervision: Corigliano, Oppert, Czernichow, Bouillot.
Conflict of Interest Disclosures: None reported.