Jaime Ponce

Early postoperative outcomes of metabolic surgery to treat diabetes from sites participating in the ASMBS bariatric surgery center of excellence program as reported in the bariatric outcomes longitudinal database.

Objective:Small case series suggest bariatric surgery may be an effective treatment for type 2 diabetes mellitus in patients who do not meet body weight criteria for morbid obesity (body mass index [BMI], <35 kg/m2), but large multi-institutional series, which allow better assessment of the safety and efficacy of treatment, have not been reported. Methods:Data from 66,264 research-consented patients with a primary bariatric surgery encounter in the Bariatric Outcomes Longitudinal Database from June 2007 to June 2009 were queried to identify patients with a BMI ≥30 but <35 kg/m2 (1.2%, n = 794) and diabetes requiring any medication (29%). Results:A total of 235 patients met inclusion criteria. The 2 most common procedures, adjustable gastric banding (n = 109) and gastric bypass (n = 109), were compared. Laparoscopic access was used in 92% of procedures. Gender (76.6% female), race (80.4% White), and age (mean 52.6 ± 10.4 years) did not differ between procedure groups. Gastric bypass provided superior weight loss and diabetes remission but demonstrated more frequent complications (90-day complications: 18% vs. 3%, P < 0.05). No mortalities were reported, and most complications were minor. Conclusions:The data suggest early effectiveness of surgical treatment of diabetes in patients who do not meet criteria for morbid obesity. Gastric bypass provides more effective treatment for diabetes than adjustable gastric banding within 6 to 12 months.

Effect of Lap-Band®-Induced Weight Loss on Type 2 Diabetes Mellitus and Hypertension

Background: Severe obesity is associated with type 2 diabetes and hypertension. Improvement in these comorbidities after surgically-induced weight loss has been documented, and laparoscopic adjustable gastric banding (LAGB) is an effective weight loss operation. Methods: Of 840 patients who underwent Lap-Band®, data are available in 402 out of 413 patients whose surgery took place at ≥ 1 year ago. Preoperative and follow-up data were studied retrospectively to examine the effect of Lap-Band®-induced weight loss on diabetes and hypertension. Results: Of 413 patients with at least 1 year postoperative follow-up, 53 (12.8%) were taking medications for type 2 diabetes preoperatively and 189 (45.7%) were on antihypertensive medications. 66% (n=35) of diabetic patients were also hypertensive. Resolution of diabetes was observed in 66% at 1-year and 80% at 2-year follow-up. HbA1c dropped from 7.25% (5.6-11.0, n=53) preoperatively to 5.58% (5.0-6.2, n=15) at 2 years after surgery. Hypertension resolved in 59.8% and 74% at 1 and 2 years, respectively. Percent excess weight loss (%EWL) was lower for diabetic patients than for our cohort population (39.2% vs 41.2% at 1 year, 46.7% vs 54.2% at 18 months, and 52.6% vs 63.3% at 2 years, respectively). Patients in whom diabetes was improved but not resolved had lower %EWL than did those whose diabetes went into remission (27.0% at 1 year and 26.5% at 2 years). Patients with the shortest duration of diabetes (<5 years) and better weight loss after surgery achieved higher resolution rates. Conclusions: Dramatic improvement in – and frequent resolution of – diabetes and hypertension have been observed as a result of weight loss after Lap-Band® surgery.

Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force.

BACKGROUND Reoperative bariatric surgery has become a common practice in many bariatric surgery programs. There is currently little evidence-based guidance regarding specific indications and outcomes for reoperative bariatric surgery. A task force was convened to review the current evidence regarding reoperative bariatric surgery. The aim of the review was to identify procedure-specific indications and outcomes for reoperative procedures. METHODS Literature search was conducted to identify studies reporting indications for and outcomes after reoperative bariatric surgery. Specifically, operations to treat complications, failed weight loss, and weight regain were evaluated. Abstract and manuscript reviews were completed by the task force members to identify, grade, and categorize relevant studies. RESULTS A total of 819 articles were identified in the initial search. After review for inclusion criteria and data quality, 175 articles were included in the systematic review and analysis. The majority of published studies are single center retrospective reviews. The evidence supporting reoperative surgery for acute and chronic complications is described. The evidence regarding reoperative surgery for failed weight loss and weight regain generally demonstrates improved weight loss and co-morbidity reduction after reintervention. Procedure-specific outcomes are described. Complication rates are generally reported to be higher after reoperative surgery compared to primary surgery. CONCLUSION The indications and outcomes for reoperative bariatric surgery are procedure-specific but the current evidence does support additional treatment for persistent obesity, co-morbid disease, and complications.

The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity

BACKGROUND Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. OBJECTIVE To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. SETTING Academic and community practice, United States. METHODS Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. RESULTS Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). CONCLUSION The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.

American Society for Metabolic and Bariatric Surgery estimation of bariatric surgery procedures in 2015 and surgeon workforce in the United States

American Society for Metabolic and Bariatric Surgery estimation of bariatric surgery procedures in 2015 and surgeon workforce in the United States Jaime Ponce, M.D.*, Eric J. DeMaria, M.D., Ninh T. Nguyen, M.D., Matthew Hutter, M.D., Ranjan Sudan, M.D., John M. Morton, M.D. Chattanooga Bariatrics, Chattanooga, Tennessee Bon Secours Health System, Hampton Roads, Virginia Department of Surgery, University of California Irvine Medical Center, Orange, California Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts Department of Surgery, Duke University Medical Center, Durham, North Carolina Department of Surgery, Stanford University, Palo Alto, California Received August 22, 2016; accepted August 22, 2016

Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity

BACKGROUND Intragastric balloons are designed to occupy space within the stomach and induce satiety. The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. METHODS After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (TG) or control group (CG) in a 2:1 ratio. Three sites randomized a total of 30 patients to the TG (n = 21) or CG (n = 9). Patients randomized to the TG underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48-week study duration. RESULTS Our patient population included 26 women and 4 men aged 26-59 years. At 24 weeks, the mean excess weight loss in the TG and CG was 31.8% ± 21.3% and 18.3% ± 20.9%, respectively (P = .1371). At 48 weeks, 24 weeks after device removal, the TG maintained 64% of their weight loss. No deaths, unanticipated adverse effects, early removals, balloon deflations, or balloon migrations occurred. In the TG, 4 patients were readmitted for severe nausea, 1 had asymptomatic gastritis at balloon removal, and 1 patient experienced transient hypoxia during device removal. CONCLUSION In the present small study, the dual balloon proved easy to use, was associated with a trend toward greater weight loss than the CG, and demonstrated a good safety profile.

Safety and effectiveness of Realize adjustable gastric band: 3-year prospective study in the United States

BACKGROUND The effectiveness and safety of bariatric surgery using laparoscopic adjustable gastric bands have been demonstrated in numerous published studies. We present the results of the first U.S. multicenter trial of the Realize adjustable gastric band, a laparoscopic adjustable gastric band previously available only outside the United States as the Swedish adjustable gastric band. METHODS A total of 405 morbidly obese patients were screened at 12 different centers from May to November 2003 to participate in a prospective, single-arm study of the safety and effectiveness of the laparoscopically implanted Realize band. Changes in excess body weight, the parameters of diabetes and dyslipidemia, and the incidence of complications were assessed at 3 years of follow-up. RESULTS Of the 405 patients, 276 (78.3% women and 61.2% white) qualified for the study. The average age was 38.6 + or - 9.4 years (range 18-61), and the preoperative body mass index was 44.5 + or - 4.7 kg/m(2). The mean hospital stay was 1.2 + or - 1.3 days. At 3 years, the average excess weight loss was 41.1% + or - 25.1% or a decrease in the body mass index of 8.2 kg/m(2) (18.6%) (P < .001). In diabetic patients with a baseline elevated hemoglobin A(1)c level, the level decreased by 1% (P < .001). The total cholesterol, low-density lipoprotein cholesterol, and triglycerides decreased by 9%, 16%, and 50%, respectively (P < .001), and the high-density lipoprotein cholesterol increased by 25% (P < .001) in patients with abnormal baseline values. One patient required conversion to an open surgical technique. No 30-day mortality occurred. The complication frequencies were generally low and included esophageal dysmotility in 0.4%, late balloon failure in 0.4%, band erosion in 0.4%, slippage in 3.3%, esophageal dilation in 3.3%, pouch dilation in 3.6%, catheter kinking in 1.1%, port displacement in 2.5%, and port disconnection in 4.3%. Reoperations were required in 15.2% of the patients and involved 2 band replacements, 9 band revisions, 5 port replacements, 22 port revisions, and 4 explants. CONCLUSION The results of our study have shown that the Realize adjustable gastric band is safe and effective in a diverse U.S. population of morbidly obese patients. Significant weight loss was achieved throughout the 3 years of follow-up, with corresponding improvements in the indicators of diabetes and dyslipidemia.

Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial

Evaluate safety and efficacy of the pose™ procedure for obesity treatment.

New adjustable gastric bands available in the United States: a comparative study

BACKGROUND New gastric bands have been available for the past 3 years in the United States: Lap-Band AP (LBAP), Realize Band (RB), and Realize Band C (RBC). No RBC data have been previously published. The objective of the present study was to report our experience with 3 newer gastric bands in an experienced, private, U.S. bariatric surgery center. METHODS Data were prospectively collected and retrospectively reviewed. The characteristics evaluated include age, body mass index (BMI), gender, percentage of excess weight loss, band fill volumes, and complications. RESULTS From April 2007 through February 2010, 633 patients (mean age 42.3 ± 10.3 years) underwent laparoscopic band placement. The LBAP was placed in 384 patients (78% women, BMI 45.4 ± 6.9 kg/m(2)), the RB in 167 patients (84% women, BMI 46.4 ± 7.9), and the RBC in 82 patients (76% women, BMI 46.1 ± 8.2). The corresponding mean 1-year percentage of excess weight loss was 44.4% ± 19%, 38.9% ± 16.2%, and 32.1% ± 16.1% (LBAP versus RB and RBC, P <.05), with a 91%, 90%, and 83% follow-up rate. The 2-year percentage of excess weight loss for the LBAP and RB patients was 52.5 ± 21.2 and 43.3 ± 21.3 (P <.05), respectively, with a 76% and 67% follow-up rate. The corresponding mean band volumes at 1 year were 4.6, 7.6, and 10.2 mL, with 2%, 12%, and 38% of the bands filled more than the manufacturers maximal volume capacity recommendation. The postoperative complications included slippages and erosions in .5% and .5% of the LBAP, .6% and 1.8% of the RB, and 1.2% and 0% of the RBC patients, respectively. CONCLUSION Of the new bands available in the United States, the LBAP provided significantly better weight loss in our private practice setting. The RBC patients had the least weight loss, with a high band-fill volume needed to achieve effective restriction.

Safety and effectiveness of bariatric surgery: Roux-en-y gastric bypass is superior to gastric banding in the management of morbidly obese patients: a response

Background The recent article by Guller, Klein, Hagen was reviewed and discussed by the authors of this response to critically analyze the validity of the conclusions, at a time when patients and providers depend on peer reviewed data to guide their health care choices. The authors of this response all have high volume bariatric surgery practices encompassing experience with both gastric bypass and gastric banding, and have made significant contributions to the peer reviewed literature. We examined the assumptions of the paper, reviewed the main articles cited, provided more evidence from articles that were included in the materials and methods of the paper, but not cited, and challenge the conclusion that Roux-en-Y gastric bypass is superior to gastric banding.BackgroundThe recent article by Guller, Klein, Hagen was reviewed and discussed by the authors of this response to critically analyze the validity of the conclusions, at a time when patients and providers depend on peer reviewed data to guide their health care choices. The authors of this response all have high volume bariatric surgery practices encompassing experience with both gastric bypass and gastric banding, and have made significant contributions to the peer reviewed literature. We examined the assumptions of the paper, reviewed the main articles cited, provided more evidence from articles that were included in the materials and methods of the paper, but not cited, and challenge the conclusion that Roux-en-Y gastric bypass is superior to gastric banding.Results and discussionThe paper by Guller et al was subject to significant bias. The authors did not demonstrate an understanding of gastric banding, selectively included data with unfavorable results towards gastric banding, did not provide equal critique to the literature on gastric bypass, and deliberately excluded much of the favorable data on gastric banding.ConclusionThe papers conclusion that gastric bypass is the procedure of choice is biased, unsubstantiated, not supported by the current literature and represents a disservice to the scientific and health care community.