Ali Aminian

Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 3-Year Outcomes

BACKGROUND Long‐term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited. METHODS We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body‐mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux‐en‐Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications. RESULTS Of the 150 patients who underwent randomization, 1 patient died during the 5‐year follow‐up period; 134 of the remaining 149 patients (90%) completed 5 years of follow‐up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention‐to‐treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention‐to‐treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric‐bypass and sleeve‐gastrectomy groups were superior to the changes seen in the medical‐therapy group with respect to body weight (‐23%, ‐19%, and ‐5% in the gastric‐bypass, sleeve‐gastrectomy, and medical‐therapy groups, respectively), triglyceride level (‐40%, ‐29%, and ‐8%), high‐density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (‐35%, ‐34%, and ‐13%), and quality‐of‐life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36‐Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation. CONCLUSIONS Five‐year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo‐Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.)

Can Diabetes Be Surgically Cured?: Long-Term Metabolic Effects of Bariatric Surgery in Obese Patients with Type 2 Diabetes Mellitus

Objective: Evaluate the long-term effects of bariatric surgery on type 2 diabetes (T2DM) remission and metabolic risk factors. Background: Although the impressive antidiabetic effects of bariatric surgery have been shown in short- and medium-term studies, the durability of these effects is uncertain. Specifically, long-term remission rates following bariatric surgery are largely unknown. Methods: Clinical outcomes of 217 patients with T2DM who underwent bariatric surgery between 2004 and 2007 and had at least 5-year follow-up were assessed. Complete remission was defined as glycated hemoglobin (A1C) less than 6% and fasting blood glucose (FBG) less than 100 mg/dL off diabetic medications. Changes in other metabolic comorbidities, including hypertension, dyslipidemia, and diabetic nephropathy, were assessed. Results: At a median follow-up of 6 years (range: 5–9) after surgery (Roux-en-Y gastric bypass, n = 162; gastric banding, n = 32; sleeve gastrectomy, n = 23), a mean excess weight loss (EWL) of 55% was associated with mean reductions in A1C from 7.5% ± 1.5% to 6.5% ± 1.2% (P < 0.001) and FBG from 155.9 ± 59.5 mg/dL to 114.8 ± 40.2 mg/dL (P < 0.001). Long-term complete and partial remission rates were 24% and 26%, respectively, whereas 34% improved (>1% decrease in A1C without remission) from baseline and 16% remained unchanged. Shorter duration of T2DM (P < 0.001) and higher long-term EWL (P = 0.006) predicted long-term remission. Recurrence of T2DM after initial remission occurred in 19% and was associated with longer duration of T2DM (P = 0.03), less EWL (P = 0.02), and weight regain (P = 0.015). Long-term control rates of low high-density lipoprotein, high low-density lipoprotein, high triglyceridemia, and hypertension were 73%, 72%, 80%, and 62%, respectively. Diabetic nephropathy regressed (53%) or stabilized (47%). Conclusions: Bariatric surgery can induce a significant and sustainable remission and improvement of T2DM and other metabolic risk factors in severely obese patients. Surgical intervention within 5 years of diagnosis is associated with a high rate of long-term remission.

How safe is metabolic/diabetes surgery?

Although recent studies have shown the impressive antidiabetic effects of laparoscopic Roux‐en‐Y gastric bypass (LRYGB), the safety profile of metabolic/diabetes surgery has been a matter of concern among patients and physicians. Data on patients with type 2 diabetes who underwent LRYGB or one of seven other procedures between January 2007 and December 2012 were retrieved from the American College of Surgeons National Surgical Quality Improvement Program database and compared. Of the 66 678 patients included, 16 509 underwent LRYGB. The composite complication rate of 3.4% after LRYGB was similar to those of laparoscopic cholecystectomy and hysterectomy. The mortality rate for LRYGB (0.3%) was similar to that of knee arthroplasty. Patients who underwent LRYGB had significantly better short‐term outcomes in all examined variables than patients who underwent coronary bypass, infra‐inguinal revascularization and laparoscopic colectomy. In conclusion, LRYGB can be considered a safe procedure in people with diabetes, with similar short‐term morbidity to that of common procedures such as cholecystectomy and appendectomy and a mortality rate similar to that of knee arthroplasty. The mortality risk for LRYGB is one‐tenth that of cardiovascular surgery and earlier intervention with metabolic surgery to treat diabetes may eliminate the need for some later higher‐risk procedures to treat diabetes complications.

Risk prediction of complications of metabolic syndrome before and 6 years after gastric bypass

BACKGROUND Roux-en-Y gastric bypass (RYGB) surgery has been shown to have favorable effects on components of metabolic syndrome. However, the long-term effect of RYGB on predicted risk of end-organ complications is less clear. The objective of this study was to examine long-term changes in predicted risk of metabolic syndrome-related complications after RYGB. METHODS The predicted risk of metabolic syndrome-related complications in a cohort of 131 diabetic patients was compared between baseline and last follow-up points after RYGB using validated risk assessment tools. RESULTS After a median postsurgical follow-up time of 6 years (range, 5-9), a mean percent excess weight loss of 60.7 ± 25.1% was associated with a diabetes remission rate of 61%. At long-term follow-up, the levels of glycated hemoglobin, low-density lipoprotein, and blood pressure were within the recommended American Diabetes Associations goals in 85%, 73%, and 63% of patients, respectively (P<.001). RYGB was associated with a relative risk reduction of 27% for 10-year overall risk of coronary heart disease (CHD), stroke, and peripheral vascular disease; 20% for 10-year risk of CHD; 40% for 10-year risk of myocardial infarction; 42% for 10-year risk of stroke; 47% for 4-year risk of intermittent claudication; 45% for 5-year risk of moderate-severe kidney disease; and 18% for 5-year risk of cardiovascular mortality. Four-year risk of diabetic retinopathy was also significantly decreased. CONCLUSION RYGB in diabetic patients results in remarkable control of diabetes, dyslipidemia, and hypertension, and is associated with a significant reduction in predicted risk of major complications including nephropathy, retinopathy, and cardiovascular disease and mortality in the range of 18-47% at long-term follow-up.

Can Sleeve Gastrectomy "Cure" Diabetes? Long-term Metabolic Effects of Sleeve Gastrectomy in Patients With Type 2 Diabetes.

Objective: The aim of the study was to assess long-term metabolic effects of laparoscopic sleeve gastrectomy (LSG) in patients with type 2 diabetes (T2DM) and to identify predictive factors for long-term diabetes remission and relapse. Background: LSG has become the most common bariatric operation worldwide. Its long-term metabolic effects in patients with T2DM are, however, unknown. Methods: Outcomes of 134 patients with obesity with T2DM who underwent LSG at an academic center during 2005 to 2010 and had at least 5 years of follow-up were assessed. Results: At a median postsurgical follow-up of 6 years (range: 5–9), a mean body mass index loss of −7.8 ± 5.1 kg/m2 (total weight loss: 16.8% ± 9.7%) was associated with a reduction in mean glycated hemoglobin (HbA1c, −1.3 ± 1.8%, P < 0.001), fasting blood glucose (−37.8 ± 70.4 mg/dL, P < 0.001) and median number of diabetes medications (−1, P < 0.001). Long-term glycemic control (HbA1c <7%) was seen in 63% of patients (vs 31% at baseline, P < 0.001), diabetes remission (HbA1c <6.5% off medications) in 26%, complete remission (HbA1c <6% off medications) in 11%, and “cure” (continuous complete remission for ≥5 years) was achieved in 3%. Long-term relapse of T2DM after initial remission occurred in 44%. Among patients with relapse, 67% maintained glycemic control (HbA1c <7%). On adjusted analysis, taking 2 or more diabetes medications at baseline predicted less long-term remission (odds ratio 0.19, 95% confidence interval 0.07–0.55, P = 0.002) and more relapse of T2DM (odds ratio 8.50, 95% confidence interval: 1.40–49.20, P = 0.02). Significant improvement in triglycerides (−53.7 ± 116.4 mg/dL, P < 0.001), high-density lipoprotein (8.2 ± 12.9 mg/dL, P < 0.001), systolic (−8.9 ± 18.7 mmHg, P < 0.001) and diastolic blood pressure (−2.6 ± 14.5 mmHg, P = 0.04), and cardiovascular risk (13% relative reduction, P < 0.001) was observed. Conclusions: LSG can significantly improve cardiometabolic risk factors including glycemic status in T2DM. Long-term complete remission and “cure” of T2DM, however, occur infrequently.

Development of a sleeve gastrectomy risk calculator

BACKGROUND Laparoscopic sleeve gastrectomy (LSG) is rapidly gaining popularity. Estimating the risk of postoperative adverse events can improve surgical decision-making and informed patient consent. The objective of this study was to develop and validate a risk prediction model for early postoperative morbidity and mortality after LSG. METHODS Cases of primary LSG in the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) data set at year 2012 (n = 5871) and 2011 (n = 3130) were identified to develop and examine the validity of model. The composite primary outcome was defined as presence of any of 14 serious adverse events within the 30-days after LSG. Multiple logistic regression analysis was performed and a risk calculator was created to predict the primary outcome. RESULTS Thirty-day postoperative mortality and composite adverse events rates of 5871 LSG cases were .05% and 2.4%, respectively. Of the 52 examined baseline variables, the final model contained history of congestive heart failure (odds ratio [OR] 6.23; 95% CI 1.25-31.07), chronic steroid use (OR 5.00; 95% CI 2.06-12.15), male sex (OR 1.68; 95% CI 1.03-2.72), diabetes (OR 1.62; 95% CI 1.07-2.48), preoperative serum total bilirubin level (OR 1.57; 95% CI 1.11-2.22), body mass index (OR 1.03; 95% CI 1.01-1.05), and preoperative hematocrit level (OR .95; 95% CI .89-1.00). The risk model was then validated with the 2011 data set and was used to create an online risk calculator with a relatively good accuracy (c-statistic .682). CONCLUSIONS This risk assessment scoring system, which specifically estimates serious adverse events after LSG, can contribute to surgical decision-making, informed patient consent, and prediction of surgical risk for patients and referring physicians.

Bariatric Surgery Improves the Metabolic Profile of Morbidly Obese Patients With Type 1 Diabetes

A growing body of evidence has demonstrated significant and sustained improvement in glycemic control in type 2 diabetes after bariatric surgery. However, there are limited data on the impact of bariatric surgery in type 1 diabetes (T1D). Only fewer than 10 cases of bariatric surgery in patients with T1D have been reported in the literature, which show a significant weight reduction and improvement in glycemic control (1–3). A recent experimental study in a rat model of spontaneous development of T1D has also shown that a particular type of gastrointestinal bypass (duodenal-jejunal bypass surgery) lowers blood glucose concentration within 2 days after surgery (4). The aim of this study was to assess the metabolic outcomes, including the glycemic status, of patients with T1D after bariatric surgery. Clinical outcomes and metabolic parameters of 10 morbidly obese patients with poorly controlled T1D who underwent laparoscopic bariatric surgery between 5 January 2005 and 12 …

Exploring the impact of bariatric surgery on high density lipoprotein

Low HDL cholesterol is an independent cardiac risk factor. A general efficacy gradient exists for the resolution of cardiovascular risk factors after bariatric surgery (i.e., biliopancreatic diversion [BPD]>Roux-en-Y gastric bypass [RYGB]>sleeve gastrectomy [SG]>adjustable gastric banding [AGB]). However, a review of high level of evidence clinical studies shows a different hierarchy for the effect of bariatric surgery on HDL (i.e., RYGB=SG>BPD, AGB). Surgically induced weight loss effectively reverses many steps in HDL metabolism that have been altered with obesity. Furthermore, enterocytes contribute to HDL levels through the synthesis of apolipoproteins A-IV and A-I. RYGB and SG that preserve the small intestine (particularly the jejunum) lead to a significant rise in HDL. However, when the small intestinal contribution does not reinforce the weight loss dependent mechanisms (e.g., after BPD and AGB), only a modest rise in HDL occurs. Further experimental and clinical studies are required to better delineate the issue.

Who Should Get Extended Thromboprophylaxis After Bariatric Surgery?: A Risk Assessment Tool to Guide Indications for Post-discharge Pharmacoprophylaxis.

Objective: To determine the risk factors for 30-day postdischarge venous thromboembolism (VTE) after bariatric surgery and to identify potential indications for extended pharmacoprophylaxis. Background: VTE is among most common causes of death after bariatric surgery. Most VTEs occur after hospital stay; still a few patients receive extended pharmacoprophylaxis postdischarge. Methods: From American College of Surgeons-National Surgical Quality Improvement Program, we identified 91,963 patients, who underwent elective primary and revisional bariatric surgery between 2007 and 2012. Regression-based techniques were used to create a risk assessment tool to predict risk of postdischarge VTE. The model was validated using the 2013 American College of Surgeons-National Surgical Quality Improvement Program dataset (N = 20,575). Significant risk factors were used to create a user-friendly online risk calculator. Results: The overall 30-day incidence of postdischarge VTE was 0.29% (N = 269). In those experiencing a postdischarge VTE, mortality increased about 28-fold (2.60% vs 0.09%; P < 0.001). Among 45 examined variables, the final risk-assessment model contained 10 categorical variables including congestive heart failure, paraplegia, reoperation, dyspnea at rest, nongastric band surgery, age ≥60 years, male sex, BMI ≥50 kg/m2, postoperative hospital stay ≥3 days, and operative time ≥3 hours. The model demonstrated good calibration (Hosmer-Lemeshow goodness-of-fit test, P = 0.71) and discrimination (c-statistic = 0.74). Nearly 2.5% of patients had a predicted postdischarge VTE risk >1%. Conclusions: More than 80% of post-bariatric surgery VTE events occurred post-discharge. Congestive heart failure, paraplegia, dyspnea at rest, and reoperation are associated with the highest risk of post-discharge VTE. Routine post-discharge pharmacoprophylaxis can be considered for high-risk patients (ie, VTE risk >0.4%).

Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity

Objective: To construct and validate a scoring system for evidence-based selection of bariatric and metabolic surgery procedures according to severity of type 2 diabetes (T2DM). Background: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) account for >95% of bariatric procedures in United States in patients with T2DM. To date, there is no validated model to guide procedure selection based on long-term glucose control in patients with T2DM. Methods: A total of 659 patients with T2DM who underwent RYGB and SG at an academic center in the United States and had a minimum 5-year follow-up (2005–2011) were analyzed to generate the model. The validation dataset consisted of 241 patients from an academic center in Spain where similar criteria were applied. Results: At median postoperative follow-up of 7 years (range 5–12), diabetes remission (HbA1C <6.5% off medications) was observed in 49% after RYGB and 28% after SG (P < 0.001). Four independent predictors of long-term remission including preoperative duration of T2DM (P < 0.0001), preoperative number of diabetes medications (P < 0.0001), insulin use (P = 0.002), and glycemic control (HbA1C < 7%) (P = 0.002) were used to develop the Individualized Metabolic Surgery (IMS) score using a nomogram. Patients were then categorized into 3 stages of diabetes severity. In mild T2DM (IMS score ⩽25), both procedures significantly improved T2DM. In severe T2DM (IMS score >95), when clinical features suggest limited functional &bgr;-cell reserve, both procedures had similarly low efficacy for diabetes remission. There was an intermediate group, however, in which RYGB was significantly more effective than SG, likely related to its more pronounced neurohormonal effects. Findings were externally validated and procedure recommendations for each severity stage were provided. Conclusions: This is the largest reported cohort (n = 900) with long-term postoperative glycemic follow-up, which, for the first time, categorizes T2DM into 3 validated severity stages for evidence-based procedure selection.