News & Updates

26/04/16
Obesity is not only a risk factor for developing knee arthritis. It is also linked to less favorable outcomes after joint replacement surgery. A study at Hospital for Special Surgery (HSS) in New York City finds that bariatric surgery prior to total knee replacement (TKR) is a cost-effective option to improve outcomes. The research appeared in the January issue of The Journal of Bone and Joint Surgery.

It is well known that obesity takes a toll on one's health. Bariatric surgery and subsequent weight loss reduce the risk of heart disease, diabetes and some forms of cancer. "We know that bariatric surgery is a cost-effective intervention for morbid obesity," said Alexander McLawhorn, MD, MBA, lead investigator. "Yet, the cost-effectiveness of bariatric surgery to achieve weight loss prior to joint replacement and thus decrease the associated complications and costs in severely obese patients was unknown."

Investigators used a sophisticated computer software program to answer that question. The computer model compared the cost-utility of two treatment protocols for patients who were morbidly obese and had advanced knee osteoarthritis. One group had joint replacement immediately, without losing weight. The other group had knee replacement two years after bariatric surgery and subsequent weight loss.

"For the study, we chose a decision analysis design because we could use a mathematical model to simulate the outcomes and costs of each treatment path based on results and costs that have already been published in the literature," Dr. McLawhorn explained.

In the study, patients had a BMI of at least 35. (Normal BMI is 18.5 to 24.9). For study purposes, researchers assumed that at least one-third of the patients having bariatric surgery lost their excess weight before knee replacement.

The computer model predicted that the patients who had bariatric surgery two years prior to TKR were more likely to enjoy improved quality of life, measured in quality-adjusted life years (QALYs), compared to patients undergoing TKR without prior weight loss surgery. In addition, the cost necessary for this level of improvement was $13,910 per QALY, which is below the amount society and health care payers, such as insurance companies and the government, are typically willing to "The computer model supports bariatric surgery prior to total knee replacement as a cost-effective option for improving outcomes in morbidly obese patients with end-stage knee osteoarthritis," Dr. McLawhorn said.

However, he notes that for some patients experiencing severe knee pain, it may be impractical to hold off on joint replacement. Sometimes an orthopedic surgeon is the first doctor a patient sees for arthritis pain, and individual patient preferences for treatment should be taken into account.

Another important consideration is the nutritional assessment for patients scheduled for orthopedic surgery, especially those who have had bariatric surgery, according to Dr. McLawhorn. Any nutritional deficiencies need to be addressed prior to joint replacement. "Ideally, a team approach should be used to treat severely obese patients with knee arthritis in which various health care professionals are in place to help a patient lose weight, improve his or her health, and optimize nutrition before joint replacement to maximize its benefits," he said.

"The results of our study may help physicians when counseling patients and developing an individualized treatment plan that includes optimization of overall health, nutrition and weight prior to knee replacement," said Dr. McLawhorn.
26/04/16
This commentary discusses a randomized clinical trial published in JAMA Surgery that investigated remission rates of type 2 diabetes among patients treated with bariatric surgery and a lifestyle intervention vs a lifestyle intervention alone.

JAMA Surgery
Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical TrialAnita P. Courcoulas, MD, MPH; Steven H. Belle, PhD, MScHyg; Rebecca H. Neiberg, MS; Sheila K. Pierson, BS, BA; Jessie K Eagleton, MPH; Melissa A. Kalarchian, PhD; James P. DeLany, PhD; Wei Lang, PhD; John M. Jakicic, PhD

Importance Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).

Objective To compare the remission of T2DM following surgical and nonsurgical treatments.

Design, Setting, and Participants In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population.

Interventions Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.

Main Outcomes and Measures Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change.

Results Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention–alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (PConclusions and Relevance Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone.

JAMA Surg. 2015;150(10):931-940. doi:10.1001/jamasurg.2015.1534
20/04/16
Abstract
Importance Accumulating evidence suggests that bariatric surgery improves survival among patients with severe obesity, but research among veterans has shown no evidence of benefit.

Objective To examine long-term survival in a large multisite cohort of patients who underwent bariatric surgery compared with matched control patients.

Design, Setting, and Participants In a retrospective cohort study, we identified 2500 patients (74% men) who underwent bariatric surgery in Veterans Affairs (VA) bariatric centers from 2000-2011 and matched them to 7462 control patients using sequential stratification and an algorithm that included age, sex, geographic region, body mass index, diabetes, and Diagnostic Cost Group. Survival was compared across patients who underwent bariatric surgery and matched controls using Kaplan-Meier estimators and stratified, adjusted Cox regression analyses.

Exposures Bariatric procedures, which included 74% gastric bypass, 15% sleeve gastrectomy, 10% adjustable gastric banding, and 1% other.

Main Outcomes and Measures All-cause mortality through December 2013.

Results Surgical patients (n = 2500) had a mean age of 52 years and a mean BMI of 47. Matched control patients (n = 7462) had a mean age of 53 years and a mean BMI of 46. At the end of the 14-year study period, there were a total of 263 deaths in the surgical group (mean follow-up, 6.9 years) and 1277 deaths in the matched control group (mean follow-up, 6.6 years). Kaplan-Meier estimated mortality rates were 2.4% at 1 year, 6.4% at 5 years, and 13.8% at 10 years for surgical patients; for matched control patients, 1.7% at 1 year, 10.4% at 5 years, and 23.9% at 10 years. Adjusted analysis showed no significant association between bariatric surgery and all-cause mortality in the first year of follow-up (adjusted hazard ratio [HR], 1.28 [95% CI, 0.98-1.68]), but significantly lower mortality after 1 to 5 years (HR, 0.45 [95% CI, 0.36-0.56]) and 5 to 14 years (HR, 0.47 [95% CI, 0.39-0.58]). The midterm (>1-5 years) and long-term (>5 years) relationships between surgery and survival were not significantly different across subgroups defined by diabetes diagnosis, sex, and period of surgery.

Conclusions and Relevance Among obese patients receiving care in the VA health system, those who underwent bariatric surgery compared with matched control patients who did not have surgery had lower all-cause mortality at 5 years and up to 10 years following the procedure. These results provide further evidence for the beneficial relationship between surgery and survival that has been demonstrated in younger, predominantly female populations.
18/03/16
Diabetes patients are 10 times more likely to go into remission a year after having gastric bypass surgery compared to relying on intensive exercise, healthy eating and optimal treatment alone, a US study suggests.

Gastric bypass surgery is 'much more effective' than intensive exercise, healthy eating and medical treatment alone at reversing type 2 diabetes, a study published in Diabetologia has found.

The researchers say the results call into question putting cut-offs on BMI eligibility as the primary criteria for gastric bypass surgery.

It is already known that gastric bypass surgery leads to improved glycaemic control, resulting in type 2 diabetes remission in many cases.

The current trial compared patient outcomes one year after receiving a Roux-en-Y gastric bypass surgery (RYGB) with patients who spent a year on ‘the most rigorous intensive lifestyle and medical intervention yet tested against surgery in a randomised trial’.

Patients on the intervention scheme did at least 45 minutes of aerobic exercise five days a week, ate a dietician-directed weight and glucose lowering diet and received optimal diabetes treatment.

Diabetes remission
Over 30 patients aged 25-64 with a BMI between 30 and 45 were involved in the trial. Of these, 15 received gastric bypass surgery and 17 were put in the intervention group.

After one year, the researchers – from the University of Washington – found that 60% of patients in the bypass group were in diabetes remission, compared to just 6% in the intervention group. Diabetes remission was defined as HbA1c below 6%.

Observed weight loss was also higher in the gastric bypass group at 26% compared to 6% in the intervention group. Weight loss in the gastric bypass group also remained more stable over time.

The researchers said: ‘Despite these limitations, our trial and other relevant randomly-controlled trials demonstrate that commonly used bariatric and metabolic operations are all more effective than a variety of medical and/or lifestyle interventions to promote weight loss, diabetes remission, glycaemic control, and improvements in other CVD risk factors, with acceptable complications, for at least 1–3 years.

‘These results apply to patients with a BMI <35, and our study and others show that neither baseline BMI nor the amount of weight lost dependably predicts diabetes remission after RYGB, which appears to ameliorate diabetes through mechanisms beyond just weight reduction. These findings call into serious question the longstanding practice of using strict BMI cut-offs as the primary criteria for surgical selection among patients with type 2 diabetes.’3535
23/02/16
Los Angeles—It’s been a decades-long effort to have bariatric surgery accepted as a safe, effective treatment for people who are morbidly obese.

Now, a new study presented at ObesityWeek 2015 suggests that bariatric procedures also should be considered a safe, effective treatment for people who have type 2 diabetes and are overweight or mildly obese.

“A two-hour operation and a two-day hospital stay has the potential to resolve or improve what is a chronic, progressive and dangerous disease,” said John M. Morton, MD, immediate past president of the American Society for Metabolic and Bariatric Surgery, and chief of bariatric and minimally invasive surgery at Stanford University School of Medicine, in California, who was not involved in the study.

“The risk–benefit profile that has emerged for bariatric surgery in people with type 2 diabetes and low body mass index [BMI] is very favorable and should be considered as a treatment option in carefully selected patients.” The Cleveland Clinic researchers who conducted the study say it is the largest published series of bariatric surgery in patients with type 2 diabetes and a BMI of 35 kg/m2 or less.

They evaluated 1,003 patients from North America with a BMI between 25 and 35 kg/m2. The average BMI in the study cohort was 33.5 kg/m2. Forty percent of patients were taking insulin injections and 60% were on oral medications for their diabetes before surgery. Analysis showed that bariatric surgery was associated with a low rate of complications and mortality in these lower BMI patients. The 30-day postoperative mortality rate was 0.2% and the cumulative rate of postoperative adverse events was 4%; 1.6% of patients required reoperation within 30 days. The procedures averaged 110 minutes, and patients were discharged from the hospital within two days.

“We are seeing significant improvement or remission of type 2 diabetes in most lower-BMI patients,” said lead investigator Ali Aminian, MD, laparoscopic and bariatric surgeon at the Cleveland Clinic Digestive Disease Institute, in Ohio. “Currently, evidence suggests that baseline BMI is unrelated to diabetes remission following bariatric and metabolic surgery.

“Our data, which is from a large sample size, shows a modest early morbidity and low mortality following bariatric surgery in nonseverely obese patients. These data are important because most patients with diabetes fall into this BMI category.”

The study, which used data from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), lacks long-term follow-up—which is key to assessing the long-term durability of results in these patients. The ACS-NSQIP collects data on more than 150 variables, including preoperative details and 30-day postoperative mortality and morbidity outcomes, on patients undergoing major surgical procedures in the United States. It does not capture adverse events beyond 30 days after surgery, which can lead to inderestimation
of real risks.

Other small series looked at the effects of bariatric surgery in patients with type 2 diabetes who are overweight and mildly obese, but had not been large enough to examine safety.

Despite growing evidence to support bariatric surgery in this population, only a few private insurance carriers provide bariatric coverage for people with a BMI below 35 kg/m2. The existing cutoff of a BMI of 35 kg/m2 for insurance coverage was arbitrarily established nearly 20 years ago, Dr. Aminian said.

“Over the last quarter century, however, the field has significantly evolved with introduction of new, less invasive surgical approaches and surgical procedures, which have led to improvements in the safety profile of surgery and can potentially expand the indications for surgery.”

There are still many unanswered questions about bariatric surgery as a treatment for type 2 diabetes, he added. Although studies have confirmed that surgery can control blood glucose concentrations and cardiovascular risk factors in low-BMI patients, the long-term effects of gastrointestinal surgical procedures on diabetes outcomes, such as retinopathy, nephropathy and cardiovascular events, are not known. Several randomized controlled trials are currently underway to address these concerns.
17/10/15
Clinical Factors Associated With Remission of Obesity-Related Comorbidities After Bariatric Surgery ONLINE FIRSTIda J. Hatoum, ScD1,2; Robin Blackstone, MD3; Tina D. Hunter, PhD4; Diane M. Francis, MPH5,6; Michael Steinbuch, PhD5,6; Jason L. Harris, PhD5,6; Lee M. Kaplan, MD, PhD1,2

Importance Little is known about comorbidity remission after bariatric surgery during typical clinical care across diverse and geographically distributed populations.

Objective To estimate the improvement in obesity-related comorbidities after bariatric surgery and to identify clinical factors associated with these responses using a large representative population of patients.

Design, Setting, and Participants This retrospective cohort study included all patients (N = 33 718) with a recorded Current Procedural Terminology code for Roux-en-Y gastric bypass (RYGB) or adjustable gastric banding (AGB) in the MarketScan Commercial Claims and Encounters Medicare Supplemental Databases from January 1, 2005, to June 30, 2010, and who had continuous enrollment from 6 months or more before to 12 months after surgery.

Main Outcomes and Measures Comorbidities before and after surgery were identified using both diagnoses (from International Classification of Diseases, Ninth Revision [ICD-9] codes) and prescription drug fills. Remission was based on a record of the comorbidity within 6 months before surgery, without record of the condition 18 months after surgery, using both ICD-9 codes and medication fills, as applicable. Multivariable logistic regression models were developed to identify factors associated with remission of diabetes and hypertension.

Results Among the 33 718 patients, 13 comorbidities with at least 1% prevalence before surgery were identified. Both RYGB and AGB led to statistically and clinically significant reductions in these comorbidities; remission rates for all comorbidities were higher after RYGB than AGB. For comorbidities that could be defined using both ICD-9 and prescription drug fill codes, prevalence was higher before and lower after surgery when measured by fill codes. Diagnoses using ICD-9 codes, but not prescription fill codes, increased in the 3 months before surgery. In multivariable logistic regression models for remission of diabetes mellitus after RYGB and AGB, age (RYGB: odds ratio [OR], 0.976; 95% CI, 0.965-0.988 and AGB: OR, 0.982; 95% CI, 0.971-0.933), procedure year (RYGB: OR, 1.11; 95% CI, 1.012-1.218 and AGB: OR, 1.185; 95% CI, 1.039-1.351), preoperative insulin use (RYGB: OR, 0.14; 95% CI, 0.114-0.171; AGB: OR, 0.174; 95% CI, 0.131-0.230), preoperative sulfonylurea use (RYGB: OR, 0.616; 95% CI, 0.505-0.752 and AGB: OR, 0.449; 95% CI, 0.357-0.566), and other antidiabetic medication use (RYGB: OR, 0.747; 95% CI, 0.568-0.981 and AGB: OR, 0.506; 95% CI, 0.359-0.715) were significantly associated with response after both procedures. For remission of hypertension, age (RYGB: OR, 0.964; 95% CI, 0.957-0.972 and AGB: OR, 0.968; 95% CI, 0.959-0.977), number of preoperative antihypertensive medications (RYGB: OR, 0.104; 95% CI, 0.067-0.161 and AGB: OR, 0.239; 95% CI, 0.140-0.408), and preoperative diuretic use (RYGB: OR, 1.729; 95% CI, 1.462-2.045 and AGB: OR, 1.648; 95% CI, 1.380-1.967) were significantly associated with response after both procedures.

Conclusions and Relevance Analysis of a large, representative administrative database confirmed established predictors and revealed novel variables associated with comorbidity remission after bariatric surgery. Incorporating these factors into clinical tools to assess an individual patient’s risk-to-benefit profile for these procedures could enhance patient selection and the overall use of surgery for the treatment of obesity and metabolic disease.
15/10/15
Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment:
A Randomized Clinical Trial

Anita P. Courcoulas, MD, MPH1; Steven H. Belle, PhD, MScHyg2,3; Rebecca H. Neiberg, MS4; Sheila K. Pierson, BS, BA1; Jessie K Eagleton, MPH1; Melissa A. Kalarchian, PhD5; James P. DeLany, PhD6; Wei Lang, PhD4; John M. Jakicic, PhD7

Importance Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).

Objective To compare the remission of T2DM following surgical and nonsurgical treatments.

Design, Setting, and Participants In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population.

Interventions Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.

Main Outcomes and Measures Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change.

Results Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention–alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01).

Conclusions and Relevance Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone.

Trial Registration clinicaltrials.gov Identifier: NCT01047735