- Metabolic, or bariatric, weight-loss surgeries ought to be taken seriously as a means to reduce incidence of major adverse cardiovascular events like heart failure, atrial fibrillation and heart attack, according to new research funded partly by Medtronic. The retrospective study was published Monday in the Journal of the American Medical Association and presented at the European Society of Cardiology Congress.
- "When balancing the imperfections in the evidence for both medical and surgical treatment of diabetes, the many benefits associated with bariatric surgery-induced weight loss suggest that it should be the preferred treatment option for carefully selected, motivated patients who are obese and have diabetes and cannot lose weight by other means," JAMA Deputy Editor Edward Livingston wrote in a related editorial.
- Findings from the study must be confirmed in randomized clinical trials, researchers concluded.
Medtronic markets a number of access and closure devices used in bariatric procedures, including visualization, dissection, suturing and stapling products. Almost 230,000 of the procedures, which make changes to the digestive system, took place in the U.S. in 2017. That was up from close to 160,000 in 2011, according to an estimate from the American Society for Metabolic and Bariatric Surgery. More than 100 million American adults, or close to one-third of the U.S. population, live with diabetes or prediabetes, per a 2017 report from the Centers for Disease Control and Prevention.
The Medtronic-supported study notes while metabolic surgery is thought to significantly improve cardiometabolic risk factors, which include diabetes, heart disease and stroke, the impact on cardiovascular outcomes hasn't been as well-characterized.
Researchers sought to better understand the relationship between metabolic surgery and major adverse cardiovascular events, or MACE, using the Cleveland Clinic Electronic Health Record system. They retrospectively examined outcomes in 13,722 patients with diabetes, about 17% of whom underwent metabolic surgery between 1998 and 2017 and the rest of whom served as matched controls and received typical care for Type 2 diabetes and obesity. Median follow-up duration was 3.9 years.
Patients who had metabolic surgery showed favorable, statistically significant differences against the control group on each of the pre-specified secondary outcomes, which considered incidence of myocardial infarction, ischemic stroke, and mortality, as well as the six individual components of the primary endpoint — first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation.
All-cause mortality occurred in 112 patients who received metabolic surgery and in 1,111 of the patients in the non-surgical group, the researchers reported. About 31% of the surgical group experienced one of those primary endpoints by the time of eight-year follow up; the rate was roughly 48% among the control group.
The Medtronic-backed research comes a little less than a year after a larger, NIH-supported study was published in JAMA that also found bariatric surgery to be associated with lower risk of major macrovascular events, and similarly called for confirmation through randomized clinical trials.
JAMA's Livingston wrote in a related editorial that while medication is a universally accepted method for lowering glucose, bariatric surgery is not deemed "a first-line approach" for addressing diabetes in people with obesity.
"Compared with the large amount of clinical trial information available for drug treatment of diabetes, much less exists for bariatric surgery," he wrote.
Livingston also noted limitations of the observational research included imprecise matching of the study groups, with the control group averaging slightly higher patient ages and diastolic blood pressures, in addition to having "much more" missing data.
"The results of this study should be interpreted with caution," he wrote. "Although patients are referred to as 'matched' in observational studies, a more appropriate description is 'similar.'"
The European Society of Cardiology Congress continues in Paris through Wednesday.