AHA Scientific Sessions Feature Miller School’s Pioneering Research
- The LEAF study is the first to show that treating overweight and obese patients with AFib with a combination of risk management strategies and a weight loss drug greatly improved ablation outcomes.
- The study compared groups who received only risk management strategies to those who combined risk management strategies with use of the weight loss drug liraglutide.
- Eighty-three percent of those who implemented both liraglutide and risk management were free of atrial fibrillation after a year, whereas the group that used only risk modification report 57 percent experienced no atrial fibrillation.
Researchers at University of Miami Miller School of Medicine led a study that could result in significantly improved outcomes from ablation used to treat atrial fibrillation (AFib), an irregular heartbeat or arrythmia.
That study was among the featured science presentations at the American Heart Association’s Scientific Sessions held November 11-13 in Philadelphia.
Study principal investigator Jeffrey Goldberger, M.D., a Miller School professor of medicine in the Division of Cardiovascular Medicine, presented the Liraglutide Effect on Atrial Fibrillation (LEAF) study.
Treating AFib with Risk Management and Liraglutide
Dr. Goldberger and fellow Miller School professors of medicine, Division of Cardiovascular Medicine, Gianluca Iacobellis, M.D., Ph.D., and Raul Mitrani, M.D., were the first to show that treating obese atrial fibrillation (AFib) patients with a combination of risk management strategies and the weight loss drug liraglutide prior to ablation led to better outcomes than risk management alone.
“Currently, only about 50% of patients with persistent AFib and about 70% with paroxysmal, or episodic, AFib remain free of AFib after ablation,” Dr. Goldberger said. “In LEAF, 83% of AFib patients who received liraglutide in addition to usual care remained AFib-free a year after their ablations.”
The Health Ramifications of AFib
AFib can lead to blood clots, stroke, heart failure and other heart-related issues. The CDC estimates that more than 12 million people in the U.S. will have AFib by 2030.
Treatments include making healthy lifestyle changes, medicines to control the heart’s rhythm and to prevent blood clots and procedures like ablation and surgery.
According to Dr. Goldberger, it is important to develop an individualized and comprehensive approach to the management of AFib that addresses the factors that led to its development.
Obesity’s Relationship to AFib
Dr. Goldberger noted that obesity is a major risk factor for atrial fibrillation. Recent guidelines have added risk factor modification including weight loss as a class 1, or primary, indication for treatment of AFib.
Working with Dr. Iacobellis, a leading expert in epicardial adipose tissue (fat tissue surrounding the heart), Drs. Goldberger and Iacobellis hypothesized that some of the effects of obesity are related to this fat tissue that sits on the heart.
“There’s no membrane that separates fat tissue from heart cells (the myocardium),” Dr. Goldberger said. “Dr. Iacobellis has shown that the approved weight loss medication liraglutide, a glucagon‐like peptide‐1 receptor agonist that is similar to the brand name medications Ozempic and Wegovy, can greatly reduce epicardial fat.”
Study Design and Findings
Researchers compared two groups of AFib patients with body mass indexes of 27 kg/m2 or higher who were scheduled to have ablations. For at least three months prior to their ablations, one group received guideline-recommended risk factor modification, including nurse practitioner-led telehealth sessions to help patients lose weight and lead healthier lifestyles. The other group received the risk factor modification intervention and liraglutide, also known as Victoza.
While other brand-name medications Wegovy and Ozempic would also be options, Victoza was FDA approved for weight loss at the time of the study, according to Dr. Goldberger.
Researchers followed patients after ablation and report on follow-ups of six months or more.
“Now we have data on follow-ups of a year or more,” Dr. Goldberger said. “We have found that one year freedom from atrial fibrillation was 83% in the risk factor modification and liraglutide group compared to 57% for the risk factor modification only group—a huge and significant difference.”
Dr. Goldberger and colleagues reported weight loss in both groups. While the risk factor modification group with liraglutide lost slightly more weight, the difference between the groups was not statistically significant.
“There has been a lot of work on weight loss as concomitant therapy with ablation, but we are the pioneers in this specific approach,” he said. “This is a relatively small study, with a total of 59 patients. The next step is to finish our follow up and report the data, then we’d like to proceed with a larger scale randomized clinical trial.”