Late-Breaking Clinical Trial Results Announced At Heart Rhythm 2015: Botox Injections Help Prevent Atrial Fibrillation After Cardiac Surgery

Study finds botulinum toxin injections in epicardial fat pads reduce AF risk immediately following surgery and after one year of follow-up

May 14, 2015

Media Contact

Shane Osborne
Heart Rhythm Society
media@hrsonline.org
202-464-3431

BOSTON – The first study to examine the safety and efficacy of botulinum toxin (botox) injections into epicardial fat pads during coronary artery bypass graft (CABG) surgery found that the approach not only reduces the incidence of post-operative atrial fibrillation (AF), but also provides substantial AF suppression after one year. The results showing the benefit of botox injections after cardiac surgery were presented today at Heart Rhythm 2015, the Heart Rhythm Society’s 36th Annual Scientific Sessions.

AF is the most common arrhythmia complicating cardiac surgery and occurs in approximately 30-40 percent of patients undergoing CABG surgery. CABG is the most common type of open-heart surgery in the United States and improves blood flow to the heart to treat people with coronary heart disease. Patients who develop AF after cardiac surgery are at an increased risk of stroke and congestive heart failure. [1] , [2]

The prospective, double-blind study randomized 60 patients with a history of paroxysmal AF undergoing CABG to receive either botox injections or a saline placebo injection during surgery. Patients were followed for one year to assess maintenance of sinus rhythm using an implantable loop recorder. All patients in both groups had successful epicardial fat pad injections without complications and with minimal additional surgery time. 

The incidence of early postoperative AF within 30 days after surgery was 2 patients (7 percent) in the botox group compared to 9 patients (30 percent) in the placebo group. Between the 30 day period and up to the 12-month follow-up examination, 7 of the 30 patients in the placebo group (27 percent) had recurrent AF, while no patients in the botox group (0 percent) experienced recurrent AF. Further, there were no complications observed during the one year follow-up. 

“Currently, there are no therapies available to reduce AF after open heart surgery, so the study results are very promising and help fulfill an unmet need in cardiology care,” said lead author Evgeny Pokushalov, MD, PhD, State Research Institute of Circulation Pathology, Novosibirsk, Russian Federation. “Botox injections in the epicardial fat pads have the potential to become standard of care for patients undergoing open heart surgery and provide a new opportunity to reduce AF and associated complications.”

The lead authors call for a large, multi-center study to assess the safety and efficacy of botox injections in the epicardial fat pads for AF prevention and to further showcase the clinical benefit of this technique.                        

Sessions details:
“Botulinum toxin injection in epicardial fat pads for prevention of atrial fibrillation after cardiac surgery: one year follow-up of a randomized pilot study” [Thursday, May 14, 2015, 1:30 p.m. – 3:00 p.m. EDT,Ballroom West]

Heart Rhythm 2015 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

 

[1] Atrial fibrillation: The management of atrial fibrillation after cardiac surgery. Heart 2009;95:5 422-429

[2] National Heart, Lung, and Blood Institute: What is Coronary Artery Bypass Grafting? http://www.nhlbi.nih.gov/health/health-topics/topics/cabg

About the Heart Rhythm Society

The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of more than 5,900 heart rhythm professionals in more than 70 countries around the world. For more information, visit www.HRSonline.org .