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Procedure to prevent stroke in patients with atrial fibrillation safe and effective, study finds

March 29, 2020

Patients with atrial fibrillation or AFib are on average five times more likely to suffer a stroke than patients with a regular heartbeat. To counteract the risk of stroke, physicians will often prescribe anticoagulants such as warfarin to reduce the risk of blood clots forming in the heart. Despite the effectiveness of blood thinners, long-term use increases the risk of major bleeding and studies have shown that 30-50% of patients who meet indication for blood thinners are not taking them. A one-hour procedure provides an effective alternative to anticoagulants for these patients, according to a new Yale-led study.

In patients with AFib, blood clots typically form in the left atrial appendage (LAA). Boston Scientific’s WATCHMAN is the first FDA-approved procedure for stroke risk reduction, although several other devices are currently being tested. This study examines patient, hospital, and physician characteristics in comparison with other therapies.

The results are published in JACC.

Lead author and director of the Yale Atrial Fibrillation Program, James Freeman, MD and Jeptha Curtis, MD, led a national project to assess the use patterns and safety of this treatment. Their study used the American College of Cardiology Left Atrial Appendage Occlusion (LAAO) Registry to evaluate data from 38,158 patients who underwent the WATCHMAN procedure between January 2016 and December 2018. The end result is the largest study of LAAO procedures in the world. Patients currently undergoing LAAO are at higher risk of both stroke and bleeding than those who participated in the clinical trials that led to FDA approval of the WATCHMAN device. However, despite this more complex patient population, implant success rates were very good and procedural complications were relatively rare.

“Over the three years of our study since FDA approval of the WATCHMAN, 98% of devices that were deployed were successfully implanted, and in-hospital adverse events were also lower than in the previous pivotal randomized trials at approximately 2%,” said Freeman. On average, hospitals performed 30 procedures per year, but the authors noted considerable variation.

Performance measurement is a cornerstone of the LAAO Registry. A computer-based algorithm sends quarterly reports with valuable data including, hospital enrollment volume, process measures, and outcomes data. “The LAAO Registry serves a vital role in quality improvement. Participating hospitals receive real-time feedback, making it an excellent tool.” said Curtis. The authors hope that this data will serve as a foundation for further inquiry to address critical knowledge gaps regarding LAAO procedures.

The LAAO Registry is supported by the American College of Cardiology, and the Society for Coronary Angiography and Interventional Cardiology in collaboration with the U.S. Food and Drug Administration, the Centers for Medicare and Medicaid Services, and Boston Scientific.

Submitted by Elisabeth Reitman on March 29, 2020