New Recommendations For LAA Occlusion Devices Released
The ACC, along with the Heart Rhythm Society (HRS) and Society for Cardiovascular Angiography and Interventions (SCAI), have published a new overview on the implantation of left atrial appendage (LAA) occlusion devices. The document, published June 29 in the Journal of the American College of Cardiology, is the first in a series from the ACC, HRS and SCAI that will address the integration of new technologies into the care of patients with atrial fibrillation (AFib).
Studies have shown that LAA occlusion devices may lower the risk of stroke in patients with AFib and can be an alternative for those unable or unwilling to adhere to long-term oral anticoagulation therapy. As these new devices are developed and approved, it is expected that the use of LAA occlusion technologies in clinical practice will expand. However, the writing committee cautions that the new technology should be disseminated thoughtfully, with emphasis on team-based care and the collection of the necessary data in longitudinal registries to determine ideal patient selection, effectiveness and safety. They note that it will also be necessary to develop and implement new guidelines, expert consensus statements, requirements for training, operator credentialing and institutional policies.
“This document highlights the critical issues surrounding LAA occlusion therapies,” said Frederick A. Masoudi, MD, MSPH, FACC, professor of medicine at the University of Colorado Anschutz Medical Campus and chair of the writing committee. “We aimed to facilitate the alignment among patients and their families, primary care physicians, general cardiologists, and additional heart team members and procedural specialists. We also identified the need to collect robust clinical data on outcomes for patients who are treated with these devices in clinical practice, especially because in some cases, the evidence for some devices in use is sparse.”
In March, the U.S. Food and Drug Administration approved the WATCHMAN device for patients who are at an increased risk of stroke based upon their clinical profile, are deemed suitable for anticoagulation therapy with warfarin, and have an appropriate rationale to seek a non-pharmacological alternative to warfarin therapy after taking into account the safety and effectiveness of the device.
In addition, the Centers for Medicare and Medicaid Services (CMS) recently began the process of developing a national coverage determination (NCD) for percutaneous LAA closure therapy. ACC member leaders from the electrophysiology and interventional sections worked closely with staff and colleagues from the HRS and the SCAI to develop joint comments to CMS. The Societies support national coverage with evidence development utilizing robust data collection through registries. The comments highlighted critical issues regarding clinical trial data, patient selection and coverage of future LAA closure technologies. Draft coverage will be released before Nov. 21, at which time societies and stakeholders will have another opportunity to comment.
< Back to Listings