SCAI/ACC/HRS Institutional and Operator Requirements for Left Atrial Appendage Occlusion

December 10, 2015 — The evolution of LAA occlusion technology has spanned nearly two decades and three FDA panel hearings, leading to FDA approval in 2015. As this technology becomes clinically available to a broader population of patients, it is essential that physician stakeholders establish criteria for the performance of these procedures that will be used in granting initial and ongoing privileges. These criteria are offered to support The Joint Commission mandate that medical staff privileges be granted on the basis of professional criteria specified in the medical staff bylaws to ensure safe and effective patient-centered care.

Ischemic stroke remains a significant risk for patients with atrial fibrillation (AF). The Food and Drug Administration (FDA) approval of the WATCHMAN device for percutaneous closure of the left atrial appendage (LAA) represents an important addition to the physician’s armamentarium to help mitigate this problem.

The evolution of LAA occlusion technology has spanned nearly two decades and three FDA panel hearings, leading to FDA approval in 2015. As this technology becomes clinically available to a broader population of patients, it is essential that physician stakeholders establish criteria for the performance of these procedures that will be used in granting initial and ongoing privileges. These criteria are offered to support The Joint Commission mandate that medical staff privileges be granted on the basis of professional criteria specified in the medical staff bylaws to ensure safe and effective patient-centered care.

The emergence of transcatheter valve therapies has provided a model whereby multiple societies collaborate to provide recommendations to institutions and operators to assess their potential to establish and maintain programs for these therapies. As an extension of this concept, the Society of Cardiovascular Angiography and Interventions (SCAI), the Heart Rhythm Society (HRS), and the American College of Cardiology (ACC) agreed to provide recommendations to institutions and interested physicians for the establishment and maintenance of LAA occlusion programs.

Along with this document, the Societies submitted a joint letter to the Centers for Medicaid & Medicare Services commenting on its proposed National Coverage Analysis for Percutaneous Left Atrial Appendage (LAA) Closure Therapy. To prepare our comments for CMS, the Societies relied on this document and the “2015 ACC/HRS/SCAI Left Atrial Appendage Occlusion Device Societal Overview” to advocate for Medicare coverage of LAA closure therapy.