Expert Consensus on LAA Institutional and Operator Requirements Released
Recommendations to institutions and interested physicians for the establishment and maintenance of left atrial appendage (LAA) occlusion programs performing LAA closure (LAAC) procedures were released Dec. 10 by the ACC, the Society for Cardiovascular Angiography and Interventions (SCAI), and the Heart Rhythm Society (HRS). The expert consensus paper, titled, “SCAI/ACC/HRS Institutional and Operator Requirements for Left Atrial Appendage Occlusion,” was published in the Journal of the American College of Cardiology.
The document recommends that physicians performing LAAC procedures have significant knowledge of atrial fibrillation (AFib), including medical management, rate and rhythm control, tools for assessing stroke risk, management of oral anticoagulant therapy, knowledge of available medications, an understanding of bleeding risks, and knowledge of risks associated with LAAC. The document also recommends physicians have a detailed understanding of the left atrium and LAA, and experience with procedures requiring access to the left side of the heart.
In addition, the authors recommend that institutions performing LAAC procedures should perform at least 50 structural heart disease or left-sided catheter ablations, with at least 25 involving transseptal puncture through an intact septum in the year prior to starting a LAAC program. They add that procedures should be performed in a cardiac catheterization laboratory, electrophysiology suite or hybrid suite, with quality imaging available.
Also addressed is the importance of continuing to collect data on these procedures as the number of devices and approaches to minimally invasive LAAC expands in the coming years. Participation in a national registry should be mandatory, according to the authors, and individual institutions should establish processes to regularly review aggregate and physician-specific results, including number of implants, complications and outcomes.
“[This document] will set the standard for safe and effective implementation of this technology to fulfill an important unmet need in treating patients with AFib who are at risk for stroke,” says Clifford J. Kavinsky, MD, PhD, FACC, lead author of the document. “[It] will ensure that institutions and operators developing LAA occlusion programs will have the necessary experience, training and infrastructure to carry out this procedure in a way that optimizes patient outcomes.”
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