Expert Consensus Addresses Left Atrial Appendage Institutional and Operator Requirements

December 10, 2015—Recommendations to institutions and interested physicians for the establishment and maintenance of left atrial appendage occlusion (LAAO) programs performing LAA closure (LAAC) was published in Catheterization and Cardiovascular Interventions, Journal of the American College of Cardiology, and HeartRhythm Journal.

The Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) published the recommendations in the document titled, “SCAI/ACC/HRS Institutional and Operator Requirements for Left Atrial Appendage Occlusion.”

Additionally, after the publication of this document, the SCAI, ACC, and HRS will be submitting a multispecialty comment letter to the Centers for Medicaid & Medicare Services regarding the recent draft of the National Coverage Determination for LAAO.

According to the societies, the expert consensus paper was developed by a committee of interventional cardiologists and electrophysiologists to help physicians and hospitals offer consistent and appropriate care to atrial fibrillation patients treated with LAAC to reduce their stroke risk.

The lead author of the document is Clifford J. Kavinsky, MD, who is Director of the Center for Adult Structural Heart Disease at Rush University Medical Center in Chicago, Illinois.

In the announcement, Dr. Kavinsky commented, “Through our collaboration, SCAI, the ACC, and HRS have brought together combined experience in LAA closure to produce a document that will set the standard for safe and effective implementation of this technology to fulfill an important unmet need in treating patients with artrial fibrillation who are at risk for stroke.”

He continued, “This document 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.”

In the paper, the committee recommends physicians performing LAAC procedures have significant knowledge of atrial fibrillation, 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.

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. Procedures should be performed in a cardiac catheterization laboratory, electrophysiology suite, or hybrid suite, with quality imaging available.

The societies noted that the document also stresses 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 committee, and individual institutions should establish processes to regularly review aggregate and physician-specific results, including number of implants, complications, and outcomes.