• SCAI, ACC and HRS Release Expert Consensus on Left Atrial Appendage Institutional and Operator Requirements

    December 10, 2015

    New Paper Provides Guidance for Physicians and Institutions Performing LAAC Procedures

    Washington, DC – Recommendations to institutions and interested physicians for the establishment and maintenance of left atrial appendage occlusion (LAAO) programs performing LAA closure (LAAC) was published today. 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,” today in Catheterization and Cardiovascular Interventions (CCI), Journal of the American College of Cardiology (JACC) and HeartRhythm Journal.

    LAAO is providing a new transcatheter treatment option for patients at risk for stroke who cannot be treated long-term with anticoagulation medications.  Atrial fibrillation (AF) is an irregular heartbeat caused by an abnormal heart rhythm that makes the heart’s upper chambers quiver. During an AF episode, blood can collect inside the small portion of the heart known as the LAA. If a blood clot escapes from the LAA, it can travel to the brain and cause a stroke. Anticoagulant medications such as warfarin are the standard of care for most AF patients but are associated with an increased risk of bleeding. As a result, treatment has been developed to close the LAA for those who are unable to take anticoagulants on a long-term basis.

    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 AF patients treated with LAAC to reduce their stroke risk.

    “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 AF who are at risk for stroke,” said Clifford J. Kavinsky, MD, PhD, FSCAI, lead author of the document and director of the Center for Adult Structural Heart Disease at Rush University Medical Center in Chicago.

    In the paper released today, the committee recommends physicians performing LAAC procedures have significant knowledge of AF, including medical management, rate and rhythm control, tools for assessing stroke risk, management of oral anticoagulant therapy, knowledge of available medications, an understanding 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 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.

    “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,” Kavinsky continued.

    On Thursday, Dec. 10, 2015, shortly after the publication of this document, SCAI, the ACC and HRS will be submitting a multi-specialty comment letter to the Centers for Medicaid & Medicare Services regarding the recent draft National Coverage Determination for LAAO.

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