Societies release consensus statement on institutional, operator requirements for LAA closure

The Society for Cardiovascular Angiography and Interventions, the American College of Cardiology and the Heart Rhythm Society released an expert consensus statement outlining requirements for institutions and operators performing left atrial appendage, or LAA, occlusion procedures.

The transcatheter procedures are performed on patients with atrial fibrillation who are at high risk for stroke but cannot be treated long term with oral anticoagulation. The FDA has approved one device (Watchman, Boston Scientific) for this purpose, but other devices are sometimes used off-label.

The societies convened a writing group of interventional cardiologists and electrophysiologists to help physicians and institutions offer consistent, high-quality care to this patient population.

“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,” Clifford J. Kavinsky, MD, PhD, FACC, FSCAI, director of the Center for Adult Structural Heart Disease, Rush University Medical Center, Chicago, and chair of the writing group, said in a press release.

Understanding of AF necessary

The group recommends that doctors who perform an LAA occlusion procedure have a firm grasp of AF principles, including:

understanding its medical management and clinical course;
understanding rhythm and rate control principles;
knowledge of the CHA₂DS₂-VASc scoring system and other tools to assess stroke risk;
knowledge of indications for oral anticoagulation therapy and the oral anticoagulation agents;
understanding risks and benefits of agents used for rate and rhythm control;
understanding bleeding risks related to oral anticoagulants and bleeding risk assessment tools such as HAS-BLED;
knowledge of indications, risks and benefits of catheter-based ablation techniques as well as invasive surgical ablation techniques; and
agreeing to engage in shared decision making.

Operators should also have a strong understanding of the left atrium and LAA, and have experience with left-heart procedures, the authors wrote.

Institutional requirements

Before starting an LAA closure program, an institution should have performed at least 50 structural heart disease or left-sided catheter ablations, at least half of which should involve a transseptal puncture through a septum that is intact, they wrote.

Institutions should have a cardiac catheterization laboratory, an electrophysiology suite or a hybrid suite in which to perform the procedures, Kavinsky and colleagues wrote.

They recommend mandatory participation in a nationwide registry, and that institutions conduct reviews of aggregate and physician-specific results regularly.

“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 said in the release.

The societies plan to submit a comment letter to the CMS on the draft national coverage determination for LAA occlusion, which was released in November and specified that national coverage for the procedure should occur only if seven conditions are met, one of which is that the device must be approved by the FDA. – by Erik Swain

References:

Kavinsky CJ, et al. Catheter Cardiovasc Interv. 2015;doi:10.1002/ccd.26381.

Kavinsky CJ, et al. Heart Rhythm. 2015;doi:10.1016/j.hrthm.2015.12.018.

Kavinsky CJ, et al. J Am Coll Cardiol. 2015;doi:10.1016/j.jacc.2015.12.001.

Disclosure: Kavinsky reports no relevant financial disclosures. See the full statement for a list of the other authors’ relevant financial disclosures.