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Societies release recommendations for implantation of percutaneous LAA occlusion devices
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Percutaneous left atrial appendage occlusion devices are intended to reduce risk for stroke in patients with atrial fibrillation who are unable or unwilling to adhere to long-term anticoagulation therapy, and the use of these devices is likely to expand.
According to a new statement, this technology should be disseminated thoughtfully, with emphasis on team-based care and the collection of data in longitudinal registries.
The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions released an overview on left atrial appendage (LAA) occlusion, with recommendations on implantation, operator training, protocols for care and patient selection.
Frederick A. Masoudi
“This document highlights the critical issues surrounding [LAA] occlusion therapies,” Frederick A. Masoudi, MD, MSPH, FACC, professor of medicine at the University of Colorado Anschutz Medical Campus and chair of the writing committee, said in a press release. “We aimed to facilitate the alignment among patients and their families, primary care physicians, general cardiologists, and additional heart team members and procedural specialists. We also identified the need to collect robust clinical data on patients who are treated with these devices in clinical practice, especially because in some cases, the evidence for some devices in use is sparse.”
LAA occlusion devices mentioned in the document include the Watchman (Boston Scientific), the Amplatzer Cardiac Plug and other devices from the Amplatzer family (St. Jude Medical), the Lariat (SentreHeart), the WaveCrest (Coherex Medical), the LAmbre (Lifetech) and the AtriClip (Atricure). The Watchman device was approved for use in the United States in March. Aside from the Watchman, the other devices are used off-label for LAA closure or are not used in the United States except for the AtriClip, which has FDA approval for LAA closure under direct visualization in conjunction with other open cardiac surgical procedures.
Heart team needed
The statement includes a recommendation that a multidisciplinary heart team be convened to discuss any patient being considered for LAA occlusion. The heart team should include an expert in medical therapy; a procedural specialist; experts in echocardiography, X-ray imaging modalities such as CT; and, when general anesthesia is planned, experts in anesthesiology. In addition, any procedure should have a cardiac surgeon available as backup in case of emergency.
Anyone performing an LAA occlusion procedure “should have an understanding of stroke and stroke syndromes, AF, the pharmacology of anticoagulants and the regional anatomy of the left atrium and LAA. They should also possess the requisite technical procedural skills,” the authors wrote.
The document stated that institutions performing LAA occlusion should have “the full range of facilities for diagnostic imaging as well as electrophysiology, interventional or cardiac surgical suites … available on site,” and lists necessary personnel and equipment.
The authors called for the development of specific recommendations for training in LAA occlusion, as existing recommendations for training in electrophysiology or interventional techniques do not provide specific guidance for LAA occlusion.
Necessary protocols
An institution’s protocols should include assessment of the patient’s stroke risk, bleeding risk, contraindications to anticoagulation, adherence to and history of anticoagulation, cardiac structural factors and patient preferences. All decision making should be documented, especially consideration of pharmacotherapy as an alternative. In addition, preprocedure evaluation, postprocedure evaluation and follow-up should all be standardized, according to the statement.
Creating a registry for LAA occlusion or adding LAA occlusion to an existing registry is strongly recommended, Masoudi and colleagues wrote.
The document has been published on the websites of the ACC, HRS and SCAI, and will be published in future issues of the Journal of the American College of Cardiology, Heart Rhythm and Catheterization and Cardiovascular Interventions, according to the release. – by Erik Swain
Disclosure: Masoudi reports no relevant financial disclosures. See the full document for relevant financial disclosures of the other writers and reviewers.
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