SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure

Abstract

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices. Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices. 1.Transcatheter left atrial appendage closure (LAAC) is appropriate for patients with nonvalvular atrial fibrillation with high thromboembolic risk who are not suited for long-term oral anticoagulation and who have adequate life expectancy (minimum >1 year) and quality of life to benefit from LAAC. There should be patient-provider discussion for shared decision making.2.1.Physicians performing LAAC should have a prior experience, including ≥50 prior left-sided ablations or structural procedures and ≥25 transseptal punctures (TSPs). Interventional imaging physicians should have experience in guiding ≥25 TSPs before supporting any LAAC procedures independently.2.2.For maintenance of skills, implanting physicians should perform ≥25 TSPs and >12 LAACs over each 2-year period.2.3.New programs and implanting physicians early in their LAAC experience should have on-site cardiovascular surgery backup.3.Baseline imaging with transesophageal echocardiography (TEE) or cardiac computed tomography is recommended before LAAC.4.Intraprocedural imaging guidance with TEE or intracardiac echocardiography is recommended.5.Technical aspects of the procedure, including venous access, anticoagulation, transseptal puncture, delivery sheath selection and placement, left atrial pressure measurement, and device deployment, should be performed in accordance with the labeling of each specific LAAC device.6.Operators need to be familiar with avoidance, recognition, and management of procedural complications associated with LAAC.7.Predischarge imaging should be performed with 2-dimensional transthoracic echocardiography to rule out pericardial effusion and device embolization. Same-day discharge may be appropriate after several hours of observation demonstrating no complications or pericardial effusion after LAAC.8.Device-related thrombus should be treated with anticoagulation. Repeat imaging at 45- to 90-day intervals can be performed to assess for resolution with eventual cessation of anticoagulation.9.Routine closure of iatrogenic atrial septal defects associated with LAAC should not be performed.10.The clinical impact and management of peridevice leaks are not fully understood, and all efforts should be made to minimize such leaks at the time of implantation.11.Patients should be prescribed antithrombotic therapy with warfarin, direct oral anticoagulants, or dual antiplatelet therapy after LAAC according to the studied regimen and instructions for use for each specific device and tailored to the bleeding risks of each patient.12.TEE or cardiac computed tomography is recommended at 45 to 90 days after LAAC for device surveillance to assess for peridevice leak and device-related thrombus.13.Combined procedures with LAAC (eg, structural interventions, pulmonary vein isolation) are not routinely recommended, as data are pending from ongoing randomized controlled trials. This statement has been developed according to the Society for Cardiovascular Angiography & Interventions (SCAI) Publications Committee policies for writing group composition, disclosure and management of relationships with industry, internal and external review, and organizational approval.1Szerlip M. Feldman D.N. Aronow H.D. et al.SCAI publications committee manual of standard operating procedures.Catheter Cardiovasc Interv. 2020; 96: 145-155Crossref PubMed Scopus (7) Google Scholar The writing group has been organized to ensure diversity of perspectives and demographic characteristics, multistakeholder representation, and appropriate balance of relationships with industry. Relevant author disclosures are included in Supplemental Table S1. Before appointment, members of the writing group were asked to disclose financial and intellectual relationships from the 12 months before their nomination. A majority of the writing group disclosed no relevant, significant financial relationships. Disclosures were periodically reviewed during document development and updated as needed. SCAI policy requires that writing group members with a current, relevant financial interest are recused from participating in related discussions or voting on related recommendations. The work of the writing committee was supported exclusively by SCAI, a nonprofit medical specialty society, without commercial support. Writing group members contributed to this effort on a volunteer basis and did not receive payment from SCAI. Literature searches were performed by group members designated to lead each section, and initial section drafts were authored primarily by the section leads in collaboration with other members of the writing group. The recommendations and supporting text for each section were discussed and agreed upon by the full writing group. All recommendations are supported by a short summary of the evidence or specific rationale. The draft manuscript was peer reviewed in August 2022, and the document was revised to address pertinent comments. The writing group unanimously approved the final version of the document. The SCAI Publications Committee and Executive Committee endorsed the document as official society guidance in December 2022. The SCAI statements are primarily intended to help clinicians make decisions about treatment alternatives. Clinicians also must consider the clinical presentation, setting, and preferences of individual patients to make judgments about the optimal approach.

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