OR WAIT null SECS
The expert consensus statement provides updated recommendations on evidence-based best practices for transcatheter LAAC, with a focus on endovascular devices.
The Society for Cardiovascular Angiography and Interventions (SCAI) and the Heart Rhythm Society (HRS) have released an updated expert consensus statement on transcatheter left atrial appendage closure (LAAC).1
The SCAI/HRS prioritized an update to the consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC, with a focus on endovascular devices, according to the writing group.
“This consensus statement demonstrates the evolvement of LAAC treatment, since our first statements that were issued in 2015 and 2016,” said Jacqueline Saw, MD, chair of the writing group, Division of Cardiology, Vancouver General Hospital, University of British Columbia.1 “Since then, the results from several important clinical trials and registries, as well as other technological and clinical advancements have evolved and changed the way we look at operator requirements, patient selection, and shared decision making, which explains the need for this updated guidance.”
A minimally invasive procedure, LAAC is used to reduce the risk of stroke associated with atrial fibrillation (AF), a common form of arrhythmia. The SCAI’s previously published statements in 2015 and 2016 provided societal overview of the technology, institutional, and operator requirements for LAAC. New findings from pivotal clinical trials and registries have been published since the release of these guidelines and technical expertise and clinical practice have evolved over time.
The updated statement was led by a writing group organized by the SCAI to ensure diversity of perspectives and demographic characteristics, multi stakeholder representation, and appropriate balance of relationships with industry. Literature searches were performed by the designation group members in each section and recommendations for each section were agreed upon by the full writing group.
Saw and colleagues indicated transcatheter LAAC is appropriate for individuals with nonvalvular atrial fibrillation with thromboembolic risk who are not suited for long-term oral anticoagulation and have adequate life expectancy.
Those performing LAAC were recommended to have prior experience, including ≥50 prior left-sided ablations or structural procedures and ≥25 transseptal punctures (TSPs). Additionally, interventional imaging physicians should have experience in guiding ≥25 TSPs before supporting any LAAC procedures independently, according to the writing group.
To maintain skills, implanting physicians were recommended to perform ≥25 TSPs and >12 LAACs over each 2-year period. Additionally, new programs and implanting physicians early into their LAAC experience should require on-site cardiovascular surgery backup.
The writing committee recommended baseline imaging with transesophageal echocardiography (TEE) or cardiac computed tomography be performed before LAAC. Intraprocedural imaging guidance with TEE or intracardiac echocardiography was recommended as well.
The procedure’s technical aspects, including venous access, anticoagulation, TSPs, delivery sheath selection and placement, left atrial pressure measurement, and device deployment, was recommended to be performed in accordance with the labeling of each specific LAAC device.
Operators are required to be familiar with avoidance, recognition, and management of procedural complications associated with LAAC, added the writing group. Moreover, they indicated predischarge imaging should be performed with 2-dimensional transthoracic echocardiography to rule out pericardial effusion and device embolization. Saw and colleagues recommended device-related thrombus be treated with anticoagulation.
On the other hand, routine closure of iatrogenic atrial septal defects associated with LAAC was recommended against by the writing group. Additionally, as the clinical impact and management of peridevice leaks is not well-understood, they recommended all efforts should be taken to minimize leaks at implantation.
The writing committee recommended performing TEE or cardiac computed tomography at 45 to 90 days after LAAC for device surveillance to assess for peridevice leak and device-related thrombus. After LAAC, individuals should be prescribed antithrombotic therapy with warfarin, direct oral anticoagulants, or dual antiplatelet therapy, according to the studied regiment and instructions for each device and additionally tailored to the patient’s bleeding risk.
Lastly, Saw and the colleagues noted combined procedures with LAAC (structural interventions, pulmonary vein isolation) are not routinely recommended, due to pending data from ongoing randomized controlled trials.
The SCAI/HRS statement was endorsed by the American College of Cardiology and the Society of Cardiovascular Computed Tomography.