SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure

doi:10.1016/j.jcin.2023.01.011

JACC: Cardiovascular Interventions

Volume 16, Issue 11, 12 June 2023, Pages 1384-1400

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https://doi.org/10.1016/j.jcin.2023.01.011 Get rights and content

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.

Section snippets

Summary of recommendations 1385
Methodology 1386
Introduction 1386
Patient Selection for LAAC 1388
- Transcatheter LAAC is appropriate for patients with nonvalvular AF with high thromboembolic risk who are not suited for long-term OAC 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 1388
Physician and institutional requirements 1389
- Physician initial requirements 1389
- Skill maintenance 1389

Summary of Recommendations

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

Methodology

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.¹

The writing group has been organized to ensure diversity of perspectives and demographic characteristics, multistakeholder representation, and appropriate balance of relationships with industry. Relevant

Transcatheter LAAC is appropriate for patients with nonvalvular AF with high thromboembolic risk who are not suited for long-term OAC 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

Recent guidelines issued by the United States and European professional societies¹⁹^,²⁰ have both made a IIb recommendation for LAAC in those with AF and contraindication to long-term OAC (Tables 2 and 3).¹¹^,20, 21, 22, 23 Because the RCTs were designed to demonstrate noninferiority of LAAC to long-term OAC, they enrolled only patients eligible for long-term OAC.¹¹^,²¹ The mandate by the Centers for Medicare and Medicaid Services (CMS) to perform LAAC for patients for whom long-term OAC is not

Physician initial requirements

≥50 prior left-sided ablations or structural procedures and ≥25 transseptal punctures

Skill maintenance

≥25 transseptal punctures and >12 LAACs over 2 years

Institutional requirements

on-site cardiovascular surgery (CVS) program backup during implanter’s early learning curve

The SCAI/ACC/Heart Rhythm Society (HRS) LAAC institutional and operator requirements were published in 2015,²⁹^,³⁰ which outlined standards for the operator knowledge base and procedural skill sets, as well as institutional requirements required for LAAC. Physicians’

Baseline preprocedural imaging with TEE or cardiac computed tomography angiography is recommended before LAAC

Baseline preprocedural imaging with TEE or cardiac computed tomography (CT) angiography (cardiac CT) is recommended before embarking on the LAAC procedure. The most commonly employed preprocedural LAA imaging is TEE. Some experienced centers have evolved to performing the baseline TEE at the beginning of the LAAC procedure. This practice may be acceptable but should be discouraged with new programs and inexperienced operators. Furthermore, this approach will necessitate periodically cancelling

Intraprocedural imaging guidance with TEE or ICE and contrast angiography is strongly recommended

It is strongly recommended that intraprocedural imaging guidance be utilized for all LAAC procedures. Intraprocedural imaging is essential for ruling out LAA thrombus; monitoring for pericardial effusion; guidance of TSP; visualization of device implantation, stability, compression, and PDL; and assessment of iatrogenic ASD.⁴¹^,⁴² Fluoroscopy alone without TEE/ICE is not recommended. TEE guidance by a dedicated experienced interventional imaging physician with standardized views as described

LAAC implantation step-by-step

A detailed description of procedural steps for LAAC is beyond the scope of this article. Rather, certain points requiring clarification will be highlighted.

Operators need to be familiar with avoidance, recognition, and management of complications associated with LAAC

WATCHMAN, the first LAAC device approved for general use, underwent a lengthy, multistepped approval consisting of 2 randomized clinical trials, 2 continued access registries, and an unprecedented 3 FDA panel hearings spanning 2 decades before approval for commercialization was obtained. This was largely due to safety concerns surrounding the LAAC procedure. In the PROTECT AF RCT, there was an 8.7% complication rate driven largely by a 4.8% serious pericardial effusion, as well as 0.6% device

Device-related thrombosis

Device-related thrombosis (DRT) (Figure 4) has been reported after 3% to 5% of LAAC procedures in large clinical trial and registry experiences.¹⁰^,¹¹^,²⁴ DRT has been shown to be more likely in patients with prior stroke, large LAA dimensions, those with permanent AF, and those with previous LA thrombus.¹¹^,47, 48, 49 The relationship between DRT and long-term adverse cardiovascular events is unclear, but registry-based analyses have found an association between DRT and stroke/transient ischemic

Future directions and landscape of LAAC

The field of transcatheter LAAC has evolved tremendously in its first 2 decades, with marked improvements in safety, efficacy, and device iterations. Ongoing trials and evolving practices indicate significant future advancements to come. The FDA approval of WATCHMAN FLX and Amulet devices, in-progress RCTs evaluating new devices, and an array of other technologies in the development and approval queue will mean a larger toolbox for LAAC. Several RCTs comparing LAAC to controls in OAC-ineligible

Declaration of Competing Interest

João Cavalcante received consulting fees from Boston Scientific and Abbott. Matthew Price serves on the advisory board and has received consulting, honoraria, and Speakers Bureau fees from Abbott. Brian Whisenant received consulting fees from Boston Scientific and Abbott. Dee Dee Wang is a principal investigator for investigator-initiated research for Boston Scientific and has received consulting fees from Abbott. Jacqueline Saw, David Holmes, Andrew Goldsweig, James Freeman, Thomas Munger,

Funding Sources

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation. ClinicalTrials.gov...

Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long...

Cited by (13)

Incidence, impact and predictors of residual device patency after left atrial appendage closure with the LACbes device
2024, International Journal of Cardiology
The residual device patency (RDP) after left atrial appendage closure (LAAC) with the LACbes device has not been specifically explored in atrial fibrillation (AF) patients. This study aims to explore the incidence, impact and predictors of RDP detected by cardiac computed tomography angiography (CCTA) post LAAC.
AF patients implanted with the LACbes device were prospectively enrolled. CCTA device surveillance was performed at 3 months post-procedure. Major adverse events (MAEs), including stroke/transient ischemic attack, major bleeding and all-cause death, were evaluated.
Among 141 patients with CCTA surveillance, 56 (39.7%) showed no visible leak and 85 (60.3%) showed RDP. During the median follow-up of 443 [232, 706] days, the presence of RDP was not associated with an increased risk of MAEs (adjusted hazard ratio [HR]: 4.07, 95% confidence interval [CI]: 0.49–34.24, p = 0.196), while peri-device leak (PDL) at the lobe was associated with heightened risks of MAEs (adjusted HR: 6.85, 95% CI: 1.62–28.89, p = 0.009). In patients with PDL at the lobe, antiplatelet after 6 months (HR: 0.20, 95% CI: 0.05–0.91, p = 0.038) was independent protective predictor of MAEs. Besides, current smoking (odds ratio [OR]: 7.52, 95% CI: 2.68–21.08, p < 0.001) and maximum diameter of LAA orifice (OR: 1.16, 95% CI: 1.00–1.34, p = 0.048) were independent predictors of PDL at the lobe.
Presence of PDL at the device lobe detected by CCTA at 3-month post LAAC with LACbes is associated with unfavorable prognosis in AF patients.
Clinical trial registration: ClinicalTrials.gov Identifier: NCT03788941.
Physicians' perspectives on percutaneous left atrial appendage occlusion for patients with atrial fibrillation
2023, American Heart Journal
There has been an increasing uptake of transcatheter left atrial appendage occlusion (LAAO) for stroke reduction in atrial fibrillation.
To investigate the perceptions and approaches among a nationally representative sample of physicians.
Using the American Medical Association Physician Masterfile, we selected a random sample of 500 physicians from each of the specialties: general cardiologists, interventional cardiologists, electrophysiologists, and vascular neurologists. The participants received the survey by mail up to three times from November 9, 2021 to January 14, 2022. In addition to the questions about experiences, perceptions, and approaches, physicians were randomly assigned to 1 of the 4 versions of a patient vignette: white man, white woman, black man, and black woman, to investigate potential bias in decision-making.
The top three reasons for considering LAAO were: a history of intracranial bleeding (94.3%), a history of major extracranial bleeding (91.8%), and gastrointestinal lesions (59.0%), whereas the top three reasons for withholding LAAO were: other indications for long-term oral anticoagulation (87.7%), a low bleeding risk (77.0%), and a low stroke risk (65.6%). For the reasons limiting recommendations for LAAO, 59.8% mentioned procedural risks, 42.6% mentioned “limiting efficacy data comparing LAAO to NOAC” and 32.8% mentioned “limited safety data comparing LAAO to NOAC.” There was no difference in physicians’ decision-making by patients’ race, gender, or the concordance between patients’ and physicians’ race or gender.
In the first U.S. national physician survey of LAAO, individual physicians’ perspectives varied greatly, which provided information that will help customize future educational activities for different audiences.
Although diverse practice patterns of LAAO have been documented, little is known about the reasoning or perceptions that drive these variations. Unlike prior surveys that were directed to Centers that performed LAAO, the current survey obtained insights from individual physicians, not only those who perform the procedures (interventional cardiologists and electrophysiologists) but also those who are closely involved in the decision-making and referral process (general cardiologists and vascular neurologists). The findings identify key evidence gaps and help prioritize future studies to establish a consistent and evidence-based best practice for AF stroke prevention.
Antithrombotic Therapy for Primary and Secondary Prevention of Ischemic Stroke: JACC State-of-the-Art Review
2023, Journal of the American College of Cardiology
Stroke is a devastating condition with significant morbidity and mortality worldwide. Antithrombotic therapy plays a crucial role in both primary and secondary prevention of stroke events. Single or dual antiplatelet therapy is generally preferred in cases of large-artery atherosclerosis and small-vessel disease, whereas anticoagulation is recommended in conditions of blood stasis or hypercoagulable states that mostly result in red thrombi. However, the benefit of antithrombotic therapies must be weighed against the increased risk of bleeding, which can pose significant challenges in the pharmacological management of this condition. This review provides a comprehensive summary of the currently available evidence on antithrombotic therapy for ischemic stroke and outlines an updated therapeutic algorithm to support physicians in tailoring the strategy to the individual patient and the underlying mechanism of stroke.
Long-term Clinical Outcomes in Contemporary Patients Undergoing Left Atrial Appendage Occlusion Procedures in Ontario, Canada
2023, CJC Open
Percutaneous left atrial appendage occlusion (LAAO) is an alternative for stroke prevention in patients with atrial fibrillation with contraindications to oral anticoagulation. Population-level real-world data describing the use and outcomes of LAAO procedures are evolving, with a paucity of longer-term follow-up data. We report on the patient characteristics, procedure complications, and longer-term clinical outcomes in all patients undergoing LAAO procedures in Ontario, Canada.
All patients undergoing LAAO procedure between April 1, 2013 and March 31, 2022 were identified. Linked administrative databases were utilized to determine patient clinical and procedural characteristics. Outcomes of interest included procedural complications at 7 and 30 days, and longer-term rates of stroke, bleeding, all-cause rehospitalization, and mortality.
A total of 549 individuals were included in the study cohort. The average age was 75 ± 8 years, with 66% being of male sex, with a mean CHA₂DS₂VASc score of 4.4 ± 1.6, and with 68% not receiving oral anticoagulation. Follow-up for 2.6 ± 2.0 patient-years was available. Stroke occurred in 2.8% during the follow-up period (1.1 per 100 patient-years), bleeding in 10% (4.0 per 100 patient-years), and any hospital readmission in 63% (43 per 100 patient-years). A total of 29% of the cohort died during the follow-up period (11 per 100 patient-years), with 1.8% of the cohort dying during the procedural hospitalization. The mortality rate was unchanged during the study period (P for trend = 0.72).
Long-term stroke and bleeding rates are low in patients undergoing LAAO procedures in Ontario, Canada. All-cause mortality in this population is high and remained unchanged during the study period.
La fermeture percutanée de l’appendice auriculaire gauche (FPAAG) est une intervention possible pour prévenir les accidents vasculaires cérébraux (AVC) chez les patients atteints de fibrillation auriculaire chez qui les anticoagulants oraux sont contre-indiqués. Les données populationnelles en contexte réel décrivant l’utilisation de la FPAAG et les résultats cliniques qui y sont associés sont de plus en plus nombreuses, mais il y a toujours peu de données sur le suivi à long terme. Nous présentons ici les caractéristiques des patients, les complications liées à l’intervention et les résultats cliniques à long terme pour l’ensemble des patients ayant subi une FPAAG en Ontario (Canada).
Tous les patients ayant subi une FPAAG entre le 1^er avril 2013 et le 31 mars 2022 ont été recensés. Des bases de données administratives liées ont été utilisées pour relever les caractéristiques des patients et des interventions. Les résultats cliniques d’intérêt incluaient les complications liées à l’intervention à 7 et à 30 jours ainsi que les taux de divers événements à long terme : AVC, hémorragie, réadmission à l’hôpital toutes causes confondues et mortalité.
Au total, 549 personnes faisaient partie de la cohorte à l’étude. L’âge moyen des patients était de 75 ± 8 ans, et 66 % étaient des hommes. La moyenne du score CHA₂DS₂VASc s’élevait à 4,4 ± 1,6, et 68 % des patients ne prenaient pas d’anticoagulants par voie orale. En moyenne, les données de suivi portaient sur 2,6 ± 2,0 patients-années. Un AVC est survenu chez 2,8 % des patients au cours du suivi (1,1 pour 100 patients-années), une hémorragie est survenue chez 10 % des patients (4,0 pour 100 patients-années) et le taux de réadmission hospitalière toutes causes confondues s’élevait à 63 % (43 pour 100 patients-années). Au total, 29 % des patients de la cohorte sont morts au cours de la période de suivi (11 pour 100 patients-années), et 1,8 % des patients de la cohorte sont morts au cours de l’hospitalisation liée à l’intervention. Le taux de mortalité est demeuré le même au cours de la période à l’étude (valeur p de 0,72 pour la tendance).
Les taux de survenue d’AVC et d’hémorragie à long terme sont faibles chez les patients ayant subi une FPAAG en Ontario (Canada), mais leur taux de mortalité toutes causes confondues est élevé et est demeuré le même au cours de la période à l’étude.
Who watches the WATCHMAN? A case of recurrent strokes after transcatheter left atrial appendage closure
2024, Journal of Cardiovascular Medicine
Left atrial appendage occlusion
2024, Nature Reviews Cardiology

View all citing articles on Scopus

: Endorsement: This statement was endorsed by the American College of Cardiology and the Society of Cardiovascular Computed Tomography.

: J.L.C. is a Society of Cardiovascular Computed Tomography representative.

: J.V.F. and T.M. are Heart Rhythm Society representatives.

: M.W.S. is an American College of Cardiology representative.

: This article has been copublished in Journal of the Society for Cardiovascular Angiography & Interventions and Heart Rhythm.

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Scientific Society Co-PublicationSCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure

Abstract

Section snippets

Table of Contents

Summary of Recommendations

Methodology

Physician initial requirements

Skill maintenance

Institutional requirements

Baseline preprocedural imaging with TEE or cardiac computed tomography angiography is recommended before LAAC

Intraprocedural imaging guidance with TEE or ICE and contrast angiography is strongly recommended

LAAC implantation step-by-step

Operators need to be familiar with avoidance, recognition, and management of complications associated with LAAC

Device-related thrombosis

Future directions and landscape of LAAC

Declaration of Competing Interest

Funding Sources

Ann Thorac Surg

Lancet

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Chest

Heart Rhythm

Heart Rhythm

Struct Heart

Interv Cardiol Clin

J Am Coll Cardiol Intv

J Am Coll Cardiol Intv

J Am Coll Cardiol Img

J Am Coll Cardiol EP

J Am Coll Cardiol Intv

J Am Coll Cardiol Intv

Can J Cardiol

Am J Cardiol

Heart Rhythm

J Am Coll Cardiol Intv

J Am Coll Cardiol Intv

Heart Rhythm

Can J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol EP

J Am Coll Cardiol Intv

J Am Coll Cardiol Intv

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol EP

J Am Coll Cardiol Intv

Am Heart J

SCAI publications committee manual of standard operating procedures

Catheter Cardiovasc Interv

Heart disease and stroke statistics-2019 update: a report from the American Heart Association

Circulation

Therapy persistence in newly diagnosed non-valvular atrial fibrillation treated with warfarin or NOAC. A cohort study

Thromb Haemost

The left atrial appendage: our most lethal human attachment! Surgical implications

Eur J Cardiothorac Surg

Left atrial appendage occlusion during cardiac surgery to prevent stroke

N Engl J Med

Scientific Society Co-Publication
SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure