Favourable outcomes with transcatheter atrial appendage occlusion

Real-world data from the National Cardiovascular Data Registry (NCDR) left atrial appendage occlusion (LAAO) registry showed a decrease in thromboembolic events 1 year after receiving a WATCHMAN implant [1]. These 1-year clinical outcomes suggest a favourable alternative to anticoagulants for patients with non-valvular atrial fibrillation who are unable to take oral anticoagulants.

The WATCHMAN device is a permanent device that is implanted into the left atrial appendage to prevent clot formation. It is used as an alternative to oral anticoagulant therapy for stroke prevention in atrial fibrillation for patients in whom oral anticoagulants are contraindicated. It was approved by the FDA in 2015 based upon favourable data from the PROTECT AF (n=463 implants) and PREVAIL (n=269 implants) trials [2,3]. It has also been approved for Medicare/Medicaid coverage in the US, but the eligibility criteria to qualify for reimbursement differ from the inclusion criteria used in the PROTECT AF and PREVAIL trials. Therefore, there was a need to monitor the clinical outcomes achieved under these different criteria and to assess long-term safety and effectiveness data.

Dr Matthew Price (Scripps Clinic, CA, USA) shared the results of the US national LAAO Registry, which examined the rates of thromboembolic and bleeding events at 1-year follow-up in 36,681 patients who received a WATCHMAN device in 2016, 2017, and 2018. Kaplan-Meier estimated endpoints examined were the 1-year rates of ischaemic stroke (1.5%; 95% CI 1.4–1.7), major bleeding (6.2%; 95% CI 6.0–6.5), and mortality (8.5%; 95% CI 8.2–8.8). There was a 77% risk reduction in ischaemic stroke with LAAO compared with the expected rate as predicted by congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischaemic attack, vascular disease, age 65 to 74 years, sex category (CHA2DS2-VASc) score.

Dr Price concluded that these data support the early-to-mid-term clinical effectiveness of transcatheter LAAO as it is currently being employed in the US.

1. 
   
   1. Price M. One-year Clinical Outcomes Following Watchman Transcatheter Left Atrial Appendage Occlusion for Stroke Prevention in Patients with Atrial Fibrillation: A Report from The NCDR LAAO Registry. ACC 2021 Scientific Session, 15–17 May.
   2.  Reddy VY, et al. JAMA. 2014;312(19):1988–1998.
   3. Holmes DR, et al. J. Am. Coll. Cardiol. 2014;64(1):1–12.

 

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Posted on 9 July, 202129 July, 2021