Two‐Year Outcomes With a Next‐Generation Left Atrial Appendage Device: Final Results of the PINNACLE FLX Trial

Abstract

Background The PINNACLE FLX (Protection Against Embolism for Non‐valvular AF [Atrial Fibrillation] Patients: Investigational Device Evaluation of the Watchman FLX LAA [Left Atrial Appendage] Closure Technology) trial evaluated the safety and efficacy of a next‐generation left atrial appendage closure device (WATCHMAN FLX; Boston Scientific, Marlborough, MA). At 1 year, the study met the primary end points of safety and anatomical efficacy/appendage closure. This final report of the PINNACLE FLX trial includes the prespecified secondary end point of ischemic stroke or systemic embolism at 2 years, also making it the first report of 2‐year outcomes with this next‐generation left atrial appendage closure device. Methods and Results Patients with nonvalvular atrial fibrillation with CHA 2 DS 2 ‐VASc score ≥2 (men) or ≥3 (women), with an appropriate rationale for left atrial appendage closure, were enrolled to receive the left atrial appendage closure device at 29 US centers. Adverse events were assessed by an independent clinical events committee, and imaging was assessed by independent core laboratories. Among 395 implanted patients (36% women; mean age, 74 years; CHA 2 DS 2 ‐VASc, 4.2±1.5), the secondary efficacy end point of 2‐year ischemic stroke or systemic embolism was met, with an absolute rate of 3.4% (annualized rate, 1.7%) and an upper 1‐sided 95% confidence bound of 5.3%, which was superior to the 8.7% performance goal. Two‐year rates of adverse events were as follows: 9.3% all‐cause mortality, 5.5% cardiovascular death, 3.4% all stroke, and 10.1% major bleeding (Bleeding Academic Research Consortium 3 or 5). There were no additional systemic embolisms, device embolizations, pericardial effusions, or symptomatic device‐related thrombi after 1 year. Conclusions The secondary end point of 2‐year stroke or systemic embolism was met at 3.4%. In these final results of the PINNACLE FLX trial, the next‐generation WATCHMAN FLX device demonstrated favorable safety and efficacy outcomes.

Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial

“…Both of the trials suggested that LAA occlusion was non-inferior to DOACs on the composite endpoint event. Recently, next-generation Watchman FLX device also demonstrated favourable safety and efficacy outcomes for stroke prevention and improved certain limitations observed with the first-generation device, such as perforation risk and residual peridevice leak 41. Percutaneous LAA occlusion has been commonly used for stroke prevention, and the successful closure rate of percutaneous transcatheter LAA occlusion devices ranged from 91% to 98.5% 42–46.…”

The Shape of Things to Come? Is a Trial of Combined Interventional Procedures Necessary in Today’s World?

“…2 LAAO has become increasingly popular, affording >90% of treated patients the opportunity to avoid long-term anticoagulants (OACs), thereby lowering the risk of hemorrhagic stroke and other bleeding complications. [3][4][5] By nature of their age, comorbidities, and symptomatic status, nearly all TAVI candidates with atrial fibrillation have both an indication for OACs and an elevated bleeding risk.…”

Watchman FLX's Sophomore Year Report Card

“…In the present study by Doshi et al in this issue of Journal of the American Heart Association ( JAHA ), 4 the authors report the 2‐year safety and effectiveness outcomes from the PINNACLE FLX study. From an effectiveness perspective, the combined risk of ischemic stroke or systemic embolism at 2 years was 3.4%.…”

“…At 1 year of follow‐up, the risks of ischemic stroke/systemic embolism and major bleeding were 3.1% and 7.9%, respectively. 3 , 4 …”