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Comment
. 2023 Mar 30;25(3):914-921.
doi: 10.1093/europace/euac270.

Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study

Tim R Betts  1 , Marek Grygier  2 , Jens Erik Nielsen Kudsk  3 , Thomas Schmitz  4 , Marcus Sandri  5 , Gavino Casu  6 , Martin Bergmann  7 , David Hildick-Smith  8 , Thomas Christen  9 , Dominic J Allocco  9 ; FLXibility investigators
Affiliations
Comment

Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study

Tim R Betts et al. Europace. .

Abstract

Aims: The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting.

Methods and results: Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-up, core-lab adjudicated complete seal was 88.2% (149/169), 9.5% (16/169) had leak <3 mm, 2.4 (4/169) had leak ≥3 mm to ≤5 mm, and 0% had >5 mm leak. At 1 year, 93.3% (280/300) had final follow-up; 60.5% of patients were on a single antiplatelet medication, 21.4% were on DAPT, 5.6% were on direct oral anticoagulation, and 12.1% were not taking any antiplatelet/anticoagulation medication. Adverse event rates through 1 year were: all-cause death 10.8% (32/295); CV/unexplained death 5.1% (15/295); disabling and non-disabling stroke each 1.0% (3/295, all non-fatal); pericardial effusion requiring surgery or pericardiocentesis 1.0% (3/295); and device-related thrombus 2.4% (7/295).

Conclusion: The WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.

Keywords: Atrial fibrillation; Left atrial appendage closure; Left atrial appendage obstruction; Stroke prevention (limit 6); WATCHMAN FLX.

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Conflict of interest statement

Conflict of interest. T.R.B.: proctoring/consultancy honoraria (Boston Scientific). M.G.: proctoring/consultancy honoraria (Abbott, Boston Scientific), research grants (Boston Scientific). J.E.N.K.: procotoring/consultancy honoraria (Abbott, Boston Scientific), research grants (Abbott, Boston Scientific). T.S.: proctoring/consultancy honoraria (Boston Scientific). M.S.: nothing to disclose. G.C.: proctoring/consultancy honoraria (Abbott, Boston Scientific, Lifetech). M.B.: Speaker honoraria and study support (Abbott, Boston Scientific, Daiichi, Medtronic, MSD/Pfizer). D.H.-S.: proctoring/advisory board honoraria (Abbott, Boston Scientific, Eclipse Medical). T.C.: salary and equity (Boston Scientific Corporation). D.J.A.: salary and equity (Boston Scientific Corporation).

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Patient disposition. Patient flow throughout the study. One enrolled patient did not meet the eligibility criteria and did not undergo an attempted implant; thus, the Attempt/Implant population consisted of 300 patients.
Figure 2
Figure 2
Left atrial appendage seal at first follow-up visit (45–120 days). Results are core-lab adjudicated assessment by transoesphageal echocardiography.
Figure 3
Figure 3
Antiplatelet/anticoagulation medications at hospital discharge and 1 year. DAPT, dual antiplatelet therapy; DOAC, direct oral anticoagulant; SAPT, single antiplatelet therapy; VKA, Vitamin K antagonist.
See this image and copyright information in PMC

Comment on

References

    1. Holmes DR, Reddy VY, Turi ZGet al. . Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet 2009;374:534–42. - PubMed
    1. Holmes DR, Kar S, Price MJet al. . Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 2014;64:1–12. - PubMed
    1. Reddy VY, David H, Doshi Shephal K, Petr N, Saibal K. Safety of percutaneous left atrial appendage closure. Circulation 2011; 123:417–24. - PubMed
    1. Reddy VY, Möbius-Winkler S, Miller MAet al. . Left atrial appendage closure with the watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA plavix feasibility study with watchman left atrial appendage closure technology). J Am Coll Cardiol 2013;61:2551–6. - PubMed
    1. Reddy VY, Doshi SK, Kar Set al. . 5-Year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials. J Am Coll Cardiol 2017;70:2964–75. - PubMed

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