{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:36:02Z","timestamp":1791851762977,"version":"4.3.4"},"reference-count":14,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,2,3]],"date-time":"2023-02-03T00:00:00Z","timestamp":1675382400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Boston Scientific Corporation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,3,30]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and results<\/jats:title><jats:p>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 \u00b1 8.0 years, mean CHA2DS2-VASc score was 4.3 \u00b1 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 &amp;lt;3 mm, 2.4 (4\/169) had leak \u22653 mm to \u22645 mm, and 0% had &amp;gt;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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1093\/europace\/euac270","type":"journal-article","created":{"date-parts":[[2023,2,3]],"date-time":"2023-02-03T10:21:08Z","timestamp":1675419668000},"page":"914-921","source":"Crossref","is-referenced-by-count":32,"title":["Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval 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Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Schmitz","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Elisabeth-Krankenhaus-Essen GmbH , 45138 Essen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Sandri","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine\/Cardiology, University of Leipzig, Heart Centre , Str\u00fcmpellstra\u00dfe 39, 04289 Leipzig , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9923-9473","authenticated-orcid":false,"given":"Gavino","family":"Casu","sequence":"additional","affiliation":[{"name":"Cardiologia Clinica e Interventistica, Azienda Ospedaliero Universitaria di Sassari , Sassari 07100 , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6140-7870","authenticated-orcid":false,"given":"Martin","family":"Bergmann","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Cardiologicum Hamburg Praxis Wandsbek , Schlo\u00dfstra\u00dfe 12, 22041 Hamburg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1147-1436","authenticated-orcid":false,"given":"David","family":"Hildick-Smith","sequence":"additional","affiliation":[{"name":"Sussex Cardiac Centre, Univeristy Hospitals Sussex NHS Trust , Brighton, BN2 3EW , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Christen","sequence":"additional","affiliation":[{"name":"Boston Scientific , 100 Boston Scientific Way, Marlborough, MA 01752 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0577-1555","authenticated-orcid":false,"given":"Dominic J","family":"Allocco","sequence":"additional","affiliation":[{"name":"Boston Scientific , 100 Boston Scientific Way, Marlborough, MA 01752 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"For the FLXibility investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,2,3]]},"reference":[{"key":"2023033021224560100_","doi-asserted-by":"crossref","first-page":"534","DOI":"10.1016\/S0140-6736(09)61343-X","article-title":"Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority 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