Ignacio Cruz-González1, Kasper Korsholm2, Blanca Trejo-Velasco3, Jean Benoit Thambo4, Patrizio Mazzone5, Gilles Rioufol6, Marek Grygier7, Sven Möbius-Winkler8, Timothy Betts9, Felix Meincke10, Marcus Sandri11, Boris Schmidt12, Thomas Schmitz13, Jens Erik Nielsen-Kudsk14. 1. Cardiology Department, Hospital Universitario de Salamanca. Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain; Centro de Investigación en Red de Enfermedades Cardiovasculares (Network Research Centre for Cardiovascular Diseases), CIBER-CV, Madrid, Spain. Electronic address: https://twitter.com/icruzgonzalez. 2. Cardiology Department, Aarhus Universitetshospital, Aarhus, Denmark. Electronic address: https://twitter.com/KasperKorsholm. 3. Cardiology Department, Hospital Universitario de Salamanca. Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain. Electronic address: treejooblanca@hotmail.com. 4. Cardiology Department, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France. 5. Cardiology Department, San Raffaele Hospital, Metropolitan City of Milan, Italy. 6. Cardiology Department, Claude Bernard University Lyon 1, Villeurbanne, Lyon, France. 7. Cardiology Department, Poznan University of Medical Sciences, Poznan, Poland. 8. Cardiology Department, Friedrich Schiller University Jena, Jena, Germany. 9. Cardiology Department, Oxford Biomedical Research Centre, Oxford, United Kingdom. 10. Cardiology Department, Asklepios Klinik St. Georg, Hamburg, Germany. 11. Cardiology Department, Heart Center at University of Leipzig, Leipzig, Germany. 12. Cardiology Department, Cardiovascular Center Bethanien, Frankfurt am Main, Germany. 13. Cardiology Department, Contilia Herz & Gefäßzentrum, Elisabeth Krankenhaus Essen, Essen, Germany. 14. Cardiology Department, Aarhus Universitetshospital, Aarhus, Denmark.
Abstract
OBJECTIVES: This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts). BACKGROUND: The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis. METHODS: A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program. RESULTS: Mean age was 75.4 ± 8.9 years, and CHA2DS2-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred. CONCLUSIONS: LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.
OBJECTIVES: This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts). BACKGROUND: The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis. METHODS: A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program. RESULTS: Mean age was 75.4 ± 8.9 years, and CHA2DS2-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred. CONCLUSIONS:LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.