Lluis Asmarats1, Jean-Bernard Masson2, Paolo A Pagnotta3, Stéphane Cook4, Mike Foresti5, Réda Ibrahim6, Adam Sukiennik7, Robert Sabiniewicz8, Diego Maffeo9, Julio Carballo10, Ignacio Cruz-González11, Carmelo Grasso12, Francesco Pisano13, Gaetano Senatore14, Giuseppe Tarantini15, Adolphe Kasongo2, Mauro Chiarito3, Serban Puricel4, Nathan Messas6, Jose Carlos Moreno-Samos11, Gilles O'Hara1, Josep Rodés-Cabau16. 1. Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada. 2. Department of Cardiology, Centre Hospitalier de l'Université de Montreal, Montreal, Canada. 3. Department of Cardiology, Cardio Center, Humanitas Research Hospital, Rozzano-Milan, Italy. 4. Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland. 5. Department of Cardiology, Kliniken Maria Hilf GmbH Mönchengladbach, Mönchengladbach, Germany. 6. Department of Cardiology, Montreal Heart Institute, Montreal, Canada. 7. Department of Cardiology, Nicolaus Copernicus University, Bydgoszcz, Poland. 8. Department of Cardiology, Medical University Gdansk, Gdansk, Poland. 9. Department of Cardiology, Fondazione Poliambulanza, Brescia, Italy. 10. Department of Cardiology, Hospital El Pilar-CM Teknon, Barcelona, Spain. 11. Department of Cardiology, University Hospital of Salamanca, Salamanca, Spain. 12. Department of Cardiology, Ferrarotto Hospital, Catania, Italy. 13. Department of Cardiology, Regional Hospital Aosta, Aosta, Italy. 14. Department of Cardiology, Presidio Ospedaliero di Ivrea-Ciriè, Torino, Italy. 15. Department of Cardiology, University of Padua Medical School, Padua, Italy. 16. Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca.
Abstract
OBJECTIVES: This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk. BACKGROUND: The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy. METHODS: This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3. RESULTS: A total of 126 patients (mean age 75 ± 8 years; mean CHA2DS2-VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis. CONCLUSIONS: In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device.
OBJECTIVES: This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk. BACKGROUND: The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy. METHODS: This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3. RESULTS: A total of 126 patients (mean age 75 ± 8 years; mean CHA2DS2-VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis. CONCLUSIONS: In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device.