Author + information
- Received March 14, 2018
- Revision received May 1, 2018
- Accepted May 15, 2018
- Published online October 1, 2018.
- Lluis Asmarats, MDa,
- Jean-Bernard Masson, MDb,
- Paolo A. Pagnotta, MDc,
- Stéphane Cook, MDd,
- Mike Foresti, MDe,
- Réda Ibrahim, MDf,
- Adam Sukiennik, MDg,
- Robert Sabiniewicz, MD, PhDh,
- Diego Maffeo, MDi,
- Julio Carballo, MDj,
- Ignacio Cruz-González, MD, PhDk,
- Carmelo Grasso, MDl,
- Francesco Pisano, MDm,
- Gaetano Senatore, MDn,
- Giuseppe Tarantini, MD, PhDo,
- Adolphe Kasongo, MDb,
- Mauro Chiarito, MDc,
- Serban Puricel, MDd,
- Nathan Messas, MDf,
- Jose Carlos Moreno-Samos, MDk,
- Gilles O’Hara, MDa and
- Josep Rodés-Cabau, MDa,∗ ()
- aDepartment of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada
- bDepartment of Cardiology, Centre Hospitalier de l’Université de Montreal, Montreal, Canada
- cDepartment of Cardiology, Cardio Center, Humanitas Research Hospital, Rozzano-Milan, Italy
- dDepartment of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland
- eDepartment of Cardiology, Kliniken Maria Hilf GmbH Mönchengladbach, Mönchengladbach, Germany
- fDepartment of Cardiology, Montreal Heart Institute, Montreal, Canada
- gDepartment of Cardiology, Nicolaus Copernicus University, Bydgoszcz, Poland
- hDepartment of Cardiology, Medical University Gdansk, Gdansk, Poland
- iDepartment of Cardiology, Fondazione Poliambulanza, Brescia, Italy
- jDepartment of Cardiology, Hospital El Pilar-CM Teknon, Barcelona, Spain
- kDepartment of Cardiology, University Hospital of Salamanca, Salamanca, Spain
- lDepartment of Cardiology, Ferrarotto Hospital, Catania, Italy
- mDepartment of Cardiology, Regional Hospital Aosta, Aosta, Italy
- nDepartment of Cardiology, Presidio Ospedaliero di Ivrea-Ciriè, Torino, Italy
- oDepartment of Cardiology, University of Padua Medical School, Padua, Italy
- ↵∗Address for correspondence:
Dr. Josep Rodés-Cabau, Quebec Heart & Lung Institute, Laval University, 2725 chemin Ste-Foy, G1V 4G5 Quebec City, Quebec, Canada.
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.
Dr. Asmarats has been supported by a grant from the Fundacion Alfonso Martin Escudero. Dr. Rodés-Cabau holds the Canadian Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. Dr. Pagnotta has served as a proctor for Cardia. Dr. Ibrahim has served as a consultant for Abbott, Boston Scientific, and Gore; has served as a consultant for Abbott and Boston Scientific; and has received honoraria from Medtronic. Dr. Rodés-Cabau has received institutional research grant support from Cardia. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 14, 2018.
- Revision received May 1, 2018.
- Accepted May 15, 2018.
- 2018 American College of Cardiology Foundation