Author + information
- Received August 13, 2018
- Revision received October 11, 2018
- Accepted October 18, 2018
- Published online January 21, 2019.
- Jérôme Wintzer-Wehekind, MDa,
- Alberto Alperi, MDa,
- Christine Houde, MDb,
- Jean-Marc Côté, MDb,
- Lluis Asmarats, MDa,
- Mélanie Côté, MSca and
- Josep Rodés-Cabau, MDa,b,∗ (, )@universitelaval
- aQuebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
- bCentre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
- ↵∗Address for correspondence:
Dr. Josep Rodés-Cabau, Quebec Heart & Lung Institute, Laval University, 2725 Chemin Ste-Foy, G1V 4GS, Quebec City, Quebec, Canada.
Background Patent foramen ovale (PFO) closure is the gold standard for treating patients with cryptogenic stroke and PFO. However, scarce data exist on the long-term outcomes following PFO closure.
Objectives The purpose of this study was to determine the long-term (>10 years) clinical outcomes (death, ischemic, hemorrhagic events) following transcatheter PFO closure.
Methods We included 201 consecutive patients (mean age: 47 ± 12 years, 51% women) who underwent PFO closure due to a cryptogenic embolism (stroke: 76%, transient ischemic attack [TIA]: 32%, systemic embolism: 1%). Echocardiographic examinations were performed at 1- to 6-month follow-up. Ischemic and bleeding events and antithrombotic medication were collected at a median follow-up of 12 years (range 10 to 17 years), and follow-up was complete in 96% of the patients.
Results The PFO closure device was successfully implanted in all cases, and residual shunt was observed in 3.3% of patients at follow-up echocardiography. A total of 13 patients died at follow-up (all from noncardiovascular causes), and nondisabling stroke and TIA occurred in 2 and 6 patients, respectively (0.08 strokes per 100 patient-years; 0.26 TIAs per 100 patient-years). A history of thrombophilia (present in 15% of patients) tended to associate with a higher rate of ischemic events at follow-up (p = 0.067). Bleeding events occurred in 13 patients and were major (intracranial bleeding) in 4 patients (all of them under aspirin therapy at the time of the event). A total of 42 patients stopped the antithrombotic treatment at a median of 6 months (interquartile range 6 to 14 months) post-PFO closure, and none of them had any ischemic or bleeding episode after a mean of 10 ± 4 years following treatment cessation.
Conclusions PFO closure was associated with a low rate of ischemic events (stroke, 1%) at >10 years of follow-up. Major bleeding events occurred in 2% of the patients (all of them in patients on antiplatelet therapy). One-fifth of patients stopped the antithrombotic therapy during the follow-up period (the majority within the first-year post-PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up.
Dr. Wintzer-Wehekind has received grant support from the “Association de Recherche Cardio-vasculaire des Alpes.” Dr. Asmarats has received grant support 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. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received August 13, 2018.
- Revision received October 11, 2018.
- Accepted October 18, 2018.
- 2019 American College of Cardiology Foundation
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