Abstract
Background: Percutaneous transcatheter closure of patent foramen ovale (PFO) and atrial septal defect (ASD) has been shown to be feasible. Aim: The aim of this study was to evaluate the safety and efficacy of transcatheter interatrial septal shunt closure with prosthesis implantation in adults patients during long‐term follow‐up. In addition, the impact of thrombophilia and pulmonary hypertension on the outcome were investigated. Methods: Between June 1999 and November 2009, 287 patients (112 males, 43 ± 14 years) were treated in our institution by transcatheter closure of PFO (N = 175) or ASD (N = 112). Clinical and echocardiographic follow‐up were prospectively performed at 1, 6 and 12 months followed by a 1 once a year evaluation. Results: All procedures were successful with eight procedural complications (2.7%): one stroke, two femoral pseudoaneurysms, three transient atrial fibrillation, two minors pericardial effusions. Among patients with presumed paradoxical embolism, thrombophilia was observed in 29 patients (17%); only one of them experienced a recurrent stroke. Among patients with ASD, pulmonary hypertension was observed in 32 cases (28%) and significantly reduced 6 months after shunt closure (from 47 ± 7 to 31 ± 11 mm Hg, P < 0.0001). 99% of patients achieved a complete follow‐up. Clinical improvement was observed in 93%. Freedom from death, cardiac surgery or recurrent embolism was 98 ± 1% at 5 years. Conclusion: Percutaneous transcatheter interatrial septal defect closure is a safe and effective treatment in adults patients, even in case of thrombophilia or pulmonary hypertension, during a long‐term follow‐up, up to 11 years. © 2011 Wiley Periodicals, Inc.