A Comparison Between Gore Cardioform and Amplatzer Septal Occluder for Percutaneous Closure of Patent Foramen Ovale Associated With Atrial Septal Aneurysm: Clinical and Echocardiographic Outcomes
Carmine Musto, Alberta Cifarelli, Francesco Dipasquale, Diana Chin, Marco Stefano Nazzaro, Rocco Edoardo Stio, Mauro Pennacchi, Francesco De Felice, Carmine Musto, Alberta Cifarelli, Francesco Dipasquale, Diana Chin, Marco Stefano Nazzaro, Rocco Edoardo Stio, Mauro Pennacchi, Francesco De Felice
Abstract
Objectives: To evaluate the short- and long-term clinical and echocardiographic outcomes of the percutaneous closure of the patent foramen ovale (PFO) with an atrial septal aneurysm (ASA) using 2 different devices.
Methods: We enrolled 100 patients with PFO and ASA. Fifty consecutive patients had transcatheter closure of the PFO with the Gore Cardioform septal occluder (GSO) (Gore Medical) and a second group of 50 consecutive patients with the Amplatzer PFO occluder (APO) (Abbott). A clinical and transthoracic echocardiographic follow-up was performed at 1, 3, 6, and 12 months after the implant procedure. The primary endpoint was the incidence of moderate-to-severe residual right-to-left shunting (rRLS) at the 6-month follow-up. The procedural results and the recurrence of embolic events at 1 year were also investigated.
Results: The procedure was successful in all patients. The immediate postprocedural moderate-to-severe rRLS incidence was similar between the 2 groups (GSO 14% vs APO 12%; P=NS) as well as the incidence of moderate-to-severe rRLS at the 6-month follow-up (GSO 4% vs APO 4%; P=non-significant). In only 1 patient of the GSO group, there was a persistent moderate rRLS at the 1-year follow-up. The 6-month and 1-year complete occlusion rate for all subjects was 93% and 96%, respectively. No devices embolized and no death or recurrent embolic events were observed during hospitalization through the 1-year follow-up.
Conclusions: GSO and APO devices appear to be safe and effective devices for the percutaneous closure of a PFO with ASA, showing similar results for the presence of rRLS at the 6-month follow-up, complete occlusion rate, and clinical embolic recurrences.
Keywords: Amplatzer septal occluder; Gore Cardioform septal occluder; atrial septal aneurysm; intracardiac echography; patent foramen ovale; residual right-to-left shunting.
Source: PubMed