A propensity score-matched comparison between Cardia and Amplatzer PFO closure devices - insights from the SOLUTION registry (Swiss percutaneOus patent foramen ovale cLosUre in recurrent clinical events prevenTION)

Abstract

Aims: To compare clinical outcome of Amplatzer PFO (APFO) to Cardia PFO (CPFO) occluder. Percutaneous patent foramen ovale (PFO) closure prevents stroke recurrence in stroke due to paradoxical embolism. Methods and results:The primary endpoint was a composite of stroke, TIA, or peripheral embolism at follow-up. The secondary endpoint was residual shunt. Outcome was compared among 934 (APFO: 712; CPFO: 222) patients, and in 297 propensity score-matched patients. The primary endpoint occurred in 29 patients (0.71/100 patient-years): four (2%) with the CPFO (0.31/100 patient-years), and 25 (4%) with the APFO (0.89/100 patient-years) (p=0.20). Residual shunt at six months was more frequent with the CPFO (31% versus 9%, p<0.001). No differences in residual shunts were seen at the last available echocardiographic follow-up (9±18 months): APFO 11%, CPFO 14%, p=0.22.Conclusions: This study suggests that PFO closure with APFO or CPFO is equally effective for the prevention of recurrent events. Residual shunt was more frequent at six months with CPFO, but was similar to APFO at later follow-up.

Percutaneous Implantation of a Second Device in Patients with Residual Right‐to‐Left Shunt after Patent Foramen Ovale Closure

“…Although the type of device was not a predictor of residual shunting, this was nevertheless slightly, but not significantly, more frequent with the Cardia PFO Occluder. This is consistent with recent literature works and can be explained by the fact that septum healing after Amplatzer PFO Occluder implantation is quicker than after Cardia PFO Occluder.…”

“…This study provides an overview of the treatment options offered in our centre to patients presenting with the evidence on TCD (and/or TEE) of moderate‐to‐large rRLS after transcatheter PFO closure. In our analysis, the rate of rRLS is 12.1%, consistent with literature data …”

“…The choice of the device (Amplatzer PFO Occluder vs. Cardia PFO Occluder) used in the second procedure depended on the operator's preferences, and it was largely dictated by the anatomic morphology and size of the residual PFO channel. Furthermore, literature data prove that clinical performance of these 2 PFO Occluders seems comparable. A redo PFO closure procedure was not suggested to patients with only a minor residual shunt, where the shunt was likely to regress further over time and where the risk of thromboembolic events was likely to be small …”

Long‐Term Contrast Echocardiography and Clinical Follow‐Up after Percutaneous Closure of Patent Foramen Ovale Using Two Different Atrial Septal Occluder Devices

“…Gore & Associates) (74.2%; P = 0.031 and P = 0.034, respectively) and Amplatzer (76.4%; P = 0.036 and P = 0.041, respectively). In a recent study by Puricel et al, a residual shunt at 6 months was more frequent after Cardia PFO implantation than after Amplatzer implantation (31% vs 9%, P < 0.001). However, no differences in residual shunts were seen at the last available echocardiographic follow‐up examination (9 ± 18 months).…”

Persistent pathology of the patent foramen ovale: a review of the literature

“…A 2014 study ( n = 934) with PFO closure devices found 100% procedural success rates, with 86% of patients having no residual shunt at 6‐month follow‐up 23 . Residual shunt at 6 months was higher in the patients with the Cardia device (31% of patients) compared with the Amplatzer device (9% of patients; P < 0.001), but without significant differences in the clinical endpoints of stroke, TIA and peripheral embolism, and no significant differences in procedural complications rates 23 . A residual shunt is also more common in the presence of an atrial septal aneurysm (odds ratio [OR], 7.6; 95% CI, 1.38–42.35) 24 .…”