Retrospective Comparison of Device Versus Suture for Patent Foramen Ovale Closure.

Abstract

Background: The use of an implantable closure device with medical therapy to prevent recurrent stroke in patent foramen ovale (PFO)-associated stroke has been shown to be superior to medical therapy alone. Recently, an alternative, suture-based method also has shown promise for effective PFO closure. There has been little published data comparing the outcomes of these two technologies.

Methods: This retrospective study explores the safety and efficacy outcomes of device-based versus suture-based percutaneous PFO intervention. The occurrence of post-procedural atrial fibrillation was of primary interest. Data from 55 single-institution, single-operator PFO closure cases between 1 January 2021 and 8 April 2022 were analyzed. Closure occurred via one of two Food and Drug Administration (FDA)-approved occluders or the NobleStitch™ EL suture-based approach. Data were transcribed into a registered REDCap database for descriptive analysis. Demographics, medical history, imaging, procedural and post-procedural outcomes were the variables collected for each participant.

Results: All patients had successful PFO closure without major adverse outcomes. Overall efficacy was similar between the two groups. No patient had a residual shunt greater than grade 1. Several suture-group patients required multiple sutures for satisfactory closure. Those who had multiple sutures had no anomalous anatomic PFO features. Three patients (5%), all from the device group, developed atrial fibrillation after PFO closure.

Conclusions: This study supports the safety and efficacy of device- and suture-based approaches in PFO closure. Suture-based closure would seem a reasonable option where device-based closure raises concerns. Future studies could further explore the observed disparity of atrial fibrillation occurrence between the two PFO closure strategies.