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

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.