https://doi.org/10.1007/s00392-025-02625-4
1Universitätsklinikum Heidelberg Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie Heidelberg, Deutschland; 2Kardiologen am Brückenkopf Fachärzte für Innere Medizin & Kardiologie Heidelberg, Deutschland
Introduction: Stroke remains a leading cause of morbidity, especially in patients under 65, where it is frequently associated with a patent foramen ovale (PFO). Beyond its role in stroke, PFO has been linked to migraine. Current management strategies for PFO include lifelong anticoagulation or defect closure. The RESPECT trial recently established that interventional PFO closure is superior to medical therapy alone in reducing recurrent stroke risk. Despite these advances, long-term comparative outcomes of different PFO occluder devices remain unclear. This study aims to address this gap by evaluating the safety and efficacy of various PFO closure devices over a 23-year period.
Objectives: To compare the safety and efficacy of four commonly used PFO occluder devices, focusing on implantation success rates and peri- and post-interventional complications.
Methods: This retrospective single-center study included 716 patients who underwent PFO closure between January 2000 and February 2023 at the University Hospital Heidelberg. Primary endpoints were successful device implantation and peri- and post-interventional complication rates. Clinical data, including electrocardiograms (ECG), transesophageal echocardiography (TEE), transthoracic echocardiography (TTE), and laboratory values, were collected before and after the procedure, with follow-up at 1, 6, and 12 months.
Results:
A total of 716 patients were included (60.8% male, 39.1% female; mean age 50.57 ± 12.59 years). Four different closure devices were used: Occlutech (n = 106), Amplatzer (n = 227), Gore Septal Occluder (GSO) (n = 296), and Cardistar PFO Star (n = 87). The primary indications for PFO closure were ischemic stroke (66.8%), transient ischemic attack (TIA) (18.0%), or both (4.5%).
All devices showed high procedural success rates: Occlutech (100%), Amplatzer (97.8%), GSO (99.3%), and Cardistar PFO Star (98.9%) (p = 0.27). Fluoroscopy time varied, being longer for Occlutech and GSO. Procedural complications occurred in 3.1% of patients, including new-onset atrial fibrillation and minor bleeding, with no significant differences between devices (p = 0.66).
During follow-up, cerebrovascular events were rare. Recurrent strokes occurred in four patients (1 Occlutech, 1 Amplatzer, 2 GSO, p = 0.90), and TIA was noted in three patients (2 Amplatzer, 1 GSO, p = 0.84). New-onset atrial fibrillation occurred in 6.0% of patients, with comparable rates across devices (p = 0.07). However, GSO was associated with a higher incidence of device-related thrombus during follow-up (p = 0.0005).
Conclusion:
All four PFO closure devices demonstrated high safety and efficacy in achieving successful closure, with comparable procedural outcomes and complication rates. No significant differences in follow-up cerebrovascular events were observed, except for an increased risk of device-related thrombus in the GSO group. These findings highlight the need for further prospective, randomized studies to validate these results and explore long-term outcomes.