Background: Patent foramen ovale (PFO) was found to be associated with the increased risk of recurrent strokes or transient ischemic attacks (TIA) and there is a need of secondary prevention. Numerous devices have been developed and used for treatment.
Objectives: The aim of the study was to evaluate the safety and effectiveness of a new PFO occluder Nit-Occlud PFO Occlusion Device (PFM medical, Germany).
Methods: Between January 2012 and August 2016, 151 patients (mean age 41 ± 11 years) who had suffered from a cryptogenic thromboembolic event underwent transcatheter PFO closure with the PFM Nit-Occlud PFO device. The procedure was successful in 150 patients (99.3%). Mean clinical follow-up time was 24.4 ± 16.1 months. Echocardiographic follow-up was done at 6 weeks and 6 months post intervention by transesophageal contrast echocardiography in 90 (60%) of patients. Clinical end-point was death, non-fatal stroke, or TIA.
Results: No major periprocedural or in-hospital complications occurred. Stroke or TIA reoccurred generally in 5 (3.3%) patients (2 strokes and 3 TIA's). In one patient (0.7%) device, thrombosis was observed. Closure was sufficient with only minimal right-to-left residual shunt in seventeen cases of 90 examined patients (19%) after 6 weeks and in one patient (1.1%) 6 months post implantation.
Conclusions: The Nit-Occlud PFO device and its delivery system are safe and provides sufficient closure of PFO in patients who suffered from cryptogenic stroke, TIA or paradoxical peripheral embolism. It is associated with high procedural success and favorable rates of complete closure.
Keywords: complications; prognosis; stroke; structural interventions.
© 2017 Wiley Periodicals, Inc.