May 13, 2019
Long-Term Follow-Up Data Published for Occlutech's Figulla Percutaneous PFO Occluder
May 13, 2019—A Dutch analysis of the safety and efficacy of the Figulla patent foramen ovale (PFO) occluder (Occlutech International AB) with long-term follow-up of approximately 6 years was published by Roel J. R. Snijder, MD, et al in Catheterization and Cardiovascular Interventions (2019;93:1080–1084).
As background to the analysis, the investigators noted that the Occlutech device has been proven safe and effective at 6‐months postprocedure. Now, they provide data after > 1,300 patient-years of follow-up. The study included all consecutive patients who underwent percutaneous PFO closure using the Occlutech device between October 2008 and December 2015 at St. Antonius Hospital in Nieuwegein, the Netherlands.
As summarized in Catheterization and Cardiovascular Interventions, the study was composed of 250 patients (mean age, 53.5 ± 10.7 years; 46.8% women) with a mean follow-up of 5.9 ± 1.8 years, or a total of 1,345 patient‐years.
Transient ischemic attack (TIA) or stroke were the main indications for closure (89.6%). All complications were registered. Residual right‐to‐left shunt was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe.
The investigators reported that implantation was successful in 100% of cases with no major complications. Minor complications were inguinal hematoma in 16 (6.4%) patients, pericardial effusion without the need for intervention in one (0.4%) patient, and supraventricular tachycardia in one (0.4%) patient.
At 1-year follow-up, the investigators had found that a moderate or large shunt was present in 5.9% of patients; a cerebrovascular vascular event (CVE) occurred in 2% of patients (four TIA, one stroke). At long-term follow-up, 7.4% of patients experienced a CVE (nine TIA, eight stroke), with a total CVE rate (TIA and stroke) of 0.02% per patient‐year of follow-up and stroke rate of 0.01%.
"The Occlutech device appears to be safe at long‐term follow-up with a very low annual cerebrovascular event rate and a low moderate-to-large–shunt rate at 1-year follow-up," concluded Dr. Snijder et al in Catheterization and Cardiovascular Interventions.