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Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient‐years of follow up
Author(s) -
Snijder Roel J. R.,
Renes Laura E.,
Suttorp Maarten Jan,
ten Berg Jurrien M.,
Post Martijn C.
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27984
Subject(s) - medicine , patent foramen ovale , surgery , percutaneous , pericardial effusion , stroke (engine) , shunt (medical) , cardiology , mechanical engineering , engineering
Objective To evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long‐term follow‐up (FU). Background The Occlutech device has been proven safe and effective six‐months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient‐years of FU. Methods All consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right‐to‐left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe. Results In total, 250 patients (mean age 53.5 ± 10.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9 ± 1.8 years, a total of 1,345 patient‐years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one‐year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1‐year FU (four TIA, one stroke) and in 7.4% at long‐term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patient‐year of FU, with a stroke rate of 0.01%. Conclusion The Occlutech device appears to be safe at long‐term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1‐year FU.