Clinical Outcomes and Quality of Life after Patent Foramen Ovale (PFO) Closure in Patients with Stroke/Transient Ischemic Attack of Undetermined Cause and Other PFO-Associated Clinical Conditions: A Single-Center Experience.

INTRODUCTION: The aim of this study was to assess clinical outcomes and quality of life after PFO closure in patients with previous stroke/TIA of undetermined cause and in patients with other complex PFO-associated clinical conditions.

METHODS: Between July 2009 and December 2019 at our University Cardiology Department, 118 consecutive patients underwent a thorough diagnostic work-up including standardized history taking, clinical evaluation, full neurological examination, screening for thrombophilia, brain magnetic resonance imaging (MRI), ultrasound-Doppler sonography of supra-aortic vessels and 24 h ECG Holter monitoring. Anatomo-morphological evaluation using 2D transthoracic/transesophageal echocardiography (TTE/TEE) color Doppler and functional assessment using contrast TTE (cTTE) in the apical four-chamber view and contrast transcranial Doppler (cTCD) using power M-mode modality were performed to verify the presence, location and amount of right-to-left shunting via PFO or other extracardiac source. Completed questionnaires based on the Quality-of-Life Short Form-36 (QoL SF-36) and Migraine Disability Assessment (MIDAS) were obtained from the patients before PFO closure and after 12 months. Contrast TTE/TEE and cTCD were performed at dismission, 1, 6 and 12 months and yearly thereafter. Brain MRI was performed at 1-year follow-up in 54 patients.

RESULTS: Transcatheter PFO closure was performed in 106 selected symptomatic patients (mean age 41.7 ± 10.7 years, range 16-63, 65% women) with the following conditions: ischemic stroke ( n = 23), transient ischemic attack ( n = 22), peripheral and coronary embolism ( n = 2), MRI lesions without cerebrovascular clinical events ( n = 53), platypnea-orthodeoxia ( n = 1), decompression sickness ( n = 1) and refractory migraine without ischemic cerebral lesions ( n = 4). The implanted devices were Occlutech Figulla Flex I/II PFO ( n = 99), Occlutech UNI ( n = 3), Amplatzer PFO ( n = 3) and CeraFlex PFO occluders ( n = 1). Procedures were performed under local anesthesia and rotational intracardiac monitoring (Ultra ICE) alone. The devices were correctly implanted in all patients. The mean fluoroscopy time was 15 ± 5 min (range = 10-45 min) and the mean procedural time was 55 ± 20 min (range = 35-90 min). The total occlusion rate at follow-up (mean 50 months, range 3-100) was 98.1%. No recurrent neurological events were observed in the long-term follow-up.

CONCLUSIONS: The data collected in this study demonstrate that percutaneous PFO closure is a safe and effective procedure, showing long-term prevention of recurrent cerebrovascular events, significant reduction in migraine symptoms and substantial improvement in quality of life.