Résumé
IntroductionAn increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized studies but systematic screening of AF was not performed in these studies. The objective is to evaluate incidence of AF and clinical events in patients who underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring during 6 months follow-up.MethodsAll consecutive patients undergoing PFO closure for cryptogenic stroke or decompression sickness were prospectively included in 2 centers (Montpellier and Nîmes University Hospitals, France). A 24-hours AECG was performed after the procedure (day 0), and at 1 and 6 months follow-up in all patients. Primary endpoint was incidence of AF defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on ECG monitoring. Secondary endpoints were clinical outcomes (hospitalization from cardiovascular causes, new stroke or bleeding) up to 6 months follow-up.ResultsBetween February 2018 and March 2019, a total of 62 patients underwent PFO closure59 (95.2%) for cryptogenic stroke and 3 (4.8%) for decompression sickness. In the overall population, 40 were male (64.5%) and the mean age was 48 ± 9.5 years. An atrial septal aneurysm was present in 37 patients (64.9%), 57 (91.9%) received an Amplatzer PFO Occluder device (Abbott Vascular, Santa Clara, CA, USA) and 5 (8.1%) an Occlutech PFO device (Occlutech, Helsingborg, Sweden) with a mean size of 26 ± 5.0 mm. After a mean follow-up of 27.7 ± 17.6 weeks, new onset AF occurred in 3 patients (4.84%), all in the first month (paroxysmal AF, including one periprocedural) and all were asymptomatic. Two patients (3.2%) requiring oral anticoagulant therapy according to a high stroke risk based on the CHA2DS2-VASc score. There was no adverse outcomes in all patients. Age (RR 1.26 [0.98;1.61] p=0.276), sex (p=0.55) and device (p=1.0) were not independent of AF but all patients with AF were men and received an Amplatzer device.ConclusionsIncidence of AF, evaluated with systematic 24-hours AECG at 6 months follow-up after PFO closure, was relatively low (<5%). Always paroxysmal, AF occurred only in the first month after the procedure and was no associated with adverse outcomes.