Supraventricular arrhythmia may be diagnosed in patients with use of systematic cardiac loop recording within at least 28 days following patent foramen ovale (PFO) closure. These findings were published in JACC: Cardiovascular Interventions.
Investigators sought to determine the incidence and timing of atrial fibrillation (AF), using systematic 28-day or longer electrocardiography monitoring with implantable loop recorders (ILR) or external loop recorders and their determinants and impact in patients who had PFO closure.
All participants received PFO percutaneous closure at a hospital in Paris, France, and were proposed to be monitored with ILR in case of high-risk features.
The ILR devices were implanted before hospital discharge, with patients being rhythmically monitored for up to 3 years. Patients with an ILR implanted before the PFO closure for ruling out AF were also included. Participants without postprocedural arrhythmia or high-risk features were monitored for 4 weeks with external loop recorders, initiated before discharge.
The primary endpoint was the incidence of new onset AF, supraventricular tachycardia, or flutter lasting 30 seconds or longer, according to the European Society of Cardiology guidelines, within 28 days of the procedure.
A total of 225 patients (median age, 52.2 years; 57.3% men) were included from June 2018 to October 2021. Of these patients, 97.3% had PFO percutaneous closure for secondary prevention of embolic events, including a cerebrovascular event in 215 cases.
The overall incidence of the primary endpoint at 28 days was 20.9% (95% CI, 16.1-26.7). Postdischarge, 36.9% patients were monitored with an ILR, of which 7 (8.4%) were implanted preprocedure as part of ruling out AF. The percentage of patients monitored with an external loop recorder was 58.7%, with a median duration of analyzable data of 22.3 (21-26) days.
The incidence of new-onset supraventricular arrhythmia from hospital discharge to 28 days postprocedure was 9.9% (95% CI, 5.9-16.1) and 28.9% (95% CI, 20.3-39.4) among external loop recorder-monitored and ILR-monitored patients, respectively. The median follow-up in ILR-monitored patients was 428 (211-752) days.
At 1 year, the cumulative incidence of supraventricular arrhythmia in ILR-monitored patients was 32.7% (95% CI, 23.7-44.0), and the median delay to the first sustained supraventricular arrhythmia episode was 14.0 (6.5-19.0) days. A total of 26 of 51 patients had 1 episode of arrhythmia.
Independent determinants of the primary endpoint were age at procedure (per 10-year increase) (adjusted odds ratio [aOR], 1.67; 95% CI, 1.18-2.36; P =.004), device left disc diameter 25 mm or wider (aOR, 2.67; 95% CI, 1.19-5.98; P =.017), and male sex (aOR, 4.78; 95% CI, 1.96-11.66; P =.0006), in stepwise multivariate logistics regression.
Clinical symptoms related to arrhythmia occurred in 28 (54.9%) patients and resulted in an unplanned medical visit in 9 cases and unplanned hospital admission in 4 additional cases.
The researchers noted that using ILR and external loop recorders devices may limit the information obtained on the timing of AF episodes in lower-risk patients and may have resulted in an unbalanced comparison between the 2 groups. In addition, the incidence of arrhythmia reported in the external loop recorder-monitored groups may be underestimated, and data regarding the type and duration of cardiac monitoring performed before the PFO closure are not available.
“Our study provides a precise timing of when these events occur, which were recorded rapidly after PFO closure, with a median of 2 weeks after the procedure,” wrote the investigators. “Few patients appear to have recurrences beyond 1 month.”
Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Guedeney P, Laredo M, Zeitouni M, et al. Supraventricular arrhythmia following patent foramen ovale percutaneous closure. JACC Cardiovasc Interv. Published online August 22, 2022. doi: 10.1016/j.jcin.2022.07.044