New-onset atrial fibrillation following percutaneous closure of patent foramen ovale: a systematic review and meta-analysis.

PURPOSE: A patent foramen ovale (PFO), present in up to 25% of adults, is an embryologic remnant which allows for right to left shunting and has been implicated in cryptogenic stroke (Neill and Lin, Methodist Debakey Cardiovasc J. 13(3):152-159, 2017; Bass 2015). The current standard of care for selected patients with PFO and cryptogenic stroke is transcatheter closure, but the risk of post-closure, new-onset atrial fibrillation (AF) is unknown (Vaidya et al., Cardiovasc Diagn Ther. 8(6):739-753, 2018; Kjeld et al., Acta Radiol Open. 7(9):2058460118793922, 2018; Staubach et al., Catheter Cardiovasc Interv. 74(6):889-95, 2009). This systematic review and meta-analysis synthesized evidence on AF development post transcatheter PFO closure and predictors of AF development, and assessed existing knowledge gaps. METHODS: Randomized controlled trials and observational studies were selected according to the inclusion criteria of adults that underwent a transcatheter PFO closure without a history of AF. Studies were retrieved from electronic databases from inception until February 2019. A Freeman-Tukey arcsine transformation was performed for meta-analysis of AF incidence rate. RESULTS: From 765 studies, 45 were included in quantitative data synthesis. Study sample sizes ranged between 20 and 1887 individuals, and average patient age between 37 to 67 years across studies. The overall incidence rate was 0.013 person-years, and 0.014 person-years for the within 6 months follow-up subgroup. There was no consistency in reported predictors of AF development. CONCLUSIONS: The incidence of AF post-PFO closure was low across studies, with a high level of between-study heterogeneity. Until a concerted effort is made to improve accurate AF diagnosis, it will be difficult to gauge the association between transcatheter PFO closure and incidence of AF.