Sex effect on efficacy of pulmonary vein cryoablation in patients with atrial fibrillation: data from the multicenter real-world 1STOP project

Danilo Ricciardi, Giuseppe Arena, Roberto Verlato, Saverio Iacopino, Paolo Pieragnoli, Giulio Molon, Massimiliano Manfrin, Giuseppe Allocca, Giuseppe Cattafi, Giusy Sirico, Giovanni Rovaris, Luigi Sciarra, Daniele Nicolis, Claudio Tondo

Research output: Contribution to journalArticle

Abstract

PURPOSE: Pulmonary vein isolation (PVI) using cryoablation (PVI-C) is a widespread therapy for treating symptomatic, recurrent atrial fibrillation (AF). The impacts of sex on efficacy and safety of PVI-C in a real-world clinical practice is lacking. In a multicenter prospective project, we evaluated whether clinical characteristics, procedure parameters, procedural complications, long-term AF recurrence rates, and/or AF-related symptoms differed according to sex in patients treated with PVI-C.

METHODS: Data from the study population were collected in the framework of the 1STOP ClinicalService® project, involving 47 Italian cardiology centers. Multivariable statistical analyses were conducted to determine if any baseline clinical characteristics impacted the efficacy of PVI-C.

RESULTS: From April 2012, 2125 patients (27% female, 59 ± 11 years, 73% paroxysmal AF, and mean left atrial diameter = 42 ± 8 mm) underwent PVI-C. According to baseline characteristics, women were more likely to be older, with higher clinical risk scores (e.g., CHA2DS2-VASc), and a higher number of tested antiarrhythmic drugs before the index PVI-C procedure. Male and female cohorts showed comparable procedure time (mean = 107.7 ± 46.8 min) and a similar incidence of periprocedural complications (4.5% overall), even after adjustment for baseline characteristics (P = 0.880). The multivariable analyses demonstrated that the strongest predictor of AF recurrences was sex (0.74; 95% CI 0.58-0.93; P = 0.011). After propensity score adjustment, the hazard ratio from a multivariable model, which included age and AF type (persistent) as covariates, was 0.76 (0.60-0.97) (P = 0.025).

CONCLUSIONS: According to the 1STOP project, in a real-world setting, PVI-C was relatively safe regardless of the patient's sex; however, when considering efficacy of the procedure, female patients had a lower long-term efficacy in comparison to males.

CLINICAL TRIAL REGISTRATION: NCT01007474.

Original languageEnglish
Pages (from-to)9-18
Number of pages10
JournalJournal of Interventional Cardiac Electrophysiology
Volume56
Issue number1
DOIs
Publication statusPublished - Oct 2019

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    Ricciardi, D., Arena, G., Verlato, R., Iacopino, S., Pieragnoli, P., Molon, G., Manfrin, M., Allocca, G., Cattafi, G., Sirico, G., Rovaris, G., Sciarra, L., Nicolis, D., & Tondo, C. (2019). Sex effect on efficacy of pulmonary vein cryoablation in patients with atrial fibrillation: data from the multicenter real-world 1STOP project. Journal of Interventional Cardiac Electrophysiology, 56(1), 9-18. https://doi.org/10.1007/s10840-019-00601-3