BACKGROUND: Atrial fibrillation (AF) is a growing healthcare burden, for which pulmonary vein isolation (PVI) using cryoballoon (CB) or radiofrequency (RF) represent attractive therapies. Women are at higher risk of recurrence after AF ablation and present a specific complications profile. Therefore, a systematic catheter-specific assessment of pulmonary vein isolation is urgently needed in women. OBJECTIVE: Systematically assessing the sex-specific efficacy/safety of CB vs RF ablation. METHODS: We performed a structured database search of the scientific literature for randomized controlled trials (RCTs) and observational prospective studies (OPS) comparing CB and RF ablation efficacy at 1 year. We investigated the reporting of sex-specific analyses and assessed the comparative sex-specific efficacy, safety and procedural characteristics of CB vs RF using random-effect meta-regression accounting for the proportion of enrolled women. RESULTS: Twenty-three studies were included (18 OPS and 5 RCTs) for a total of 13 509 patients. Sex-specific outcomes by ablation device were reported in two and sex-specific regression in four studies, none of which took the ablation device into account. Meta-regression accounting for the proportion of enrolled women showed no significant difference in outcomes between RF or CB. CONCLUSION: The sex-specific reporting in trials comparing CB to RF is extremely low. A quantitative meta-regression using the percentage of enrolled women as sex-specific indicator did not show any difference between CB and RF but acknowledging the low percentage of enrolled women and the lack of sex-specific data, further research including patient-level data is urgently needed to draw more definitive conclusions.
BACKGROUND:Atrial fibrillation (AF) is a growing healthcare burden, for which pulmonary vein isolation (PVI) using cryoballoon (CB) or radiofrequency (RF) represent attractive therapies. Women are at higher risk of recurrence after AF ablation and present a specific complications profile. Therefore, a systematic catheter-specific assessment of pulmonary vein isolation is urgently needed in women. OBJECTIVE: Systematically assessing the sex-specific efficacy/safety of CB vs RF ablation. METHODS: We performed a structured database search of the scientific literature for randomized controlled trials (RCTs) and observational prospective studies (OPS) comparing CB and RF ablation efficacy at 1 year. We investigated the reporting of sex-specific analyses and assessed the comparative sex-specific efficacy, safety and procedural characteristics of CB vs RF using random-effect meta-regression accounting for the proportion of enrolled women. RESULTS: Twenty-three studies were included (18 OPS and 5 RCTs) for a total of 13 509 patients. Sex-specific outcomes by ablation device were reported in two and sex-specific regression in four studies, none of which took the ablation device into account. Meta-regression accounting for the proportion of enrolled women showed no significant difference in outcomes between RF or CB. CONCLUSION: The sex-specific reporting in trials comparing CB to RF is extremely low. A quantitative meta-regression using the percentage of enrolled women as sex-specific indicator did not show any difference between CB and RF but acknowledging the low percentage of enrolled women and the lack of sex-specific data, further research including patient-level data is urgently needed to draw more definitive conclusions.
Authors: Sven Knecht; Christian Sticherling; Laurent Roten; Patrick Badertscher; Laurève Chollet; Thomas Küffer; Florian Spies; Antonio Madaffari; Aline Mühl; Samuel H Baldinger; Helge Servatius; Stefan Osswald; Tobias Reichlin; Michael Kühne Journal: J Interv Card Electrophysiol Date: 2021-07-28 Impact factor: 1.759