Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation

Kück, Karl‐Heinz; Brugada, Josép; Fürnkranz, Alexander; Chun, K.R. Julian; Metzner, Andreas; Ouyang, Feifan; Schlüter, Michael; Elvan, Arif; Braegelmann, Kendra M.; Kueffer, Fred; Arentz, Thomas; Albenque, Jean‐Paul; Kühne, Michael; Sticherling, Christian; Tondo, Claudio; Investigators, Ice

doi:10.1161/circep.118.006204

Cited by 85 publications

(117 citation statements)

References 18 publications

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“…Regarding the other risk factors for recurrences, we identified female sex and persistent AF as significant parameters for the increased recurrence rate (Table ). This fitted the data from previous studies . There was also a tendency for the LA diameter, but unlike the study of Tzou et al, this was not significant in our study.…”

Section: Discussionsupporting

confidence: 85%

Relevance of esophageal position and temperature on thermal injuries and rhythm outcome in atrial fibrillation ablations

Stauber

Kornej

Bollmann

et al. 2020

Pacing Clinical Electrophis

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Background Thermolesions are a dangerous complication of atrial fibrillation (AF) ablation. We aimed to assess the reasons for thermolesions and the effect of esophageal position on recurrences. Methods The study included consecutive patients undergoing AF catheter ablation at Heart Center Leipzig between January and September 2014. We collected data of esophagus localization, temperature, endoscopy, and follow‐up. Results The study included 645 patients into analyses. A total of 626 (97.2%) received a temperature probe. Esophageal position was categorized: (A) behind left pulmonary veins, (B) left ostial, (C) in the middle of left atrium, (D) right ostial, and (E) behind right pulmonary veins. The most frequent esophageal position was B‐C (n = 201, 32.1%), followed by B (n = 161, 25.7%), and C (n = 147, 23.5%). The temperature was highest in A‐B positions (42.04°C) and in D‐E positions (41.70°C). There was a significant correlation between the endoscopically detected esophageal lesions (EDEL) and the esophageal position (r² = −.115, P = .004) and the esophageal temperature (r² = .162, P = .000), but not with body mass index (BMI) (r² = −.016, P = .688). Additional substrate modification in the left atrium resulted in significantly higher esophageal temperatures (P < .001) and more frequent EDEL (P = .049). An EDEL was found in 15 patients (2.3% of all patients, 5.6% of patients receiving endoscopy). Of those, the median esophageal temperature was 41.8°C (interquartile range [IQR]: 41.2‐42.4). Neither esophageal position nor temperature during ablation was associated with arrhythmia recurrences (both P > .400). Conclusions EDEL depended on the esophageal position and temperature, but not on BMI. Esophageal position and intraluminal temperature during ablation had no effect on recurrences.

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Section: Discussionsupporting

confidence: 85%

Relevance of esophageal position and temperature on thermal injuries and rhythm outcome in atrial fibrillation ablations

Stauber

Kornej

Bollmann

et al. 2020

Pacing Clinical Electrophis

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“…The publication by Hunter at al supported this observation, as female sex was significantly associated with AF recurrence in their analysis. This sex‐dependent lesser efficacy in women might be due to several factors, such as the incompletely understood role of hormones in AF progression or the smaller heart and vessel size of women potentially increasing the technical difficulty of the procedure only few of them focused on a sex‐specific difference between RF and CB.…”

Section: Discussionmentioning

confidence: 99%

“…This sex‐dependent lesser efficacy in women might be due to several factors, such as the incompletely understood role of hormones in AF progression or the smaller heart and vessel size of women potentially increasing the technical difficulty of the procedure only few of them focused on a sex‐specific difference between RF and CB. The study by Mörtsell et al and by Kuck et al conducted a sex‐specific analysis by device type.…”

Section: Discussionmentioning

confidence: 99%

“…Regarding safety, an increased rate of in‐hospital complications, led by vascular and bleeding complications, and a longer length of stay postablation have been shown in women as compared to men. A longer total procedural time in women has been highlighted by Zylla et al and was proposed as a surrogate of more complicated interventions and as a possible contributor to bleeding complications.…”

Section: Discussionmentioning

confidence: 99%

“…[4][5][6][7][8] Female sex has been associated with increased risk of arrhythmia recurrence, with a different profile of complications and cardiovascular rehospitalizations after catheter ablation for AF. 9,10 However, little is known about the comparative efficacy and safety of both ablation devices in female patients.…”

Section: Introductionmentioning

confidence: 99%

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Sex‐specific efficacy and safety of cryoballoon versus radiofrequency ablation for atrial fibrillation: A systematic review and meta‐analysis

Lavallaz

Clerc

Pudenz

et al. 2019

Cardiovasc electrophysiol

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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.

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Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Turagam,

Neuzil,

Schmidt

et al. 2023

JAMA Cardiol

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ImportancePrevious studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile.ObjectiveTo compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry.Design, Setting, and ParticipantsThis was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF.ExposurePFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator.Main Outcomes and MeasuresThe primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (&lt;7 days postprocedure) and chronic (&gt;7 days) major adverse events (MAEs).ResultsOf 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P &lt; .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P &lt; .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P &lt; .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19).Conclusion and RelevanceResults of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.

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Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation

Abstract: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01490814.

Cited by 85 publications

References 18 publications

Relevance of esophageal position and temperature on thermal injuries and rhythm outcome in atrial fibrillation ablations

Relevance of esophageal position and temperature on thermal injuries and rhythm outcome in atrial fibrillation ablations

Sex‐specific efficacy and safety of cryoballoon versus radiofrequency ablation for atrial fibrillation: A systematic review and meta‐analysis

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

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