There are no sex differences in the effectiveness and safety of pulsed field ablation (PFA), a novel modality that uses short, high-energy electrical pulses to treat atrial fibrillation (AF), results of a large registry study show.
The study included all 1568 patients (mean age 64.5 years and 35.3% women) in the MANIFEST-PF registry, which includes 24 European centers that began using PFA for treating AF after regulatory approval in 2021.
Researchers categorized patients by sex and evaluated them for clinical outcomes of PFA, including freedom from AF and adverse events.
All patients underwent pulmonary vein isolation (Farawave, Boston Scientific) and were followed up at 3, 6, and 12 months.
The primary effectiveness outcome was freedom from atrial arrhythmia outside the 90-day blanking period lasting 30 seconds or longer.
The primary safety outcome included the composite of acute (less than 7 days post-procedure) and chronic (more than 7 days post-procedure) major adverse events, including atrioesophageal fistula, symptomatic pulmonary vein stenosis, cardiac tamponade/perforation requiring intervention or surgery, stroke or systemic thromboembolism, persistent phrenic nerve injury, vascular access complications requiring surgery, coronary artery spasm, and death.
There was no significant difference in 12-month recurrence of atrial arrhythmia between male and female patients (79.0% vs 76.3%; P = .28), with greater overall effectiveness in the paroxysmal AF cohort (men, 82.5% vs women, 80.2%; P = .30) than in the persistent AF/long-standing persistent AF cohort (men, 73.3% vs women, 67.3%; P = .40).
Repeated ablation rates were similar between sexes (men, 8.3% vs women, 10.0%; P = .32).
Among patients who underwent repeat ablation, pulmonary vein isolation durability was higher in female than in male patients (per vein, 82.6% vs 68.1%; P = .15 and per patient, 63.0% vs 37.8%; P = .005).
Major adverse events occurred in 2.5% of women and 1.5% of men (P = .19), with such events mostly consisting of cardiac tamponade (women, 1.4% vs men, 1.0%; P = .46) and stroke (0.4% vs 0.4%, P > .99), and with no atrioesophageal fistulas or symptomatic pulmonary valve stenosis in either group.
“These results are important, as women are underrepresented in prior ablation studies and the results have been mixed with regards to both safety and effectiveness using conventional ablation strategies such as radiofrequency or cryoablation,” lead author Mohit Turagam, MD, associate professor of medicine (cardiology), Icahn School of Medicine at Mount Sinai, New York, NY, said in a press release.
In an accompanying commentary, Peter M. Kistler, MBBS, PhD, Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia, and a colleague said that the study authors should be congratulated “for presenting much-needed data on sex-specific outcomes in catheter ablation,” which “reassuringly” suggest that success and safety for AF ablation are comparable between the sexes, although the study does have “important limitations.”
The study was conducted by Turagam and colleagues. It was published online on November 1, 2023 in JAMA Cardiology.
Researchers can’t rule out the possibility that treatment selection and unmeasured confounders between sexes affected the validity of the study findings. The median number of follow-up 24-hour Holter monitors used for AF monitoring was only two, which may have resulted in inaccurate estimates of AF recurrence rates and treatment effectiveness.
The study was supported by Boston Scientific Corporation, the PFA device manufacturer. Turagam has no relevant conflicts of interest; see paper for disclosures of other study authors. The commentary authors have no relevant conflicts of interest.
Source link : https://www.medscape.com/viewarticle/998189?src=rss
Publish date : 2023-11-07 22:55:43
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