Observational studyBMC cardiovascular disorders2025
Does cryoballoon ablation affect the symptom severity of atrial fibrillation? Insights from 12-months continuous cardiac monitoring.
Observational study in BMC cardiovascular disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03587181 (Investigation of Substrates Associated With the Recurrence of Atrial Fibrillation After PV Cryoablation), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Investigation of Substrates Associated With the Recurrence of Atrial Fibrillation After PV Cryoablation
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Authors and funding
8 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundMost data on asymptomatic atrial fibrillation (AF) recurrence following catheter ablation primarily derive from studies on radiofrequency ablation (RFA). Our previous study with a small sample size revealed no significant difference in AF freedom rates detected via patient history, ECG, Holter monitoring, and continuous cardiac monitoring in the cryoballoon ablation (CBA) group. This study aims to evaluate alterations in AF symptoms following pulmonary vein (PV) CBA using implantable loop recorders (ILR) and patient-reported data.
methodsA total of 145 patients with highly symptomatic AF (EHRA score ≥ 2b) were consecutively enrolled and underwent primary PV CBA with simultaneous ILR implantation. Follow-up visits occurred at 3-, 6-, and 12-months post-ablation. Data were collected from patients' symptom logs, ILR readings, and clinical events at each visit. Clinical efficacy was defined as the absence of AF recurrence based on patients' symptom logs, while absolute efficacy was defined as the absence of AF detected by ILR. ILR detection served as the reference standard, and detection via patient symptom log was considered the test method.
resultsThe absolute efficacy was 57,2% (n = 83). All cases of AF relapse were also reported by patients in their symptom logs. Agreement between patient-reported data and ILR data was substantial, with a κ statistic value of 0.98. The agreement between patient-reported data and ILR data showed a κ statistic value of 0.98.
conclusionsCBA using second-generation cryoballoon does not significantly alter AF symptom perception in highly symptomatic patients. Cardiac rhythm in these patients might be effectively monitored through symptom logs, ECGs, or Holter monitoring.
trial registrationClinicalTrials.gov NCT03587181, SubstrateAF study, first posted date July 16, 2018.
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