Comparative Safety of Pulsed Field Ablation and Cryoballoon Ablation Technologies for Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation: A Critical Literature Review and Indirect Treatment Comparison.

INTRODUCTION: Cryoballoon ablation (CBA) is a standard catheter ablation technology with demonstrated clinical effectiveness for the treatment of paroxysmal atrial fibrillation (PAF); however, it can be associated with major adverse events, including phrenic nerve paralysis. Pulsed field ablation (PFA) is a novel, minimally thermal technology with comparable effectiveness and low safety risk. This study aimed to compare the safety profiles of PFA and CBA through critical analyses of the literature and indirect treatment comparisons. METHODS: Studies were identified by searching the MEDLINE database and the Clinicaltrials.gov registry. Registered clinical trials and/or Food and Drug Administration Investigation Device Exemption (FDA IDE) studies evaluating PFA or CBA in adult patients with drug-refractory PAF between January 2008 and March 2023 were selected. Comparative safety between PFA and CBA was assessed for major and prespecified adverse events. Indirect comparisons were conducted using the proportion of patients experiencing adverse events and confirmed with single-arm meta-analyses and sensitivity analyses. RESULTS: Data were extracted from three PFA publications including a total of 497 patients and six CBA studies including a total of 1113 patients. The analysis revealed that PFA was associated with significantly lower risk of major adverse events {risk difference - 4.3% [95% confidence interval (CI) - 5.8, - 2.8]; risk ratio 0.16 [95% CI 0.07, 0.45]} and prespecified adverse events [risk difference - 2.5% (95% CI - 4.4, - 0.5); risk ratio 0.53 (95% CI 0.31, 0.96)]. Meta-analyses confirmed the lower rate of major adverse events for PFA [0.4% (95% CI 0.0, 1.3)] vs. CBA [5.6% (95% CI 2.6, 8.6)] and prespecified adverse events for PFA [2.7% (95% CI 1.2, 4.1)] vs. CBA [5.8% (95% CI 2.7, 9.0)]. Sensitivity analyses exploring heterogeneity across studies confirmed robustness of the main analyses. CONCLUSION: The findings of this study show that PFA has a more favorable safety profile than CBA, with significantly lower risks of major and prespecified adverse events. These indirect comparisons help contextualize the safety of PFA compared to CBA for the treatment of drug-refractory PAF in the absence of head-to-head studies.

Atrial fibrillation ablation with advanced radiofrequency catheter versus second-generation cryoballoon catheter.

Aim: To compare cost and readmissions among atrial fibrillation (AF) patients undergoing ablation using the THERMOCOOL SMARTTOUCH™ SF (STSF) radiofrequency catheter versus the Arctic Front Advance™ (AFA) cryoballoon catheter. Patients & methods: The Premier Healthcare Database was used for the study purposes. Propensity score matching was used to match patients in the two groups. Costs and readmissions were assessed. A regression model was used for outcome assessment. Results: After propensity matching, 2767 patients were identified in each of the STSF and AFA cohorts. In the matched cohort, STSF patients had significantly lower supply costs than AFA patients. STSF patients had significantly lower 4-12-month AF-related inpatient readmissions compared with AFA patients (2.58% vs 3.99%; p = 0.0402). Costs of care summing index procedure and readmission costs were also lower for the STSF patients versus AFA patients. Conclusions: Patients who underwent AF ablation using the STSF catheter versus the AFA catheter had lower cost and AF-related readmissions.