Dataset Information

Effectiveness of Radiofrequency Catheter Ablation Using Ablation Index Versus Second Generation Cryoballoon in the Treatment of Persistent Atrial Fibrillation: A Matching-Adjusted Indirect Comparison.

ABSTRACT:

Introduction

Both radiofrequency (RF) and cryoballoon (CB) ablation are treatment options for persistent atrial fibrillation (PsAF). An important recent innovation in RF ablation is Ablation Index (AI), known also as the VISITAG SURPOINT™ Module, a composite lesion quality marker whose use has been shown to significantly reduce the incidence of acute and late pulmonary vein (PV) reconnection and the recurrence of atrial arrhythmias in PsAF. Due to a lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option in PsAF. The objective of the present study was to conduct a matching-adjusted indirect treatment comparison (MAIC) using individual patient-level data (IPD) to assess the comparative effectiveness of the THERMOCOOL SMARTTOUCH™ Catheter or the THERMOCOOL SMARTTOUCH™ SF Catheter with AI/VISITAG SURPOINT™ Module (STAI) versus the second-generation CB catheter (Arctic Front Advance™; herein referred to as CB) with respect to 12-month atrial arrhythmia recurrence, fluoroscopy time, and procedural efficiency.

Methods

IPD for STAI were obtained from four investigator-initiated studies and were pooled. Comparable CB studies identified from a systematic literature review were also pooled. In the absence of a common treatment arm between STAI and CB studies, an unanchored MAIC was conducted. The primary analysis compared the pooled STAI IPD to the pooled CB cohort, with corrections for differences across trials, including eligibility criteria and patient baseline characteristics. Scenario and sensitivity analyses were conducted to assess the robustness of the primary analysis.

Results

In the primary analysis, which was adjusted for left atrial diameter (LAD), age, diabetes, and sex, STAI was associated with a statistically significant 65% relative reduction in the rate of arrhythmia recurrence compared to CB at 12-month follow-up (HR 0.35; 95% CI 0.23, 0.52). STAI was associated with shorter total fluoroscopy time than CB but longer procedure time. Results were consistent across scenario and sensitivity analyses.

Conclusion

Radiofrequency ablation with AI significantly reduced atrial arrhythmia recurrence at 12-month follow-up and fluoroscopy time compared to CB, with longer procedure times.

SUBMITTER: Hussein A

PROVIDER: S-EPMC8342373 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionAblation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF).MethodsIndividual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted.ResultsPrimary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions.ConclusionsRadiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.