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Outcomes of cavotricuspid isthmus-dependent flutter ablation: randomized study comparing single vs. multiple catheter procedures—the SIMPLE study

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Abstract

Background

Catheter ablation is recommended as first-line therapy for patients with symptomatic typical AFl. Although the conventional multi-catheter approach is the standard of care for cavotricuspid isthmus (CTI) ablation, a single-catheter approach was recently described as a feasible alternative. The present study sought to compare safety, efficacy, and efficiency of single vs. multi-catheter approach for atrial flutter (AFl) ablation.

Methods

In this randomized multi-center study, consecutive patients referred for AFl ablation (n = 253) were enrolled and randomized to multiple vs. single-catheter approach for CTI ablation. In the single-catheter arm, PR interval (PRI) on the surface ECG was used to prove CTI block. Procedural and follow-up data were collected and compared between the two arms.

Results

128 and 125 patients were assigned to the single-catheter and to the multi-catheter arms, respectively. In the single-catheter arm, procedure time was significantly shorter (37 ± 25 vs. 48 ± 27 minutes, p = 0.002) and required less fluoroscopy time (430 ± 461 vs. 712 ± 628 seconds, p < 0.001) and less radiofrequency time (428 ± 316 vs. 643 ± 519 seconds, p < 0.001), achieving a higher first-pass CTI block rate (55 (45%) vs. 37 (31%), p = 0.044), compared with the multi-catheter arm. After a median follow-up of 12 months, 11 (4%) patients experienced AFl recurrences (5 (4%) in the single-catheter arm and 6 (5%) in the multi-catheter arm, p = 0.99). No differences were found in arrhythmia-free survival between arms (log-rank = 0.71).

Conclusions

The single-catheter approach for typical AFl ablation is not inferior to the conventional multiple-catheter approach, reducing procedure, fluoroscopy, and radiofrequency time.

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Data availability

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

Abbreviations

AV:

Atrioventricular

AF:

Atrial flutter

CTI:

Cavotricuspid isthmus

CS:

Coronary sinus

ECG:

Electrocardiogram

PRI:

PR interval

RF:

Radiofrequency

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Correspondence to Antonio Berruezo.

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Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by Ethics Committee of each center.

Conflict of interest

A. Berruezo is a stockholder of Galgo Medical. D. Soto-Iglesias is an employee of Biosense Webster. A. Berruezo received speaker fees from Biosense and research grants from Biotronik. P. Francia received speaker fees and research and educational grants from Boston Scientific and Abbott. The other authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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Penela, D., Chauca, A., Fernández-Armenta, J. et al. Outcomes of cavotricuspid isthmus-dependent flutter ablation: randomized study comparing single vs. multiple catheter procedures—the SIMPLE study. J Interv Card Electrophysiol 66, 1979–1988 (2023). https://doi.org/10.1007/s10840-023-01511-1

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