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Randomized Controlled Trial
. 2024 Dec 17;150(25):2007-2018.
doi: 10.1161/CIRCULATIONAHA.124.069993. Epub 2024 Oct 7.

Ablation Strategies for Repeat Procedures in Atrial Fibrillation Recurrences Despite Durable Pulmonary Vein Isolation: The Prospective Randomized ASTRO AF Multicenter Trial

Boris Schmidt  1   2 , Stefano Bordignon  1 , Andreas Metzner  3 , Philipp Sommer  4 , Daniel Steven  5 , Tilmann Dahme  6   7 , Matthias Busch  8   9 , Roland Richard Tilz  10 , David Schaack  1 , Andreas Rillig  3 , Christian Sohns  4 , Arian Sultan  5 , Karolina Weinmann-Emhardt  6 , Astrid Hummel  8 , Julia Vogler  10 , Thomas Fink  4 , Jakob Lueker  5 , Alexander Pott  6   11 , Christian Heeger  10 , K R Julian Chun  1
Affiliations
Randomized Controlled Trial

Ablation Strategies for Repeat Procedures in Atrial Fibrillation Recurrences Despite Durable Pulmonary Vein Isolation: The Prospective Randomized ASTRO AF Multicenter Trial

Boris Schmidt et al. Circulation. .

Abstract

Background: Ablation strategies for patients with symptomatic atrial fibrillation and isolated pulmonary veins vary and their effects on arrhythmia recurrence remain unclear. A prospective randomized German multicenter trial sought to compare 2 ablation strategies in this patient cohort.

Methods: Patients with atrial fibrillation despite durable pulmonary vein isolation were randomly assigned at 7 centers to undergo low-voltage area ablation using 3-dimensional mapping and irrigated radiofrequency current ablation (group A) or empirical left atrial appendage isolation (LAAI) using the cryoballoon followed by staged interventional left atrial appendage closure (group B). The primary end point was freedom from atrial tachyarrhythmias between 91 and 365 days after index ablation. The study was powered for superiority of LAAI compared with low-voltage area.

Results: Patients (40% women; mean age, 68.8±8 years) with paroxysmal (32%) or persistent atrial fibrillation (68%) were randomized to undergo low-voltage area ablation (n=79) or cryoballoon-guided LAAI (n=82). After a planned interim analysis, enrollment was halted for futility on January 10, 2023. In the LAAI group, 77 of 82 left atrial appendages were successfully isolated with subsequent left atrial appendage closure in 57 patients. Procedure-related complications occurred in 4 (5%) and 11 (13.5%) patients in group A and B, respectively (P=0.10). The median follow-up was 367 days (interquartile range, 359-378). The Kaplan-Meier point estimate for freedom from atrial tachyarrhythmias was 51.7% (CI, 40.9%-65.4%) for group A and 55.5% (CI, 44.4%-69.2%; P=0.8069) for group B.

Conclusions: The current study did not detect superiority of cryoballoon-guided LAAI over low-voltage area ablation in patients with atrial fibrillation despite durable PVI.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04056390.

Keywords: arrhythmias, cardiac; atrial fibrillation; pulmonary veins.

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Conflict of interest statement

Dr Schmidt has received lecture honoraria from and is a member of the advisory board for Boston Scientific, Medtronic, and Biosense Webster. Dr Bordignon has received speaker fees from Boston Scientific, Medtronic, and Biosense Webster. Dr Metzner has received consultant fees and lecture honoraria from Medtronic, Biosense Webster, and Boston Scientific. Dr Sommer is an advisory board member for Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Steven has received lecture honoraria from Abbott, Biosense, and Boston Scientific and is a member of the advisory boards of Abbott, Biosense Webster, and Edwards. Dr Sohns has received lecture fees from and is a consultant for Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Chun has received lecture honoraria from and is a member of the advisory boards for Boston Scientific, Medtronic, and Biosense Webster. The other authors report no conflicts of interest.

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