Junctional AV ablation in patients with atrial fibrillation undergoing cardiac resynchronization therapy (JAVA-CRT): results of a multicenter randomized clinical trial pilot program

Abstract

Introduction: Cardiac resynchronization therapy (CRT) improves outcomes in sinus rhythm, but the data in atrial fibrillation (AF) is limited. Atrio-ventricular junctional ablation (AVJA) has been proposed as a remedy. The objective was to test if AVJA results in LV end-systolic volume (ESV) reduction ≥ 15% from baseline to 6 months.

Methods: The trial was a prospective multicenter randomized trial in 26 patients with permanent AF who were randomized 1:1 to CRT-D with or without AVJA.

Results: LVESV improved similarly by at least 15% in 5/10 (50%) in the CRT-D-only arm and in 6/12 (50%) in the AVJA + CRT-D arm (OR = 1.00 [0.14, 7.21], p = 1.00). In the CRT-D-only arm, the median 6-month improvement in LVEF was 9.2%, not different from the AVJA + CRT-D arm, 8.2%. When both groups were combined, a significant increase in LVEF was observed (25.4% at baseline vs 36.2% at 6 months, p = 0.002). NYHA class from baseline to 6 months for all patients combined improved 1 class in 15 of 24 (62.5%), whereas 9 remained in the same class and 0 degraded to a worse class.

Conclusion: In patients with permanent AF, reduced LVEF, and broad QRS who were eligible for CRT, there was insufficient evidence that AVJA improved echocardiographic or clinical outcomes; the results should be interpreted in light of a smaller than planned sample size. CRT, however, seemed to be effective in the combined study cohort overall, suggesting that CRT can be reasonably deployed in patients with AF.

Trial registration: ClinicalTrials.gov Identifier: NCT02946853.

Keywords: AV junctional ablation; Atrial fibrillation; Biventricular pacing; Cardiac resynchronization therapy; Cardiomyopathy; Heart failure.

Conflict of interest statement

JSS (research support from NHLBI, AliveCor, Atricure, Allergan; consulting with Medtronic, Corfigo, Hillrom, Braveheart, National Cardiac, Cardioelectra; equity with AliveCor, Braveheart, National Cardiac); JG (research support from EBR Systems, V-Wave Ltd, AADi Pharmaceuticals); SKJ (research support from Medtronic, Boston Scientific and Abbott); WZ (research support from Boston Scientific, Biotronik, LivaNova; consulting with Medtronic, Abbott). The remaining authors have indicated that they have no relevant conflicts to report.

© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Figures

Fig. 1

Individual changes in left ventricular ejection fraction (LVEF) between baseline and 6 months (black are CRT-D only and red are CRT-D with AVJA)

Fig. 2

Left ventricular ejection fraction (LVEF) at baseline and at 6 months, in all patients combined (with and without AVJA)

Fig. 3

Changes in New York Heart Association (NYHA) class over 6 months, by randomization arm (CRT-D only vs CRT-D and AVJA)

Fig. 4

Changes in NYHA class over 6 months in both arms combined