Long-Term Changes in Atrial Arrhythmia Burden After Renal Denervation Combined With Pulmonary Vein Isolation: SYMPLICITY-AF

Larry Chinitz; Michael Böhm; Rudolph Evonich 3rd; Samir Saba; Robert Sangriogoli; Ralph Augostini; P Gearoid O'Neill; Christopher Fellows; Min-Young Kim; Douglas A Hettrick; Elena Viktorova; Christian Ukena

doi:10.1016/j.jacep.2024.04.035

Long-Term Changes in Atrial Arrhythmia Burden After Renal Denervation Combined With Pulmonary Vein Isolation: SYMPLICITY-AF

JACC Clin Electrophysiol. 2024 Jun 13:S2405-500X(24)00383-9. doi: 10.1016/j.jacep.2024.04.035. Online ahead of print.

Authors

Affiliations

¹ New York University Langone Medical Center, New York, New York, USA. Electronic address: larry.chinitz@nyulangone.org.
² Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany.
³ Bellin Health, Green Bay, Wisconsin, USA.
⁴ University of Pittsburgh Heart and Vascular Institute, Pittsburgh, Pennsylvania, USA.
⁵ Doylestown Health, Doylestown, Pennsylvania, USA.
⁶ The Ohio State University Wexner, Medical Center, Columbus, Ohio, USA.
⁷ Mercy Medical Group, Sacramento, California, USA.
⁸ Virginia Mason Medical Center, Seattle, Washington, USA.
⁹ Medtronic, Santa Rosa, California, USA.
¹⁰ Universitätsklinikum des Saarlandes, Saarland University, Homburg, Germany; Marien Hospital Herne, Ruhr University Bochum, Herne, Germany.

PMID: 38934973
DOI: 10.1016/j.jacep.2024.04.035

Abstract

Background: The autonomic nervous system plays an important role in atrial fibrillation (AF) and hypertension. Renal denervation (RDN) lowers blood pressure (BP), but its role in AF is poorly understood.

Objectives: The purpose of this study was to investigate whether RDN reduces AF recurrence after pulmonary vein isolation (PVI).

Methods: This study randomized patients from 8 centers (United States, Germany) with drug-refractory AF for treatment with PVI+RDN vs PVI alone. A multielectrode radiofrequency Spyral catheter system was used for RDN. Insertable cardiac monitors were used for continuous rhythm monitoring. The primary efficacy endpoint was ≥2 minutes of AF recurrence or repeat ablation during all follow-up. The secondary endpoints included atrial arrhythmia (AA) burden, discontinuation of class I/III antiarrhythmic drugs, and BP changes from baseline.

Results: A total of 70 patients with AF (52 paroxysmal, 18 persistent) and uncontrolled hypertension were randomized (RDN+PVI, n = 34; PVI, n = 36). At 3.5 years, 26.2% and 21.4% of patients in RDN+PVI and PVI groups, respectively, were free from the primary efficacy endpoint (log rank P = 0.73). Patients with mean ≥1 h/d AA had less daily AA burden after RDN+PVI vs PVI (4.1 hours vs 9.2 hours; P = 0.016). More patients discontinued class I/III antiarrhythmic drugs after RDN+PVI vs PVI (45% vs 14%; P = 0.040). At 1 year, systolic BP changed by -17.8 ± 12.8 mm Hg and -13.7 ± 18.8 mm Hg after RDN+PVI and PVI, respectively (P = 0.43). The composite safety endpoint was not significantly different between groups.

Conclusions: In patients with AF and uncontrolled BP, RDN+PVI did not prevent AF recurrence more than PVI alone. However, RDN+PVI may reduce AF burden and antiarrhythmic drug usage, but this needs further prospective validation.

Keywords: atrial fibrillation; atrial fibrillation burden; autonomic modulation; catheter ablation; renal denervation.