Multielectrode Radiofrequency Balloon Catheter for Paroxysmal Atrial Fibrillation: Results From the Global, Multicenter, STELLAR Study

Sandeep K Goyal; Carlo Pappone; Massimo Grimaldi; Sung W Lee; Stavros Mountantonakis; J Brian DeVille; Venkata S Sagi; Chen-Yang Jiang; Haseeb Jafri; Alan P Wimmer; Li-Qun Wu; Srinivas Dukkipati; Haroon Rashid; Hugh Calkins; Moussa Mansour; Javier Roman-Gonzalez; Andrea Natale; Giuseppe Ciconte; Arash Aryana; STELLAR investigators

doi:10.1111/jce.16524

Multielectrode Radiofrequency Balloon Catheter for Paroxysmal Atrial Fibrillation: Results From the Global, Multicenter, STELLAR Study

J Cardiovasc Electrophysiol. 2024 Dec 16. doi: 10.1111/jce.16524. Online ahead of print.

Authors

Sandeep K Goyal¹, Carlo Pappone^{2

3}, Massimo Grimaldi⁴, Sung W Lee⁵, Stavros Mountantonakis⁶, J Brian DeVille⁷, Venkata S Sagi⁸, Chen-Yang Jiang⁹, Haseeb Jafri¹⁰, Alan P Wimmer^{11

12}, Li-Qun Wu¹³, Srinivas Dukkipati¹⁴, Haroon Rashid¹⁵, Hugh Calkins¹⁶, Moussa Mansour¹⁷, Javier Roman-Gonzalez¹⁸, Andrea Natale^{19

20

21

22}, Giuseppe Ciconte^{2

3}, Arash Aryana²³; STELLAR investigators

Affiliations

¹ Division of Cardiac Electrophysiology, Piedmont Heart Institute, Atlanta, Georgia, USA.
² Department of Arrhythmology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
³ Department of Arrhythmology, Vita-Salute San Raffaele University, Milan, Italy.
⁴ Department of Cardiology, General Regional Hospital F. Miulli, Bari, Italy.
⁵ Division of Cardiology, MedStar Southern Maryland Hospital Center, Clinton, Maryland, USA.
⁶ Department of Cardiac Electrophysiology, Northwell Health-Lenox Hill Hospital, New York City, New York, USA.
⁷ Division of Cardiology, The Heart Hospital Baylor, Plano, Texas, USA.
⁸ Baptist Heart Specialists, Baptist Medical Center, Jacksonville, Florida, USA.
⁹ Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
¹⁰ Kettering Physician Network Cardiac Electrophysiology, Kettering, Ohio, USA.
¹¹ Division of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.
¹² Division of Cardiology, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USA.
¹³ Department of Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
¹⁴ Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
¹⁵ Virginia Heart, Heart Rhythm Center, Falls Church, Virginia, USA.
¹⁶ Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹⁷ Cardiac Arrhythmia Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
¹⁸ South Texas Cardiovascular Consultants, Texan Medical Center, San Antonio, Texas, USA.
¹⁹ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.
²⁰ Division of Cardiology, Department of Biomedicine and Prevention, University of Tor Vergata, Rome, Italy.
²¹ Metro Health Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
²² Interventional Electrophysiology, Scripps Clinic, San Diego, California, USA.
²³ Mercy General Hospital and Dignity Health Heart and Vascular Institute, Sacramento, California, USA.

PMID: 39686569
DOI: 10.1111/jce.16524

Abstract

Introduction: The safety and efficacy of paroxysmal atrial fibrillation (PAF) ablation with the HELIOSTAR multielectrode radiofrequency (RF) balloon catheter have been demonstrated in European studies; data from elsewhere are lacking. This prospective, multicenter study conducted in the United States, Italy, and China investigated the safety and efficacy of pulmonary vein isolation (PVI) using HELIOSTAR in drug-refractory symptomatic PAF.

Methods: The primary effectiveness endpoint (PEE) was 12-month freedom from documented atrial fibrillation/atrial flutter/atrial tachycardia plus freedom from acute procedural failure, nonstudy catheter failure, repeat ablation failure, direct current cardioversion (DCCV), and Class I/III antiarrhythmic drug (AAD) failure. The primary safety endpoint was the occurrence of early-onset primary adverse events (PAEs). Cerebral magnetic resonance imaging (MRI) and cardiac computed tomography were performed in a patient subset to assess silent cerebral lesions (SCLs) and severe pulmonary vein (PV) stenosis, respectively.

Results: Across 36 centers, 257 eligible subjects in the main phase had the study catheter inserted. Acute PVI was achieved in all subjects, with the majority (94.1%) using the balloon catheter only. In 67.7% and 92.2% of subjects, respectively, PEE and freedom from repeat ablation were met; clinical success rate was 77.7%. The PAE rate was 5.1%. One of 15 (6.7%) subjects with MRI showed a new SCL at 1 month postablation, which resolved at 3 months. Clinically meaningful improvements in Atrial Fibrillation Effect on QualiTy-of-life scores were seen at 3 months and were sustained to 12 months postablation, and accompanied with reduction of Class I/III AAD use and DCCV.

Conclusion: STELLAR confirmed the safety and efficacy of the HELIOSTAR catheter for PVI, with clinically meaningful improvements in quality of life in patients with drug-refractory symptomatic PAF. Most PVIs were achieved without focal touch-up, and > 90% of patients were free from repeat ablation at 12 months.

Trial registration: ClinicalTrials.gov Identifier: NCT03683030.

Keywords: drug‐refractory; paroxysmal atrial fibrillation; radiofrequency balloon catheter.

Associated data

ClinicalTrials.gov/NCT03683030

Grants and funding

This study was sponsored by Biosense Webster, Inc. part of Johnson & Johnson MedTech.