Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial

Wilber W Su; Vivek Y Reddy; Kabir Bhasin; Jean Champagne; Robert M Sangrigoli; Kendra M Braegelmann; Fred J Kueffer; Paul Novak; Sanjaya K Gupta; Teiichi Yamane; Hugh Calkins; STOP Persistent AF Investigators

doi:10.1016/j.hrthm.2020.06.020

Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial

Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24.

Authors

Affiliations

¹ Banner University Medical Center Phoenix, Phoenix, Arizona.
² Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York.
³ Northwell Health-Lenox Hill Heart and Lung, New York, New York.
⁴ Institut Universitaire de Cardiologie et du Pneumologie de Quebec, Quebec, Canada.
⁵ Doylestown Cardiology Associates, Doylestown, Pennsylvania.
⁶ Medtronic, Inc., Minneapolis, Minnesota.
⁷ Royal Jubilee Hospital, Victoria, Canada.
⁸ Saint Luke's Health System, Kansas City, Missouri.
⁹ Jikei University School of Medicine, Tokyo, Japan.
¹⁰ Johns Hopkins Medical Institutions, Baltimore, Maryland. Electronic address: hcalkins@jhmi.edu.

PMID: 32590151
DOI: 10.1016/j.hrthm.2020.06.020

Abstract

Background: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF).

Objective: The purpose of this study was to assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF.

Methods: STOP Persistent AF (ClinicalTrials.gov Identifier: NCT03012841) was a prospective, multicenter, single-arm, Food and Drug Administration-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes <6 months). The primary efficacy endpoint was 12-month freedom from ≥30 seconds of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at >40% and <13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life) and SF (Short Form)-12 questionnaires.

Results: Of 186 total enrollments, 165 subjects (70% male; age 65 ± 9 years; left atrial diameter 4.2 ± 0.6 cm; body mass index 31 ± 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 ± 46 minutes, 102 ± 41 minutes, and 19 ± 16 minutes, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% confidence [CI] 46.7%-62.1%) freedom from AF, AFL, or AT. There was 1 primary safety event, translating to a rate of 0.6% (95% CI 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months postablation (P <.001).

Conclusion: The STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes <6 months.

Keywords: Cryoballoon ablation; Persistent atrial fibrillation; Pulmonary vein isolation; Quality of life; Repeat ablation.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Ablation Techniques / methods*
Aged
Atrial Fibrillation / physiopathology
Atrial Fibrillation / surgery*
Cryosurgery / methods*
Female
Follow-Up Studies
Heart Atria / physiopathology
Humans
Male
Prospective Studies
Pulmonary Veins / surgery*
Quality of Life*
Recurrence
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03012841