Abstract 17570: Clinical Predictors of Arrhythmia Recurrence Following Cryoballoon Ablation of Paroxysmal AF in the STOP-AF Post Approval Study
Introduction: This analysis evaluates clinical predictors of arrhythmia recurrence in patients with drug-refractory recurrent symptomatic paroxysmal AF who have undergone ablation using the second generation cryoballoon (CB2).
Methods: The STOP-AF Post Approval Study is a prospective, multi-center, non-randomized, single-arm, unblinded condition of approval study designed to provide long-term efficacy and safety data for cryoballoon ablation for drug-refractory recurrent symptomatic paroxysmal AF. Three hundred and forty five (345) patients (66.4% male) were treated with CB2. At baseline, medical histories, previous AAD use, and arrhythmic-related symptoms were collected. Additionally, all subjects underwent a 12-lead ECG, TTE, and CT/MRI. Clinical follow-up visits occur at 3, 6, and 12 months, and annually thereafter through 60 months. All subjects are scheduled for a 12-lead ECG at each visit, 24-hour Holter at the 6-month visit, 48-hour Holter at each annual visit, and event recorder as needed to assess for AF/AFL/AT recurrence. Documented AF lasting > 30 seconds and symptomatic AFL/AT outside of the 90-day blanking period are considered recurrences. Univariate analyses utilizing Cox Regression were used to identify clinical predictors of recurrence.
Results: At 12 months post ablation, 79.4% of subjects were free from arrhythmia recurrence (mean follow-up 588 ± 241 days). Age was a predictor of AF recurrence (HR= 1.03; 95% CI 1.01, 1.06; p = 0.01). Univariate predictors of AF/AFL/AT recurrence were age (mean: 60.2 ± 10.4 years, HR= 1.04; 95% CI 1.01, 1.06; p < 0.01), CHADS2 score (mean: 0.8 ± 0.8; HR= 1.31; 95% CI 1.02, 1.67; p = 0.03), CAD (n=33 [9.6%] HR= 2.06; 95% CI 1.16, 3.65; p = 0.01), and hypertension (n=162 [47.0%]; HR= 1.60; 95% CI 1.04, 2.45; p = 0.03). BMI, diabetes, dyslipidemia, gender, years of AF, LAD, and number of failed AADs were not significantly associated with arrhythmia recurrence.
Conclusions: Older paroxysmal AF patients, higher baseline CHADS2 score, history of CAD and hypertension were associated with an increased risk of AF/AFL/AT. Older paroxysmal AF patients demonstrated a greater rate of AF recurrence after ablation with CB2. These data may help identify the most suitable candidates for cryoballoon ablation.
Author Disclosures: B.P. Knight: Research Grant; Modest; Medtronic. Speakers Bureau; Modest; Medtronic. Consultant/Advisory Board; Modest; Medtronic. P.G. Novak: Speakers Bureau; Modest; Medtronic. R. Sangrigoli: Speakers Bureau; Modest; Medtronic. Consultant/Advisory Board; Modest; Medtronic. V. Essebag: Consultant/Advisory Board; Modest; Medtronic. J. Champagne: None. M. Dubuc: Research Grant; Modest; Medtronic. Speakers Bureau; Modest; Medtronic. Consultant/Advisory Board; Modest; Medtronic. S.K. Jain: Research Grant; Modest; Medtronic. J. Svinarich: Consultant/Advisory Board; Modest; Medtronic. R.M. John: Consultant/Advisory Board; Modest; Medtronic. M. Mansour: None.
- © 2016 by American Heart Association, Inc.