POST-ABLATION EARLY SYMPTOMATIC RECURRENCE PREDICTS LATE SYMPTOMATIC RECURRENCE OF ATRIAL FIBRILLATION (AFIB)- FINDINGS FROM A LARGE STUDY IN REAL-WORLD SETTINGS
Author(s)
Zhang S1, Kalsekar I1, Lin G1, Yadalam S1, Boo L2, Ghaly N3, Khanna R1
1Johnson & Johnson Co., New Brunswick, NJ, USA, 2Biosense Webster Inc. Part of the Johnson & Johnson Family of Companies, Irvine, CA, USA, 3Biosense Webster, Inc. Part of the Johnson & Johnson Family of Companies, Diamond Bar, CA, USA
OBJECTIVES: The development of innovative cardiac ablation technologies for AFib resolution is rapidly evolving. Clinical research using ≥12-month follow-up for AFib recurrence may result in delay release of useful clinical data that could be critical during early adoption of novel technologies. This study examined the relationship between early and late symptomatic recurrence to understand if early data may be a useful surrogate for the 12-month outcome. METHODS: A retrospective cohort study was conducted in patients undergoing an ablation procedure for AFib during 2011-2016 from the IBM MarketScan® Commercial Database. We calculated Spearman's rank correlation coefficients, sensitivity, and negative predictive value (NPV) comparing symptomatic recurrence (a composite of AFib-related readmission, cardioversion and repeat ablation) during the first 6 or 9 months to the entire 12 months. Kaplan-Meier analysis with log-rank tests and Cox models (multivariable hazard ratios [HRs]; 95% confidence intervals [CIs]) were used to evaluate the association between early and late symptomatic recurrence. RESULTS: This study included 14,239 patients (median age=57 years; male=74%). The number of cumulative symptomatic recurrence during the first 6 (ρ=0.86, P<0.001, ρ2=0.74) or 9 months (ρ=0.95, P<0.001, ρ2=0.90) was strongly correlated with 12 months’ recurrence. The sensitivity comparing the first 6 and 9 months to the 12 months was 79% and 91%, respectively, and NPV was 92% and 97%, respectively. Freedom from late symptomatic recurrence was significantly higher among patients free from symptomatic recurrence during the first 3 months than those with recurrence (86.6% vs 70.5% at 12 months, P<0.001). Freedom from symptomatic recurrence during the first 3 months was strongly associated with decreased risk of developing late symptomatic recurrence during the 4-6 (HR=0.36; 95%CI=0.32-0.40), 4-9 (HR=0.41; 95%CI=0.37-0.45), and 4-12 months (HR=0.42; 95%CI=0.39-0.46). CONCLUSIONS: There was a strong relationship between early and late symptomatic recurrence. Early data may be a useful surrogate for the 12-month outcome.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PCV6
Topic
Clinical Outcomes, Epidemiology & Public Health, Medical Technologies
Topic Subcategory
Medical Devices, Relating Intermediate to Long-term Outcomes
Disease
Cardiovascular Disorders