Treatment of Atrial Fibrillation Using Ablation Index-Guided Contact Force Ablation: A Matching-Adjusted Indirect Comparison to Cryoballoon Ablation

被引:3
|
作者
Hussein, Ahmed [1 ]
Gupta, Dhiraj [2 ]
De Potter, Tom [3 ]
Spin, Paul [4 ]
Eaton, Kiefer [5 ]
Goldstein, Laura [6 ]
Velleca, Maria [7 ]
Costa, Graca [8 ]
Grima, Daniel [5 ]
Patel, Leena [5 ]
Stabile, Giuseppe [9 ]
机构
[1] St Louis Univ, St Louis, MO 63103 USA
[2] Liverpool Heart & Chest Hosp, Liverpool, Merseyside, England
[3] Onze Lieve Vrouw Hosp, Cardiovasc Ctr, Aalst, Belgium
[4] Cornerstone Res Grp Inc, Sydney, NS, Canada
[5] Cornerstone Res Grp Inc, Burlington, ON, Canada
[6] Biosense Webster Inc, Irvine, CA 92618 USA
[7] Johnson & Johnson Med SpA, Pomezia, Italy
[8] Johnson & Johnson Med NV, Diegem, Belgium
[9] Casa Cura San Michele, Clin Montevergine Mercogliano AV, Maddaloni, CE, Italy
关键词
Ablation Index; Atrial fibrillation; Catheter ablation; Contact force; Matching-adjusted indirect comparison; Radiofrequency ablation; VISITAG SURPOINT (TM) Module; PULMONARY VEIN ISOLATION; RADIOFREQUENCY ABLATION; TRIAL; POINT; 1ST;
D O I
10.1007/s12325-019-01173-4
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Introduction Ablation Index, also known as VISITAG SURPOINT (TM), is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF). Methods Individual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted. Results Primary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions. Conclusions Radiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.
引用
收藏
页码:785 / 799
页数:15
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