Abstract 18323: Complication Rates of Ventricular Tachycardia Ablation: Comparison of Safety Outcomes From Real World to Contemporary Clinical Studies
Introduction: The availability, national scope and perceived unbiased nature of administrative claims data makes it an attractive choice by health care policy makers for evaluating quality and outcomes. We calculated Ventricular tachycardia (VT) ablation complication rates from national administrative data and compared them with data from randomized trials and prospective studies.
Methods: A PUBMED database search was done to identify existing studies of VT ablation. Studies were divided into clinical (randomized controlled trials (RCTs) and prospective studies). Pooled rates of vascular, cardiac, neurological complications and procedure related mortality were computed and compared to reported complication rates from administrative database studies
Results: We identified two administrative database studies of VT ablation that included a total of 14,352 procedures and 18 clinical studies with a total of 1,705 procedure. Overall complication rate in administrative studies was higher than in clinical studies (9.39% vs. 7.97%). Rates of cardiac/pericardial (4.47% vs. 2.29%) and vascular access complications (6.9% vs. 3.0%) were higher in real world studies. Neurological complications (1.17% vs. 0.45%) and procedure related mortality (1.53% vs. 1.29%) were higher in clinical studies. Among clinical studies, RCTs had the lowest reported complication rate.
Conclusion: Despite substantial improvement, “real-world” complication rates from administrative data remain higher than those reported in RCTs. The discrepancy may be attributable to differences in operator skills, selection bias and variation in data quality. Use of large databases provides an important analytical resource as we embark on improving national health care efficacy and safety in the current challenging environment.
Author Disclosures: N.K. Pothineni: None. A. Deshmukh: None. D. Padmanabhan: None. S. Kovelamudi: None. S. Mulpuru: None. P.A. Noseworthy: None. H. Paydak: None.
- © 2015 by American Heart Association, Inc.