Long-Term Success of Irrigated Radiofrequency Catheter Ablation of Sustained Ventricular Tachycardia: Post-Approval THERMOCOOL VT Trial

J Am Coll Cardiol. 2016 Feb 16;67(6):674-683. doi: 10.1016/j.jacc.2015.11.041.

Abstract

Background: Radiofrequency catheter ablation is used to treat recurrent ventricular tachycardia (VT).

Objectives: This study evaluated long-term safety and effectiveness of radiofrequency catheter ablation using an open-irrigated catheter.

Methods: Patients with sustained monomorphic ventricular tachycardia associated with coronary disease were analyzed for cardiovascular-specific adverse events within 7 days of treatment, hospitalization duration, 6-month sustained monomorphic ventricular tachycardia recurrence, quality of life measured by the Hospital Anxiety and Depression Scale, long-term (1-, 2-, and 3-year) survival, symptomatic VT control, and amiodarone use.

Results: Overall, 249 patients, mean age 67.4 years, were enrolled. The cardiovascular-specific adverse events rate was 3.9% (9 of 233) with no strokes. Noninducibility of targeted VT was achieved in 75.9% of patients. Post-ablation median hospitalization was 2 days. At 6 months, 62.0% (114 of 184) of patients had no sustained monomorphic ventricular tachycardia recurrence; the proportion of patients with implantable cardioverter-defibrillator shocks decreased from 81.2% to 26.8% (p < 0.0001); the frequency of VT in implantable cardioverter-defibrillator patients with recurrences was reduced by ≥50% in 63.8% of patients; and the proportion with normal Hospital Anxiety and Depression Scale scores increased from 48.8% to 69.1% (p < 0.001). Patient-reported VT remained steady for 1, 2, and 3 years at 22.7%, 29.8%, and 24.1%, respectively. Amiodarone use and hospitalization decreased from 55% and 77.2% pre-ablation to 23.3% and 30.7%, 18.5% and 36.7%, 17.7% and 31.3% at 1, 2, and 3 years, respectively.

Conclusions: Radiofrequency catheter ablation reduced implantable cardioverter-defibrillator shocks and VT episodes and improved quality of life at 6 months. A steady 3-year nonrecurrence rate with reduced amiodarone use and hospitalizations indicate improved long-term outcomes. (NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia [THERMOCOOL VT]; NCT00412607).

Keywords: ThermoCool; catheter ablation; quality of life; radiofrequency; safety; ventricular tachycardia.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Catheter Ablation / instrumentation
  • Catheter Ablation / methods*
  • Device Approval
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Heart Rate / physiology*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Recurrence
  • Retrospective Studies
  • Tachycardia, Ventricular / physiopathology
  • Tachycardia, Ventricular / surgery*
  • Therapeutic Irrigation / methods
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00412607