Contact force catheter ablation for the treatment of persistent atrial fibrillation: Results from the PERSIST-END study

Monica Lo, Devi Nair, Moussa Mansour, Hugh Calkins, Vivek Y. Reddy, B. Judson Colley, Christine Tanaka-Esposito, Sri Sundaram, David B. DeLurgio, Prashanthan Sanders, Sammy Khatib, Michael Bernard, Nicholas Olson, Douglas Gibson, Amber Miller, Jingyun Li, Andrea Natale

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Use of a novel magnetic sensor enabled optical contact force ablation catheter has been established to be safe and effective for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF) but has yet to be demonstrated in the persistent AF (PersAF) population. Methods: PERSIST-END was a multicenter, prospective, nonrandomized, investigational study designed to demonstrate the safety and effectiveness of TactiCath™ Ablation Catheter, Sensor Enabled™(SE) (TactiCath SE) for use in the treatment of subjects with documented PersAF refractory or intolerant to at least one Class I/III AAD. The ablation strategy included pulmonary vein isolation and additional targets at physician discretion. Follow-up through 15-months, including a 3-month blanking period and 3-month therapy consolidation period, was performed with cardiac event and Holter monitoring. Primary safety, primary effectiveness, clinical success, and quality of life (QOL) endpoints were analyzed. Results: Of 224 subjects enrolled at 21 investigational sites in the United States and Australia, 223 underwent ablation with the investigational catheter. The primary safety event rate was 3.1% (seven events in seven subjects). The Kaplan–Meier estimate of freedom from AF/atrial flutter/atrial tachycardia recurrence at 15-months was 61.6% and clinical success at 15 months was 89.8%. Subject QOL significantly improved following ablation as assessed via AFEQT (31.6 point increase, p <.0001) and EQ-5D-5L (10.7 point increase, p <.0001) and was met with a 53% reduction in all cause cardiovascular healthcare utilization. Conclusion: The sensor-enabled force-sensing catheter is safe and effective for the treatment of drug refractory recurrent symptomatic PersAF, reducing arrhythmia recurrence while improving QOL and healthcare utilization.

Original languageEnglish (US)
Pages (from-to)279-290
Number of pages12
JournalJournal of cardiovascular electrophysiology
Volume34
Issue number2
DOIs
StatePublished - Feb 2023

Keywords

  • atrial fibrillation
  • catheter ablation
  • clinical trial
  • persistent atrial fibrillation
  • quality of life

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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