TY - JOUR
T1 - Contact force catheter ablation for the treatment of persistent atrial fibrillation
T2 - Results from the PERSIST-END study
AU - Lo, Monica
AU - Nair, Devi
AU - Mansour, Moussa
AU - Calkins, Hugh
AU - Reddy, Vivek Y.
AU - Colley, B. Judson
AU - Tanaka-Esposito, Christine
AU - Sundaram, Sri
AU - DeLurgio, David B.
AU - Sanders, Prashanthan
AU - Khatib, Sammy
AU - Bernard, Michael
AU - Olson, Nicholas
AU - Gibson, Douglas
AU - Miller, Amber
AU - Li, Jingyun
AU - Natale, Andrea
N1 - Publisher Copyright:
© 2022 Wiley Periodicals LLC.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
KW - atrial fibrillation
KW - catheter ablation
KW - clinical trial
KW - persistent atrial fibrillation
KW - quality of life
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U2 - 10.1111/jce.15742
DO - 10.1111/jce.15742
M3 - Article
C2 - 36352771
AN - SCOPUS:85142346664
SN - 1045-3873
VL - 34
SP - 279
EP - 290
JO - Journal of cardiovascular electrophysiology
JF - Journal of cardiovascular electrophysiology
IS - 2
ER -