TY - JOUR
T1 - Paroxysmal atrial fibrillation ablation with a novel temperature-controlled CF-sensing catheter
T2 - Q-FFICIENCY clinical and healthcare utilization benefits
AU - Hussein, Ayman A.
AU - Delaughter, M. Craig
AU - Monir, George
AU - Natale, Andrea
AU - Dukkipati, Srinivas
AU - Oza, Saumil
AU - Daoud, Emile
AU - Di Biase, Luigi
AU - Mansour, Moussa
AU - Fishel, Robert
AU - Valderrabano, Miguel
AU - Ellenbogen, Kenneth
AU - Osorio, Jose
N1 - Funding Information:
We thank the following individuals for their efforts in trial execution, statistical analysis, and input during the development of this article: Melissa Mert, Gu Xiaoxue, Bita Najimipour, Josiah Gillespie, Sonia Maccioni, Lee Ming Boo, and Lycely Sepulveda-Torres. Michelle Hughes, PhD, of Lumanity Communications Inc. (Yardley, PA) provided medical writing and editorial support, in accordance with Good Publication Practice guidelines, which were funded by Biosense Webster, Inc. (Irvine, CA), under direction of the authors. This study was supported by Biosense Webster, Inc.
Funding Information:
We thank the following individuals for their efforts in trial execution, statistical analysis, and input during the development of this article: Melissa Mert, Gu Xiaoxue, Bita Najimipour, Josiah Gillespie, Sonia Maccioni, Lee Ming Boo, and Lycely Sepulveda‐Torres. Michelle Hughes, PhD, of Lumanity Communications Inc. (Yardley, PA) provided medical writing and editorial support, in accordance with Good Publication Practice guidelines, which were funded by Biosense Webster, Inc. (Irvine, CA), under direction of the authors. This study was supported by Biosense Webster, Inc.
Publisher Copyright:
© 2023 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.
PY - 2023/12
Y1 - 2023/12
N2 - Introduction: The prospective, nonrandomized, multicenter Q-FFICIENCY study demonstrated the safety and 12-month efficacy of paroxysmal atrial fibrillation (AF) ablation with the novel QDOT MICRO temperature-controlled, contact force-sensing, radiofrequency (RF) catheter. Participants underwent pulmonary vein isolation with very high-power short-duration (vHPSD) mode (90 W, ≤4 s) alone or combined with conventional-power temperature-controlled (CPTC) mode (25–50 W). This study aimed to assess quality-of-life (QOL) and healthcare utilization (HCU) benefits experienced by Q-FFICIENCY study participants. Methods: Besides evaluating procedural efficiency, QOL and HCU were assessed through 12 months postablation via Atrial Fibrillation Effect on Quality-of-Life Tool (AFEQT) score, antiarrhythmic drug (AAD) use, and incidence of cardioversion and cardiovascular hospitalization. Results: Of 191 participants enrolled, 166 were ablated with the new catheter. Compared to baseline, statistically significant, clinically meaningful improvements in composite and subcategories of AFEQT scores were observed at 3 months and sustained through 12 months (12-month increase, 29.3–44.2 points). Class I/III AAD use decreased from 97.6% (162/166) at baseline to 19.6% (31/158) during Months 6–12, representing a significant 79.9% reduction. The cardioversion rate significantly declined by 93.9% from 31.3% (12 months preablation) to 1.9% (evaluation period). One-year Kaplan–Meier estimates of freedom from all-cause and cardiovascular hospitalization were 80.9% (95% confidence interval [CI], 74.8%–86.9%) and 88.8% (95% CI, 84.0%–93.7%), respectively. Conclusions: Paroxysmal AF ablation with the novel temperature-controlled RF catheter in vHPSD mode, alone or with CPTC mode, led to clinically meaningful improvement in QOL and significant reduction in AAD use, cardioversion, and cardiovascular hospitalization.
AB - Introduction: The prospective, nonrandomized, multicenter Q-FFICIENCY study demonstrated the safety and 12-month efficacy of paroxysmal atrial fibrillation (AF) ablation with the novel QDOT MICRO temperature-controlled, contact force-sensing, radiofrequency (RF) catheter. Participants underwent pulmonary vein isolation with very high-power short-duration (vHPSD) mode (90 W, ≤4 s) alone or combined with conventional-power temperature-controlled (CPTC) mode (25–50 W). This study aimed to assess quality-of-life (QOL) and healthcare utilization (HCU) benefits experienced by Q-FFICIENCY study participants. Methods: Besides evaluating procedural efficiency, QOL and HCU were assessed through 12 months postablation via Atrial Fibrillation Effect on Quality-of-Life Tool (AFEQT) score, antiarrhythmic drug (AAD) use, and incidence of cardioversion and cardiovascular hospitalization. Results: Of 191 participants enrolled, 166 were ablated with the new catheter. Compared to baseline, statistically significant, clinically meaningful improvements in composite and subcategories of AFEQT scores were observed at 3 months and sustained through 12 months (12-month increase, 29.3–44.2 points). Class I/III AAD use decreased from 97.6% (162/166) at baseline to 19.6% (31/158) during Months 6–12, representing a significant 79.9% reduction. The cardioversion rate significantly declined by 93.9% from 31.3% (12 months preablation) to 1.9% (evaluation period). One-year Kaplan–Meier estimates of freedom from all-cause and cardiovascular hospitalization were 80.9% (95% confidence interval [CI], 74.8%–86.9%) and 88.8% (95% CI, 84.0%–93.7%), respectively. Conclusions: Paroxysmal AF ablation with the novel temperature-controlled RF catheter in vHPSD mode, alone or with CPTC mode, led to clinically meaningful improvement in QOL and significant reduction in AAD use, cardioversion, and cardiovascular hospitalization.
KW - QDOT MICRO
KW - QMODE+
KW - healthcare utilization
KW - quality of life
KW - temperature-controlled ablation
KW - very high-power short-duration
KW - Temperature
KW - Prospective Studies
KW - Humans
KW - Treatment Outcome
KW - Catheters
KW - Catheter Ablation/adverse effects
KW - Anti-Arrhythmia Agents/therapeutic use
KW - Patient Acceptance of Health Care
KW - Quality of Life
KW - Pulmonary Veins/surgery
KW - Atrial Fibrillation/diagnosis
UR - http://www.scopus.com/inward/record.url?scp=85174574759&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85174574759&partnerID=8YFLogxK
U2 - 10.1111/jce.16093
DO - 10.1111/jce.16093
M3 - Article
C2 - 37870157
AN - SCOPUS:85174574759
SN - 1045-3873
VL - 34
SP - 2493
EP - 2503
JO - Journal of Cardiovascular Electrophysiology
JF - Journal of Cardiovascular Electrophysiology
IS - 12
ER -