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 - 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
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 -