TY - JOUR
T1 - Very High-Power Short-Duration, Temperature-Controlled Radiofrequency Ablation in Paroxysmal Atrial Fibrillation
T2 - The Prospective Multicenter Q-FFICIENCY Trial
AU - Q-FFICIENCY Trial Investigators
AU - Osorio, Jose
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
N1 - Funding Information:
The authors thank all Q-FFICIENCY study personnel and patients for their valuable participation in this trial, as well as the following individuals for their efforts in trial execution, statistical analysis, and input during the development of this article: Robert Stagg, Reecha Sharma, Kendra McInnis, Tiffany Tan, Melissa Mert, Chris Sierra, Louise Lee, Bita Najimipour, Swati Trivedi, Zhong Wang, Lee Ming Boo, and Lycely Sepulveda-Torres. Michelle Hughes, PhD, with Lumanity Communications Inc, provided medical writing and editorial support, which were funded by Biosense Webster, Inc, under direction of the authors.
Publisher Copyright:
© 2022 The Authors
PY - 2023/4
Y1 - 2023/4
N2 - BACKGROUND: QDOT MICRO (QDM) is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency (RF) ablation. The very high-power short-duration (vHPSD) algorithm modulates power, maintaining target temperature during 90 W ablations for ≤4 seconds.OBJECTIVES: This study aims to evaluate safety and 12-month effectiveness of the QDM catheter in paroxysmal atrial fibrillation (AF) ablation using the vHPSD mode combined with conventional-power temperature-controlled (CPTC) mode.METHODS: In this prospective, multicenter, nonrandomized study, patients with drug-refractory, symptomatic paroxysmal AF underwent pulmonary vein (PV) isolation with QDM catheter with vHPSD as primary ablation mode, with optional use of the CPTC mode (25 to 50 W) for PV touch-up or non-PV ablation. The primary safety endpoint was incidence of primary adverse events within ≤7 days of ablation. The primary effectiveness endpoint was freedom from documented atrial tachyarrhythmia recurrence and acute procedural, repeat ablation, and antiarrhythmic drug failure.RESULTS: Of 191 enrolled participants, 166 had the catheter inserted, received RF ablation, and met eligibility criteria. Median procedural, RF application for ablating PVs, and fluoroscopy times were 132.0, 8.0, and 9.1 minutes, respectively. The primary adverse event rate was 3.6%. Imaging conducted in a subset of participants (n = 40) at 3 months did not show moderate or severe PV stenosis. The Kaplan-Meier estimated 12-month rate for primary effectiveness success was 76.7%; freedom from atrial tachyarrhythmia recurrence was 82.1%; clinical success (freedom from symptomatic recurrence) was 86.0%; and freedom from repeat ablation was 92.1%.CONCLUSIONS: Temperature-controlled paroxysmal AF ablation with the novel QDM catheter in vHPSD mode (90 W, ≤4 seconds), alone or with CPTC mode (25 to 50 W), is highly efficient and effective without compromising safety. (Evaluation of QDOT MICRO Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation [Q-FFICIENCY]; NCT03775512).
AB - BACKGROUND: QDOT MICRO (QDM) is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency (RF) ablation. The very high-power short-duration (vHPSD) algorithm modulates power, maintaining target temperature during 90 W ablations for ≤4 seconds.OBJECTIVES: This study aims to evaluate safety and 12-month effectiveness of the QDM catheter in paroxysmal atrial fibrillation (AF) ablation using the vHPSD mode combined with conventional-power temperature-controlled (CPTC) mode.METHODS: In this prospective, multicenter, nonrandomized study, patients with drug-refractory, symptomatic paroxysmal AF underwent pulmonary vein (PV) isolation with QDM catheter with vHPSD as primary ablation mode, with optional use of the CPTC mode (25 to 50 W) for PV touch-up or non-PV ablation. The primary safety endpoint was incidence of primary adverse events within ≤7 days of ablation. The primary effectiveness endpoint was freedom from documented atrial tachyarrhythmia recurrence and acute procedural, repeat ablation, and antiarrhythmic drug failure.RESULTS: Of 191 enrolled participants, 166 had the catheter inserted, received RF ablation, and met eligibility criteria. Median procedural, RF application for ablating PVs, and fluoroscopy times were 132.0, 8.0, and 9.1 minutes, respectively. The primary adverse event rate was 3.6%. Imaging conducted in a subset of participants (n = 40) at 3 months did not show moderate or severe PV stenosis. The Kaplan-Meier estimated 12-month rate for primary effectiveness success was 76.7%; freedom from atrial tachyarrhythmia recurrence was 82.1%; clinical success (freedom from symptomatic recurrence) was 86.0%; and freedom from repeat ablation was 92.1%.CONCLUSIONS: Temperature-controlled paroxysmal AF ablation with the novel QDM catheter in vHPSD mode (90 W, ≤4 seconds), alone or with CPTC mode (25 to 50 W), is highly efficient and effective without compromising safety. (Evaluation of QDOT MICRO Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation [Q-FFICIENCY]; NCT03775512).
KW - Q-FFICIENCY
KW - QDOT MICRO catheter
KW - contact-force sensing
KW - temperature-controlled ablation
KW - very high-power short-duration
KW - Temperature
KW - Prospective Studies
KW - Radiofrequency Ablation
KW - Humans
KW - Catheter Ablation/methods
KW - Treatment Outcome
KW - Atrial Fibrillation
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U2 - 10.1016/j.jacep.2022.10.019
DO - 10.1016/j.jacep.2022.10.019
M3 - Article
C2 - 36752484
AN - SCOPUS:85152529020
SN - 2405-500X
VL - 9
SP - 468
EP - 480
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 4
ER -