Very High-Power Short-Duration, Temperature-Controlled Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: The Prospective Multicenter Q-FFICIENCY Trial

Abstract

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.).

Keywords: Q-FFICIENCY; QDOT MICRO catheter; contact-force sensing; temperature-controlled ablation; very high-power short-duration.

Conflict of interest statement

Funding Support and Author Disclosures This study was supported by Biosense Webster, Inc. Dr Osorio has received grants from Biosense Webster, Inc, and Abbott; has received consulting fees from Biosense Webster, Inc, Boston Scientific, and Medtronic; and has received payments or honoraria for lectures/presentations/speakers’ bureaus from Biosense Webster, Inc, and Boston Scientific. Dr Hussein has received steering committee funding from Biosense Webster, Inc. Dr Delaughter has received consulting fees and advisory board payments from Biosense Webster, Inc. Dr Natale has received consulting fees from Abbott, Baylis, Biosense Webster, Inc, Boston Scientific, Biotronik, and Medtronic. Dr Dukkipati has received grants from Biosense Webster, Inc. Dr Oza has received consulting fees from Biosense Webster, Inc and Atricure. Dr Daoud has received consulting fees from Biosense Webster, Inc, Medtronic, and S4 Medical; has received payments or honoraria for lectures/presentations/speakers’ bureaus from ABIM, Western AF, and JACC: Clinical Electrophysiology; has patents planned, issued, or pending; has a leadership role in S4 Medical; and has stock/stock options from S4 Medical. Dr Di Biase has received consulting fees from Biosense Webster, Inc, Stereoataxis, and Rhythm Management; and has received speaker honoraria/travel from Biosense Webster, Inc, St Jude Medical (now Abbott), Boston Scientific, Medtronic, Biotronik, Atricure, Baylis, and Zoll. Dr Mansour has received grants from Biosense Webster, Inc, and Boston Scientific; has received consulting fees from Biosense Webster, Inc, Boston Scientific, Philips, and Medtronic; has received support for attending meetings/travel from Biosense Webster, Inc, and Boston Scientific; and has stock/stock options from New Pace Limited and EPD Solutions. Dr Valderrabano has received consulting fees from Baylis and Circa; and has received payments or honoraria for lectures/presentations/speakers’ bureaus from Biosense Webster, Inc. Dr Ellenbogen has received grants, consulting fees, and payment for lectures and advisory board from Biosense Webster, Inc, and has leadership positions at the American College of Cardiology and Heart Rhythm Society. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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