Safety and effectiveness of near-zero fluoroscopy paroxysmal AF radiofrequency ablation with a temperature-controlled, contact force-sensing catheter: a Q-FFICIENCY study sub-analysis

Abstract

Abstract Background/Introduction Q-FFICIENCY evaluated 12-month (M) safety and efficacy of temperature-controlled paroxysmal atrial fibrillation ablation with a novel contact force-sensing, radiofrequency catheter with 3 microelectrodes and 6 thermocouples. Patients underwent pulmonary vein isolation with very high-power short-duration (vHPSD; 90 W/ up to 4 s) mode in combination with conventional-power temperature-controlled (CPTC; 25–50 W) mode. Purpose To assess procedural efficiency, safety, and 12M outcomes of participants ablated under near-zero fluoroscopy guidance compared to procedures performed with standard fluoroscopy. Methods In this US multi-centre (22 sites), non-randomised investigational study, patients underwent pulmonary vein isolation with vHPSD as primary ablation mode; CPTC was used for PV touch-up or non-PV ablation. Primary safety endpoint was incidence of primary adverse events ≤7 days post-procedure. Primary effectiveness was freedom from documented atrial tachyarrhythmia recurrence and additional pre-defined failure modes (acute failure, repeat ablation, new/higher dose anti-arrhythmic drug). Participants were followed-up through 12M post-ablation (3M blanking & 9M evaluation) to assess safety, effectiveness, and healthcare utilisation. Results Of 191 participants enrolled (63.5±10.7 years, CHA2DS2-VASc 2.4±1.5, 60.7% men), 166 were ablated with the investigational catheter, and 165 had fluoroscopy data available for inclusion in this analysis. Forty-four participants received ≤1 minute of fluoroscopy. Compared to the >1-minute of fluoroscopy cohort, the ≤1-minute group showed improved efficiencies in all procedural parameters (Table). Primary adverse event rates were similar among groups (≤1-minute, 4.5%; >1-minute, 3.3%). Kaplan-Meier estimated 12M clinical success rates (i.e., freedom from documented symptomatic recurrence) were similar regardless of fluoroscopy exposure (≤1-minute, 85.4%; >1-minute, 86.0%). Freedom from cardiovascular hospitalisation 12M post-ablation was comparable among groups (90.8% vs 88.0%). Conclusion Near-zero fluoroscopy paroxysmal atrial fibrillation ablation with the novel temperature-controlled catheter in vHPSD mode, alone or combined with CPTC, led to enhanced procedural efficiencies with good effectiveness and clinical success without comprising safety. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Biosense Webster, Inc.