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

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. Fortyfour 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.