Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results

Abstract

Aims Pulsed field ablation (PFA) has emerged as a promising alternative to thermal ablation for treatment of atrial fibrillation (AF). We report performance and safety using the CENTAURI™ System (Galvanize Therapeutics) with three commercial, focal ablation catheters. Methods and results ECLIPSE AF (NCT04523545) was a prospective, single-arm, multi-centre study evaluating safety and acute and chronic pulmonary vein isolation (PVI) durability using the CENTAURI System in conjunction with the TactiCath SE, StablePoint, and ThermoCool ST ablation catheters. Patients with paroxysmal or persistent AF were treated at two centres. Patients were analysed in five cohorts based upon ablation settings, catheter, and mapping system. Pulsed field ablation was performed in 82 patients (74% male, 42 paroxysmal AF). Pulmonary vein isolation was achieved in 100% of pulmonary veins (322/322) with first-pass isolation in 92.2% (297/322). There were four serious adverse events of interest (three vascular access complications and one lacunar stroke). Eighty patients (98%) underwent invasive remapping. Pulsed field ablation development Cohorts 1 and 2 showed a per-patient isolation rate of 38% and 26% and a per-PV isolation rate of 47% and 53%, respectively. Optimized PFA Cohorts 3–5 showed a per-patient isolation rate of 60%, 73%, and 81% and a per-PV isolation rate of 84%, 90%, and 92%, respectively. Conclusion ECLIPSE AF demonstrated that optimized PFA using the CENTAURI System with three commercial, contact force-sensing, solid-tip focal ablation catheters resulted in transmural lesion formation and high proportion of durable PVI with a favourable safety profile, thus providing a viable treatment option for AF that integrates with contemporary focal ablation workflows.

Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results

“…An acute procedural success rate of 100% was achieved with high first-pass isolation (96.8%), with a PAE rate consistent with other ablation technologies and previous STSF studies (4.4%). 20–22 Noteworthy is the absence of oesophageal lesions with systematic endoscopy evaluation confirming tissue selectivity of PFA from pre-clinical data. In addition, good PVI durability was demonstrated, with 86% of PVs remaining isolated at scheduled remapping.…”

“…In the recent ECLIPSE AF study involving 82 patients with paroxysmal or persistent AF in Europe, delivery of optimized PFA with CF-sensing solid-tip focal ablation catheters achieved first-pass isolation in 92.2% of PVs. 20 A study investigated a focal ablation catheter able to toggle between RF and PF energy in the treatment of 178 patients with paroxysmal or persistent AF and demonstrated first-pass isolation in 95% of PV pairs. 23 First-pass isolation reported with the STSF RF catheter and index-guided workflow ranges between 73% and 83%.…”

“…The PAE rate of 4.4% is consistent with past studies of initial experience of novel technologies. 2 , 3 , 20 , 24 Although PF energy has a promising safety profile for collateral tissue, risk of AEs related to procedure and catheter manipulation are not uncommon. 9 , 25 Accurate display of the catheter location and ablation parameters on a 3D navigation system can be beneficial to further minimize procedure-related AEs.…”

Catheter–tissue contact optimizes pulsed electric field ablation with a large area focal catheter

“…Monopolar PEF energy is delivered asynchronously using a proprietary biphasic waveform (25 A, 1.6 ms) that minimizes microbubble formation and muscle contraction. 10 The system measures LI between each spline and a central ring electrode. LI information is displayed using a graphical representation of the catheter tip where color and bar length changes represent increasing impedance on each spline (Figure 1D).…”

Predicting Lesion Durability With PFA: One Step Closer

“…Indeed, clinical reports demonstrated frequent pulmonary vein reconnections at relook procedures despite near universal acute isolation at the initial procedure. [8][9][10][11][12][13][14] See Article by Amorós-Figueras et al…”