Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience.

BACKGROUND: Pulsed field ablation has recently emerged as an interesting non-thermal energy for atrial fibrillation ablation. At a time of rapid spread of this technology, there is still a lack of prospective real-life data. AIM: To describe multicentre prospective safety and 1-year efficacy data in three of the first French centres to use pulsed field ablation. METHODS: All consecutive patients undergoing a first pulsed field ablation were included prospectively. The primary outcome was freedom from documented atrial arrhythmia. The safety endpoint was a composite of major adverse events. Univariate and multivariable analyses, including patient and procedural characteristics, were performed to identify factors predictive of recurrence. RESULTS: Between May 2021 and June 2022, 311 patients were included (paroxysmal atrial fibrillation in 53%, persistent atrial fibrillation in 35% and long-standing persistent atrial fibrillation in 11%). Additional non-pulmonary vein pulsed field ablation applications were performed in 104/311 patients. One-year freedom from arrhythmia recurrence was 77.6% in the overall population and was significantly higher in patients with paroxysmal atrial fibrillation (88.4%) compared with patients with persistent atrial fibrillation (69.7%; P<0.001) and those with long-standing persistent atrial fibrillation (49.0%; P<0.001). The major complication rate was 2.6% (tamponade in four patients, stroke in two patients and coronary spasm in one patient). Besides the usual predictors of recurrences (left atrium size, CHA2DS2-VASc score, type of atrial fibrillation), the presence of atrial fibrillation at procedure start was independently associated with arrhythmia recurrence (hazard ratio: 2.04, 95% confidence interval: 1.10-3.77). CONCLUSION: In this prospective multicentre real-world study, pulsed field ablation for atrial fibrillation ablation seems to be associated with a good safety profile and rather favourable acute and 1-year success rates.

Pentaspline Pulsed Field Ablation Catheter Versus Cryoballoon for Atrial Fibrillation Ablation: Results From a Prospective Comparative Study.

BACKGROUND: Cryoballoon ablation is currently the gold standard technique for single-shot pulmonary vein isolation (PVI). Pulsed field ablation (PFA) has recently emerged as an interesting nonthermal alternative energy for PVI. The purpose of our study was to evaluate the safety and long-term efficacy of PVI using the pentaspline PFA catheter in comparison to cryoballoon ablation. METHODS AND RESULTS: Between January 2021 and December 2022, we included all consecutive patients of our center in whom a first PVI-only procedure was performed using PFA or cryoballoon. The choice of the energy was based on patients' preference between general anesthesia (PFA) and local anesthesia (cryoballoon). The primary end point was freedom from documented atrial arrhythmia recurrence after a 3-month blanking period. A total of 301 patients (paroxysmal atrial fibrillation in 220 patients) underwent a first PVI procedure performed using PFA (n=151) or cryoballoon (n=150). Complete short-term PVI was obtained in 144 of 150 patients (96%) in the cryoballoon group and in all patients of the PFA group (P=0.01). Procedure duration was significantly longer in the cryoballoon group. Transient and persistent phrenic nerve injuries were observed in the cryoballoon group only (13/150 and 2/150, respectively). One-year freedom from atrial arrhythmia was significantly higher in the PFA group compared with the cryoballoon group (87.9% versus 77.7%; adjusted hazard ratio, 0.53 [95% CI, 0.30-0.96]; P=0.037). CONCLUSIONS: This prospective, comparative, real-life study suggested that PFA could overcome safety limitations of cryoballoon with optimal effectiveness. Randomized controlled studies are required to further investigate the potential superiority of PFA over cryoballoon.

Is excessive ventricular irregularity predictive of rehospitalization in patients with permanent AF and HFpEF?

AIMS: There are currently limited therapeutic approaches for patients with heart failure with preserved ejection fraction (HFpEF) who have developed permanent atrial fibrillation (AF). We aimed to analyse the impact of ventricular irregularity on heart failure rehospitalization in patients with permanent AF and HFpEF. METHODS AND RESULTS: All 24 h ambulatory Holter monitoring performed in our centre within a month after a first heart failure hospitalization were screened. Patients with HFpEF and permanent AF were included in the retrospective analysis. The following parameters of ventricular irregularity were calculated over the 24 h recording period: standard deviation of all RR intervals (SDNN), coefficient of variation of SDNN (CV-SDNN = SDNN/mean RR), root of the mean squared differences of successive RR intervals (RMSSD), and percentage of consecutive RR intervals with difference over 50 ms (pNN50). The primary endpoint was rehospitalization for acute heart failure (HFrH). From 2010 to 2021, 51/216 screened patients were included. During a median follow-up of 3.13 years, 29/51 patients reached the primary endpoint. HFrH patients had higher SDNN (205 ± 65 vs. 154 ± 46 ms; P < 0.01), CV-SDNN (26 ± 8% vs. 19 ± 5%, P < 0.01), RMSSD (182 ± 47 vs. 138 ± 65 ms, P = 0.013), and pNN50 (76 ± 9 vs. 58 ± 26, P < 0.001) when compared with patients with no HFrH. In multivariate analysis, all those parameters remained significantly associated with HFrH. CONCLUSIONS: In this pilot study, we found some evidences for a deleterious impact of excessive ventricular irregularity on HFrH in AF patients with HFpEF. Those new findings could pave the way for new prognosis and therapeutic approaches in this patients' population.