Alexandre Ouss

Background: With the introduction of pulsed field ablation (PFA) to treat atrial fibrillation (AF), there is interest in studying workflow and sedation strategies to optimize integration into clinical practice. This sub-analysis characterizes early real-world use of general anesthesia versus deep sedation during AF ablation using the pentaspline PFA catheter. Methods: EU-PORIA is an all-comer AF registry enrolling consecutive patients at seven high-volume centers in Europe. Patients were treated based on institutional standard-of-care. During follow-up, any episode of atrial tachycardia (AT) or AF >30s was considered an arrhythmia recurrence. Results: EU-PORIA enrolled 1233 patients, of which 250 (20%) and 983 (80%) cases were performed using general anesthesia and deep sedation, respectively. Patients treated with general anesthesia were more often male and non-paroxysmal AF. In the general anesthesia group, 72% received pulmonary vein isolation (PVI)-only versus 90% in the deep sedation group (p<0.01), and 3D mapping was used in 60% of general anesthesia and 27% of deep sedation cases (p<0.01). Procedure and fluoroscopy times were shorter with deep sedation (51[36-84] vs 75[60-90] min; 13[8-19] vs 19[15-26] min; p<0.01). There were no differences in the incidence of serious adverse events. At 1-year follow-up, 74.8% and 73.8% of patients in the general anesthesia and deep sedation groups, respectively, were free from recurrent AF/AT (p=0.87). Conclusion: AF ablation using deep sedation with the pentaspline PFA catheter demonstrated a safety and efficacy profile consistent with procedures performed under general anesthesia. This characterization of real-world use warrants further evaluation to understand optimal sedation strategies with PFA technologies.

Aims: Clinical studies with protocol-mandated workflow and monitoring have analysed performance of pulsed field ablation (PFA) for treating atrial fibrillation (AF). The FARADISE registry captures global use of the pentaspline PFA catheter in real-world clinical practice with a follow-up of 3 years. Methods and results: FARADISE is a prospective, non-randomized, multi-national registry (NCT05501873) that enrolled subjects clinically indicated for ablation using the pentaspline PFA catheter per medical judgement and hospital standard-of-care. Procedural characteristics, safety, and clinical effectiveness up to 12-months were collected. In total, 1158 AF patients received PFA across 48 centres in 21 countries (64 ± 11 years, 33% female, 90% de novo, 65% paroxysmal AF). Pulmonary vein isolation (PVI)-only procedures were performed in 80.8% of paroxysmal vs. 57.5% for non-paroxysmal patients (P < 0.01). Median procedure, left atrial dwell, and fluoroscopy times were 51[40–70], 31[24–41], and 12[8–17] min, respectively. The rate of early onset serious adverse events was 1.5% and did not differ by ablation strategy or AF indication. At 1-year, clinical effectiveness was 80.8% for paroxysmal AF and 67.7% for non-paroxysmal AF, with no difference within indication by lesion set (paroxysmal: 81.2% PVI-only vs. 79.0% PVI+, P = 0.65; non-paroxysmal: 67.5% PVI-only vs. 67.7% PVI+, P = 0.79). Acute results reinforce a short procedural learning curve with no difference in 1-year effectiveness by operator experience. Conclusion: The FARADISE registry provides a snapshot of real-world clinical use of the pentaspline PFA catheter. Acute results demonstrate favourable procedural and safety outcomes regardless of AF indication. One-year outcomes are encouraging, with no differences seen within indication based on ablation strategy.

Background: Real‐life data on efficacy and safety of pulsed‐field ablation (PFA) using the pentaspline multi‐electrode catheter in symptomatic atrial fibrillation (AF) patients is still scarce. Objective: This study aims to assess the efficacy and safety of PFA in patients with persistent AF. Methods: Data from early commercial use across seven European centers were collected in a registry. To confirm the efficacy and safety of extra pulmonary vein (PV) ablation, patients were categorized into two groups: those undergoing pulmonary vein isolation (PVI) alone and those receiving additional ablation. Procedural and follow‐up data were collected. Results: The study included 448 patients (347 PVI only, 101 PVI + α ). In the PVI + α group, extra PV ablation included left atrial posterior wall isolation (87%), mitral isthmus ablation (37%), and cavo‐tricuspid isthmus ablation (3%). At 1‐year follow‐up, the PVI only group showed significantly fewer atrial tachyarrhythmia recurrences compared to PVI + α group (69% vs. 56%, p = 0.013). While AF recurrence did not significantly differ (25% vs. 28%, p = 0.713), PVI + α group had a significantly higher atrial tachycardia recurrence (8% vs. 22%, p < 0.001). Major complications occurred in 2.0% versus 1.0% (PVI only vs. PVI + α ), including pericardial tamponade (6 vs. 0; p = 0.345) and stroke (1 vs. 1; p = 0.400). Conclusions: PVI plus extra PV ablation using a pentaspline PFA catheter is associated with a higher incidence of atrial tachycardia recurrences. For persistent AF, a simpler approach of performing only PVI may be more effective.

Aims: The optimal substrate ablation approach for post-myocardial infarction (MI) ventricular tachycardia (VT) is unknown. Proposed ablation targets are prone to individual interpretation making the ablation outcome potentially operator dependent. Evoked delayed potentials (EDPs) are a well-defined target. Evoked delayed potential ablation was effective in preventing post-MI VT recurrence in a prior study. The aims of this study were to assess long-term outcomes of EDP ablation in a large multicentre cohort of post-MI patients and to compare ablation outcomes between centres with and without prior experience in EDP ablation. Methods and results: Patients with post-MI VT undergoing ablation in one centre performing EDP ablation since 2013 and five centres without prior experience in EDP ablation were prospectively included. A uniform mapping protocol including right ventricular extra-stimulation aiming to EDP identification was followed. Ablation endpoints were EDP elimination and VT non-inducibility. Patients were followed for VT recurrence, mortality, heart transplant, and left ventricular assist device implantation. In total, 130 patients were included. The protocol was successfully performed in 99%, and in 94%, EDPs were identified and ablated. In total, 78% of patients were rendered non-inducible. Ventricular tachycardia-free survival was 78% [95% confidence interval (CI) 71–85] and 71% (95% CI 63–80) at 6 and 12 months, respectively. No difference in VT-free survival was observed among centres with and without prior experience in EPD ablation. Conclusion: In a large multicentre prospective cohort of patients with post-MI VT, EDP ablation resulted in good long-term outcomes. Importantly, VT recurrence rates did not differ among centres with and without prior experience in EDP ablation, indicating that this approach can be easily reproduced by operators previously not familiar with the technique.

Aims: Initial clinical studies of pulsed field ablation (PFA) to treat atrial fibrillation (AF) indicated a >90% durability rate of pulmonary vein isolation (PVI). However, these studies were largely conducted in single centres and involved a limited number of operators. We aimed to describe the electrophysiological findings and outcomes in patients undergoing repeat ablation after an initial PF ablation for AF. Methods and results: In the MANIFEST-REDO study, we investigated patients who underwent repeat ablation due to clinical recurrence—AF or atrial tachycardia (AT)—following first-ever PVI with a pentaspline PFA catheter (Farawave, Boston Scientific Inc.). At 22 centres, 427 patients (age 64 ± 11 years; 37% female) were included. Of note, the recurrent arrhythmia leading to the repeat ablation was paroxysmal AF (51%), persistent AF (30%), or AT (19%). At the repeat procedure, the PV reconnection rates were 30% (left superior pulmonary vein), 28% (left inferior pulmonary vein), 33% (right superior pulmonary vein), and 32% (right inferior pulmonary vein). In 45% of patients, all PVs were durably isolated at the beginning of the repeat procedure, with the previous use of any imaging or mapping modality being univariately associated with durable PVI. After a post-redo follow-up period of 284 (90–366) days, the primary effectiveness endpoint (freedom from documented AF/AT lasting ≥30 s after 3-month blanking without class I/III antiarrhythmic drugs or symptoms) was achieved in 65% of patients, with significant differences between groups (PAF 65% vs. PersAF 56% vs. AT 76%; P = 0.04). Persistent AF as recurrent arrhythmia after the initial PFA ablation predicted AT/AF recurrence after repeat ablation [hazard ratio 1.241 (95% confidence interval 1.534–1.005); P = 0.045]. The procedural complication rate was 2.8%. Conclusion: In repeat procedures for AF/AT performed after an index procedure with PFA for AF, PV reconnections are not uncommon. Repeat procedures can be performed safely and with an acceptable subsequent success rate.

BACKGROUND: Recent studies have demonstrated the benefit of early ablation in preventing the progression of atrial fibrillation (AF). Clinical practice has reflected this shift in AF management and no longer requires patients to fail antiarrhythmic drugs (AADs) before receiving ablation. However, there is limited evidence on outcomes with pulsed field ablation (PFA) as a first-line therapy. Examination of real-world data may shed light on clinical practices and the effectiveness of PFA with and without a prior history of AAD usage. METHODS: European Real World Outcomes with Pulsed Field Ablation is an all-comer AF registry enrolling consecutive patients treated with the pentaspline PFA catheter at 7 high-volume centers in Europe. This subanalysis evaluates patients with a history of class I/III AAD use versus those with no documented history of class I/III AAD use (first-line patients). Patients with incomplete AAD history, long-standing persistent AF, and those undergoing a repeat ablation procedure were excluded. Patients were treated and followed based on institutional standard of care. Any episode of atrial tachycardia or AF lasting longer than 30 s was considered an arrhythmia recurrence. RESULTS: Of 1233 patients enrolled in European real world outcomes with pulsed field ablation, 1091 met the inclusion criteria (mean age, 66 years; 40% females; and persistent AF, 36%). Pulmonary vein isolation-only was used in 90% of the patients, and 10% received extra-PV ablation. Ablation as the first-line approach was chosen in 589 patients, and 502 patients had prior class I/III AAD use. In the first-line PFA group, paroxysmal AF was more frequent (68% versus 59%; P P P =0.076). CONCLUSION: In this large real-world PFA registry, freedom from AF/atrial tachycardia recurrence after 1 year was similar in patients undergoing PFA as a first-line treatment and those with prior failed AAD therapy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05823818.

Pulmonary vein isolation (PVI) is a well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing the promise of pulsed-field ablation (PFA) for this treatment, long-term efficacy and safety data demonstrating single-procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF. FARA-Freedom, a prospective, non-randomized, multicentre study, enrolled patients with PAF undergoing de novo PVI with PFA, who were followed for 12 months with weekly transtelephonic monitoring and a 72-h Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success, which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time. The study enrolled 179 PAF patients (62 ± 10 years, 39% female) at 13 centres. At the index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20-min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high, with 88.4 and 90.3% with weekly events and 72-h Holter monitors, respectively. Freedom from the composite primary effectiveness endpoint was 66.6%, and 41 patients had atrial tachyarrhythmia recurrence, mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE fistula. There were four cases of transient phrenic nerve palsy, but all resolved during the index procedure. In this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety. Clinical Trials.gov Identifier: NCT05072964 (sponsor: Boston Scientific Corporation).

Aims: Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multi-electrode PFA catheter. Methods and results: All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 patients (61% male, mean age 66 ± 11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n = 127). Median procedure and fluoroscopy times were 58 (interquartile range: 40–87) and 14 (9–21) min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. At a median follow-up of 365 (323–386) days, the Kaplan–Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients, a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated. Conclusion: The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population.

The EU Horizon 2020 Framework-funded Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) consortium has been established as a large research network for investigating STereotactic Arrhythmia Radioablation (STAR) for ventricular tachycardia (VT). The aim is to provide a pooled treatment database to evaluate patterns of practice and outcomes of STAR and finally to harmonize STAR within Europe. The consortium comprises 31 clinical and research institutions. The project is divided into nine work packages (WPs): (i) observational cohort; (ii) standardization and harmonization of target delineation; (iii) harmonized prospective cohort; (iv) quality assurance (QA); (v) analysis and evaluation; (vi, ix) ethics and regulations; and (vii, viii) project coordination and dissemination. To provide a review of current clinical STAR practice in Europe, a comprehensive questionnaire was performed at project start. The STOPSTORM Institutions’ experience in VT catheter ablation (83% ≥ 20 ann.) and stereotactic body radiotherapy (59% > 200 ann.) was adequate, and 84 STAR treatments were performed until project launch, while 8/22 centres already recruited VT patients in national clinical trials. The majority currently base their target definition on mapping during VT (96%) and/or pace mapping (75%), reduced voltage areas (63%), or late ventricular potentials (75%) during sinus rhythm. The majority currently apply a single-fraction dose of 25 Gy while planning techniques and dose prescription methods vary greatly. The current clinical STAR practice in the STOPSTORM consortium highlights potential areas of optimization and harmonization for substrate mapping, target delineation, motion management, dosimetry, and QA, which will be addressed in the various WPs.