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.

Pulsed field ablation of spatiotemporal electrogram dispersion following pulmonary vein isolation and left atrial linear lesions for persistent atrial fibrillation: a case report.

Background: Ablation of persistent atrial fibrillation (AF) remains challenging, with atrial substrate modification often being performed as an adjunct to pulmonary vein isolation (PVI). Pulsed field ablation (PFA) is a novel ablation modality that carries a favourable safety profile, which could facilitate complex procedures. Case summary: We present the case of a 60-year-old male undergoing catheter ablation for symptomatic persistent AF. The procedure was performed with the Farapulse™ PFA system in a stepwise manner, including PVI and linear lesions for the isolation of the posterior left atrial wall and the ablation of the mitral isthmus. The final step of the procedure included the ablation of areas exhibiting spatiotemporal electrogram dispersion, identified with the help of artificial intelligence-based software (VX1, Volta Medical) in both atria. Sinus rhythm was restored after the abolition of an electrogram dispersion zone in the right atrium. The procedure was carried out without any complications. Discussion: Complex ablation procedures for persistent AF can be successfully performed with PFA. In the context of such extensive ablation strategies, PFA is an attractive energy source, given its non-thermal nature that is known to prevent damage to surrounding tissue and result in less chronic fibrosis. However, caution should be exercised to avoid excessive ablation when using the currently available multispline PFA catheter, as it may inadvertently target adjacent areas of healthy myocardium.

Pulsed field ablation of the right superior pulmonary vein prevents vagal responses via anterior right ganglionated plexus modulation.

BACKGROUND: Pulsed field ablation (PFA) is selective for the myocardium. However, vagal responses and reversible effects on ganglionated plexi (GP) are observed during pulmonary vein isolation (PVI). Anterior-right GP ablation has been proven to effectively prevent vagal responses during radiofrequency-based PVI. OBJECTIVE: The purpose of this study was to test the hypothesis that PFA-induced transient anterior-right GP modulation when targeting the right superior pulmonary vein (RSPV) before any other pulmonary veins (PVs) may effectively prevent intraprocedural vagal responses. METHODS: Eighty consecutive paroxysmal atrial fibrillation patients undergoing PVI with PFA were prospectively included. In the first 40 patients, PVI was performed first targeting the left superior pulmonary vein (LSPV-first group). In the last 40 patients, RSPV was targeted first, followed by left PVs and right inferior PV (RSPV-first group). Heart rate (HR) and extracardiac vagal stimulation (ECVS) were evaluated at baseline, during PVI, and postablation to assess GP modulation. RESULTS: Vagal responses occurred in 31 patients (78%) in the LSPV-first group and 5 (13%) in the RSPV-first group (P <.001). Temporary pacing was needed in 14 patients (35%) in the LSPV-first group and 3 (8%) in the RSPV-first group (P = .003). RSPV isolation was associated with similar acute HR increase in the 2 groups (13 ± 11 bpm vs 15 ± 12 bpm; P = .3). No significant residual changes in HR or ECVS response were documented in both groups at the end of the procedure compared to baseline (all P >.05). CONCLUSION: PVI with PFA frequently induced vagal responses when initiated from the LSPV. Nevertheless, an RSPV-first approach promoted transient HR increase and reduced vagal response occurrence.

Case Report: A leadless and endovascular pacemaker teamwork.

Background: Cardiac Implantable Electronic Device infections increase short- and long-term mortality, along with healthcare costs. Leadless pacemakers (PM) were developed to overcome pocket- and minimize lead-related complications in selected high-risk patients. Recent advancements enable leadless devices to mechanically detect atrial activity, facilitating atrioventricular (AV) synchronous stimulation. Case summary: A 90-year-old woman, implanted with a dual-chamber pacemaker eight years ago due to sinus node dysfunction, presented with syncope. A diagnosis of complete AV block, in the setting of ventricular lead dysfunction was made. Due to a high risk of infection, the patient was implanted with a leadless PM capable of maintaining AV synchrony in VDD mode (MICRA™ model MC1AVR1). The transvenous PM was programmed to AAI-R mode to drive the atria, which, in turn, triggered the leadless PM to stimulate the ventricles. At six month follow-up, the AV synchrony rate was 85%. Conclusion: The combination of classic atrial pacing with leadless ventricular stimulation can be used in high-risk patients to reduce the risk of complications, in the setting of ventricular lead dysfunction. In this manner, AV synchrony can be maintained, improving hemodynamic parameters and quality of life. Low sinus rate variability at rest is essential to achieve a high AV synchrony rate in such cases.

Temporal Trends in Pacemaker Implantations Over the Past Decade in France: Impact of Transcatheter Aortic Valve Implantations.

In this study, we assessed the temporal trends of permanent pacemaker implantations in France from 2008 to 2018 using data from the Échantillon Généraliste de Bénéficiaires (EGB) administrative database, a representative sample of the French population. Additionally, we evaluated the impact of transcatheter aortic valve implantations on the overall pacemaker implantation rate. Our data suggest that the incidence of permanent pacemaker implantations in France increased significantly only in patients ≥80 years old, with post-transcatheter aortic valve implantations accounting for at least 2/3 of this increase.

A novel stepwise approach incorporating ethanol infusion in the vein of Marshall for the ablation of persistent atrial fibrillation.

Introduction: Apart from pulmonary vein isolation (PVI), several step-by-step procedures that aim to modify left atrial substrate have been proposed for the ablation of persistent atrial fibrillation (AF), yet the optimal strategy remains elusive. There are cumulative data suggesting an incremental benefit of adding vein of Marshall (VOM) ethanol infusion to PVI in patients with persistent AF. We sought to evaluate the feasibility and efficacy of a novel stepwise ablation approach, incorporating a VOM alcoholization step, for persistent AF. Methods: In this single-center study, we prospectively enrolled 66 consecutive patients with symptomatic persistent AF and failure of at least one antiarrhythmic drug (ADD). The ablation procedure consisted of (i) PVI, (ii) left atrial segmentation with VOM ethanol infusion and the deployment of linear radiofrequency lesions across the roof and the mitral isthmus and (iii) electrogram-based ablation of dispersion zones. The first two steps were performed in all patients, whereas the third step was carried out only in those still in AF at the end of the second step. Atrial tachycardias during the procedure were mapped and ablated. At the end of the procedure, cavotricuspid isthmus ablation was additionally performed in all patients. The primary endpoint was 12-month freedom from AF and atrial tachycardia after a single procedure and an initial three-month blanking period. Results: Total procedure time was 153 ± 38.5 min. Fluoroscopy time was 16 ± 6.5 min and the radiofrequency ablation time was 26.14 ± 0.26 min. The primary endpoint occurred in 54 patients (82%). At 12 months, 65% of patients were off any AAD. In the univariate Cox regression analysis, left ventricular ejection fraction < 40% was the only predictor of arrhythmia recurrence (HR 3.56; 95% CI, 1.04-12.19; p = 0.04). One patient developed a pericardial tamponade and another a minor groin hematoma. Conclusion: A novel stepwise approach, including a step of ethanol infusion in the VOM, is feasible, safe and provides a high rate of sinus rhythm maintenance at 12 months in patients with persistent AF.

Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison.

AIMS: Pulsed field ablation (PFA) has emerged as a novel, non-thermal energy source to selectively ablate cardiac tissue. We describe a multicentre experience on pulmonary vein isolation (PVI) via the pentaspline Farapulse™ PFA system vs. thermal-based technologies in a propensity score-matched population of paroxysmal atrial fibrillation (PAF) patients. METHODS AND RESULTS: Propensity score matching was adopted to compare PVI-only ablation outcomes via the Farawave™ system (Group PFA), cryoballoon (Group CRYO), or focal radiofrequency (Group RF) (PFA:CRYO:RF ratio = 1:2:2). Among 1572 (mean age: 62.4 ± 11.3 years; 42.5% females) PAF patients undergoing first time PVI with either PFA (n = 174), CRYO (n = 655), or RF (n = 743), propensity score matching yielded 174 PFA, 348 CRYO, and 348 RF patients. First-pass isolation was achieved in 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CRYO, and 73.1% with RF (P < 0.001). Procedural and dwell times were significantly shorter with PFA, whereas the availability of a 3D mapping system led to a significant reduction in X-ray exposure with RF. Overall complication rates were 3.4% (n = 6) with PFA, 8.6% (n = 30) with CRYO, and 5.5% (n = 19) with RF (P = 0.052). The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CRYO, and 72.4% with RF (log-rank P-value: 0.24). Among 145 repeat ablation procedures, PV reconnection rate was 19.1% after PFA, 27.5% after CRYO, and 34.8% after RF (P = 0.01). CONCLUSION: Pulsed field ablation contributed to significantly shorter procedural times. Follow-up data showed a similar arrhythmia freedom, although a higher rate of PV reconnection was documented in post-CRYO and post-RF redo procedures.

Intensified immunosuppressive therapy in patients with immune checkpoint inhibitor-induced myocarditis.

BACKGROUND: Myocarditis is a rare but life-threatening adverse event of cancer treatments with immune checkpoint inhibitors (ICIs). Recent guidelines recommend the use of high doses of corticosteroids as a first-line treatment, followed by intensified immunosuppressive therapy (IIST) in the case of unfavorable evolution. However, this strategy is empirical, and no studies have specifically addressed this issue. Therefore, we aimed to investigate and compare the clinical course, management and outcome of ICI-induced myocarditis patients requiring or not requiring IIST. METHODS: This case-control study included all patients consecutively admitted to The Mediterranean University Center of Cardio-Oncology (Aix-Marseille University, France) for the diagnosis of ICI-induced myocarditis according to Bonaca's criteria and treated with or without IIST. In addition, we searched PubMed and included patients from previously published case reports treated with IIST in the analysis. The clinical, biological, imaging, treatment, all-cause death and cardiovascular death data of patients who required IIST were compared with those of patients who did not. RESULTS: A total of 60 patients (69±12 years) were included (36 were treated with IIST and 24 were not). Patients requiring IIST were more likely to have received a combination of ICIs (39% vs 8%, p=0.01), and developed the first symptoms/signs of myocarditis earlier after the onset of ICI therapy (median, 18 days vs 60 days, p=0.002). They had a significantly higher prevalence of sustained ventricular arrhythmia, complete atrioventricular block, cardiogenic shock and troponin elevation. Moreover, they were more likely to have other immune-related adverse events simultaneously (p<0.0001), especially myositis (p=0.0002) and myasthenia gravis (p=0.009). Patients who required IIST were more likely to die from any cause (50% vs 21%, p=0.02). Among them, patients who received infliximab were more likely to die from cardiovascular causes (OR, 12.0; 95% CI 2.1 to 67.1; p=0.005). CONCLUSION: The need for IIST was more common in patients who developed myocarditis very early after the start of ICI therapy, as well as when hemodynamic/electrical instability or neuromuscular adverse events occurred. Treatment with infliximab might be associated with an increased risk of cardiovascular death.