Khaldoun G. Tarakji

Background Catheter ablation is beneficial in patients with symptomatic persistent atrial fibrillation (PerAF), and pulsed field ablation (PFA) is a promising energy source to safely and durably create ablation lesions. However, catheter-specific “PFA waveforms and designs” result in effectiveness and safety profiles that are not transferable to other PFA technologies. A head-to-head comparison between the dual-energy, wide-footprint lattice-tip (Sphere-9, Medtronic) and pentaspline PFA catheter (Farawave, Boston Scientific) is not yet available. Consequently, this study aims to perform an indirect treatment comparison (ITC). Methods Outcomes (efficacy, safety, and procedure times) between the SPHERE Per-AF trial (N = 212; NCT05120193) and ADVANTAGE AF trial (N = 260; NCT05443594) studies were compared using matched-adjusted indirect comparison (MAIC) methods. Matching was performed based on subjects’ baseline characteristics. Results After matching, SPHERE Per-AF showed a higher probability (OR 0.51 (95% CI:0.32 – 0.80), p = 0.003) of 12-month freedom from arrhythmias (77.4%) compared to ADVANTAGE AF (63.5%). There was no evidence of adjusted probability of a primary safety difference (OR 0.76 (95% CI:0.17 – 3.42), p = 0.72) between trials (1.8% vs. 2.3%, respectively). Adjusted procedure and pulmonary vein isolation time were comparable, but fluoroscopy time was significantly shorter in SPHERE Per-AF compared to ADVANTAGE AF (-14.4 min (95% CI:-16.2, -12.5); p < 0.01). Conclusion PFA is generally safe and efficient; however, in this ITC, SPHERE Per-AF showed a higher probability of treatment success in PerAF patients compared to ADVANTAGE AF. Overall, these results underline possible differences even amongst PFA systems, which must be validated in randomized trials. Until then, MAIC methods fill the current evidence gap. Registry and the Registration No. SPHERE Per-AF: NCT05120193 and ADVANTAGE AF: NCT05443594. Graphical Abstract

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193.

Introduction: Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient‐centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient‐reported outcomes (PRO) registry.Methods: All patients undergoing redo AF ablation (2013–2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow‐up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient‐reported improvement, AF burden, and AF‐related healthcare utilization including emergency room (ER) visits and hospitalizations.Results: A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5–18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF‐related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow‐up across all time points (p < .0001 for all variables).Conclusion: Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization.

Background: Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes. Methods: We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group. Results: A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; P <0.001). There were 5 major complications with 3 vascular lacerations all occurring in zone 2 in the study. Conclusions: Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03772704.