Safety and effectiveness of a mid-voltage pulsed-field ablation catheter in persistent atrial fibrillation: acute outcomes
B Ren, R Zeng, X Hu, F Li, W Li, A Gong, G Lv, Y Du, L Cai, L Huang, H ChenAbstract
Background
High-voltage pulse field ablation (PFA) can disrupt red blood cell membranes, leading to an increased risk of hemolysis. A novel small-balloon, mid-voltage PFA system is expected to reduce the risk of hemolysis through lower pulse voltages while achieving favorable acute success rates.
Purpose
To evaluate the acute safety and effectiveness of a small-balloon, mid-voltage PFA catheter for pulmonary vein isolation (PVI) and linear ablation in patients with persistent atrial fibrillation (PersAF).
Methods
A prospective, multicenter, single-arm study was conducted at seven centers on 127 patients with drug-refractory PersAF. All patients underwent PVI using the small-balloon PFA catheter integrated with a mid-voltage PFA generator (850 V), and an electroanatomic mapping system (Panel A-B). In addition to PVI, investigators could choose one or more linear ablation strategies, including the left-atrial roof or floor, mitral isthmus, or right-atrial tricuspid isthmus. Endpoints were the incidence of post-procedural serious adverse events within 7-days, laboratory parameters related to hemolysis to assess asymptomatic hemolysis and procedural effectiveness within acute phase.
Results
Patients’ mean age was 60.53 ± 8.30 years (73.2% male), with a median of 152 [114-217] applications per patient. Acute success of PVI and linear-block was 100% (127/127) and 99.2% (126/127), respectively. Mean procedure, fluoroscopy, and ablation times were 126.5 ± 32.8, 10.5 ± 5.7, and 30.4 ± 14.5 min, respectively. Changes from baseline in haptoglobin, indirect bilirubin, and lactate dehydrogenase 2-days post-procedure were -0.10 ± 0.12 g/L, 7.55 ± 7.52 μmol/L, and 98.95 ± 58.72 U/L, respectively (Panel C). No serious adverse events related to delivery of PFA using the integrated system occurred within the 7-day perioperative period.
Conclusion
This clinical trial demonstrated that the small-balloon, mid-voltage PFA delivery and mapping system safely achieved superior acute PVI and linear ablation in patients with PersAF. The use of mid-voltage PFA may explain the reduced risk of hemolysis. Twelve-month outcomes will be reported when available.Panel