Abstract
PurposeThe second-generation multi-electrode catheter, pulmonary vein ablation catheter (PVAC) GOLD, was designed to improve the delivery of phased radiofrequency energy and reduce procedure times using a ‘single-shot’ approach for pulmonary vein isolation (PVI), while retaining efficacy and safety. This large registry presents acute success rates and safety outcomes in a daily practice setting.MethodsA total of 1017 patients undergoing first-time ablation for atrial fibrillation (AF) using PVAC GOLD were included, 644 patients with paroxysmal AF and 373 patients with non-paroxysmal AF, divided into 175 patients receiving PVI only and 198 patients receiving PVI with additional substrate modification.ResultsHigh and comparable percentages of successful PVI could be achieved in all groups (98%, 95% and 99%; p = 0.108). The median total procedure time for all groups was 90 min [70–100]. As expected, the total procedure, ablation and fluoroscopy time were significantly longer in the PVI + substrate modification group compared with the PVI-only cases (all p < 0.001), but not between the PVI-only groups (p = 0.306, p = 0.088, p = 0.233, respectively). A total of 44 complications were observed in 43 patients (4.2%). Major complications were seen in 19 patients (1.87%) and non-major procedure–related complications were seen in 25 patients (2.46%). Complications leaving permanent sequelae were rare and occurred in only four patients (0.39%). Complications did not differ between groups (p = 0.199, p = 0.438, p = 0.240 and p = 0.465 respectively).ConclusionPVAC GOLD performs successful PVI, while reducing procedure times and retaining safety for paroxysmal, persistent and long-standing persistent AF. Safety was unaffected by additional substrate modification.
Highlights
Catheter ablation of atrial fibrillation (AF) is a wellestablished treatment option for patients with symptomatic, drug refractory A [1]
Persistent and long-standing persistent AF treated between May 2013 and December 2016 with the pulmonary vein ablation catheter (PVAC) GOLD phased RF ablation system were enrolled in the study
Patients with persistent or long-standing persistent AF were divided into two groups: those who underwent ablation of the pulmonary veins (PV) only (‘PersAF-pulmonary vein isolation (PVI)’) and patients who underwent ablation of the PVs with additional ablation of complex fractionated atrial electrograms (CFAE) in the left atrium (‘PersAF-PVI + CFAE’)
Summary
Catheter ablation of atrial fibrillation (AF) is a wellestablished treatment option for patients with symptomatic, drug refractory A [1]. Conventional point-bypoint procedures require high operator skills and are often lengthy. This leads to an increasing demand for operating rooms and operator time. The multi-electrode phased radiofrequency pulmonary vein ablation catheter (PVAC) was designed to allow circumferential ablation of the pulmonary veins (PV), using a ‘single-shot’ approach and reduce procedure times, while retaining efficacy and safety. Limited data is available evaluating the performance and safety of the second-generation PVAC GOLD to achieve PVI and the safety of additional substrate modification using multielectrode phased RF ablation. This large single-centre registry was designed to fulfil this knowledge gap and present data in an all-comers daily practice setting
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