Key result
The second-generation PVAC GOLD phased RF ablation catheter achieved acute successful pulmonary vein isolation in 97.5% of patients with atrial fibrillation, with a major complication rate of 1.87%.
Why the study?
The second-generation multi-electrode PVAC GOLD catheter was designed to improve phased radiofrequency energy delivery and reduce procedure times for PVI, prompting evaluation of its acute success and safety in daily practice.
Does the second-generation PVAC GOLD phased RF ablation catheter safely and effectively achieve acute pulmonary vein isolation in patients undergoing first-time ablation for atrial fibrillation?
Observational (n=1,017)
No
Does the second-generation PVAC GOLD phased RF ablation catheter safely and effectively achieve acute pulmonary vein isolation in patients undergoing first-time ablation for atrial fibrillation?
The second-generation PVAC GOLD catheter demonstrates high acute procedural success for pulmonary vein isolation with short procedure times and a low rate of major complications across different types of atrial fibrillation.
Answers are grounded in this paper and cite their sources.
Supports acute PVI feasibility with PVAC GOLD but should not change practice; leaves open need for randomized durability data.
PURPOSE: The 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. METHODS: A 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. RESULTS: High 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). CONCLUSION: PVAC 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.
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Klaver et al. (2020) conducted an observational in Atrial fibrillation (n=1,017). PVAC GOLD phased RF ablation catheter was evaluated on Acute success (electrical isolation of all pulmonary veins). The second-generation PVAC GOLD phased RF ablation catheter achieved acute successful pulmonary vein isolation in 97.5% of patients with atrial fibrillation, with a major complication rate of 1.87%.
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