Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

Pulmonary vein isolation durability after very high-power short-duration ablation utilizing a very-close protocol - The FAST AND FURIOUS redo study.

Background: Very high-power short-duration (vHP-SD) radiofrequency (RF) ablation of atrial fibrillation (AF) treatment by pulmonary vein isolation (PVI) aims for safer, more effective and faster procedures. Although acute efficacy and safety for PVI was recently shown data on chronic PVI durability is limited. Here chronic PVI durability was evaluated during repeat electrophysiological procedures in patients after initial vHP-SD and conventional RF based PVI. Methods: A total of 25 consecutive patients with repeat left atrial procedures after initial vHP-SD based PVI were included in this study. Twenty-five patients with previous conventional RF based PVI and repeat left atrial procedures served as control (control group). Results: For index procedures the median RF time was 328 (277, 392) seconds (vHP-SD) and 1470 (1310, 1742) seconds (control); p < 0.001, the median procedure time was 55 (53, 68) minutes (vHP-SD) and 110 (94, 119) (control); p < 0.001). First pass isolation rate was 84 % (vHP-SD) and 88 % (control, p = 0.888). No differences for severe adverse events (vHP-SD: 1/25, 4 % vs. control: 0/25, 0 %; p = 0.676 were detected.Chronic durability of all PVs was assessed in vHP-SD: 16/25 (64 %) and control: 8/25 (32 %) patients (p = 0.023) and vHP-SD: 81 % and control: 62 % of PVs were found to be isolated (p = 0.003). For right PVs vHP-SD: 84 % vs. control: 60 % of PVs (p < 0.001) and for left PVs vHP-SD: 78 % vs. control: 64 % (p = 0.123) were found to be isolated. Conclusions: PVI solely utilizing vHP-SD via a very close-protocol provides fast, safe and effective acute PVI. High rates of chronically isolated pulmonary veins have been detected.