VCS device supports early ambulation without bleeding events after AF ablation

The use of a venous closure system (VCS) post ablation for atrial fibrillation (AF) shortens ambulation time without recurrence of bleeding in the STYLE-AF study presented at EHRA 2024.

“Currently, the standard of care to achieve haemostasis after catheter ablation is manual compression with or without the figure-of-eight (F8) suture,” said lead author Prof Roland Tilz from the Department of Rhythmology at the University of Heart Centre in Lübeck, Germany.

However, manual compression can be time-consuming and requires intensive compression by operator and requires prolonged bed rest. [Catheterization and Cardiovascular Interventions 2008;71:1-5]

The researchers sought to compare the safety and efficacy of the VCS vs manual compression following single shot pulmonary vein isolation.

The study involved 125 patients who were referred for AF ablation at three centres in Germany between November 2022 and January 2024. After successful ultrasound-guided venous puncture of the groin, participants were randomized to VCS (Perclose™ ProGlide™ or Perclose™ ProStyle™; n=63) or manual compression with F8 suture (n=62). [Tilz R, et al. EHRA 2024, Late-Breaking Science: clinical]

In the VCS arm, a single vascular closure was deployed at each puncture site, and manual compression was applied for 2–5 minutes after the sheath was removed.

In the standard of care arm, an F8 suture was used before sheath removal, followed by manual compression until haemostasis and a pressure bandage for ≥30 minutes.

All patients were followed up via a telephone call for 30 days.

At follow-up, the VCS arm achieved a significantly shorter time to ambulation than the standard of care arm (109 vs 269 minutes; p<0.001), with a difference of 160 minutes. No major periprocedural complications occurred until discharge.

Time to haemostasis and time to discharge eligibility were shorter in the VCS arm (1 vs 5 min and 270 vs 340 min, respectively; p<0.001 for both). “This is extremely important because if you have a faster time to discharge eligibility, you can do more procedures,” Tilz said.

None of the patients had major vascular access-related complications.

The rate of minor complications was lower in the VCS group vs the standard of care group (20.6 percent vs 35.5 percent). Fewer patients in the VCS group experienced groin haematoma (<6 cm; 9.5 percent vs 24.2 percent).

In addition, patients in the VCS group expressed higher satisfaction in terms of their comfort level during the procedure.

“I believe the VCS might be of great value to increase patient satisfaction, particularly in patients undergoing same-day discharge AF ablation,” Tilz said.

“Overall, the use of a VCS resulted in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility vs standard of care,” said Tilz.

The next step is to conduct the SHAZAM-AF trial to confirm whether the VCS is superior to conventional approach for same-day ablation, he added.