Safety and Efficacy of a Novel Sealant-Based Vascular Closure Device Following Electrophysiology Procedures: ReliaSeal Trial.

Abstract

Background: While manual compression (MC) remains the standard of care to achieve hemostasis, a novel vascular closure device (VCD) was designed to achieve faster hemostasis without compromising safety. The objective of the ReliaSeal trial was to evaluate the safety and effectiveness of the Mynx Control Venous VCD to close a single or multiple femoral venous access sites in one or both limbs in patients undergoing catheter-based procedures.

Methods: The ReliaSeal trial was a prospective, randomized controlled trial comparing VCD to MC in patients undergoing catheter-based procedures requiring single or multiple access sites utilizing up to 12F sheaths. Endpoints included time to ambulation (TTA), time to hemostasis (TTH), time to discharge eligibility (TTDE), procedural/device success, and 30-day major and minor access site complications.

Results: Two hundred and seventy subjects were randomized to the VCD or MC arm (n = 177 vs. n = 93) with a mean age of 66.7 ± 11.27 years. TTA, TTH, and TTDE were significantly reduced in VCD subjects compared to MC (TTA: 2.6 ± 1.03 vs. 5.1 ± 4.35 h, p < 0.001; TTH: 2.1 ± 1.79 vs. 11.4 ± 7.19 min, p < 0.001; TTDE: 3.1 ± 1.24 vs. 5.5 ± 4.58 h, p < 0.001, respectively). Procedural and device success was achieved in 100% of VCD subjects, compared to 98.9% of the MC group. No major or minor complications occurred in the VCD group; with a 5% minor complication rate in the MC group.

Conclusion: The use of VCD resulted in significant reductions in TTA, TTH, and TTDE, with no major or minor complications and a high success rate.