A real-world, prospective, observational, investigator initiated trial to evaluate early discharge following Angio-Seal™ vascular closure device in patients undergoing percutaneous coronary intervention

Cardiac catheterization procedures such as percutaneous coronary intervention (PCI) are widely used but with complications of access site bleeding. Manual compression (MC )is the well accepted technique to control bleeding but time consuming (15-20 mins); vascular closure devices (VCDs) are used increasingly as an alternative to MC and require <5 minutes for deployment. We aimed to document the real-world experience with a bioabsorbable collagen closure device (Angio-Seal™ ) with absorbable traction suture in patients undergoing PCI. The primary objective was time (hours) to discharge from hospital after the procedure; to document the incidence of vascular access site complications, time to ambulation and time to hemostasis were the secondary objectives. This was a prospective, observational, investigator-initiated clinical trial wherein adult patients who underwent PCI procedure through femoral access route, with deployment of Angio-Seal™ femoral closure device were included. Amongst the 100 patients enrolled, 68% were males. systemic hypertension (63%), and type-2 diabetes mellitus (37%) were the major comorbidities reported. Mean overall time from the end of procedure to hemostasis was 2.32±0.99min. Time to ambulation was 156.08±36.81min and to hospital discharge was 25.21±4.49 hours, One subject experienced hematoma. No other complications particularly pertaining to vascular access site were observed. Angio-Seal™ is an effective and safe VCD and results in early ambulation, rapid hemostasis, and discharge in patients undergoing PCI.