A Novel Suture-Based Vascular Closure Device to Achieve Hemostasis after Venous or Arterial Access While Leaving Nothing behind: A Review of the Technological Assessment and Early Clinical Outcomes

Abstract

Vascular hemostasis after venous and arterial access in cardiovascular procedures remains a challenge. As sheath size gets larger for structural heart and vascular procedures, no dedicated closure devices exist that can overcome all the challenges of achieving vascular hemostasis, in particular on the venous side. Efficiently and reliably ensuring hemostasis at the access point is crucial for enhancing the safety of a procedure. Historically, hemostasis relied on manually compressing venous access sites. However, the shift towards larger sheaths and the more frequent use of continuous anticoagulation has strained this approach. Achieving hemostasis solely through compression in these scenarios demands heightened vigilance and prolonged application, resulting in increased patient discomfort and extended immobility. Consequently, manual compression may consume more time for healthcare providers and contribute to bed occupancy in hospitals. This review article summarizes the development of the SiteSeal^® Vascular Closure Device, a novel leave-nothing-behind approach to achieve hemostasis. The introduction of this technology has provided clinicians with a safer and more effective way to achieve immediate hemostasis, facilitate early ambulation, and enable earlier discharges with fewer access site complications compared with traditional manual compression.

Keywords: hemostasis; large bore sheath; medical device; vascular closure; venous access.

Figure 1

Illustration of the SiteSeal VCD. The SiteSeal design includes a crossbar, springs, a suture slot, a notched slot, and an incline plane. The incline plane is designed to position the north side towards the heart on the proximal side of the venotomy site.

Figure 2

Step-by-step deployment of the SiteSeal VCD at a venotomy site. (A) A Z-stitch using a 2-0 Vicryl suture is created and a double half knot is formed, creating an ‘X’ over the venotomy site. (B) Hemostatic powder is then placed around the sheath and the half-knot. (C) The SiteSeal is then positioned over the sheath at the venotomy site with the incline plane facing north. (D) The sheath is then removed while the two loose suture ends are pulled tight against the sheath. The suture ends are pulled up through the design slots and tightly knotted. (E) Following unloading of the springs, the tension created by the Z-stitch continues to fold the soft tissue surrounding the venotomy site, closing the opening in a linear fashion. (F) This is followed by placing elastic tape on top of the SiteSeal device for stabilization.

Figure 3

Clinical images showing the placement of the SiteSeal VCD. Briefly, (A) a Z-stitch using a 2-0 Vicryl suture is created and a double half knot is formed, creating an ‘X’ over the venotomy site. (B) Hemostatic powder is then placed around the sheath and the half-knot. (C) The SiteSeal is then positioned over the sheath at the venotomy site with the incline plane facing north. The sheath is then removed while the two loose ends of the suture are pulled tight against the sheath. The suture ends are pulled up through the design slots and the suture is tightly knotted. Following the release of the loaded springs, the roof is placed on the SiteSeal and (D) the procedure is repeated on the opposite groin. (E) This is followed by placing elastic tape on top of both SiteSeal devices for stabilization. (F) The removal of both SiteSeals demonstrates no hematoma or bleeding at the venotomy site.

Figure 4

The beneficial design of the SiteSeal spring system. The release of the springs by the operator leads to an increase in the Z-stitch tension and increases focal downward pressure.