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

TL;DR

This paper reviews a new suture-based device for achieving vascular hemostasis after procedures, offering a safer and more efficient alternative to manual compression.

Contribution

The paper introduces a novel leave-nothing-behind vascular closure device with early clinical benefits.

Findings

The SiteSeal® device enables immediate hemostasis and reduces access site complications.

It facilitates early patient ambulation and hospital discharge compared to manual compression.

The device addresses challenges posed by larger sheaths and anticoagulation use.

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.

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