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Review

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

by
Saami K. Yazdani
1,*,
Omer Shedd
2,
George Christy
3 and
Rex Teeslink
4
1
Department of Engineering, Wake Forest University, Winston-Salem, NC 27101, USA
2
Department of Cardiology and Electrophysiology, CaroMont Regional Medical Center, Gastonia, NC 28054, USA
3
Department of Interventional Cardiology, Advocate Good Shepherd Hospital, Barrington, IL 60010, USA
4
EnsiteVascular LLC, Olathe, KS 66061, USA
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2024, 13(16), 4606; https://doi.org/10.3390/jcm13164606
Submission received: 24 June 2024 / Revised: 26 July 2024 / Accepted: 3 August 2024 / Published: 7 August 2024
(This article belongs to the Section Vascular Medicine)
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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: vascular closure; medical device; hemostasis; venous access; large bore sheath vascular closure; medical device; hemostasis; venous access; large bore sheath

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MDPI and ACS Style

Yazdani, S.K.; Shedd, O.; Christy, G.; Teeslink, R. 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. J. Clin. Med. 2024, 13, 4606. https://doi.org/10.3390/jcm13164606

AMA Style

Yazdani SK, Shedd O, Christy G, Teeslink R. 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. Journal of Clinical Medicine. 2024; 13(16):4606. https://doi.org/10.3390/jcm13164606

Chicago/Turabian Style

Yazdani, Saami K., Omer Shedd, George Christy, and Rex Teeslink. 2024. "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" Journal of Clinical Medicine 13, no. 16: 4606. https://doi.org/10.3390/jcm13164606

APA Style

Yazdani, S. K., Shedd, O., Christy, G., & Teeslink, R. (2024). 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. Journal of Clinical Medicine, 13(16), 4606. https://doi.org/10.3390/jcm13164606

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