In patients undergoing peripheral vascular interventions (PVI), a minimally invasive procedure that restores blood flow to the lower extremities, the safety and effectiveness after using the VASCADE Closure Device System (VCD) was comparable to the standard treatment option for patients with severe peripheral artery disease (PAD), according to a new Yale-led study.
In this single-center retrospective review, 200 patients from Yale New Haven Hospital were identified. The overall objective of this study was to assess the safety and effectiveness of VCD compared to manual compression (MC) in high-risk patients undergoing endovascular procedures between 2018 and 2020.
The results were published in the journal Catheterization and Cardiovascular Interventions.
Cardiva Medical’s vascular closure device was approved by the United States Food and Drug Administration in January 2013. The VASCADE closure device uses an extravascular collagen plug to stop bleeding more effectively than manual compression alone. The researchers found that the 30-day mortality rates were similar between the two groups of patients. They also found that there was no difference in minor or major complications at 30 days.
The first author is Sameer Nagpal MD, Assistant Professor of Medicine.
The senior author is Carlos Mena-Hurtado, MD, associate professor of medicine.
The other authors of the study are Lindsey E. Scierka, Yulanka Castro‐Dominguez, Dhruv Kansal, Steffne Kunnirickal, Yasin Hussain, Keith Love, Edouard Aboian and Kim G. Smolderen.
The study was supported by Cardiva Medical. Smolderen is the recipient of research grants from Cook Medical, Merck & Co, Shockwave Medical and Johnson & Johnson. Mena-Hurtado has received support from Shockwave Medical.
Submitted by Elisabeth Reitman on September 21, 2022
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