In patients undergoing peripheral vascular interventions (PVIs), a minimally invasive procedure that restores blood flow to the lower limbs, safety, and efficacy after using the VASCADE closure device (VCD) system was comparable with the standard treatment option for patients with severe peripheral artery disease (PAD), a new Yale-led study finds.
In this single‐center, retrospective review, 200 patients at Yale New Haven Hospital were identified. The overall aim of this study was to evaluate the safety and efficacy of the VCD compared with manual compression (MC) in higher‐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 U.S. Food and Drug Administration in January 2013. The VASCADE closure device uses an extravascular collagen plug to stop bleeding more efficiently that manual compression alone. The researchers found that 30‐day mortality rates were similar between the two patient groups. They also discovered there were no differences in minor or major complications at 30 days.
First author is Sameer Nagpal MD, assistant professor of medicine.
Senior author is Carlos Mena-Hurtado, MD, associate professor of medicine.
Other study authors are Lindsey E. Scierka, Yulanka Castro‐Dominguez, Dhruv Kansal, Steffne Kunnirickal, Yasin Hussain, Keith Love, Edouard Aboian, and Kim G. Smolderen.
The study is 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.