Vascular Innovation Unit
The Vascular Innovation Unit (VIU) focuses on being the first to bring the latest limb salvage techniques to our patients before anywhere else. Given the commitment of University Hospitals Harrington Heart & Vascular Institute to education and public health, Mehdi Shishehbor, DO, MPH, PhD, has trained more than 400 physicians across the United States in advanced techniques for limb salvage. Dr. Shishehbor offers these courses annually. Innovative limb salvage clinical trials are underway at University Hospitals Cleveland Medical Center.
LimFlow Percutaneous Deep Vein Arterialization (pDVA) System
This breakthrough first-in-human clinical trial employs a novel proprietary technique to provide endovascular venous arterialization that cannot be corrected by surgery or other endovascular approaches. The goal is to redirect blood from ischemic arteries into the tibial veins, providing a bypass around the blockage in the artery and resupplying oxygen to the surrounding tissue. Outcomes from the procedure include wound healing, limb salvage and remarkable changes in the vasculature of the foot.
As an adjunctive therapy to revascularization, bioactive agents are injected into the foot to observe wound healing more quickly. In addition, the biologic stimulates and directs naturally occurring angiogenic factors in the body to the site of injury with the hope that new small blood vessels will build to improve perfusion.
“Chocolate” Drug-Coated Balloon Catheter
The “Chocolate Touch” clinical trial evaluates whether this second-generation device is superior to the older Lutonix model. The primary endpoint of the trial is “true drug-coated balloon success,” defined as the patient achieving primary patency without bail-out stenting.
Radial to Peripheral (R2P) Program
R2P allows complex procedures in the leg to be performed via the radial approach, widely used for cardiac procedures. The last five to 10 years have shown when patients are treated from the wrist, it is less risky and associated with less bleeding, and that patient satisfaction and quality of the procedure are higher than if done through the groin.