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Advancing Limb Preservation

Novel therapies addressing lower extremity limb salvage available at UH Harrington Heart & Vascular Institute

Innovations in Cardiovascular Medicine and Surgery - Summer 2018

Vikram Kashyap, MD


Chief, Division of Vascular Surgery and Endovascular Therapy, University Hospitals Cleveland Medical Center, Co-Director, Vascular Center, University Hospitals Harrington Heart & Vascular Institute Alan H. Markowitz, MD, Master Clinician for Cardiac and Vascular Surgery; Professor of Surgery, Case Western Reserve University School of Medicine

Mehdi Shishehbor, DO, MPH, PhD


Director, Interventional Cardiovascular Center and Co-Director, Vascular Center, UH Harrington Heart & Vascular Institute; Professor of Medicine, Case Western Reserve University School of Medicine

For patients with lower extremity wounds and ulcers, it can often seem that there are no good treatment options. Studies show that some patients, in fact, undergo an amputation without ever having a vascular assessment.

At University Hospitals Cleveland Medical Center, interventional cardiologist Mehdi Shishehbor, DO, MPH, PhD, is aiming to disrupt this status quo. He is a national principal investigator for four different clinical trials aimed at reducing leg amputations, giving UH patients important access to novel therapies to prevent lower extremity limb loss. Dr. Shishehbor is Director of the Interventional Cardiovascular Center and Co-Director of the Vascular Center at UH Harrington Heart & Vascular Institute.

“We are so excited to have recruited Dr. Shishehbor to University Hospitals,” says Vikram Kashyap, MD, Chief of the Division of Vascular Surgery and Endovascular Therapy at UH Cleveland Medical Center and Co-Director of the Vascular Center at UH Harrington Heart & Vascular Institute. “He is internationally recognized for innovative treatments in peripheral artery disease.  In the Vascular Center, we aim to provide high-quality, seamless and integrated care for our patients with vascular problems.  Working as a collaborative team, we can offer patients medical evaluation, imaging, endovascular therapies and surgery with the best options for each patient.”

Perhaps the most innovative limb salvage trial under way at UH is one exploring whether veins can be turned into an artery to provide a bypass around the blockage in the artery that cannot be corrected by surgery or endovascular approaches. Dr. Shishehbor recently performed the first such case in Ohio month, and UH is the only center in Ohio that is currently offering this last-resort treatment.

At the American College of Cardiology meeting last March, Dr. Shishehbor presented data on another critical limb ischemia research priority – biologic therapy. The STOP-PAD trial evaluated the effectiveness of JVS-100, manufactured by Juventas Therapeutics.

“We were injecting biologic therapy into the foot as an adjunctive therapy to revascularization to observe healing in those wounds in a more timely fashion,” Dr. Shishehbor says. “This biologic attracts  natural angiogenic factors to the wound area where healing is occurring. Injecting this biologic in the foot should stimulate and direct the naturally occurring angiogenic factors in the body to the site of injury. By doing so, we hope that we build new small blood vessels to improve perfusion.”

Initial results from STOP-PAD show no effect on wound healing from JVS-100, measured at three months after the initial dose. However, Dr. Shishehbor says it’s too soon to close the book on the product.

“We are very much looking forward to the six-month data,” he says. “Based on those results, we will determine whether we will investigate this biologic therapy in a longer study, or perhaps consider studying a combination therapy that involves more than one biologic therapy.”

In the realm of investigational devices is the “Chocolate” drug-coated balloon catheter, manufactured by QT Vascular. Dr. Shishehbor is national co-principal investigator of the “Chocolate Touch” clinical trial evaluating 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.

“We are excited to enroll patients in this worldwide study evaluating Chocolate, a second-generation drug-coated balloon,” Dr. Shishehbor says. “This first head to head trial will help guide physicians as they choose the best drug-coated balloon for their patients.”

Another very exciting approach is the R2P program which has been started at UH. R2P stands for radial to peripheral and will allow complex procedures in the leg to be performed via the radial approach, widely used for cardiac procedures. However, the right devices and techniques have previously not been available to use this approach to treat peripheral artery disease.

“We are the first institution in the world to start a program like this,” says Dr. Shishehbor. “In the heart, that has become the normal path. The last five to 10 years have shown us that when you treat patients from the wrist, it is less risky, it is associated with less bleeding, it is associated with less cost, and patient satisfaction and the quality of the procedure are higher than if you do the procedure from the groin. We have been working with a device manufacturer to see if we can move the field forward in the area of lower extremities. It’s a series of devices that are able to complete a procedure that is currently being done through the groin.”


For more information about novel treatments for limb salvage available at UH Harrington Heart & Vascular Institute or to refer a patient, please call 216-844-5170.