MUSC Vascular Surgery offers device to improve outcomes for complex below-the-knee arteries

Drs Genovese and Wooster
Dr. Elizabeth Genovese performed the first implant of the 4F TACK system at MUSC; Dr. Mathew Wooster was the first to implant the 6F TACK system.

Most South Carolinians realize that with heart or vascular disease, you can have a heart attack or stroke, especially in a state where heart disease is the No. 1 killer and stroke No. 3, according to the American Heart Association and the S.C. Department of Health and Environmental Control, respectively.

But fewer realize that blockages, which are caused by buildups of plaque and cholesterol, affect more than just the arteries of the heart. Blockages can occur in arteries throughout the body – and with serious effects.Take for instance, peripheral arterial disease (PAD), which occurs when atherosclerosis, or hardening of the arteries, causes a buildup of plaque in the blood vessels that carry oxygen and nutrients to the body’s tissues.

As plaque builds, it can narrow the arteries, reducing critical blood flow to the limbs, or cause complete blockages of the arteries. Early on, people with PAD may experience only difficulty and pain with walking. But, in its most severe forms, PAD can cause infections, painful foot ulcers, even gangrene, which could lead to amputation. Worse still, people with PAD are three times more likely to die of heart attacks or strokes.

Dr. Elizabeth Genovese, a vascular surgeon at MUSC and assistant professor in the Department of Surgery notes that “South Carolina has some of the highest rates of limb loss in the entire country, especially in more rural areas of the state, due to underdiagnosed and undertreated peripheral vascular disease.”MUSC Health is a state leader in treating vascular disease, like PAD, and the first hospital in the state to offer the Tack Endovascular System (4F), a minimal metal implant used to repair dissections following balloon angioplasty in complex below-the-knee arteries.

MUSC Health has adopted this innovative new technology as part of its commitment to improving care for critical limb ischemia patients.Critical limb ischemia (CLI) is the most severe form of PAD, occurring when an obstruction in an artery severely reduces blood flow, causing painful wounds, debilitating reset pain, recurring ulcers and life-threatening infection.

Historically, vascular surgeons have had limited treatment options available for these extremely sick patients.According to vascular surgeon Mathew Wooster, M.D., an assistant professor in the Department of Surgery, CLI is an enormous burden on the health care system, and MUSC is dedicated to advancing the treatment of CLI with technologies such as the Tack System.Balloon angioplasty is a minimally invasive, first-line intervention for CLI; however, the procedure can create dissections, or tears, in the vessel wall that inhibit blood flow and promote thrombus formation.

“While we have seen the benefits of drug elution and stenting in the superficial femoral artery and the coronary arteries,” explained Wooster, “for CLI patients, where the tibial vessels are prone to spasm and dissection like coronary vessels, yet too long for total stenting, we have not had any options other than balloon angioplasty – until now.”The novel Tack implant has been rigorously studied as part of the robust TOBA (Tack optimized balloon angioplasty) clinical program, notably the only clinical trials to investigate 100% dissected vessels.

The global, multicenter pivotal study verified that the Tack Endovascular System (4F) is a safe and effective therapeutic option, demonstrating post-angioplasty improvement in blood flow, wound healing and amputation prevention in a complex CLI patient population.“Incorporating this first-of-its-kind implant into our treatment algorithms provides an innovative solution for our CLI patients,” said Wooster. “We are excited to be able to finally have something more to offer CLI patients before resorting to major amputation.”