G. Chad Hughes, MD

Will Neighbors, already a survivor of quadruple coronary artery bypass grafting and a lower right lobectomy to remove a lung tumor, had a heart attack in May 2011. The event required no immediate surgery, but it did exacerbate his aortic valve stenosis.

Neighbors first came to Duke from his home in southern Arkansas in 2008, when he was diagnosed with valve disease.

When he returned three years later, his doctors saw a once-active man laid low by his aortic valve stenosis. Neighbors was so short of breath, he would get dizzy and fall if he attempted to walk or to bend over to pick up an object.

He was ruled ineligible for open surgery because of the position of bypass grafts under his sternum. CoreValve -- an experimental, stent-based valve-replacement procedure -- was his only option for treatment. “It was this,” he says, “or nothing at all.”

Neighbors was among the early Duke participants in the Medtronic CoreValve transcatheter aortic valve implantation (TAVI) clinical trial.

Almost a year after the first CoreValve implant at Duke, it’s still too early to draw conclusions, but trial leaders say initial results are encouraging. That’s a positive sign in a study in which all patients are high-risk for valve treatment, and all patients have additional concomitant health problems, such as lung disease or kidney disease.

J. Kevin Harrison, MD

Because other stent-based valves have shown an increased risk of stroke compared to standard valve surgery, choosing patients cautiously is critical.

Cardiologist J. Kevin Harrison, MD, who along with cardiothoracic surgeon G. Chad Hughes, MD, leads the study at Duke, says that prospective study participants frequently tell him that their ability to remain somewhat independent is key to their quality of life.

They are interested in survival and having their symptoms improve, but if the cure is worse than the disease, they aren’t interested. “If they have a stroke and they’re left so that they can’t walk or they can’t function,” says Harrison, “you haven’t really helped them.”

Harrison and Hughes lead a large team performing the procedure. Despite the extensive preparation by the two physicians, Harrison jokes, “It’s like running a football team.”

They rely on a crew of about 15, including highly trained surgical and cath lab nurses and technicians, cardiothoracic anesthesiologists, and cardiac CT and echocardiography specialists. Electrophysiology staff implant and run temporary pacemakers to allow accurate valve positioning and to treat episodes of slow heart rates. Two people are assigned only to load the valve in the delivery catheter properly.

The doctors implanted Neighbors’s valve on July 23, 2011, a few days after his 79th birthday. Hours following the procedure, he walked the hospital hallway with assistance.

Neighbors now feels so good, he walks twice a day and is signing up for a 12-week physical rehab class. He’s also looking forward to driving again, which along with his reinstated vigor will give him freedom that was missing for three months. “I’m going to get loose,” he laughs, “and nobody’s going to catch me.”

To inquire about enrolling a patient in the CoreValve TAVI trial, call 919-681-3763. 

Details About the CoreValve Trial

There are two cohorts to the CoreValve trial: The first includes only patients with severe aortic valve stenosis for whom open surgery is not an option. All of these patients receive the CoreValve.

The second cohort is patients who are high-risk for standard valve surgery. These participants are randomized one-to-one to receive either CoreValve or standard valve surgery.

Although Duke delayed its enrollment in the trial by four months to be sure the device had been thoroughly bench-tested for durability, it’s in the top five of 41 enrolling sites in the United States.