J. Alan Wolfe, M.D., and A. Daniel Winston, M.D., cardiovascular surgeons with Northeast Georgia Physicians Group Cardiovascular & Thoracic Surgeons, recently implanted new technology that could improve the quality of life for patients who need heart bypass surgery as part of an initial feasibility clinical trial. The surgery was performed at Northeast Georgia Medical Center (NGMC) on February 5, 2013, with a second patient treated as part of the trial on February 13.
“We are very early in the process and still have a lot to learn, but, if this product performs like many in the clinical world think it will, it could be the biggest game-changer heart surgery has seen in decades,” says Dr. Wolfe. “We’re talking about improving a basic principle of the way bypass surgery has been performed since the late 1960’s.”
Heart bypass surgery is typically performed when one or more of a patient’s coronary arteries are blocked, which makes it difficult for the heart to pump blood to the rest of the body. The surgeon will take healthy arteries or veins from other parts of the patient’s body and attach them to the blocked artery in a way that allows blood flow to “bypass” the blockage.
Saphenous veins are most commonly used to bypass blockages, because they are readily available in most patients, but using them presents two key issues:
1) Saphenous veins are also more likely to degenerate following surgery because they have thinner, less rigid walls than arteries.
2) Veins have a normal blood pressure of 10, which is significantly less than the blood pressure of 120 in arteries.
That’s where the eSVS Mesh comes in. It’s an extremely thin, flexible tube of knitted mesh metal (nitinol) that is placed around the saphenous vein, like a sheath, to make the vein stronger and prevent enlargement. Medical research suggests that the sudden enlargement of the vein bypass graft often results in a buildup of plaque within the graft that ultimately causes it to narrow and stop working.
“Recent studies confirm that as many as 30-40 percent of saphenous vein grafts are closed within one year after surgery, which means patients may have to come back for a second surgery down the road and are put at risk for future heart attacks,” says Dr. Wolfe. “As a clinician, our goal is to devise a way to make the vein perform more like an artery. If the eSVS Mesh proves to help accomplish that goal, it may help spare patients the pain and expense of future heart problems.”
Dr. Wolfe says the first eSVS patient treated at NGMC is doing well and recovering normally at home. Although NGMC is currently the only hospital in the United States participating in the clinical trial, several other cardiac surgery centers from across the nation – including Cleveland Clinic, Mayo Clinic and Emory University – are expected to join the clinical trial.
The trial site at Northeast Georgia Medical Center is coordinated by the research department of Northeast Georgia Heart Center, a private cardiology practice affiliated with Northeast Georgia Health System.
Dr. Wolfe received his medical degree from Duke University and completed his residency at Brigham and Women’s Hospital, Bellevue Hospital and New York University Hospital. In addition to being the first surgeon in the nation to implant the eSVS Mesh in a patient, Dr. Wolfe has developed his own technique of minimally invasive heart valve reconstructions.