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.
Gainesville, GA (PRWEB) February 18, 2013
Northeast Georgia Medical Center (NGMC) is the first hospital in the United States to implant new technology that could improve the quality of life for patients who need heart bypass surgery. The first implant was performed on February 5, 2013, by J. Alan Wolfe, MD, and A. Daniel Winston, MD, cardiovascular surgeons with Northeast Georgia Physicians Group Cardiovascular & Thoracic Surgeons, as part of an initial feasibility clinical trial recently approved by the U.S. Food and Drug Administration (FDA) to test a new product created by Kips Bay Medical called eSVS® Mesh. A second patient was 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 preeminent cardiac surgery centers from across the nation – including Cleveland Clinic, Mayo Clinic and Emory University – are expected to join the clinical trial.
“We are honored that NGMC is the first hospital in the nation to test this breakthrough in medical technology,” says Carol Burrell, President and CEO of Northeast Georgia Health System. “To lead the way in a clinical trial of this magnitude, a trial that could change the way heart surgery is performed and help millions of people, is further evidence that the future of heart care is already in Gainesville, Georgia, at NGMC.”
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.
ABOUT NORTHEAST GEORGIA MEDICAL CENTER (Gainesville, Ga.)
Northeast Georgia Medical Center (NGMC) offers a full range of healthcare services through a medical staff of more than 500 physicians which serve more than 700,000 people across more than 13 counties. NGMC is recognized as Georgia’s #1 Cardiology Hospital for 2013 by Healthgrades®. NGMC is part of Northeast Georgia Health System, a not-for-profit community health system dedicated to improving the health and quality of life of the people of Northeast Georgia. Learn more at http://www.nghs.com.
ABOUT NORTHEAST GEORGIA PHYSICIANS GROUP (Gainesville, Ga.)
Northeast Georgia Physicians Group (NGPG) is one of the largest multispecialty groups in North Georgia. Representing 17 medical specialties, we bring together more than 125 talented physicians, physician assistants and nurse practitioners, along with other clinical staff, at more than 30 locations. Learn more at http://www.ngpg.org.
NGPG Cardiovascular and Thoracic Surgeons specialize in conditions of the heart, lungs, esophagus, diaphragm and great vessels. The practice performs more than 600 cases each year, including procedures involving minimally invasive techniques.
J. Alan Wolfe, MD, received his medical degree from Duke University and completed his residency at Brigham and Women’s Hospital (a teaching affiliate of Harvard University), Bellevue Hospital and New York University Hospital. He has practiced since 1991, including more than a decade in the Atlanta area. In addition to being the first surgeon in the nation to implant the eSVS Mesh in a patient, Dr. Wolfe has also developed his own technique of minimally invasive heart valve reconstructions.
ABOUT NORTHEAST GEORGIA HEART CENTER (Gainesville, Ga.)
Northeast Georgia Heart Center (NGHC) is a private cardiology practice and the state's leader in cardiac care. Our nationally recognized physicians perform more than 5,000 cardiac procedures and consult more than 30,000 patients each year. NGHC has been a leader in the conduction of national and global clinical research since 2002, participating in an average of 30 clinical trials per year. To learn more about current clinical trials contact our research department at 678-989-5001 or visit http://www.ngheartcenter.com/cardiacresearch.asp.