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April 03, 2014
Loyola first hospital in Illinois to implant newly approved nonsurgical heart valve replacement
The device, recently approved by the Food and Drug Administration, is called the Medtronic CoreValve® System. On March 28, Loyola became the first Illinois hospital to implant the device in a patient who was not part of a clinical trial. Prior to FDA approval, the device was available only to patients enrolled in a clinical trial.
The new device is deployed with a catheter, which is inserted in an artery in the groin and guided up to the heart. Once in place, the artificial valve takes over the function of a diseased valve. The system is much less invasive than traditional open-heart surgery.
Loyola physicians also have implanted the device in patients participating in clinical trials, including a landmark trial published March 29 in the New England Journal of Medicine.
The study found that patients who received the device had significantly lower mortality than heart valve patients who underwent open-heart surgery.
The study, published in the New England Journal of Medicine, included 795 seriously ill heart-valve patients who were randomly assigned to receive the new device or to undergo open-heart surgery. After one year, the mortality rate was 19.1 percent in the group that underwent open-heart surgery, but only 14.2 percent in the group that received the new device.
After 30 days, quality-of-life scores improved 19 points for patients who received the new device, compared with 3.7 points for open-surgery patients. At the one-year mark, quality-of-life scores increased 23.2 points in the device group and 21.9 points in the open-heart surgery group. Quality of life is measured on a 100-point scale, in which 5 points is considered important and 20 points is considered a very large improvement.
Aortic stenosis occurs when the heart’s aortic valve is narrowed, restricting blood flow from the heart to the body. The valve doesn't open properly, forcing the heart to work harder to pump blood.
Symptoms include fatigue, dizziness, chest pain/pressure, heart murmur, shortness of breath during activity, heart palpitations and fainting. Aortic stenosis can lead to heart failure and death. About 100,000 people in the United States have aortic stenosis. The traditional treatment is to replace the aortic valve through open-heart surgery.
The FDA approved the device in January 2014 to treat patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced through open-heart surgery. Such patients have a nearly 50 percent risk of death at the one-year mark unless they are treated.
As part of an ongoing clinical trial, Loyola also is making the device available to patients who have a one-year mortality risk of between 10 percent and 50 percent without treatment.
Low-risk patients (one-year mortality risk of between 4 percent and 10 percent) also can receive the device at Loyola as part of a clinical trial. These low-risk patients are randomly assigned to receive the device or to undergo traditional open-heart surgery to replace the heart valve.
Leya is a professor of medicine and director of Interventional Cardiology, and Bakhos is professor and chair of Thoracic and Cardiovascular Surgery at Loyola University Chicago Stritch School of Medicine.
For more information about minimally invasive heart valve replacement at Loyola, call our Cardiology department at (708) 216-4225.
Loyola University Health System (LUHS) is a member of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus is a 559-licensed-bed hospital that houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children's Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 255-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.