Loyola First in State to Implant New Heart Valve | Loyola Medicine
Tuesday, August 18, 2015

Loyola first in state to implant newly designed, minimally invasive heart valve

newly  designed, minimally invasive heart valve

MAYWOOD, Ill.  – Loyola University Medical Center is the first center in Illinois to implant a new percutaneous aortic heart valve that does not require open heart surgery.

The device is called the CoreValve®Evolut™ R System. It is deployed with a catheter, which is inserted into an artery and guided to the heart. Once in place, the artificial valve takes over the function of the diseased valve. The system is much less invasive than open surgery.

The newly designed system enables the physician to recapture and reposition the device in order to obtain a more accurate deployment every time. The system, recently approved by the Food and Drug Administration, is the first and only recapturable and repositionable device commercially available in the United States. It sets a new standard for transcatheter aortic valve replacement (TAVR) in the United States.

J. Michael Tuchek, DO, lead implanter of the CoreValve® device at Loyola, and Bruce Lewis, MD, implanted the first CoreValve® Evolut™ R System in Illinois. Dr. Tuchek, who consulted in the engineering and design of the device, is a clinical associate professor in the Department of Thoracic and Cardiovascular Surgery. Dr. Lewis is an interventional cardiologist and a professor in the Department of Medicine.

Dr. Tuchek said the unique design of the CoreValve® Evolut™ R System “allows for superior control during deployment of the CoreValve®, along with the ability to recapture and reposition the valve.”

Dr. Tuchek noted the device is the smallest-diameter TAVR device that is commercially available.  “The new device also optimizes the valve design to enhance sealing and thus prevent aortic insufficiency postoperatively,” Dr. Tuchek said.

The new system represents a significant advance in the TAVR field, said Fred Leya, MD, Loyola’s director of Interventional Cardiology. “There’s no question that this is a superior product,” Dr. Leya said. “The technology is a game changer for patients with aortic stenosis.” Dr. Leya is a professor in the Division of Cardiology of Loyola University Chicago Stritch School of Medicine.

Loyola was the only center in Illinois to participate in a landmark clinical trial of  CoreValve®, which was published 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.

After the device was approved by the U.S. Food and Drug Administration, Loyola became the first Illinois center to offer it outside of a clinical trial.

Loyola has been implanting CoreValves® for more than four years. Loyola’s dedicated implanting team includes two cardiovascular surgeons (Drs. Tuchek and Mamdouh Bakhos, MD) and two interventional cardiologists (Drs. Leya and Lewis). The team is participating in ongoing CoreValve® trials and leads the state in implanting the device.

The CoreValve® system has been implanted in more than 75,000 patients in 60 countries, including in more than 150 Loyola patients.

The improved device now is FDA-approved for patients judged to be at high or extremely high risk for conventional open-heart aortic valve surgery (with an estimated 30-day mortality rate of at least 15 percent). Loyola is the only site in Illinois participating in a clinical trial in which the device is being implanted in lower-risk patients. The trial is called SURTAVI (SURgical vs. Transcatheter Aortic Valve Implantation). SURTAVI is being conducted in 76 sites in eight countries for patients who do not qualify for the transcatheter valves commercially. The trial provides the only opportunity for lower-risk patients (called intermediate risk) to receive CoreValve®.

In addition, extreme-risk patients with other valve disorders are being enrolled in the Expanded Use Study (EUS). Principal investigators at the Loyola site for the SURTAVI and EUS trials are Drs. Leya and Bakhos. Dr. Bakhos is chair of the Department of Thoracic and Cardiovascular Surgery.

For more information, or to make an appointment to be evaluated, please contact Loyola’s Valve Center at 708-327-2120.

CoreValve® is used to treat aortic stenosis, which occurs when the heart’s aortic valve is narrowed, restricting blood 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 murmurs, 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.

About Loyola Medicine and Trinity Health

Loyola Medicine, a member of Trinity Health, is a quaternary care system based in the western suburbs of Chicago that includes Loyola University Medical Center (LUMC), Gottlieb Memorial Hospital, MacNeal Hospital and convenient locations offering primary and specialty care services from 1,877 physicians throughout Cook, Will and DuPage counties. LUMC is a 547-licensed-bed hospital in Maywood that includes the William G. and Mary A. Ryan Center for Heart & Vascular Medicine, the Cardinal Bernardin Cancer Center, a Level 1 trauma center, Illinois's largest burn center, a certified comprehensive stroke center and a children’s hospital. Having delivered compassionate care for over 50 years, Loyola also trains the next generation of caregivers through its teaching affiliation with Loyola University Chicago’s Stritch School of Medicine and Marcella Niehoff School of Nursing. Gottlieb is a 247-licensed-bed community hospital in Melrose Park with 150 physician offices, an adult day care program, the Gottlieb Center for Fitness, the Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park. MacNeal Hospital is a 374-bed teaching hospital in Berwyn with advanced inpatient and outpatient medical, surgical and psychiatric services, advanced diagnostics and treatments. MacNeal has a 12-bed acute rehabilitation unit, a 25-bed inpatient skilled nursing facility, and a 68-bed behavioral health program and community clinics. MacNeal has provided quality, patient-centered care to the near west suburbs since 1919.

Trinity Health is one of the largest multi-institutional Catholic healthcare systems in the nation, serving diverse communities that include more than 30 million people across 22 states. Trinity Health includes 92 hospitals, as well as 109 continuing care locations that include PACE programs, senior living facilities and home care and hospice services. Its continuing care programs provide nearly 2.5 million visits annually. Based in Livonia, Mich., and with annual operating revenues of $18.3 billion and assets of $26.2 billion, the organization returns $1.1 billion to its communities annually in the form of charity care and other community benefit programs. Trinity employs about 129,000 colleagues, including 7,800 employed physicians and clinicians. Committed to those who are poor and underserved in its communities, Trinity is known for its focus on the country's aging population. As a single, unified ministry, the organization is the innovator of Senior Emergency Departments, the largest not-for-profit provider of home health care services—ranked by number of visits—in the nation, as well as the nation’s leading provider of PACE (Program of All Inclusive Care for the Elderly) based on the number of available programs.