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The PROTECT IV study is comparing cardiac catheterization with and without the addition of a small heart pump called Impella® to see if Impella support relieves heart disease symptoms and improves heart function and overall health better than catheterization alone. “As a leading provider of cardiovascular care, ranked #43 in the nation — the highest ranked medical center in New Jersey for Cardiology & Heart Surgery by U.S. News & World Report in 2022 — Hackensack University Medical Center is often able to provide patients with leading-edge clinical trials like this one,” noted David B. Landers, M.D., FACC, FSCAI, interim director, Division of Cardiology, Hackensack University Medical Center and assistant professor of Cardiology, Hackensack Meridian Health School of Medicine.
In people with coronary artery disease, cardiac catheterization is performed to view and open blockages in the arteries supplying oxygen-rich blood to the heart. Patients may have angioplasty to open the blockage and then have a stent inserted to keep the artery open. A catheter is advanced to the heart through a blood vessel, usually the femoral artery in the groin, and the interventional cardiologist inserts tiny tools through the catheter to restore blood flow through a blocked heart artery.
Some people with complex coronary artery disease and congestive heart failure may not be healthy enough to undergo open heart surgery however. For them, medical treatment was once the only option. For these patients, doctors recently started using the Impella device to support heart function during percutaneous intervention. The Impella heart pump is inserted into the heart via the same catheter used during angioplasty to provide hemodynamic support to the patient during the procedure.
With the hemodynamic support of the Impella device, the heart is rested, the kidneys receive adequate blood, and there is no time during the procedure when the patient’s hemodynamic status is compromised. “The addition of the heart pump offers another treatment option for patients who are either not candidates for surgery or who have chosen not to have surgery,” explained Dr. Faraz. “But there has not been rigorous data showing that using Impella for hemodynamic support translates into long-term clinical benefit. That is what PROTECT IV was designed to determine.
“Hackensack University Medical Center’s heart care team has been instrumental in establishing an infrastructure here that gives us the ability to perform these pioneering research activities,” he continued. “With my appointment as Regional Leader for the Southeast, we have opportunities to interact with more study sites and potentially broaden exposure to the Hackensack Meridian Health brand.”
“If the data show conclusively that the hemodynamic support provided by the Impella device is superior to coronary angioplasty alone, it could lead to a new standard of care for high-risk patients with complex coronary artery disease and impaired heart function, including new guidelines from the American Heart Association and American College of Cardiology,” concluded Mark Anderson, M.D., chairman of the Department of Cardiac Surgery and a cardiothoracic surgeon at the Heart and Vascular Hospital at Hackensack Meridian Hackensack University Medical Center.
Eligible patients for PROTECT IV include people ages 18-90 with coronary artery disease in multiple blood vessels and congestive heart failure (left ventricular ejection fraction of 40% or less, an indicator of weakened heart pumping ability). Hackensack University Medical Center is now recruiting for this study. For more information, contact 844-HMH-WELL (844-464-9355).
ABOUT HACKENSACK UNIVERSITY MEDICAL CENTER
Hackensack University Medical Center, a 771-bed nonprofit teaching and research hospital, is the largest provider of inpatient and outpatient services in New Jersey. Founded in 1888 as Bergen County’s first hospital, it was the first hospital in New Jersey and second in the nation to become a Magnet®-recognized hospital for nursing excellence. The academic flagship of Hackensack Meridian Health, Hackensack University Medical Center’s campus is home to facilities such as John Theurer Cancer Center, the Heart & Vascular Hospital, and the Sarkis and Siran Gabrellian Women’s and Children’s Pavilion. Recognized as being in the top 1% of hospitals in the nation and #1 in New Jersey by U.S. News & World Report’s 2021-22 “Best Hospitals” Honor Roll, Hackensack University Medical Center also ranked as high-performing in cancer care, cardiology and heart surgery, gastroenterology and GI surgery, geriatrics, nephrology, neurology and neurosurgery, orthopedics, pulmonology, and urology. Hackensack University Medical Center’s comprehensive clinical research portfolio includes studies focused on precision medicine, translational medicine, immunotherapy, cell therapy, and vaccine development.
ABOUT HACKENSACK MERIDIAN HEALTH RESEARCH INSTITUTE (HMHRI):
HMHRI leads and organizes a connected ecosystem bringing together clinicians, scientists, and educators to respond to the health problems of our time, in real-time. HMHRI is dedicated to accelerating discovery, innovation, and translation of scientific breakthroughs that address unmet clinical needs.
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