Newswise — HACKENSACK, N.J. — Heart doctors at Hackensack University Medical Center were the first in northern New Jersey and the third in the state to perform Tendyne™ Transcatheter Mitral Valve Implantation (TMVI) in a patient with a leaky mitral valve in the heart. Tendyne TMVI, which is being offered through a clinical trial, may become another therapeutic option for patients who cannot have surgery or other procedures.
The mitral valve regulates one-way blood flow from the left atrium into the left ventricle of the heart, where it can be pumped out to the rest of the body. Mitral regurgitation is a disorder that happens when the mitral valve doesn’t close completely, allowing blood to backflow into the left atrium. As a result, the heart must work much harder to pump out oxygen-rich blood. People with untreated mitral regurgitation may develop heart failure and experience shortness of breath that makes it difficult to go up a flight of stairs or walk a block. If the heart failure becomes severe, it could be fatal.
Current treatments include open-heart surgery (which requires the patient to be put on a heart-lung machine and have a large incision in the chest) or the insertion of a device called the MitraClip®. But not all patients are candidates for these approaches because they had two or three prior heart surgeries already, they have other health problems that make open-heart surgery too dangerous, or their anatomy prohibits the insertion of the MitraClip (which is advanced to the heart through a catheter).
The Tendyne TMVI device is implanted using a “hybrid” approach that brings together a cardiac surgeon and structural heart cardiologist. Through a 1-inch incision made in the left side of the chest by the surgeon, as well as a catheter inserted into a blood vessel by the structural cardiologist, the various components of the Tendyne device are advanced to the left atrium and ventricle of the heart. A self-expanding parachute-like device containing a functioning valve (available in a variety of sizes) deploys inside the defective mitral valve. A tether anchored to the outside of the heart secures the device in place. The procedure can be completed without needing to attach the patient to a heart-lung machine, with the patient’s heart still beating during the operation.
“We have highly experienced cardiac surgery and structural heart teams, making us well-positioned to offer this treatment. The first patient we treated is doing exceedingly well,” noted Joseph E. Parrillo, MD, chair of the Heart and Vascular Hospital at Hackensack University Medical Center. “Depending on what type of mitral valve problem a patient has, there may now be a greater range of treatment choices. If the clinical trial results are positive, this could be a potentially revolutionary technique that may become the standard of care for replacing a damaged mitral valve without surgery. This is about as innovative as it gets.”
The Tendyne valve is the first-of-its-kind for patients in need of symptom relief and quality-of-life improvement without open surgery and when transcatheter mitral repair is not possible. It is already approved for use in Europe. Global clinical trial results to date have demonstrated that the procedure is safe and that 98.9% of Tendyne patients experienced elimination of mitral regurgitation by the time they left the hospital, which was sustained through the one-year follow-up period.
“Of the 2,000 cardiac surgery programs in the United States, only about 30 are offering TMVI,” explained Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. “This is another example of our commitment to offer the latest technologies to the members of the communities we serve, as early in their development as possible.”
ABOUT HACKENSACK UNIVERSITY MEDICAL CENTER
Hackensack University Medical Center, a 771-bed nonprofit teaching and research hospital located in Bergen County, is the largest provider of inpatient and outpatient services in New Jersey. Founded in 1888, it was the 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, receiving its sixth consecutive designation in 2019 from the American Nurses Credentialing Center. The academic flagship of the Hackensack Meridian Health network, Hackensack University Medical Center ranked #1 in New Jersey and #7 in the New York metro area by U.S. News & World Report’s 2021-2022 “Best Hospitals” Honor Roll. Hackensack University Medical Center is also rated as High Performing in 14 procedures and conditions, and sets the standard for all New Jersey hospitals in several specialties including New Jersey's only nationally-ranked Neurology & Neurosurgery and Urology programs; ranked nationally in Cardiology & Heart Surgery; New Jersey’s Best Urology and Neurology & Neurosurgery programs since 2013; with Cardiology & Heart Surgery, Gastroenterology & GI Surgery, Geriatrics and Orthopedics ranked among the top in New Jersey. This award-winning care is provided on a campus that is home to facilities such as John Theurer Cancer Center, a consortium member of the NCI-designated Georgetown Lombardi Comprehensive Cancer Center and recognized as the #1 hospital for cancer care in New Jersey by U.S. News & World Report’s 2021-22 "Best Hospitals" Honor Roll; the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women’s and Children’s Pavilion, which houses the Joseph M. Sanzari Children’s Hospital and Donna A. Sanzari Women’s Hospital, recognized as being in the top 1% of children’s hospitals in the nation and #1 children’s hospital in New Jersey by U.S. News & World Report’s 2021-22 "Best Hospitals" Honor Roll; as well as the Deirdre Imus Environmental Health Center. Hackensack University Medical Center is listed on the Green Guide’s list of Top 10 Green Hospitals in the U.S. Our comprehensive clinical research portfolio includes studies focused on precision medicine, translational medicine, immunotherapy, cell therapy, and vaccine development. The hospital has embarked on the largest healthcare expansion project ever approved by the state: Construction of the Helena Theurer Pavilion, a 530,000-sq.-ft., nine-story building, which began in 2019. A $714.2 million endeavor, the pavilion is one the largest healthcare capital projects in New Jersey and will house 24 state-of-the-art operating rooms with intraoperative MRI capability, 50 ICU beds, and 150 private patient rooms, including a dedicated 50-bed Orthopedic Institute.