Newswise — HACKENSACK, N.J. — Interventional cardiologists and heart surgeons at Hackensack University Medical Center were the first in New Jersey to treat a patient with heart failure after a heart attack using a unique device that makes a weak, enlarged heart smaller — enabling it to pump blood more efficiently, relieving heart failure symptoms, and improving quality of life. The procedure is being evaluated through a clinical trial called ALIVE (American Less Invasive Ventricular Enhancement). Hackensack University Medical Center is participating in this study and is now enrolling eligible patients with heart failure and left ventricular scars and/or aneurysms.
Heart failure occurs when the heart becomes inefficient and weak, making it difficult for organs throughout the body to receive enough oxygenated blood to work effectively. Patients may experience shortness of breath, fatigue easily, have swelling in their legs, and develop other symptoms. When someone has had a major heart attack that causes scarring of tissue in the left ventricle of the heart (the chamber responsible for propelling freshly oxygenated blood out of the heart), the ventricle can become enlarged. An aneurysm can result, where part of the ventricle wall bulges out. In both cases, it becomes very difficult for the ailing heart to do its job.
The ALIVE study is evaluating the LIVE procedure (left invasive ventricular enhancement) in patients with heart failure who have left ventricular scars or aneurysms on the front of the heart and whose symptoms are not responding well to medical treatment. An interventional cardiologist and surgeon work together, taking a hybrid approach to implant the device components through a catheter threaded into the heart via a vein in the neck and a probe inserted through a 1-inch incision in the chest. Multiple anchors inserted into the heart pinch the area of dead tissue closed, excluding the non-functioning scar tissue from the rest of the heart and reshaping the healthy part of the heart to a more normal size.
This procedure is a promising alternative to traditional open-heart surgery to remove scarred heart tissue, which requires a large incision in the chest, attachment to a heart-lung machine, and a two-week hospital stay. "With the LIVE procedure, there is just a one-inch chest incision and the patient stays in the hospital for only two days," noted cardiologist Joseph E. Parrillo, MD, chair of the Heart and Vascular Hospital at Hackensack University Medical Center. "If successful, the patient experiences a relief of heart failure symptoms."
The LIVE device was approved in Europe and has been shown to improve function, such as a better ability to walk. At Hackensack University Medical Center, doctors performed the procedure in July 2021 in a 63-year-old man, reducing the volume of his left ventricle by 30% to a more normal size and already relieving his shortness of breath. Tests also showed that his heart is beating more effectively and that his ejection fraction (a measure of the strength of the left ventricle) has improved, too.
"This approach is very promising. It is not for everyone with heart failure, but for those with scar tissue in the heart, it offers another option," explained Tilak K.R. Pasala, MD, interim director, Structural and Congenital Heart Program and the structural interventional cardiologist involved in the first LIVE procedure at Hackensack University Medical Center.
“This minimally-invasive procedure has the potential to treat heart failure patients whose disease is beyond medications but not severe enough for heart transplant or implantation of an external left ventricle assist device," added Mark B. Anderson, MD, the cardiac surgeon who participated in the groundbreaking LIVE procedure.
The ALIVE study is recruiting patients who:
- Have symptomatic heart failure (New York Heart Association functional class III or ambulatory class IV)
- Are referred for treatment of left ventricular scars/aneurysms on the front of the heart that are contiguous
- Have a left ventricular ejection fraction under 45%
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.
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