West Orange, NJ – RWJBarnabas Health performed an integral role in the groundbreaking PARTNER 3 study, which was recently published in The New England Journal of Medicine and presented at the 2019 American College of Cardiology Scientific Session in New Orleans, LA.
The PARTNER 3 Trial compared treatment with the minimally invasive Transcatheter Aortic Valve Replacement (TAVR) using the SAPIEN 3 valve, versus conventional open heart surgical aortic valve replacement, in 1,000 patients with severe symptomatic aortic stenosis (AS), who were considered to be at low risk of death from surgery. Aortic stenosis is a narrowing of the aortic valve that occurs as a result of calcium deposits that cause the valve to narrow. Findings from this trial demonstrated that—even in this group of patients considered to be excellent candidates for heart surgery—death, stroke and the need for rehospitalization at one year were significantly less likely for those treated with TAVR compared with surgery.
“These are great findings for patients with aortic stenosis and those who care for them,” said Mark J. Russo, MD, MS, the Chief of Division of Cardiac Surgery at Rutgers-Robert Wood Johnson Medical School and the Director of Structural Heart Disease at Robert Wood Johnson University Hospital, an RWJBarnabas Health facility. The PARTNER 3 study, based out of Newark Beth Israel Medical Center, also an RWJBarnabas Health facility, demonstrated that TAVR was as good or better than surgery on nearly every metric and in every subgroup. “We now have two excellent treatment options for this condition. As an organization, we are proud to provide a leadership role and be among the highest enrolling centers in this groundbreaking study.”
Dr. Russo was one of the co-authors of the study which was published in the New England Journal of Medicine: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. He went on to say, “The PARTNER studies represent a 10-year effort to expand and improve treatment options for patients with severe symptomatic aortic stenosis. Following these landmark findings, the next step in this journey is to ensure all patients have access to treatment. There are an estimated 250,000 to 350,000 people in the U.S. afflicted with severe symptomatic aortic stenosis. However, approximately one-half of those patients never undergo treatment. In the absence of treatment, the prognosis with severe symptomatic aortic stenosis is dismal. As many as 50 percent of untreated patients die within two years of onset, and nearly all untreated patients are dead within five years. In 2019, with this technology and these findings, no patient in the U.S. should die from untreated aortic stenosis.”
The results of the randomized PARTNER 3 trial, sponsored by Edwards Lifesciences Corporation, makers of the SAPIEN 3 transcatheter aortic valve, demonstrated superiority for the more minimally invasive TAVR approach over conventional surgical aortic valve replacement. The PARTNER 3 Trial randomized 1,000 total patients at 71 centers between March 2016 and October 2017. Patients were assigned to undergo either TAVR with the SAPIEN 3 valve or surgery with any commercially available surgical valve. All patients were followed for at least one year, and 10-year clinical and echocardiographic follow-up is planned for all patients.
The results of the trial were presented Sunday, 3/17, as part of the late-breaking clinical trials at the American College of Cardiology 68th Annual Scientific Session in New Orleans, LA.
Dr. Russo, an internationally known expert on heart valve disease, specializes in complex and reoperative aortic and valvular surgery. He is one of the few surgeons in the country that is an expert in both TAVR and open heart valve replacement, and he leads multiple clinical trials focused on developing novel therapies for valvular disease that are now ongoing within RWJBarnabas Health. Please find his full bio here.
Transcatheter Aortic Valve Replacement (TAVR) is a treatment approved by the U.S. Food and Drug Administration for aortic stenosis. During the procedure, a synthetic or artificial valve is collapsed and threaded through a blood vessel, usually through the groin, to the heart. Imaging technology is used to visualize the valve’s precise placement and then expand the new valve. It begins to function immediately and works like a normal, healthy valve that allows for proper blood flow through the chambers of the heart. No chest incision is required, resulting in quicker recovery time, less pain, and fewer complications. Patients undergoing this procedure at RWJBarnabas hospitals typically go home the day following the procedure.
As New Jersey’s most extensive heart care network, RWJBarnabas Health continues to provide the state's premier TAVR program with outcomes that far exceed national benchmarks in safety, life expectancy, and risks of complications. More information on the program can be found here.
ABOUT RWJBarnabas Health
RWJBarnabas Health is the largest, most comprehensive health care system in New Jersey, with a service area covering nine counties with five million people. The system includes eleven acute care hospitals – Clara Maass Medical Center in Belleville, Community Medical Center in Toms River, Jersey City Medical Center in Jersey City, Monmouth Medical Center in Long Branch, Monmouth Medical Center Southern Campus in Lakewood, Newark Beth Israel Medical Center in Newark, RWJUH in New Brunswick, RWJUH Somerset in Somerville, RWJUH Hamilton, RWJUH Rahway and Saint Barnabas Medical Center in Livingston; three acute care children’s hospitals and a leading pediatric rehabilitation hospital with a network of outpatient centers (Children’s Specialized Hospital) with its multiple outpatient centers, a freestanding 100-bed behavioral health center, two trauma centers, a satellite emergency department, ambulatory care centers, geriatric centers, the state’s largest behavioral health network, comprehensive home care and hospice programs, fitness and wellness centers, retail pharmacy services, a medical group, multi-site imaging centers and two accountable care organizations.
RWJBarnabas Health is New Jersey’s largest private employer – with more than 33,000 employees, 9,000 physicians and 1,000 residents and interns – and routinely captures national awards for outstanding quality and safety. RWJBarnabas Health recently announced a partnership with Rutgers University to create New Jersey’s largest academic health care system. The collaboration will align RWJBarnabas Health with Rutgers’ education, research and clinical activities, including those at the Rutgers Cancer Institute of New Jersey and Rutgers University Behavioral Health Care. RWJBarnabas Health, in partnership with Rutgers Cancer Institute of New Jersey - the state's only NCI-designated Comprehensive Cancer Center - brings a world class team of researchers and specialists to fight alongside you, providing close-to-home access to the latest treatment and clinical trials.
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