Clinical trial evaluates minimally invasive treatment of severe heart valve disorder
Individuals with severe tricuspid valve regurgitation, in which the valve between the two right heart chambers closes incorrectly, may be eligible for a new clinical trial to treat the condition. The clinical trial is being led by cardiothoracic surgeons at Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital (RWJUH) who recently treated a patient with a next-generation, investigational transcatheter heart valve designed as part of the trial.
Tricuspid regurgitation (TR) is a condition in which the heart's tricuspid valve does not close tightly, causing blood to flow backwards in the heart during part of the cardiac cycle. This condition increases the workload on the heart and if left untreated ultimately leads to heart failure, liver disease, and lung damage.
Though tricuspid valvular disease is highly prevalent and fatal in its most advanced stages, the tricuspid valve has long been referred to as the "forgotten" valve in large part because there have been no good treatment options for patients, according to Mark J. Russo, MD, MS, professor of surgery and chief of cardiac surgery at Rutgers Robert Wood Johnson Medical School, who is principal investigator for the clinical trial. The standard treatments available to patients with TR are open-heart surgery or, more often, management with medications for patients who are not able to have surgery. While medications may be temporarily palliative for some of the patient's symptoms, if the underlying valve condition is not corrected, the disease will worsen.
The TRISCEND II Pivotal clinical trial studies a percutaneous, or through the skin, treatment option for patients with symptomatic, severe TR. The purpose of the study is to evaluate the safety and effectiveness of an investigational device called the EVOQUE system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with severe or greater TR.
Through the clinical trial, Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital have the capacity to offer a minimally invasive procedure to patients who meet the trial's criteria. Using the EVOQUE valve system, the TRISCEND II trial provides a catheter-based treatment alternative to surgery and medical management. This is a minimally invasive alternative for patients who are not candidates for traditional surgical therapy.
In mid-June, the Rutgers Robert Wood Johnson team led by Dr. Russo treated the first patient in New Jersey to undergo transcatheter tricuspid valve replacement. The procedure lasted approximately 90 minutes and the patient was successfully discharged with improvement in heart failure symptoms a few days following the procedure.
"Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital continue to serve as a national leader in treating valve disease. Our focus on less invasive approaches and rapid recovery have helped us maintain outcomes that far exceed national benchmarks in safety, life expectancy, and risks of complications," said Leonard Y. Lee, MD, James W. Mackenzie, M.D. Endowed Chair in Surgery and chair and professor of the Department of Surgery at Rutgers Robert Wood Johnson Medical School.
"By providing a new and effective treatment for patients who previously had no option, the EVOQUE valve may change the paradigm for the treatment of tricuspid regurgitation," said Dr. Russo. "As one of only a few sites in the region—and the first in New Jersey—to offer this important therapy, Robert Wood Johnson University Hospital continues to pioneer new treatments in an effort to offer lifesaving therapies for more patients."
Provided by Rutgers Robert Wood Johnson Medical School
