Lankenau Medical Center, part of Main Line Health, has performed the first minimally invasive catheter-based procedure to treat aortic regurgitation in the Philadelphia region.
A cardiac team led by Basel Ramlawi, MD, chief of cardiothoracic surgery at Main Line Health, conducted the procedure in May as part of the JenaValve ALIGN-AR trial using an experimental Trilogy™ heart valve system. The trial is the first use of a valve designed to treat aortic regurgitation through a minimally invasive procedure called transcatheter aortic valve replacement (TAVR).
Lankenau Medical Center has used TAVR to treat patients with aortic stenosis for over 10 years and was one of the first U.S. medical centers selected to offer it after the FDA approved the treatment option.
Aortic regurgitation is a condition where the aortic valve does not close tightly and allows blood to leak back into the heart’s main pumping chamber. The leakage may prevent the heart from operating efficiently to deliver blood to the rest of the body. Symptoms may include fatigue and shortness of breath and tend to develop gradually over months or years. The ALIGN-AR trial is for patients with symptomatic, severe aortic regurgitation who are at high risk for open surgery. The trial, among other Lankenau innovations, allows the Lankenau heart team to offer treatment strategies for complex valve disease in a patient-tailored approach.
“We seek to treat our patients with the most effective, minimally invasive therapies available for their specific condition,” said Ramlawi, who also is co-director of the Lankenau Heart Institute and a professor for Lankenau Institute for Medical Research, which is Main Line Health’s research division and oversees clinical trials. “We bring unique and distinct capabilities to this effort, with a decade of experience treating patients suffering from aortic stenosis using TAVR.”
Lankenau heart surgeons are national leaders in teaching minimally invasive and catheter-based valve procedures. Lankenau has performed more than 2,100 TAVR procedures for various conditions since 2012, including more than 300 in 2022. It is among the top 10% of highest performing TAVR centers in the nation.
The JenaValve Trilogy™ has been approved for commercial use in Europe but is not approved in the United States and is currently being investigated in the ALIGN-AR trial.
Lankenau continues to be a national leader in minimally invasive heart surgery. It performs the highest percentage of robotically assisted coronary bypass procedures in the country. It also is a leader in mitral valve repair using the MitraClipTM, a minimally invasive treatment for mitral valve regurgitation. The cardiac team performed its 300th MitraClip procedure last year.
This document uses words such as treatment, minimally invasive, and patient. Please remember the JenaValve ALIGN-AR is a research study and the use of these terms does not mean the use of the device has been found to be safe or effective for your condition.