Setting Standards for Diagnosis, Repair & Replacement
The Valve Team at Washington University School of Medicine is among the first in the world to use a transfemoral transcatheter device for the treatment of severe tricuspid regurgitation (TR).
“In the middle of the COVID pandemic, we submitted a request to the Food & Drug Administration (FDA) for “expanded access” — or compassionate use — of the Intrepid™ mitral valve system to treat an elderly gentleman who had had three previous bypass surgeries and was experiencing severe TR,” said interventional cardiologist Alan Zajarias, MD, co-director of the Washington University/Barnes-Jewish Hospital Center for Valvular Heart Disease. “We used a transfemoral approach and it worked beautifully! We’re now working to make this an option for other patients.”
The procedure was the fifth in the country of using the manufactured mitral valve for transcatheter tricuspid valve replacement. Six months ago, Dr. Zajarias, along with cardiovascular surgeon Puja Kachroo, MD, and other colleagues, performed the same procedure on a second patient, a female diagnosed with severe pulmonary hypertension. She also was granted FDA- expanded access approval and is doing well.
“We have made great strides in aortic and mitral valve repair and replacement,” said Dr. Zajarias. “Now there’s raised awareness that tricuspid valve problems are not as benign as we thought, and we need to better understand who will benefit from these procedures. We have several new patients a week that have severe TR, and while surgery is considered the standard of care, we see good options on the horizon for transcatheter repair and replacement that are currently being evaluated in clinical trials.”
In the United States, there are no FDA-approved devices for catheter-based tricuspid valve replacement or repair. While some devices exist that can repair the valves, none are FDA-approved for use in the United States. Dr. Zajarias believes that could change within the next two to three years. The Washington University Valve team has joined the CLASP-2TR study, a large, multi-center clinical trial evaluating the Pascal Transcatheter Tricuspid Valve Repair
(TTVR) System. The device was approved for use in Europe last year.
As the field rapidly evolves, Washington University cardiologists are leading efforts to establish standardization of image acquisition for valvular heart disease. Nishath Quader, MD, chair of the Interventional Echo Council for the American Society of Echocardiography, said, “When it comes to assessing patients for percutaneous valve therapies, there appears to be a lot of discrepancies in the screening TEE. The Council just published guidelines that will standardize the images needed for tricuspid valve analysis prior to considering patients for tricuspid valve therapies.”
Majesh Makan, MD, associate director of the Cardiac Diagnostic Laboratory, already is working to implement new protocols for TR analysis here at Washington University/Barnes-Jewish Hospital. “Transthoracic echocardiography (TTE) is very challenging in obese and elderly patients,” he noted. “It takes an experienced sonographer to get all of the images necessary to understand the etiology and severity of TR and TV pathologies. With Dr. Quader’s efforts to develop national guidelines, we have a jumpstart in implementing those here.”
I’m very optimistic that with new imaging guidelines, we can accurately diagnose TR earlier and determine who is a good candidate for surgery or transcatheter therapies. We envision that better diagnosis, early detection and new devices coming soon will help lower the risk of heart failure, hospitalizations, or death as a result of severe tricuspid valve regurgitation
Alan Zajarias, MD, Professor of Medicine and Co-director of the Washington University/Barnes-Jewish Hospital Center for Valvular Heart Disease
Treatment of aortic stenosis continues to evolve. In addition to Drs. Zajarias, Quader and Makan, other members of the valve team include cardiologists Marc Sintek, MD, and John Lasala, MD, PhD, as well as cardiovascular surgeons Puja Kachroo, MD; Spencer Melby, MD; and Harold Roberts, Jr., MD.
For more news from the Cardiovascular Division, view their Winter 2022 Alumni Newsletter here.