The heart teams at the Piedmont Heart Institute and the University of Virginia Health System successfully performed the first two implantations in the United States of the Trisol transcatheter tricuspid valve replacement.
These procedures were part of a US Food and Drug Administration-approved early feasibility study (EFS), led by principal investigator Isaac George, MD, which aims to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
The first case was performed in an 84-year-old woman with severe symptomatic TR at Piedmont Heart Institute through the right internal jugular vein. The TR level was reduced from severe to none, and the patient was discharged from the hospital within two days after the procedure.
“This marks a major milestone in the management of TR. We were able to abolish the patient’s valvular heart disease via a minimally invasive procedure without the need for cardiopulmonary bypass. The patient was mobilizing within hours of the procedure and her recovery was steam-lined and expeditious,” according to Pradeep Yadav, MD, James Stewart, MD, and Vinod Thourani, MD, of the Piedmont Heart Institute who conducted the first case, in a release.
The second case was performed in a 77-year-old woman with severe symptomatic TR at the University of Virginia Health System. The TR level was reduced from severe to trace, and the patient was discharged from the hospital within two days after the procedure.
“The patient had a gratifying result with essentially elimination of her tricuspid regurgitation, and rapid recovery, along with significant and rapid improvement in her symptoms. We look forward to further investigation of the Trisol valve,” says Scott Lim, MD, of University of Virginia Health System, who conducted the second case, in a release.
Trisol’s patented valve features a distinctive design that sets it apart from other tricuspid valves technologies, according to a release from Trisol. Trisol valve is comprised of a single leaflet, the leaflet is affixed by two commissures enabling it to function as a bi-leaflet valve. Notably, this novel design facilitates a slower closing of the leaflets, a feature intended to preserve the right ventricular function following the valve replacement. Trisol’s valve employs axial anchoring, which reduces the risk of conductive issues.
“We are fortunate to collaborate with such skilled investigators. We are pleased with the preliminary outcomes and look forward to ongoing progress of the US EFS,” says Ron Davidson, Trisol’s CEO, in a release.
To date, Trisol Valve has been implanted in 10 human subjects. Five of these implants were performed as part of the Israeli Pilot Study, led by principal investigator Ran Kornowski, MD. Currently, the longest follow-up period exceeds two years. Trisol aims to complete its EFS and initiate pivotal studies in 2024.
Photo caption: An illustration depicting Trisol valve deployment
Photo credit: Trisol / PR Newswire