Florida Hospital Performs Nation's First Tricuspid Valve Repair With PASCAL Precision System After FDA Approval
Naples Comprehensive Health (NCH) announced on October 29 in Naples, Florida, that its Rooney Heart Institute has performed the nation's first tricuspid valve repair using Edwards Lifesciences' PASCAL Precision system following the system's U.S. Food and Drug Administration approval for this use. The procedure was led by Robert Cubeddu, MD.
Tricuspid regurgitation occurs when the valve on the right side of the heart does not close properly, allowing blood to flow backward. Patients with severe disease may experience fatigue, shortness of breath and swelling that can make everyday activities exhausting. The PASCAL Precision system repairs the valve through a catheter-based transcatheter edge-to-edge procedure, bringing portions of the valve's leaflets together to help reduce leakage without open-heart surgery. It is approved to improve quality of life and functional status in patients who continue to experience symptoms of severe tricuspid regurgitation despite optimal medical therapy; eligible patients must be at intermediate or greater risk for surgery and be evaluated by a multidisciplinary heart team.
NCH said the Rooney Heart Institute treats more patients with tricuspid regurgitation than any other center in Florida, and that before FDA approval it was the nation's highest-enrolling clinical trial site for the treatment, helping evaluate the therapy. The institute has also performed Florida's first percutaneous tricuspid valve replacement, a separate catheter-based procedure that replaces rather than repairs the valve.
Dr. Cubeddu, the Brynne and Bob Coletti Endowed Chair and President of the Rooney Heart Institute, said that for patients with severe tricuspid regurgitation even simple activities can become exhausting, and that having another minimally invasive treatment option allows care to be better tailored to each patient's needs. NCH President and CEO Paul Hiltz said helping evaluate the treatment through clinical research and then performing the nation's first procedure following FDA approval speaks to the team's expertise and gives Florida patients access to a team experienced in the therapy.
Source: GSM · USA (original Chinese edition)
Photo: 图：医护人员在心脏导管实验室进行导管手术（资料图，非本例手术画面）。照片：美国海军医学（Navy Medicine），公共领域，经 Wikimedia Commons。 / Medical staff performing a catheter-based procedure in a cardiac catheterization laboratory (illustrative photo, not the procedure in this story). Photo: Navy Medicine, public domain, via Wikimedia Commons.
