佛罗里达州Naples医院完成全美首例PASCAL Precision三尖瓣修复术，为FDA批准后首次临床应用
Naples Comprehensive Health（NCH）10月29日在佛罗里达州 Naples 宣布，其 Rooney Heart Institute 已完成全美首例使用 Edwards Lifesciences 的 PASCAL Precision 系统进行的三尖瓣修复手术。这是该系统获美国食品药品监管局（FDA）批准用于三尖瓣修复后的首次临床应用，手术由 Robert Cubeddu 博士主刀。
三尖瓣反流是指心脏右侧的三尖瓣关闭不全、血液反流。重症患者会出现乏力、气短与浮肿，日常活动也会变得吃力。PASCAL Precision 系统经导管进行缘对缘修复，把瓣叶部分拉拢以减少反流，无需开胸手术。该系统获批的用途是：在已接受优化药物治疗后仍有重度三尖瓣反流症状、且手术风险为中危以上的患者中，改善其生活质量与功能状态；是否适用须经多学科心脏团队评估。
NCH 表示，Rooney Heart Institute 治疗的三尖瓣反流患者数量为佛罗里达州各中心之最；在 FDA 批准之前，该中心也是这项疗法全国入组量最高的临床试验点，参与评估了该疗法。此前，该中心还完成过佛罗里达州首例经皮三尖瓣置换（以导管置换瓣膜，与本例的修复是不同的术式）。
Cubeddu 博士是 Brynne and Bob Coletti 冠名主席、Rooney Heart Institute 院长。他表示，对重度三尖瓣反流患者来说，连简单的活动都可能令人精疲力竭；多一种微创治疗选择，能让医生更好地按每位患者的情况定制治疗。NCH 总裁兼首席执行官 Paul Hiltz 表示，从参与临床研究评估这项疗法、到在 FDA 批准后完成全国首例手术，体现了该团队的专业能力，也让佛罗里达州患者能就近获得这项新疗法。
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.
来源：GSM·美国（原文链接）
图片来源：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.
