Transcatheter tricuspid valve repair toward a surgical standard: first-in-man report of direct annuloplasty with a cardioband device to treat severe functional tricuspid regurgitation

Cardioband (ValtechCardioR, OrYehuda, Israel) is a transcatheter annuloplasty system designed to implant a Dacron surgical-like adjustable band with a sutureless technique under echocardiographic and fluoroscopic guidance. We describe the first-in-human clinical experience of treatment of severe tricuspid regurgitation (TR) with this device. The ‘first-in-human’ patient was a 74-year-old woman with torrential functional TR associated with tricuspid annular dilation and a pacemaker lead. She was admitted in New York Heart Association functional class II after an episode of decompensated heart failure. The EuroSCORE II–estimated risk of operative mortality was 7.0%. After multidisciplinary heart team discussion, the patient was considered eligible for transcatheter tricuspid valve (TV) annuloplasty. The intervention was performed under general anaesthesia, fluoroscopy, as well as transoesophageal echocardiography (TEE) guidance (Panel A). The catheter was advanced from anterior-septal commissure, in a clockwise direction, along the septal-posterior commissure (Supplementary material online, Video S1). Finally, following adjustments of Dacron band under TEE guidance, TR was reduced from severe to mild (Panels B and C to D and E), with a corresponding change in regurgitant volume by two-dimensional proximal isovelocity surface area method from 264 ml/s to 36 ml/s (Supplementary material online, Video S2). The TV septolateral dimension was reduced from 43 to 22 mm with no damage of the right coronary artery. Due to rupture of the tensioning wire, a second band was implanted. The second implant was tensioned more conservatively resulting in less reduction of TR. Predischarge echo showed stable annular remodeling and a reduced, as compared to baseline, but still severe TR. This first-in-human case demonstrates the feasibility of the percutaneous remodelling of the TV by implanting the Cardioband device, associated with reduction in annular dimensions and TR severity. Longer-term follow-up and more patients are required to confirm these initial results and will define the standard transcatheter strategies of future TR treatment. Supplementary material is available at European Heart Journal online.