Percutaneous transvenous direct annuloplasty of a human tricuspid valve using the Valtech Cardioband

We report here a case of a 80-year-old man with signs of right heart failure, severe tricuspid regurgitation (TR), tricuspid annular dilatation to 5.2 × 7cm, mixed pre- and post-capillary pulmonary artery hypertension (systolic pulmonary artery pressure (sPAP) 60 mmHg), beginning lung fibrosis, infrarenal abdominal aortic aneurysm, and porcelain aorta underwent a direct tricuspid annuloplasty using a novel transvenous approach with a flexible ring system (Valtech Cardioband Tricuspid). The implantation procedure of this non-CE-mark device was approved by ethics committee and the national German Medical Product Control Authorities (BfArM, Bonn, Germany). Procedural workup included transthoracic and transoesophageal echocardiography and a pre-procedural computed tomography scan of the tricuspid ring anatomy to check for its relation to the right coronary artery. Invasive left and right heart catheterization was performed before the implantation and a significant coronary artery disease successfully treated with two drug eluting coronary stents in the left anterior descending and circumflex artery. Implantation of the device was performed under general anesthesia with a coronary guidewire placed in the right coronary artery. There was also a femoral venous access with a 24 F transseptal steerable sheath that was placed next to the aortic root in the right atrium. After simulation of all necessary ring positions with the transseptal steerable sheath and an implant catheter, the procedure was executed under fluoroscopic and three-dimensional transoesophageal echocardiography flexible slice MPR (multi-planar reconstruction) guidance using a GE Vivid E 95 ultrasound scanner. A flexible fabric tube (Cardioband) size F was implanted in the tricuspid ring from the aortic root via anterior and posterior tricuspid ring to the beginning of the septal leaflet near the coronary sinus. The band was implanted along the anatomic ring using 16 anchor screws of 6 and 4 mm length. Finally, the band was released and cinched to 3.5 cm shortening achieving an acute reduction to TR I+. Direct percutaneous annuloplasty in human tricuspid valve. (A) Pre-procedural severe tricuspid regurgitation (TR) in three-dimensional transoesophageal echocardiography quantification. (B) Three-dimensional flexible slicing (online multi-planar reconstruction) and implant catheter (IC) control during implantation procedure. (C) Post-procedural mild TR post cinching in beating heart procedure. (D) Pre-procedural computed tomography (CT) planning of anchor screws relative to right coronary artery (RCA) and ring. (E) Fluoroscopy during implantation prior to cinching, anchors deployed, tricuspid valve (TV) en-face view. (F) CT control 4 days after implant showing regular position in all 16 anchors and patency of RCA. Thus, this beating heart annuloplasty may offer a new perspective for patients with significant TR that are inoperable or at high surgical risk. A CE mark study is currently under way to be started in Q4 2016 in Europe.