Safety and Efficacy of Pivot‐Bridge for Severe Functional Tricuspid Regurgitation: The First‐in‐Human Experiences

ABSTRACT Background The management of severe tricuspid regurgitation (TR) remains challenging. Although several promising transcatheter devices have been developed, procedural complexity and the need for special imaging techniques are hurdles to their widespread clinical application. Aims The study aimed to evaluate the safety and efficacy of a novel atraumatic vertical spacer, Pivot‐Bridge, for severe TR. Methods Patients with severe TR who were considered surgical candidates were enrolled. All procedures were guided by fluoroscopy and transthoracic echocardiography (TTE). Baseline characteristics, serious adverse events, and functional status were collected. TTE and cardiac computed tomography (CT) were serially performed for evaluation of TR and right ventricular (RV) remodeling. Results Fifteen patients (68 ± 11 years old, 27% women) were enrolled. Procedural success was achieved in all patients (the mean procedural time of 47 ± 24 min). During the device implantation (median 5 days), no serious adverse events occurred. TR was reduced by one grade or more in all patients. In TTE, vena contracta width and effective regurgitant orifice area significantly decreased by Pivot‐Bridge (1.6 ± 0.8 to 0.8 ± 0.3 mm; p < 0.001 and 1.2 ± 0.5 to 0.6 ± 0.3 cm 2 ; p < 0.001). RV end diastolic volume also significantly reduced at follow‐up CT (320.2 ± 93.7 to 294.4 ± 81.1 mm 3 ; p = 0.026). Ten patients underwent surgery with removal of the device, and five patients were stabilized by medical treatment, in whom the Pivot‐Bridge was removed percutaneously. Conclusions The Pivot‐Bridge was safe and effective in patients with severe TR. TR reduction was observed in all patients without periprocedural complications or adverse cardiovascular events during device placement. Registration ClinicalTrials.gov number: NCT05854095.