UNICA − a novel single-stent, double-valve, heterotopic, cross-caval approach for severe tricuspid insufficiency

We present an 85-year-old female patient in New York Heart Association (NYHA) Functional Class III, with preserved left ventricular ejection fraction, who experienced recurrent valvular heart failure hospitalisations and cardiac decompensation due to severe, torrential tricuspid regurgitation (TR) with a large coaptation defect (grade 5/5, 16 mm gap) (Figure 1A, Moving image 1). She also exhibited typical flow reversal in the liver veins, recurrent pleural effusion, and severe peripheral oedema. Due to her advanced age, clinical condition, complex anatomy, and comorbidities, which resulted in a calculated Society of Thoracic Surgeons (STS) short-term risk score of 13% and a TRI-SCORE of 5/12 with a predicted in-hospital mortality of 14%, she was deemed unfit for conventional tricuspid valve surgery and ineligible for established transcatheter edge-to-edge repair (TEER) or transcatheter tricuspid valve replacement (TTVR) procedures by our institution's interdisciplinary Heart Team.

After careful consideration, the patient and her medical team decided to explore compassionate treatment options. Authorisation was obtained from the higher federal competent authority, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), for the implantation of the novel cross-caval prosthesis known as...