Transcatheter mitral valve replacement — a new option for a selected group of patients?

Abstract

Mitral regurgitation (MR) is the second most common valvular disease. Symptomatic MR is associated with a poor prognosis. Cardiac surgery is recommended in the severe form of the disease. If the surgical risk is high or functional mitral regurgitation repair/replacement cannot be combined with aorto-coronary bypass graft surgery, a transcatheter edge-to-edge valve repair should be considered. Currently, there is no recommended procedure in patients with severe symptomatic MR, high cardiac surgical risk, and low probability of success or contraindications to the percutaneous edge-to-edge treatment. A recent alternative is the mitral valve implantation using a transapical approach or through the interatrial septum. Currently, the only CE-marked transcatheter bioprothesis valve using transapical approach and implanted without extracorporeal circulation support is the Tendyne valve. This paper discusses the safety, clinical efficacy and cost effectiveness of this valve and the size of the target population in Poland. The clinical efficacy was evaluated in a study of 100 patients with severe symptomatic MR. The total 2-year mortality was 39%. The hospitalisation rate due to heart failure decreased from 1.3 events/year prior to the surgery to 0.51. MR was not recorded in 93.2% of the survivors. An economic analysis accounting for the survival, health-related quality of life, and the risk of hospitalisation due to heart failure showed that the Tendyne system is cost-effective compared to pharmacological treatment: the incremental cost-utility ratio equalled 93,324–110,696 PLN, depending on the approach, clearly below the official threshold in Poland. The annual number of eligible patients was estimated at 60.