Transcatheter Aortic Valve Implantation (TAVI): a Health Technology Assessment Update

Transcatheter Aortic Valve Insertion – TAVI – is a technique involving the implantation of an artificial valve into a narrowed aortic valve without the need to stop the heart. There are two variants of this procedure. In the first, the artificial valve is inserted through an artery, generally the femoral artery, in which case it is called a «transfemoral TAVI». If, however, due to significant atheromatosis, neither of the two femoral arteries is accessible, a TAVI can also be performed directly through the thoracic wall and the apex of the heart. This variant is called a «transapical TAVI». Since 2007, two different TAVI valves have been launched on the market in Europe: the Sapien® valve of Edwards Lifesciences and the CoreValve® of Medtronic. Thousands of each type have already been implanted. In 2008, the KCE published its first report on this technique. The conclusion was that reimbursement of TAVI could not be supported at that time due to safety issues for patients and because the target population was not sufficiently defined. The proposal was made to review this recommendation at the time of publication of the results of the PARTNER (Placement of AoRtic TraNscathetER valve) trial, a randomised clinical trial with the Sapien® valve that was ongoing at that time. The results were published in September 2010 and June 2011 and additional analyses of those same results were released in the minutes of a meeting of the US Food and Drug Administration (FDA) on 20 July 2011. We also contacted the trial sponsor and received additional data.