“Excellent” one-year outcomes for Direct Medical TAVI valve


A press release reports that one-year data, which were presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) meeting (11–15 October, San Francisco, USA), from the DISCOVER post-market study, demonstrate “excellent real-world results” for the Direct Flow Medical transcatheter aortic valve implantation (TAVI) device.

The one-year commercial data for 200 consecutive patients showed that device was associated with 82% freedom from all-cause mortality and 90%  freedom from cardiovascular mortality—similar to the 90% survival rate at one year previously reported from the DISCOVER CE Mark trial. The average age of patients in the trial was 83 years with a mean logistic EuroScore of 18.2%. In the study, 95% of patients experienced mild or less paravalvular regurgitation, with 85% of patients showing no or trace paravalvular leak. Clinical improvement was sustained over time, with 84% of patients in NYHA functional class I or II.

Study presenter Federico De Marco (Policlinico San Donato in Milan, Italy) comments: “The consistency between valve performance in this real world, post-market registry and the outstanding results from the DISCOVER pre-market trial is impressive. Overall, the data demonstrate excellent results and low complications. In particular, I expect the consistently low incidence of mild or higher paravalvular leak to translate into improved long-term outcomes for these patients.”