Direct Flow Medical has announced 30-day outcomes from the DISCOVER post-market registry that demonstrate positive real world results for the Direct Flow Medical Transcatheter Aortic Valve System consistent with the ground-breaking results seen in the DISCOVER CE mark trial. The data were presented at EuroPCR 2015 (19–22 May, Paris, France) by Christoph C K Naber, from the Contilia Heart Centre in Essen, Germany.
The 30-day data on 250 all-comer patients from the DISCOVER post-market study showed a 98% survival rate, which emulated the 99% survival rate previously reported at 30 days from the DISCOVER CE mark trial. The average age of patients in the trial was 82.5 years, with a mean logistic euroSCORE of 18.3%.
Mild or less post-procedural aortic regurgitation was achieved in 97% of patients, with 80% of patients experiencing none to trace aortic regurgitation.
The stroke rate and incidence of myocardial infarction within 30 days was low, at 2% and 0.8%, respectively. A low major vascular complications rate of 4% demonstrates the system’s flexibility and trackability even in tortuous anatomy. No patient required rapid pacing during deployment or post-dilatation following deployment, minimising the risk of haemodynamic stress. In addition, no patient required more than one valve, eliminating the need for a valve-in-valve procedure and the associated negative outcomes observed with non-retrievable transcatheter aortic valves.
“Treating patients with the Direct Flow Medical valve in a real-world setting and getting the same consistent results seen in the clinical trial shows outstanding performance,” said Naber. “In daily practice we are faced with patients that are normally excluded by protocol from clinical studies, but these patients need treatment, as well. It is reassuring to know that we can reproduce the same results in challenging clinical scenarios with this valve.”
The DISCOVER post-market study is a prospective, multicentre, all-comers registry of up to 1,000 patients conducted at up to 75 European sites to evaluate the outcomes of the Direct Flow Medical valve on patients with severe aortic stenosis in routine clinical practice.