On the 22 May 2013 at EuroPCR in Paris, France, Direct Flow Medical, a transcatheter heart valve company focused on improving patient outcomes, announced that it had met its primary endpoint in the fully-enrolled, 100-patient DISCOVER CE mark trial by achieving 99% freedom from all-cause mortality at 30 days.
Patients were treated with the Direct Flow Medical Transcatheter Aortic Valve System and demonstrated excellent results relative to overall patient haemodynamics, as well as the avoidance of post-procedural aortic regurgitation and adverse events. The DISCOVER trial full 30-day outcomes were recently presented by trial investigator Joachim Schofer from the Medical Care Center, Hamburg, Germany.
The Direct Flow Medical Transcatheter Aortic Valve System is designed to minimise the risk of aortic regurgitation following transcatheter aortic valve implantation (TAVI). In the DISCOVER trial, 99% of patients experienced mild or less aortic regurgitation, with 73% experiencing none/trace aortic regurgitation. The mean gradients pre-procedure, at discharge and out to 30 days of 46mmHg, 14.1mmHg and 12.6mmHg, respectively, demonstrated the system’s ability to significantly reduce, and then maintain, low gradients over time. All haemodynamic outcomes were assessed and reported by an independent imaging core laboratory.
The Valve Academic Research Consortium (VARC) defined Combined Safety rate was 89%. Within 30 days, there were two strokes (major or minor) and one patient experienced a myocardial infarction. There were only two major vascular complications, despite accessing vessels as small as 5.2mm. The VARC defined Device Success rate was 91%. No patient required rapid pacing during deployment or post-dilatation following deployment, minimising the risk of haemodynamic stress for patients.
At 30 days, 83% of patients had improved by more than one New York Heart Association (NYHA) functional class, and 68% were classified as NYHA class I. The average age of patients in the trial was 83.1 years, with a mean logistic euroSCORE of 22.5%.
“These results are unprecedented for a TAVI device,” said Schofer. “The Direct Flow Medical system is demonstrating in this landmark trial that it can successfully treat aortic stenosis with low mortality, whilst addressing the issue of aortic regurgitation in a clinically meaningful way in order to significantly improve patient outcomes.”
According to the company, the DISCOVER trial is a prospective, multicentre study conducted at nine European sites in 100 patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair. The device studied was the Direct Flow Medical Transcatheter Aortic Valve System, which includes a heart valve with a metal-free frame that was delivered transfemorally via a flexible, 18 french delivery system.
The Direct Flow Medical system received the CE mark in January 2013 and is currently available commercially in Europe.