A new study, presented at the ACC 2014 congress last week, is the first prospective, randomized study to compare transcatheter aortic valve replacement to open heart surgery in patients with severe aortic valve stenosis. Results, also published in The New England Journal of Medicine suggest that patient survival and Quality of Life are better in the transcatheter valve group, which will be music to Medtronic’s ears as it aims to extend CoreValve’s indications.
Among patients diagnosed with severe aortic stenosis, about one-third are thought to be at too high a risk for traditional valve surgery. Sitting just below this extreme risk group are patients for whom open surgery is considered “high risk” so it is logical that someone should actually put some numbers on the comparison between open surgery and TAVR in this group, for whom both options are theoretically available.
Medtronic’s CoreValve System is designed to provide a minimally invasive treatment option for patients with symptomatic, severe aortic valve stenosis. It was approved by the U.S. FDA in January 2014 for patients considered extreme risk for surgery, but is not currently approved in the U.S. for use with patients at high risk. New clinical data will support Medtronic’s efforts to extend the valve’s indications to include this group.
This new study was undertaken by PinnacleHealth Heart Valve Clinic, which has been actively involved in the extreme risk and high-risk trials of the CoreValve system thus far and continues to participate in further research for those with intermediate risk.
In the study, physicians replaced diseased aortic valves in 747 patients, approximately half of who were randomized to the new minimally invasive CoreValve System, and half of whom were randomized to open heart surgery. The all-cause mortality rate was 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving surgery, a statistically significant finding at one year (the primary endpoint of the trial).
The rate of stroke, one of the complications most concerning to physicians and patients due to increased mortality, was low and produced similar results between the two groups of patients.
Patients also saw significant improvements in their quality of life, scores for which improved 19.0 points for CoreValve patients and 3.7 points for surgical patients at 30 days. At one year both patient groups improved significantly, with CoreValve patients improving 23.2 points and surgical patients improving 21.9 points (as measured by Kansas City Cardiomyopathy Questionnaire 100-point scale, where five points is considered improvement, and 20 points is considered a very large improvement).
“In patients with aortic valve stenosis, the self-expanding transaortic transcatheter aortic valve bioprosthesis implant, was associated with a significantly higher rate of survival after one year, than open heart surgical aortic valve replacement,” states Brijeshwar Maini, MD, FACC, medical director of the PinnacleHealth Heart Valve Clinic.
Source: PinnacleHealth Heart Valve Clinic, PR Newswire