New clinical data presented at EuroPCR 2011 on 17 May 2011 demonstrate immediate and long-term health-related quality-of-life benefits for patients receiving the CoreValve System (Medtronic).
The favourable two-year results from the 18F CoreValve multicentre prospective study are the largest set of CoreValve health-related quality-of-life data and the longest-term health-related quality-of-life data available from all transcatheter aortic valve implantation (TAVI) systems.
“Together with positive two-year performance and durability data presented at EuroPCR 2010, these results offer clear, mounting evidence that CoreValve is a truly transformational therapy for many patients with severe aortic stenosis, resulting in sustained clinical benefits and improved quality of life,” said Raoul Bonan, professor of medicine and interventional cardiology at Montreal Heart Institute in Montreal, Canada.
The study included 126 patients at nine centres in Europe and Canada who were implanted with the CoreValve system. Investigators reported the following HRQoL outcomes based on patient completion of the EuroQoL (EQ-5D) questionnaire and Visual Analog Scale (VAS) at baseline and after three, six, 12 and 24 months post-procedure:
- Mean health utility scores (range 0-1): By 12 months, CoreValve patients reached the normal range of health utility scores (relative to UK general population norms for this age group) and this was sustained for 24 months. They improved from 0.60 at baseline to 0.71 at three months, 0.73 at 12 months and 0.76 at 24 months (p<0.05).
- Visual Analog Scores (range 0-100): Reflecting patients’ improved perceptions of their health, these scores increased from 53.1% at baseline to 64.4% at three months, 67.3% at 12 months and 69.1% at 24 months (p<0.0001).
- Pain/discomfort and anxiety/depression: For individual patients, significant improvements were observed in these domains at three months and were maintained through 12 months (p<0.05).