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Studies show encouraging results for CoreValve
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PARIS — Two studies presented here show that the CoreValve transcatheter aortic valve replacement system results in low mortality and stroke rates at 1 year and is cost effective in patients at high surgical risk.
Both studies featured data from the ADVANCE trial, which looked at “real-world” outcomes of the CoreValve TAVR system (Medtronic) in 1,015 patients from 44 centers in 12 countries in Western Europe, Asia and South America. The TAVR device was implanted in 996 patients with severe aortic stenosis who were deemed high risk for surgery.
The first study presented by Stephen Brecker, MD, of St. George’s Hospital in London, included 1-year follow-up data on 806 out of the 824 patients available at 1 year (97.8%).
Similar to 1-month data previously reported, patients at 1 year had low rates of all-cause mortality (17.9%), CV mortality (11.7%) and stroke (4.5%; minor stroke, 2.3%; major stroke, 2.2%). As a result of CoreValve implantation, patients’ hemodynamics were significantly improved.
Also of note, patients classified at NYHA class I or II increased by more than four times from baseline to 1 year (20% vs. 87%).
Stephen Brecker
In the second study, also presented by Brecker, the ADVANCE trial was compared with the medical management cohort of the PARTNER cohort B study to determine the cost effectiveness of CoreValve implantation. The cost-effectiveness model compared the benefits, including life years gained and improvement in quality adjusted life years (QALY), with the lifetime costs, which factored in measures such as the procedure, device, physicians and hospitalizations.
Although the initial cost of medical therapy in patients with severe aortic stenosis was quite low, it ended up being high because of repeat hospitalization and demands on medical care in the last period of the patient’s life, Brecker told Cardiology Today’s Intervention in an interview. “They were often back in the hospital being treated for HF,” he said.
On the other hand, the cost of TAVR, which was initially high, wound up being cost effective, with the cost to gain a year of life of £7,700 and the cost per QALY gained of nearly £11,300, well below the benchmark of the United Kingdom’s National Health Service (NHS).
“Despite high upfront costs, you score quite a lot of QALYs [with TAVR] and that’s why the cost per QALY comes within the benchmark of what the NHS uses, which is about £20,000 per QALY,” he said. – by Brian Ellis
For more information:
Brecker S. Presented at: EuroPCR; May 21-24, 2013; Paris.
Linke A. Presented at: EuroPCR; May 21-24, 2013; Paris
Disclosure: Brecker is a proctor for Medtronic.
Perspective
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Larry S. Dean, MD
The results of ADVANCE are remarkable for a high procedure success and an acceptable mortality of 4.5% at 30 days with the CoreValve. Follow-up at 1 year showed a mortality of 17.9% and a trend suggesting that moderate-to-severe aortic regurgitation following TAVR impacted mortality. This adds to the concern noted in the PARTNER trial that residual aortic regurgitation impacts patient outcome. However, it remains hypothesis generating, and additional data will be required to more fully understand this finding. Also noted was that 29% of patients required placement of a permanent pacemaker at 1 year, which is quite high and is approximately fivefold higher than what was seen in the PARTNER trial. Results from the US CoreValve pivotal trial are eagerly awaited, which may or may not confirm the high rates of pacemaker insertion using the CoreValve.Click Here to Manage Email Alerts