ADVANCE: TAVR with CoreValve Safe, Effective at 6 Months
CHICAGO, IL—In high-risk, inoperable patients, transcatheter aortic valve replacement (TAVR) with the CoreValve device is safe and associated with an improvement in aortic valve function and low stroke and mortality rates at 6 months, according to study results presented March 24, 2012, at the annual American College of Cardiology/i2 Scientific Session. The study is the first to evaluate the safety and efficacy of TAVR per the Valve Academic Research Consortium’s (VARC) standards defining adverse events.
For the prospective ADVANCE trial, Axel Linke, MD, of the University of Leipzig Heart Center (Leipzig, Germany), and colleagues enrolled 1,015 high-risk patients with severe aortic stenosis at 44 centers in 12 countries in Western Europe, Asia, and South America. All patients underwent TAVR with the CoreValve prosthesis (Medtronic, Minneapolis, MN) between March 2010 and July 2011.
At 30 days, the primary endpoint of VARC–defined major adverse cardiac and cerebrovascular events (MACCE; composite of death from any cause, spontaneous MI, stroke, urgent or emergency conversion to surgery, or life-threatening/disabling bleeding) occurred in 8.3% of patients. Life-threatening/disabling bleeding and MI were observed in 4.0% and 0.2% of patients, respectively. Acute kidney injury occurred in 0.4% of patients. New pacemakers were implanted in 26.3% of patients.
All-cause mortality, cardiac mortality and stroke remained acceptable through 6 months follow-up (table 1).
Table 1. VARC-Defined Endpoints Over Time
|
1 Month |
6 Months |
|
|
All-Cause Mortality |
4.5% |
12.8% |
|
Cardiac Mortality |
3.5% |
8.4% |
|
Stroke |
2.9% |
3.4% |
When stratified by EuroScore, patients were more likely to survive the lower their score (P < 0.001).
Promising Results, Loose Ends Need to Be Tied
Dr. Linke said the procedure is “extremely safe” based on these results. Since all contributing centers were required to have performed at least 40 TAVR procedures before joining ADVANCE, Dr. Linke said that they did not run into any learning curve issues.
“Experience is one of the major contributors to success with this kind of procedure,” he said. “From our own experience, at the early phase you might have unrecognized complications that lead to death, and this was one of the reasons we selected highly experienced centers.”
There was a “huge difference” in pacemaker implantation rates among countries, Dr. Linke said, and the reasoning for this is still under examination. “The stability of the conduction system is relatively equally distributed across Europe, so it has a lot to do with the implantation,” he said, adding that some operators place the device during TAVR while some wait up to 2 days.
In response to a question regarding using the Bleeding Academic Research Consortium (BARC) standards to analyze bleeding events, Dr. Linke said that he would like to do so in the future. However, despite “a high bleeding rate that needs to be improved…there are less bleeding-related cases of death.”
In comparison with other TAVR studies, ADVANCE observed a relatively low stroke rate, Dr. Linke said, and although the reasons for this are unclear, it might have to do with the way the valve is implanted. With aggressive oversizing he suggested that the calcium build-up can be easily released into the bloodstream, but with passive expansion “the calcium is still covered by fibrotic tissue and not exposed.”
Study Details
Just over half of patients were women, and the average age was 81 years. At baseline, about 80% of patients were NYHA class III or IV and about a third had diabetes.
Source:
Linke A. Treatment of high risk aortic stenosis patients with transcatheter Medtronic CoreValve implantation: Results from the international multicenter ADVANCE study. Presented at: American College of Cardiology Scientific Session; March 24, 2012; Chicago, IL.
Related Stories:
Disclosures
- ADVANCE was funded by Medtronic.
- Dr. Linke reports serving as a consultant to Medtronic.
Comments