|Medtronic CoreValve U.S. Pivotal Trial Affirms Benefits of Self-Expanding Transcatheter Aortic Valve Replacement in Patients Treated Via Alternative Access Routes|
First Rigorous Prospective Analysis of Extreme Risk Patients Presented at TCT13
SAN FRANCISCO and MINNEAPOLIS - Oct. 30, 2013 - Following the first U.S. data presented on the Medtronic CoreValve® System in patients treated via the transfemoral approach, Medtronic, Inc. (NYSE: MDT) today announced the positive results of patients treated via alternative access routes as part of the same Extreme Risk Study within the CoreValve U.S. Pivotal Trial. Presented at Transcatheter Cardiovascular Therapeutics (TCT) Conference, the first-of-its-kind observational analysis found that the novel self-expanding valve provided life-saving and quality of life benefits to patients treated via the subclavian and direct aortic ("non-iliofemoral") access routes despite the higher risk nature of the patient population.
As part of the Extreme Risk Study, 146 patients were treated via alternative access approach after extensive screening showed they were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery, and were ineligible for the more common transfemoral transcatheter aortic valve replacement (TAVR). Through one year these patients demonstrated high rates of procedural success and valve performance that were consistent with transfemoral patients.
The strong clinical results were achieved in spite of statistically significant differences between transfemoral and alternative access patients, which showed an increased presence of peripheral vascular disease (35.3 percent vs 61.6 percent, p<0.0001), chronic lung disease/COPD (58.8 percent vs 73.3 percent, p=0.0017), STS severe-rated chronic lung disease (24.0 percent vs 40.4 percent, p=0.0002) and diffusion capacity of less than 50 percent (22.3 percent vs 40.4 percent, p<0.0001) in the alternative access patients.
"For the 20 to 25 percent of extreme risk patients who are not eligible for transfemoral TAVR due to vascular anatomy, this study confirms that TAVR can be successful in these patients as well," said David H. Adams, M.D., chair of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center, national co-principal investigator of the CoreValve U.S. Pivotal Trial and presenter of the data at TCT. "These results demonstrate a non-iliofemoral approach is a viable option for patients with severe aortic stenosis who are not candidates for surgery or transcatheter valve replacement through traditional peripheral access."
The major stroke rate was 6.3 percent at one month, which trended higher than patients receiving the device via femoral artery (2.4 percent), but lower than previously reported rates; moreover, in the CoreValve Continued Access Study, alternate access patients had a rate of major stoke of 2.3 percent at one month.
Similar to patients treated transfemorally, these patients experienced significant and sustained functional and quality-of-life improvements, with most patients (91.6 percent) in NYHA Class III and IV at baseline improving to 25.0 percent at one month and 12.0 percent at one year (as measured by NYHA Class). Quality-of-life scores improved 22.9 points at one year (as measured by the KCCQ 100-point scale, in which a 20-point change is considered highly significant). At one year, the rate of survival was 63.0 percent for the alternative access patients.
This study evaluated the self-expanding, low 18Fr profile CoreValve System with three valve sizes (26mm, 29mm, 31mm). Medtronic intends to seek approval for these access routes as part of its Extreme Risk submission to the U.S. Food and Drug Administration (FDA).
Approximately 300,000 people worldwide suffer from severe aortic stenosis, including one-third who are ineligible for open-heart surgery because they are deemed at too high risk.Since receiving CE (Conformité Européenne) Mark in 2007, the CoreValve System has been implanted in more than 45,000 patients in more than 60 countries. The CoreValve System currently is not approved for commercial use in the United States.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
- end -
Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: Why are so many denied surgery? Eur Heart J. 2003;26:2714-2720.