WASHINGTON—Researchers presented promising clinical data on Monday for the CoreValve ReValving System for percutaneous aortic valve replacement (PAVR) in high-risk patients with aortic stenosis at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Patients enrolled in the registry—covering nearly 100 centers in 20 countries—had a predicted 30-day mortality rate of 23 percent as measured by the logistical EuroScore. By contrast, the survival rate at one-month post-procedure follow-up for these high-risk and often inoperable octogenarian registry patients was about 90 percent.
These data are from the subset of patients that are included in the CoreValve’s post CE-Mark expanded clinical evaluation registry. More than 1,800 patients have been treated with the system to date.
Researchers reported that quality of life improvement, as measured by the New York Heart Association (NYHA) functional classification, was significantly improved as well.
Follow-up on patients that are now one year post-procedure demonstrates good longer-term valve function and sustained survival and quality of life benefits.
“The growing volume of very positive clinical data from an ever increasing number of physicians is most satisfying,” said Eberhard Grube MD, chief of cardiology at the HELIOS Heart Center, Siegburg, Germany. “In the hands of an experienced user, use of the ReValving System is fast becoming a routine alternative for high-risk patients suffering from severe aortic stenosis.”
The ReValving System procedures are performed on the beating heart without cardiac assistance or rapid pacing, and may result in less trauma to the patient. This technology may also offer substantial cost-savings to the healthcare system. The catheter-based technology includes a proprietary framed/self-expanding tissue heart valve that is specifically designed and engineered for transcatheter delivery, according to the Irvine, Calif.-based company.
Complications including neurological events are comparable to traditional aortic valve surgery although there is a modest, but clinically acceptable increase in pacemaker dependency in PAVR patients, according to CoreValve.
“We are highly encouraged by the clinical data from outside the United States that was presented at TCT,” said Daniel T. Lemaitre, president and CEO of CoreValve. "Additionally, we continue to see strong sequential growth in procedure volume as 2008 unfolds; a testimony to the significant patient population whom we believe will benefit from our technology."
The CoreValve ReValving System is not yet available for sale in the U.S.