Tech Update: SAPIEN Aortic Valve Replacement Shines At S.T.S.
By Adam Pick on February 1, 2012
Earlier this week, the 48th annual Society of Thoracic Surgeons Meeting (STS) was held in Fort Lauderdale, Florida. During the meeting, cardiac surgeons from around the world gather to discuss the latest strategies for optimal cardiac treatment — including heart valve repair and heart valve replacement procedures.
As our patient and caregiver community is fascinated by medical advances impacting heart valve surgery, I thought you might be interested to learn about a new study released at STS specific to the SAPIEN transcatheter aortic valve replacement device. The SAPIEN, which is manufactured by Edwards Lifesciences, is positioned in the heart using a minimally invasive catheter.
Here are the most recent findings about the SAPIEN’s clinical performance in 822 “inoperable patients” who suffered from severe aortic valve stenosis and received this aortic valve replacement device transapically — through the ribs:
- The average predicted risk of operative mortality at 30 days, according to the STS Adult Cardiac Database, was 12.2 percent. During this SAPIEN study, mortality at 30 days was 8.2 percent.
- Mortality after one year was 23.6 percent, a significant decrease from 29.1 percent in an earlier SAPIEN study.
- The stroke rate, one month after SAPIEN implant, was 2 percent — compared with 7 percent in the initial study and 5.5 percent of those getting traditional surgery.
In a statement, Mike Mussallem, the CEO of Edwards Lifesciences noted, “We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients who are at high-risk for surgery.”
To see how the SAPIEN aortic valve replacement is implanted, here is a fascinating animation which shows the transapical approach.
If you didn’t know, the SAPIEN received FDA-approval for inoperable patients last November. Edwards is now waiting for FDA approval of the device for patients at “high-risk” from standard surgery.
Keep on tickin!