SAPIEN Transcatheter Cardiac Valve Trial Going Ahead

Edwards Lifesciences has recently begun a multi center clinical trial of the SAPIEN Transcatheter Heart Valve. Northwestern Memorial Hospital’s Bluhm Cardiovascular Institute has just announced their first placement of the valve in a 91 year old patient with aortic stenosis, who otherwise would not have been a candidate for open heart surgery. As we have reported before, the experimental Edwards’ valve is primarily designed for percutaneous transfemoral treatment of severe aortic stenosis. The valve is also being tested to be deployed across the pulmonary valve, to treat those that are suffering from congenital right ventricular outflow tract obstructions.
Here’s an animation of a transcapical placement of the valve:

From the statement by Northwestern Memorial Hospital:

“Balloon aortic valvuloplasty has been traditionally offered as a palliative therapy for patients who were not candidates for aortic valve surgery,” said the hospital’s Director of the Cardiac Catheterization Laboratory Charles J. Davidson, MD, who is also a co-principal investigator for the trial and a professor of medicine at Northwestern University’s Feinberg School of Medicine. “This particular technique is a more durable treatment than balloon valvuloplasty and is potentially a breakthrough for treating high-risk patients.”
“Surgery becomes far too risky when patients are conditionally weak or frail,” says Chris Malaisrie MD, a Northwestern Memorial cardiac surgeon and member of the site team evaluating this new procedure. “The goal is to replace diseased valve at minimal risk to these patients—many of whom have very limited therapeutic options. Aortic valve replacement is one of few therapies offering both symptomatic relief and improved long-term survival.”
During insertion, the artificial valve remains collapsed until it reaches its destination. It is then expanded and released in place of diseased aortic heart valves. The prosthesis is made of stainless steel and biological leaflets that help direct the flow of blood in the heart. It is permanent and integrates an expandable stent that holds the valve in its intended position. Northwestern Memorial utilizes both the transfemoral (through the groin) and transapical (through the ribs) approaches. Implantation occurs in a hybrid operating room suite that incorporates elements of both a traditional OR and catheterization laboratory.

Press release: Diseased Heart Valve Replaced Through Small Chest Incision
Product page with videos: Edwards SAPIEN Transcatheter Heart Valve
Clinical trial page: Placement of AoRTic TraNscathetER Valve Trial
Flashbacks: Edwards Sapien Transcatheter Aortic Valve Makes Human Debut ; Edwards Trials Company’s Minimally-Invasive Pulmonic Valve