Novel Replacement Valve Offers Nonsurgical Aortic Valve Repair

An innovative transcatheter heart valve (THV) offers a treatment option for patients too ill to undergo open-heart surgery for the repair of their calcified aortic valves.

The Sapien THV is intended for transcatheter aortic valve implantation (TAVI), and is based on a balloon expandable stainless steel frame with a polyethylene terephthalate (PET) skirt that encases bovine pericardial tissue leaflets, and is intended to be placed in the subcoronary position.


The tri-leaflet bovine pericardial prosthesis is treated with an anticalcification treatment, while the PET fabric skirt has been designed to decrease perivalvular leaks. The valve is available in two sizes (23 and 26 mm), treating an annulus range of 18 mm to 22 mm and 21 mm to 25 mm, respectively.

The system also includes the proprietary RetroFlex 3 delivery system, RetroFlex 3 introducer sheath set, RetroFlex dilator kit, and the RetroFlex balloon catheter, crimper, and Atrion inflation device. The RetroFlex Balloon Catheter is indicated for predilatation of a stenotic cardiac valve prior to implantation of the THV, while the Crimper is indicated for preparing the THV for implantation. The Sapien THV is a product of Edwards Lifesciences (Irvine, CA, USA), and has been approved by the US Food and Drug Administration (FDA), following the pivotal PARTNER trial.

In a quality of life (QOL) sub-study of the trial, 358 patients were assessed upon enrollment and at follow-up intervals of one month, six months, and 12 months, on a broad range of factors, such as their symptoms, physical and social limitations, and heart-failure related quality of life. On a scale from 0 to 100, the Edwards THV patients had a 25-point improvement in quality of life scores compared to the control group (at one year).

“The degree and immediacy of the quality of life improvement was striking, with significant benefits seen as early as one month. By one year, patients experienced both cardiovascular and physical health benefits, with the physical improvements roughly comparable to a 10-year reduction in age,” said David Cohen, MD, MSc, director of cardiovascular research at St. Luke's Mid America Heart and Vascular Institute (Kansas City, MO, USA), and principal investigator for the QOL substudy. “Quality of life is critically important, particularly for patients like those in this trial -- and they are not just surviving, but also thriving.”

Related Links:
Edwards Lifesciences
St. Luke's Mid America Heart and Vascular Institute