From Starr-Edwards to SAPIEN: The History of Transcatheter Aortic Valve Replacement (pp. 715-742)
Authors: (Francis G Duhay, and Sarah Huoh)
Abstract: To understand the history of transcatheter valve technology, it is important first to gain a perspective of the advancements in surgery and interventional cardiology that provided its foundation – valves, stents and balloons. Much as today‘s portable computing technologies trace their lineage to the supercomputers of the 1960s that once occupied entire rooms, transcatheter heart valves arose from purposeful, incremental innovation. In this context, the clinical reality of transcatheter aortic valve replacement (TAVR) could only have been achieved ―by standing on the shoulders of giants.‖
This chapter will review the evolution of the Edwards SAPIEN™ THV (Transcatheter Heart Valve) by first exploring the history of surgical heart valve prostheses, which still remain the standard of care for the treatment of many valvular heart conditions. The history of percutaneous diagnostic and therapeutic cardiovascular catheterization then will be summarized, culminating in the rebirth of a procedure long abandoned – balloon aortic valvuloplasty – so that the foundations of transcatheter aortic valve replacement can be best understood. Transcatheter aortic valve replacement will then be reviewed, from concept and experimentation, to the historic undertaking of the first-in-man procedure in 2002. Finally, in these challenging times of growing regulatory and third-party payer scrutiny over medical devices, it is mandatory to make the case for clinical value. To this end, the final section will summarize the two pivotal clinical trials (PARTNER Cohorts A and B) from the standpoint of safety, efficacy, quality of life and health economics.