Back to Program
Julie A. Swain, M.D.
Bram Zuckerman, M.D
In 1954, Hufnagel, Harvey and colleagues published the first report of effective surgical treatment for end-stage aortic valve disease, and in so doing initiated a 50-year tradition of successful surgical therapy for cardiac valvular disease. Today, with explosive transcatheter device development and equally enthusiastic adaptation of percutaneous therapy techniques, we stand poised to wholly transform this longstanding, reliable tradition. Given the excellent track record of safety and efficacy of surgical intervention, we must give great attention to adequate characterization of the risk/benefit profile for these new, less invasive modalities. Currently, there remain a wide variety of unique safety and efficacy concerns with percutaneous heart valve technology.
The vast differences in process and procedure between open and closed therapies pose important questions which may only be adequately answered through implementation of the gold standard – the randomized, controlled clinical trial. Furthermore, trial design in this arena poses additional complexities, including the development of appropriate inclusion\exclusion criteria, agreement on choice of a control population, and establishment of salient, interpretable clinical endpoints. The rapid evolution of technology in this area requires an equally dynamic approach to device regulation. Here we aim to address these issues within the context of currently evolving regulatory guidelines for device testing standards, pre-clinical testing and clinical trial requirements which may be broken down into six (not so) easy steps:
1) Materials biocompatibility and toxicity
2) In Vitro Physical testing
3) Animal testing
4) Feasibility Study
5) Pivotal Study for safety and efficacy
6) Post-approval requirements
We will discuss current suggestions in each of these areas.
