Last Thursday, the Cardiology Grand Rounds talk was delivered by Dr. Albert Starr, M.D., co-developer of the Starr-Edwards heart valve. The presentation was entitled "Mitral Valve Surgery 50-year Anniversary Address," in a nod to the start of Starr's research on heart valve replacement surgery at the University of Oregon Medical School back in 1958.
Starr shared his personal reminiscences of his work with engineer and inventor Lowell Edwards (who once developed an automobile signalling mechanism using an inflatable rubber obstetrical glove) and his experiences as a researcher at UOMS in the 1950s. He noted that there was a definite "frontier mentality" at the school ("Dogs would be delivered to the lab at midnight from undisclosed locations") that facilitated the development of groundbreaking new devices and techniques.
Oregon was not the only frontier in those days: medical research itself was a rapidly expanding area that lacked many of the oversight mechanisms we now take for granted. Starr reminded the audience that in 1958, when the team began to consider human trials, there was no FDA, no informed consent, no surgical techniques for valve replacement, no surgical ICUs, no applicable ethical guidelines, no company to produce the devices, no name for the artificial valves themselves, and no clear data yet on which of Edwards' designs was more effective: simple ball-and-cage or the more complicated shielded design.
Indeed, the lack of standards and guidelines made the research appear too risky to many. At a meeting in 1960, Michael DeBakey, M.D., declared that, had the research proposal come to him at the NIH, he never would have funded it. Lucky for Starr and Edwards that the Oregon Heart Association was at that time ably led by Mr. Howard Stroud, who ensured that there was funding enough to proceed.
And Starr was committed to excellence and patient safety. Early on, when it looked like post-operative staph infections might be a "show-stopper" for additional human trials, Starr implemented a rigorous screening process for all OR staff, taking nasal cultures of all surgical personnel and using antibiotics prophylactically on patients.
Starr finished his talk with a look ahead to the future of heart valve replacement and repair, and noted that the marketplace for percutaneous valve repair alone will soon amount to $1.2 billion. With numbers like those, there certainly seems to be no shortage of money for continued research.
The fifty years of mitral valve surgery presented in the lecture was nicely mirrored in Starr's career at OHSU: at the end of the talk, Division Chair Sanjiv Kaul, M.D., presented Starr with a pin and pen honoring his 50 year tenure on the university's faculty.
The lecture was videotaped, and the Oregon Chapter of the American College of Cardiology will be creating copies of the tape for viewing. Check with the OHSU Division of Cardiovascular Medicine for availability.