The 25-Year TCT Journey of Interventional Innovation
This multi-part presentation was begun with “Then and Now: The Evolution of Translational Science, Clinical Evidence-Based Medicine, and Socioeconomic Considerations,” delivered by Elazer R. Edelman, MD, PhD, physician at Brigham and Women’s Hospital and professor at Harvard Medical School and MIT. He began by discussing the history of innovation in biomedical research and then outlining a current problem in US innovation. According to Dr Edelman, the United States has fallen to 10th in Global Innovation Index (GII) innovation and 70th in GII efficiency. Although failure rates of interventional cardiology have dramatically decreased, and optimization of devices based on a firm understanding of many disciplines have allowed us to reduce cardiovascular disease, there remains a problem in innovation and the introduction of new technology. According to Dr Edelman, the crisis is on multiple levels, and the biggest crisis is the public perspective that funding has had a minimal impact. He cited problems in regulation, government funding, obtaining patents, and the medical device act. Dr Edelman described 3 barriers to innovation: the barrier to envisioning (conceptual science), the barrier to implementation (engineering), and the barrier to profit (entrepreneurship). He stated that we need to teach people how to think across multiple domains and how to investigate mechanism. He then concluded by encouraging the audience to think about how we can meld innovation, science, and medicine optimally.
The second portion of the presentation, titled “Untold Stories 1: Development of a Balloon-Expandable Stent,” was given by Julio C. Palmaz, MD, professor at the University of Texas Health Science Center at San Antonio. Dr Palmaz told his personal story of the development and patent of the world’s first cardiac stent. According to Dr Palmaz, it is one of the most litigated patents in history. After 11 years of litigation, including 12 court proceedings and 10 jury trials, he was finally declared the owner of the balloon-expandable stent. Dr Palmaz was inducted into the National Inventors Hall of Fame in 2004 and the National Academy of Inventors in 2012.
Alain G. Cribier, MD, professor of medicine at Hôpital Charles Nicolle in Rouen, France, delivered the final presentation, called “Untold Stories 2: Development of a Transcatheter Heart Valve.” In his talk, Dr Cribier described his lengthy process of getting the transcatheter aortic valve replacement (TAVR) approved and integrated into practice. He met much resistance initially, but reached a crucial milestone with the first cadaver study in 1994. The first human implantation took place in 2002, followed by larger patient trials starting in 2005. According to Dr Cribier, procedural success has increased from 85% in 2003 to 95% in 2010. The final device, a tri-leaflet bovine pericardial valve with stainless steel stent, was US Food and Drug Administration–approved for non-surgical patients in October 2011 and for high-risk patients in October 2012. Dr Cribier ended his presentation by saying it “should assume a dominant role in the management of degenerative AS (aortic stenosis) in the future,” and he highlighted that ongoing improvement of results and safety remains a priority