January 18, 2015- By Steven E. Greer, MD
On July 20th, 2011, the FDA convened an advisory committee to help it determine whether to approve the first ever TAVR device called the Sapien, made by Edwards Lifesciences. I was a public speaker raising the red flag that once a device is approved in the United States, warning labels of risk are very ineffective at preventing unnecessary usage of medical devices. I pointed out the high percentage of patients who were suffering serious stroke as a result of embolic aortic debris flowing to the brain during the TAVR.
The FDA ignored my warnings and approved the Sapien device. It also approved hundreds of medical centers to implant the devices rather than limiting it to the few qualified medical centers with the most experienced interventional cardiologists.
Now, as little surprise, a group of researches at the University of Pennsylvania have analyzed the website marketing campaigns of the hospitals in implanting TAVR devices and found that the benefits are being promoted while the deadly risks are being downplayed. Only 18% of the hospitals even mentioned the risk of stroke (Kincaid M, Neuman M, et al. Presentation on US hospital websites of risks and benefits of Transcatheter Aortic Valve Replacement. JAMA Intern Med. Published online January 12, 2015).
Dr. Marty Leon is the cardiologist at Columbia who has a large financial stake in the success of the Sapien valve, and who has used the powerful platform of his Cardiovascular Research Foundation and its TCT meeting to champion TAVR for decades. His group is downplaying the risks of TAVR just as they downplayed the risk of heart attack from aneurysms caused by drug eluting stents, which they also pioneered for personal profit (see video above).