In April, fans of Rolling Stones lead singer Mick Jagger breathed a collective sigh of relief after reports emerged that Jagger’s heart surgery had been successful.
Although some have focused on Jagger’s decision to come to the United States to receive treatment, rather than rely on the government-run National Health Service in England, Jagger’s surgery offers an even more important lesson for Americans, one about health care innovation and the development of new technologies.
As a voice specialist, I was captivated by the new approach that was used to replace Jagger’s aortic heart valve, called transcatheter aortic valve replacement. TAVR eliminates the risk of a vocal cord nerve injury that exists when the chest is opened using the standard method. Such an injury could have ended Jagger’s career.
The history of TAVR is an excellent example of how technology should evolve in medicine. Dr. G. Alain Cribier performed the predecessor to TAVR more than 30 years ago. Working alongside other physicians, Cribier developed a method for creating an expandable stent with a heart valve constructed inside of it. The expandable stent is delivered to the heart the same way coronary artery stents are delivered, via the femoral artery in the groin. Under this method, a balloon expands the stent and deploys the new valve.
After developing this innovative approach, Cribier and three others started a company to begin building and testing transcatheter heart valves. The first procedure took place in 2002, involving a patient with no other viable options.
In the years that followed, the technology was refined and discussed in peer-reviewed literature, and TAVR’s use has been gradually and carefully expanded. One of the most recent peer-reviewed articles about TAVR, published in The New England Journal of Medicine mere days before Jagger’s procedure, shows that TAVR offers better outcomes, lower complication rates and shorter hospital stays (and therefore lower costs) than the traditional approach. As Dr. Cribier stated in a recent review article, “The potential for this disruptive technology remains explosive.”
The development of the TAVR technology shows clearly how best to foster innovation in medicine. TAVR didn’t emerge overnight. It was developed over decades. Shortcomings and other unintended consequences were addressed early in its development, avoiding pain and suffering for patients. TAVR’s advancements were continuously supported by high-quality, peer-reviewed literature. There were no government incentives or mandates involved in TAVR’s development or rollout. Instead, doctors and other health care professionals led the way, and they continue to do so.
Unfortunately, not all new medical technologies have received the same treatment. In many cases, the government has imposed unnecessary, burdensome, or even dangerous mandates that have increased costs and limited innovation. One example is health care information technology, especially as it relates to electronic medical records.
Compared to TAVR, health care IT has been implemented along a completely different path and with totally different results. Relying on a single survey published in 2007, Congress “picked a date out of a hat” — as Charles Krauthammer once described it — and mandated a highly accelerated, five-year expansion of HIT, forcing it upon every physician and patient in America through the government’s Meaningful Use program.
When Congress chose to impose MU, there were no studies proving that HIT and the use of electronic medical records are safe and effective compared to paper charts, and Congress didn’t allow health care professionals to have the time needed to refine the technology and address unintended consequences before millions of patients were affected.
Meaningful Use and its successor, MACRA/MIPS, have caused extensive, irreparable harm to patients and health care professionals by forcing unsafe, ineffective information technology down the throats of patients and their doctors.
A report recently published in Fortune, “Death by a Thousand Clicks,” outlines the frightening array of unintended consequences resulting from this reckless deployment of unproven technology.
Tens of thousands of patients have died, and hundreds of thousands of others have been harmed, because of electronic health records errors and technical glitches. In place of peer-reviewed research, HIT developers have relied on marketing fads like Big Data and artificial intelligence. With government mandates driving sales, they have no need to develop software that would help doctors do their job.
America’s health care system needs innovative solutions to a number of problems, but the path to innovation can be properly developed only by health care experts relying on tried-and-true research methods — not government mandates driven by political goals.
I was indeed relieved to hear Mick Jagger is doing well. I was even more relieved that HIT and Meaningful Use haven’t killed him — at least not yet.
Mike Koriwchak, M.D. (firstname.lastname@example.org), is board vice president of Docs 4 Patient Care Foundation, host of The Doctor’s Lounge Radio Show, and an ear, nose, and throat specialist in Atlanta, Georgia.
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