technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”
- David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA's Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed.
To win an expensive technology on behalf of patients these days, there will have be "harmony" between doctors and their professional organizations and government regulators. If not, patients lose.
At issue is a transformative technology - another milestone forwarding medical innovation on behalf of some of our oldest and sickest patients: those with critical aortic stenosis who are too sick to undergo open heart surgery. Aortic stenosis tends to be a disease of the elderly that carries at least a 2-year 50% mortality when accompanied by a weakened heart muscle. Yet thanks to the wonders of careful engineering and some daring researchers that paired their expertise and lessons learned from a variety of disciples (cardiothoracic and peripheral vascular surgery, cardiology, and even cardiac electrophysiology), technigues and technology have combined to offer a percutaneous option for aortic valve replacement.
Everyone involved in this research (and even those who have watched from afar) knows this therapy works. Most believe in the long run, it will prove to be a safer option than open heart surgery in these patients.
But that's about where the harmony ends.
The new valve is expensive and so is the procedure to implant it. Although rumor, the valve itself might cost $20,000 US. Medicare (the insurer of the elderly) pays only 80% of the costs, typically, and has an arcane coding system that pays more for the code for aortic valve "replacement" than it does for aortic valve "insertion." (For goodness sakes, doctors, stop calling it TAVI and stick with TAVR, okay?!?) Will hospitals and insurers be able to afford a run on these devices? And what about Medicare that's already struggling with a huge unfunded liability?
And then there's the whole issue that doctors can't be trusted to do what's right for their patients anymore. They are uniformly greedy, at least in the eyes of the media and the regulators. They care about themselves more than their patients and thanks to a few unscrupulous doctors (and the fee-for-service system in which they work) ample evidence exists to contribute to this perception handsomely. Marcus Welby, MD: rest in peace.
But doctors still hold sway with their patients. For regulators, this is the biggest problem. Doctors, you see, get to stare directly into the eyes of the patients (and their families) as they discuss their principle problem: their narrowed aortic valve. We have to explain the options for treatment available: (1) doing nothing (and what will happen), (2) having open heart surgery (and what will happen), or (3)
Guess which option the patient is most likely to choose?
The fear with this new technology unleashed on the public, of course, is that the implant rate will reach a fever pitch as hospitals, ever hungry for the latest technology to tout, splash their cardiologists faces over billboards and national TV promoting
But if you really want to see all hell break loose, splash the images of a frail minority patient that was denied the option to receive a percutaneous valve on the basis of their age that turns to the media to expose their story.
Katie bar the door.
So we must be polite. We must demonstrate harmony. We must have databases. We must have panels of doctors and regulators and professional bodies assembled that sing Kum-By-Yah by their campfire is a great display of good will and uniform conviction to diffuse responsibility.
After all, rationing's a bitch.