While most of the world was sizing up Y2K, two innovative engineers — Stan Rowe and Stan Rabinowitz — and two cardiologists — Alain Cribier and Marty Leon — were looking for a better way to treat aortic stenosis, a common heart condition.
Aortic stenosis — or tightening — is a condition in which the valve between your heart and aorta narrows.
This restricts the flow of blood out of your heart and to the rest of your body, which can lead to vital organs not getting enough oxygen and eventual death.
Creating the Device
Historically, we addressed this problem by inserting a new valve during open heart surgery. As you might imagine, cracking open a chest and cutting into the heart can cause significant problems and lead to prolonged and expensive hospital stays, and even stroke and death.
The group studied the possibility that rather than using a scalpel, they could sneak a catheter loaded with a new valve into the heart through an artery by making only a tiny incision in the groin.
Less than a year later they invited a heart surgeon (me) to join a unique scientific advisory board that brought together specialists who did not usually operate with each other to help create this device.
We built it over the next year, but the device was considered so risky that it was only inserted as a very last resort in patients in Europe who were already dying from other causes like cancer.
Over the ensuing decade, scientists, surgeons, cardiologists, and anesthesiologists improved the technique enough to gain government approval for use in patients for whom traditional surgery was considered to carry a very high risk of complications.
‘Attractive on the front lines of care’
Still, at the time, almost none of the experts believed this technology could compete with a 50-year-old proven approach of opening the chest, putting the heart on a bypass machine, and then opening the heart to allow surgeons to remove the damaged valve and insert an animal or metal alternative.
But the new upstart minimally invasive catheter valves were attractive on the front lines of care, so patients and their doctors began to push for this option. In fact, technological enhancements and procedural simplification allowed this novel approach to improve, while the standard procedures remained essentially unchanged.
The results of early trials on really sick patients had excellent results and almost a quarter million have already been implanted in Americans for whom surgery was considered risky.
But one question still remained unanswered: were these less invasive valves as safe and effective as the old-fashioned proven approach in people with low risk of complications from surgery? In other words, could they be offered to all 2.5 million older Americans with aortic stenosis? After all, no one wants to gamble with their own heart.
Moving away from open heart surgical options?
The results of a just-published study have the answer. In the new trial, the first patients enrolled in March 2016 and over the next 18 months — a total of 1,000 patients — got either the old fashioned surgery or the new-fangled transcatheter aortic-valve replacement (TAVR) procedure. The researchers wanted to know if there was a difference in the rates of death from any cause, stroke, or re-hospitalization at 1 year after the procedures. The final results reported this weekend at the American College of Cardiology meeting revealed that 15.1 percent of the traditional surgical patients had these complications which was almost twice as many of the new TAVR recipients (8.5 percent). The new approach had lapped its ancestor, even though the traditional procedures in the trial had superb results. The patients even felt better and did better afterward.
No study is perfect, and the most important limitation of this trial is that the current results reflect only 1-year of outcomes and do not address the problem of long-term valve deterioration from wear and tear, which the researchers will continue to study.
But these results should change every office visit going forward and will prompt the federal government and insurance companies to ask if this minimally invasive valve replacement using a catheter from the groin is equivalent — or even preferable — for almost all patients with aortic stenosis.
This study, along with another recent paper that showed remarkable results using a similar catheter approach to repair another heart valve, the mitral valve, in heart failure patients with the mitraclip device, herald a major change in medicine. Heart specialists are moving away from open heart surgical options that have dominated for decades to minimally invasive procedures.
The transition is emblematic of a larger truth. Technology advances faster than the human body changes, so caregivers and providers have to juggle novel medical approaches while focusing on patients' desires. When offered the decision between a maximally invasive option that works well enough and a minimally invasive technique that industry can rapidly improve, the latter prevails.
One of the trial authors and my long-time colleague Michael Mack quipped that 90 percent of our operations have changed since his career started 3 decades ago. Indeed, the world changes in unexpected ways — just ask Kodak and Blockbuster.