Dr. Elazer R. Edelman: Interventional Innovation is Alive and Well

October 31, 2016

Is innovation on the decline in interventional cardiology?

Since 1980, there have been 10,000 papers on whether there is a crisis in innovation, with more coming every year, said Elazer R. Edelman MD, PhD, in his Innovators Roundtable lecture.

But that’s not so much an indication that innovation is fading as it is evidence that there are shortcomings when it comes to evaluating innovative advances and a lack of understanding about what innovation really is.

Sometimes new medical technology may leak out too early, which can lead us to abandon it too early as well, said Dr. Edelman, who is professor of health sciences and technology at the Massachusetts Institute of Technology, professor of medicine at Harvard Medical School and a senior attending physician at Brigham and Women’s Hospital.

Take, for example, renal denervation for treating resistant hypertension. The technology was “leaked,” and the SYMPLICITY HTN-3 trial that tested the new approach in 2014 determined it was ineffective. But looking back, Dr. Edelman questioned whether or not the right approach was taken to evaluate this new technology. A year later, a different set of researchers evaluated renal denervation using heat mass transfer and tissue microanatomy, and they ended up concluding that the microanatomy of the artery determined the success of energy-based renal denervation in controlling hypertension.

 

“As it was, the (first) study put a serious dent in renal denervation,” - he said.

 

A lot of things get in the way of device development, Dr. Edelman said. The new technology must be developed before it can be tested, and tested before it can be deemed safe and effective. Late in the technology pipeline there is no room for failure, no time to learn, no room for adjustment, and no time to innovate. And new technology is challenged by “focused homogenous trials” that are biased and limited, he said.

“We are often confronted with little data and little power,” Dr. Edelman said. “We have no idea what to measure.”

Another challenge to innovation is that true innovation is often confused with better engineering. Engineering is acquiring and practicing knowledge to design new structures and devices that safely realize improvements in the lives of patients, he said. Innovation, on the other hand, is a new way of thinking, such as a new concept of a disease.

Certainly, the introduction of drug-eluting stents (DES) has had a big impact on the lives of patients when compared to coronary artery bypass graft (CABG), but were stents truly novel? Dr. Edelman asked.

“Engineering may have impact, but innovation has novelty,” he said.

Consider aortic stenosis, a disease that was defined nearly 400 years ago, Dr. Edelman said. The excitement of TAVR is not so much that it is a new technology or metric when compared to standard treatments, but that it redefined a 400-year-old understanding of a disease. That is, inoperable critical aortic stenosis was thought to be untreatable; TAVR showed that it could be successfully treated.

We may also need to change our thinking when it comes to door-to-balloon times, he said. Although dramatic progress has been made in reducing the time in which acute myocardial infarction (AMI) patients receive percutaneous intervention, AMI remains a deadly disease. Nearly 10 percent of AMI patients die during hospitalization, while many survivors suffer significant heart damage and go on to develop chronic heart failure. Only about 15 percent of those who have AMI will come out with their health completely intact, Dr. Edelman said.

Dr. Edelman cited a number of recent studies that suggest that unloading the left ventricle may reduce the damage to the heart.

“Unloading may be the thing we need to do,” he said. And that would reflect a new understanding of how to treat AMI – a true innovation.  Only time will tell.

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