Clinical Innovation - Predicting Odds of Sudden Cardiac Death and Preventing Them

When I started this blog, 1082 blogs ago and three years ago, I focused on clinical innovations that made a difference. Then along came the health reform debate. It consumed and sidetracked me. It should not have. Reform and innovation are interrelated because a so-called government takeover, with its rules and regulations and hostility to private enterprise, dampens innovation.

In any event, I periodically return to the subject of clinical innovation because I believe it is a way out of the health care pit. Over the last two decades, cardiologists have reduced sudden death odds from 30% after heart attacks to 6%, thanks to bypass surgeries, angioplasties, beta-blockers, ACE inhibitors, rhythm regulating and defibrillating devices, and new-found awareness of factors predictive of sudden cardiac death.

To track cardiovascular innovation, I follow the writings of Ron Winslow, chief Wall Street Journal reporter, who reports on developments of the annual meetings of the American Heart Association, and the progress of SHAPE Medical Systems, a St. Paul, Minnesota company that has created an FDA approved system that, among other things, predicts odds of sudden death from heart disease.

Here is the latest news, in the words of Ron Winslow and Alan Price, MD, and Abraham Kocheri, MD, of the department of cardiology at the University of Illinois at Chicago.

“Researchers said men at age 40 in the U.S. have a one-in-eight chance of suffering sudden cardiac death over the rest of their lives, a stark indication of the toll cardiovascular disease exacts on society.

For women, researchers said, the risk is 1 in 24. The prevalence has long been of concern to heart and public-health experts, but lifetime risks for the condition haven't previously been estimated, researchers said.

Some 300,000 Americans a year suffer sudden cardiac death, an event generally defined as death resulting from coronary heart disease within an hour of the onset of symptoms. Heart attack is the most common cause, but valve disease, infections and heart-beat irregularities can also result in sudden cardiac death.”

‘It's fairly astonishing data,’ said Muriel Jessup, a cardiologist at University of Pennsylvania who headed the program committee for the American Heart Association's Scientific Sessions here, where the findings were presented Sunday, and who wasn't involved in the study.

The condition may get less attention because of a belief that little can be done to prevent it, she said. But she and other scientists said steps can be taken to prevent the problem.”

Source: Ron Winslow, “For Men at 40, Risk of Cardiac Death 1 n 8, Wall Street Journal, November 16, 2009

• "Shape Medical System, which gained FDA approval earlier this year and was introduced at the 2009 Heart Rhythm Society (HRS) in Boston, allows physicians to quantify shortness of breath while tracking and measuring patient progress and response to therapy. Its test parameters offer criteria for patient functional classification, correlate with biochemical markers of heart failure (BNP and ANP), and provide data that are predictive of patient mortality and hospitalization risk, according to the company.

The test takes 15 minutes and involves measuring ventilation parameters while the patient exercises on a treadmill at a very low intensity of one mile per hour with a treadmill set at a 2% grade. The device includes five components : a data analyzer, disposable patient interface or mask, a pulse oximeter, and a computer and a printer.”

Source: Cardiovascular Business, June 10, 2009, and EPLLab Digest, “He Shape-HF Carioplulmonary Exercise Testing System, “ November, 2009.

Why do these two pieces of news intrigue me? Because the health system has within its grasp an affordable realistic cardiac testing system to predict sudden cardiac death and response to drugs and rhythm devices. Further, individuals at risk – those who faint, develop sudden shortness of breath, or who are involved inexplicably in accidents or collapse for no apparent reason – can be tested in decentralized settings, such as a physician’s office or even a health club – by a nurse or tech – at no risk to the patient because only suboptimal exercise is required.