Data-driven care, heart disease, prevention - Evidence-Driven Care: The SHAPE of Things to Come

By Richard L. Reece, MD, author of Innovation-Driven Care: 34 Key Concepts for Transformations (Jones and Bartlett, 2007) and Obama, Doctors, and Health Reform: A Doctor Assesses Odds for Success (Iuniverse, 2009)

The future is embedded in the present. Only an objective and unbiased study of the present can reveal the future.

John Naisbitt, Author of Megatrends (1982) , and Mind Set! (2006)

How can we move towards a high-quality, lower-cost health system? There are four key steps: 1) health information technology, because we can’t improve what we don’t measure; 2) more research into what works and what doesn’t, so doctors don’t recommend treatments that don’t improve health; 3) prevention and wellness, so that people do the things that keep them healthy and avoid costs assocated with health risks such as smoking and obesity; and 4) changes in financial incentives for providers so that they will be incentivized rather than penalized for deliverying high quality care.

Peter Orzag, director of the White House Office of Management and Budget, “Health Costs are the Real Deficit Threat,” Wall Street Journal, May 15, 2009

I’m not a cardiologist. Rather I’m a retired pathologist and commentator of the role of innovation and the probable impact of the Obama administration’s proposed health reforms. I’m also a hard-nosed pragmatist who believes future Medicare and health plan payments will flow to those who provide hard data to back their claims.

A Beginning

Let me being by stating the obvious. We are in an era of data-driven health care. We are also in an era in which health costs threaten to bankrupt Medicare. To head off this bankruptcy, government will focus on bringing down costs on preventing and treating those chronic diseases – coronary artery disease, heart failure, chronic obstructive lung disease, depression, and asthma – and precursors that consume 70% of costs.

And government will concentrate on high ticket procedures for evaluating and treating health disease – coronary bypass, diagnostic angiography, coronary stents, and cardiac pacemakers – for it there that Medicare expends massive funds, funds it will try to justify, rationalize, reduce, or even deny in any way it can.

Anticipating Government Actions

The diagnostic and invasive cardiology industry should anticipate inevitable government actions to reduce costs – and take constructive, objective, and innovative steps to meet the threat. I belong to the school of innovation that says there’s rarely anything new under the sun. Evaluation of heart disease with or without accompanying pulmonary disease is a good example. Doctors in general and cardiologists in particular have known or sensed the following for a long time.

• Shortness of breath is a common presenting symptom of underlying heart and pulmonary disease.
• Shortness of breath is a sign of underlying disease rather than of normal aging.
• It’s difficult to differentiate whether the cause of dyspnea is cardiac or pulmonary or a combination of both.
• Heart and lung function are interrelated but no devices are available to conveniently available to evaluate both functional relationships.
• Some sort of early warning device to spot heart and/or pulmonary disease would be useful before either disease reaches chronic, and progressive and irreversible stages.
• The traditional coronary treadmill stress test is useful for evaluating cardiac ischemia but carries a small risk requiring the presence of a cardiologist.
• Portable devices for measuring functional heart and lung capacity and producing reproducible data are not available outside of cardiologists’ offices, and do not lend themselves to testing in primary care offices, fitness centers, or in the home.
• Most criteria for staging heart failure are either primitive or subjective - seeing how far one can walk in 6 minutes or even the New York Heart Association’s functional classification (NYHA) – I – No symptoms, II- Mild symptons, III Marked limitation, IV Severe limitation- are not reproducible between cardiologists.
• Despite sophisticated programming and cost of current cardiac pacemakers ($50,000 to $65,000 per pacemaker, not including cardiologist placement costs), it’s still not possible to predict whether a patient’s rhythm disorder will respond to pacing – the failure, or non-responder rate is in neighborhood of 30%

SHAPE Medical Systems

The device developed by SHAPE medical systems, a Saint Paul, Minnesota -based company, helps meet evidence-based criteria – reproducible data, objective measurement of what works and doesn’t work, early data or preventable and reversible disease, portability to different settings – that the government and the provider community will seek to reduce costs.

Among other things, the SHAPE device – consisting of a small gas analyzer, a one step stair, a face fitting mask to capture expelled air, and a laptop computer comparing the patient’s performance to a large database – produces reproducible, easy-to-interpret data.

The data :
1) calculates the risk of hospitalization or death;
2) can be assembled into one cumulative data number that signals early or late stages of disease and need for further evaluation;
3) defines and differentiates the cause of shortness of breath and cardiac and pulmonary function;
4) does so in six minutes or less after a low and steady walk not requiring exertion or risk to patient;
5) determines if a patient is likely to respond to different programming pacing options;
6) can serve as a supplement to traditional treadmill evaluation;
7) can be used at least four times a year to evaluate responses to drugs.

In addition to these features, the device is small (components can be carried in an ordinary duffle bag or its equivalent), can be set in any setting (primary care office, home, or fitness center) with electrical outlets, is cost-effective ($2000 for monthly lease or other flexible arrangements) , has received FDA approval, has been evaluated and confirmed as useful and reproducible at the Mayo Clinic, can be deployed on the frontlines of medicine by primary care physicians, who badly need a device for objectively evaluating early symptoms of heart and lung disease(the number 1 and number 4 killers of Americans), and shows the power of innovation for rationally transforming health care based on both anatomical and functional criteria.