An Engineering Feat Gives Hearts Extra Life

With the release of their new HeartAssist5 heart pump, ReliantHeart is making real-time, personalized feedback possible for the millions of Americans suffering from heart failure. The new technology allows for real-time, remote monitoring of implantable devices, years of added life for patients, and flexibility to travel without a physician nearby. With a staggering projected 46% growth in heart failure by 2030, advances in heart failure innovation are on the forefront of changing medical treatment, policy, device research and physician reimbursements. Further, with heart failure and disease disproportionately affecting minorities in the US, advances in length and quality of life could be huge strides for medical equality.

Heart Failure In America

Approximately 7.5 million people in the United States currently suffer from heart failure, a figure that is increasing over time as more people survive heart attacks and various other heart conditions. According to the Heart Failure Society of America, an estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year, with deaths averaging 250,000 annually, more than double since 1979. Even worse, an estimated one half of heart failure patients die within five years of diagnosis and 20% within the first year.

With a waiting list for heart transplants at an overwhelming 3,736 at publication, and less than 2,500 hearts donated annually, the need for a bridge between heart failure and transplant is literally life and death.

LVADs

Left ventricular assist devices (LVAD) are implantable heart pumps that were created to temporarily support patients with advanced heart failure as the bridge between diagnoses and transplant. However, with new scientific advancements, LVADs are becoming a long-term tool for improving heart function without transplant.

The right ventricle pumps blood to the lungs, but the left ventricle is responsible for pumping blood to the rest of the entire body, making it much more susceptible to failure. Therefore, LVADs have been the focus of most modern research to prolong and improve life saving implants.

Patient-Centered Care

Reliant’s system acts like your car’s dashboard. “If a patient’s pump has any sign of a challenge, like dehydration or low flow, the remote monitoring system signals the change to a data-collection center that notifies the transplant center as well as the individual,” ReliantHeart CEO Rodger Ford says. This is what makes the HeartAssist5 unique; at the first sign of a problem the right people are notified immediately.

Essentially, if the engine light goes on, the heart center and patient are notified to get the engine checked.

He also notes that the patients can set monitors to send text message notifications, thus making changes in blood flow, speed and power truly personalized. Individual blood flow is collected and transmitted every 5 minutes, making one’s own body the standard comparator.

The greatest importance to Founder and CTO Bryan Lynch is his ability to use his background as an engineer to, “Get involved in a project where you can actually see how you saved a life. While the docs and nurses are the real lifesavers, we give them the tool to make it possible.” He continues that it is vitally important for engineers and innovators to gain a patient-centered approach to get a real reduction in cost burden and improve quality of life.

Sailesh Saxena, CFO, continues highlighting the patient focus of the company by telling about the origination of the design of the VAD pack. “Bryan and I used to go to Schlotsky’s Deli ($BUNZ) for lunch,” he said, “and we used to see this man wearing a coat although it wasn’t cold out. Bryan noticed immediately that he was attempting to hide an LVAD controller and batteries. Well, this happened more than once, and we recognized that he was always concealing the VAD controller. So we decided that we needed to create a unique insert so that our LVAD control system could slip right into a Louis Vuitton ($LVMH) or Gucci ($GUC) bag unnoticed. It’s the small things that make the patient feel like we understand what they really want.”

Expanding The Geography Of Care

Remote monitoring, like other methods of telemedicine, is a key to expanding the geography of health care. “As technology matures, with the help of remote monitoring, the cardiologist and patient will feel safer with greater distances between them,” says Saxena.

This growth in telemedicine as a whole, and specifically in heart care, has major implications for the Centers for Medicare & Medicaid Services (CMS) as well as health care policy and reform. Because CMS is beginning to assign reimbursements and penalties based on patient outcomes instead of traditional fee-for-service metrics, it will become more and more important to have reimbursements reflect remote monitoring and its likely benefits.

Reimbursement codes also need to be reworked to genuinely target geographic discrepancies in care, which are fundamentally important for transplant centers. However, at present, CMS is slowly beginning to take growth rates of heart implants seriously based on the agency’s continued increases in payments, including their slight variations in geographic differences.

An Engineering Feat

In a recent study, researchers found that platelets flowing through the HeartAssist5 are exposed to significantly lower cumulative shear stress levels than in competitive devices tested. Ultimately, this means that the ReliantHeart product allows for what the CTO calls “a more physiologically normal cardiac output, including the pulse.”

What Bryan means is that people with failing hearts have low blood flow throughout the body, which is why they are so sick. When an LVAD is implanted, patients return to a more normal flow, but they also need blood flow that is as natural as possible. With the HeartAssist5, blood is not damaged and any pulse that the recovering heart produces is naturally transmitted to the body.

The LVAD and heart now work together to help the patient recover.

Although there are two other continuous flow LVADs on the market (THOR and HTRW), the ReliantHeart team claims their careful design capitalizes on working with the natural ventricle to the benefit of the patient, almost like a gym trainer for your heart.

Their “implantable flow probe” is also a revolutionary aspect of the HeartAssist5. This ultrasonic probe measures the blood flow from the LVAD in real-time providing critical feedback that is a one-of-a-kind technology providing data that makes the aforementioned remote monitoring so valuable. Ford says this ability to see patient-specific trends remotely in real time not only helps all patients improve quality of life, but the longevity of the HeartAssist5 creates a life support system, far beyond the “bridge” that the LVAD was originally created to be.

So this month, for American Heart Month, think about what innovation really is. It might be the ability to prolong and add quality of life for individuals and families across the nation, to share more time with loved ones.

 

Stork Edition: Health Care Delivery in 2013

I’d like to send a very heartfelt CONGRATULATIONS to our brilliant Wright on Health creator Brad Wright and his lovely wife, Laura!

Brad’s writing on Health Care Delivery in the US is going to take on an entirely new meaning, as they have just announced that there will be a Wright family addition in 2013!!!

Congratulations to you both, and we all look forward to your tiny bundle of joy.

 

Just How Much Do Hidden Health Care Costs Cost Americans?

Most of us have no idea how much our employers contribute to the costs of our health insurance to begin with, so it’s no surprise that we don’t know how much more they end up paying on our behalf each year. If you wanted to get people immediately outraged at the costs of care in this country, all you’d need to do is make the employee foot the entire bill. Employers know this, though, so they continue to compete for employees by absorbing the rising costs of insurance coverage rather than passing them on to employees through higher premiums and increased co-payments. Please don’t think, however, that employers are picking up the tab out of the kindness of their hearts. On the contrary, what they’re doing is passing the costs on to employees ever so subtly, by giving them smaller and less frequent increases in pay. It’s harder to miss the money you never laid your hands on in the first place. But what if that money didn’t go to health care? What if your paycheck got a little bit bigger? What could you have done with that money last year? RAND has put together a striking info-graphic showing just how much hidden increases in the cost of health care are costing Americans.

 

Wasting Money At the End of Life?

Peter Bach is a physician with a recent op-ed appearing in the New York Times. Dr. Bach’s piece about whether or not end-of-life health care spending is wasteful is compelling. I recommend you read his essay, but I want to hit some of the high points.

The first is that we may be making an error based on hindsight. Precisely because hindsight is 20/20, we can fall into the trap of evaluating health care decisions after the outcome is known, which is not how health care decisions are actually made. So, as Dr. Bach stresses, a tremendous amount of health care spending may be deemed warranted if it saves the life of the patient, but the same spending would be labeled wasteful if the patient dies. This is an excellent point.

Other points Dr. Bach makes relate to supposed sources of bias. For example, sick people need more health care (which costs more money) and are also more likely to die. Ergo, the link between health care spending and death is likely to be positive, but the reality is that health status is the common denominator. He also laments the fact that data on end-of-life spending is much more readily available than data on other types of health care spending. That’s also a pretty accurate assertion.

It’s in his concluding remarks that Dr. Bach gets to the real matter at hand: We don’t know who is going to benefit and who isn’t. In his essay, he describes how he saved someone’s life. As it turns out, the condition that person had is fatal in about 1 of every 8 cases. In other words, paying to intervene for that condition seems like a good bet. If, on the other hand, only 1 out of 8 people with the condition survived, it might be a tougher sell. Of course, what that scenario underscores is that the overall costs and benefits are important to understand, but so are the individual risks and benefits. For example, if you have the condition, you are probably hoping that you are the 1 person who will survive after receiving the intervention, not counting on your being 1 of the other 7.

Research that can help us understand not only which procedures are generally more effective than others, but also who the 1 person who loses or benefits (given the two scenarios above) will be, are the next frontier in improving the health care system–cutting costs without harming quality. Of course, this type of research will bring accusations of “death panels” back out of the woodwork. I just hope few people will actually take such things seriously, so that the necessary work can proceed. Without it, I’m not sure that there’s much hope.

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