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.

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IPAB

Contrary to the title, the IPAB is not a new Apple product. Rather, it is the “Independent Payment Advisory Board” created by the Affordable Care Act to solve the problem of ever-increasing Medicare spending. In people’s worst nightmares, the IPAB is a death panel that will make decisions about how to ration health care for the elderly and disabled. Images of 15 people sitting in a room handing out death sentences flash through the minds of the anti-government crowd. Of course, nothing could be further from the truth, as the IPAB has no authority to limit benefits, increase beneficiaries’ out-of-pocket costs, or otherwise alter the Medicare program in any way that would “ration” care.

So, what can the IPAB actually do to promote slower spending growth in Medicare? They can suggest legislation, that’s what. Legislation that, for example, would reduce or alter the way in which payments are made to providers. It’s debatable if the recommendations from IPAB will work to actually control spending. What’s not up for debate is whether action will be taken, and that’s what I’m most pleased about.

You see, I hear often from family and friends about how Congress “never does anything” and how we should “vote the whole sorry bunch out and start from scratch.” It doesn’t seem to matter which party is in power, either. Congressional disapproval knows no party affiliations. And this isn’t just a trend among my social circle. Americans generally disapprove of the job Congress is doing. The IPAB puts an end to that, and here’s how:

Starting in 2013, the chief actuary of the Centers for Medicare and Medicaid Services (CMS) will report both a projected and a target Medicare growth rate for the next five years. If the projected growth rate exceeds the target growth rate, IPAB is tasked with making recommendations to bring things in line. These recommendations are formally submitted to Congress as proposed legislation. In the past, this is where progress ceased to occur, but no longer.

With the ball in Congress’ court, the options are straightforward. Congress may either enact the legislation recommended by IPAB, introduce and enact its own legislation that achieves the same cost savings as the recommendations from IPAB, or fail to act. If Congress fails to act, however, the secretary of the Department of Health and Human Services must implement IPAB’s recommendations, which cannot be overruled by either the executive or the judicial branches. In short, when Medicare spending increases too rapidly, something will be done to address it, even if Congress fails to act.