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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Closing Racial And Ethnic Disparity Gaps: Implications Of The Affordable Care Act

For all intents and purposes, the Affordable Care Act (ACA), the President’s signature piece of legislation, will provide more health care coverage to poor and underserved populations. Persistently disadvantaged communities have much further to go than those with insurance, and new means of accessing and paying for care will benefit them disproportionately. Nevertheless, with more than 20 percent of the nation’s Black population uninsured, more than 30 percent of Hispanics uninsured and a country still grappling with understanding and properly addressing disparities, just how far does the ACA take us?

By mandating individual health insurance coverage and expanding the list of covered preventative services, ACA legislation should, theoretically, improve the quality of health care for those populations at disproportionate risk of being uninsured and having low incomes. In advance of the January 2014 start of major health reform initiatives, some estimate that more than half of the uninsured will gain insurance coverage.

However, research has shown that having health insurance itself does not have a substantial impact if people cannot find a doctor to see them, do not have proper information about accessing resources, or are not treated in a culturally and environmentally competent manner. Moreover, when the number of uninsured could be decreased by more than half, but being uninsured is not equitable across racial and ethnic groups in the US, what happens to our countries most vulnerable?

It has been well documented that low-income individuals and those without employee-sponsored insurance (ESI) are more likely to be people of color. Kaiser and US Census estimates indicate that there are significant differences in insurance rates by race and ethnicity, with national averages approximating there are almost three times as many uninsured Hispanics as Whites. In Louisiana, for example, it is believed that more than 50% of the state’s Hispanics are uninsured, while only 18% of Whites are. In the same state, it is estimated that 30% of Blacks are uninsured, reiterating just how unbalanced our country remains and how terribly far we have to go to eliminate inequalities.

The oft-cited example of health reform success is Massachusetts, where Blue Cross Blue Shield 2013 estimates indicate that about 97 percent of the state’s population has health insurance thanks to health reform. While this is a grand feat for gaining an insurance card, insurance alone does not constitute affordable, quality care, or improved long-term health and equity. The real successes come from improved statistics on accessing care, preventative care and disease reduction.

For those looking to Massachusetts, data does support a slight improvement in overall access to care by showing that Whites, Blacks and Hispanics all had increases in the number of insured, and further that the percentage of the state’s population that had “any doctor visit in prior year” between 2006 and 2009 rose by more than five percent.

Unfortunately, as many have argued, those for and against health reform, Massachusetts is not necessarily a good representation of other US states or populations, as anyone who has been to Massachusetts knows that the state population looks and behaves very differently from places such as southern California or the Southside of Chicago. Furthermore, even in Massachusetts the number of Blacks and Hispanics that remain uninsured is two and three times that of Whites, respectively.

Many of those who will be left uninsured will be Blacks, immigrants and Hispanics, who will continue to use Emergency Departments for critical care or, worse, go untreated.

Additionally, there are those who are lower middle class (a growing group in this nation) who fall into the economic gap where they cannot afford the employer/exchange insurance offered to them, but earn too much to receive subsidies for offsetting the mandatory cost of insurance, which are often people of color.

Other groups of concern are those minorities who do not have the knowledge of where to access care, do not have the financial or transportation means to access care or still distrust the system due to systemic problems with culturally competent care.

Although the ACA takes us a step forward in giving many of the countries uninsured an insurance card, the US must address what to do about probable provider shortages that will result from a lack of primary care physicians and different utilization in care. We must be prepared to understand both to cultural differences in demand and pent-up demand of the previously uninsured, as well as start to really face how to deal with persistent racial and ethnic inequality in this nation that shows itself in our health care system every day.

In the coming weeks, months and years the US citizens have to do more than champion or attempt to repeal the ACA. Party lines and moderate attempts at change will never fix our broken health care system. We have to start addressing the real issues our country faces, those of injustice, unequal access and treatment and how we properly care for and address the needs of those who are not White and wealthy.