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.

 

Do Readmission Rates Really Indicate Hospital Quality?

Unplanned readmissions to the hospital have been the focus of much attention in recent years for obvious reasons: First, they are relatively easy to measure using administrative claims data. Second, like all inpatient hospitalizations, they cost a lot of money–and are therefore a target for reducing spending. Third, they are a proxy for quality of care, as at least some portion of them are likely avoidable if the hospital does its job well. On this last point, many disagree, citing the lack of continuity of care that exists post-discharge as a major source of readmissions. According to the folks in this camp, the patients themselves and their primary care physicians–not the hospital–are to blame for many of the unexpected returns to the hospital.

While this debate rages on, however, the federal government is taking action. Since 2009 they have published data on hospital quality using the Hospital Compare website, so that the public can be better informed. Then, starting last October, readmission rates for three conditions (heart attack, congestive heart failure, and pneumonia) were tracked, and hospitals with higher than expected rates were subjected to a reduction in Medicare reimbursement.

But a recent study from Matthew Press and colleagues in the June issue of Health Affairs finds that hospital readmission rates may not be such a good indicator of hospital quality after all. First, they found that across all hospitals, readmission rates for heart attack ranged from a low of 15.3% to a high of 25.6%. When they divided the hospitals up into quartiles, they found that only 1.7 percentage points separated the bottom 25% from the top 25%. Then, not surprisingly given the limited distance between the groups, they found that in just two years, many of those in the best performing group moved into the worst performing group and vice versa. Part of the explanation is what statisticians and econometricians call “regression to the mean.” In short, if you’re at the top of the pack, it is statistically more likely that you will move down than move up, just because you’ve got much more room to move in one direction than the other. The same is true in the reverse for the low performers. The investigators also found that, with few exceptions (e.g., teaching status), risk-standardized readmission rates were not correlated with other measures of hospital quality.

So what does this mean? Well, the authors suggest, there could be quite a few problems with policies that rely heavily on readmission rates alone as an indicator of hospital quality. Instead, they argue that other measures should be considered in addition to readmission rates when comparing hospital quality and that it is important to take regression to the mean into account by adjusting accordingly. In short, when it comes to measuring hospital quality, the more ways in which it is measured, the better.