ROCHESTER, NY ( Ivanhoe Newswire) - It kills more people than any other disease in the U.S. Now new technology is helping doctors keep better tabs on heart disease.
Rodney Clarke already has a pacemaker, a defibrillator, and an aortic valve implant. Now he's one of the first heart disease patients to get a newimplanted monitor.
"It's given me the availability of being able to have some of the quality of my life back," Rodney Clarke told Ivanhoe.
"It's actually one of the latest technology advances that allows us to move to what we call personalized medicine," Spencer Rosero, M.D, an associate professor of medicine and director of the pacemaker clinic at The University of Rochester, explained.
Doctor Rosero is one of the leading researchers on the device. It's implanted in the chest and a wire is connected to the heart to continually monitor heart pressure. Patients collect readings by waving a hand-held device over their chest. The information helps them figure out when and how much medication to take.
"If you have the information there every day then you can adjust the medications every day. But if you're only getting information once a month, you can only adjust the medications once a month," Dr. Rosero said.
The constant monitoring helps better control heart disease.
"The goal is to keep patients out of the hospital and modify the medications so they only take the medicine when they really need it," Dr. Rosero said.
Keeping close tabs on his heart has helped Rodney avoid a transplant.
"I'm humbled. I'm very, very humbled," Rodney said.
Doctor Rosero said the monitor allows patients to take a proactive role in their own care much like the way people with diabetes test their own blood sugar levels. Hundreds of people are needed for phase three trials across the U.S. To learn more about how to enroll go to www.clinicaltrials.gov
BACKGROUND: Heart disease kills more people than any other disease in America. It can be defined as the narrowing of the small blood vessels that supply blood and oxygen to the heart. It is caused by the buildup of plaque in the arteries to the heart. There are certain risk factors that are out of our hands. They include age, gender, genes and race. (Source: www.ncbi.nlm.nih.gov).
HAVE A HEART: The heart pumps 5.6 liters of blood through the entire body in roughly 20 seconds. Each day your blood travels some 12,000 miles, and your heart beats about 100,000 times. This delivers oxygen and other essential nutrients to the body's cells and organs. A heart attack occurs when the blood supply to the heart muscle is cut off, either because part of the heart is damaged (such as the valves to the chambers), or because plaque has built up inside the arteries, narrowing them and severely restricting blood flow. (Source: www.ncbi.nlm.nih.gov).
SYMPTOMS: Usually symptoms are very noticeable and sometimes you can have the disease and not know it. The most common symptom is chest pain, usually felt when the heart does not receive enough oxygen or blood. Other symptoms include shortness of breath and fatigue with activity. There already have been medical advances that have significantly changed the impact of heart disease on the population, such as, pacemakers, defibrillators, and aortic valve implants. Now researchers are studying a new implanted monitor. They believe the best way to treat a disease is to learn every possible detail about what is happening to the patient. (Source: www.ncbi.nlm.nih.gov).
INSERTABLE CARDIAC MONITOR: An Insertable Cardiac Monitor is a small implantable device that continuously monitors heart rhythms and records them automatically or when you use a hand-held patient activator. The device is implanted just beneath the skin in the upper chest area. Then a wire is connected to the heart to continually monitor heart pressure. The readings are collected and then sent to a hand-held device. The monitor will allow patients to take a proactive role in their own care.
"The device itself will process the information which includes, a prescription (programmed by their doctor) already built into the device that tells them, for example, take your water pill a little earlier today, take an extra dose today, don't take it today," Dr. Spencer Rosero, the lead author of the study explained. "It is so far the only one that actually integrates this kind of personalized hand held-device with the patients and real time managements in medications and prescriptions. It's the first fully integrated system to empower the patient in heart failure." (Source: www.medtronic.com, interview with Ivanhoe Broadcast News).
CLINICAL TRIALS: Hundreds of people are still needed for phase three trials across the U.S. To learn more about how to enroll visit: www.clinicaltrials.gov
Dr. Spencer Rosero, M.D, a cardiologist that specializes in heart rhythm disturbances and electrical rhythm problems talks about a device to monitor heart disease.
How big of a problem is heart failure is in this country?
Dr. Rosero: Hundreds of thousands of patients are being diagnosed with new heart failure every year, and those patients are also counting on technology that's available today that wasn't available twenty years ago to live longer. The challenge we are facing today is we want a better quality of life, not just longer lives.
Is heart failure challenging to control?
Dr. Rosero: Heart failure also requires a lot of visits, but the main thing with heart failure is that it affects so many systems. The heart provides the blood flow to the brain, the kidneys and several of the other vital organs. Also, heart failure is one of those diseases that the patient may feel well one day but four days later, they don't feel as well, and it can be very subtle. Over a period of time a lot of patients may lose some of what they call their energy level or develop a little bit of fatigue. If they compare how they were doing a year before then it's a huge difference.
What are the common symptoms?
Dr. Rosero: The most common symptoms are many times shortness of breath or I don't feel as good, I'm walking and I get out of breath, I thought I was out of shape but now I'm really not feeling good. People will first show up in an office and then they'll go through a history. The more information you get, the easier it is for the healthcare provider to narrow down the diagnosis. Heart failure, heart rhythm or heart problems are usually the first on the list for that.
When someone is diagnosed with heart failure and they have these symptoms, are you able to adjust their medication and get them back in control?
Dr. Rosero: They do a battery of tests. Some of them would involve blood tests to see how the kidneys and heart are doing, and some of them do involve something like what's called an echocardiogram, which is an ultrasound of the heart. It gives us the anatomy and actual function. You can actually see how well the heart is squeezing . Based on that information, you can decide on the next step in treatment.. Medications are almost always involved. Sometimes you have to go further. If there's a blockage in an artery, the physician may consider opening it in some cases to improve the blood flow to the heart. In other cases, not much else can be done to the anatomy itself.
What's the goal of the medication?
Dr. Rosero: Several have been shown to improve survival. In some studies, certain very simple medications have been shown to make people live longer with a certain kind of heart disease. Some of the other medications are really meant to improve how they feel. By making the heart more efficient, they can feel better and they can go back to walking to the store, walking around the mall without getting short of breath.
What's the study about?
Dr. Rosero: It involves a new technology that was developed by St.Jude Medical. It's a left atrial pressure monitoring device. It is actually one of the latest technological advances that allow us to provide more personalized medical care. If we can predict how a patient is going to feel and what the heart is going to be doing ahead of time then maybe we can intervene early. The HeartPod device goes into the heart with a small wire, the sensor goes into the left side of the heart where it measures pressure.. It then sends the information to a small portable device that looks like a smart phone. It's called PAM. By holding it over their chest, tegh patents download information regarding their heart .
How does it work?
Dr. Rosero: The device itself will process the information which includes, a prescription (programmed by their doctor) already built into the device that tells them , for example, take your water pill a little earlier today, take an extra dose today, don't take it today. The goal here is we know that the human body isn't the same every day; it changes during the day, it changes at night. We then integrate this information so we can actually personalize it to the patient. We've noticed in the past that when these parameters or this information becomes available way ahead before you feel sick the body starts to change. A group of patients will be getting the implantable version of the device and the little smart phone palm type device, that's held in their palm. That group of patients will be compared to a group of patients who doesn't get the implanted version but does get the hand held device that has their prescriptions and all their medications on it. These two study groups are going to be followed and our question is whether the patients who are actively managed using the new system will do better overall and have less need for hospitalizations.
What is the patient looking for at home?
Dr. Rosero: Data from the heart, data from the brain, data from the blood, we could always get them in what we call a single point of time. Just because I draw your blood this morning it doesn't mean that all the chemicals are exactly the same at the end of the day, they go up and down all day long. In the past that's the way a lot of studies were done because it was the only thing that technology allowed. What this new approach does, is it records the information and the information is combined with the patient's real life experience .
Does it record 24 hours a day?
Dr. Rosero: It depends on which system. There are a couple of different versions. If the current technology is incorporated in to a full defibrillator pacemaker, it can potentially record all the time. In one part of the study, patients who don't need a defibrillator, but just need a monitoring device for their heart failure, will have the data looked at least two times per day. Whenever the patient grabs their hand held device, holds it over the device it downloads the information. Whenever they sync it at the end of the day it downloads all the information to the computer. Then we combine that information with their medications and we can see the trends during the daytime and the nighttime. The goal is to monitor the patients long term knowing that each patient will have a different scenario or different changes in their physiology the way the heart handles things before they get sick. Once we recognize that signature, everybody is going to respond a little differently. We may learn that every time they have that matching pattern for three or four days, the dashboard light is going to go on, they're not going to feel good. We can then start acting on that information ahead of time and adjust medications. If you have the information every day, the patient can adjust the medications themselves. But if you're only getting information once a month, you can only adjust the medications once a month.
Are you looking at each patient everyday as their doctor?
Dr. Rosero: The investigators, which are multiple centers in the country, are involved in the study and it's a combined team. We have cardiologists as specialized electrophysiology or implantable devices and electrical devices and we have cardiologists that are heart failure transplant specialists. Dr Leway Chen, principal investigator, and his heart failure team analyze the data as it comes in. Every thirty days it gets reviewed by the team as part of the protocol. But as time goes by we'll be looking at almost on a daily day pattern. Once the patterns are established for the patients, we can use fine tune these algorithms and personalize the treatment.. It doesn't have to be looked at by a health professional every single day. Our patients are very proactive in following their own numbers and that additional input makes a big difference because they can pick up patterns before we can notice the patterns. At least one or two of the patients are already very active and looking at their own data and saying, well whenever this happens this is what I need to do.
When you say they are looking at the information, what exactly are they looking at?
Dr. Rosero: For part of the trial they're not able to see their data but once the data is open they can see the numbers of the pressures in their heart, just some very basic numbers. They see their medications, the prescriptions and they start making some correlations internally on their own, some assumptions. The research team on the other hand, will look at the data being transmitted. We also know the patient will tell us how they feel on the PAM device. It's kind of interesting that so far even though the study is very early, patients are starting to recognize a connection with the data and the symptoms and what we're seeing it from a separate standalone area.
What does this mean for patients?
Dr. Rosero: The goal is to keep patients out of the hospital and modify their medications so they only take the medicine when they really need it, which means that you may get less side effects. It's also to improve the quality of life long term. Maybe instead of getting sick a couple of times a month for several days at a time, you can make that just a couple times a year. It changes the way you do your planning. Right now we have a lot of patients that will say, well I can go visit family, I can go to that party. I think right now we're still under reactive basis in medicine. We do some preventive maintenance especially for heart failure, but now we can do real time therapy.
Part of the approach depends on improving technology to recognize changes the same way family and friends of those people who have heart failure kind of know when they're not doing well one day versus the other. Sometimes it's very subtle, it's just how they're talking and how they're moving. From a clinician, nurse practitioner and physician assistant standpoint, when we see the patients in the office we just see them that day. We just see one snapshot maybe for fifteen minutes, that one time of day, but they can be very ill. We're trying to use some of that information on these new technologies. Can we pick up trends earlier and then if we can, can we avoid them having to come in to the hospital by treating them earlier. It has to be both patient and technology.
This is not a treatment for heart failure this is a monitoring device, correct?
Dr. Rosero: It is a monitoring device but part of the protocol involves managing their treatment based on the information.
When you explain it to them are they excited about it?
Dr. Rosero: It varies from patient to patient. I think the majority have been excited about it. It is a pivotal study with a new technology, so of course we're very careful to explain everything to the patient because there are risks. We are trying to answer a question with the trial to try to figure out if it helps patients long term in a large clinical study. We haven't proven that yet, there have been smaller studies that suggested and proven that it may reduce hospitalizations. It may make patients feel better, but a large trial is really what you need to make it a standard of care. We do have patients that would rather not participate in a research trial and that's perfectly fine and understandable. All new technologies have some risks with it and the main question wont be answered until the trial is completed. I think it requires the patients to be comfortable with technology, comfortable having that little palm or smart phone with them that they can synchronize and download information. We have some other patients that just can't wait to get hands on the device and start looking at the numbers and using it.
What patients qualify for the study?
Dr. Rosero: Most of the patients who are being enrolled have been hospitalized for heart failure. If they've gone to the hospital and stayed overnight for heart failure and required IV therapy, intravenous injections of medications to help them with their heart failure, they are candidates. It's the sicker patients who feel sick or have more symptoms that we're starting off with.
This could in the future be used with mild heart failure?
Dr. Rosero: That's right. Once the algorithms and once the devices are well developed and we have enough human data that we know what works and doesn't work or how to fine tune it, it will most likely be available for patients with early heart failure.
Tell me again the results you have seen from the earlier studies.
Dr. Rosero: Prior studies have been quite small, but tend to suggest a decrease in hospitalization and a tendency to using less water diuretics or water pills in terms of dosage. In some patients for example they may be taking more water pills than they need. By fine tuning it every day, we can then change the dose every day. I think that's what kind of empowers the patient to make that choice.
How exciting is this for you?
Dr. Rosero: We're very excited because it is one of the new technologies that has the potential to change how we use implantable devices and how we practice medicine, especially in heart failure. It is so far the only one that actually integrates this kind of personalized hand held device with the patients and real time managements in medications and prescriptions. It involves the patient, heart failure team and the nurse practitioners working together to modify the medications and their prescriptions. It's the first fully integrated system to empower the patient in heart failure. The patients have been pretty happy in participating so far, which is good because it does take a lot of commitment and dedication from the patient's standpoint as well.
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