ROYAL OAK, Mich. ( Ivanhoe Newswire) - It may share the name of a popular beat from the eighties, but the HeartLightwe're talking about is helping heartbeats get back to normal. This new treatment for a problem affecting millions of Americans is helping doctors do something they've never done before.
"It felt like my heart was going to explode," Bret Story, who suffers from atrial fibrillation, told Ivanhoe. "I thought I was probably having a heart attack."
That was Bret Story's first episode of atrial fibrillation, a condition that causes your heart to beat fast and out of rhythm. It's the most common form of arrhythmia and can lead to stroke or heart attack. Bret said over those years it happened more and more.
"Out of breath and zero energy," Bret said.
Bret was picked to be one of the first people to undergo a new procedure. The HeartLight is a balloon catheter with a camera inserted through a tiny hole in the groin, giving doctors a new way to burn away the problem.
"We can actually look into the heart, which is fascinating," Dr. David E. Haines from Beaumont Hospital said. "To actually see the heart, the beating heart and to actually see the target right there in front of us."
Doctor David Haines said traditional ablation treatments that purposely damage problem areas in the heart to fix it, aren't too precise.
"Very difficult to manipulate the catheter around," Dr. Haines said.
He said the beating heart images he sees with the HeartLight allow him to aim and fire the laser more accurately to make a perfect line of burns around the problem area.
"Well, that's very powerful," Dr. Haines says.
It's been two years since Bret's HeartLight treatment. He hasn't had an a-fib episode since.
"I can do anything I used to do," Bret said.
Doctor Haines said the HeartLight is designed for patients whose atrial fibrillation starts and stops by itself. People with chronic a-fib would need more treatment on top of the HeartLight procedure.
Recruiting for phase three trials of the HeartLight are going on right now at sites across the country. To learn more go to clinicaltrials.gov.
BACKGROUND: Atrial fibrillation or AF, is the most common type of arrhythmia. An arrhythmia is a problem with the rate or rhythm of the heartbeat. During an arrhythmia, the heart can beat too fast, too slow, or with an irregular rhythm.
AF occurs if rapid, disorganized electrical signals cause the heart's two upper chambers—called the atria—to fibrillate. The term "fibrillate" means to contract very fast and irregularly.
In AF, blood pools in the atria. It isn't pumped completely into the heart's two lower chambers, called the ventricles. As a result, the heart's upper and lower chambers don't work together as they should.
People who have AF may not feel symptoms. However, even when AF isn't noticed, it can increase the risk of stroke. In some people, AF can cause chest pain or heart failure, especially if the heart rhythm is very rapid.
AF may happen rarely or every now and then, or it may become an ongoing or long-term heart problem that lasts for years. (Source: National Heart Lung and Blood Institute)
WHAT CAUSES ATRIAL FIBRILLATION?
Abnormalities or damage to the heart's structure are the most common cause of atrial fibrillation. Possible causes of atrial fibrillation include:
High blood pressure
Abnormal heart valves
Heart defects you're born with (congenital)
An overactive thyroid gland or other metabolic imbalance
Exposure to stimulants such as medications, caffeine or tobacco, or to alcohol
Sick sinus syndrome — improper functioning of the heart's natural pacemaker
Emphysema or other lung diseases
Previous heart surgery
Stress due to pneumonia, surgery or other illnesses
However, some people who have atrial fibrillation don't have any heart defects or damage, a condition called lone atrial fibrillation. In lone atrial fibrillation, the cause is often unclear, and serious complications are rare. (Source: mayoclinic.com)
THE HEARTLIGHT: The HeartLight® Endoscopic Ablation System, is the first technology that allows cardiologists to see inside a beating heart while performing laser energy catheter ablation, a treatment aimed at restoring normal heart rhythm after medication has failed. The HeartLight incorporates a small camera, or endoscope, that allows cardiologists to see inside a beating heart on a monitor to more precisely deliver ablation energy. While the technology is only available at trial sites in the U.S., it is currently used at medical centers throughout Europe. (Source: beaumont.edu)
David E. Haines, MD, Director, Heart Rhythm Center at Beaumont Hospital, talks about how seeing inside beating hearts is helping doctors beat a dangerous problem.
Tell us a little bit about the HeartLight TM, how is it different than other procedures?
Dr. Haines: The goal of atrial fibrillation ablation in patients with paroxysmal or intermittent atrial fibrillation is to isolate the source of that rhythm from the rest of the heart. Those beats seem to arise from the pulmonary veins. They are spots of irritability that fire off rapid heartbeats that get the rest of the heart traveling at a high and irregular rate. The standard approach is a point by point ablation with the catheter moving around on the inside of the heart. We do this with fluoroscopy, a computer mapping system, but the precision of placement of these burns is sometimes very difficult to manipulate the catheter around. In contrast the heart light catheter is a balloon catheter that after insertion into the heart the balloon is inflated and we put that balloon right over our target. We can actually look into the heart, which is fascinating to actually see the inside of the heart, and to see the target right there in front of us. We aim, very simply aim the laser beam where we need the ablation to go. We then zap it in sequence and create a perfect line encircling the source of this rapid rhythm.
You said it was exciting to see the inside of the heart, what did you first think compared to the traditional procedure?
Dr Haines: Well I've been looking at the heart beating in front of me my entire career and x-ray is a poor representation. You just see a faint shadow and you have to sort of guess where you are. We use intracardiac ultrasound and we actually see the inside of the heart beating, but it's not a real visual image. To actually see the inside of the heart in a patient that's lying in front of you, all you have is a tiny little puncture in to the vein to get the access to it. So it's really, really striking, really astounding.
How did you become part of the trial?
Dr. Haines: I have had a long standing interest in the treatment of atrial fibrillation and in the ablation of atrial fibrillation. I participated in a number of research projects over the years in order to try and determine the most efficient and the safest way to treat these very symptomatic patients. When I saw the heart light technology I was immediately attracted to it and I approached the sponsors and expressed my strong interest in participating. They liked our program and we had been working together ever since.
How does that make you feel and how confident do you feel it will get FDA approved and be able to help a lot more people?
Dr. Haines: Well there's nothing better than to take a highly symptomatic patient and in one procedure fix the problem. We use the term "cure" very carefully in medicine. Usually it's trading one condition for another and medications for symptoms, but then you get medicine side effects. But we are able to go in and with a procedure fix the problem and render them free from problems for decades to come. Well that's very powerful and we think that this tool is going to be an excellent solution for this problem.
In other invasive treatments sometimes it comes back, is that correct?
Dr. Haines: All treatment of atrial fibrillation is associated with some recurrence of arrhythmia. The HeartLight TM has some patients who have recurred as well. The goal is to fix as many people in a single setting as possible and that's where our hopes lie, that the HeartLight TM will be better at that than the standard technologies. When people recur it's usually due to reconnection across the line of ablation that we created. We recommend in those cases to bring people back to the lab for a very focused session where we map where we've done our prior work and we target our ablation specifically on the spots that need touchup work.
How big of a problem is a-fib?
Dr. Haines: Atrial fibrillation is a huge problem. In the United States alone it's estimated about six million people have atrial fibrillation. Now, it's more of an old person's arrhythmia, as you get in to eighties and nineties the prevalence of a-fib is very high. That's not really the population that we are targeting with these therapies. In the younger age groups it is still a significant problem. There are a lot of people out there with this issue. As the epidemic of obesity continues in our country and weight is directly related to a-fib we're going to see more and more a-fib in younger and younger patients. This approach will give one targeted treatment to take care of this issue.
Are there some people the HeartLight TM might not be right for?
Dr. Haines: The HeartLight TM is specifically designed at this point in time for isolation of the pulmonary veins, the so called pulmonary vein isolation procedure. That is really best suited for people with the paroxysmal form of a-fib, the one that starts and stops by itself. People with more persistent atrial fibrillation or chronic atrial fibrillation will need additional ablation aside from just the pulmonary vein isolation procedure. I envision after approval we may use the HeartLlight TM for the vein isolation component of the procedure but then we'll use other tools in a tool kit approach to go after everything that needs to be ablated in these other patients.
Is the trial still recruiting?
Dr. Haines: We are still recruiting. Actually we are in the early phases of the pivotal trial. This is a randomized trial comparing HeartLight TM to the standard approved ablation system and we've been enrolling for a couple of months, but we're actively seeking out patients.
Does it go through the catheter through the groin or is it right through the heart?
Dr. Haines: The access for insertion of the heart light is in the groin. It's a needle puncture into the vein and then a catheter that's about three millimeters in diameter is inserted through the vein up into the heart. Then we make a tiny puncture and slide that catheter from the right atrial chamber over to the left atrial chamber where we do our work. When we pull the catheter out those holes seal up by themselves, we hold pressure on the groin so there's no bleeding. The patient is in bed for about six hours but then they're up and around and they do fine.
How long do they stay in the hospital?
Dr. Haines: We keep people hospitalized overnight after the procedure just to monitor their rhythm, to make sure there are no other symptoms, no problems. Then they're usually ready to go by first thing the next morning.
How does this compare to other a-fib breakthroughs that we've seen over the years?
Dr. Haines: The first big breakthrough in the a-fib treatment was the recognition that most of these paroxysmal a-fib patients had their origin of their rhythm from the pulmonary veins. Once we were able to identify that and start targeting those areas for ablation our success rates started to climb. It's been over the past ten years the effort from our lab and other investigators to try and figure out the very best way to create a permanent and effective burn in that pattern around the veins. There have been a number of tools that have been tested, some of them have been effective but haven't been safe. Other tools have been easy to use but not effective. We're hopeful that the HeartLight TM will be both highly effective and very safe. And that's exactly what we're testing in this protocol.
Nationwide do you know how many people are going to be involved?
Dr. Haines: This is the pivotal trial and I believe that there will be twenty-five centers that are enrolling. The total number of patients will be about three hundred and fifty.
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