SOUTHFIELD, Mich. (Ivanhoe Newswire) – In 2014, half a million people will be told they have atrial fibrillation. In simple terms, it’s an irregular heartbeat. AFib can set off a stroke, but now a new device is helping catch the clots before they kill.
"I'm not afraid to take a chance,” Paul Burris told Ivanhoe.
Paul is ready for a change.
"I couldn't participate in sports. Even walking was real painful for me,” Paul said.
Paul lives with an irregular heartbeat. He took blood thinners to prevent clots, but they also prevented him from enjoying the things he loves, especially his grandchildren.
“Their parents are constantly yelling ‘don't do that because you're going to bruise grandpa. You know he bruises easy,’” Paul explained.
Then, Paul became one of the first to try out the cardiac plug.
Electrophysiologist Christian Machado is the first heart care expert in the nation to treat patients with it for a new FDA trial.
“It's almost like a filter, or an umbrella filter, that is deployed in the left atrial appendage, which is the area of the heart that collects clots in patients with atrial fibrillation," Christian Machado, MD, F.A.C.C., F.H.R.S., and F.A.H.A, Medical Director of Electrophysiology Services and Arrhythmia Device Clinic, Providence Hospital, told Ivanhoe.
The plug collects any loose clots and reduces the risk of stroke. It’s changed Paul’s life.
“The biggest part of it is being able to play with my grandchildren,” he said. “That was the greatest gift that they've given me."
Dr. Machado says the plug has worked in every single patient he’s tried it on, without complications. So far that is seven patients.
BACKGROUND: Atrial fibrillation, often called A-Fib, is the most common kind of arrhythmia, or irregular heartbeat. It affects close to 500,000 new people every year in the United States. Normally, an electrical signal works its way from the top of the heart to the bottom, causing it to contract and pump blood. But with A-Fib, this rhythm is disrupted. The electrical signal doesn’t come from the sinoatrial node, where it normally does, and instead causes the left and right atria to contract irregularly. Blood begins to pool in the atria, and the ventricles, the chambers which hold blood before it exits the heart, don’t work in coordination with the atria. This causes blood to be pumped out to the body irregularly. A-Fib can cause a heart to beat 100 to 175 times a minute; a normal heart beats between 60 and 100 times a minute. A-Fib can cause stroke, blood clots, or even heart failure. (Source: http://www.nhlbi.nih.gov/health/health-topics/topics/af/)
CAUSES: The cause of A-Fib is an irregular electrical signal pumping the heart randomly, but what causes the electrical signal is usually hear damage. This kind of damage can come from any of these:
NEW TECHNOLOGY: The AMPLATZER Cardiac Plug (ACP) from St. Jude Medical, Inc. is designed to stop blood clots associated with A-Fib. Clots can cause stroke or become deadly if they travel through the body, known as clot migration, and patients with untreated A-Fib are four to five times more likely to have a stroke. The ACP is an umbrella-like plug inserted into the left atrium in the heart, as 80 to 90 percent of clots originate there. The plug then stops all clots from leaving the heart. The plug is already available in Europe and Asia, but it currently in clinical trials in the United States. (Source: http://www.stjohnprovidence.org/InnerPage.aspx?
Christian Machado, MD, FACC, Medical Director of Electrophysiology Services and Arrhythmia Device Clinic, Providence Hospital, talks about a new way to catch clots.
What is the St. Jude AMPLATZER Cardiac Plug designed to do?
Dr. Machado: This is a very innovative device which we call a cardiac plug. It’s almost like a filter or an umbrella filter that is deployed in the left atrial appendage, which is the area of the heart that collects clot in patients with atrial fibrillation. The purpose is once it’s deployed, it prevents any flow or any migration of clot from the heart to the brain or rest of the body, so it prevents clot embolization or clot migration. This device is used in patients with atrial fibrillation who are not candidates for long term use of anticoagulants. We are doing a pilot trial at this time and what’s amazing about this technology is that it offers patients a chance to come off life-long anticoagulation, which is a big issue for many patients. Anti- coagulation can be a quality of life l and economic burden, and it is associated with increased risk of bleeding complications including fatal ones. It can also be a hassle for patients to have to change their diet, change their lifestyle, because they are taking anticoagulation long term.
Why isn’t it more widely used?
Dr. Machado: So, it’s not widely used because right now the device is under investigation. It’s a pilot study, trying to demonstrate that the device is safe, and it’s feasible to deploy with acceptable risk of complications. So we suspect once the data is collected, and favorable outcome is demonstrated, then the FDA will expand its indication and actually allow more medical centers to be able to provide this therapeutic technology to their patients.
Is this device comparable to balloon angioplasty and why is this device better than what is currently being used by some doctors?
Dr. Machado: It’s not comparable to a balloon angioplasty. It’s very different. The purpose of the device is to prevent or reduce risk of clot migration and strokes in patients with atrial fibrillation. A balloon angioplasty is designed to open up arteries in the case of angina or heart attacks. So that’s a big difference. Now, why it’s not available, or why other physicians are not using this technology is because number one, it’s restricted at this point because it’s only to be used as part of this pilot clinical trial. Number two, many physicians are not trained in the use or the deployment of this device yet, and they will have to go through the proper training before they can use it.
What is AF and why is it the most common heart rhythm disorder?
Dr. Machado: AF is atrial fibrillation, which means chaotic irregular heartbeat, associated with clot formation. It’s the most common sustained arrhythmia in this country. It’s the number one cause of ER visits and ER admissions for a sustained arrhythmia. It increases your chances of having a stroke up to 5 times and it’s very common in patients who are elderly, who have hypertension, who are obese, who have obstructive sleep apnea; all conditions that are very common in this society.
So basically this device would help prevent a stroke? Why is that?
Dr. Machado: This device is designed to hopefully prevent thromboembolic events, specifically strokes, and is designed also to be used so that instead of anticoagulation therapy. For example, right now we treat patients with Warfarin, which is a blood thinner and this causes a lot of aggravations for patients. Number one, it requires close monitoring; number two it requires a very strict diet; number three, it’s associated with a high incidence of bleeding especially in the elderly. This device offers the opportunity to withdraw and stop anticoagulation and it’s been shown to work as a filter preventing the migration of clot from the atrium to the rest of the body, so that’s why we are so excited with this technology.
Who is a good candidate for this device?
Dr. Machado: Well there are strict criteria. Patients with atrial fibrillation, whether they have it in a persistent or intermittent form, or chronic, would be good candidates. Patients with atrial fibrillation who are wishing not to take anticoagulation therapy for the rest of their life, they cannot have congestive heart failure.
Are you currently training other physicians to use this device?
Dr. Machado: We are in the process of beginning to train physicians in this facility; that’s correct.
Is this covered by insurance?
Dr. Machado: This procedure is certainly covered by insurance. The process that this kind of trial goes through for approval with the FDA and with the NIH, allows this trial to actually be accepted by all insurance companies, including Medicare, and the billing goes through insurance companies as any other standard procedure.
How will you or how are you measuring the success of this device?
Dr. Machado: Patients are followed very closely and we have modality of tests that we perform, pre- and post-procedure, that confirm that the device is working as it should. For example, we do cardiac MRIs, we do brain MRIs, and we do a variety of ultrasound testing that confirm that the device stays in its position and its location, and that its working as a filter. So far, the 7 patients we have performed the procedure on are all doing well, all of them are off of anticoagulation, and without any side effects or symptoms to suggest that the device is not working.
Can you walk us through a demonstration of anything regarding this device?
Dr. Machado: It requires an overnight stay, and takes no more than two and a half hours average. Patients are heavily sedated for the procedure. We get access through the femoral vein and we need only two sheath or little tiny tubes that are introduced into the vein. We use fluoroscopy, which is x-ray technology, to guide us where we need to deploy the device. We also use intracardiac ultrasound. Once we identify the location where the device needs to be deployed, we confirm this with an injection of dye. The device can be screwed in and unscrewed through wires in the outside of the device. So it’s a very simple procedure and relatively short, as compared to other types of procedures that in the past would require open heart surgery.
And what’s the recovery like for the patient?
Dr. Machado: Well the patient goes home the next day. There are maybe two to three day physical restrictions that would have to do with maybe not performing any strenuous physical activity, not lifting any heavy weight, but after 3 days the patient goes back to their normal lifestyle.
When do you think it might be approved?
Dr. Machado: Well the trial is trying to recruit at least 500 cases so I suspect at least one more year before we go in front of the FDA to request their approval.