NEW YORK. (KFSN) -- Shortness of breath, fatigue, even the inability to get up and move across the room; that's what happens when your heart is not working properly. Five million people suffer from heart failure in the United States. Half of those people will die within five years of diagnosis. Now, there's a new technology that may keep hearts beating longer and stronger.
Forty-four year old Annelies Jacobs felt twice her age. Her heart was out of synch. She told Ivanhoe, "I was housebound. I could not do anything."
"Normally, the heart contracts in a synchronous matter, meaning all the walls come in at the same time," explained Vivek Reddy, M.D., Cardiologist at Mount Sinai Hospital in New York.
But, in Annelies, the heart walls contracted at different times. Doctors implanted a traditional pacemaker with three wire leads sending electrical currents to the heart but it didn't help.
Now, Dr. Reddy is one of the first to implant a new type of pacemaker called WiSE.
Dr. Reddy detailed, "Instead of a lead, we actually put a pacing pellet. It's a very small pellet."
Placed directly into heart tissue, it's powered by an ultrasound device implanted in the chest wall. It wirelessly sends ultrasound waves to the pellet.
"The pellet converts this ultrasound energy to electrical energy and that paces the heart," Dr. Reddy continued.
All without a wire. Of the 34 patients implanted in Europe, 80 percent saw improvement in their heart function.
Rick Riley, Chief Operating Officer of EBR Systems, who created the device, said, "I think several of these patients today are alive because of this."
Annelies is one of them. She said, "Now, I can almost do everything. I can go on a bike. I'm walking, I go to the gym and I even got back to work."
Dr. Reddy says the WiSE implant has just been approved for use in Europe. Researchers hope to take it into clinical trials in the United States by next year.
WiSE Ways to Treat Heart Failure -- Research Summary
BACKGROUND: Heart failure is a serious and long-term condition that affects as many as 5.1 million people in the United States. The condition occurs when the heart is too weak to pump blood as well as it should and cannot supply cells with enough blood. The condition is caused by both genetic and lifestyle factors like coronary heart disease, diabetes, smoking and obesity. During heart failure, the body tries to over compensate by enlarging the heart, forcing it to pump faster and causing the blood vessels to narrow and keep blood pressure up. Though these measures cause the symptoms to subside, it does not fix the condition but instead, causes it to worsen until the heart declines. (Source: http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm, http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/About-Heart-Failure_UCM_002044_Article.jsp)
TREATMENTS: Because heart failure is a chronic disease, treatment does not cure the condition but helps to improve the symptoms and the heart muscle itself. Doctors may include adding physical activity, losing weight or changing a patient's diet in order to reduce the symptoms of heart failure caused by lifestyle factors. Medications are the most commonly prescribed course of treatment for the condition and are usually given in combination to treat several different symptoms. Medication like digoxin, beta blockers and ACE inhibitors are several drugs used to treat heart failure. For more severe cases, a cardiologist can recommend surgery to implant a defibrillator or heart pump to maintain the hearts rhythm and output. Coronary bypass surgery is another option, especially if the patient has severely blocked arteries that are causing the condition. The procedure takes blood vessels from the arm, leg or chest and uses them to "bypass" the blocked artery to allow flow to continue. (Source: http://www.mayoclinic.org/diseases-conditions/heart-failure/basics/treatment/con-20029801, http://www.heart.org/HEARTORG/Conditions/HeartFailure/PreventionTreatmentofHeartFailure/Prevention-Treatment-of-Heart-Failure_UCM_002048_Article.jsp)
NEW TECHNOLOGY: EBR Systems has developed a new implantable cardiac technology used for cardiac resynchronization therapy (CRT), a treatment for heart failure patients. The device called WiSE (Wireless Stimulation Endocardially) does not use leads like typical cardiac resynchronization implantables like pacemakers. Its wireless capabilities is the key reason the technology is so effective and free from problems associated with wire leads. Vivek Reddy, MD, Helmsley Professor of Medicine at Icahn School of Medicine at Mount Sinai in New York and his colleague Petr Neuzil, MD, Chief of Cardiology were the first to implant the device in a patient in a clinical study in Prague. Dr. Reddy is a consultant to from EBR Systems and received research grant support from the company. He says the WiSE system has just been approved for use in Europe and the FDA is currently reviewing for U.S. clinical trials, which Dr. Reddy hopes will begin next year. (Source: Vivek Reddy, MD, http://www.ebrsystemsinc.com/news)
WiSE Ways to Treat Heart Failure -- Doctor's In-depth Interview
Vivek Reddy, M.D., Professor of Medicine in Cardiac Electrophysiology at Mount Sinai Hospital in New York talks about a wireless way to help patients suffering from congestive heart failure.
Interview conducted by Ivanhoe Broadcast News in May 2015.
What is the heart's left ventricle and what does it do?
Dr. Reddy: The heart consists of four different chambers. There are the two top chambers and the two bottom chambers. The bottom left chamber is called the left ventricle and this is the most important chamber of the heart because it's the main pumping chamber. It's the contraction of this chamber that really pushes the blood forward to the rest of the body.
Why does it get out of sync with the rest of the heart in some patients?
Dr. Reddy: In some patients the problem is that this left ventricle, the main pumping chamber, doesn't contract as effectively as it should. As the effectiveness of the heart decreases, this can result in something called congestive heart failure. Congestive heart failure is a problem where the heart is not pumping effectively, and in that situation when it's not pumping effectively, patients have different symptoms, most importantly shortness of breath, an inability to exercise, or to even carry out their normal activities. Ultimately if the heart doesn't work properly, one could require a transplant.
How many U.S. patients have heart failure?
Dr. Reddy: Congestive heart failure is a prevalent condition. It affects approximately five million individuals in the United States alone. This is something that is increasing slowly over time. And it's something that's increasing with the increasing age of the population. It's also important because about two fifths of these patients, somewhere between 30 to 40 percent of these patients have, in addition to congestive heart failure, an electrical abnormality. It's something we called, dyssynchrony. It refers to how this particular chamber contracts. Normally, the heart contracts in a synchronous manner meaning all the walls come in at the same time. But in some patients, there is dyssynchorony, meaning one wall contracts before the other wall. You have a situation where the heart is not contracting in an as effective a manner as possible.
Can you explain how this problem affects the patient?
Dr. Reddy: Congestive heart failure affects patients in several ways. It can cause different symptoms, most notably shortness of breath. Also, an inability to exert oneself, so even with a small amount of activity, the patient may get very tired. It can be something as mild as fatigue or it can progress to fatigue that's bad enough that patients can't even conduct their daily activities of living. It can be so severe that the patients can't even walk, for example, across the room. It can also cause more advanced cases of heart failure like dangerous life-threatening arrhythmias. The heart failure can be so bad that arrhythmias can occur which result in cardiac arrest, and potentially death.
How is this problem currently treated?
Dr. Reddy: In terms of treating congestive heart failure the first approach is medications. There are different medications we can use that can alleviate some of these symptoms. They can help the heart muscle become stronger. When patients have dyssynchrony, patients whose electrical conduction is not normal in that 30 or 40 percent of patients, then there are approaches where we can actually pace the heart in a way to resynchronize the heart so that you don't have this dyssynchronous activation.
What are the main problems with current devices that are implanted in the heart and why do they use wire leads?
Dr. Reddy: What we do is put one lead on the right side of the heart here and we put a second lead on the left side. To get to the left side, it's somewhat tricky. If you go behind the heart, we put a wire through the heart and it enters the back of the heart. It's positioned in one of these veins outside the heart. We end up having one lead here and one pacing spot here and one pacing spot here, so that helps the heart contract in a more synchronous manner. This approach works very well, but there are certain problems. First, in some patients, we don't have a good vein on this lateral wall of the heart in order to position that lead. And in all patients this involves a lead. Leads are wires that travel in the veins in order to get to locations that we want to pace. And these leads can have problems over time. They can get infected and then the lead has to be removed. As the wire goes from the chest wall through the veins all the way to the heart, this is under constant stress over the lifetime of the patient. With that stress, the lead can fracture and then the lead is no longer able to pace the heart. It becomes ineffective. The other problem that this imposes is that when you have to take out the lead, it becomes much more complicated. When you have a lead that comes all the way down from the chest through the vein all the way to the heart, to be able to take it out, you have to cut away this all the way down to the heart. And this can be a much more complicated procedure. And can even lead to some complications that can be life threatening.
Is it true that in one third of U.S. patients you have, one of the current implants enjoys no benefit?
Dr. Reddy: It's true not everybody who receives the current type of device actually derives a benefit from this. About a third of the patients don't get benefit from that resynchronization. Now, it's not that they don't get any benefit. They may get let's say a small amount of benefit, but certainly not the kind of benefit we're expecting when we implant this device.
Is it true that one billion dollars' worth of implants are wasted annually because they don't help one third of the patients who receive treatment?
Dr. Reddy: Because those devices don't help everybody, approximately one third of patients who we call non-responders to this therapy, in some ways you can say that this is sort of wasted therapy. These are not trivial numbers. It can be as much as probably close to a billion dollars in terms of the aggregate of all of these patients who receive these devices. The problem is right now, we can't identify which patients are going to get benefit and which patients are not going to get benefit.
What is the WiSE technology that you have implanted in patients in Europe?
Dr. Reddy: As a way to try to avoid some of the limitations of the current technology, there is a new technology called WiSE. It's a wireless cardiac stimulation technology. This WiSE technology involves several different steps. The first step is to place a lead actually directly inside of the heart. Now, when we put something inside the left ventricle, we can't have a long wire because with wires, clots can form on them, and the left side of the heart, those clots can travel to the brain and cause strokes. Instead of a lead, we put a pacing pellet. It's a very small pellet, about a half a centimeter long and we put it directly into the heart tissue. That pellet is too small to contain a battery, so in order to power that, there's a separate battery that's placed in the chest wall. Then that battery has an ultrasound transmitter and ultrasound energy goes through and hits this pellet. The pellet converts this ultrasound energy to electrical energy and that paces the heart. The idea is to separate the battery away from the point of pacing and not have a lead connecting between these two.
Why is it wireless and what are the benefits?
Dr. Reddy: The way this particular pellet is designed, there is no wire that connects the battery to the actual pacing stimulation electrode. The advantage of that is you don't have any of the problems associated with the wire, in terms of the connection and the possible lead fractures, etc. By allowing you to put the pellet directly in the chamber, you have much more leeway in terms of positioning the pellet. One of the additional benefits of having this wireless technology is we can put the pacing pellet anywhere inside the chamber. We have a lot more flexibility than what we do from the outside where we have to put the pacing lead wherever the vein is.
Does it convert ultrasound energy into an electrical pulse that keeps the left ventricle in sync?
Dr. Reddy: The way the actual pacing occurs is by converting the ultrasound energy that's submitted by the transmitter in the chest wall. The way this actually works is the ultrasound energy is emitted from the chest wall transmitter, hits the pacing pellet and that energy is converted from ultrasound to electrical energy which is then what paces the heart.
How many patients have been treated in Europe and how have they done?
Dr. Reddy: We've treated a total of about 40 patients in Europe with this technology and they've done well. By well I mean that four fifths of those patients or 80 percent of these patients have derived improvement from a heart failure perspective. Now, I want to stress one thing. All of these patients who underwent implantation of this technology were patients who had failed the standard approach; either because we couldn't get a lead into the standard location or they just didn't actually do any better, clinically better with the standard approach. This is technology that's affecting or that's addressing that unmet clinical need in those patients who really don't have other good options.
Do you think endocardial left ventricle pacing will make a big difference for patients?
Dr. Reddy: The process of pacing from the inside of the heart with these pacing pellets is called endocardial pacing and we believe it's going to make a very big benefit. There's a lot of data showing that when we pace from the inside of the heart, as opposed to the standard outside of the heart, the effectiveness of this resynchronization is greater. We believe that this will actually improve patient outcome significantly.
Where does WiSE stand with FDA?
Dr. Reddy: This WiSE technology is approved in Europe and other countries outside the U.S., but it's not yet approved in the United States. This technology is being submitted to the FDA and ultimately there will be a large clinical trial that will happen here in the United States; and assuming that the trial is positive, this would then allow approval in the United States.
If you would like more information, please contact:
Vivek Reddy, M.D.
1190 Fifth Avenue
New York, NY 10029