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Getting On Your Nerves To Save Your Heart

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ORLANDO, Fla. (Ivanhoe Newswire) - Heart failure is the fastest growing cardiovascular disorder in the U.S., affecting more than 6 million people. It occurs when a person's heart is too weak to pump and circulate blood in the body. However, now a new device that gets on your nerves could help save those with heart failure.

For years taking a walk was a tough task for Laquita Fossitt.

"I just felt out of breath, tired, and weak," Fossitt told Ivanhoe.

At age 35, she was diagnosed with congestive heart failure. Two decades later, she was told she needed a transplant.

"Some days I didn't even want to get up," Fossitt explained, but thanks to a new nerve stimulation device for the heart, she has a new option.

"I think it's a very promising therapy," Dr. Kishore Ranadive, Cardiologist, Orlando Heart Specialists, told Ivanhoe.

Dr. Ranadive said the CardioFit device helps the nervous system come into balance, which is needed to regulate the heart.

"The device is to kind of optimize that system by stimulating the nerve in the neck," Dr. Ranadive said.

The device is implanted in the chest and consists of a sensor lead that monitors changes in the heart and a stimulation lead that's attached to the vagus nerve.

"We slowly increase the current based on the response to the heart rate," Dr. Ranadive said.

It helps patients improve their symptoms. Five months post-surgery, Fossitt is up doing things she couldn't do before.

"It has gotten better," Fossitt explained.

Patients take anywhere from 6 to 12 weeks to respond to treatment.

CardioFit is already approved in Europe. In the U.S., a multi-center clinical trial is currently recruiting patients. For more information, go to: www.clinicaltrials.gov.

RESEARCH SUMMARY

BACKGROUND: Congestive heart failure is a condition that occurs when the heart can't pump out enough oxygen-rich blood to the rest of your body. It's often a long-term condition but symptoms could come on suddenly. It may affect only the right side or only the left side of the heart. Blood may back up in other areas of the body and fluid may build up in the lungs, liver, gastrointestinal tract, arms, and legs. Heart failure affects more than 6 million people in the United States and is the fastest growing cardiovascular disorder. (Source: National Institutes of Health)

CAUSES: Heart failure can be caused by a narrowing of the small blood vessels that supply blood and oxygen to the heart. Another cause is high blood pressure that is not well controlled. This can lead to stiffness and muscle weakening. Coronary artery disease can also be a cause. When plaque builds up in the arteries, less blood can reach the heart, causing it to work harder. Heart attacks can essentially kill parts of the heart muscle which were starved of oxygen, making the heart work more to compensate for the lost muscle. Even lung disease can be a cause: if the lung's ability to provide enough oxygen to the body is impaired, the heart has to compensate by pumping more blood.

(Source: American Heart Association/heart.org)

NEW TECHNOLOGY: The CardioFit nerve stimulator acts almost like an implantable pacemaker. It's placed under the skin of the chest and consists of a stimulator, a sensor lead, and a stimulation lead. The sensor lead monitors changes in the heart and a stimulation lead is attached to the vagus nerve, which can trigger the parasympathetic nervous system when stimulated. The parasympathetic nervous system has been shown to be able to reduce heart rate, which in turn reduces the workload on the heart. Current to the nerve is increased based on the response of the heart rate. The CardioFit can be programmed on and off with external wireless communication. It can take about 6 to 12 weeks to respond to the treatment. Vagus nerve stimulation has also been proven to be effective in treating epilepsy and depression. There's one vagus nerve on each side of the body, which runs from the brainstem through the neck then to the chest and abdomen. (Source: Dr. Kishore Ranadive) 

INTERVIEW

Kishore Ranadive, M.D., Cardiologist at Orlando Heart Specialists, talks about a new neurostimulator for the heart.

How has congestive heart failure been treated up until now?  

Dr. Ranadive: The first strategy is a combination of medications to help the heart get stronger. When the heart function does not improve despite optimal medication, then we pursue other treatments like a defibrillator therapy and they have helped a significant number of individuals. And then for those who are unable to respond to all of these, then we have newer therapies like CardioFit device, and in the last stages, we consider these individuals for cardiac transplantation.   

There's really is no cure for this, it's something that just has to be managed, right?

Dr. Ranadive: Generally, there is no cure. Now some conditions like postpartum cardiomyopathy causing congestive heart failure may improve spontaneously. But there is no specific cure. These are chronic patients that need to be monitored; they need therapies; medications, etc., for their life.

So, can you talk about this new therapy with CardioFit?

Dr. Ranadive: This is actually a very exciting field of research. Up until now what we have done in the treatment of congestive heart failure is use medications which act on these different systems. The concept behind this new therapy is a system that we have so far not treated: the parasympathetic nervous system. The system begins to malfunction in some individuals and this device is to kind of optimize that system by stimulating the carotid nerve in the neck. Through that stimulation and  a complex algorithm, we are able to fine tune the output of the heart to the best that we can. 

The CardioFit is kind of a pacemaker-like device that's actually implanted in the chest, right? 

Dr. Ranadive: Yes. It is like a pacemaker in appearance. It is implanted currently on the right side of the chest and there are two leads, one which is attached to the nerve in the neck for the parasympathetic stimulation and the second goes to the right lower chamber of the heart to regulate the heart beat and to time the impulse. Then there is an algorithm which allows us to appropriately increase the parasympathetic stimuli along with modulating the heart rate.

What has the response been so far from patients? 

Dr. Ranadive: The response so far has been really phenomenal. Mrs. Fossitt, for example, who is the first patient to have this device in Florida, prior to the device she had heart defibrillator, she was on maximum medication, she has coronary disease, and was getting more and more limited to the point where she was unable to do her simple tasks without getting tired and out of breath. She could barely walk from here to the car in the parking lot, and now that she's got this device, and she is able to do all her normal activities. She is no longer short of breath doing the kinds of activities she was having trouble doing, and so she feels much improved.

How big of a breakthrough would you say this is for heart patients?  

Dr. Ranadive: I don't think every patient with CHF will need this device, but we do know that there are a significant number of patients who, despite everything that we can offer them currently, remain limited and their only option now becomes cardiac transplantation. Now prior to reaching that, I think this will serve as an important therapeutic step and may also perhaps avoid the need for a transplant in some. As we know, cardiac transplantation, is limited to only a select few patients because obviously the availability of the heart. So I think this will allow a fair number of patients who have reached an endpoint in their current treatments to have another option. This is all about quality of life. If we can improve their quality of life, they get more functional, I think it will be a great improvement in their overall sense of well-being.

So the ideal patient for this is someone that's almost at the end of their rope?  

Dr. Ranadive: Not necessarily. The ideal patient would be one who remains limited, especially in their day-to-day activities despite optimal treatment. So having given the current treatment a reasonable chance, they are not making progress; that's the group that we want to act early before they get to a point where they now have no option but the cardiac transplantation.

FOR MORE INFORMATION, PLEASE CONTACT:

Erich A. Sandoval
Lazar Partners Ltd.
917-497-2867

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