Niraj Varma, MD, PhD, Professor of Medicine and Director of Cardiac Pacing & Tachyarrhythmia Devices at Cleveland Clinic talks about a breakthrough heart surgery.
Interview conducted by Ivanhoe Broadcast News in 2024.
Can you explain heart failure?
Varma: Yes, heart failure is an epidemic just now, throughout the country. It’s worse in particular regions of the country as well. There are a variety of reasons for heart failure. Heart attacks are one of these reasons. In some cases, we simply don’t know. In others, it may be genetic, so a variety of different causes for heart failure. It’s a significant problem because it increases the risks of death, it reduces survival. It increases the risk of sudden cardiac death as well. On a day to day basis, it reduces patient’s capabilities to do their everyday work. It makes them feel poorly. This is a significant cause of morbidity and mortality in the general population.
What are the common symptoms?
Varma: Symptoms are a lack of exercise tolerance, so patients cannot do their general activities, their daily activities, when it’s severe. They might have congestive symptoms, so they have swelling of the hands and feet, particularly of the feet. They might be breathless, lying flat. They might want to be propped up at night. That’s often a sign of heart failure starting. These are the signs of heart failure.
These can be very debilitating, right?
Varma: Yes. There’s a range of heart failure symptoms. Some patients, particularly at the beginning of their condition, have minimal symptoms, maybe only on exercise. They find they can’t exercise as much as they used to be able to. But as it progresses, then it becomes more and more debilitating. In extreme forms, people can’t walk 10 yards. They can’t do the activities of daily living. There’s a whole range of symptoms and limitations that accompany heart failure.
What are the current treatments?
Varma: The current treatments for heart failure are built around medications. We want to optimize medical therapy. We are fortunate in that we have some very good drugs. Some have only been available in the last two or three years, and they have been very effective at controlling heart failure and sometimes reversing the condition. In heart failure, the pumping action of the heart is reduced, and that is a significant problem. The heart enlarges, and becomes more baggy. It reduces the pump function and just dilates. We found that these drugs can help reverse that. The pumping action can increase and the heart shrinks towards normal sizes. We’ve had a variety of drugs that can achieve that. It takes several months for them to have an effect, but we’ve been very fortunate, we’ve had some very good agents for drugs. Together with drugs, we use device therapies as well.
What are some of the side effects from the treatments?
Varma: With drugs, every drug has a potential side effect, depending on the person. But generally, heart failure drugs can drop the blood pressure. They can affect kidney function. They can affect lab values such as potassium. Depending on the causes of the heart failure in the first place, and also the degree of heart failure, some patients may not be able to tolerate all these drugs. There is a limitation with drugs that way.
But now you’re leading a clinical trial of a device that may help treat the symptoms. What is it and how does it work?
Varma: Apart from drugs, we use devices. Often in many patients, we use the hybridized approach, we use drugs and devices. The way that we use devices traditionally for heart failure patients has been to reduce the risk of sudden death. It’s a cardiac arrest. I said earlier that the heart enlarges and becomes more baggy with heart failure, and it reduces its pumping action. With heart failure, there is scar that’s built up in the heart muscle. What that does is produce electrical instability in the heart. The heart has a natural electrical system, and that electrical system, like any electrical system, can break down or short circuit. Under those conditions, there’s a risk of sudden death, and we know heart failure patients are especially vulnerable to that risk of sudden death. For 20 or more years, we have used defibrillator therapies. This is an implantable device that can pace the heart if necessary, but its primary function is to prevent sudden death by treating ventricular arrhythmias, when and if they occur, and we know every heart failure patient is vulnerable to them. Defibitors are very reliable devices. They’re an established part of implantable device therapy for heart failure patients. They typically have a battery life of seven to 10 years, and they’re very effective at treating cardiac arrest. This is a standard form of therapy. But they don’t treat heart failure. They treat one of the consequences of heart failure. Patients are still left with their symptoms and the debilitation. The traditional defibrillator just watches and waits, and the heart goes out of rhythm, then it treats, but otherwise, it doesn’t treat heart failure. Now, we do have a particular device, it is a cardiac resynchronization therapy device, which can be used to treat heart failure patients, but only about 10 to15 percent of heart failure patients are eligible for it. It’s a very limited sector. We know cardiac resynchronization therapy works very well in the patients in whom it’s indicated for. It improves heart failure in those patients. More than 80 percent of heart failure patients do not have that available. The device that we are now testing, is a combined heart failure therapy device with cardiac contractility modulation, as well as a defibrillator. Taking a step back, cardiac contractility modulation has been around for 20 years or so, but it’s been an independent device, which we used together with the defibrillator. That is a lot of hardware to implant in a patient, and that also carries its own limitations and also risks. What we have started is a trial using a combined device. It delivers cardiac contractility modulation, as well as defibrillator therapy. Cardiac contractility modulation is a therapy that can be used for heart failure patients who are not eligible for resynchronization therapy. Remember there was only 10, 15, 20 percent the heart failure population. But potentially cardiac contractility modulation is available and effective in the large population of heart failure patients. The advantage of the device that we are providing is that it does everything that a defibrillator does. It protects from sudden cardiac death. It also treats heart failure all the time. Patients have the potential to benefit from an ongoing heart failure therapy, which is in addition to their medications to their drug therapy. That is the purpose of this device.
How is it powered? How often will the battery be replaced?
Varma: It’s a very important question. This is a game changer in the world of implantable device therapies because it is rechargeable. I mentioned earlier that a defibrillator is very effective, but a traditional defibrillator is not rechargeable, and you have to replace it every seven to 10 years, and that’s expensive. It carries risks. It’s an extra surgery. It has significant limitations. The integral device, which is the trial that we are leading, that is the defibrillator with cardiac contractity modulation is rechargeable. Potentially that device will last 20 or more years. The way it’s recharged is that a patient applies it. Basically, it’s a mouse and puts it over the device for an hour once a week and that’s it. It’s a rechargeable unit. It avoids the need for repetitive surgeries, and all those limitations associated with it. This is a game changer. It’s the first time in the world of implantable devices, and this field has existed for more than 50 years, that we have a rechargeable device. This is very exciting.
Are you still enrolling?
Varma: We’re still enrolling. It’s a 300 patient trial, and our requirements are to test this platform as a defibrillator platform. We know cardiac contractity modulation works, but this device is unique because it combines that with a defibrillator. We are testing the defibrillator function. We are more than halfway through our enrollment for the defibrillator testing and cross fingers, everything has been successful so far. Every patient has had a successful implant. We’re very excited by this device.
Anything you’d like to add?
Varma: I think this is a trial, and therefore, it is something that we are testing. We don’t know what the final outcome would be, but this is very well thought out. It’s very well prepared for, and the engineering so far has worked out very nicely. We’re very excited by the possibilities that this creates because in the future, we will have a defibrillator platform that treats heart failure patients, the majority of heart failure patients, so a rechargeable unit. This really is a significant step in the world of implantable device therapy. We’re very excited.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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