Interventional cardiologist at the Ohio State Wexner Medical Center, Scott Lilly, MD talks about Diastolic Heart Failure.
Interview conducted by Ivanhoe Broadcast News in 2022
We’ll start there. Diastolic heart failure. What’s happening with the heart?
LILLY: Diastolic heart failure, it’s more common than systolic heart failure. The general population generally understands diastolic heart failure as when the pumping chamber of the heart becomes stiff. The heart becomes more of a copper pipe, than a water balloon. When blood comes back from the lungs into the heart, it’s less able to accommodate that blood because it’s stiff. It doesn’t relax or expand as well, and it makes a harder time for the blood to get into the heart. It remains in the lungs, and it causes shortness of breath.
What causes DHF and how common is it?
LILLY: Diastolic heart failure is more common than a weak heart or systolic heart failure. It is associated with high blood pressure. It is associated with being fortunate enough to live a longer period. In general, if folks make it to their seventh or eighth decade and have a history of hypertension, some degree of diastolic heart failure is apparent.
Is this in phases? Can some people have a less severe case?
LILLY: Yes. Diastolic heart failure can be asymptomatic, particularly in the early stages, as it becomes more severe. We stage this in different classes, people start to experience symptoms related to stiff heart, shortness of breath, difficulty lying flat, perhaps some puffiness in the legs, or swelling in your abdomen.
What are the treatments right now for this?
LILLY: So far approved therapies for diastolic heart failure are rather limited. In general, they’re not very specific to this type of heart failure. The guidelines suggest limiting salt. That’s to reduce your blood pressure and to reduce the amount of fluid inside the vascular system. They recommend controlling blood pressure with anti-hypertensive therapies. Then in those that are symptomatic with shortness of breath or swelling, we use diuretics medications that make you urinate to remove fluid from your body.
Those are treating the symptoms rather than the condition?
LILLY: They’re managing the symptoms of diastolic heart failure. The medications that get at the mechanism through which this was establish or obtained haven’t been established yet. Now, we use specific blood pressure medications in some cases. As far as a preventative medication for diastolic heart failure, it’s not been established.
Can you tell me about you and your colleagues who are looking at surgical treatment?
LILLY: This is the first real procedural therapy for diastolic heart failure. Diastolic heart failure means the left side of the heart is stiff. As blood’s trying to go into that left side of the heart, it has trouble getting there. This procedure creates a shunt or a hole between the left and the right side of the heart. As the pressure starts to accumulate and the left side of the heart to the point at which it may congest the lungs. There’s an off let valve. That valve allows the blood to go from the left side to the right side. Presumptively reduces the amount of congestion in the lungs and improves shortness of breath.
Can you about the surgery? Is it placed with a catheter or is it open heart surgery? How do you go about it?
LILLY: The procedure is in a patient that’s sedated. We usually use an ultrasound probe that goes in from one of the veins of the leg. Then we place the device also from one of the veins of the legs. In general, there’s no breathing tube. There’s no open-heart surgery or heart-lung bypass machine. We go up from one of the veins of the leg into the top chamber on the right side of the heart. We make a hole in the top chamber of the left side of the heart. Then we deploy this device, which is basically two disks with a hole in the middle. The disc mark the perimeter of that circle and the hole in the middle allows communication between the atria.
What is the device called?
LILLY: This is a core via interatrial shunt device.
How long does the procedure take?
LILLY: Once the patient is asleep, about 25 minutes. It’s a quick procedure.
How quickly do patients feel a difference?
LILLY: We’ve done a lot of these. It is all clinical trial based. Everyone responds differently. I can share with you that we have done this in patients that wake up feeling different immediately. Other patients tend to take longer to show any symptomatic change. We will see them for 30 days and thereafter. There have been patients that have woken up and immediately feel like their readings better.
Is this a game-changer in your mind?
LILLY: I think so. The data will tell us for sure there’s potential ramifications for creating the shunt in the first place. So far it has seemed to help people. It has seemed to reduce the number of times that patients come back to the hospital, and it has helped them live better lives. We’ll see how the trial plays out and go from there.
What stage trial are you? Third stage trial?
LILLY: Phase III.
Once you get the data back on this, is it up for consideration by the FDA?
LILLY: The FDA approved yet. This is the phase 3 trial. After this trial, I’m sure the FDA will commercially approve it or say no.
Who’s the best patient for something like this?
LILLY: The typical patient for something like this is someone that’s had shortness of breath, fatigue, and has not been living the life that they wanted for a period of time. In general, this patient has seen the lung, a heart, they might have had a heart cath, they may have had stress tests, and there’s not a great explanation for their symptoms. When we see those types of patients, many times we do an additional heart catheterization, and we make them reproduce their symptoms sometimes with exercise. We will do the heart cath. We’ll be measuring the pressures inside the heart. We say, let’s make you short of breath and see what happens. A lot of these patients look normal at rest. When you get them exercising and they’re recreating their symptoms, all of a sudden things are wildly abnormal. The conventional or general patient here is someone that’s been exasperated because they can’t understand why they’ve been short of breath and this provides a solution for them.
Is there anyone for whom this would not be a good idea?
LILLY: It’s not a great idea for people that have very weak hearts. An ejection fraction less than 20 percent. This isn’t a good therapy for people that have severely elevated blood pressures in the lungs or pulmonary hypertension. This isn’t a good therapy for people that have uncontrolled blood pressure.
Is there anything I didn’t ask you that you would want people to know?
LILLY: This is an exciting therapy because it represents the first procedural therapy for diastolic heart failure, for which we have very few therapies in general. If this works, then it’s a whole brand-new population of patients that we can treat that really didn’t have an option for before, reclaim lives for them and keep them out of the hospital. It’s a game changer.
Would you mind opening the device?
LILLY: This is the core via interatrial shunt device. You can see it’s one continuous loop of nitinol, but it is arranged to form two discs basically with a hole in the center. When this comes collapsed, it’s in a tube so somewhat smaller than the diameter of my small finger. As you cross the inter atrial septum, you’ll expose the left side of the disc that catches on the septum. Then you unshift the right side and it forms this nice shape that again has two disks with a hole in the middle interconnected at the neck.
You said it’s made of nitinol?
LILLY: It’s cobalt chromium manganese nitinol.
Smaller than a quarter?
LILLY: About the size of a quarter, maybe a little smaller.
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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