Phillip Cuculich, MD, a Cardiologist and a Heart Rhythm Specialist at Washington University in St. Louis talks about a procedure that uses radiation as an alternative to treat ventricular tachycardia. It is currently in clinical trials but the results could be promising.
Interview conducted by Ivanhoe Broadcast News in April 2018
What is ventricular tachycardia?
Dr. Cuculich: Ventricular tachycardia is an abnormal electrical signal in the heart. And it’s in the bottom chamber of the heart which is the ventricle. Most importantly ventricular tachycardia is a major cause of sudden cardiac arrest. It’s a major reason why people drop dead suddenly.
And what causes that?
Dr. Cuculich: It can be a number of things, but in general it’s scarring in the heart. The most common reason that people get scarring in the heart is from prior heart attacks. But other exposures and infections can also do such a thing.
So people who have had heart attacks are at risk for this?
Dr. Cuculich: That’s exactly right.
What percentage of those people have developed it?
Dr. Cuculich: I look at it a different way. Sudden cardiac arrest itself claims about three hundred and fifty thousand American lives every year. Half of those are due to arrhythmias like ventricular tachycardia.
What’s the standard treatment for that?
Dr. Cuculich: If somebody has a weak heart from a prior heart attack or from some other reasons, one of the things that we want to do is install a defibrillator underneath the skin. A defibrillator’s job is to act like a paramedic. If the heart were to misbehave, misfire, or cause sudden cardiac arrest a defibrillator can charge up and deliver a jolt of lifesaving electricity. When that happens, it’s wonderful that they’re saved but it can be a very difficult thing for them to recover from. It’s painful to be shocked; it makes people very nervous once you’ve been shocked once or twice. People get essentially posttraumatic stress disorder from being shocked repetitively. In an effort to minimize the chances of shocking, we’ll often times give people medicine. But medicines themselves are not particularly effective. They’re only about thirty to fifty percent effective every year. And they have a long list of side effects. So that gets us to the more up to date thing that we can do. The procedure is a catheter ablation. That is when we enter the body through a vein or an artery, often times in the top of the leg. We run long skinny tubes called catheters in to the heart. And what we try to do is steer those catheters inside the heart and identify where that scar is. Once we can identify the scar we find the misbehaving electricity within the scar and heat up the tip of the catheter to cauterize that region of the heart. A catheter ablation procedure for a life threatening arrhythmia, often times takes seven or eight hours to do.
So this isn’t an easy procedure for many people, including elderly
Dr. Cuculich: It’s not an easy procedure really for anybody. It’s difficult to do a procedure that goes seven or eight hours at a time and can often times show multiple different arrhythmias to tackle. It certainly is very hard on the patient. And these are patients as you point out who are already sick. They already have weak hearts are not in their best shape. And to take them through seven or eight hours of general anesthesia is a tall task.
I was really surprised at the high numbers of events. We’re not just talking one or two events a day or a month or a week even. That procedure is kind of a standard, does that fix the problem?
Dr. Cuculich: Yeah. I think if you look at the overall numbers, three percent of patients who have a weak heart will receive a shock from their defibrillator every year. So in general, most people don’t require shocks from their defibrillator each year. But once you have started to get shocks, you have a twenty or twenty five percent chance every year to have recurrent shocks. And when we do a catheter ablation it’s about fifty percent effective and up to seventy or eighty percent effective in some patient populations. It depends on the size of the scar and the location of the scar within the heart.
So the first study had five patients with six hundred and eighty episodes during the first six weeks of recovery following radiation therapy. Before that they experienced more than sixty five hundred ventricular attacks. Those are astounding numbers, so explain what that is.
Dr. Cuculich: The five patients in the first study were patients who were at the end of the road. They had already tried catheter ablations, they had already tried medications and their defibrillator was still being called in to duty to rescue them. And when a defibrillator gets called in to duty there’s one of two ways it can do it. The way that I described to you before was the shock, the jolt of energy. Before that happens, we often times try to pace the heart in a rapid rate to pace out of the life threatening bad heart rhythm. So the defibrillator can actually count how many times it needed to pace out of a bad heart rhythm or how many times it needed to shock out of a bad heart rhythm. So in that study, we accumulated the data from those five patients in the three months before we treated them and there were over sixty five hundred episodes
Could there be that many episodes in lots of people across the country?
Dr. Cuculich: It’s possible and I would say it’s probable. We know that cardiovascular disease is the leading killer of Americans. We know that sudden cardiac arrest is the way that most of those patients die. And so by sheer numbers, we know there are a lot of patients who are at the end of their road who have a bad heart and arrhythmias and really have no other good options. The options on the table are medicines that are ineffective or a catheter ablation procedure which carries a modest risk.
What was the thought behind using radiation?
Dr. Cuculich: I would say the idea of noninvasively treating the heart kind of came together in a lot of different ways. As I’ve practiced medicine and have seen how catheter ablation can work, it’s really very satisfying to fix patients hearts and get them back on the road to recovery. And it’s very humbling when we can’t do it and when we fail at it. Being honest with our numbers and our success rates and failure rates has led me to start thinking about what are the other ways that we can deliver energy to the heart in an effort to stop these arrhythmias from occurring. Sort of simultaneous with all this, my research mentor, Dr. Rudy has invented a way to non-invasively image the electrical system of the heart. So, in a single beat patients can wear a vast of electrodes and we can figure out exactly where in the heart are the arrhythmias are coming from. That sort of process would take me four hours or more with a catheter inside the body to really pinpoint down with that level of accuracy. So there’s a simultaneous movement to treating patients in a different way, applying energy in a different way and map the heart in a noninvasive way. This is what brought me to meet with Dr. Robinson.
There must have been some concerns about irradiating the heart? It seems like an organ you don’t want radiation near.
Dr. Cuculich: That’s true. If you look at any of our ablation technologies right now we’re destroying portions of the heart. When I put a catheter inside the heart and I map around where the misbehaving parts of the scar are, I heat up the tip of that catheter and I’m destroying that part of the heart. Increasingly we are now finding better success rates with our procedures as we destroy more and more of that scar. We want to keep all that destruction within the scar and avoid the healthy areas of the heart. When we start looking at improved catheter ablation, outcomes with more destruction inside the scar takes more time. So now patients are subjected to longer procedures in an effort to treat the entirety of that scar. In cancer, Dr. Robinson can point directly to where those diseased areas on a tumor or in the body and deliver energy to that location. So the big leap of faith when Cliff and I came together was the idea that I was asking him not to ablate the heart. But I was asking him to ablate the scarred portions of the heart and to intentionally miss the healthy portions of the heart.
So this is highly targeted?
Dr. Cuculich: Correct, we don’t want to ablate the whole heart. We want the heart to remain as healthy as possible. But we want to focus that energy down to just the critical components in the scar that are causing the arrhythmia.
if you hit the scar you can avoid the rest of the heart with this treatment?
Dr. Cuculich: Exactly. And that’s an important component of it. We think that patients will do better if we can find ways to avoid and minimize exposures to the healthy parts of the heart.
In the study with just the five patients what were the results? What did you see and what was your response to that?
Dr. Cuculich: We had fought through this procedure for probably over a year, working through the potential risks, ways to mitigate those risks, and ways to improve the outcomes and ultimately the patients presented themselves to us. And you get patients who have no other options. We start having those difficult conversations with patients. To say this hasn’t been done before and we don’t know if it’s going to help you or not. But I think it says a lot about the bravery of our patients and really shows they have their back against the wall. These patients are often times looking for any level of help, any hope. And so for us this was a very sobering experience to be able to talk to these patients and to really become a part of their lives and to see what kind of things go in to them making such an important and brave decision.
What did you find, what were the results?
Dr. Cuculich: we treated five patients over the course of 2015. Initially we were only planning on treating three but the results were so overwhelmingly positive that many of the local doctors in our hospital had asked to consider their patients as well because they were also at the end of the road.
You’re talking about the overwhelming response and how positive it was when people starting coming to you. That shows desperation of doctors and patients themselves. Were you surprised by this?
Cr. Cuculich: When we first started treating patients in 2015 I think our eyes were wide open. It could have been good or it could have been bad. And any result would have been surprising. We would have taken anything. And when I think back to the care and the discussions that went in to the first patient, we thought this through and we watched him getting treatments from his defibrillator that were rescuing his life. And we knew that there really were no other options for him. He was being listed for a heart transplant as the last course of action. We were doing everything that we could prior to a transplant to try to stabilize his life. And when we treated him I was surprised at how well he just looked immediately afterwards. In my line of work, when we treat patients for seven or eight hours of general anesthesia, they’re in the hospital for a day or two or more. But that patient lay down on the table when he got up and walked off, that was very surprising to me. And then we watched him not have any more arrhythmias for the first day, and then the second day, and the third. And we let him leave the hospital and had follow ups over several weeks. We would see him every week, and ask how he was doing and feeling. It was really eye opening and encouraging to see his recovery without shocks and to start talking about coming off of some medicines. And that process played out very similarly for the next patients and beyond. It is encouraging even though we have to keep a cautious optimism to this. Because we know that radiation can have affects that we’re trying to avoid.
Is it just one treatment they get?
Dr.Cuculich: Correct, a single treatment.
How long does it take?
Dr. Cuculich: The shortest treatment so far has been seven minutes. That’s the world’s fastest VT ablation. But in general, it’s been about ten to fifteen minutes.
That’s so much faster than I thought. So this is miles apart from the seven or eight hours?
Dr. Cuculich: Correct. And when we do this procedure the patients lay down and listen to music, they’re awake. There are no invasive components to this. No sedatives, it’s while they’re wide awake and following directions.
The results are immediate, this isn’t something that two months later they might be helped, this is the same day?
Dr. Cuculich: That’s a great question and we don’t know what the full effect of intentional focused radiation is on scared parts of the heart. And so it’s a very specific sort of answer. But we have seen results where the arrhythmias go away nearly immediately, within the first day or two. And we’ve seen some take several weeks to have an effect. And so there’s more for us to learn. There does seem to be roughly about a six week window where there’s less and less arrhythmia. And then after the six week window there seems to be very little arrhythmia.
What does this mean for patients?
Dr. Cuculich: Well, I don’t want to step beyond what we know from treating five patients. We opened up a clinical trial; it’s a Phase I/ Phase II. Meaning we’re looking at the safety and the efficacy in a very careful way. When we opened that trial in the middle of 2016 we expected it to take roughly two to three years to enroll the number of patients that we needed. But it took us just over a year to complete that enrollment. I think that shows how many of these desperate patients and physicians are out there. Their referrals for this trial were much higher than we expected. And so we’ll know more from those nineteen patients. Did it work, when did it work, how did it work and was it safe.
If a patient undergoes a treatment like this or an ablation therapy that works wonderfully, what does it mean to be somebody who is at the end of their road has no other options has all of these events, to not having this anymore. How does that affect a person’s life?
Dr. Cuculich: Right, that’s a great question. Cliff and I get very deep in to the relationships with our patients. We become pretty close when you see them at their worst. It is extremely gratifying to see a patient’s quality of life improve. It’s extremely gratifying to see people get better. And it doesn’t happen in everybody, I wish it did. But most of our patients have had improved qualities of life and have been able to come off of medicines, have been able to step forward with their lives. That being said, the patients that we’re currently treating have gone through a lot. They are patients who have been shocked multiple times and people never really forget that. So the single biggest thing that Cliff and I have been addressing in our follow up visits is actually not heart related. It has to do with their minds. Patients are nervous about getting shocked in the future. The single biggest thing that we address with our patients is managing the anxieties of being shocked so many times. Now as we talk to our patients, we say the only way to really move past that is to have days turn into weeks without getting shocked. And then weeks turn into months. And then have months turn into years. You never fully forget it but you turn the page on that and you move on with life.
So after they receive this treatment the defibrillator stays in? Is it possible you could take that out?
Dr. Cuculich: I think it’s important to think about what we’re doing and what we’re not doing. We’re trying to make the arrhythmia less likely to happen through that scar. But what we’re not building the heart back; we’re not eliminating that scar. So I think patients will always be at risk because they have the presence of that scar. Importantly we’re also not building the heart to get stronger. I think a lot of people are hoping that they’ll get a treatment and maybe heart gets stronger. That’s not really the intent of this. We’re trying to make the electricity, the bad electricity stop. The short circuits within the scar stop. But it doesn’t really build the heart back up. So I think it’s important for our patients to maintain close relationships with their heart rhythm doctors and their heart failure doctors to help make sure that they can continue as best as possible.
And is it the cause and effect if you have fewer events you’re less likely to have a heart attack? If you diminish the events you can diminish the risk that you might have a heart attack?
Dr. Cuculich: There’s strong evidence that shows that being shocked is detrimental to heart function. And it weakens the heart further. And if you get several of those the heart potentially could get weak to the point where it no longer pumps adequately. By minimizing or eliminating those shocks we think that it can only stand for good for the heart. It can only mean good things moving forward. That’s been our experience so far too. We’ve been surprised to see the number of patients whose heart function has actually gotten a little stronger because they’re not getting shocked repetitively.
So there’s a lot more to study on this then. Is there a cause and effect of if you have fewer events will you be less likely to have a heart attack?
Dr. Cuculich: It’s been shown in some of the literature that when a weak heart receives a shock, it actually becomes weaker. And there’s a tie between being shocked and mortality and dying. And what we found is that when our patients who already have weak hearts no longer get shocked we’ve seen a number actually get improvement in their heart function because they’re not under that constant shocking or constant stress.
The stress too, the mental anxiety is not good for your heart. That’s a different story.
Dr. Cuculich: That’s a different story and we can certainly talk about that. When you talk with our patients, the number one thing they will deal with after the procedure is that they’re still worried about future shocks and it’s very difficult for them to shake that.
So now you are involved with the next phase of the study. When is that expected to be completed?
Dr. Cuculich: We completed the Phase I/Phase II trial in late 2017. And we’ll have six month follow up in mid-2018. So, soon we’re building the multicenter trial that will extend from here.
So this is the only place it’s been studied so far and you’ll be the principle investigator and then the Phase III will be multiple across the country?
Dr. Cuculich: Right. So there’s been enormous interest in participating. Doctors, patients, Cliff and I have gotten e-mails almost every day from centers that want to participate or patients who want to volunteer to be a part of this. So this is a big thing and we want to go forward but in a careful way. We want to build the science in the right way. And not just treat everybody but really understand who benefits from this and how can we do this in the safest way possible. And the best ways to do that are in clinical trials.
So this will come out in about June or July. Once the follow up is done will you have the results? Will you take another few months to analyze them or will you have that this summer?
Dr. Cuculich: As fast as Dr. Robinson can write it.
END OF INTERVIEW
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