Jay Franklin, MD, Clinical Cardiac Electrophysiologist at Baylor Heart and Vascular Hospital in Dallas, Texas, talks about implantable defibrillators and a new study that is recommending physicians allow these patients to exercise and participate in vigorous athletic activities.
Interview conducted by Ivanhoe Broadcast News in September 2017.
There is a new study that Yale has done that shows people who have these implantable defibrillators are okay to do sports, I guess there a different mindset previously that said people who had these congenital heart problems should not do sports?
Dr. Franklin: Implantable defibrillators have been used to prevent sudden cardiac deaths since the early 1980’s and it was recognized that a small group of patients that are athletic may be at risk of dying suddenly due to life-threatening rhythm abnormalities. A larger group of patients are at risk of dying suddenly due to damage to the heart muscle, decreased pump function, previous heart attack, and other issues that predispose risk of life-threatening rhythm problems; but healthy athletes are also at risk most often due to either congenital, inherited, or genetic sort of rhythm problems. But this study was done to evaluate whether or not if it was safe for athletes to exercise vigorously, or for anyone to exercise vigorously, and in the old days our approach was to be as safe as we possibly could be and if it was felt that exercise could precipitate a life-threatening rhythm problem or could put a patient at risk for example, they have a life-threatening rhythm abnormality on the playing field and collapse. Would they be injured, would they have a head injury for example, or a fracture because of collapsing on the field? Those concerns resulted in a standard approach to tell patients, do not exercise vigorously, but obviously people want to live their normal lives, they want to do what they want to do; and we as physicians want them to do everything they can to live their normal lives. These devices should be an adjunct not a restriction for the patient.
A lot of these came to light because a couple of pro athletes, one a college and a pro athlete who did collapse, these were great athletes and they collapse on the floor and died?
Dr. Franklin: Yes, so the Reggie Lewis story and the Hank Gathers story really had huge repercussions and reinforced the concept that an athlete with a potential life-threatening rhythm abnormality should not exercise; and in fact we were putting implantable defibrillators in at the time that both Hank Gathers and Reggie Lewis died of their life-threatening rhythm problems and they could have both been protected and probably would have survived had they had that sort of protection. At the time they would have not been able to continue on with very productive careers, so it impacted them and unfortunately, it has impacted a lot of our decision making along the way, but still the feeling came about that, you know that it probably is safe but until we prove it and the sports ICD registry that was developed published initial results, I believe in 2013. And then came out with an update just recently which allowed for there to finally be a consensus statement in 2015 that came from all the powers that be within the cardiovascular world, primarily the arrhythmia world, but from heart rhythm society, from the European society of cardiology, from the American College of Cardiology all together saying; in a selected group of patients that have implantable defibrillators that are at risk it is actually safe for these patients to continue to participate in vigorous activities and we are continuing to gather data and data looks pretty good for the majority of those patients.
Basically in a nutshell, what is the new conclusion, the new consensus?
Dr. Franklin: The significance of this study and the impact is that this consensus statement that has come out, said that it is actually safe for patients to participate in vigorous athletics and so it is recommended that the physician and the patient work together. In the majority of cases individual patients can continue to exercise vigorously and participate in sports, even contact sports; with safety and that the patients are not significantly at risk. We found by continuing to look at these patients that yes, some of them have their life-threatening rhythm abnormality while they are exercising, but they have not been hurt, they have not died, they have been successfully resuscitated from their life-threatening rhythm disturbance. There have been lead problems and that was a concern. Would athletics damage leads? When we look at the lead issues the number of lead issues that occurred in this athletic population is no different than the number or percentage of lead problems happening in, or occurring in sedentary patients who have implantable defibrillators.
Explain the leads here what we are talking about?
Dr. Franklin: The leads for these devices are connected to the device, which is under the skin typically implanted in an area just underneath the clavicle down on the pectoralis muscle, the big muscle in the chest wall. It is implanted at that location, but the lead has to connect directly inside the heart, so it goes through a vein underneath the collarbone into the heart under X-ray guidance and they are typically attached to the heart muscle. It may have a coil or a pair of coils inside the heart and the entire circuit for delivery of a shock to save someone’s life is delivered between the lead itself and the device can itself; so it can complete that circuit to deliver the shock directly to the heart, relative low energy, much lower energy than when we deliver a shock heroically in the field resuscitating someone who has had a cardiac arrest, who does not have an implantable defibrillator but it does it automatically; it does it very quickly and it is incredibly successful at restoring normal rhythm. We tell patients that long-term success rates are in the 95 percent range. So this lead combination has to go through a lot, I mean I have to explain to patients, how do we break a wire? Well, we break a wire by bending it over and over again and what do we ask of these very sophisticated defibrillator leads? We ask them to be able to be bend 60 times a minute, 24 hours a day, every day of the patients’ life and stand up to that vigorous use because your heart; even though patients think of it being fixed in one location it is not, so the lead inside the heart is moving constantly; that lead has to cross between two and important bone structures, it goes right between the first rib and the collarbone. And we all recognize that every time you move your arm, your collarbone moves and in the past the feeling was that a lead could be damaged by where we implanted that lead, so if it was very close to the first rib and collarbone interface that the lead might be fractured as a result that is in part true. For the past 15 maybe 20 years all of us that implant the device have learned that if we insert the lead further lateral or further out into the vessel, it traverses in a way that it is much less likely be crushed by the collarbone and first rib, so we have modified what we do to make the risk lower, but we also recognize as it is not purely movement of the lead. If the device is implanted correctly it has the ability for the lead to be bent every heartbeat and not fracture; in most cases.
One thing that occurs to me, it was probably a concern that if you are exercising heavy then you are breathing a lot harder and you are just putting more stress on the system.
Dr. Franklin: That is part of it, but just movement period is how leads end up having trouble, but there are other issues that cause lead failure; it is not typically, it is not necessarily a fracture. When we attached the lead to a tissue we cause inflammation and that inflammatory scarring process around the tip or around the coil of the lead may affect its function down the line, but again the bottom line is what the study shows is that leads are very durable and they tolerate you know athletes, just like they tolerate the movement of the heart in sedentary patients.
What happens if it is damaged, let say an athlete has a defibrillator, got the leads, he is a mountain biker and he breaks his collarbone and it cracks the lead?
Dr. Franklin: Antidotes are not the way to decide to make decisions in medicine, but we all have antidotes. In a 30-year career I have seen one patient fracture a lead as a result of trauma and it was in a motor vehicle accident. The patient had a terrible clavicular fracture and damaged the leads as a result of that, so yes it can happen; so what are the consequences of a fractured lead? Well they can be bad, it could result in failure of the device to deliver appropriately therapy, it could result in the device delivering inappropriate therapy, and some of the worst things we see for patients are inappropriate shocks – in essence receiving a shock that they do not need while awake and in normal rhythm. So we do a lot of things and a lot of things have been done over the years to help lessen that, for the athlete we may run them on a treadmill to see what their normal heart rate response is like so we do not program their device in such a way that normal activity could result in an inappropriate shock due to a normal heart rate being misinterpreted as a life threatening rhythm problem.
So you program the device to meet the lifestyle of the patient?
Dr. Franklin: Exactly, so for patients that are athletes we may set their detection interval for a life-threatening rhythm a little bit higher than we would for the sedentary patient, but we do that for all patients, it is not just for the athlete. Sometimes we cannot program around it, but most of the time we can. There are other things now that are being done, our devices are smarter these days, not that they can think but they have programming characteristics that are set up so that the device if it detects default, it checks its own lead impedance, which checks the integrity of the lead, the integrity of the installation, the connection with the device itself, and actually many of our newest devices are actually directly connected all the time, if not continuously monitored by home monitoring system, intermittently monitored by their home unit every time the patient gets into their bedroom to go to bed, their device is checked by the monitoring system and will alert us the next day or in the middle of the night if there is a problem. The devices have warning tones that most patients can hear, if it detects a lead fault then a warning tone will go off and the patient will be alerted to download information to us, so we can evaluate for evidence of lead fracture or device malfunction.
So the device implanted under the clavicle it is designed to only deliver a mild shock when called upon, when there is an arrhythmia that happens in the heart?
Dr. Franklin: Yeah, patients often times are disappointed when I tell them that the device does not prevent their life-threatening rhythm disturbance. The device is an insurance policy, it is a safety net; it is there in case they have a life-threatening rhythm problem, so it will detect and treat life-threatening fast rhythm disturbances when they occur. And we have learned over the years that we do not want the device to treat a short episode that terminates on its own, and often times they will stop. Patients can have short spells of ventricular tachycardia or even short spells of ventricular fibrillation; the two rhythms we intend to treat that terminated spontaneously and patients are better off if they stop on their own without the device having to treat it. The device is programmed in most patients to deliver a life-saving shock to restore normal rhythm for a prolonged episode that is not going to stop on its own. It also can use rapid pacing techniques to terminate certain rhythm disturbances without having to deliver a shock and the intensity of the shock always feels intense as far as the patient is concerned. Even if it is what we consider a small shock or a big shock, the patient feels like he put his finger in a light socket and he knows that he got shocked; not all of them are awake when they get a shock. Some patients collapse faster than others and it may be the patient – he or she – may be unconscious at the time of the shock, but the majority of patients know something happened and if they have an implantable defibrillator they pretty quickly recognize that they probably had treatment from the device when they realize that something happened.
Once somebody has one of those shocks do they need to call their doctor immediately?
Dr. Franklin: So we have worked very hard to tell patients that these devices are automatic. They are designed to be automatic so that you do not have to go rushing off to the emergency room and go rushing into your doctor’s office should you have a shock. Now physicians vary in what they instruct patients, but in general I think most of us, most electrophysiologists tell their patients if you get a shock call us and tell us that you got a shock. Download your data over the system and each of them now have a connected internet system, so that we can look at the information, tell them that the device saved their life or that it was unfortunate that they had an inappropriate shock and we let them know. If a patient gets multiple shocks that could be more of an emergent circumstance, and so for patients that get a series of shocks then we want them going to the ER if they need to, but downloading data helps us know exactly what we are dealing with and as they are in route to the emergency room. Single shocks usually do not require an emergent trip to the ER.
So the Reggie Lewis and Hank Gathers stories, did they have congenital problems that had not been diagnosed?
Dr. Franklin: I have to go back and look at the details but both Reggie Lewis and Hank Gathers had symptoms and had collapses prior to their ultimate event. There were the warnings symptoms of a potentially life-threatening rhythm disturbance. They had been evaluated, and had an implantable defibrillator been implanted at that time we could have saved their lives. In the middle of 1990, which was when Hank Gathers died we had been putting in implantable defibrillator for less than 10 years and device therapy was not as sophisticated. Reggie Lewis was 1993, so we could have protected both of them but it probably would have ended both a collegiate and a professional career.
Because at that time it would have been recommended that you did not do vigorously activities?
Dr. Franklin: Absolutely yes. That has changed now; I am not sure that this study is going to have an immediate impact on the professional sports world and the reason for that is that there are a whole lot of factors that come into play for a professional athlete. We would like to think that my advice to a professional coach or team owner that their players continue to play with implantable defibrillators would allow them to play, but time will tell whether not that holds true, as we continue to develop this data I think we will ultimately get there.
Do you know of any pro athletes who have implantable defibrillators?
Dr. Franklin: I do not know of a pro athlete that is continuing to play with an implantable defibrillator, there may be one but I am not aware of it.
And there probably will be in the future.
Dr. Franklin: There will be.
It seems like these implantable defibrillators are a breakthrough with enormously significance, how many lives have been saved by this?
Dr. Franklin: It is really tremendous, in the early days you qualified for an implantable defibrillator if you were fortunate enough to have fallen over dead, then were resuscitated and lived through a life-threatening episode; then you qualified to have a device implanted and those were the criteria present from the early 1980’s until 1990’s. We realized that we were missing out on opportunities to save many more lives and so most of the devices that we implant today are actually prophylactic devices. Devices implanted prior to the patient having their life-threatening rhythm disturbances we call primary prevention devices. The majority of implants that I do are for patients who we determine are at increased risk. I do not know if they are going to have a life-threatening rhythm problem but our data, our evaluation of the patient suggests that the patients in the high risk group and as a result we put a device in before they have an episode; so if they do have an episode they are much more likely to survive. Without a device, the patient that arrests outside the hospital has survival success rates that are terrible, somewhere in the 30 percent or less resuscitation rate and even if they are resuscitated outside the hospital many of these patients are left with significant brain injuries and other problems. In contrast, the patient that is at risk who has a life-threatening rhythm abnormality and has an implantable defibrillator, 95 percent of them can get up and walk away from that event like it was a minor event.
So as far as medical breakthroughs go this is major league?
Dr. Franklin: It is incredible and we are putting in more devices all the time. You ask numbers? I do not know what the total number is but it is a gigantic number on a yearly basis to the point that the powers in governmental health care are overseeing every device we implant to make sure we are appropriately putting them in and not putting in ones that are not necessary.
But you are saving so many tax dollars here by putting them in?
Dr. Franklin: We are, I think that is true, it does not take in that data available. It does not take many primary prevention prophylactic device implants to save a life, and when we compare the cost of healthcare is always compared to dialysis. The number of treatments provided to save a life with prophylactic, primarily prevention, ICD implants for high risk patients clearly is better when it comes to cost saving than dialysis, transplants, open heart surgery, than many other more expensive medical procedures.
In order to do it prophylactic you have to know there is a problem?
Dr. Franklin: Sure, so the majority of patients that we put primary prevention devices in have been evaluated for some other symptom they have. They typically are patients that have heart muscle damage, either a cardiomyopathy where the heart muscle just weakens, or just had a heart attack that damaged the heart muscle and so they are at risk. So those patients are seen by their primary care physicians, or by their general cardiologist or maybe seen by an electrophysiologist initially and they are evaluated and found to have decreased pumping function. We then treat them with appropriate medicine because a fair number of bad pumps get better over time with appropriate treatment, so we treat them aggressively with medication and then re-evaluate and in general if a patient’s pump does not improve significantly and the number that we use is a ejection fraction of 35 percent now. Normal pump function is 55 percent, a patient whose pump function is squeezing less than 35 percent of the blood out every time the heart beats is a patient that may be at risk and if it does not improve above 35 percent with appropriate medical therapy, over an appropriate amount of time, then we consider primarily prevention device therapy for that patient.
What about the congenital problem that have not resulted in some kind of a triggering during activity?
Dr. Franklin: The patients that have congenital or genetically-based heart disease, inherited heart disease, those folks may be recognized because of other family members that have died suddenly. In the case of Long QT Syndrome, that is something that we see that is clearly an inherited disorder, and there may be a history of sudden cardiac death in other family members and it may be diagnosed because a particular family member has an episode, then as we look at the other family members genetically based on what is discovered, now that we can do great genetic testing in patients and we’ll provide prophylactic treatment.
Are there other ways to determine?
Dr. Franklin: Yeah, there are other ways too that we find some of these less common varieties of rhythm disturbances and that may be based on patients symptoms. They might have palpitations, they may even have lightheadedness or feeling like they might pass out and in the evaluation just plain electrocardiograms may show evidence of abnormalities, but that leads us down the road of making a diagnosis of genetically determined abnormalities.
So this the kind of thing that maybe starts with your primary care but with more testing and things to do in your annual physical for example something will show up, I mean we will have to change our doctor every year now?
Dr. Franklin: There are good things and bad things about that and a new look from a different physician sometimes helps us discover things that we may have not seen, that your doctor of twenty years may not have paid attention to. There are some blessings in disguise from having a new physician reviewing everything. Family history is important, just looking at the plain EKG, having palpitations may help identify things. The most important symptom that we key in on is when a patient either passes out or has a near passing out episode. The great majority of passing out spells in an adult population are benign; most commonly plain old every day fainting spells. But an occasional patient that passes out has a potential life-threatening rhythm abnormality, so we recommend further evaluation for anybody who passes out more than once.
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.
If you would like more information, please contact:
Susan Hall
Jay Olen Franklin, MD, FACC, FHRS
469-800-7400
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