When a patient requests to have their implanted device removed, it requires a discussion with the patient and evaluation of device indication. In this month’s podcast, Drs. Callahan and Wilkoff discuss how they approach ICD and pacemaker patients.
Podcast: Episode 6 – Elective CIED Device Removal Transcript
Callahan, M.D., Thomas
Hello and welcome to the Lead Connection podcast where we talk about all things related to lead management. I’m Tom Callahan.
Wilkoff, M.D., Bruce
And I’m Bruce Wilkoff and we’re both from the Cleveland Clinic and leadconnection.org and we’re glad you’ve joined us for this discussion. Tom, what are we talking about this morning?
Callahan, M.D., Thomas
I’m excited to talk about our topic today. Today, I thought we would talk about the patient that presents for elective removal of a device and leads and you know, that’s a really broad group of patients. Although I think a pretty small group of patients, but they present I think some very unique management issues that are probably worth discussing. So maybe let’s start with the patient with an ICD that perhaps had soft indications or maybe never really had indications for the ICD and now years later are presenting, asking for the device to be removed; and just to paint a picture, I saw a patient a while back that had this sort of scenario. They had had an arrest in the setting of an MI and were revascularized with PCI. The ejection fraction was actually always normal, but they got an ICD anyway. And then years later EF remained preserved. No further VT or VF, no therapies from the device, and now they presented asking for the device to be removed.
Callahan, M.D., Thomas
So I guess I’d start with that as a springboard and just ask for your thoughts.
Wilkoff, M.D., Bruce
Well, these are difficult conversations because they’re not just medical discussions, they’re emotional discussions and sometimes it’s tied up within the patient’s self-concept and you know how they feel about themselves and how they feel about themselves now that they have an implantable device in it and people have trouble sometimes dealing with this, just like they have depression after heart surgery or and other things.
Having something wrong with your heart really is a big deal, particularly for some people. And, we have to be sure that we have the facts right because we understand that the patient may not be the most careful or unbiased witness in this whole circumstances, so getting primary data is really important.
The other part of this is that the patient may not realize how emotionally dependent, they’ve become upon this defibrillator that they probably didn’t need and you know at some base level hate
Callahan, M.D., Thomas
Right, yeah.
Wilkoff, M.D., Bruce
And they because what I do after, let’s say, I’ve gone through this and wait, this guy, you know, half hour after he had his chest pain, had a VF arrest, he’s resuscitated – and it’s not 48 hours out, it’s not 24 hours out, it’s you know, it’s right during his MRI he gets necessitated, and he’s very lucky and but yet still gets a gets the defibrillator.
But then I saw I said OK. I am willing to take out your device and your leads. There’s some risk.
You know, it depends on how long they’ve been in as to what the risk might be. If it’s really early, it’s really not much risk at all. But I said what I’m going do first is I’m going to shut off your defibrillator for six months and make sure that you’re comfortable with this concept.
And approximately half the patients I tell this to, people who are begging me to take out their device won’t let me shut it off.
Callahan, M.D., Thomas
Yeah, yeah.
Wilkoff, M.D., Bruce
And so, I know there’s more to the story than what’s going on. And until they and their family members can deal with me shutting it off – because taking it out is surely shutting it off as well, then there’s more to talk. And just like we shouldn’t rush to put in a defibrillator, we shouldn’t rush to take it out. We have to make sure that we’re dealing with both the medical and the emotional part of this equation. I don’t know.
Callahan, M.D., Thomas
Right. You bring up so many good points, you know. I think that first part where you’re talking about removing the device and really the importance of going through and ensuring that you have all the facts straight. I often tell our patients that the burden of proof is really quite high when it comes to the decision to take a device out. So I think that part is so important and then you bring up many other great points as well, but really engaging the patient, you know, making sure that they’re an active participant in this decision. Of course they’ve come to you with this request, but continuing to engage them and making sure they understand all the nuances of removing the device because really the risk of sudden cardiac death even in a patient that perhaps never had the indications for an ICD, it’s not zero. And as we all know the risk of removing these devices and leads, that’s not zero either.
Wilkoff, M.D., Bruce
Yeah, There is another point to this. There were a category of patients in the AVID trial (Circulation, Volume 99, Issue 13, 6 April 1999; Pages 1692-1699 ) sometimes that, not quite this population, but could masquerade as this population, so in the AVID trial, and they’re not many people left that that’s still remember enrolling in the AVID trial. But in any case, in the AVID trial you had to have a clearer cardiac arrest not related to an MI and not related to transient reversible type of things.
But there was a registry of patients that were kept track of those people with what was called transient reversible causes of cardiac arrest. And it turns out those patients, mostly did not get defibrillators, didn’t do so well and that so we what we published said “transient, reversible and preventable”. So things like hypokalemia, you know, dehydration and whatever people were coming up with. And it was it was some sort of stressful circumstance. And it turns out that those people actually were at quite high risk of sudden cardiac death. Now whether they died of the ventricular arrhythmias or other things, or inflammation or they had other coronary disease. I mean there’s a lot of stuff there, but those people had a high risk of VF.
So we are contrasting these patients. That’s why it’s so important to get out why was it put in, you know and what are whole circumstances? And I think that’s really important and overlaid on top of all this is some people are having pain at their defibrillator site. Or some people felt coerced to get the defibrillator. They are, I don’t know how this happens, but some doctors say you can’t leave the hospital without a defibrillator. I mean, I’ve heard that so many times it must be true. Some people must say this.
And I really think that that’s a problem because defibrillator is a strategic therapy. It’s a strategy to prolong somebody’s life and help them deal with their life. And if you don’t sort of engage the patient and make them a participant and understanding that there’s some overhead to having a defibrillator then, you’re in trouble and the patients in trouble. You haven’t helped anybody. It’s better to wait a month, two months, three months till the patient says, yeah, I think I want to be protected. Then they are making the decision. You’re not making the decision for them. So I think that’s the key is preventing this situation.
And making sure that your indications are clear, not just for insurance reasons, because that’s sometimes there’s a problem too, but because you can always write the chart in a way that sounds convincing. But the point is it’s still important that we make sure that it gets put in properly. On the other hand, I think we have a value to add if the patient really never had an indication for a defibrillator and they have it, maybe they’ll develop a need for it later. But the leads that they have and whatever else like that, they’re going through, you should preserve that for the later point in time, and so I think we have a role and I think this is a valid indication for removal of the defibrillator.
Callahan, M.D., Thomas
I agree, and you bring up so much there’s a lot there. I think the point that you bring up about really making sure a patient is ready and invested in that decision to have a device, that’s so critical to making sure that they are comfortable with the device and don’t feel resentful for a device that can be a challenge emotionally down the road anyway. It’s great to have the patient on board with the decision to place the device.
What about pacemakers? Maybe let’s move on to the story of a patient with a pacemaker that comes in now questioning whether they still need the device, one that comes to mind is a patient with maybe neurocardiogenic syncope, was having episodes where they passed out. They received a device and has done well. But now question whether they still need the device. Maybe they think the circumstances have changed or something like this.
Wilkoff, M.D., Bruce
Well, that’s a whole different group of categories that we’re talking about here. I think we first step back to say we know patients with AV block that pacemakers make a difference in their survival, but patients with sinus node dysfunction, frankly the data suggests that we just improve quality of life. Maybe we prevent syncope and other things, but mostly we’re improving quality of life, not quantity of life. So the burden of necessity is a little bit different.
And about half of all pacemakers are put in for sinus node dysfunction and/or some sort of Neurocardiogenic Reflex, a hypotension of various sorts, and but having said that pacemakers play a role and even for your cardiogenic extent could be vasovagal syncope. While it may not cure that syncope, it may improve the quality of life or help that person to manage life.
Callahan, M.D., Thomas
Right.
Wilkoff, M.D., Bruce
But having said that, it’s not the primary therapy and should not be thought as such.
Callahan, M.D., Thomas
Right.
Wilkoff, M.D., Bruce
Then there’s those patients also with atrial fibrillation that didn’t have had sinus node dysfunction. Now with afib and now with the heart rate, if anything, it’s too fast and so we have to work with that. And then we get back to even infections. We’re not going talk about infections here. We’re just talking about a person who had questionable indications for their pacemaker and getting the primary data on these patients is even harder I think, than the defibrillator patients.
Nobody scrutinizes the indications for pacemakers. It’s not the same intensity, let’s put it that way, as we do for implantable defibrillators.
Particularly, these patients get told well, you have less than, pick the number 1%, less than 1/10 of percent pacing. You never use your pacemaker, you don’t need a pacemaker. They hear this and or some people think that even 10% might be the well, what? What’s the point? It’s only 10% of the time.
But percentages can be fooling you, because if all that percentage comes up in over a minute period of time, then you’re having syncope and problems and work on that. So, this in particular for me is a reason that that patients, not just turned down the heart rate and the doctor’s not just turned down the heart rate of the pacemaker, but actually shut it to the off mode or the just the diagnostic mode for a period of time, because it is a serious increase in morbidity to take it out and then have to put it back in.
Callahan, M.D., Thomas
Right. Yeah, that can be a real challenge, especially for these patients where maybe you know in the setting of syncope, for instance, we don’t expect that they’re going to need pacing that much, right? They may have 5 or 10% pacing just because of the lower rate limit and so forth. But really the important pacing may just be a percent or less, but that’s still keeping them from passing out occasionally. And that’s really something that can be difficult to communicate to the patient.
Wilkoff, M.D., Bruce
Right.
Callahan, M.D., Thomas
And then actually tease out, do they still have that that need so you bring up a really good point about turning the pacemaker off? You know, we’ve done things like changing the pacing to subthreshold so that so that we can really tease out whether this this device is helping keep them upright.
Wilkoff, M.D., Bruce
Right and it does make a difference a little bit as how long ago it was put in. I mean I have many times been approached by somebody that just had a pacemaker put in a few months ago and the doctor held them hostage until they [At least that’s their perception] Until they got the pacemaker.
It’s often there’s a story about them having a pneumothorax or another problem along with this, and. they’re angry and they’re resentful and working through this.
We don’t even call pacemakers or defibrillators that were implanted within a year, an extraction and the risk is exceedingly small. But waiting another six months doesn’t really change it. And so it is still better – You know the only thing worse than the bad decision is making another bad decision to back it up. And so being thoughtful, being empathetic, helping them to step back and take a deep breath and work through this and say, listen, I’m going to work with you. We’re going to resolve the problem. They need somebody to be on their side and to listen to them.
Never has empathy been a more important aspect of our care, then in these kinds of patients who are confused sometimes. Very little explanation has been made to the patient.
You know it’s so important up front because lifetime risk of the device is substantial.
Callahan, M.D., Thomas
Sure.
Wilkoff, M.D., Bruce
Broken leads, coming in to see people, infections as time goes on. The younger the patient is, the more problems it is. But just to bring it back to you, age is a big part of this too. The younger the patient is, the more important is that you spend more time working with us. The older the patient is, I am more prone to shutting off the pacemaker and say listen, it’s not worth the risk of taking it out.
Callahan, M.D., Thomas
Right.
Wilkoff, M.D., Bruce
You know, you have other comorbidities, you have other things that are going on with you. So the comorbidities, age, circumstances, duration of implant. All these things come into the calculus here.
Callahan, M.D., Thomas
Right. And that really brings up the point that each patient is different. You know, you really have to consider the whole patient, the back story, the circumstances that led to the implant, what’s happened since and then as you point out, what’s going on right now, their age, their comorbidities and all the rest. And in some ways, I think we’ve just sort of scratched the surface. There’s so many other types of patients that we see with this sort of problem where they’re presenting asking for an elective lead extraction but but I think this sets the framework for how we think about these types of patients.
Wilkoff, M.D., Bruce
Tom, I really appreciate you bringing up the topic and and talking through this because in a way this is kind of a dirty laundry type of a situation. We don’t want to throw anybody under the bus or anything else like that. I may have been a bit critical of, you know, the way some patients have been treated. We really don’t know the story. We have to be very careful. It doesn’t do anybody any good to throw other people under the bus and we need to just try to do sort of the service recovery part of this. And I think this kind of discussion needs to be made much more especially as our young trainees come through, I try to get this across and I hope this has been a helpful discussion for more than even then.
Callahan, M.D., Thomas
Well, I’m looking forward to our next one.
Wilkoff, M.D., Bruce
Me too and goodbye.
Callahan, M.D., Thomas
Alright, have a good day.