In memory of Bruce Wilkoff, MD, founder of LeadConnection.org, champion of lead management.   Two weeks ago, Dr. Tom Callahan was lucky to sit down with Dr. Bruce Wilkoff. They talked about his experience with early lead extraction, lessons learned and his hopes for future lead management.

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[Note: edits and references have been added to the transcript for additional information and clarification]

Podcast Transcript:  Episode 18:  A sit-down with Dr. Bruce Wilkoff

Thomas Callahan, M.D.
Hello and welcome to the Lead Connection podcast where we talk about all things related to lead management. I’m Tom Callahan and I’m joined by Doctor Bruce Wilkoff.  Hi, Doctor Wilkoff.

Bruce Wilkoff, M.D.
Hi, Tom and this is a little bit different.  I’m the interviewee this time, and so I guess I get to accept instead of asking questions I get to answer them.

Thomas Callahan, M.D.
That’s right. We’re going to put you on the hot seat this week.

Bruce Wilkoff, M.D.
OK.

Thomas Callahan, M.D.
So, I’ve been really excited for this conversation. I know some of the stories, some of the answers to my questions, but I don’t know all of the answers and I’m excited to hear what you have to say and I’m sure our listeners will be really intrigued by the conversation.

So, we’ll just jump right in. I know this story, but I always find it fascinating. I want to ask how you got into lead extraction. What was it that got you into that field?

Bruce Wilkoff, M.D.
Well, it’s complicated and I was always a very technophilish type of person and I had a manufacturers Rep who knew this guy down in Florida, Charlie Byrd, who has a physics major, and she knew I was a biomedical engineer and she said, “boy talking to you guys, it sounds like you’re the same person.” So, she brought me down there while I was in an EP Fellow and I got to know Charlie Byrd.

I didn’t know his interest in lead extraction at that time, and maybe it was just developing, but what I did know was his understanding the mechanisms of how sensing worked, how pacing worked, which I loved.  I actually learned all my pacing from reading a textbook by Serge Barold and I didn’t really have anybody that mentored me at Ohio State.  I basically learned it all from the book and when I finished, I ended up taking the first NASPE exam and I was really excited to take it because it was an objective measure of my knowledge whether I did or I didn’t, and I did well and that was good.

But then my father developed a lead infection, that turns out it was a lead infection of a pacemaker lead, the Medtronic 6972, which is the sort of like the most characteristic of fragile lead that we’ve had out there. And it was infected. We had known that it been recalled.  And so, when we upgraded him from a single chamber to a dual chamber, we left a cut lead on one side and gave him a dual chamber on the other side and he started draining from the cut lead and I said dad, nobody really knows how to do this.

Charlie Byrd has been fooling around with this. He’s a friend. You and I are going to go down to Florida and he was in Miami at the time, and we were able to, well, I was able to watch Charlie take things out.  Now, there wasn’t much to do it with.  There were sutures, and there were Teflon sleeves, sheaths that were cut into the various pieces. Ah, let’s see in 1984, that’s when my dad’s lead went in. And this was in 1988, so four years later.  So it wasn’t that old of a lead. It hadn’t failed by the time we chose to not use it.  But it’s a very fragile lead and so we brought into this our knowledge of the construction of the lead from the very beginning. And it’s just seemed to me that this was not the way to go about it.

Both Charlie and I worked together, mostly with Cook, at that point in time to develop tools. We first worked on locking stylettes and then both polypropylene and Teflon sheaths and then steel sheaths and we started doing things and until about the early 90s, 1992, there really wasn’t much else started.

There were some femoral tools as well, but it was the thing that happened.  My dad already thought that I was using him as a Guinea pig because when in 1984, when I went in to do my cardiology fellowship, he had asked me to sign his Boy Scout doctor’s permission and I took his pulse, and it was 40 and got an EKG and his heart rhythm was complete heart block.  So, he already thought that I had it out for him and then after that, before he had his infection, he also developed heart failure. So, he had a VVI pacemaker, and we had to upgrade him to a dual chamber pacemaker.

So, it was a long story that went past this. Ultimately, he had a CRT, he had a flutter ablation.   He had a second infection of his devices, and I actually took that one out. But he actually always felt blessed to the near the Cleveland Clinic and able to do this.

But it sort of started a process where we partnered with manufacturers, mostly Cook at that time, and a couple of more years by 1994, it was also with Spectranetics where we started working with lasers.

But Charlie and I and then a few other people, Chuck Love, Steve Kulak, a few other people that joined in with us, but it was a very different thing because what would happen is, you know, Cook was just over in Pittsburgh and they would come over with something and we would sterilize it and bring it to the lab.
You know, just flash sterilize it and we changed the locking stylettes.  It seemed weekly, if not more, and it was an exciting thing.  It was a great experience. Can’t do that type of stuff anymore, but it was a tremendous experience, and we learned a lot.   And it jump-started the development of lead extraction, but there were only a few of us at that point in time.

Thomas Callahan, M.D.
Yeah, it’s amazing, you know, thinking about the limited tools that you had to work with in the early going and the challenges that must have presented. But you’ve seen the tools now develop and actually you’ve been instrumental in helping develop new tools for lead extraction. So, it must have been exciting and must still be exciting to see all the new technology that we’ve brought to bear.   I don’t know if there’s instances that sort of really stand out and in memory.

Bruce Wilkoff, M.D.
Well, there are lots of experiences. I remember there was a veterinarian that I took care of.  His pacemaker lead was sticking out his right internal jugular, but it was only sticking out like 1/2 centimeter so there was nothing to work on and we basically didn’t have a locking stylette that could go down it.

We had to tie on to the end, sort of work on it and what we used was a straight steel sheath and you know you can draw a straight line anatomically from the right IJ to the RV apex.  So, I was able to just grind, just right down that and that is part of some of the techniques, understanding the geography of and the anatomy of how these patients work.

And he would always tell me that, he said. Should I take 25 milligrams or 50 milligrams of Lasix? And I said, what kind of Lasix are you using? And he said, “horse Lasix.”  So, there were a lot of experiences like that, but the real key to it at that point in time is that at that same time, people were learning how to do not extractions, but learning how to do ablations and they were doing AV nodal ablations.

I mean, just before that they were doing DC ablations, which it’s questionable which was more barbaric, the extraction or the DC ablation.  You’ve never seen a DC ablation.

Thomas Callahan, M.D.
No I have not.

Bruce Wilkoff, M.D.
Well, you should be glad. And so, I had no competition for space. I could do an extraction faster than they could do an AV nodal ablation and starting to do with RF, but it’s no good if there’s Charlie Byrd and me and Steve Kulak and Chuck Love and a few other people that were available at that point in time, you have to learn how to communicate it.  My parents taught me that a long time ago and that, you know, it doesn’t matter that you like math and like all this other stuff, but you have to be able to communicate it to other people.  It’s not good enough to know it yourself. You’ve got to be able to communicate it to others so that it doesn’t stay with you. But it grows.

Thomas Callahan, M.D.
Well, that’s been a huge part of your career is, you know, not just being the person that everybody sends their most complicated patients for extraction, but also being this leader in both advocacy and education. I mean, I’m sure you’ve touched thousands and thousands of other physicians and then through that probably 10s of thousands of patients that you’ve impacted through for your education.

Bruce Wilkoff, M.D.
Yes. It’s what motivated me to do research. Understanding that what we think is true is not necessarily true, so we have to do research and then we have to communicate it, and then we have to take it on and learn how to teach it to the next generation.

So, in 1992, well actually 1990, at the Cleveland Clinic, we had a policy conference on lead durability at that point in time, we thought that leads lasted forever. We didn’t know that they didn’t last forever and so we more and more began to understand that there was an end of life to leads and that was before the defibrillator leads. But defibrillator leads started to become more prominent, transvenous defibrillator leads, the first defibrillator leads were not very robust and so they would go in for a while and then they we’d have to take them out and fortunately they weren’t very old.  So, they were easier to take out, but they were mammoth. They were very large diameter leads, so we had to be very careful.

Ultimately, I thought originally that defibrillator leads were going be the reason that everybody would get experience with extraction. They would learn and they were going to be young defibrillator because transvenous defibrillators were taken off. But what scooped that was the Accufix leads.

These were leads that had been implanted for a while, not a huge while, but a while, and these leads really frightened people because they could puncture the atrium, or the aorta and people started doing lead extraction because of that. And so there needed to be a motivation. Now, it turned out that people didn’t take the risk adequately and it took a while to get this going.

So is it combination of Accufix leads, defibrillator leads, but slowly in the 90s we started to work through these leads that were actually fairly fragile, were not that old.

Fortunately, because I think if they had been old, we would have had some very bad experiences.  But fortunately, that impacted the manufacturer of leads because, so we had several educational audiences here.

One was the was the other physicians understanding that there’s a need.  There’s infection, there’s broken leads.

But talking to the manufacturers about the need to construct their leads with materials and techniques that were going to be able to really make a difference.  And by the year 2000 or so, things were a lot different. At least we thought so.  But then we got into the second phase of defibrillator lead problems with Fidelis and with Riata type of leads. Fortunately, I think we’re back, passed both of those eras, that we’re doing better and fortunately now we’re in an era where we’re in at least the second generation of trainees.

So in the 80s, it was a boutique thing. In the 90s it was, they just thought we were crazy and they sort of left us alone.  By 2000 we had another lead management conference, and people started to see that there was something to this.  But we really still had very little data and so in the 2000s we started to actually collect data and understand and that made a huge difference.

Thomas Callahan, M.D.
You have talked about two different communities where you and others have had just an incredible impact you know on the trainees and the growth of the lead management, the lead extraction community, but also with our industry partners.  Maybe we talk a little bit about the partnering with industry.

You know, our industry partners, I’m sure, have 1000 competing demands when it comes to developing a new lead. Whether it’s the size of the lead and many, many other factors.  But one of them that I think you have always championed is to try and make sure that this lead can come out. I wonder if you can talk a little bit about that experience.

Bruce Wilkoff, M.D.
Yes, well, this was a sort of a love hate relationship. And then in addition, the FDA had a role in this.  So, when there are recalls, they are recalled because the device or the lead, whatever it is, doesn’t perform when used in accordance with its labeling.

And the labeling is for pacing, or defibrillation or sensing. It’s nothing about noise or, you may not realize this, but we didn’t even have lead impedance in the early 90s. We just barely had multiple programmable devices in the early 90s, so there was very little of self-diagnostics that we could work with, and the companies were worried about. I mean they knew there was a problem, but if they started to talk about it, then there was something wrong with their product, and then they had a problem with the FDA. And we started bringing the FDA and it was it was sort of like the physicians, the patients, the manufacturers and then the lead extraction manufacturers as well. And then there was the FDA as well.

And with these recalls, we really sort of developed the science as it as it happens.  Everybody didn’t know exactly what to do.  Matter of fact, the most recent thing that happened with that, which I see is a real change and in sort of perspective, is we’re doing some bench testing at the Cleveland Clinic, but we did some bench testing with Medtronic a little bit, maybe we talked about it once before, but the point being is that when we did bench testing on these leads, we found out how to best prepare the leads to be taken out.

Well, Medtronic wanted to publish this, and I was working with them and there were other people and when it came down to it, there was a problem because they are not labeled to be taken out, they’re labeled to be put in.  But then the FDA realized well it’s good to get this information out there so that people can, you know we’re all trying to do what’s best for the patient, and so with some caveats, we were able to publish this, but it was not easy.

And it was, what I see is as a maturation process where we can do that, which is now why we’re doing this bench testing at the Cleveland Clinic because we’re not trying to make it hard for everybody, but we’re hoping to have an independent testing facility so that we can get this data out there so people can learn, you know things. And we’re not trying to, you know, stomp on the toe of the FDA or the manufacturer. And when it came down to it, we were trying to do with the extraction companies. But it turns out the extraction companies make ‘How well does the locking stylet lock on to the inner coil?’ It doesn’t really talk about the mechanical properties of the lead – or how to best use it under those circumstances? It’s just use it according to the labeling.

So, I think here we are started in 88 basically. And so we’re going 98, 2008, 2018. Here we are. We have 35 years of extraction and I think now we’re finally getting to a maturation process where everybody’s understanding their roles and realizing that they have to bend the rules a little bit in order to be able to get this done well and that we need to be partners one with each other. And I think it is working out. It is one of the reasons that we have LEADonnection because this information tends to be segregated.  It’s one manufacturer versus another manufacturer, one extraction company versus another extraction company.  How do you use tools in this lead versus the next lead? What’s the best way to go about doing this? It a multifaceted problem and I think we’re just now getting to the point where we’re thinking this in a more mature way of being able to put it all together.

Thomas Callahan, M.D.
You know the work that you’re talking about, this tensile strength work is so exciting to me. As you say, we’re all just trying to do the best that we can for our patients and there’s 1000 different factors that really play a role in which device or which leads we choose for an individual patient. But from your work and others, we know that when it comes to taking the leads out, one of the most important factors is the preparation of the lead. And since each lead is constructed in a little bit different way, how you prep that lead, it could be different. You know, how you best prep that lead might be different and so since we were stuck with basically outcomes data to help guide our decision making and extraction for so long, this actually gives us some real, hard bench top data on how we might best prep these leads and then that hopefully translates into better outcomes for extraction patients.  So, I’m so excited about this line of work.

You know to that end; you talked a little bit about the growth over years of the extraction community. And you know, there really is a much larger field, if you will, of lead management professionals. And so, it’s exciting to see that, that larger community. But one thing we still battle is sort of that misperception around lead management or lead extraction. A lot of people still are very fearful of that procedure. I wonder if you can talk about either change in the perception or how we might battle those misperceptions going forward.

Bruce Wilkoff, M.D.
Yeah. It is definitely poorly understood.   I had a conversation, a podcast where Eric Topol, our former chief. We did a podcast, and he was talking about me going out and doing things that nobody else would do, and it was so dangerous, and I said well, you know, Eric, that’s not really true. And Eric’s one of the smartest guys you or I know, right?

Thomas Callahan, M.D.
Absolutely.

Bruce Wilkoff, M.D.
And, but it’s still the perception out there.   And so we need to get it out there.   I mean, valve surgery is dangerous and bypass surgery is dangerous. And I mean, everything is dangerous, but you’ve got to put it in perspective of how you go about doing it. How? What kind of protection that you have? What kind of systematic process that you have to make it make it work?

If you can be systematic about it and this does not have to be dangerous; and in fact, it is proven not to be dangerous, that doesn’t mean you never can have bad outcomes, but the outcomes when you have infection are so bad, we would have to have the world’s worst procedure for us to not want to do this.

Thomas Callahan, M.D.
Yeah.

Bruce Wilkoff, M.D.
You know, when my dad had his infection, I mean, what are you going to do? You’re going to have a guy live with an infection? As it turns out that you know your five year survival is you know, is at least only 75% even if you get it all out and there’s so much, I mean, lead extraction, the mortality rates are sub 1%, I mean complications, we live with complications in all of our procedures that we have, and we don’t treat the complications as horrors, I mean we just we just have to be able to put it in perspective.

So, I think we have some room. I think we now are getting a good sense of the data and the perspective of how we can do this with managing the risk and not really worry about the real complications.  Now, the fact of the matter is some of these patients are very sick and, but even in these very sick patients, they do very well and they’re really unlikely to develop a mortality type of endpoint. It’s really, we need to put this in perspective.

Of course, you have a conversation, and of course you have to tell that the patient the risks and the benefits and such like that. But how do you want to live?  Do you want to live with this sticking out of your chest? How do you want to live? And I think it’ll take another 10 years before we get everything, but there’s been a dramatic change in the perceptions, but we still have to do more.

Now its going to get more, with new topics with leads, with more interventions. So tricuspid valve interventions. There’s only so much space inside the chest and we’ve got to work on managing the risks and the benefits.  I think we’ll get there.

Thomas Callahan, M.D.
Yeah.

Bruce Wilkoff, M.D.
It’s just that it’s not going to happen just by sitting on our hands. We’ve got to work through it. We’ve learned the Cleveland Clinic has been very good at this, but I think medicine is getting better and better at this, developing a multidisciplinary approach to these things, and saying, OK, what is the risk? What’s the benefit? Should we take it? Should we not take it?

Thomas Callahan, M.D.
Sure.

Bruce Wilkoff, M.D.
There are very few always or nevers and given the number of people that have now been trained in lead extraction, it can be safely done in a majority patients without undue risk.

Thomas Callahan, M.D.
Right.  Well, this has been a great conversation. I wish we could just go on for hours, but I guess we have to wrap at some point. Thank for sitting in the hot seat for this one.

Bruce Wilkoff, M.D.
Not a problem. I really enjoy it. I’m really excited about LEADconnection because it allows us to communicate what’s going on and take what we’ve learned and not lose it. It’s so easy to forget what we’ve learned in the past. It takes effort to keep it going, keep the whole scenario going, so thank you for taking the effort to interview me and many other people, and let’s hope that people learn from our old mistakes and begin to do better things.

Thomas Callahan, M.D.
Well, thanks for blazing the trail and I’ll look forward to our next one.

Bruce Wilkoff, M.D.
See you later Tom.

Thomas Callahan, M.D.
All right, take care.

Bruce Wilkoff, M.D.
Bye bye.