Valay Parikh, MD, FACC, FHRS, Cardiac Electrophysiologist at Baptist Health System, San Antonio talks about pacemaker infections and their treatments.
Interview conducted by Ivanhoe Broadcast News in December 2018.
What’s the actual surgery called where you put these leads in?
Parikh: Placing leads is called a pacemaker or defibrillator implantation. And taking them out is called lead extraction we take out a pacemaker/a defibrillator and leads – everything together.
So what’s the difference between the pacemaker and the defib in terms of what they do electrically?
Parikh: The job of pacemaker is whenever it sees your heartbeat going down below a certain level, it just props it up. Every defibrillator has pacemaker capabilities. But a defibrillator has additional capabilities that when your heart goes fast in which some of the fast rhythms can be life threatening, it takes care of it by either going faster than that rhythm for temporary purposes or shocking them.
When the leads go in, it just kind of melds in with the whole system in the body?
Parikh: When we please the lead and a pacemaker, the generator or the battery goes under your chest. But the wires through the veins, they go inside your heart. When they go inside your heart they’re freely floating inside the heart, except the terminal portion of the pin, which we attach with a small screw to your heart. But over the time, it grows inside your body. It grows inside the blood vessel wall.
How the body adapts to it.
Parikh:
The surgery involving the lead extractors has been around for how long?
Parikh: It’s been there for decades.
For a long time.
Parikh: Initially there were not advanced tools, so traditionally, like many years ago, they used to just open the pocket where we put the generator and attach bricks to the leads and put it next to the bed. Every day, they will add another brick. So slowly by slowly, the wire will come out. And as you can imagine, many of those people did not survive.
Now when they go in, there is a problem with various things like infection on the leads themselves. Can you discuss that for us?
Parikh: On an average approximately 14 million leads go inside the heart worldwide. And 7 million devices go worldwide. The incidence of infection is around 1 percent every year, and about 50 percent of those infections, they don’t get treated properly. The mortality or dying because of infection is seven fold. If you don’t take those wires out, and if they are involved. Just giving antibiotics is not sufficient in this case.
When infection involves the pocket where the generator is placed or if there is a bloodstream infection, which has the wires, then those wires ideally should come out. And depending upon how all those wires are, how long they have been inside your heart and some other factors – clinically, how old are you, what are the risk factors such as kidney disease, liver disease, have heart failure – they determine whether you are a candidate for extraction. But ideally if you are a candidate and if it’s possible, lead extraction should be the number one.
Tell us about how long her wires had been inside of her body and what happened.
Parikh: Recently, I treated a 90 year old lady who presented at my hospital with infection in the pocket. She had a pacemaker for 26 years. She had two wires and they were the original wires. And she had battery change for five times. So every seven to eight years, they need to change the battery with current standard, but old pacemakers date out quickly. So now, every time you open the pocket, the risk of infection goes higher. So finally after 5th generator change, she had infection. And she came to our hospital. She was 90. And her weight was forty five kilos. So by traditional means, she falls into a high risk. But the alternate option of taking the wires out is to give antibiotics and wait and see if she responds. The problem with that is that when you give just antibiotics, you’re actually not taking care of the whole infection. And approximately a quarter of people will die within a month. And the risk of infection coming back by just giving antibiotics is almost seven times more than just taking everything out.
When you say that you’re giving antibiotics, it’s not killing the infection, is it? Because the infection is widespread around the equipment?
Parikh: The majority of time, the antibiotics curtail the infection spread. Some antibiotics do cure an infection, but when you have a foreign material – a pacemaker or lead, something like that – it’s hard to treat infection just by antibiotics because the infection is attached to these wires ,and it needs to be taken care of.
When you went in there, describe to us what you did once you opened her up to get – to do the lead extraction.
Parikh: After detailed discussion with her, her family and her primary providers, we came up with a lead extraction is a better choice for her. Obviously, the decision making was difficult. But we were confident in our abilities because we have the latest advanced tools. We do this in a hybrid OR (operating room)with a cardio thoracic surgeon at the bedside under general anesthesia. And we use new technology like laser lead extraction materials and something called bridge balloon. And so we opened a pocket where the generator is put in. And we clean the pocket, take care of the infection in the pocket. And then we use the laser to take out those wires.
You clean the pocket where the main portion is, and then do you pull the wires out, or how do they come out?
Parikh: Pulling wires is okay if they has been there for a few months. But after a few months, they become part of your body. They are not coming out just like that. We use technologies like laser technology or mechanical tools. We’re trying to separate the wires from around the blood vessel and trying to take care of one binding site at a time until we take out the whole lead out completely free of the body.
You’re hitting where it’s bound to the blood vessel – you’re actually hitting it with the laser to loosen it up and then you’re pulling it out.
Parikh: Yes. Gentle traction.
How do you then put in the new non-infected new sterile wire?
Parikh: Depending upon where the infection is and how long the infection is that, we can put the device back within a few days to few weeks on the other side of the chest because despite of doing everything, taking care of pocket, giving antibiotics, we cannot be hundred percent sure the pocket where she had infection that it will not recur there.
You’re moving it?
Parikh: We move the pacemaker on the other side of the chest. If it’s on the left side, we put it on the right side. If it’s on the right side, we put it on the left side.
Do you know why the infection arises, like in her?
Parikh: In about one percent of people, infection happens attached with the leads and wires. And it is going happen in the pocket because we are all surrounded by bacteria. It can spread through blood stream. If you have a bad infection due to some other reason, or a urinary tract infection, sometimes it can just spread through blood and through that, just attach to wires. These wires are still inside the bloodstream.
The actual infected device inside the pocket, what does the infection look like?
Parikh: It ranges from just a thickening of tissues and become something what we call necrosis, means dying tissue, or sometimes we can have pus. That usually suggests an active infection. That’s what we can see in the pocket. Around the leads, we can see our own tissue binding. And many times, you can see blood clots attached to it.
How many hospitals across the country actually utilize this technology?
Parikh: Many hospitals. However, proportionately very small percent of hospitals offer these services.
How long have you been doing this particular surgery?
Parikh: I just passed my fellowship, I was trained extensively in my fellowship and not many people get trained.
Tell us, if you will, the 90 year old woman – how was she doing physically before the surgery and now after the surgery?
Parikh: When I saw her, I asked her – and we should always determine – what is her functional capacity because that goes into our discussion about what are the risks and what are the benefits she is going to get off this procedure. She was fully active. She lives by herself. And she does all the activities by herself. Her family history is that all her sisters live in ninety nine, hundred years. And she’s not forgetful, no significant medical problems. So in my definition that age is just a number at that point because she had so much life left in her.
You get down to the actual brass tacks of the infection, you said a very small percentage get the infection on the leads or on the actual device. Just hit that again if you will, and how critical it is to attack that infection.
Parikh: Around seven million devices go every year – 40 million leads goes inside – placed in worldwide every year. And these devices and these leads, they stay in your life forever. That means we are talking about billions and trillions of wires and pacemakers around us. The risk of infection is around one percent annually without doing any intervention. But many people get interventions not related to a pacemaker, but related to something else. So the infection that 1 percent incidence of infection is, to me, is underreported. There are so many people who donot get proper care because it does not get identified in time.
That brings up a very important point. How does an individual with this in their body, how would they ever make that connection mentally that it’s that and not something else like a UTI?
Parikh: Every infectionpresents with fever, chills and other symptoms. And most of time, you are prescribed antibiotics. If you have pacemaker wires and if the infection doesn’t get better within a few days, then you should ask your physician whether there’s a possibility that my pacemaker may be infected. And they should be able to do more tests, or they should able to provide more information based on their judgment. If possible, you should talk to your pacemaker doctor and ask them those questions. If your pocket is infected, where we put the generator, you will see local signs of infection which includes redness, swelling and feeling of pain when you touch it. It’s warm, and you may also have fever or chills.
And if the actual wires themselves are infected?
Parikh: If the wires are infected and the generator’s infected, they will present in a similar way.
What are the new developments in this particular area?
Parikh: Lead extraction therapies that are growing day by day. In recent years, the biggest evolution in this field was a laser lead extraction. Previously people used to use different mechanical tools to take out the wires. It takes longer time. It’s considered more technically challenging and riskier. With laser technology, things have become more predictable and easier. So that’s one of the newer technologies we have at our disposal. The other biggest invention is something called a bridge balloon. It’s a balloon, a malleable balloon, but what it does is that during the procedure sometimes life-threatening bleeding can happen. And the surgeons have to go inside the chest to open and fix that thing right at that moment. The risk is low of that happening. But if it happens, it is life threatening. So what we can do is we can inflate the balloon where the site of bleeding is suspected. And that way, we can stop the bleeding temporarily and give surgeons more time. And we can potentially save the life.
END OF INTERVIEW
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