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Advances in Lead Extraction Techniques: Interview With Roger A. Freedman, MD
In this feature interview, EP Lab Digest speaks with Dr. Roger Freedman from the University of Utah about his advanced lead extraction techniques.
What is your background in lead extraction? How many lead extraction procedures have you performed?
I have been doing lead extractions for 15-20 years, and have grown more experienced over the years in terms of the techniques that I use. In my lifetime I’ve done over 500 lead extractions. I’m currently doing about 50 lead extractions a year.
Why and during what clinical circumstances do you select the various lead extraction devices? What is your primary approach for extracting leads, and why have you settled on this approach? What other alternative approaches do you use?
In my experience, the most common indications for lead extraction include infection (either pocket or endovascular infection), problems with venous access in patients who need new leads (including forming a new venous channel in an occluded vein), or to remove failed or unnecessary leads to reduce the burden of hardware in a patient. In terms of specific approaches, our program at the University of Utah is different from many other programs in that our techniques do not include the laser. Many programs around the country use a laser specifically developed for lead extraction, but I’ve never used the laser in a single case. The primary reason that we don’t use the laser is that we can get the job done with safer techniques. There is a safety advantage in not using a laser; a potentially catastrophic complication known as a superior vena cava (SVC) tear can be associated with the laser. In all the extractions that I’ve done, I’ve had exactly one SVC tear, which I believe is a much lower rate than the typical laser user might experience. Another advantage of not using the laser is cost; the tools that I use are much cheaper than the laser sheath, and we also don’t have to invest in the generator console that is used to connect to the laser sheath.
Now that I’ve told you what we don’t use, there are very important tools that we do have. We use mechanical sheaths from above, in other words, these are sheaths that pass over the lead from the subclavian area where the leads are generally first implanted, and they pass over the leads and break up the adhesions with a rotating tip at the end. We also have sometimes used an electrodissection sheath, which is the same idea, but instead of having a mechanical sheath on the end, there are 2 cautery electrodes at the end that connect to a standard cautery generator (found in any surgical unit). This somewhat older technology allowed one to cauterize through the adhesions with a particular sheath.
However, what really distinguishes our program in terms of what we use is a femoral snare. The Needle’s Eye Snare is introduced into the femoral vein and passed up the IVC to the right atrium, and the leads are snared in the right atrium and pulled up inferiorly through the femoral vein. This is our primary “go-to” technique that can be used for any extraction that is of at least moderate difficulty. We find that there is much less resistance to pulling out a lead in the inferior direction than trying to free it up from above. Exactly why that is the case is still unclear, but it is a very clear observation for anyone who uses the femoral sheath. I’ve used the sheath in probably 75-80% of my cases, and the only cases in which I don’t use the femoral sheath are those where the leads have been implanted for a relatively short period of time (1-2 years) and it is still fairly easy to get them out from above. Therefore, while other centers might use the femoral sheath only as a bailout procedure when they’re unsuccessful from above, we see it as our primary tool for extraction.
What type of procedural challenges have the femoral tools helped you overcome? Do you feel this approach helps to avoid complications?
Yes, the number one complication that it avoids is the SVC tear. We’ve never had an SVC tear using the femoral approach. The one tear that we had was using a cutting sheath from above. Thus, for all practical purposes, I think it’s safe to say the SVC tear is simply not a complication of the femoral approach. It also allows you to avoid a lot of the difficulties in passing the sheath from above — e.g., calcification, dense fibrosis, and damage to other leads as you’re freeing them up above where the leads are tightly constricted in the subclavian vein — all these complications can be avoided by snaring the leads and pulling them up from below.
Should the femoral approach be considered more often as a primary approach?
I think it depends on the experience of the user. We have found it to be an extremely useful, effective and safe approach, but there is definitely a learning curve to snaring leads from below. For instance, just yesterday I was taking out a 13-year-old CRT-D system that was infected, and although the atrial and LV leads came out very easily from below, the RV lead actually broke into 2 pieces as we tried to take it out from below. We had to go back up and snare the 2 pieces individually, which was challenging because it was a smaller target to snare fragments of leads as opposed to a whole lead. I’m happy to say we were successful in getting everything out. However, there is definitely a level of expertise that needs to be developed with the snare. Having said that, if you only use the femoral snare occasionally as a bailout procedure, rather than as more of a primary approach, you’re never going to develop a level of expertise — you’ll only be trying the most challenging cases, and that would be an impossible learning curve. So my recommendation for someone starting out is to use the femoral sheath liberally on all cases, and develop your skills. That way you’ll be able to use it for the most difficult cases as well.
What key points on lead extraction procedures and techniques do you repeatedly emphasize to the EP fellows at the University of Utah?
My advice is to be prepared: know your patient and all the details about the leads you’re going to be taking out. You’ll want to be thoroughly updated on the patient’s cardiac history, their ventricular function, arrhythmia history, if they are pacemaker dependent or whether you’ll need to put in a temporary pacemaker, and if they have had previous heart surgery (pericardial tamponade is a much less likely complication for someone who has had previous heart surgery). In addition, it is important to know your leads. There are some leads that are more fragile and tend to break from either approach (superior or inferior), and some leads are active fixation versus passive fixation. Therefore, have a very clear understanding going into the procedure. Following that, one should know the limitations and capabilities of the techniques they’re going to be using. Based on your own personal experience, know when to use a superior approach, know when to use an inferior approach, and know when to use both. I’m emphasizing the inferior approach, but every case requires some degree of the superior approach in that one has to open up the pocket superiorly, disconnect the generator, free up the leads of their adhesions in the pocket area, and take off the suture sleeves, etc., which are all considered part of the superior approach (or lead preparation). Since you’re always going to initially be working in the pectoral area, so you have to ask yourself how much more do you want to have to do superiorly before you then transition to the inferior approach. For instance, I sometimes will use a hybrid approach in which we’ll put in a locking stylet from above; this stylet goes down the lumen of the lead, locks at the end, and allows you to go down the lead to some distance with the mechanical cutting sheath, just to free things up in the subclavian area before we go to the inferior approach. Sometimes that’s necessary and helpful, and sometimes it really isn’t needed — you’re just spending more time on doing that and using additional costly supplies from above. So going into the case, it’s important to have a game plan based on your knowledge of the patient, the leads that are implanted, and how long they’ve been in. That’s not to say you can’t make course corrections — during lead extraction procedures, you need to continuously use judgment and not be afraid to alter your game plan if there are unexpected barriers that you might find. For instance, maybe you’re planning on doing a superior approach since the lead has not been in very long; however, when you go in with your locking stylet, you can only get it a very short way down the lead. This will severely limit your options for a superior approach, because generally speaking whether it’s with a laser or a mechanical cutting sheath (anything you’re using from above), you only want to advance as far as a locking stylet has gone. Therefore, if your locking stylet isn’t going down very far, then you will need to switch over to a femoral approach. Always be prepared and have the femoral areas prepped, draped and ready to go, even if going into the case you don’t think that you’re going to need that approach.
Does the EP staff at University of Utah receive specific education on how to prepare for and support lead extraction procedures? If so, can you briefly explain this?
Yes, absolutely. We’re doing an average of one lead extraction a week now, so the procedure is becoming more common and is something we do on a routine basis. The staff is very highly trained and has taken part in orientation sessions. In addition, we have a cath lab staff that is very attentive during cases — they are involved and pay attention, and learn from every case, just as I do. Together we’re continuously fine-tuning our approaches to these patients.
Is there anything else you’d like to add?
The only other thing that I would add has to do with the surgical backup. The published guidelines for lead extraction state that there should be a cardiac surgeon and a surgical team immediately available on standby for every lead extraction. This turns out to be impractical and in my opinion, not necessary. Certainly for the most challenging cases (e.g., a 20-year-old defibrillator lead case), you want the surgeons, the surgical nursing team, the cardiopulmonary bypass technicians, and pump techs on standby. However, surgical backup is really not necessary for a patient with a pacemaker lead that is only 2 or 3 years old, as the likelihood of a procedural disaster that would require emergency surgery in that patient is really very low. At the University of Utah, we risk stratify our patients into 3 categories: low, medium, and high risk. The high-risk case is one in which there is a very old defibrillator lead or multiple leads, etc., and there is a significant risk of an emergency. However, this can actually be fairly resource intense, because you have the surgeons and operating room on standby and you’re essentially holding up another heart surgery on the schedule. On the other end of the spectrum, for low-risk cases, the surgeons are aware that there is a case going on and are in house, but the likelihood that we are going to need them is very low, and therefore we don’t have all those resources standing by. Most of our cases actually end up in the medium risk category, so the surgeon and operating room are available, but we don’t have the pump team or the nurses standing by; the surgeon might actually be doing another case next door in the heart room, but he knows that he can break out in the case of an emergency. The bottom line is that despite published guidelines, I do not think it’s necessary or practical to have a full surgical team standing by with every lead extraction. I think it’s possible to risk stratify your cases and to arrange for the level of backup that is appropriate to the risk of that particular case.