New Opportunities in Simulated Lead Extraction: Interview with Steven P. Kutalek, MD

   In this interview, Dr. Kutalek talks with EP Lab Digest about his initial experience using Spectranetics’ new advanced laser lead extraction simulation system. Dr. Kutalek is the Director of Clinical Cardiac Electrophysiology at Hahnemann University Hospital and Associate Professor of Medicine at Drexel University College Medicine in Philadelphia, Pennsylvania.

Tell us about the components and features of the simulation system.

   The simulation system is designed to familiarize doctors and operators with the laser system and its operation. There are two parts to it. The first is a preparation area where the operator gets a chance to work with the actual lead locking device and preparing the lead for extraction. This is crucial because preparing a lead is as important as actually using the laser to remove the lead. The second component is a computer-based extraction simulator in which a laser simulation system is used to advance over the lead after it has been prepared, and gives a sense of reality in terms of what the laser feels like as it advances through lesions.

Tell us about your experience with Spectranetics’ simulation system.

   In my experience, the simulator provided a realistic sense of what lesions feel like, and there is a visual component as well. Simulated fluoroscopy allows the operator to see what is going on inside the patient and see how both the laser and the outer sheath advance. It also allows the operator to position the laser and outer sheath, torque the laser and outer sheath, put tension on the lead, watch the laser get through the lesions, and move forward to the next lesion. It’s a really good experience.

How long have you been using the simulator?

   Thus far I have just used it at the HRS meeting in Denver. The simulator is still very new, but I worked with Spectranetics on developing simulated lesions to demonstrate their interaction with the leads and laser sheath, and I think it has helped giving some idea as to what the computer simulator should be like in terms of lesion stiffness and difficulty getting through lesions. One of the aspects of the simulator is that it can be adjusted sort of like a flight simulator for good or bad weather — you can change the settings to lesions that are easy to get through or lesions that are difficult to get through, and actually get a good experience dealing with both types.

What is the learning curve like in using the simulator system?

   I don’t think there’s much learning curve at all — it’s a hand-on experience. The first time that you have a chance to use it, you’ll have a good understanding as to how it works. A lot of fellows in training and doctors now have used simulators in other areas of the medical field — simulators are being used in cardiac catheterization as well as in carotid stenting — so I think extending it to lead extraction makes perfect sense. Simulators have also been used in terms of placing left ventricular coronary sinus leads. So the experience is there, and transitioning to this simulated system is not difficult.

What types of simulated cases or patient scenarios are available when using this simulation system? For example, how do these simulation training experiences help avoid potential complications down the road?

   I have not yet tried all the different scenarios on the system, but the difficulty of the lesions can be changed so you can change how fibrotic the lesion would be or how difficult it would be to get the laser through different regions of vasculature. You can also change to different types of leads and different sized laser sheaths; you can use the standard laser sheath with or without a VisiSheathTM (Spectranetics, Colorado Springs, CO) outer sheath. Spectranetics will continue to reach out to us, the physician community, to develop additional scenarios and cases.    One of the advantages of the simulator is the fluoroscopic imaging, in which you can actually see the “lead” on a simulated fluoroscopic image. Maintaining proper alignment of the laser with the lead is so important, and if you don’t put enough tension on the lead properly during extraction, the simulator will actually show that you’re not doing it properly — that is a mentorship/proctorship type of thing that can be explained readily using the simulator. Another advantage is that the simulator allows you to go all the way down to the apex of the heart. Sometimes when we do laser cases, even in training with real laser cases, the lead comes out before you get down to the apex of the heart of the right ventricle. The operator who is in training doesn’t have the experience of knowing what to do when you get all the way down to the apex and how you tease the lead out of the heart, so you can actually do that with the simulator as many times as you want without causing the perforation in the right ventricle. This is a specific area where using the simulator is really useful in terms of not causing harm to patients and yet being able to train in an area that has high risk. There are two high-risk areas in particular: one is the superior vena cava (SVC) and right atrial (RA) junction, and the second is at the right ventricular apex. Those are two areas that you can perforate. If you perforate in the SVC-RA junction, you will cause bleeding into the right thorax and it is a critical life-threatening bleed; if you perforate into the right ventricular apex, you can cause pericardial tam- ponade. Therefore, these are two areas in which finesse with the laser system and appropriately aligning the bevel of the laser and the bevel of the outer sheath are most important, and the simulator gives you a chance to do that not once, not twice, but as many times as you want to without causing harm to a real patient.

Who will be facilitating the simulation events?

   Simulation events will be facilitated by Spectranetics with the help of Medical Simulation Corporation. Several of the events may also involve an experienced teaching physician.    Optimally I think that simulator sessions like this are most useful when you have an experienced operator working with the trainees, in which you can actually work through with them extraction details, depending on the lead type. Having an experienced operator is really useful in terms of the details and fine points of removing the leads.

Has Spectranetics determined when the simulation events will occur? Will the events have open registration?

   Spectranetics is currently finalizing the dates and locations for simulation events. Physicians interested in learning more should contact their local Spectranetics representative.

What other methods are currently available for lead extraction training?

   Fellowship training is the most comprehensive way to get experience. As you know, the HRS guidelines came out in 2009 recommending operators have experience with 40 lead extractions; however, in our training program, our fellows have experience with 80-100 cases before they leave.    A second way to get training is through mentorship programs in which physicians visit other facilities and learn about the equipment, the indications, and some of the basic techniques of extraction. Another way is through on-the-job (OTJ) training, which you learn as you go. However, that has to be done with the caveat of understanding that there are certain risks and types of lead systems that you remove that you’re not going to see until you’ve gone through 80-100 cases, when you’ve actually had the lead break or the lead tip migrate into the pulmonary artery, or you have to use a femoral extraction system, or have to switch from a standard to a laser sheath. One of the goals of training is to try and get experience with as many of the different tools that are available so that you have operating flexibility to be able to use what is needed for each case.    There is another type of training that is also becoming important now, which is the lead extraction symposia. At this year’s HRS meeting, there was a lead extraction symposium run by Ohio State, last year there was one run by the Cleveland Clinic, and there are various symposia being sponsored around the country at different locations. I think these are very useful for people who are interested in lead extraction — I don’t think you can learn too much in this area. The symposia have been fantastic, especially the ones that I have attended or participated in where there is a give and take between participants and the audience.    One of the main goals of the simulator is to enhance safety in the operators doing the procedure. As you know, the complication rates have come down over the years in terms of extraction as a whole, and even with laser extraction, if you look at the recent LExICon study in terms of lower morbidity and mortality rates compared to earlier laser experience. Part of that has been because of operator experience, but also because of training, and those of us who are involved very heavily in lead extraction agree that training is so important. So simulator training is so useful in terms of enhancing patient safety long term by getting the mistakes out of the way early, learning where you can mess up, and trying over and over in a simulated environment in which you can gain some hands-on expertise and learn how the laser feels.

How often does one need to use the simulation system in order to gain proper experience? How long does each training session last, on average?

   I think a half hour is a reasonable starting time. Based on what each individual needs, I’d maybe add on another 15 minutes, so 30-45 minutes total would probably give one enough time to get through the lead preparation at the beginning of the simulator session. Each laser extraction case is going to take between 5-6 minutes on the simulator, and after getting through the prep you probably have time to get 2 or 3 different leads removed, depending on the operator’s experience. Someone who is working de novo is probably going to want to spend some more time, such as an hour per session, to try this out, but I think about 30-45 minutes is pretty reasonable.

Is there anything you’d like to add?

   The one caveat for a simulator system is that the operator has to understand that it is only a simulation, not the real patient setting. Even though there are educational modules involved in the simulator training, which I think are very good, the operator needs to understand in doing this that it is easy to overlook certain things but that they can’t overlook aspects of safety in terms of lab preparation, preparation of patients, making sure you have arterial lines in, having their staff up to speed, having operator surgical backup, etc. So there are a lot of aspects available on a simulator that one can learn about, but it is not the real world. All the leads that you work on in the simulator are going to come out, but that’s not always the case in the real world, and one doesn’t see the real potential complications of hypertension or morbidity that you’d see in the EP laboratory.