Evaluating the Safety and Effectiveness of Mechanical Lead Extraction: Interview with Dr. Saumya Sharma

In this feature interview, EP Lab Digest speaks with Saumya Sharma, MD about his lead extraction practice techniques. Dr. Sharma is the director of Clinical Research for the Complex Arrhythmia Center at Memorial Hermann-Texas Medical Center and an assistant professor of Cardiac Electrophysiology at McGovern Medical School at UT Health.

Tell us about your background in electrophysiology and lead extraction. How many lead extraction procedures have you performed? How has lead extraction influenced your practice?

When I graduated from fellowship in 2009 from the University of Texas Medical School at Houston, I initially did not perform lead extractions. At the time, a senior partner was performing some lead extractions, and I would accompany him at times. My practice changed when I developed a new territory in Houston, and began encountering many chronic lead-related complications. I found myself in a situation where lead extraction became a necessity that needed to be performed. In that time, we recognized that there was not a comprehensive lead extraction program in the city of Houston — or at least not an organized one with dedicated days to perform lead extraction and with staff and surgical backup that was routinely available. Therefore, we set out to develop an organized lead extraction program at the Memorial Hermann-Texas Medical Center, which is the main teaching hospital for the University of Texas Health Science Center at Houston (at the time, we had an affiliation with the University of Texas, and now we’re part of the faculty at the University of Texas). It is now a full-fledged lead extraction program that takes place every Wednesday, performing 2-3 lead extraction cases within that group. So that is how this program started off — it was not something that I initially saw myself doing, but once we recognized the necessity for lead extraction and realized we didn’t have a very good organized program in place to perform these procedures, we set out to create that program. I believe I have now performed over 400 lead extractions since 2011. 

What factors led you to choosing mechanical tools for your lead extraction practice?

In my training, we used mechanical lead extraction as our tool of choice for lead extractions. My senior partner also used mechanical lead extraction. Over time, our experience with the tool taught us how to safely, effectively, and efficiently remove leads. Our outcomes have been so good that it is hard for us to consider using another tool.

You recently published a paper on mechanical lead extraction,¹ with impressive results. Can you tell us about it? Did the data surprise you?

Our program is a little bit different than others. Many of the programs around the country that perform lead extraction use an excimer laser system. However, we specialize in using mechanical lead extraction utilizing the Evolution^® RL Controlled-Rotation Dilator Sheath Set (Cook Medical) (Figure 1). Because of our high volume and the number of skilled operators that perform lead extraction in our program, we were fortunate to perform lead extraction on over 400 patients and remove about 683 leads between the years 2009 to 2016. This ended up being the largest lead extraction pool of patients utilizing the mechanical lead extraction tool. Therefore, we wanted to evaluate the data to heed the safety and efficacy of the system, since there was really not a large published data set on this tool. We assumed the data would be favorable since we were already using the tool, and we found that the success rates were very high and the complication rates were pretty low. Our complete lead removal rate was over 97%, with a clinical success rate of 99.7%. Major complications were noted in 1.5%, and our minor complication rate was 6%. 

Do you think that the size and results of this study will help to spur further studies on this platform? 

Yes, we hope that this spurs a multi-center perspective study. This was a single-center experience with this tool in a very controlled environment, utilizing a hybrid OR with skilled operators and well-trained staff. We want to perform a multicenter international trial using Cook Medical’s mechanical lead extraction system to show that this tool is usable, safe, and effective, not just in our hands, but in the hands of multiple operators in different centers throughout the country and worldwide. 

Can you explain the high percentage of lead failure vs infection? 

In most of the older studies on lead extraction, the reason to remove leads was infection. Because lead extraction was considered to be a very high-risk procedure with a high mortality and morbidity, the only reason to remove leads was due to sepsis, endocarditis, or pocket infection. But as time has gone on and the tools for lead extraction have evolved and the operators have become more skilled, lead removal due to other reasons — such as lead failure, lead malfunction, device upgrade, or loss of venous access — has become more feasible for considering lead extraction. I think lead extraction can be performed safely with the right tools in the right setting, even in patients who don’t necessarily have life-threatening conditions but still need leads removed because they’re nonfunctional or in need of a device upgrade. 

With success and complication rates being comparable, should mechanical lead extraction be adopted by more users? 

I think that mechanical lead extraction is a reasonable alternative to laser lead extraction because it’s safe, effective, and cost effective. It’s also a tool that can be adopted relatively easily by hospitals. If your hospital system is cost conscious and wants to start a lead extraction program, and you have an operator that is comfortable with a mechanical lead extraction tool, I think it works just as effectively and safely as a laser system. It’s important to have options, especially those that are cost effective and as safe and effective as the tools that are currently being used. 

What were the main factors for you wanting to share your data? 

Up to this point, operators have been adopting and using laser lead extraction systems. What we wanted to show was that we have a safe and effective alternative that is easy to train on and is a good tool to start a lead extraction program with. It does require creating a specialized program for it, ensuring all the necessary backup systems are in place, and having supportive hospital staff, but it’s something that can be developed in a relatively inexpensive way, and is just as safe and effective.

How do you expect the results will influence your colleagues?

To the physicians who are interested in developing a lead extraction program but have had trouble developing one because the system may be too expensive for their hospital or they are getting pushback about the program because of the cost, we want them to consider this as an alternative model. Up to this point, because the Evolution tool has not had data showing that it’s just as safe and effective as laser lead extraction, I think people have not been as eager to adopt mechanical lead extraction. However, now that we have a large retrospective study demonstrating its safety and effectiveness, there is hard scientific data showing that it can be used as an option. For operators who want to start a lead extraction program, this will hopefully make their hospital a little more conducive. This may be a good alternative for them, rather than not being able to perform lead extraction in these centers because of cost issues. 

Have you trained other physicians on lead extraction?

Yes, I have trained several of my colleagues in lead extraction. We also have a fellowship program in which our fellows perform lead extractions. In addition, we have an observation course in which colleagues can come and observe our lead extraction procedures. Many of these operators have been from countries such as Mexico and South America, where they could not afford a laser lead extraction system. Since taking part in our observation course, they have started large-scale lead extraction programs in Mexico City and Brazil. This is one of the reasons I’m most proud of the work that we’ve done with this system. Prior to having these physicians observe and support mechanical lead extraction, a lot of their patients in Mexico and South America were having their leads removed via open heart surgery. Now, with mechanical lead extraction programs starting in these countries, patients are not having to go to surgery. These programs are having very good success. 

What do you think are the most valuable takeaways from training?

The Evolution tool is safe and effective, and gives very good tactile feedback. It has the ability to control the power with a hand-triggered mechanism, which helps the operator decide how much power to deliver and how much pressure to use in order to remove the leads. The takeaway message that I always give to my trainees and fellows is that it is crucial to have a good system in place. You also need to have a good backup surgeon that can do this in a very controlled environment and with the right staff that knows what they are doing. Having that system in place is 50 percent of the battle — having an operator and the right tools are the other key elements. Mechanical lead extraction can be a very good tool for lead extraction in this setting.

Disclosure: Dr. Sharma has no conflicts of interest to report regarding the content herein. Outside the submitted work, he reports receiving personal fees for lectures for physician training from Cook Medical. 

This article is published with support from Cook Medical.

Sharma S, Ekeruo IA, Nand NP, et al. Safety and Efficacy of Transvenous Lead Extraction Utilizing the Evolution Mechanical Lead Extraction System: A Single-Center Experience. JACC Clin Electrophysiol. 2018;4(2). DOI: 10.1016/j.jacep.2017.12.010.