Advances in Lead Extraction: Interview with Saumya Sharma, MD

In this interview we speak with Dr. Saumya Sharma from Memorial Hermann in Houston, Texas, about his tips for successful lead extraction.

Tell us about your background in EP.

I completed my internal medicine, cardiology and electrophysiology fellowships and residencies at the UT Health Science Center at Houston. 

I joined a very busy private practice and for four years we expanded the practice throughout the city of Houston. Over the last two years we developed the Complex Arrhythmia Center at Memorial Hermann Heart & Vascular Institute. This is a center where we perform advanced ablation procedures and lead extraction. Last July, the University of Texas partnered with us so we are now part of the division of cardiac electrophysiology at UT Health Science Center at Houston.  

How long have you been performing lead extraction procedures? How many extraction procedures have you performed?

I’ve been performing lead extraction procedures since I left my fellowship, although I was only very hesitantly performing these procedures for the first two years. My senior partner was more regularly performing lead extractions, but I think coming out of fellowship, there was definitely quite a bit of fear associated with the procedure because of the risk and skill set involved in performing lead extractions. Therefore, I did all of my lead extraction procedures with my senior partner for about two years, and there were very few cases;  we did about 25-30 lead extraction a year for the first two to three years in practice. Most of the time I was electing not to perform lead extractions on patients, out of fear and risk of the procedure, unless there was an absolute requirement. However, about two and a half years ago when I expanded my practice in south Houston, I saw a very glaring need for lead extraction. We were seeing large numbers of patients with fractured leads, infected devices, and vascular access issues. Therefore, in April 2011, we developed a lead extraction program at the University of Texas and Memorial Hermann. The program has been a huge success for us. We started by taking patients who needed an almost absolute requirement for lead extraction, and soon became very proficient at lead extraction. We created a protocol and trained staff in lead extraction, and quickly had such good results with our program that we started expanding our indications for lead extraction. Since 2009 we have performed over 200 lead extraction procedures and removed nearly 300 leads.  About 80 percent of those have been at the lead extraction center. Our caseload at the lead extraction center has ramped up tremendously over the last two and a half years. 

What are your primary indications for extracting leads?

What we would call “level 1” or absolute indications are device infections such as lead or pocket infections. Once a device gets infected, the bacteria on that device cannot be completely removed or eliminated without the actual device being removed from the body — this includes the leads. Even if a pocket is infected from a pacemaker or defibrillator and you remove the generator, the leads that are left in the pocket will still remain infected with bacteria. Most of the bacteria that infects devices will create a biofilm around the insulation of these devices or around the core of the metal around the devices, which most of the time cannot be eliminated, even with high-dose antibiotics. Therefore, it requires us to remove those completely. Infection involving the pacemaker or ICD leads is also an absolute indication for lead extraction. Other reasons to extract devices include recalled or fractured leads; however, this can be a relatively controversial topic. Lead extraction can be a dangerous procedure in inexperienced hands, and therefore, the Heart Rhythm Society guidelines do not recommend lead extraction for all fractured leads. However, most experienced lead extraction programs with an experienced lead extractor are removing fractured leads from patients, particularly in patients who are young, because the alternative for lead extraction in patients with fractured or recalled leads is lead abandonment. This means leaving the lead in place and going into the opposite side or adding additional leads to the same side. Although lead abandonment is less risky at the time of the procedure, it defers the risk of chronic leads in the heart until later. These leads have the potential for causing infection, vascular obstruction, and may require extraction at a later date. For example, if you have a 40-year-old patient with an abandoned defibrillator lead, and you implant a new defibrillator lead, by the age of 50 they’ve fractured that lead and you’ll need to put another lead in; how many leads do you put in until eventually the device gets infected, but now you have very old leads in the body that also need to be removed, and the patient is higher risk? It would have been better to have initially removed the old lead and placed the new lead at that time. I think that is the message we’ve been trying to send out to the public, which is that in experienced hands, lead extraction is a safe procedure. Lead abandonment is an easy thing to do at the time; however, when you abandon a lead you are eventually deferring that problem for a later date. Somewhere down the line in a younger patient — anyone younger than 65 — you are going to set them up for a problem with their device in the future. They may or may not have that problem in the future, but every generator change has a 5% chance of infection, and every 10 years approximately 20% of ICD leads fail. Therefore, if you can visualize your patient having another generator change or living 10 years with their device, it’s probably wiser to remove the old lead and put a new one in. 

Where do you perform your lead extraction procedures? Why?

We perform our lead extractions in the CV OR and hybrid suites. We were fortunate there was a hybrid suite available in our hospital, and they built a second hybrid suite in which we have a block day in that suite. Therefore, every Wednesday we have our lead extraction day in the hybrid CV OR. Between myself and my partners, we usually keep it very busy, usually doing three or four lead extractions a week. 

Is your staff specially trained to support lead extraction procedures?

Yes, we have excellent support staff that work with a backup surgeon. We have a very close affiliation with a CV surgery group that provides us with surgical backup, and we use their OR staff as well. Doing two to three lead extractions a week, they have become very comfortable with lead extraction procedures and understand the risks associated with it. We are fortunate to have been able to train them and have them be interested in the procedure as well. 

What is your primary device method for extracting leads? Why? How often and when do you use an alternate approach?

We use almost exclusively Cook Medical’s Evolution device; it’s what we were trained on, what my senior partner uses, and what I used in my fellowship program. We’ve had such good results with the device that we have not seen the necessity to use other tools, particularly because some of the other tools have been associated with higher risk events. We have been fortunate in that of the approximate 300 leads we have removed in the last five years, we’ve had no patients die; we’ve had a 98% complete success extraction rate with leads that were as old as 25 years. Therefore, it’s difficult for me to try a new technology unless I know it’s safer and more effective than the technology that I’m currently using. 

What extraction sheath devices have you used in the past?

I’ve used Cook Medical’s Byrd Dilator Sheath Telescoping Polypropylene. I’ve also used the older Evolution device as well as the newer Evolution RL mechanical extraction device. 

What is your preferred technique for gaining vessel access when attempting to remove a cardiac lead?

We do lead extractions through the left pocket; we open up the existing device pocket, remove the leads, and then place locking stylets down the leads. Once we do this, we use the Evolution device to destroy the scar tissue that surrounds the lead in the heart and vascular system. Once the lead is removed, it creates a channel for us to place wires down and maintain access. If you’re removing one lead, the outer sheath of the Evolution is a way for us to maintain access as well. Once you remove the Evolution device, you have a sheath that you can put the wire into and then eventually put the new lead in. Another reason for lead extraction is to upgrade a patient from a dual-chamber to a biventricular device, and often those veins are completely occluded. In that circumstance you can extract one of the wires or leads, remove that lead and maintain a channel — therefore, you can put access wires back down and then upgrade the patient without having to abandon the entire left side and go to the right side in a patient. 

What guidance can you provide on the best ways to establish and maintain lead and sheath control during the extraction procedure? Has the availability of the One-Tie Compression Coil impacted how you manage targeted leads during the extraction process?

The use of the locking stylet is very important in lead extraction when trying to get the locking stylet as far down as you can into the lead. We do also utilize Cook Medical’s One-Tie Compression Coil, which has been a great advantage for us, particularly with defibrillator leads. When you cut and place locking stylets, they have multiple components to them; the One-Tie binds all those components to the locking stylet and insulation, so that you’re grasping onto many different components inside the lead and pulling them at once. This kind of traction is very useful. Furthermore, we use Cook Medical’s Bulldog Lead Extender, which helps us gain control of the lead, particularly if the lead breaks while we’re trying to extract it. The Bulldog Lead Extender helps us grasp the fragments and maintain traction so that we can extract them. 

What has been the most impactful advancement in lead extraction technologies during the past five years?

I think the new Evolution RL is a great advance. Although it’s a mechanical tool for lead extraction, I feel it provides you with a lot of positive feedback and tells you by the resistance of the trigger the kind of adhesion that you’re up against, so you can control the power and speed of the device as well as your traction. For extraction, I think the components of the new bits on the end of the Evolution RL device are safer, sharper, and rotate in different directions. Sometimes we have multiple leads that we’re extracting, and when you try to extract one lead, you end up tying the other leads together and it becomes very difficult to remove. This device rotates in two different directions, so that if a lead is tying up with your tool, it can rotate in the opposite direction to avoid that. The One-Tie has also been a very useful tool for us to try and capture those components, tie them together and pull traction on all those components while we’re extracting them, so that we don’t leave behind fragments of the leads and they don’t break inside the body.  

How have the Cook Medical Advanced Platform Devices for Lead Extraction impacted your lead removal practice?

We exclusively use Cook Medical’s lead extraction devices, because we find this to be the safest and most effective tool for lead extraction. Our data shows that we have over 98% success in complete lead removal; only a small fraction of our patients have lead fragments left behind, and we’ve had zero mortality as well as one patient that ended up having a cardiac complication requiring surgery. If you compare that to other types of lead extraction technology, it is a favorable if not superior comparison in terms of safety and efficacy. 

What are the primary procedure consequences that the Cook Medical Advanced Platform Devices for Lead Extraction help you avoid? Why?

It has helped us to avoid cardiac perforation and hemothorax. For the last 10 years, lead extraction was thought to be a procedure associated with very high morbidity and mortality, and that is because the technology that was being used resulted in a higher risk for cardiac perforation, tamponade, tear of the superior vena cava, and hemothorax. These required patients to get emergency surgery, and some of these patients who were frail and elderly would die. The tools that we have now, particularly from Cook Medical, have been excellent at avoiding these complications known to occur with lead extraction. 

How do you address the proximal end of a cardiac lead that you are planning to extract?

We usually cut the lead off, place a locking stylet down and place a One-Tie over the proximal end of the lead — this is the way we normally capture the lead and use it for traction prior to extraction. 

What are the most important principles for lead extraction?

The most important factor is experience; this is definitely not a procedure that should be done by every electrophysiologist, cardiologist or cardiac surgeon. It needs to be done in a place where there is high volume, where operators are doing them on a regular basis and they’ve seen a lot of different issues related to lead extraction — this tends to make the procedure safer. There is no one lead extraction procedure that is similar to another; each one has its own unique risks and difficulties. Secondly, it must be done with cardiothoracic or cardiovascular surgical backup available within minutes in case of immediate thoracotomy or cardiac repair. Finally, it is also important that these procedures are done in an environment where you have the appropriate ability to do the procedure safely; in our lab this is the hybrid CV OR, where we have excellent fluoroscopy presence to visualize the components of the leads. In the hybrid OR, the patients are intubated and treated as if they are going through heart surgery.  Transesophageal echocardiography is immediately available and sometimes used preventatively  for monitoring high-risk procedures. 

What is your advice to clinicians on how to best avoid a misadventure during a lead extraction procedure?

Take your time to think about the problem — don’t be in a hurry. This procedure is associated with a significant amount of risk. I know that in every procedure there is the potential for the patient to have a serious complication, so you have to walk in there with a healthy dose of fear as well as respect for the procedure. Fortunately with the new technologies that we have, these complications occur very rarely, but when they do, they can occur rapidly and require you to recognize them and act upon them quickly. Therefore, going through the procedure slowly and methodically, and having respect for potential risks and complications that can happen is the most important advice that I could give to anyone who is doing lead extraction today.  

Disclosures: Dr. Sharma has no conflicts of interest to report regarding the content herein. Outside the submitted work, he reports receiving honoraria and consultancy fees from Cook Medical and Boston Scientific.