Developing and Managing a Successful Lead Extraction Program

© 2023 HMP Global. All Rights Reserved.

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of EP Lab Digest or HMP Global, their employees, and affiliates. 

EP LAB DIGEST. 2023;23(5):1,16-18.

Availability of lead extraction in our institution has become essential in delivering appropriate care to our many device patients. In our practice, we have been performing lead extractions for over 20 years. A successful lead extraction program requires planning, institutional support, and ongoing education of staff, referring physicians, and operators. While not all institutions implanting cardiac implantable electronic devices (CIEDs) should perform this procedure, every practice that treats patients with a CIED should work closely with an experienced extraction center.

Case Presentation

The patient is a 60-year-old female with sick sinus syndrome and a permanent dual-chamber pacemaker (Ingevity MRI pacing lead (model/length 7741/52 cm and 7740/46 cm, Boston Scientific) implanted 5 years prior. She was admitted for heart failure (HF) with an ejection fraction (EF) of 40%, atrial fibrillation (AF), and moderate mitral regurgitation (MR). The chest x-ray showed the ventricular lead to be in the left ventricle (LV) via the atrial septum (Figures 1 and 2). She was referred to us for extraction and device revision. The case raised several questions as to management of HF, AF, and an abnormally located lead impinging upon the mitral apparatus. Surgical extraction of the lead was discussed as well. As the onset of HF coincided with AF, and considering that the patient could require atrial septal device (ASD) closure after extraction, it was recommended that the patient first undergo AF ablation before extraction. She underwent pulmonary vein isolation and additional LA posterior wall and cavotricuspid isthmus ablation at our institution. Intraprocedural transesophageal echocardiography (TEE) allowed us to confirm the aberrant course of the lead and impingement on the mitral apparatus. Keeping in mind the relative urgency due to MR, she was scheduled for extraction 3 weeks later. Apixaban was held on the morning of the procedure and resumed post procedure the same evening. The case was coordinated with the interventionalist, cardiothoracic (CT) surgeon, and neurointerventional radiologist, anticipating potential issues such as development of a large ASD post extraction that could require a closure device, mitral apparatus damage resulting in acute MR and decompensation, and cerebral embolization of debris. In addition to the usual femoral sheaths (discussed later), the Sentinel Cerebral Protection System (Boston Scientific) was positioned prophylactically via the right radial approach by the interventionalist in the hybrid room (Figure 3). TEE imaging did not reveal any thrombus or vegetations on the lead body. A 12 French (F) GlideLight Laser Sheath (Philips) was used along with a VisiSheath Dilator Sheath (Philips). Laser applications were performed along the lead, specifically in the innominate vein and to cross the atrial septum. The VisiSheath was used to break adhesions along the mitral annulus and LV apex. A larger (14F) sheath may have theoretically allowed less shearing of debris and embolization risk, with the potential downside of creating a larger ASD. In a more chronically implanted lead, this issue may be taken into consideration when selecting sheath size. The lead came out with countertraction at the LV apex. A residual patent foramen ovale was seen that was small and did not require closure. MR was negligible with no visible damage to the mitral valve leaflets or chordal apparatus. The new right ventricular (RV) lead was implanted on the RV septum, confirming position by orthogonal fluoroscopic views and TEE. The patient had intact conduction with a narrow QRS and the decision was made not to implant a conduction system pacing lead; instead, the RV lead was positioned on the RV septum. No debris was seen in the Sentinel device after removal and careful examination. She was discharged home the next day with an uneventful postop course. She remains symptom free without further AF or HF after 6 months and has a normalized LVEF.

Discussion

Traditionally, lead extraction has been performed in tertiary academic centers; however, with expanding indications and sheer volume of CIED patients, it is important that high-volume community hospitals be set up to extract leads. We currently have 4 EP lead extractors. Most of the cases are performed individually, with a second operator only scrubbing in for cases with unique learning points or difficulty. Having multiple operators has improved access to the procedure, helps meet the needs of the community, and allows ease of scheduling. However, to maintain competency, the expectation is that each operator participate in ongoing medical education and extract 20 leads per year, as recommended by the 2017 Heart Rhythm Society consensus statement.¹

Identifying Patients

CIED infections are the strongest indication for extraction. We have worked with our sepsis team to create an order set that triggers an electrophysiology (EP) consultation for inpatients with CIED and sepsis. This allows early detection of some CIED infections. We are also working toward establishing an electronic medical record (EMR) alert system that would trigger an EMR alert message to the electrophysiologist for patients who have a CIED and are admitted with bacteremia and sepsis. Early intervention is critical in patients with a CIED and sepsis, reducing in-hospital morbidity and 1-year mortality compared to delayed extraction.² Management of infected devices requires familiarity with wound management techniques such as capsulectomy, simple skin flaps, submuscular and intermuscular device relocation, and use of Aquamantys (Medtronic), as well as different drains and wound vac systems.

We often encounter leads that are relatively new that we feel should be extracted instead of being abandoned. The most common scenario is when upgrading from a pacemaker to an implantable cardioverter-defibrillator (ICD). We prefer to extract leads over abandonment in cases of lead fractures and upgrades. Other less common indications are for venous obstruction, magnetic resonance imaging compatibility, or refractory device site pain. Extracting and replacing RV leads with conduction system pacing leads in patients with pacing-induced cardiomyopathy may be considered instead of abandonment. Occasionally, we have extracted leads if the primary bradycardia indication has resolved. We anticipate we will see this more frequently as cardioneuroablation for syncope becomes prevalent and we remove some currently implanted devices in younger patients.

The Initial Consultation

We pursue best available practices in lead extraction. All cases are evaluated with a careful preoperative assessment and review of imaging and implant data. The chest x-ray is invaluable in planning for lead extraction. We have not routinely adopted computed tomography (CT) imaging in our practice, although there are cases where this is very helpful. CT scans can be helpful in determining areas of heavy adhesions with chronic leads, identifying an aberrant course of leads, and evaluating possible chronically perforated leads, as well as for identification of externalized cables in some leads at risk for this complication.

It is important to discuss and document the pros and cons of each approach in the initial consultation note. In noninfected cases, there are often options for management besides extraction such as tunneling, epicardial lead placement, or even abandonment of leads. We draw pictures for the patient to help them better understand their specific situation and options. Sometimes, clever reprogramming or use of an abandoned lead can obviate the need for an extraction procedure. A good extractor must also recognize when an extraction should not be performed.

Getting Started

We recommend that new extractors start by extracting relatively simple leads such as pacemaker leads that are a few years old. Although we initially categorized our cases into low- and high-risk categories (the difference was having cardiopulmonary bypass [CPB] on standby), we have moved away from this practice and now have CPB available for all cases. It is important to follow a standardized protocol for every case, as this helps create familiarity with the equipment and procedure for the staff and operators. It is highly recommended to have another extractor available for a second opinion if needed.

In terms of preparedness, it is useful to have a separate cart with the equipment required for extractions. Our extraction cart includes laser and mechanical sheaths (using both Philips and Cook Medical), a temporary pacemaker, pericardiocentesis tray, Byrd Workstation Femoral Intravascular Retriever Set (Cook Medical), Bulldog Lead Extenders (Cook Medical), and common snares (eg, Goose Neck Snare [Medtronic], Needle’s Eye Snare [Cook Medical], and EN Snare Endovascular Snare System [Merit Medical]). We sometimes use steerable EP catheters to help snare leads. It is important to periodically review the contents of the cart to ensure none of the equipment is missing or past its expiration date. We keep a variety of interventional wires in the event that we must implant a cardiac resynchronization therapy device or if difficult vascular access is encountered. We review the case with the appropriate device company representative a few days prior in case special equipment is required. Operating room equipment such as a sternal saw is always available in the room. Four units of packed red cells are ordered for every case and available in the room during extraction.

The Procedure

All cases are done under general anesthesia monitored by a cardiac anesthesiologist. The TEE probe is introduced either by the anesthesiologist or extractor. With vascular ultrasound guidance, we place a 4F arterial line, 6F venous line, and additional 12F venous line for a superior vena cava (SVC) Bridge Occlusion Balloon (Philips) by femoral approach. A Bridge balloon is introduced in every patient when use of a powered sheath is anticipated. There can be difficulty in positioning the wire from the inferior vena cava (IVC) to the right internal jugular, so this is best done prophylactically. This sometimes requires maneuvering with a diagnostic catheter such as a JR4 or MPA. Usually, a test inflation is performed in the SVC. This is also helpful in assessing any degree of SVC stenosis as the balloon is inflated and conforms to the SVC margins. The balloon is then deflated and retracted to the inferior RA-IVC, with the wire being retained in the right internal jugular or right subclavian vein. A sticker is placed on the balloon shaft to mark the optimal insertion distance. At the end, vascular closure devices are used in select patients only, to contain cost. The femoral sheaths can easily be used for CPB if needed. After a complete baseline TEE exam, including specific assessment of SVC lead interaction, tricuspid valve function, and presence or absence of a pericardial fat pad (so as not to be misled later), the probe is positioned for a 4-chamber view. TEE imaging should include continued assessment of the pericardial space, valves, and assessment of the right atrium and RV for invagination during periods of hypotension. The CT surgeon is always available in the room at the critical time of extracting the lead.

Our preference is to start with a laser sheath and use a VisiSheath for support in almost all cases. In cases where reimplantation is to be performed, venous access is obtained prior to initiating the extraction procedure with one or multiple wires depending upon the device to be reimplanted. It is unwise to use a single wire to reimplant a multi-lead device, as this results in excessive bleeding from the entry site and possible future lead-lead interactions. An advantage of the outer VisiSheath is that it can also be used to introduce a wire for access as the laser sheath may become occluded with debris. Long peel-away sheaths should be used for reimplantation in extraction cases as leads may not pass into the RA due to stenosis or intimal dissection. We use mechanical rotational sheaths in cases where the laser sheath fails; these are usually patients with calcifications. Additionally, we believe snaring skills are mandatory learning for an extractor.

Good quality fluoroscopy is important to allow visualization of subtle findings, such as widening of the mediastinal silhouette. A pericardial effusion can often be recognized by fluoroscopy alone. Transient hypotension is not uncommon, and fortunately, it is usually not due to a catastrophic vascular tear. In case of hypotension, we immediately go through a checklist (ie, relieve any traction that may be causing invagination of the cardiac chamber, scan for pericardial effusion, perform fluoroscopy of the chest to assess the mediastinal width, visualize the costophrenic angles bilaterally for possible hemothorax, etc). There may just be increased haziness over the lung fields before an obvious hemothorax is seen with mediastinal shift, for example. Usually, releasing the traction for a few cardiac cycles results in resolution of hypotension related to cardiac invagination. Sometimes, a severe vagal response can result in hypotension. The SVC Bridge balloon is inflated if hypotension does not respond to the above measures.

How to Manage Traction and Countertraction

This is one of the core concepts of extraction that must be mastered. Different lead locking devices (LLDs) are available and require understanding of specific differences. A 2-person technique is used for traction, whereby the scrub tech provides traction using a hemostat around the LLD, additional ‘fine tuning” of traction is performed by the extractor using the left hand, and the right hand is used for controlling and advancement of the extracting sheath (Figure 4). We communicate to adjust the degree of traction for specific leads that may be more fragile and for different locations in the vasculature. Other operators may perform traction and countertraction by themselves. Regardless, one should have complete control over lead traction so that the sheath remains coaxial and does not go offline (ie, no longer coaxial with lead and resulting in vascular injury). In cases where there is difficulty noted in the SVC area, it is advisable to perform femoral traction with a snare or use a different approach for extraction instead of forcing the sheath. It is important to recognize lead-on-lead binding by distinct fluoroscopic movement of leads with traction on adjacent leads and sometimes by TEE imaging. Switching between different leads with the extraction tool can allow progress in these cases.

The majority of patients are monitored overnight unless the procedure is straightforward, in which case we have discharged patients the same day. In the event that drain(s) are placed, we have also discharged patients after 24-48 hours with a drain and have them follow up with their primary EP for further management in their local city. Infectious disease (ID) consultation is typically done in the hospital and recommendations are directly conveyed to both the referring implanter and local ID physician. Close coordination with the referring physician is necessary to allow seamless care. Many patients who travel from a distance can easily get their device reimplanted locally with their primary EP. We have increasingly adopted the use of leadless pacemakers as a bridge or final device, even in cases of endocarditis.

Outcome Transparency

Any problems occurring during cases are self- reported by physicians to a database and discussed in a peer-reviewed case conference. We also use this system for other EP procedures, and it has been invaluable in identifying and reducing the incidence of major and minor complications. Our outcomes for extraction are comparable to previously published data from multicenter trials.³

The Future

With the increased use of leadless pacemakers, there is a need to be skilled in removing these devices. There are published reports describing tools necessary for removal of leadless pacemakers. The Aveir VR Leadless Pacemaker (Abbott) has a proprietary retrieval tool. Extractors may also be called upon to remove devices such as embolized left atrial appendage occlusion devices and others such as the remedē (ZOLL Medical) and extravascular ICD (EV-ICD [Medtronic]). Extractors should be familiar with the implantation of these systems and anatomical considerations relevant to extraction.

Conclusion

Developing a lead extraction program should be considered only by operators with adequate training, a strong interest, and institutional support. Complications should be rare and can be avoided by ongoing learning, meticulous attention to detail and careful review of adverse events. Centers unable to perform the procedure with an excellent safety record should not continue to offer this service. 

Acknowledgements. We are indebted to Dr Mark Borganelli for starting our extraction program, and we express our sincere gratitude to Drs Jude Clancy and Roger Carrillo for their support and contributions to this field.

Contact the author on Twitter at @sumitvermaep.

Disclosure: Dr Verma has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. He reports that he is a current speaker for Philips, disclosing that payment was received from Philips for one educational lecture. He was previously a proctor for Spectranetics (now part of Philips). He reports a patent licensing agreement with Spectranetics.

References

1. Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm. 2009;6(7):1085-1104. doi:10.1016/j.hrthm.2009.05.020

2. Lin Ay, Saul T, Aldaas OM, et al. Early versus delayed lead extraction in patients with infected cardiovascular implantable electronic devices. JACC Clin Electrophysiol. 2021;7(6):755-763. doi:10.1016/j.jacep.2020.11.003

3. Wazni O, Epstein LM, Carillo RG, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive lead extractions. J Am Coll Cardiol. 2010;55:579-586. doi:10.1016/j.jacc.2009.08.070