Review Article

Transvenous Lead Extraction: Work in Progress

Register or Login to View PDF Permissions
Permissions× For commercial reprint enquiries please contact Springer Healthcare: ReprintsWarehouse@springernature.com.

For permissions and non-commercial reprint enquiries, please visit Copyright.com to start a request.

For author reprints, please email rob.barclay@radcliffe-group.com.
Information image

  • Views: 1196

  • Likes: 0

  • Downloads: 78

  • Citations: 2

  • Read time: 18m
Average (ratings)
No ratings
Your rating

Abstract

Cardiac implantable electronic devices are the cornerstone of cardiac rhythm management, with a significant number of implantations annually. A rising prevalence of cardiac implantable electronic devices coupled with widening indications for device removal has fuelled a demand for transvenous lead extraction (TLE). With advancement of tools and techniques, the safety and efficacy profile of TLE has significantly improved since its inception. Despite these advances, TLE continues to carry risk of significant complications, including a superior vena cava injury and mortality. However, innovative approaches to lead extraction, including the use of the jugular and femoral accesses, offers potential for further gains in safety and efficacy. In this review, the indications and risks of TLE are discussed while examining the evolution of this procedure from simple traction to advanced methodologies, which have contributed to a significant improvement in safety and efficacy.

Keywords

Transvenous lead extraction, tandem approach, ICD extraction, jugular pull-through, lead extraction, femoral extraction,

Disclosure:MS has received a research grant from Abbott Medical. MMG has received research funding from Attune Medical, and has acted as a consultant and a paid speaker for Boston Scientific and Cook Medical; and is on the European Cardiology Review editorial board; this did not influence peer review. All other authors have no conflicts of interest to declare.

Received:

Accepted:

Published online:

DOI:https://doi.org/10.15420/ecr.2023.06

Correspondence Details:Zaki Akhtar, St George’s University Hospital, Blackshaw Road, London SW17 0RE, UK. E: Zakiakhtar@nhs.net

Open Access:

This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

Cardiac implantable electronic devices (CIEDs) are central to the management of arrhythmias and to mitigating the risk of arrhythmia. In the UK alone, >40,000 devices are implanted each year.1 The extraction of leads is essential to the long-term management of CIEDs, establishing transvenous lead extraction (TLE) as a life-saving procedure. TLE has undergone an incredible evolution since its inception (Figure 1). Early methodologies relied on traction alone, applied from the original site of venous access; when this failed, cardiac surgery was used to complete the task.2,3

Figure 1: Timeline of Key Tools, Techniques and Studies in Transvenous Lead Extraction

Article image
Download

The traction used to extract leads was initially applied to the lead alone, but later enhanced by the use of locking stylets and by the use of snares to permit traction from femoral or jugular access points.4 For more challenging cases, traction-only methods were soon supplanted by methods combining dissecting sheaths with countertraction. The dissecting sheaths used in this process were initially simple tubes, sometimes used in a telescoping arrangement. The perceived technical difficulty of dissecting with these sheaths provoked the development of powered sheaths, in which radiofrequency or laser energy permits the advancement of the sheath with less physical effort. More recently, rotational sheaths have been used to achieve the same effect.

In parallel with the development of new extraction tools, the professionals performing TLE have developed protocols for maintaining safety during procedures and for preparing operators and institutions to perform TLE. Improved training has expanded the number of competent operators. Despite these advances, the risk of complication remains, including patient death, often due to injury to the superior vena cava (SVC).5 In this review, we aim to describe the principles of transvenous lead extraction, examine the challenges facing operators and evaluate current techniques.

Indications

The indications for TLE have evolved in response to improvements in procedure safety and efficacy. The most consistent indication for extraction is infection.6–8 Bacteria are able to colonise all surfaces of the non-biological material, including crevices, making infection near-impossible to eradicate completely from the surface once established.9 This is partly because colonising bacteria produce a glycocalyx biofilm, which permits the organisms to adhere firmly to the non-biological medium, and resist decolonisation from washout, antibiotics or bacteriophages.9 It is axiomatic that removal of all hardware is necessary to resolve device-related infection.10,11 Without removal, the outcome is generally poor; in a retrospective study of 416 patients with CIED infections, 30-day mortality was sevenfold higher in the group treated with antibiotics alone, while infection has been associated with an elevated risk of 1-year mortality in a cohort of patients, even after TLE.12,13 The guidelines have unsurprisingly mandated hardware removal following an infection, local or systemic.14

The venous system is prone to occlusion following introduction of leads, a process caused by thrombus, fibrosis or both. The prevalence of occlusion ranges between 2% and 22%, possibly higher in those with infection.15 In a small minority of patients, the effects of venous occlusion can be debilitating, necessitating extraction of the leads to facilitate correction of the occlusion.8 Most patients with venous occlusion remain asymptomatic, and no intervention is required as long as the CIED system functions well. If a lead has to be replaced or added to permit continued or enhanced CIED therapy, extraction of one or more leads can provide access for the new lead(s).

The use of TLE in managing malfunctioning or redundant leads requires careful consideration, as extraction is not mandatory; abandonment rather than extraction may be chosen. Current guidance stipulates a risk versus benefit approach on an individual basis for either strategy. As an approach, this is irreproachable, but the published literature does not provide an adequate basis for the calculations required to apply this guidance objectively. The risk of death associated with extraction is lower in the recent literature than previously (1–2%).5,16 The potential for harm from abandoned leads is difficult to quantify, as the risk can stretch over decades. It includes the risk of infection, thrombosis and the higher complication risk associated with deferred TLE (if required).

The dilemma of abandonment versus extraction has not been addressed by any large, randomised trial. A registry study of 6,859 patients comparing the outcomes of abandonment and extraction found that abandoning the leads was associated with a higher risk of infection than TLE, necessitating lead extraction at a later date.17 The complexity of the subsequent procedure is enhanced by the initial deferral. A study of 1,386 patients undergoing TLE for infection compared the outcomes in patients with and without previously abandoned leads. The TLE procedures took longer in patients with abandoned leads, requiring more bail-out approaches, with a higher rate of incomplete success and complications.18 Vegetations were also more prevalent with abandoned leads and, when present, were larger than in patients without any abandoned leads, probably due to the greater surface area created by the extra hardware within the vasculature. The outcome of TLE was poorer in patients with previously abandoned leads, not only in metrics of efficiency but also in 30-day mortality.18

Methods

Traction and Countertraction

The first extraction method applied was direct traction of the targeted lead, which carried risk of cardiovascular injury. There has been significant progression from the use of traction alone to the combined use of traction, and countertraction exerted with a dissecting sheath. Traction alone is still used to remove leads that have been in place for only a short time, usually <2 years. In the PROMET trial, these accounted for approximately 17.8% of the leads extracted.5 Commonly, traction is exerted with the aid of a locking stylet to permit the transmission of force to the lead tip and minimise the risk of lead breakage; in the PROMET study, 24.4% of leads were extracted using this method.

With traction, the lead is transformed into a railroad for the dissecting sheath; countertraction is applied to advance the sheath over this railroad to dissect the lead free. Early dissecting sheaths consisted of polypropylene, Teflon or steel, each with distinct physical properties. Teflon, being soft, allowed the sheath to be flexible, albeit with compromised dissecting ability. The polypropylene sheath was stiffer, useful in dissecting the leads from challenging adhesions, but with a reduced ability to negotiate curves. A steel sheath was used only to dissect dense scars at the entry site to the central vasculature.

In the early years, the femoral approach was regularly used to complete extractions. Devices, such as the Dotter snare and a tip-deflecting wire, were used for targeted leads via a large sheath positioned in the right atrium (RA).2 In combination, these tools permitted grasping of the lead, and traction could be applied inferiorly to complete the extraction.2 These techniques were effective and safe, and provided an alternative to surgical extraction, which was the predominant method in the 1970s and 1980s.3

Although there have been advancements in the equipment used for lead extraction, the balancing of traction and countertraction remains central to all methods in TLE. Achieving equilibrium between the forces is essential – traction that is too forceful can cause avulsion, and forward force on the sheath without equal traction can elicit misguided dissection. Balancing the forces permits the operator to carefully advance the dissecting tool towards the lead tip, progressing steadily while dissecting the lead free of encapsulating tissue without causing injury or lead damage. The lead is withdrawn only when the sheath tip is in a position to provide counterpressure to the myocardium surrounding the lead tip (Figure 2).

Figure 2: Traction and Countertraction

Article image
Download

Laser and Radiofrequency

Heat can be delivered to the sheath tip in the form of either laser or radiofrequency energy. These methods appear to improve the efficacy of extraction compared with simple sheaths. The theoretical advantage is the lower amount of force needed to dissect the lead free. The first powered sheath was the laser tool, which was conceived in the mid-1990s, adapted from percutaneous coronary intervention. Laser technology employs pulsed ultraviolet light with a wavelength of 308 nm at a repetition rate of 40–80 Hz to ‘vaporise’ encapsulating tissue. On a cellular level, this laser energy is absorbed by lipids and proteins, resulting in interruption of vital cellular bonds and causing tissue disintegration.19,20

Early evidence demonstrated laser to be more effective than the historical methods. The PLEXES study, a randomised trial consisting of 301 patients, compared laser lead extraction with the traditional non-laser methodology. The laser sheath achieved a significantly higher rate of complete extraction than the non-laser technique (94% versus 64%; p=0.001) and with a shorter procedure duration (10.1 ± 11.5 versus 12.9 ± 19.2 minutes; p<0.04).20 Laser lead extraction was considered an improvement on the traditional non-laser methods and remains popular.

However, there were significant methodological limitations in this study. PLEXES permitted cross-over, which may have introduced bias, and completing an extraction using polymer sheaths, but initiated with laser, was accepted as a laser lead extraction.20 Also, due to the low mortality rate in TLE (<2%), a randomised trial requires significantly more participants than the 301 patients of the PLEXES trial to unearth statistical significance for an adverse event endpoint.5,16,21 The LExICon study was a large observational study consisting of 1,449 patients and 2,405 targeted leads, evaluating the outcomes of laser lead extraction. It concluded that laser was safe and efficacious, achieving a high complete lead extraction (96.5%), with a major complication rate of 1.4% and mortality of 1.86%, figures that were considered satisfactory at the time.21 LExICon did have important advantages over PLEXES. The large population size permitted valuable statistical interpretation of the dataset, reducing the probability of ‘chance’ influencing outcomes. The retrospective nature of the study could be viewed as a limitation with confounding variables; however, it represented real-world experience. LExICon also better represented the safety and efficacy of laser lead extraction, as operators were more experienced with the technology and past the learning curve; PLEXES was better representative of the learning curve associated with laser-assisted extraction.

Electrosurgical dissecting sheaths apply radiofrequency energy to dissect the leads free from the encapsulating tissue, in a similar manner to cauterisation. The delivery of energy is local, with two poles situated at the distal tip of the extraction sheath; the application of heat is consequently linear between these poles, whereas application of energy by laser is circumferential. In comparison with the conventional dilatation technique, electrosurgical dissecting sheath tools are effective. A randomised trial of 120 patients compared electrosurgical dissecting sheaths with the conventional telescoping sheaths, and found that the powered sheath achieved a higher complete lead extraction (93% versus 73%; p<0.001, respectively).22 The overall complication rate was low in the whole study, leading to the authors concluding that TLE was relatively safe. Radiofrequency sheaths gained only a limited market share and were discontinued, being replaced by the rotational tool.

Rotational Sheath

The other category of powered sheath in current practice is the rotational tool. This motion-powered device features a stainless steel dissecting tip, which rotates with every hand-triggered activation. Like the laser sheath or simple mechanical sheaths, the rotational tool is fed over the lead, and with a balance of forward pressure and counter-traction, it is advanced as it dissects the lead free. The Evolution sheath (Cook Medical), with a unidirectional rotating mechanism, was superseded by the Evolution RL, with bidirectional rotation, as the first-generation device was prone to causing lead wrapping as it rotated in a single direction.23,24

Early experience of the rotational tool found it to be effective and safe, but these studies were small due to the relative novelty of the technique. PROMET is the largest study to date evaluating rotational tool TLE.23,24 This large observational study consisting of 2,205 patients with 3,849 targeted leads found that rotational tools were highly effective, with a complete success rate of 96.5% (clinical success 97%), and safe, with a major complication rate of 1%, including procedural mortality of 0.4%; there were no SVC injuries.5 The most significant finding was the high rate of success in leads of a significant dwell time (106 months; interquartile range 66–145 months), highlighting the strength of the rotational tool in disrupting dense, calcified scar tissue.5 The findings of PROMET were validated by the RELEASE study, a multicentre prospective trial with independent adjudication of complications. In this trial of 230 patients and 460 leads, clinical success (98.7%) and complete success per lead (96.3%) were similar to PROMET, with a major complication rate of 5.3% and procedural mortality of 0%.25

The TightRail (Philips) is a more recent rotational sheath. Although similar in appearance to the Evolution sheath, there are differences in stiffness and in tip design. Small series have revealed an effective and safe tool reaching complete success rates of 95–98%, and with a comparable safety profile to the Evolution sheath.26,27

Femoral and Jugular Extraction

In a small proportion of cases (<5%), lead extraction from the conventional subclavian approach proves unsuccessful.5,16,28 Failure in these cases is likely multifactorial. Lead dwell time is an established variate associated with failure of the conventional approach.28,29 Leads of a prolonged dwell time are encased by mature scar tissue often resistant to dissection, increasing the risk of procedural failure. These leads themselves are also of an older age, with sustained exposure to the shear forces within the vasculature. This can reduce their durability, provoking lead fracture during TLE; without a firm rail, the extraction sheath is ineffectual. The superior access also presents geometric challenges.30 There are significant angulations to navigate for dissecting tools during TLE from the subclavian access, which can reduce the tool efficacy. Severe angulations can also generate stresses on the lead, potentially compromising lead integrity and role as a rail for the dissecting sheaths.

Femoral access provides a versatile approach for the completion of percutaneous cardiac procedures and has traditionally been used as a ‘bail-out’ strategy during TLE.31 It offers important advantages over the subclavian approach (implantation vein). The femoral vein provides large, linear, direct access to the heart via the inferior vena cava and, therefore, has been used to overcome the challenging angulations associated with the subclavian access.32 The large bore access permits the use of sizable snares safely, and the direct pathway to the heart chambers provides a geometric advantage during application of extraction forces. In a small observational study, the use of femoral snare lead extraction was found to be a successful bail-out strategy; the overall rate of clinical success and complete lead extraction was improved with the addition of femoral snare extraction after the subclavian approach had failed; without this strategy, the procedural success would have been lower than contemporary expectations.31 In this study, the benefit of the inferior approach is highlighted by the removal of inaccessible leads, which were sited completely in the vasculature and challenging leads of a prolonged dwell time with passive fixation.

The importance of the inferior approach was validated by a large observational study comprising 1,080 patients. El-Chami et al. demonstrated that the inferior approach was required in a small percentage of cases, which comprised challenging cases: leads of a prolonged dwell time, numerous targeted leads and infection indication. Despite the challenges, the bail-out strategy was safe and effective in experienced hands.28

The advantages of the inferior approach can be maximised as a primary extraction strategy. Bracke et al. reported in their experience of 229 cases that femoral extraction with the use of the Needle’s Eye Snare (NES; Cook Medical) was effective and safe; 98.2% clinical success was achieved, with 0.7% major complications and 0% procedural mortality. This was safe and effective due to the linear path to the heart via the inferior vena cava, which provided a geometric advantage to extracting atrial and coronary sinus leads while reducing the risk of SVC injury. This is demonstrated by the <1% failure of atrial and coronary sinus lead extraction compared with 2.7% of right ventricle (RV) leads; RV lead removal requires the sheath to adopt an acute angulation as it enters the ventricle.33 This technique requires extensive experience to achieve a high efficacy and safety, shock leads are more challenging due to their size, and the application of force to free the lead from scar may result in lead damage, risking procedural failure.33

The jugular approach has advantages over the femoral: a linear path to the heart over a short distance. This enables the use of dissecting sheaths to complete the extraction, which is not possible with the inferior approach.34 Also, the jugular approach permits straightening of the targeted lead, which provides a straight rail for the extraction tool. This maintains the linear shape of the sheath, maximising its dissecting ability. Bongiorni et al. devised a unique technique to capitalise on the advantages of the jugular approach, the internal transjugular approach. This technique requires a multi-access approach (subclavian, jugular, femoral) to ‘pull down’ the targeted lead into the RA, rendering it free floating, and then ‘pull up’ out of the jugular to railroad a telescoping sheath for the extraction. In 213 targeted leads, the technique was highly effective, reaching a complete success rate (96.2%), comparable with powered sheath extraction, with a <1% major complication and mortality rate.35 Unlike the femoral snare extraction, the jugular technique is just as effective with large shock leads as with smaller pacing leads, and minimises the requirement to dissect in the SVC, as the lead is pulled through rather than dissected from some of the adhesions there, reducing the risk of SVC injury.35

Although highly effective and safe, the transjugular approach technique has limitations: as the targeted lead is pulled into the RA to render it ‘free-floating’, a locking stylet cannot be deployed, as it risks injuring the vasculature. Consequently, a powered sheath cannot be used in the usual manner. The lead has to ‘slide’ through the encapsulating adhesions for it to become ‘free-floating’, which may not always be possible; leads of a long dwell time may be bound by calcified encapsulation that requires powered sheath dissection. A novel technique has been described to overcome these limitations – transfer of a lead with a fully deployed locking stylet from a subclavian to jugular access point.34

Figure 3: The Jugular Pull-through Technique by Akhtar and Gallagher

Article image
Download

The Akhtar and Gallagher jugular pull-through technique has been demonstrated to be a feasible means of performing this transfer for completion of a challenging case (Figure 3).36 With this technique, the extraction can be started as normal, with the deployment of a locking stylet and advancement of a powered sheath. When needed, the unit can be transferred safely and reasonably quickly to the jugular for the powered sheath to exploit the linear direct path towards the lead tip. This technique uses a long sheath to act as a ‘tunnel’ for the metalware between the subclavian and jugular access points. Through this, the deployed locking stylet and lead unit can be transferred without exposure to the vasculature. The limitation of this method is that it requires two operators experienced in extraction. It may also add time to the procedure, which can be offset by jugular preparation from the beginning and switching to this approach early in the procedure.36

Figure 4: The Applied Forces in Modern Transvenous Lead Extraction Demonstration of the Direction of Applied Forces During Transvenous Lead Extraction

Article image
Download

‘Tandem’ Approach

The control of extraction forces is crucial to a successful TLE, whichever equipment or route of access is used. The ‘tandem’ technique uses combined superior and inferior approaches to balance the applied forces (Figure 4).37,38 The targeted lead is held taut by the NES (advanced via the femoral access) in the RA, providing countertraction to the traction applied from the superior approach. The enhancement and balancing of forces on the targeted lead by the combined ‘superior–inferior’ approach provides the strongest rail for the dissection tool.39 This allows the sheath to safely navigate angulations of the vasculature, especially at the innominate-SVC junction.38,40 The use of the NES to grasp the lead also transfers the traction force applied superiorly from the heart to the snare, reducing the risk of myocardial invagination injury as the dissecting sheath advances.

The tandem technique is effective and safe. In a retrospective series of 131 patients (267 leads), complete lead success was achieved in 96.2% of patients, with a major complication rate of 3.8% and 0% mortality; there was no SVC injury.37 The technique is particularly advantageous for leads of a prolonged dwell time. In a series of 40 cases (75 leads) with an average lead dwell time of 150 months, clinical and complete success was achieved in 98 and 92% of cases and leads, respectively.38 Lead age is a determining variate of procedural success.16,29 Encapsulating tissue around the leads over time can become dense and calcified, resisting dissection and, therefore, increasing the probability of procedural failure.29,41 The tandem procedure could help powered sheaths to overcome these challenges by providing a sturdy rail for the tool to track, thereby focusing the dissecting energy over the lead as it advances. The balancing of the superior and inferior forces also pulls the lead away from the lateral wall of the SVC, improving the geometric relationship between the dissecting sheath and the vessel, thereby reducing the risk of SVC injury.37,42

The application of the technique is limited in its anatomic scope; once the sheath reaches the right atrium, the lead is released from the NES to permit advancement of the sheath towards the lead tip. Injury to the tricuspid valve or the RV can occur from this point onwards. Muhlestein et al. reported three pericardial effusions occurring in their large series, most likely from RV injury.37 A combined approach of the tandem with the jugular pull-through has been used effectively in a small number of cases to overcome the final angulation existing between the RA and RV. Transfer to the jugular effectively straightens this angle, particularly for leads implanted at the RV apex.34,36

Other Tools

The forces applied to the lead permit it to act as a rail for the safe advancement of dissecting sheaths. Locking stylets provide control and stability of the targeted lead, permitting the operator to regulate the degree of traction being applied and, therefore, direct the countertraction by the extraction sheaths.

The two main stylets in current use are the Liberator (Cook Medical) and the Lead Locking Device (Philips), which ‘lock’ within the lumen, allowing a grip over the lead. The locking mechanism of the Liberator is targeted to the distal tip of the lead while the Lead Locking Device is designed to lock at multiple sites along the lead.43 With the stylet locked in place, more traction can be applied to the lead, providing a firm rail.39 Therefore, it is imperative that the stylet occupies the full length of the lead lumen, allowing traction to be transferred as far as the lead tip. This increases the resistance of the lead to the extraction forces, ensuring that the binding tissue gives way before the lead does.44 If the traction forces were to be applied directly to the lead, without a locking stylet, the lead components would fail at a lower load.39

An ex vivo simulation study demonstrated the effects of load bearing on pacemaker leads with and without locking stylets. Without a locking stylet, the tensile strength of the lead is based on the insulation material and its elasticity; with increasing extraction forces, the lead deforms and fails. With a locking stylet, the initial traction load is carried by the locking stylet, and when this fails, the lead bears the load. The combination of a locking stylet and lead increases the resistance to the extraction forces in comparison with the lead alone.44

The structure of the lumenless lead varies significantly compared with the stylet-driven leads; there is a core conductor in place of the lumen, which is wrapped by insulation and an outer conductor. As the lumen in a standard 7 Fr pacing lead composes almost half the diameter, the lumenless lead is considerably smaller.45 During TLE, the core cable of the lumenless lead can mimic the role of a locking stylet with the advantage that it spans the entire lead body, remaining attached to the distal screw and proximal connector. An ex vivo bench test study found that this engagement fortified the rail for a dissecting sheath, although the rail strength remained comparatively lower than a locking stylet. Mechanically, similar to the locking stylet, the inner core of the lumenless lead bears the extraction forces exerted on the lead in the beginning. Upon failure of this component, the lead stretches, relying on the tensile strength of the insulation and remaining conductor to provide a rail for the dissecting sheath.45

To further support lead integrity and thereby the rail, the lead can be reinforced by compressing all its components closely together. Currently, there are two methods for this: the use of a ligation suture with durable material or the application of the OneTie compression coil (Cook Medical), which wraps around the lead, ‘compressing’ all the lead apparatuses together. Ex vivo simulation studies have demonstrated that lead failure occurs in stages when exposed to extraction forces; each component has its own failure limit.39 By binding these components closely together, the tensile strength of the lead is theoretically improved. The degree of benefit lead compression provides is yet to be fully determined.

A bench-test study evaluating the effects of traction on lead integrity with a locking stylet and compression coil found that the compression coil provided minimal additional resistance to lead failure; the benefit was provided by the locking stylet. However, the authors did not evaluate the tensile strength of the lead with only the compression coil deployed. Importantly, the authors highlighted that there was retraction of the locking stylet with traction, which was significantly stabilised by the application of a compression coil.44 Consequently, the authors concluded that the binding of the lead components together using a compression lead provided better control of the lead with a fully deployed locking stylet, maximising the benefits of the stylet.

The bulldog lead extender (Cook Medical) is a simple, yet effective, tool; it is a metal wire with an end loop through which a lead can be threaded. Designed to grasp leads that are unable to accommodate a locking stylet, it is used to apply traction on the lead during extraction. In the event of lead disruption, the bulldog can be deployed to ‘extend’ the lead, provided it is externalised enough to be grasped. An extraction sheath can subsequently be advanced over this to dissect the lead free.46

The laser and rotational tools are complemented by outer sheaths: the VisiSheath (Philips) and the SteadySheath (Cook Medical). These provide crucial support to the powered sheaths, enhancing their dissecting capabilities and stabilising the tool when meeting resistance from highly calcified adhesions. Used in a piston action, the larger outer sheath can also dissect; it is able to engulf a lead with a broadening diameter from material snowploughing by the powered tool. The outer sheath can also be used to preserve access for new implants and for advanced extraction techniques.

Classification of Complications

Article image
Download

Complications

Invasive procedures carry a complication risk irrespective of the degree of complexity involved.47 The complications associated with TLE are classified within a minor or major category (Table 1). Any complication considered life-threatening, causing a disability or requiring a significant intervention is classified as major, while a minor complication is an undesired event that may require a minor intervention and does not lead to disability or death.6

Despite the complexity of the procedure, large series have reported a major complication rate of 1–1.7% in TLE, while procedural mortality has been found to be between 0.18 and 0.5%.5,16 This is comparable with other cardiological procedures, including percutaneous coronary intervention.48 Injury to the SVC is probably the most significant complication, which can quickly lead to death without surgical intervention. Even with intervention, mortality remains close to 50%.49 SVC injury most commonly occurs in the main SVC body – the portion that a dissecting sheath is directed towards as it enters the SVC from the innominate vein.50 This site is commonly extrapericardial and will lead to a right haemothorax with exsanguination of blood at a rate of ~500 ml/min;51 detection of the injury may not occur until haemodynamic shock develops. Conversely, myocardial injury is intrapericardial and leads to a pericardial tamponade. There is an almost immediate haemodynamic compromise, resulting in a much earlier revelation of the injury.50

Figure 5: Cadaveric Image Demonstrating the Binding Tissue Around Leads

Article image
Download

An underestimated complication of TLE is the injury to the tricuspid valve (TV). This risk of TV injury begins with the lead implant in the RV. There is risk of valve perforation, impingement, laceration, entanglement or damage to the chordal structures. With time, the lead can also become tethered to the valve apparatus (Figure 5), compounding the risk of TV injury during the TLE. It has been suggested that RV leads implanted in the apical position are most likely to become tethered to the posterior valve leaflet, while leads situated between the septal-posterior leaflets are associated with significant tricuspid regurgitation (TR).52 The presence of significant TR is associated with adverse outcomes. A systematic review of 70 studies found that severe TR was an independent variate associated with an increased all-cause mortality risk.53 Data on the prevalence of TV injury post-TLE are limited, probably because the awareness of this complication has risen recently. A large observational study of 2,631 patients analysed the effect of TLE on TR. The authors found that TLE resulted in worsening TR in 9.69% of cases, while only 2.54% were classified as severe; 90.31% of cases did not experience any deterioration of TR, indicating no significant injury.54 Unsurprisingly, lead dwell time and the presence of firm connective tissue binding the lead to the valve apparatus were associated with development of severe TR; both variates increase the complexity of the procedure and commonly require large, powered sheaths to free the leads from the TV, which invariably increase the risk of injury.54

Acute Management of Complications

In the event of a major cardiovascular injury, stabilising the patient in preparation for emergency surgical repair is critical, and there are two methods for this. An endovascular occlusion balloon has been demonstrated to be an effective bridging strategy. The balloon is inflated in the SVC to occlude venous flow, buying precious time for the cardiac surgeons to locate and repair the injury.

An observational study of 116 patients with SVC injury during TLE evaluated the outcomes of occlusion balloon deployment against not using one. The authors found that in the balloon group, 88.2% survived, while among patients in whom the balloon was not used, 56.9% remained alive; occlusion balloon deployment reduced the odds of in-hospital mortality (odds ratio 0.13; 95% CI [0.04–0.40]; p<0.001).55 The benefit of the occlusion balloon is, however, limited to an extrapericardial injury of the SVC. The uncontrollable bleeding into the third space (hemithorax) could be halted through occlusion of the vessel using the balloon; without the occlusion, haemorrhagic shock is inevitable. The balloon is rendered ineffective for myocardial injuries, as the bleeding is contained within the pericardial space leading to a pericardial tamponade; this complication requires an immediate pericardiocentesis to bridge towards emergency surgery.

Percutaneous cardiopulmonary bypass is an alternative approach to achieving stability in patients with SVC laceration.50,56 A femoral-femoral bypass circuit can be achieved quickly, within minutes of a SVC injury – provided that femoral access has already been secured from the procedure onset; modern TLE procedures use the femoral vein routinely in a multi-access approach.34,37,38 There are other advantages of this approach. The bypass system can be used to maintain volume to reduce ischaemic injury to the vital organs, including the brain and kidneys. Having CPB established before initiating emergency surgery may be advantageous to the surgeon for performing repair in a controlled manner; off-pump surgical repairs are rarely performed in an emergency.50 Percutaneous CPB is particularly useful in patients with prior sternotomies in whom surgical access can be time-consuming owing to adhesions; the majority of SVC injuries can be repaired via a right-sided anterior thoracotomy in the second intercostal space, especially if there is a right haemothorax.50

Longer-term Outcome

Patient survival is the central objective of all procedures. Although procedural mortality is the metric by which extraction outcome is usually judged, 30-day mortality is a more important marker, as many deaths occur in this period. This endpoint includes procedure-related death, but more often highlights mortality related to the complex patient cohort. Thirty-day mortality is low in TLE, ranging between 1% and 3.4%, in the context of infection indication, which accounts for ~50% of patients.5,13,16,57,58

Infection is the most consistent variate identified for carrying 30-day mortality risk. Electra, the largest TLE study to date (n=3,555), reported that sepsis was associated with an almost fivefold increase in the odds of all-cause mortality (OR 4.93; 95% CI [2.72–8.93]; p<0.0001).16 This was echoed by PROMET, the second largest TLE study to date (n=2,205), while Brunner et al. identified infection as a predictor of 30-day mortality in their predictive model.58,59 This risk is significant enough to extend to >1 year after the TLE, but can be reduced with the appropriate management.13,60 Deharo et al., in their study of 197 CIED infection cases matched with 197 non-infection cases, found that TLE combined with the appropriate postprocedural care reduced the longer-term mortality risk associated with infection to match patients with non-infectious indications.60

Age is another variate affecting 30-day mortality. A nomogram created from a large study of 2,999 consecutive TLE procedures found age as a significant variate associated with 30-day mortality. This was validated by a PROMET substudy of 2,205 patients (3,849 leads) using propensity score matching, which found that age (≥80 years) was associated with 30-day mortality, but did not predict procedural outcome.29 It has been accepted that TLE as a procedure is safe across all age groups, despite the higher number of significant comorbidities in the older patient cohort.61 However, the postprocedural period may be more significant for the older cohort, as recovery can be affected by frailty; frailty is more prevalent with advancing age and is a recognised risk factor of postprocedural adverse outcomes.62

Conclusion

Transvenous lead extraction has evolved significantly over a short period of time. It is a life-saving procedure with an excellent safety profile. This is partly related to the development of powered sheaths, which have permitted the disruption of complex scar tissue around the leads, as well as the innovation in techniques. Despite this, the concept of traction and countertraction has remained central to all TLE methods; however, the expanded usage of the femoral and jugular approaches has provided an extra dimension with geometric advantages. Although there has been significant progress in TLE, further work is required, particularly in the pre- and postprocedural management; this is increasingly relevant with an ageing population living with complex medical needs.

References

  1. National Institute for Cardiovascular Outcomes Research (NICOR). National audit of cardiac rhythm management. 2021 summary report. (accessed 20 January 2023).
    Crossref
  2. Byrd CL, Schwartz SJ, Hedin N. Intravascular techniques for extraction of permanent pacemaker leads. J Thorac Cardiovasc Surg 1991;101:989–97.
    Crossref | PubMed
  3. Byrd CL, Schwartz SJ, Sivina M, et al. Technique for the surgical extraction of permanent pacing leads and electrodes. J Thorac Cardiovasc Surg 1985;89:142–4.
    Crossref | PubMed
  4. Byrd CL, Schwartz SJ, Hedin NB, et al. Intravascular lead extraction using locking stylets and sheaths. Pacing Clin Electrophysiol 1990;13:1871–5.
    Crossref | PubMed
  5. Starck CT, Gonzalez E, Al-Razzo O, et al. Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques. Europace 2020;7:1103–10.
    Crossref | PubMed
  6. Bongiorni MG, Burri H, Deharo JC, et al. 2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS. Europace 2018;20:1217.
    Crossref | PubMed
  7. Love CJ, Wilkoff BL, Byrd CL, et al. Recommendations for extraction of chronically implanted transvenous pacing and defibrillator leads: indications, facilities, training. Pacing Clin Electrophysiol 2000;23:544–51.
    Crossref | PubMed52.
  8. Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm 2017;14:e503–51.
    Crossref | PubMed
  9. Marrie TJ, Nelligan J, Costerton JW. A scanning and transmission electron microscopic study of an infected endocardial pacemaker lead. Circulation 1982;66:1339–41.
    Crossref | PubMed
  10. Morgan G, Ginks W, Siddons H, Leatham A. Septicemia in patients with an endocardial pacemaker. Am J Cardiol 1979;44:221–4.
    Crossref | PubMed
  11. Firor WB, Lopez JF, Nanson EM, Mori M. Clinical management of the infected pacemaker. Ann Thorac Surg 1968;6:431–6.
    Crossref | PubMed
  12. Le KY, Sohail MR, Friedman PA, et al. Impact of timing of device removal on mortality in patients with cardiovascular implantable electronic device infections. Heart Rhythm 2011;8:1678–85.
    Crossref | PubMed
  13. Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol 2012;5:252–7.
    Crossref | PubMed
  14. Blomström-Lundqvist C, Traykov V, Erba PA, et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections – endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Europace 2020;22:515–49.
    Crossref | PubMed
  15. Bracke F, Meijer A, Van Gelder B. Venous occlusion of the access vein in patients referred for lead extraction: influence of patient and lead characteristics. Pacing Clin Electrophysiol 2003;26:1649–52.
    Crossref | PubMed
  16. Bongiorni MG, Kennergren C, Butter C, et al. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) registry of transvenous lead extraction outcomes. Eur Heart J 2017;38:2995–3005.
    Crossref | PubMed
  17. Pokorney SD, Mi X, Lewis RK, et al. Outcomes associated with extraction versus capping and abandoning pacing and defibrillator leads. Circulation 2017;136:1387–95.
    Crossref | PubMed
  18. Hussein AA, Tarakji KG, Martin DO, et al. Cardiac implantable electronic device infections. JACC Clin Electrophysiol 2017;3:1–9.
    Crossref | PubMed
  19. Kennergren C, Bucknall CA, Butter C, et al. Laser-assisted lead extraction: the European experience. Europace 2007;9:651–6.
    Crossref | PubMed
  20. Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results of the Pacing Lead Extraction with the EXcimer Sheath (PLEXES) trial J Am Coll Cardiol 1999;33:1671–6.
    Crossref | PubMed
  21. Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol 2010;55:579–86.
    Crossref | PubMed
  22. Neuzil P, Taborsky M, Rezek Z, et al. Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial. Europace 2007;9:98–104.
    Crossref | PubMed
  23. Hussein AA, Wilkoff BL, Martin DO, et al. Initial experience with the Evolution mechanical dilator sheath for lead extraction: safety and efficacy. Heart Rhythm 2010;7:870–3.
    Crossref | PubMed
  24. Mazzone P, Migliore F, Bertaglia E, et al. Safety and efficacy of the new bidirectional rotational Evolution® mechanical lead extraction sheath: results from a multicentre Italian registry. Europace 2018;20:829–34.
    Crossref | PubMed
  25. Sharma S, Lee BK, Garg A, et al. Performance and outcomes of transvenous rotational lead extraction: results from a prospective, monitored, international clinical study. Heart Rhythm 2021;2:113–21.
    Crossref | PubMed
  26. Mazzone P, Melillo F, Radinovic A, et al. Use of the new rotating dilator sheath TightRail™ for lead extraction: a bicentric experience. J Arrhythm 2020;36:343–50.
    Crossref | PubMed
  27. Aytemir K, Yorgun H, Canpolat U, et al. Initial experience with the TightRail™ rotating mechanical dilator sheath for transvenous lead extraction. Europace 2016;18:1043–8.
    Crossref | PubMed
  28. El-Chami MF, Merchant FM, Waheed A, et al. Predictors and outcomes of lead extraction requiring a bailout femoral approach: data from 2 high-volume centers. Heart Rhythm 2017;14:548–52.
    Crossref | PubMed
  29. Akhtar Z, Elbatran AI, Starck CT, et al. Transvenous lead extraction: the influence of age on patient outcomes in the PROMET study cohort. Pacing Clin Electrophysiol 2021;44:1540–8.
    Crossref | PubMed
  30. Morita J, Yamaji K, Nagashima M, et al. Predictors of lead break during transvenous lead extraction. J Arrhythm 2021;37:645–52.
    Crossref | PubMed
  31. Starck CT, Caliskan E, Klein H, et al. Impact of a femoral snare approach as a bailout procedure on success rates in lead extractions. Interact Cardiovasc Thorac Surg 2014;18:551–5.
    Crossref | PubMed
  32. Akhtar Z, Sohal M, Kontogiannis C, et al. Anatomical variations in coronary venous drainage: challenges and solutions in delivering cardiac resynchronization therapy. J Cardiovasc Electrophysiol 2022;33:1262–71.
    Crossref | PubMed
  33. Bracke FA, Dekker L, van Gelder BM. The Needle’s Eye Snare as a primary tool for pacing lead extraction. Europace 2013;15:1007–12.
    Crossref | PubMed
  34. Akhtar Z, Zaman KU, Leung LW, et al. Triple access transvenous lead extraction: pull-through of a lead from subclavian to jugular access to facilitate extraction. Pacing Clin Electrophysiol 2022;45:1295–8.
    Crossref | PubMed
  35. Bongiorni MG, Soldati E, Zucchelli G, et al. Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: high success rate and safety in more than 2000 leads. Eur Heart J 2008;29:2886–93.
    Crossref | PubMed
  36. Akhtar Z, Gallagher MM. Transvenous lead extraction: the subclavian-to-jugular pull-through technique. HeartRhythm Case Rep 2023;9:160–4.
    Crossref | PubMed
  37. Muhlestein JB, Dranow E, Chaney J, et al. Successful avoidance of superior vena cava injury during transvenous lead extraction using a tandem femoral-superior approach. Heart Rhythm 2022;19:1104–8.
    Crossref | PubMed
  38. Akhtar Z, Zuberi Z, Leung L, et al. Transvenous lead extraction: the Tandem approach. Europace 2022;24(Suppl 1):i781.
    Crossref
  39. Vatterott P, De Kock A, Hammill EF, Lewis R. Strategies to increase the INGEVITY lead strength during lead extraction procedures based on laboratory bench testing. Pacing Clin Electrophysiol 2021;44:1320–30.
    Crossref | PubMed
  40. Akhtar Z, Sohal M, Starck CT, et al. Persistent left superior vena cava transvenous lead extraction: a European experience. J Cardiovasc Electrophysiol 2022;33:102–8.
    Crossref | PubMed
  41. Stokes K, Anderson J, McVenes R, McClay C. The encapsulation of polyurethane-insulated transvenous cardiac pacemaker leads. Cardiovasc Pathol 1995;4:163–71.
    Crossref | PubMed
  42. Schaller RD, Sadek MM, Cooper JM. Simultaneous lead traction from above and below: a novel technique to reduce the risk of superior vena cava injury during transvenous lead extraction. Heart Rhythm 2018;15:1655–63.
    Crossref | PubMed
  43. Epstein LM, Maytin M. Strategies for transvenous lead extraction procedures. J Innov Card Rhythm Manag 2017;8:2702–16.
    Crossref | PubMed
  44. Starck CT, Stepuk A, Holubec T, et al. Compression coil provides increased lead control in extraction procedures. Europace 2015;17:499–503.
    Crossref | PubMed
  45. Vatterott PJ, Mondesert B, Marshall M, et al. Mechanics of lumenless pacing lead strength during extraction procedures based on laboratory bench testing. Heart Rhythm 2023;20:902–9.
    Crossref | PubMed
  46. Astarcıoğlu MA, Şen T, Durmuş Hİ, et al. Extraction of a proximal portion of a fractured lead using a bulldog lead extender in a patient with recurrent septicaemia following incomplete removal of pacemaker leads. Koşuyolu Heart J 2016;19:132–4.
    Crossref
  47. Akhtar Z, Leung LWM, Chen Z, et al. ‘Close’ cardiac monitoring: life-threatening complication of a loop recorder implant. Europace 2021;23:1492.
    Crossref | PubMed
  48. Riley RF, Sapontis J, Kirtane AJ, et al. Prevalence, predictors, and health status implications of periprocedural complications during coronary chronic total occlusion angioplasty. EuroIntervention 2018;14:e1199–206.
    Crossref | PubMed
  49. Hauser RG, Katsiyiannis WT, Gornick CC, et al. Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction. Europace 2010;12:395–401.
    Crossref | PubMed
  50. Arora Y, D’Angelo L, Azarrafiy R, et al. Location of superior vena cava tears in transvenous lead extraction. Ann Thorac Surg 2022;113:1165–71.
    Crossref | PubMed
  51. Clancy JF, Carrillo RG, Sotak R, et al. Percutaneous occlusion balloon as a bridge to surgery in a swine model of superior vena cava perforation. Heart Rhythm 2016;13:2215–20.
    Crossref | PubMed
  52. Chang JD, Manning WJ, Ebrille E, Zimetbaum PJ. Tricuspid valve dysfunction following pacemaker or cardioverter-defibrillator implantation. J Am Coll Cardiol 2017;69:2331–41.
    Crossref | PubMed
  53. Wang N, Fulcher J, Abeysuriya N, et al. Tricuspid regurgitation is associated with increased mortality independent of pulmonary pressures and right heart failure: a systematic review and meta-analysis. Eur Heart J 2019;40:476–84.
    Crossref | PubMed
  54. Polewczyk A, Jacheć W, Nowosielecka D, et al. Tricuspid valve damage related to transvenous lead extraction. Int J Environ Res Public Health 2022;19:12279.
    Crossref | PubMed
  55. Azarrafiy R, Tsang DC, Wilkoff BL, Carrillo RG. Endovascular occlusion balloon for treatment of superior vena cava tears during transvenous lead extraction: a multiyear analysis and an update to best practice protocol. Circ Arrhythm Electrophysiol 2019;12:e007266.
    Crossref | PubMed
  56. Gallagher MM, Akhtar Z, Starck CT. Preventing fatal injury to the superior vena cava. Ann Thorac Surg 2022;114:1523–4.
    Crossref | PubMed
  57. Deckx S, Marynissen T, Rega F, et al. Predictors of 30-day and 1-year mortality after transvenous lead extraction: a single-centre experience. Europace 2014;16:1218–25.
    Crossref | PubMed
  58. Brunner MP, Yu C, Hussein AA, et al. Nomogram for predicting 30-day all-cause mortality after transvenous pacemaker and defibrillator lead extraction. Heart Rhythm 2015;12:2381–6.
    Crossref | PubMed
  59. Akhtar Z, Gallagher MM, Elbatran AI, et al. Patient related outcomes of mechanical lead extraction techniques (PROMET) study: a comparison of two professions. Pacing Clin Electrophysiol 2022;45:658–65.
    Crossref | PubMed
  60. Deharo JC, Quatre A, Mancini J, et al. Long-term outcomes following infection of cardiac implantable electronic devices: a prospective matched cohort study. Heart 2012;98:724–31.
    Crossref | PubMed
  61. Pelargonio G, Narducci ML, Russo E, et al. Safety and effectiveness of transvenous lead extraction in octogenarians. J Cardiovasc Electrophysiol 2012;23:1103–8.
    Crossref | PubMed
  62. Lin HS, Watts JN, Peel NM, Hubbard RE. Frailty and post-operative outcomes in older surgical patients: a systematic review. BMC Geriatr 2016;16:157.
    Crossref | PubMed
Previous Volume Article Next Volume Article