Studies comparing TLE outcomes for ICD and PM leads are outdated and limited. This research aimed to evaluate the safety, efficacy, and characteristics of TLE in ICDs and PMs while assessing the impact of lead age. 

The cohort included all consecutive patients undergoing TLE for ICD and PM leads in the Cleveland Clinic Prospective TLE Registry from 2013 to 2022. Definitions of extraction success, complications, and failures followed the 2017 Heart Rhythm Society (HRS) guidelines for TLE. 

A total of 885 ICD leads with a median implant duration of 8 years (IQR: 5−11 years) in 810 patients and 1352 PM leads with a median of 7 years (IQR: 3−13 years) in 807 patients were included. Procedural success rates were higher for ICD patients compared to PM patients for leads older than 20 years, but similar for leads ≤20 years. In the PM group, complete success rates decreased significantly with increasing lead age, a trend not observed in the ICD group. ICD TLE required more extraction tools than PM TLE, but older leads in both groups often necessitated non-laser extraction tools. The most common injury sites differed between ICD and PM complications, though major complication rates were not significantly different (2.7% vs. 1.6%, p = .12). 

Procedural success rates for TLE were higher in ICD patients than in PM patients for leads older than 20 years, although more extraction tools were required. Common sites of vascular complications, as well as the influence of lead age on outcomes and required tools, varied between ICD and PM TLE. 

COMMENTARY:

In Spain, the implantation of endovascular cardiac devices remains a cornerstone in treating cardiovascular diseases, reflecting both technological advancements and the needs of an aging population. In 2022, 41,082 conventional pacemakers were implanted, equating to 866 units per million inhabitants. Additionally, 7,693 ICDs were implanted, marking a 2.6% increase from the previous year and the highest figure in historical records. 

Regarding TLE, a critical procedure in cases of infection, malfunction, or device replacement, advances in tools such as laser sheaths have improved success rates and reduced complications. Cleveland Clinic’s previously published experience from 1996 to 2012, which included 5,973 leads extracted from 3,258 patients, identified leads older than five years as a significant risk factor for complications, establishing a reference for endovascular device extraction. 

The current Cleveland Clinic cohort, spanning 2013−2022, provides a comprehensive view of TLE challenges, encompassing 1,617 patients (810 with ICDs and 807 with PMs). Tools employed included simple and locking stylets, telescoping extraction sheaths, mechanical or powered (rotational or laser) sheaths, and additional materials such as mechanical sheaths and endovascular snares. 

ICD TLE required more tools than PM TLE, regardless of lead age. In the PM group, leads ≤5 years old were extracted without advanced tools in nearly two-thirds of cases. However, in both groups, the number of required tools increased with lead age. Fibrotic tissue and calcifications around leads are major barriers, particularly for devices implanted for over 15 years. These phenomena occur in both ICD and PM leads, although ICD leads more frequently exhibit adhesions due to their robust, larger-diameter design. 

Dual-coil leads in ICDs predicted adhesions in the innominate vein and superior vena cava, while passive fixation mechanisms—becoming less common in modern practice—were associated with adhesions in the heart. Larger-diameter leads provide stronger support for extraction tools and can withstand greater traction forces without losing structural integrity. ICD leads, with their larger size and higher conductor count, demonstrate greater tensile strength compared to the more fragile PM leads. 

Partial lead extraction rates were significantly discordant, being 3.5 times higher in the PM group (2.8% in PMs vs. 0.8% in ICDs). This disparity reflects the thinner, less robust design of PM leads. These findings align with data from the 2017 ELECTRa registry, which reported a 1.7% major complication rate across 3,555 patients. 

From a clinical outcomes perspective, procedural success rates were higher in ICD patients (97.3% complete success and 98.1% clinical success) compared to PM patients (93.8% and 96.8%, respectively; p = .001). Among leads older than 20 years, complete success rates were significantly higher for ICDs (p = .005), while no differences were observed for leads ≤20 years old. Multivariate analysis identified lead age, passive fixation, and manufacturer as predictors of incomplete lead removal. 

In terms of complications, major events—defined as requiring emergent surgical or endovascular intervention—did not differ significantly between groups (2.7% in ICDs vs. 1.6% in PMs; p = .12). However, injury locations varied: superior vena cava injuries were most common in ICDs (50%), whereas right atrium injuries were predominant in PMs (33%). 

Preoperative imaging (CT or venography) was not included in this study but could help identify high-risk adhesion sites. At CHUAC, findings presented at the SECCE Congress in June 2024 identified preoperative venographic abnormalities as a risk factor for major complications in TLE using laser sheaths. 

Although major complication rates remain low, these events are severe. To ensure rapid and effective rescue, high-risk lead extractions should be conducted in cardiac surgery operating rooms under general anesthesia with extracorporeal circulation support and skilled surgeons ready to address potential complications. 

In conclusion, while TLE for ICD leads often requires more tools and presents greater technical challenges, success rates generally surpass those for PM leads, especially for devices implanted for over 20 years. These observations underscore the need for specialized protocols and advanced equipment at reference centers to optimize outcomes and minimize risks. 

REFERENCE: 

Hayashi K, Callahan T, Rickard J, et al. Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience. J Cardiovasc Electrophysiol. 2024;35(7):1382-1392. doi:10.1111/jce.16294