The prevalence of cardiac implantable electronic devices (CIED) is continuously increasing, with a high number of such devices present in young adults (1, 2). Along with this development there is a concomitant increase in the incidence of CIED-related complications, such as device-related infections (CDRI) and lead failure (3–7). Multiple pulse generator replacements, device revisions and an increase in device complexity are associated with a higher lifetime risk for CIED-related complications (7, 8). Transvenous lead extraction (TLE) has evolved into an indispensable therapeutic option for such cases. According to the international consensus statements in patients with CDRI a complete lead extraction should be aimed at and abandoned leads should be avoided (9, 10). However, there are no clear recommendations regarding lead extractions for non-infectious indications.

Abandoned leads contribute to a greater number of existing leads, leading to challenges in venous access and potential damage to the tricuspid valve (11–13). Moreover, the presence of abandoned leads worsens the overall clinical outcome of lead extraction procedures, primarily due to their prolonged lead dwell time (14).

Additionally, the young age of patients at the time of their initial implantation, regardless of the duration of the dwell lead time, is correlated with a higher occurrence of increased connective tissue proliferation on the leads and the formation of adhesions between the leads and the cardiac structures (15–17). Consequently, this results in poorer therapeutic TLE outcomes in this particular group of patients (15).

On the other hand, recent extensive registries have demonstrated that performing TLE procedures in experienced centers is a safe and effective approach (6, 13, 18).

The objective of this study was to perform a subgroup analysis of the GermAn Laser Lead Extraction RegistrY (GALLERY) to examine the patient characteristics and procedural outcomes specifically for young patients who undergo TLE. Furthermore, the study aimed to identify independent risk factors associated with adverse events in this particular subgroup.

To the best of our knowledge, this study represents the largest subgroup analysis conducted to date, focusing specifically on the outcome of young patients undergoing lead extraction using laser sheaths. The retrospective analysis from El-Chami et al. (19) included the data of 84 patients under the age of 40 years extracted with LLE, whereas in our subgroup analysis of the multicenter GALLERY-study (6) 160 patient with an age of 45 years or younger were identified.

In the GALLERY a total number of extracted leads was 6,117, of which 5.6% (348/6,117) were implanted in young patients.

The main findings in our analysis are the following: 1.

Lead dysfunction was the main indication for lead extraction in young patients (p < 0.001).

Another finding was that the median procedure time was significantly longer in the young patients, though the mean number of total leads was significantly higher in the older population. Also lead age and the number of abandoned leads was similar in both groups with a higher number of ICD-leads extracted in the young patients (Table 2). An explanation for the longer procedure time could be the higher degree of adhesions and fibrosis described in the young population (17). Segreti et al. (24) studied the major predictors of fibrous adherence in ICD-leads in comparison to PM-leads and found similar time-depended fibrous formation in both lead types, but greater distribution of fibrous tissue along the course of the ICD-leads. Furthermore, they showed that dual-coil technology and passive fixation mechanism are also predictors for adherence. In our study there were no significant difference regarding the presence of dual-coil leads between the groups. The older population had a significantly higher number of passive fixation than the younger one. But the data of fixation mechanism was incomplete so that no clear statement can be made in this regard. Kutarski et al. (15) also described a longer mean extraction time per lead in young adults, which they attributed to the need to use alternative approaches and second line tools in this cohort. There was no significant difference in the utilization of additional tools in our study, however. Furthermore, El Chami et al. (19) described a rate of 10% for the need of femoral access in their young population showing the challenging nature of TLE in this patient.

Based on the data of the studies mentioned above (15, 17, 19, 24), it can be inferred that factors such as fibrous adherence, the use of additional tools, and the need for additional femoral access may contribute to longer procedure times in the young patient population undergoing LLE. While the specific information regarding the amount of femoral access needed is missing in our database, the data from the referenced studies (15, 17, 19, 24) provide some insights into the potential factors influencing procedure duration in this population. These factors can lead to increased complexity and challenges during the extraction procedure, which in turn may contribute to longer procedure times.

Large registry studies such as LExICon, ELECTRa and GALLERY proved the safety and efficacy of LLE. The rates for complications, procedural success, clinical success, procedural-related mortality, and all-cause mortality were similar between the two age groups in our study. While Burger et al. (25) demonstrated the safety and feasibility LLE in the octogenarian population, our analysis indicates that LLE is a feasible and safe procedure also in the young population. In contrast, a subgroup analysis of the PROMET-Study (26), which focused on mechanical lead extraction with MDR sheaths, showed a numerically lower rate of procedural success in younger patients compared to the older population. This was attributed to a higher prevalence of fibrous encapsulation and a higher number of ICDs in the young cohort. Interestingly, in our study, despite the higher prevalence of ICDs in the young population, the rate of procedural success was similar between both age groups. This highlights the feasibility and efficacy of LLE in young patients.

According to the retrospective analysis by Diaz et al. (27), there was an increased mortality associated with the use of laser sheath extraction tools compared to mechanical tools. On the other hand, the recent study by Zsigmond et al. (28), which conducted a head-to-head comparison of laser versus powered mechanical sheaths as first-choice and second-line extraction tools, found no significant difference in major or minor complications between the two approaches. However, the study did observe a significant increase in clinical success rate when mechanical tools were used as a second-line option. In our study the laser sheath was use as a first choice due to its unique properties, specifically its flexibility and ability to adapt to venous anatomy, especially in challenging areas such as the confluence of the brachiocephalic veins into the superior vena cava (SVC). Additionally, the energy level can be adjusted, which is beneficial in cases with complicated adhesions, helping to minimize the risk of vascular tears and other complications.

In terms of procedural-related complications, our results indicated that lead dwell time exceeding 10 years was a significant predictor. This finding aligns with the results of the ELECTRa study, where lead dwell time over 10 years was also associated with a higher risk of procedural complications and failure. Furthermore, in the subgroup analysis of the GALLERY study focusing on patients undergoing TLE for CDRI, Chung et al. (8) similarly found that lead dwell time exceeding 10 years was a predictor for both procedural failure and complications. These findings highlight the importance of considering these risk factors when evaluating the feasibility and potential risks of lead extraction procedures.

In our subgroup analysis, CKD was identified as an independent predictor for all-cause mortality in the young population undergoing TLE. This finding is consistent with previous studies that have shown an increased mortality risk in CKD patients after TLE (6, 8, 13, 18). A meta-analysis conducted by Tan et al. (29) compared the risk of mortality in CKD patients versus control patients after TLE. The results showed a significantly higher all-cause mortality risk in CKD patients compared to the control group. The increased mortality risk was evident both in the short-term (follow-up time ≤1 year) and long-term (follow-up time >1 year). The hazard ratio (HR) for all-cause mortality was approximately 1.99 at follow-up ≤1 year and 2.36 at follow-up >1 year for CKD patients.

Despite the low event rate, our analyses demonstrated that systemic infection is a predictor for all-cause mortality also in the young patients. It is noteworthy that despite the significantly lower prevalence of comorbidities in the young population (Table 1), CDRI can still lead to fatal outcomes. While there are clear recommendations (9, 10) for lead extraction in patients with CDRI, opinions regarding lead extractions for non-infectious indications remain controversial (30–33). The lack of clear recommendations in the young population, where lead fracture is the main indication, is a concern. Certain risk factors, such as lead burden exceeding two leads, generator replacement, and device upgrades, increase the likelihood of CDRI (34), which correlates with higher rates of all-cause in-hospital mortality and procedure-related mortality (8). On the other hand, lead extraction has been associated with lower adjusted 5-year infection rates compared to cap and abandoned leads (35). Furthermore, Elgaard et al. (30) demonstrated in their long-term follow-up study of abandoned ICD leads, that the probability of lead extraction increased to 5.5%, 7.6%, and 15.2% after 2.5, 5, and 10 years of abandonment, respectively. In this content, it is important to highlight that in our study, no procedure-related mortality (0.0%) occurred in the young population and the all-cause mortality (2.5%) was primarily associated with septic shock (1.9%). These results emphasize the safety of LLE in this age group. When combined with the previously mentioned findings, these results offer additional support for advocating the use of lead extraction in the ongoing debate. However, despite the low occurrence of procedural complications, it is crucial to perform a careful and individualized evaluation, considering factors that may pose potential risks. In such cases, risk assessment tools like the ELECTRA Registry Outcome Score (EROS) (36) can be helpful in identifying patients who are at a higher risk of significant procedural complications, aiding in the decision-making process and refer these patients in high volume centers.

TLE in young patients is safe and effective with a procedure-related mortality rate of 0.0%. CKD and systemic infection are predictors for all-cause mortality, whereas lead age ≥ 10 years was identified as independent risk factor for procedural complications in young patients undergoing TLE.

The retrospective nature of our study poses a potential limitation, as it may introduce selection bias and detection bias. Despite efforts to minimize biases using standardized definitions and a predefined case report form, the influence of individual physician decisions and variations in therapeutic approaches cannot be completely eliminated. The lack of data on implantation indication and the use of alternative access methods limits a comprehensive understanding of these factors’ impact on the outcomes. Additionally, low event rates for adverse events in our subgroup may have led to less pronounced differences in inter-group comparisons and may have dimished the impact of certain predictors for regression analyses. Finally, the inclusion of only high-volume referral centers with a specific expertise in TLE may result in a skewed representation of patient characteristics and procedural outcomes, limiting the generalizability of the findings to other settings. It is important to interpret the results with caution and consider the specific context in which the study was conducted.