Introduction: Transvenous Lead Extraction (TLE) is considered the first-line strategy for managing complications associated with cardiovascular implantable electronic device (CIEDs) leads, such as lead infection and lead fracture. This study aims to understand more about the safety, feasibility, and outcomes of TLE procedures in analgo-sedation without anesthesiologic or cardiosurgical support at the university hospital of the Technical University of Munich (Klinikum rechts der Isar). 

Methods: In this retrospective observational study, patient-, device-, lead-, procedure-, and outcome-related information of 50 TLE procedures, from June 2017 to February 2022 at the Klinikum rechts der Isar were analysed. TLE was performed via mechanical extraction in analgo-sedation and without cardiosurgical support. All Patients were followed for 90 days.

Results: TLE was successful in 50 out of 50 procedures. No patient suffered major procedure-related complications or procedure-related death. 5 patients had a therapy-requiring pocket hematoma on the surgical site (minor procedure-related complication). In one of these patients, blood transfusion was administered due to a significant haemoglobin-drop. Overall, in-hospital survival was 96% and no further deaths occurred within 30 days after the TLE procedure. The survival rate after 90 days was 94%. None of the patients with minor procedure-related complications died within 90 days after TLE. Lead dwell time was associated with more complex extractions requiring mechanical extraction devices. Patients with less complex extraction procedures had a dwell time of 1.75 ± 2.42 years, and patients with complex extraction procedures had a dwell time of 6.79 ± 4.30 years (p < 0.001). Patients with complex extractions did not have a higher mortality rate or longer hospital stays compared to patients with simple extractions. Overall, median hospital stay duration was 12.1 ± 13.3 days. Patients with systemic infections required significantly longer hospitalizations (20.2 ± 18.9 days). Patients with local infections had an average hospital stay of 14.1 ± 10.2 days, while patients with a non-infectious indication for TLE had an average hospital stay of 5.4 ± 3.9 days (p = 0.002). A majority of patients had multiple risk factors for encountering major TLE-complications. When applying the DGK risk stratification score of 2022 to our study population, 4.0% of patients were included in risk group A, 20.0% in risk group B, 40.0% in risk group C, and 36% in risk group D, as shown in the graph. 

Discussion: TLE performed by a team of experienced cardiologists without the local support of cardiac surgeons was shown to be a safe procedure in a study population including high-risk patients. Procedure-related factors such as complex extractions and minor procedure-related complications were not associated with higher mortality rates or hospital stay prolongations. Infectious indications were risk factors for a prolonged hospital stay. Long-term 90-day-survival rates proved further procedure safety.

Conclusion: TLE in analgo-sedation and without anesthesiologic or cardiosurgical support in a population with a high number of risk factors for major complications has shown to be a safe and feasible procedure in an experienced center for lead extractions. No major procedure-related complications occurred and no surgical or anesthesiologic intervention was required.