CI-452765-3 INFECTION VERSUS NON-INFECTION INDICATION FOR LEAD EXTRACTION IN THE RELEASE COHORT

Abstract

Patients with infected cardiac electronic implantable devices (CIEDs) often undergo transvenous lead extraction (TLE) to achieve infection control. The risk of adverse outcomes in this population is high and not well characterized. We sought to compare population demographics and outcomes between the infection and non-infection lead extraction subgroups of the RELEASE cohort, a prospective registry of patients undergoing TLE using mechanical rotating sheaths. The RELEASE cohort was assembled from 10 sites across the United States and Europe. Population demographics, clinical success, complete lead removal, and device-related major complications were reported over a follow-up period of 4 weeks post-procedure. Patients undergoing TLE with infection versus non-infection indication were compared. 230 patients were included in this analysis. The mean age was 64.3±14.4 years, with 67.4% male, and a mean body-mass index of 29.6±6.7 kg/m2. Patients had LV dysfunction (32.2%, EF<35%), coronary artery disease (52.6%), cardiomyopathy (56.1%), diabetes (29.6%), hypertension (67.4%), and renal failure (28.3%). The mean number of leads extracted was 2.0±0.9 leads, with a mean indwell time of 113.8±75.3 months, with implantable cardioverter-defibrillators accounting for 38.3% of patients (88/230). No deaths occurred at time of extraction. 8 deaths (3.5%) occurred during the follow-up period. Demographics and outcomes are reported in Table 1. Patients with infection indication for TLE were generally older (p=0.025), more often male (p=0.032), had more renal failure (p<0.001), and more leads in situ (mean 2.4±0.9 versus 1.8±0.9 leads, p<0.001). There were similar rates of complete lead removal (p=0.91), but more deaths after TLE for infection indication compared to non-infection indication (9.5% vs. 0.6%, p<0.001). Infection indication was not associated with higher likelihood of complete lead removal. In multivariable analysis, renal failure and infection were associated with death (renal failure: OR 10.4, 95% CI 1.17-91.8, p=0.036; infection: OR 7.73, 95% CI 0.87-68.7, p=0.067). Compared to patients undergoing TLE for non-infection indication, patients with infection had more comorbidities and eight times higher odds of death during follow-up. Both infectious indication and renal failure were independent predictors of death. The high risk of morbidity in this patient population should be considered prior to TLE.Summary of Baseline Demographics and Outcomes between Infection and Non-Infection Indication Subgroups from the RELEASE StudyVariableNon-Infection Indication (n=156)Infection Indication (n=74)p-valueDemographicsAge, mean±SD62.8±14.767.4±13.00.025Male sex62.8%77.0%0.032BMI, mean±SD29.5±6.929.9±6.20.68EF<35%30.8%35.1%0.51Coronary artery disease48.7%60.8%0.086Cardiomyopathy59.6%48.6%0.12Diabetes26.9%35.1%0.20Hypertension67.3%67.6%0.97Renal failure17.3%51.4%<0.001Device InformationNumber of Leads, mean±SD1.8±0.92.4±0.9<0.001Indwell time in months, mean±SD117.8±70.8105.5±83.8<0.001ICD35.9%43.2%0.28Lead Extraction OutcomesSuperior Approach Only84.6%91.9%0.13Complete Lead Removal94.2%94.6%0.91ComplicationsDevice-Related Major Complications4.5%8.1%0.27Vascular Avulsion or Tear0.6%1.4%0.59Cardiac Avulsion or Tear0.6%1.4%0.59Bleeding requiring Treatment0.6%5.4%0.021Death0.6%9.5%<0.001Days to Death, mean±SD1520.4±14.80.74Days to Discharge, mean±SD2.9±10.18.5±10.6<0.001EF=ejection fraction; ICD=implantable cardioverter-defibrillator; SD=standard deviation Open table in a new tab