John de Heide

Combined superior and femoral TLE 113 procedure was considered a failure if complete procedural success or clinical success could not be achieved, or if any permanently disabling complication or procedure-related death occurred. A major complication was defined as any outcome related to the procedure which is life-threatening or results in death. In addition, any unexpected event that causes persistent or significant disability, or any event that requires significant surgical intervention to prevent any of the outcomes listed above is regarded as a major complication. Minor complications are defined as any undesired event related to the procedure that requires medical intervention or minor procedural intervention to remedy, and does not limit persistently or significantly the patient’s function, nor does it threaten life or cause death. 2.5 Statistical analysis Continuous data are presented as mean ± standard deviation if the data were normally distributed, or as median with interquartile range (25th and 75th percentile) otherwise. Categorical variables are presented by frequencies and percentages. Differences of continuous variables between two groups were analyzed with the unpaired Student’s t test or the Mann-Whitney U test, as appropriate. Differences between categorical variables were evaluated using the Chi-square test or the Fisher’s exact test in case of small expected cell frequencies. Statistical analyses were performed using SPSS V.25.0. All statistical tests were two-sided. P values <0.05 were considered statistically significant. 3. Results 3.1 Study population A total of 264 TLE procedures were performed in the study period. Baseline patient characteristics are presented in Table 1. The median age was 63 (51–71) years and the majority were men (67.0%). Approximately one-fifth (20.8%) of the population had a previous cardiac surgery. The main indications for TLE were lead malfunction (67.0%), isolated pocket infection/erosion (17.0%) and CIED-related systemic infection (11.7%). The median dwelling time of the oldest targeted lead was 6.8 (4.0– 9.7) years. 7

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