Methods
The presented observation study is a retrospective analysis of all lead extractions performed in our center between 2013 and 2019. We identified 190 extraction procedures in patients with infectious indications, which were divided into the three treatment paths described above. This resulted in a total of 89 procedures in which the systems were removed exclusively (Exclusive System Removal = SR), 28 procedures in which the system was removed and an epicardial pacing lead was implanted simultaneously (System Removal and Implantation of an Epicardial Pacing Lead - EL), and 73 patients in whom a completely new and definitive device system was implanted on the contralateral side (System Removal and Contralateral Implantation of a new device - SI).
In addition to patient-specific data, cardiac pre-existing cardiac conditions or treatments and relevant co-morbidities were recorded. Furthermore, the timing of the initial diagnosis, admission to our hospital, pre-operative antibiotic therapy, timing of the surgical procedure, and length of the treatment period were of interest. In particular, we also considered pre-operative infection parameters, previously identified pathogens, and the age of the implanted CIED components. Additionally, the indications for CIEDs and their implantation positions were recorded. During surgery, besides the group-specific method, the extraction techniques, number of removed electrodes, existing vegetation, pericardial effusion sizes, tricuspid valve function, and wound closure methods were documented along with the duration of the procedure, fluoroscopy, and laser times. In the post-operative course, the duration of the intensive care unit (ICU)- and overall hospital stay, further course of infection parameters (laboratory chemistry, pathogen detection), echocardiographic findings, and the discharge destination (home or another hospital) were recorded.
If a second surgery was required for re-implantation of a CIED, perioperative parameters and lead measurements were registered. At one-year follow-up we reassessed the completed healing of the CIED pockets, device function, laboratory parameters, current NYHA class, LV-EF, and lead-specific measurements. Fatal treatment courses were also recorded and distinguished between perioperative and post-discharge time points.
The collected data were obtained from the digital and analog patient records of our hospital and, in individual cases, were supplemented with additional information from treating colleagues. All data were digitalized and anonymized after the data collection was completed. Finally, the statistical analysis, tabular and graphical processing, and evaluation of the results were performed.
The investigations were carried out in accordance with the Declaration of Helsinki of the World Medical Association on the ethical principles for medical research involving human subjects and were approved by the Ethics Committee of the State Medical Association of Hessen/Germany (reference number: 2022-3185-evBO).