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).