Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
Objective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine.
Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics
Primary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery/intervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming / device revision).
Inclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age \>18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available
Patient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing \> 700 interventions are expected.
implanted CIED (e.g. pacemaker, ICD, CRT),
performed (non-CIED related) surgical or catheter-based procedure,
data from peri-procedural CIED interrogation available
age >18 years
no implanted CIED,
no data from any peri-interventional CIED interrogation available
Enrollment of all consecutive patients according to the inclusion criteria, undergoing surgery or catheter-ablation at the Klinikum Fuerth or Klinikum Nueremberg. Data collection will be * retrospectively beginning from 2008, * on-going with further prospective data collection and patient enrollment. If possible, patients will be enrolled at pre-interventional device interrogation. If there is no pre-interventional device interrogation (e.g. in case of urgent or emergency surgery), patients will be enrolled retrospectively.
Cohort
Prospective
surgery or catheter based cardiac procedure (catheter ablation)
Procedure/Surgerypatients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)
surgery or catheter-based procedure related (S)ADE
any (S)ADE related to the surgical or catheter-based procedure
device: post-procedural pacing threshold increase
post-procedural pacing threshold increase \> 50% compared with the pre-procedural threshold (given a safety margin of 100%)
device: post-procedural sensing decrease
post-procedural sensing decrease by \> 50% compared with the pre-procedural sensing
device: post-procedural lead impedance
post-procedural lead impedance is different by \> 25% compared with the pre-procedural impedance
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Klinikum-Fuerth
Lead sponsor
Klinikum Nürnberg
Collaborator
