Background: The number of worldwide implanted cardiac electronic devices (CIED) is
increasing continuously. On the other hand, the number of (more and more complex)
surgical and catheter based interventions in this population is increasing as well.
Recommendations for peri-operative management are often based on older data from case
reports and small collectives. Data especially in particular subpopulations is limited.
Objective: The study aims to evaluate the peri-operative management and outcome of
patients with implanted CIED undergoing non-CIED related surgery or catheter
interventional procedures (ablation) in clinical routine. Data from the study are
expected to provide evidence for recommendations improving perioperative management and
device programming.
Study design: bi-center, non-randomized, observational registry, retrospective
data-collection, on-going prospective patient enrollment, descriptive statistics Centers:
Klinikum Fuerth (dep. for Heart and Lung disease, section for clinical
electrophysiology), Klinikum Nuernberg (dep. for Heart surgery).
Patients and methods:
Primary endpoint: number and type of peri-operative adverse device related events (ADE)
- all complaints, adverse events and adverse device effects will be documented and
classified according to the ISO/DIS 14155 - Clinical Investigation of medical
Devices in Human Subjects - Good Clinical Practices with respect to their
relationship to the surgical or catheter intervention and [Stark NJ. A New standard
for medical device adverse event classification. J of Clinical Research Best
Practices 2009; 5(12): 1-7].
Secondary endpoints: pre-interventional data (patient characteristics, data from CIED
interrogation); peri-interventional data (type of surgery/intervention, anesthesiology
techniques, any AE), post-interventional data (data from post-interventional CIED
interrogation, need for reprogramming / device revision).
Subpopulations: cardiac surgery, vascular surgery, catheter ablation, ICD and mode of
therapy inhibition, CRT, automatic features
Inclusion criteria:
patients with implanted CIED undergoing non-CIED related surgical or catheter-based
procedure, peri-procedural CIED interrogation, age >18 years Exclusion criteria: no
implanted CIED, no data from peri-procedural CIED interrogation available.
Patient enrollment: retrospectively from the clinical records beginning from 2008,
further on-going prospective inclusion Data acquisition: Data will be collected in CRF´s
from the patient's history, the computer based clinical information system / clinical
records and data records from CIED interrogations
Sample size: For the observational study, there is no pre-specified sample size.
Data from more than 500 patients undergoing > 700 interventions are expected.
Data security: Study related data are collected by the study investigators in an
anonymous clinic-internal data-base, that is password protected.
All investigators have to provide valid GCP training.
Risk estimation: the study is observational and descriptive with anonymized data
collection/analysis and therefore adds no risk to the study population