Perioperative Management Evaluation in Patients With CIED

Condition(s) studied

Investigational drug(s) / intervention(s)

surgery or catheter based cardiac procedure (catheter ablation): patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)

Study summary

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.

Eligibility

Primary outcome measure(s)

• surgery or catheter-based procedure related (S)ADE — 1 month post-procedural
  any (S)ADE related to the surgical or catheter-based procedure

Trial sites (2)

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