Perioperative Management Evaluation in Patients With CIED (EVINCE)

Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications; Anesthesia Complication; Cardiac Pacemaker Malfunction; ICD Malfunction; Cardiac Pacemaker Electrical Interference
• Intervention / Treatment: Procedure: surgery or catheter based cardiac procedure (catheter ablation)

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Dirk Bastian, MD; Phone Number: +49 (0)911 7580 1101; Email: dirk.bastian@klinikum-fuerth.de
• Study Contact Backup: Name: Laura Vitali-Serdoz, MD; Phone Number: +49 (0)911 7580 1101; Email: laura.vitali-serdoz@klinikum-fuerth.de

Study Locations

• Germany
  • Bavaria
    • Fuerth, Bavaria, Germany, 90766
      • Recruiting
      • Klinikum Fuerth
      • Contact: Dirk Bastian, MD; Phone Number: +49 (0)911 7580 1101; Email: dirk.bastian@klinikum-fuerth.de
      • Contact: Laura Vitali-Serdoz, MD; Phone Number: +49 (0)911 7580 1101; Email: laura.vitali-serdoz@klinikum-fuerth.de
    • Nuremberg, Bavaria, Germany, 90471
      • Recruiting
      • Klinikum Nuernberg
      • Contact: Timur Mamedov; Email: timur.mamedov@klinikum-nuernberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• no implanted CIED,
• no data from any peri-interventional CIED interrogation available

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery or catheter-based procedure related (S)ADE	any (S)ADE related to the surgical or catheter-based procedure	1 month post-procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device: post-procedural pacing threshold increase	post-procedural pacing threshold increase > 50% compared with the pre-procedural threshold (given a safety margin of 100%)	1 month post-procedural
device: post-procedural sensing decrease	post-procedural sensing decrease by > 50% compared with the pre-procedural sensing	1 month post-procedural
device: post-procedural lead impedance	post-procedural lead impedance is different by > 25% compared with the pre-procedural impedance	1 month post-procedural

Collaborators and Investigators

• Sponsor: Klinikum-Fuerth
• Collaborators: Klinikum Nürnberg
• Investigators: Principal Investigator: Dirk Bastian, MD, Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pacemaker; cardiac resynchronisation therapy; implanted cardioverter defibrillator; management, peri-operative
• Other Study ID Numbers: EVINCE_KHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No