Short summary

Cardiovascuar Implanted Electronic Device related infection are a rare but very servere complication to the treatment with electronic devices. 

The infections are amongst the most dreaded complications causing significantly morbidity, mortality and generate considerable healthcare cost. 

The rate of infection has risen disproportional to the rate of implantations and the the reason remains unclear 

Rationale

At present time there are a minimum of 55.000 patients living with a pacemaker or an Implantable cardioverter defibrillator (ICD) - unit in Denmark. Each year in Denmark, there are about 5.000 de novo implantations of pacemakers and ICD system, while 2.000 patients undergo a replacement procedure.  These number are bound to raise due to demographic changes and the development of new and more advanced devices.

Pacemaker and ICD-related infections are a rare (1-2%) but very severe complication to the treatment with cardiac devices, causing significant morbidity and mortality and generating substantial healthcare costs. Our knowledge about the pathogenesis of these infections is limited at present time but recent studies suggest that colonisation with bacteria in the device pocket may play an essential role.

Purpose and methods:

The purpose of this project is to enhance our knowledge about cardiovascular implanted electronic device related infections. We plan to achieve this through 4 different purposes.

• What is the prevalence and type of bacteria in patients with device related infection? 

• Is it possible to improve the diagnostic of Cardiovascular implanted electronic device related infections with a PET/CT-scanning and advanced microbiological techniques?

• What is the prevalence of device infection and what are the risk factors for developing device infection

• What is the prognosis for patients with a pacemaker or icd unit?

To achieve these purposes we have planned 3 sub studies.

Sub study 1:

A clinical project that includes patients with suspected device related infection and therefore planned to have their system removed.

The project will examine the prevalence and type of bacteria among patients suspected for device infection. The study will also investigate if it is possible to use the PET/CT-scanning in the diagnostic of Cardiovascular implanted electronic device related infections

Sub study 2:

A project that takes hold in the Danish pacemaker and ICD register. The purpose of this study is to determine the incidence and incidencerate of device related infections in Denmark.

The study will also investigate examine potential patient-, procedure and device related risk factors.

Sub study 3:

A project that takes hold in the Danish pacemaker and ICD register and the national registers health registers in Denmark. The purpose is to determine the overall living age after first implantation of a device and identify risk factors for increased mortality.

Clinical importance:

Device related infections are an increasing problem in the western world that will continue to increase in the future. We expect that the results from the project will provide us with information that will increase our knowledge about the pathogenesis in cardiovascular implanted electronic device related infections. We expect that this knowledge will help us in the prevention and diagnosis of device related infections in the future. We also expect that the result will lead to better treatment options in the future. It is our believes that the results of the project will benefit all patients with an cardiovascular implanted electronic device in the future.

Description of the cohort

Sub study 1:

A clinical project that includes adult patients with suspected device related infection and admitted to the department of Cardiology in Odense, Aarhus or Aalborg.

Sub study 2:

All Danish patients that has recieved a cardiac implanted electronic device in Denmark between 1982 and 2018. About 100.000 patients. 

Sub study 3:

All Danish patients that has received a pacemaker of icd system in Denmark between 1982 and 20018 and a generated matched control population from the Danish population. 

Data and biological material

Register data

Collaborating researchers and departments

Department of Cardiology, Odense University Hospital

• Consultant Jens Brock Johansen, PhD

Department of Cardiology, Aarhus University Hospital

• Professor Jens Cosedis Nielsen, DMSc

Department of Thoracic and Vascular Surgery, Odense University Hospital

• Consultant Ole Dan Jørgensen, PhD

Department of Clinical Microbiology, Odense University Hospital

• Associate professor Ulrik Stenz Justesen, DMSc