Cardiac Device Registry

Background
xrayThe Kaiser Permanente Cardiac Device Registry (KPCDR) is designed as a postmarket surveillance system for pacemakers (PM) and implantable cardiac defibrillators (ICD). The Cardiac Device database is currently populated with data on over 22,000 ICD pulse generators, 52,000 pacemakers and 90,000 leads.

The key objectives of the Cardiac Device Registry are to:

  • Identify and track patients with specified cardiac implants
  • Respond immediately to identify patients involved during recalls/advisories
  • Provide an active surveillance system for adverse events
  • Monitor trends in device performance and safety
  • Provide a framework for research

Data Collection and Sources

Implant data is obtained from cardiac device manufacturers, Paceart, Apollo, American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR) and internal administrative sources, such as KP HealthConnect (KPHC). KPHC serves as a primary data source for patient demographics, diagnosis and complications as well as for validation of data received from device manufacturers.

Outcome Validation

Suspected complications are identified by queries run in the KPHC Clarity database using ICD-9 codes. Registry clinical staff validates identified complications through KPHC chart review to determine if they meet pre-established Registry criteria. Complications tracked are: Tamponade; Hematoma; Pneumothorax; Mechanical Complications of Pulse Generators and Leads; Infections: Superficial, Deep and Organ Space.

Reporting

Our annual report includes ICD and PM data from the following regions: Northern California, Southern California, Northwest, Hawaii, Colorado, Ohio, and the Mid-Atlantic states. In addition to reporting volume data by device type and region, patient demographics, and complications, the annual report includes statistical analysis of device survival rates and patient survival by age, gender and specific disease co-morbidities. Ad-hoc, customized reports based on Registry data are available on request to support contracting decisions or clinical/quality initiatives.

In addition to reporting volume data by device type and region, patient demographics, and complications, the annual report includes statistical analysis of device survival rates and patient survival by age, gender and specific disease co-morbidities. Ad-hoc, customized reports based on Registry data are available on request to support contracting decisions or clinical/quality initiatives.

Accomplishments

  • Critical role in the development of a Cardiac Rhythm Management (CRM) Formulary in the Northern California region
  • Creation of a tracking tool to capture warranty and upgrade credits specified in current vendor contracts
  • Dynamic reports designed to assess trends in lead and/or pulse generator complications: early failure, high complication rates, and trends within manufacturer or model
  • Support the national Cardiac Rhythm Management (CRM) Standards and Sourcing Team (SST) through routine and ad hoc reports
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