Multi-Center, Community-Based Cardiac Implantable Electronic Devices Registry: Population, Device Utilization, and Outcomes
Autor: | Faith Anthony, Mary Lou Kiley, Kevin F. Kwaku, Nigel Gupta, Charlie Young, Somjot S Brar |
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Rok vydání: | 2016 |
Předmět: |
Male
Pediatrics medicine.medical_specialty Pacemaker Artificial Prosthesis-Related Infections Time Factors medicine.medical_treatment Population Cardiac resynchronization therapy 030204 cardiovascular system & hematology Prosthesis Design 03 medical and health sciences 0302 clinical medicine Risk Factors medicine Patient Observation Product Surveillance Postmarketing Humans Arrhythmia and Electrophysiology 030212 general & internal medicine Cardiac Resynchronization Therapy Devices Community Health Services Registries education Device Removal Aged Original Research Aged 80 and over education.field_of_study Quality and Outcomes business.industry Incidence (epidemiology) Health Maintenance Organizations Arrhythmias Cardiac Middle Aged medicine.disease electrophysiology United States Defibrillators Implantable Prosthesis Failure Treatment Outcome Pneumothorax pacemakers Female Tamponade Cardiology and Cardiovascular Medicine business Cohort study |
Zdroj: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
ISSN: | 2047-9980 |
Popis: | Background The purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente–Cardiac Device Registry. Methods and Results This is a cohort study of implantable cardioverter defibrillators ( ICD ), pacemakers ( PM ), and cardiac resynchronization therapy ( CRT ) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6 US geographical regions. Registry data variables, including patient characteristics, comorbidities, indication for procedures, complications, and revisions, were captured using the healthcare system's electronic medical record. Outcomes were identified using electronic screening algorithms and adjudicated via chart review. There were 11 924 ICD s, 33 519 PM s, 4472 CRT s, and 66 067 leads registered. A higher proportion of devices were implanted in males: 75.1% ( ICD ), 55.0% ( PM ), and 66.7% ( CRT ), with mean patient age 63.2 years ( ICD ), 75.2 ( PM ), and 67.2 ( CRT ). The 30‐day postoperative incidence of tamponade, hematoma, and pneumothorax were ≤0.3% ( ICD ), ≤0.6% ( PM ), and ≤0.4% ( CRT ). Device failures requiring revision occurred at a rate of 2.17% for ICD s, 0.85% for PM s, and 4.93% for CRT s, per 100 patient observation years. Superficial infection rates were ICD ), 0.5% ( PM ), and 1.0% ( CRT ). Results were used to monitor vendor‐specific variations and were systematically shared with individual regions to address potential variations in outcomes, utilization, and to assist with the management of device recalls. Conclusions The Kaiser Permanente–Cardiac Device Registry is a robust tool to monitor postprocedural patient outcomes and postmarket surveillance of implants and potentially change practice patterns. |
Databáze: | OpenAIRE |
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