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
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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