title: Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study.
abstract: OBJECTIVE
  To investigate whether diagnostic data from implanted cardiac resynchronization therapy defibrillators (CRT-Ds) retrieved automatically at 24 h intervals via a Home Monitoring function can enable dynamic prediction of cardiovascular hospitalization and death.
  
  
  RESULTS
  Three hundred and seventy-seven heart failure patients received CRT-Ds with Home Monitoring option. Data on all deaths and hospitalizations due to cardiovascular reasons and Home Monitoring data were collected prospectively during 1-year follow-up to develop a predictive algorithm with a predefined specificity of 99.5%. Seven parameters were included in the algorithm: mean heart rate over 24 h, heart rate at rest, patient activity, frequency of ventricular extrasystoles, atrial-atrial intervals (heart rate variability), right ventricular pacing impedance, and painless shock impedance. The algorithm was developed using a 25-day monitoring window ending 3 days before hospitalization or death. While the retrospective sensitivities of the individual parameters ranged from 23.6 to 50.0%, the combination of all parameters was 65.4% sensitive in detecting cardiovascular hospitalizations and deaths with 99.5% specificity (corresponding to 1.83 false-positive detections per patient-year of follow-up). The estimated relative risk of an event was 7.15-fold higher after a positive predictor finding than after a negative predictor finding.
  
  
  CONCLUSIONS
  We developed an automated algorithm for dynamic prediction of cardiovascular events in patients treated with CRT-D devices capable of daily transmission of their diagnostic data via Home Monitoring. This tool may increase patients' quality of life and reduce morbidity, mortality, and health economic burden, it now warrants prospective studies. ClinicalTrials.gov  NCT00376116.
authors.affiliation: Cardiology Department, Universitätsklinikum Essen, Essen, Germany. stefan.sack@klinikum-muenchen.de
authors.forename: Stefan
authors.initials: S
authors.lastname: Sack
authors.forename: Christian Michael
authors.initials: CM
authors.lastname: Wende
authors.forename: Herbert
authors.initials: H
authors.lastname: Nägele
authors.forename: Amos
authors.initials: A
authors.lastname: Katz
authors.forename: Wolfgang Rudolf
authors.initials: WR
authors.lastname: Bauer
authors.forename: Craig Scott
authors.initials: CS
authors.lastname: Barr
authors.forename: Klaus
authors.initials: K
authors.lastname: Malinowski
authors.forename: Harald
authors.initials: H
authors.lastname: Schwacke
authors.forename: Francisco
authors.initials: F
authors.lastname: Leyva
authors.forename: Jochen
authors.initials: J
authors.lastname: Proff
authors.forename: Sergey
authors.initials: S
authors.lastname: Berdyshev
authors.forename: Vincent
authors.initials: V
authors.lastname: Paul
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy; D017147:Defibrillators, Implantable; D005260:Female; D005858:Germany; D006333:Heart Failure / Q000150:complications / Q000628:therapy*; D006699:Home Care Services; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D018670:Monitoring, Ambulatory; D009203:Myocardial Infarction / Q000150:complications / Q000401:mortality*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity