title: Clinical investigation of a new dual-chamber implantable cardioverter defibrillator with improved rhythm discrimination capabilities.
abstract: BACKGROUND
  Despite continuing advances, inappropriate implantable cardioverter defibrillator (ICD) therapies in response to nonventricular tachyarrhythmias continue to cause patient discomfort and increased follow-up demands.
  
  
  RESULTS
  We investigated the performance of a new dual-chamber ICD (Photon DR, St. Jude Medical), with specific attention to its arrhythmia discrimination and detection capabilities. The system uses a hierarchical approach to tachyarrhythmia classification utilizing a new AV Rate Branch feature and subsequently utilizing morphology analysis, onset, and stability criteria. The arrhythmia discrimination results from this study group were compared to historical control group data from a recent clinical investigation of single-chamber Contour MD (Morphology Discrimination) and Angstrom MD ICDs without the Rate Branch feature. Rhythm discrimination was evaluated by comparing ventricular tachycardia diagnosis sensitivity and specificity between the two groups. To determine whether the new discrimination scheme affected detection speed, median ventricular fibrillation (VF) detection and redetection times also were compared. The study group consisted of 107 patients, and the control group consisted of 161 patients. Use of the AV Rate Branch feature was associated with significant improvements in both sensitivity (100% vs 97.9%, P < 0.0001) and specificity (84% vs 55.7%, P = 0.0002) of ventricular tachycardia diagnosis. Use of the new scheme slightly but significantly accelerated VF detection times (2.8 vs 3.0 sec, P < 0.0001) and redetection times (1.3 vs 1.4 sec, P < 0.0001). Adverse events were typical for this patient population.
  
  
  CONCLUSIONS
  Compared with earlier St. Jude Medical ICDs, the Photon DR ICD offers improved rhythm discrimination without compromising VF detection time.
authors.affiliation: Iowa Heart Center, Des Moines, Iowa 50314, USA. sjbep@mac.com
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Bailin
authors.forename: Mark
authors.initials: M
authors.lastname: Niebauer
authors.forename: Gery
authors.initials: G
authors.lastname: Tomassoni
authors.forename: Robert
authors.initials: R
authors.lastname: Leman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017147:Defibrillators, Implantable; D015716:Electrocardiography, Ambulatory / Q000379:methods*; D019544:Equipment Failure Analysis / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017180:Tachycardia, Ventricular / Q000175:diagnosis* / Q000628:therapy*; D014481:United States; D014693:Ventricular Fibrillation / Q000175:diagnosis* / Q000628:therapy*