Clinical Investigation of a New Dual‐Chamber Implantable Cardioverter Defibrillator with Improved Rhythm Discrimination Capabilities

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Abstract
Despite continuing advances, inappropriate implantable cardioverter defibrillator (ICD) therapies in response to nonventricular tachyarrhythmias continue to cause patient discomfort and increased follow-up demands. 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. Compared with earlier St. Jude Medical ICDs, the Photon DR ICD offers improved rhythm discrimination without compromising VF detection time.

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