BACKGROUND: The long-term efficacy of atrial fibrillation (AF) detection and R-wave synchronization are critical safety requirements for the development of an implantable atrial defibrillator (IAD) for treatment of AF. METHODS AND RESULTS: The long-term efficacy of the Metrix IAD for AF detection and R-wave synchronization was tested in 51 patients. The mean duration of follow-up was 259+/-138 days (72 to 613 days). AF detection tests were performed 2240 times during observed operation with 100% specificity and 92.3% sensitivity for differentiation between sinus rhythm and AF; 2219 episodes and their electrograms stored in the device during AF detection were analyzed. The positive predictive value of the AF detection algorithm was 97.4% (lower 95% confidence limit [CL], 94.5%) in the out-of-hospital setting. A total of 242 435 R waves were analyzed for R-wave synchronization. Of these, 49% were marked for synchronized shock delivery, 82% of sinus rhythm and 36% of AF R waves, respectively. All shock markers were properly synchronized and within the R wave (overall synchronization accuracy, 100%; lower 95% CL, 99.999%). Overall, 3719 shocks have been delivered via the IAD with no instance of unsynchronized shock delivery or any episode of proarrhythmia. The observed proarrhythmic risk was 0%, with an estimated maximum proarrhythmic risk of 0.084% per shock (95% upper CL). CONCLUSIONS: The Metrix IAD can appropriately detect AF with a high specificity and sensitivity and reliably synchronize within a suitable R wave for shock delivery to minimize the risk of ventricular proarrhythmia.
BACKGROUND: The long-term efficacy of atrial fibrillation (AF) detection and R-wave synchronization are critical safety requirements for the development of an implantable atrial defibrillator (IAD) for treatment of AF. METHODS AND RESULTS: The long-term efficacy of the Metrix IAD for AF detection and R-wave synchronization was tested in 51 patients. The mean duration of follow-up was 259+/-138 days (72 to 613 days). AF detection tests were performed 2240 times during observed operation with 100% specificity and 92.3% sensitivity for differentiation between sinus rhythm and AF; 2219 episodes and their electrograms stored in the device during AF detection were analyzed. The positive predictive value of the AF detection algorithm was 97.4% (lower 95% confidence limit [CL], 94.5%) in the out-of-hospital setting. A total of 242 435 R waves were analyzed for R-wave synchronization. Of these, 49% were marked for synchronized shock delivery, 82% of sinus rhythm and 36% of AF R waves, respectively. All shock markers were properly synchronized and within the R wave (overall synchronization accuracy, 100%; lower 95% CL, 99.999%). Overall, 3719 shocks have been delivered via the IAD with no instance of unsynchronized shock delivery or any episode of proarrhythmia. The observed proarrhythmic risk was 0%, with an estimated maximum proarrhythmic risk of 0.084% per shock (95% upper CL). CONCLUSIONS: The Metrix IAD can appropriately detect AF with a high specificity and sensitivity and reliably synchronize within a suitable R wave for shock delivery to minimize the risk of ventricular proarrhythmia.