Estella Pulse Generators - BIOTRONIK USA - News

Estella Pulse Generators Technical Manual 25ACC pacing thresholds at a single follow-up. One discrepancy occurredat implant and three others occurred at pre-discharge follow-up (within2 days of implant). All subsequent follow-ups (after lead maturation) forthese four patients showed a difference of less than 0.5 volts betweenthe ACC and manual pacing threshold. All differences of 0.5 volts orhigher were recorded at instances where the ACC threshold was higherthan the manual threshold. There is little risk of non-capture or safetyconcerns because the ACC programmed output would be set to theACC threshold plus the safety margin (0.5V), providing a much highereffective safety margin. Also, it is important to note that 96.4 % of thepatients enrolled in the PACC study had an absolute difference lowerthan the actual 0.5 volt safety margin. There were no ACC thresholdsmore than 0.4 volts lower than the manual threshold. Therefore, the useof a nominal safety margin of 0.5 volts is adequate to provide patientsafety.Figure 1 below provides a distribution of the mean absolute differencesper patient.Figure 1: Absolute Ventricular Threshold Comparison50%47.1%45%40%Percentage of Patients35%30%25%20%15%31.4%10%5%0%8.6%5.0% 4.3%1.4% 2.1%0.0%0