Estella Pulse Generators - BIOTRONIK USA - News

6.4.4.7 Additional Study ResultsEstella Pulse Generators Technical Manual 41For ACC, the core laboratory analyzed 21 Holter ECG recordings with aduration of 24 hours, and revealed short episodes of atrial non-capturein 3 Holter ECGs. In one patient 3 consecutive beats, in another 9 beatswithin 1 minute, and in a third patient atrial non-capture was recorded,but not linked to the ACC feature.In total, 98 adverse events were reported, where two were classified aspacemaker-related complications. The per-patient complication-freerate is 173/175 = 98.9%, 95% confidence interval [95.9%, 99.9%].6.4.4.8 V pSuppression ResultsFor V pS, the corelab and in-house group analyzed 17 Holter ECGrecordings for patients who had completed the 1 and 3 month followupsand had the feature enabled. The purpose of the analysis was toidentify sequences that were indicative of pauses (≥2 seconds) relatedto the feature. In all of the patients, the analysis did not find a persistentproblem with respect to the V pS behavior.For V pS, an analysis of 1 month follow-up data for 132 patients in theMaster Study was conducted to demonstrate how the percentage ofventricular pacing varied between the following patient groups:• Patients with their device programmed to V pSuppression (Group 1)• Patients with their device programmed to AV-delay with Hysteresis(Group 2)• Patients with their device programmed to normal AV-delay (Group 3)The overall percentage of ventricular pacing between patientsprogrammed with V pS versus the patients programmed with AV-delaywith Hysteresis or the patients programmed with normal AV-delaydemonstrated that V pS resulted in the lowest percentage of ventricularpacing as shown in Table 12 and Table 13.