Estella Pulse Generators - BIOTRONIK USA - News

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42 Estella Pulse Generators Technical ManualTable 12: Percentage of Ventricular PacingFUInterval1 Month3MonthsV pS(Group 1)Mean[95% CI](N)16% [-5,36] (12)17% [2,31] (13)Hysteresis(Group 2)Mean [95%CI](N)33% [23,44] (38)37% [27,47] (42)NoHysteresis(Group 3)Mean [95%CI](N)95% [85,106] (6)91% [75,107] (7)%-pacing V pSversus %-pacingHysteresis,%‐pacing V pSversus %-pacingNo HysteresisS, SS, SS=SignificantNS=NotSignificantTable 13: Mean Percentage of Ventricular Pacing for Patients withoutAV-BlockIndication% VentricularPacing@ 1 month% VentricularPacing@ 3 monthsSSS, Brady-Tachy 0 N/ASSS, SA exit block 0 0Syncopeunknown originN/A 0SSS unspecified N/A 0SSS, Brady-Tachy 1 3SSS, Bradycardia N/A 12SSS, Brady-Tachy 0 N/ASSS, Brady-Tachy 56 27SSS, Brady-Tachy 3 3SSS, Brady-Tachy 6 N/ASSS, Brady-Tachy 2 N/ATotal Number patients 11Total Mean %VentricularPacing11.3 %
Estella Pulse Generators Technical Manual 43Overall, the V pS group (Group 1) had a much lower percentage ofventricular pacing compared to the patient group with Hysteresisenabled (Group 2) as well as compared to the patient group with normalAV‐delays (Group 3).6.4.4.9 ConclusionAll study endpoints were achieved successfully. The final analysisshowed that the ACC feature worked as expected. The mean differenceand standard deviation for automatic versus manual threshold testwas ‐0.01 V ± 0.14 V. A similar result of ‐0.1 V ± 0.12 V was achievedwhen including all 384 available paired measurements of all the followups.The triggered automatic atrial threshold test was successfullycompleted in 80.4%, and accordingly 19.6% were correctly aborted by thepacemaker due to high atrial rates > 108 bpm (37.0%), rate fluctuation(26.0%) or other reasons.Atrial capture performance was evaluated at the beginning of eachfollow-up. Only one out of 236 evaluations atrial stimulation was notsuccessful due to atrial fibrillation. Other than this exception, theautomatically adjusted pacing output always led to successful atrialstimulation.Over the course of the study, 21 Holter ECGs were recorded and analyzedwith respect to the atrial pacing performance with ACC activated. In 3Holter ECGs the core laboratory revealed atrial non-capture events (only3 beats and 9 beats within 24 hours). These atrial non-capture eventsmight have been avoided with higher programmed safety margin.The pacemaker related complication free rate showed the expectedappropriate behavior of Evia. In total 98 adverse events were reported,where two were classified as endpoint related. One complication wascaused by damage to the sealing plugs, very likely due to strong forcesduring the introduction of the torque wrench during implantation, butthere were no signs of a material or manufacturing problem. The secondwas a repositioning of the pacemaker due to pain in the circumference,but there were no signs of infection.The V pSuppression feature was safe as there were no issues causedby the V pS feature reported over the course of the Evia Master Study orduring analysis of seventeen 24 hour Holter recordings; the feature waseffective in demonstrating a significant reduction in the percentage ofventricular pacing compared to patients programmed to AV-delay withHysteresis or patients programmed to normal AV-delay. Analysis of thereduction in percentage of ventricular pacing in patients without AVblock and the V pSuppression feature activated showed that most hadmeaningful reductions as intended for this feature.
Page 1 and 2: BIOTRONIKEstella Pulse GeneratorsTe
Page 3 and 4: ContentsEstella Pulse Generators Te
Page 5 and 6: Estella Pulse Generators Technical
Page 9 and 10: 1. Device DescriptionEstella Pulse
Page 11 and 12: 2. IndicationsEstella Pulse Generat
Page 15 and 16: 4. Warnings and PrecautionsEstella
Page 25 and 26: 5. Adverse EventsNOTE:Estella Pulse
Page 35 and 36: 6.2.4 Clinical Study ConclusionsEst
Page 49: 6.4.4.7 Additional Study ResultsEst
Page 53 and 54: 7. Programmable ParametersEstella P
Page 57 and 58: 7.2.3 Scan HysteresisEstella Pulse
Page 65 and 66: 7.5.3.2 AV HysteresisEstella Pulse
Page 71 and 72: Figure 13: Automatic Sensor GainEst
Page 73 and 74: Table 20: Rate DecreaseDecrease inR
Page 77 and 78: 7.11.2.1 PMT Detection and Terminat
Page 79 and 80: Table 21: Acronyms and TermsCVATMTe
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Estella Pulse Generators Technical
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9. Other Functions/FeaturesEstella
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10. Product Storage and Handling10.
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11. Lead ConnectionEstella Pulse Ge
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12. Follow-up Procedures12.1 Genera
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Table 33: Nominal Pulse Generator L
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14. ExplantationEstella Pulse Gener
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AV Repetitive Hysteresis (Dual cham
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Periodic TransmissionOff, 30, 60, 9
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ParameterEstella Pulse Generators T
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16. Order InformationPulse Generato
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The AAI mode is conditionally indic
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Manufactured by:BIOTRONIK SE & Co.
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