Estella Pulse Generators - BIOTRONIK USA - News

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140 Estella Pulse Generators Technical Manual17.1.4 Single Chamber Modes17.1.4.1 VVIThe VVI mode is clearly indicated for• all symptomatic bradyarrhythmias, but particularly if--the atrium does not significantly contribute to the hemodynamics(persistent or paroxysmal atrial flutter or fibrillation,dilated atria).• there are no grounds for development of pacemaker syndromethrough loss of the atrial contribution or through negative atrialcontribution.The VVI mode is conditionally indicated for• symptomatic bradycardia when the simplicity of the pacing systemis of crucial significance due to--senility (for the sole purpose of prolonging life).--incurable illness.--great distance from the follow-up care center to the patient’shome.--absence of retrograde VA conduction.The VVI mode is contraindicated if• a pacemaker syndrome is known to exist or if the patient developsparticular symptoms during temporary pacing or pulse generatorimplantation, and/or• there is a need to maximize the atrial contribution due to--congestive heart failure, and/or--a specific need for ventricular rate adaptation.17.1.4.2 AAIThe AAI mode is clearly indicated for• symptomatic sino-atrial node dysfunction (sick sinus syndrome),given that adequate AV conduction has been established by anappropriate examination.
The AAI mode is conditionally indicated ifEstella Pulse Generators Technical Manual 141• the hemodynamics of patients with bradycardia and symptomaticallyreduced cardiac output can be improved by raising the heart rate,given that adequate AV conduction has been established by anappropriate diagnostic examination.The AAI mode is contraindicated for• previously established AV conduction delay or AV block or ifdiminishing AV conduction has been determined by appropriatetests, and/or• inadequate intra-atrial complexes that do not permit safe sensing.17.1.5 Other ModesIn addition to the ACC/AHA guidelines, the modes listed above mayhave further indications due to medical/technical complications such aselectromagnetic interference, sensing defects, fracture of the lead(s),detection of myopotentials, muscle stimulation, etc. The same appliesto the asynchronous DOO(R), AOO(R) and VOO(R) pacing modes derivedfrom the above by restricting the sensing functions [SOO(R) modeavailable with Estella SR models]. The triggered DDT, AAT and VVTpacing modes and the VDI and OFF modes are indicated for diagnosticpurposes to assess intrinsic cardiac activity. Use of the OFF mode iscontraindicated in pacemaker dependent patients.
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ContentsEstella Pulse Generators Te
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Estella Pulse Generators Technical
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1. Device DescriptionEstella Pulse
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2. IndicationsEstella Pulse Generat
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4. Warnings and PrecautionsEstella
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5. Adverse EventsNOTE:Estella Pulse
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6.2.4 Clinical Study ConclusionsEst
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6.4.4.7 Additional Study ResultsEst
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7. Programmable ParametersEstella P
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7.2.3 Scan HysteresisEstella Pulse
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7.5.3.2 AV HysteresisEstella Pulse
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Figure 13: Automatic Sensor GainEst
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Table 20: Rate DecreaseDecrease inR
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7.11.2.1 PMT Detection and Terminat
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Table 21: Acronyms and TermsCVATMTe
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Page 119 and 120: 12. Follow-up Procedures12.1 Genera
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Page 129 and 130: 14. ExplantationEstella Pulse Gener
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Page 139 and 140: Periodic TransmissionOff, 30, 60, 9
Page 141 and 142: ParameterEstella Pulse Generators T
Page 143 and 144: 16. Order InformationPulse Generato
Page 147: Estella Pulse Generators Technical
Page 154: Manufactured by:BIOTRONIK SE & Co.
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