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Stratos Family of Cardiac Resy nchronization Therapy Pacemakers Technical Manual.
Stratos CRT-Ps Implantable Cardiac Resynchronization Therapy Pacemakers Stratos X-Ray identification Radiopaque Identification A radiopaque identification code is visible on standard x-ray, and identifies the pulse generator: Stratos LV/LV-T SV C AUTION Lead / CRT-P Compatibility – Because of the numerous available 3.
Stratos LV/LV-T Technical Manual i Contents 1. General .............................................................................. 1 1.1 Device Descr iption ........................................................ 1 1.2 Indications ................
ii Stratos LV/LV-T Technical Manual 2.1.11 OFF (ODO ) .......................................................... 69 2.2 Biventricular Synchronization of the S tratos CR T -Ps .. 69 2.3 T iming Func tions ...............................................
Stratos LV/LV-T Technical Manual iii 2.14.6 Maximum Activity Rate ........................................ 98 2.14.7 Rate De cay .......................................................... 98 2.15 Sensor S tim ulation ..................................
iv Stratos LV/LV-T Technical Manual 5. Battery , Pulse a nd Lead Data ...................................... 123 5.1 Threshold T est - T esti ng the Pacing Function ........... 123 5.2 P/R Measurement - T esting the Sensing Function.... 124 5.3 T esting for Retr ograde Conduc tion .
Stratos LV/LV-T Technical Manual v 12. Order Inform ation ......................................................... 161 Appendix A ....................
vi Stratos LV/LV-T Technical Manual.
Stratos LV/LV-T Technical Manual 1 1. General 1.1 Device Description The Stratos LV and Stratos LV -T CRT-Ps are rate adaptive pacemakers designed to provide Cardiac Resynchronization Therapy (CRT). The Strato s CRT-Ps provide all standard bradycardia pacemaker therapy wi th the additional capabilities of biventricular pacing for CRT.
2 Stratos LV/LV-T Technical Manual Stratos CRT-Ps are designed to meet all indications for Cardiac Resynchronization Therapy in CHF patients as well as those for bradycardia therapy as exhibited in a wide variety of patients. The Stratos family is compris ed of two CRT-Ps that are designed to handle a multitude of situations.
Stratos LV/LV-T Technical Manual 3 1.3 Contraindications Use of Stratos LV and Stratos LV -T CRT-Ps are contraindicated for the following patients: • Unipolar pacing is contrai ndicated for patients with an implanted cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy.
4 Stratos LV/LV-T Technical Manual Magnetic Resonance Imaging (MRI) – Avoid use of magnetic resonance imaging as it has been shown to cause movement of the CRT-Ps within the subcutaneous pocket and may cause pain and injury to the patient and damage to the CRT-P.
Stratos LV/LV-T Technical Manual 5 Transcutaneous Electrical Nerve Stimulation (TENS) – Transcutaneous electrical nerve stimulation may interfere with CRT-P function. If necessary, the following measures may reduce the possibility of interference: • Place the TENS electrodes as close to each other as possible.
6 Stratos LV/LV-T Technical Manual For transurethral resection of the prostate, it is recommended that the cautery ground plate be placed under the buttocks or around the thigh, but not in the thoracic area where the current pathway could pass through or near the CRT-P system.
Stratos LV/LV-T Technical Manual 7 1.5.3 Lead Connection and Evaluation Lead Check – Feature Description : Lead Check is a feature that, when activated, automatically m easures the lead impedance with every pace. Based on these measurements, the lead configuration will be set to either unipolar or bipolar.
8 Stratos LV/LV-T Technical Manual IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators from different manufacturers are assured a basic fit.
Stratos LV/LV-T Technical Manual 9 AV Hysteresis – If the AV hysteresis is enabled along with the algorithm for recognizing and terminating PMTs (PMT management), the AV delay for recognizing and terminating a PMT has a higher priority than the AV hysteresis.
10 Stratos LV/LV-T Technical Manual Pacing thresholds – When decreasing programmed output (pulse amplitude and/or pulse widt h), the pacing threshold must first be accurately assessed to provide a 2:1 safety margin. EMI – Computerized systems are subject to (Electromagnetic Interference (EMI) or “noise”.
Stratos LV/LV-T Technical Manual 11 Atrial Sensitivity – In dual chamber systems, the atrial sensitivity of 0.1 mV should only be programmed in conjunction with a bipolar lead configuration.
12 Stratos LV/LV-T Technical Manual If the patient cannot understand or follow the instructions because of physical or mental challenges, another adult who can follow the instructions will be necessary for proper transmission. Electromagnetic Interference (EMI) – Precautions for EMI interference with the Stratos CRT-Ps are provided in Section 1.
Stratos LV/LV-T Technical Manual 13 1.5.6 Electromagnetic Interference (EMI) The operation of any implant ed device may be affected by certain environmental sources gener ating signals that resemble cardiac activity.
14 Stratos LV/LV-T Technical Manual Home Appliances – Home appliances normally do not affect CRT-P operation if the appliances are in proper condition and correctly grounded and encased. There are reports of CRT-P disturbances caused by electrical tools and by electric razors that have touched the skin di rectly over the CRT-P.
Stratos LV/LV-T Technical Manual 15 Based on testing to date, effects resulting from an interaction between cellular phones and the implanted pacemakers have been temporary. Simply moving the phone away from the implanted device will return it to it s previous state of operation.
16 Stratos LV/LV-T Technical Manual 1.6 Potential Effects of the Device on Health The following possible adverse events may occur with this type of CRT-P based on implant experience including: Potenti.
Stratos LV/LV-T Technical Manual 17 1.7 Clinical Studies The subsequent sections summarize the following three clinical studies that were used to suppor t the safety and effectiveness of the Stratos LV/LV-T CRT-Ps.
18 Stratos LV/LV-T Technical Manual • Patients assigned to Group 1 received biventricular pacing with CLS-based rate adaptive pacing using BIOTRONIK’s Protos DR/CLS, which is a dual-chamber pulse generator with CLS-based rate adaptive pacing.
Stratos LV/LV-T Technical Manual 19 Clinical Inclusion Criteria To support the objectives of this investigation, patients were required to meet the following inclusion criteria prior to enrollment: .
20 Stratos LV/LV-T Technical Manual Clinical Exclusion Criteria To support the objectives of this investigation, the exclusion criteria at the time of patient enrollment included the following: • Me.
Stratos LV/LV-T Technical Manual 21 Clinical Endpoints Primary Endpoint: Complication-free Rate (Safety) The safety of the Strato s LV was evaluated based on complications (adverse events t hat requir.
22 Stratos LV/LV-T Technical Manual No i m pl a nt A tte mp te d Wit hdraw al of C on s e nt Gr oup 1 2 Gr oup 2 4 Gr oup 3 3 N ot M eeti ng Incl usi on C r it er i a Gr oup 1 2 Gr oup 2 2 Gr oup 3 1 .
Stratos LV/LV-T Technical Manual 23 Table 1: Patient Demographics at Enrollment Characteristic Group1 Group 2 Group 3 P-value Ag e @ Enrollment (Yrs ) Mean ± SE Range N=42 73.7 ± 1.3 56 to 90 N=50 72.3 ± 1.2 51 to 86 N=25 71.5 ± 1.6 52 to 85 0.534* Gender Male Female N=42 18 (42.
24 Stratos LV/LV-T Technical Manual Table 1: Patient Demographics at Enrollment Characteristic Group1 Group 2 Group 3 P-value Other Medical History Diabetes Chronic Lung Disease Thyroid Disease Chronic Kidney Disease Prior Ischemic Stroke or TIA Prior Embolic Events (non- cerebrovascular) N=29 13 (44.
Stratos LV/LV-T Technical Manual 25 Table 2: Atrial Fibrillation Demographics at Enrollment Characteristic Group 1 Group 2 Group 3 P-value* Classification of A trial Fibrillation Persistent AF Permanent AF N=42 10 (23.8%) 32 (76.2%) N=50 17 (34%) 33 (66%) N=24 6 (25%) 18 (75%) 0.
26 Stratos LV/LV-T Technical Manual Table 2: Atrial Fibrillation Demographics at Enrollment Characteristic Group 1 Group 2 Group 3 P-value* Rate Control Medication, Reasons for Discontinuation Ineffective Not tolerated Other N=17 10 (58.8%) 8 (47.1%) 1 (5.
Stratos LV/LV-T Technical Manual 27 Table 3: Current Cardiac Medications at Enrollment Drug Category Group 1 N=42 Group 2 N=50 Group 3 N=25 P- val ue* Anti-Arrhythmics 12 (28.6%) 10 (20.4%) 4 (16.0%) 0.480 Rate Control Medications 32 (76.2%) 43 (87.8%) 20(80.
28 Stratos LV/LV-T Technical Manual • The study was designed to enroll 265 patients. However, the study was te rminated early due to slow patient enrollment.
Stratos LV/LV-T Technical Manual 29 Primary Endpoint—Complication-free Rate (Safety ) The safety of the Strato s LV was evaluated based on complications (adverse events t hat require additional inva.
30 Stratos LV/LV-T Technical Manual Table 4: AVAIL CLS/CRT Complication-Free Rate at 6 months – Stratos LV Category Number of Patients % of Patients Number of Complications Complications per patient- year Device-Related Pocket Infection/Pain 1 1.3% 2 0.
Stratos LV/LV-T Technical Manual 31 Table 4: AVAIL CLS/CRT Complication-Free Rate at 6 months – Stratos LV Category Number of Patients % of Patients Number of Complications Complications per patient- year Other Medical Worsening CHF 2 2.7% 2 0.03 Repeat Ablation 3 4.
32 Stratos LV/LV-T Technical Manual Complications and observations fo r the Stratos LV study groups are summarized in Table 5 and Table 6 . The total number of patients may not equal the sum of the number of patients listed in each category, as an indivi dual patient may have experienced more than one complication or observation.
Stratos LV/LV-T Technical Manual 33 Table 5: Summary of Complications – Stratos LV Category Number of Patients % of Patients Number of Complications Complications per patient- year Device-Related Pocket Infection or Pain 2 2.7% 3 0.05 Total 2 2.7% 3 0.
34 Stratos LV/LV-T Technical Manual Table 5: Summary of Complications – Stratos LV Category Number of Patients % of Patients Number of Complications Complications per patient- year Repeated ablation 3 4.0% 3 0.05 Lead addition 1 1.3% 1 0.02 Other medical 3 4.
Stratos LV/LV-T Technical Manual 35 Table 6: Summary of Observ ations – Stratos LV Category Number of Patients % of Patients Number of Complications Observations per patient- year Other Medical Dizziness 3 4.0% 3 0.05 Other Medical 24 32.0% 34 0.53 Worsening CHF 8 10.
36 Stratos LV/LV-T Technical Manual Primary Endpoint: Six Minute Walk Test & QOL (Effectiveness) The purpose of Primary Endpoint 1 was to evaluate the effectiveness of the CRT (Groups 1 and 2) compared to RV only (Group 3) pacing as measured by the average composite rate of improvement in six minute walk test and QOL.
Stratos LV/LV-T Technical Manual 37 Table 8: Composite of Six Minute Walk Test and QOL (Effectiveness) Category CRT (Group 1 & 2) (N = 53) Mean ± SE RV only Group 3 (N = 15) Mean ± SE p va lue (student’s t-test, 2-sided) Distance Walked at Baseline 262.
38 Stratos LV/LV-T Technical Manual Primary Effectiv eness Endpoint Analysis and Conclusions The primary effectiveness endpoint evaluated CRT effectiveness (Groups 1 and 2) compared to RV only effecti.
Stratos LV/LV-T Technical Manual 39 The gender distribution in this clinical investigation was consistent within the study groups and included a representative proportion of enrolled female participants (57.
40 Stratos LV/LV-T Technical Manual Clinical Inclusion Criteria To support the objectives of this investigation, patients were required to meet the following inclusion criteria prior to enrollment: .
Stratos LV/LV-T Technical Manual 41 Clinical Endpoints The safety of the Strato s LV was evaluated based on complications (adverse events t hat require additional invasive intervention to resolve) rel.
42 Stratos LV/LV-T Technical Manual Table 9: Patient Demographics Characteristic Results Age at Implant (Years) n=88 Mean ± SD 68 ± 10 Range 34 to 84 Gender n=89 Male 66 (74%) Female 23 (26%) QRS-w .
Stratos LV/LV-T Technical Manual 43 Safety and Effectiv eness Results • The cumulative implant duration was 760 months with a mean duration of 9.2 months. Sixty-five (77%) of the patients had implant durations greater than 6 months. • The implant success rate fo r the Stratos LV CRT-P was 100% (89 out of 89).
44 Stratos LV/LV-T Technical Manual The freedom from Stratos LV system-related and procedure- related complications was 88.76% with a one sided lower 95% confidence bound of 81.69%. Theref ore, the null hypothesis was rejected, and it was concluded that the complication-free rate at 6 months is equivalent to 85% within 10% (p = 0.
Stratos LV/LV-T Technical Manual 45 Table 10: Summary of Complications at 6 months Category Number of Patients % of Patients Number of Complications Complications per patient- year Device Related Pocket infection 1 1.1% 1 0.02 Total 1 1.1% 1 0.02 Total System Related 10 11.
46 Stratos LV/LV-T Technical Manual Table 11: Summary of Observ ations at 6 months Category Number of Patients % of Patients Number of Observations Observations per patient- year Device Related Pocket infection/ Pericardial Effusion 1 1.1% 1 0.02 Total 1 1.
Stratos LV/LV-T Technical Manual 47 1.7.3 AVAIL and OVID Combined Primary Endpoint-Complication-free Rate (Safety) The results from for the AVAIL CLS/CRT and OVID studies were pooled to evaluate the safety of the Stratos LV device.
48 Stratos LV/LV-T Technical Manual Table 12: OVID and AVAIL Complication-Free Rate - Stratos LV Category Number of Patients % of Patients Number of Complications Complications per patient- year Device Related Pocket Infection 2 1.2% 3 0.02 Total 2 1.
Stratos LV/LV-T Technical Manual 49 The freedom from Stratos LV system-related and procedure- related complications was 87.2% with a one sided lower 95% confidence bound of 82.
50 Stratos LV/LV-T Technical Manual Primarily, the study evaluates and compares the functional benefits of CRT between the two randomized groups using a composite endpoint consisting of a six-minute walk test (meters walked) and quality of life measurement (assessed using the Minnesota Living with Heart Failure Questionnaire).
Stratos LV/LV-T Technical Manual 51 • Ability to tolerate the surgical procedure required for implantation • Ability to complete all required testing including the six- minute walk test and cardio.
52 Stratos LV/LV-T Technical Manual Follow -Up Schedule After successful enrollment, all patients were randomly assigned to either the study group or t he control group.
Stratos LV/LV-T Technical Manual 53 Enrolled and Randomized Patients Study 1 33 Cont rol 67 No im plan t A ttem pted Withdrawal of Consent Study 2 Control 1 Not Meeti ng Inclusion Criteria Study 1 Con.
54 Stratos LV/LV-T Technical Manual Table 13: Patient Demographics at Pre-Enrollment Characteristic Study N=133 Control N=67 P- valu e Age at Enrollment (Years ) Mean ± SE Range 69.5 ± 0.9 43 to 88 69.1 ± 1.2 38 to 84 0.781* Gender Male Female 93 (69.
Stratos LV/LV-T Technical Manual 55 Table 14 provides a summary of ca rdiac medications patients were taking at the time of enrollment. Some categories may be more than 100% as several categories allow more than one response.
56 Stratos LV/LV-T Technical Manual • There were 192 endocardial and 19 epicardial leads implanted in 193 patients. Investigators were allowed to choose among any legally marketed LV lead according to their familiarity with t he lead and patient anatomy.
Stratos LV/LV-T Technical Manual 57 Table 15: Composite of Six Minute Walk Test and QOL (Effectiveness) Category Study Group (N = 74) Mean ± SE Control Group (N = 38) Mean ± SE P-value * Distance Walked at Baseline 310.51 ± 10.89 288.76 ± 15.37 0.
58 Stratos LV/LV-T Technical Manual Primary Effectiv eness Endpoint Analysis and Conclusions A composite rate of six minute walk test and QOL improvement from Baseline to the Six-Month follow-up is evaluated as a measure of CRT effectiveness. For this analysis both six minute walk test and QOL are equally weighted at 50%.
Stratos LV/LV-T Technical Manual 59 There are no clinically relevant di fferences in the six minute walk test results between the st udy and the control group. 2. The purpose of this secondary endpoint is to evaluate the improvement in the patient’s NYHA classification.
60 Stratos LV/LV-T Technical Manual Multi-site Poolability and Gender Analy sis The OPTION CRT/ATx clinical r eport includes data from multiple centers with centralized coor dination, data processing, and reporting at BIOTRONIK.
Stratos LV/LV-T Technical Manual 61 1.7.5 Conclusions Drawn from Studies The clinical study results suppor t the safety and effectiveness of the Stratos LV CRT-P device.
62 Stratos LV/LV-T Technical Manual.
Stratos LV/LV-T Technical Manual 63 2. Programmable Parameters For a complete list of programmable parameters and the available settings for the Stra tos CRT-Ps, see Section 11. 2.1 Pacing Modes For a complete list of pacing modes available in each Stratos CRT-P configurat ion, see Section 11.
64 Stratos LV/LV-T Technical Manual In the case of ventricular s ensed events outside of the AV delay and the VES discrimination interval after a ventricular extrasystole (VES or PVC), the basic interval starts without simultaneously starting an AV delay.
Stratos LV/LV-T Technical Manual 65 Table 18: Timing Intervals Event Timing Interval Ap As As (PMT) Vp Vsp VS VES AV delay X X Safety AV delay X Interference interval (A) X X Interference interval (V).
66 Stratos LV/LV-T Technical Manual In the DDI/T and DVT pacing modes, the basic interval is not restarted if ventricular sensi ng occurs within the AV delay.
Stratos LV/LV-T Technical Manual 67 2.1.3 DDI In contrast to DDD mode, the basic interval in the DDI mode is not restarted by sensed P-waves, but by ventricular sensed or paced events.
68 Stratos LV/LV-T Technical Manual 2.1.6 AAI and VVI The pacing modes AAI and VVI pr ovide atrial and ventricular demand pacing. The lower rate timer is started by a sense or pace event.
Stratos LV/LV-T Technical Manual 69 2.1.11 OFF (ODO) In this mode, pacing and sensing functions are off. The OFF mode is used to determine and ev aluate the morphology of an intrinsic rhythm. With external pulse control, the OFF mode is used for electrophysiological studies.
70 Stratos LV/LV-T Technical Manual During biventricular pacing in the Stratos CRT-Ps, the right ventricle is paced first. Starting from the initially paced chamber (RV), the intraventricular conduction time (VV delay) is permanently set to 5 ms after a right ventricular sensed or paced event.
Stratos LV/LV-T Technical Manual 71 In the ventricular-controlled modes, the basic interval is started by a ventricular event. C AUTION Programming Modifications – Extreme programming changes should only be made after careful clinical assessment.
72 Stratos LV/LV-T Technical Manual The rate hysteresis is deactiva ted in the standard setting, but can be programmed from -5… (-5) … -90. If Hysteresis is used in the DDI mode, the AV delay must be programmed shorter than the spontaneous AV conduction time.
Stratos LV/LV-T Technical Manual 73 Figure 3. Scan Hysteresis Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may reduce device energy consumption. The number of scan interval is programmable, OFF, 1…(1)…15 cycles. N OTES : Scan Hysteresis is not active during the programmed Night Mode.
74 Stratos LV/LV-T Technical Manual 2.3.4 Repetitive Hysteresis Repetitive hysteresis is expanded programmability of the Hysteresis feature. Repetitiv e hysteresis searches for an underlying intrinsic cardiac rhythm, which may exist slightly below the programmed lower rate (or sensor-indicated rate) of the patient.
Stratos LV/LV-T Technical Manual 75 Repetitive Hysteresis is only available when Hysteresis is selected on. Magnet application (closing of reed switch) suspends 180 consecutive event counter independent of synchronous or asynchronous magnet effect.
76 Stratos LV/LV-T Technical Manual 2.3.6 Refractory Periods Sensed events that occur during the refractory period have no effect on pacemaker timing. Thes e atrial or ventricular sensed events are classified as “unused” for normal CRT-P timing.
Stratos LV/LV-T Technical Manual 77 In the case an atrial sense event falls within the PMT protection window, the Stratos CRT-Ps start a minimal ARP. 2.
78 Stratos LV/LV-T Technical Manual 2.3.8 Ventricular Refractory Period In all modes in which a ventricular depolarization can be sensed, the Stratos CRT-Ps begin a ventri cular refractory period after each ventricular event, using a standard value of 250 ms (programmable as 150…(35)…500 ms).
Stratos LV/LV-T Technical Manual 79 The Dynamic AV Delay is intended to mimic the physiologic, catecholamine-induced shortening of the AV Delay with increasing rate.
80 Stratos LV/LV-T Technical Manual 2.3.9.4 AV Scan Hy steresis With AV Scan Hysteresis enabled, after 180 consecutive pacing cycles, the AV delay is extended for the programmed number of pacing cycles (OFF; 1…(1)…10 cycles ). If an intrinsic rhythm is detected within the extended AV delay and the longer AV delay remains in effect.
Stratos LV/LV-T Technical Manual 81 2.3.12 Ventricular Blanking Period The ventricular blanking time is the period after an atrial pacing pulse during which ventricular sensing is deactivated. It is intended to prevent ventricular sens ing of the atrial pacing pulse (“crosstalk”).
82 Stratos LV/LV-T Technical Manual Figure 5. Ventricular blanking time and safety AV 2.4 Pacing and Sensing Functions 2.4.1 Pulse Amplitude and Pulse Width The pulse amplitude and pulse width can be independently programmed for all three channels of the Stratos CRT-Ps.
Stratos LV/LV-T Technical Manual 83 C AUTION Pulse Amplitude – Programming of pulse amplitudes, higher than 4.8 V, in combination with long pulse widths and/or high pacing rates can lead to premature activation of the replacement indicator. If a pulse amplitude of 7.
84 Stratos LV/LV-T Technical Manual The Stratos CRT-Ps have a s pecially designed header that allows the CRT-Ps to simultaneous ly sense and pace in both the right and left ventricles. Bivent ricular pacing therapy requires programming of a bipolar pacing conf iguration in the ventricle.
Stratos LV/LV-T Technical Manual 85 C AUTION Lead Check – Lead check will not lead to disabling of cardiac resynchronization therapy. It limits the use of the resynchronization features. 1. Lead check is possible only when the right ventricle is paced first.
86 Stratos LV/LV-T Technical Manual 2.6 Antitachycardia Functions: The antitachycardia functions include: • Upper basic rate • Tachycardia mode • Tachycardia behavior • Mode Switching • PMT Management • Preventive Overdrive Pacing • Post-AES Pacing 2.
Stratos LV/LV-T Technical Manual 87 Wenckebach Behavior If the end of the AV delay falls within the upper threshold rate interval, ventricular pacing o ccurs at the end of the upper tracking interval. 2:1 Behavior If the high-rate atrial event occu rs in the ARP, the FFP or PMT protection window, an AV delay is not started.
88 Stratos LV/LV-T Technical Manual 2.8 Mode Switching Mode sw itching prev ents the conduction of paroxysmal atrial tachycardias to the v entricle. Therefore, after sensing an atrial tachycardia while in activated mode sw itching, the CRT-P automatically sw itches to an atrial-controlled R- mode.
Stratos LV/LV-T Technical Manual 89 Reversion back to the programmed pacing mode occurs in a similarly programmable manner. If a programmable number of atrial intervals (Z) out of 8 cons ecutive atria.
90 Stratos LV/LV-T Technical Manual To prevent occurrence of a PMT, Stratos CRT-Ps start an atrial PMT protection interval after eac h ventricular paced event (right or left). If an atrial even is s ensed within this PMT protection interval, this will neither start an AV delay nor a basic interval.
Stratos LV/LV-T Technical Manual 91 Confirmation When the suspicion criterion has been met, the Stratos CRT-Ps slightly modify the AV delay in terval (+ or - 50 ms) for one cardiac cycle. If the Vp-As interval remains stable, a PMT is confirmed. Otherwise, a PMT is not confirmed and the algorithm restarts.
92 Stratos LV/LV-T Technical Manual When the PMT is detected and te rminated, the PMT protection interval is extended by 50 ms. If no additional PMTs arise within two days, the length of the PMT pr otection interval is reduced by another 50 ms. If additional PMTs occur, the PMT protection interval is increased by another 50 ms.
Stratos LV/LV-T Technical Manual 93 The features of Atrial Overdrive pacing include: After every atrial sensed event (non-AES), the pacing rate is increased by a programmable rate increase above the last P-P interval (2… (2)…10 ppm).
94 Stratos LV/LV-T Technical Manual C AUTION Overdrive Pacing Mode - When programming the overdrive pacing mode, check whether the selected program can cause PMT, and whether atrial over drive pacing would result. Corresponding to the measured retrograde conduction time, the PMT protection interval must be programmed to a correct value.
Stratos LV/LV-T Technical Manual 95 2.13.2 Post AES Stimulation The post AES stimulation (pacing) can be programmed for all atrial-controlled modes (i.e., DDD(R), DDT/A(R), AAI(R) and AAT(R). If an AES is detected, the pacemaker starts a "Post AES Interval".
96 Stratos LV/LV-T Technical Manual The following diagnostic functions are available to tailor rate adaptive pacing for the individual patient. 2.14.2 Sensor Gain The sensor gain defines the sl ope of the linear function between exertion and pacing rate.
Stratos LV/LV-T Technical Manual 97 When the Automatic Sensor Gain is activated, the CRT-P samples the sensor-indicated rate. If, during the 24 hour period beginning at midnight, the total time recorded at maximum sensor rate exceeds 90 seconds , the sensor gain setting is reduced by one step.
98 Stratos LV/LV-T Technical Manual 2.14.6 Maximum Activity Rate Regardless of the sensor signal amplitude, the pacing rate during sensor-driven operation will never exceed the programmed maximum activity rate (MAR). The maximum activity rate only limits the pacing rate during sensor-driven operation and is independent of the rate limit.
Stratos LV/LV-T Technical Manual 99 2.16 Rate Fading Rate Fading is intended to prevent a sudden drop in heart rate when the Stratos CRT-Ps transition from tracking an intrinsic rhythm to pacing due to an abrupt decrease in the intrinsic rate or due to Mode Switching.
100 Stratos LV/LV-T Technical Manual Table 23. Backup and Target Rates Feature Description Backup Rate Rate that the CRT-P uses to pace when there is a sudden rate decrease. This can be a maximum of 10 ppm less than the intrinsic rate and follows the Target Rate with a 1 to 6 ppm per cycle increase or 0.
Stratos LV/LV-T Technical Manual 101 C AUTION Patient’s Ability - Use of the Home Monitoring system requires the patient and/or car egiver to follow the system instructions and cooperate fully when transmitting data.
102 Stratos LV/LV-T Technical Manual C AUTION Patient-Activated Report - The magnet effect must be programmed “synchronous” if the [Patient Report] function is activated.
Stratos LV/LV-T Technical Manual 103 2.17.2 Patient Device The patient device ( Figure 9 ) is designed for use in or away from the home and is comprised of the mobile unit and the associated charging station. T he patient can carry the mobile unit during his or her occupational and leisure activities.
104 Stratos LV/LV-T Technical Manual Table 24: System Requirements / Recommendations System Requirements System Recommendations (for Optimal Usage) Screen Resolution 800 x 600 ≥ 1024 x 768 Internet Bandwidth 56 kB/sec ≥ 128 kB/sec (DSL, cable modem) PC 600 MHz, 128 MB RAM N/A Internet Browser MS Internet Explorer 5.
Stratos LV/LV-T Technical Manual 105 Figure 9: Example of Patient Device with Charging Stand 2.17.4 Types of Report Transmissions When the Home Monitoring function is activated, the transmission of a .
106 Stratos LV/LV-T Technical Manual The length of the time interval (m onitoring interval) is preset to “daily”. For each monitoring interval, a data set is generated in the implant and the transmission is initiated at the designated time. 2.17.4.
Stratos LV/LV-T Technical Manual 107 N OTE : The attending physician must not ify the BIOTRONIK Service Center about which of these events he/she wishes to be informed. 2.17.4.3 Patient Report It is possible to trigger a transmission through magnet application over the CRT-P.
108 Stratos LV/LV-T Technical Manual Heart Failure Diagnostics • Mean Ventricular Heart Rate [ppm] • Mean Ventricular Heart Rate at Rest [ppm] • VES / 24 Hour • Daily Activity (hours) • Numb.
Stratos LV/LV-T Technical Manual 109 2.18 Statistics Stratos CRT-Ps can store a variety of statistical information. The various statistics consist of such features as rate histograms, event counters, sensor trends , VES statistics, and activity reports, which are described in the following sections.
110 Stratos LV/LV-T Technical Manual 2.18.6 General Statistical Information • The Stratos CRT-P’s statistics modes are always in operation and cannot be selected OFF.
Stratos LV/LV-T Technical Manual 111 2.20 Timing Statistics 2.20.1 Event Counter The event counter totals all of the sensed and paced events from all three channels.
112 Stratos LV/LV-T Technical Manual N OTE : The VV value can deviate from the number of VES’ since the Stratos CRT-Ps can also classi fy ventricular sensed events that were preceded by an atrial event such as extrasystoles via the AVES discrimination function after As.
Stratos LV/LV-T Technical Manual 113 N OTE : The bars of the histogram are standardized to a rate class width of 10 ppm to avoid distortion of the rate distribution.
114 Stratos LV/LV-T Technical Manual In addition to the detection rate, an AF is classified using X-out- of-8 algorithm of mode switchi ng. If mode switching is not programmed, the standard setting of 5-out-of-8 is used.
Stratos LV/LV-T Technical Manual 115 AES vs. Atrial Rate Information about the number of AES events as a function of the atrial rate can be found in the AES vs Atrial Rate Histograms. For Stratos CRT-Ps, single AES bar chart displays the percentage of specific AES in 17 di fferent rate ranges (< 40 ppm to > 180 ppm).
116 Stratos LV/LV-T Technical Manual VES Classification VES vs. Ventricular rate The VES versus the ventricular rate is likewise displayed in a histogram with 16 equidistant cl asses of < 40 to 180 ppm. The graphic display shows the percentage values of the individual classes in the form of a bar c hart and the total number of events.
Stratos LV/LV-T Technical Manual 117 2.22.2 Activity Report This feature operates by recording characteristic pulse generator data related to patient activity and pacing the system. It is div ided into three ranges: • No Activity • Activity • MAR (Maximum Activity Rate) This data can assist in the analys is of heart and sensor activity.
118 Stratos LV/LV-T Technical Manual R-Wave Trend This is the sensitivity of the vent ricles displayed over time. The R-wave trend is displayed in the form of a line chart. The R- wave trend is a rolling, long-term trend with a fixed resolution of 36 hours.
Stratos LV/LV-T Technical Manual 119 3. Follow-up Procedures 3.1 General Considerations The CRT-P follow-up serves to verify appropriate function of the pacing system, and to optimize the parameter settings. In most instances, pacing system malfunction attributed to causes such as chronic threshold can be corrected by reprogramming the CRT-Ps.
120 Stratos LV/LV-T Technical Manual.
Stratos LV/LV-T Technical Manual 121 4. Real-Time IEGM Stratos CRT-Ps offer the option of real-time transmission of the unfiltered intracardiac elec trogram (IEGM). In the Stratos devices, it is possible to simultaneously transmit the IEGM from all three channels as well as the IEGM marker channel.
122 Stratos LV/LV-T Technical Manual A total of 64 recordings can be stored. Each of the four triggering types of recording can be assigned a specific number (i.e., X out of 64). When a newly saved recording exceeds the programmed number of recordings per event, the oldest recording is deleted.
Stratos LV/LV-T Technical Manual 123 5. Battery, Pulse and Lead Data The following pulse, battery and lead data can be measured noninvasively by means of analog telemetry: Table 25.
124 Stratos LV/LV-T Technical Manual To determine the threshold, the ECG must be observed continuously. Based on the measured threshold, the pulse amplitude for the permanent program should be adjusted. Please consult the pertinent medi cal literature for specific recommendations regarding necessary safety margins.
Stratos LV/LV-T Technical Manual 125 5.3 Testing for Retrograde Conduction Retrograde conduction from the vent ricle to the atrium can be assumed when a 1:1 relations hip between the ventricular stimulation and atrial depolariz ation has been obtained with a constant coupling interval during ventricular stimulation.
126 Stratos LV/LV-T Technical Manual 5.4.2 Burst Stimulation Burst Stimulation offers a burst of pacing pulses to either atrium or ventricle when the programming wand is placed directly over the CRT-P. The duration of the bur st is as long as the burst key on the programmer is touched.
Stratos LV/LV-T Technical Manual 127 5.4.5 NIPS Safety Features The BIOTRONIK offers the following safety features during NIPS sessions. • Before the NIPS feature can be used, NIPS must be specifically selected and then is released through user acknowledgment.
128 Stratos LV/LV-T Technical Manual.
Stratos LV/LV-T Technical Manual 129 6. Other Functions/Features Stratos CRT-Ps offer many additional functions and features to assist with the physician in the care of the pacemaker patient.
130 Stratos LV/LV-T Technical Manual 6.2 Patient Data Memory Individual patient data can be stored in the Stratos CRT-Ps. For example, the follow ing are stored: • Patient name • Patient index (ho.
Stratos LV/LV-T Technical Manual 131 6.4 Magnet Effect Automatic Magnet Effect: After magnet application the pul se generator paces at 90 ppm for 10 cycles asynchronously. Thereafter, the pulse generator paces synchronously at the programmed basic rate.
132 Stratos LV/LV-T Technical Manual 6.6 Pacing When Exposed to Interference C AUTION EMI – Computerized systems are subject to (Electromagnetic Interference (EMI) or “noise”. In the presence of such interference, telemetry communication may be interrupted and prevent programming of the Stratos CRT-P.
Stratos LV/LV-T Technical Manual 133 Table 27: Response to EMI MODE EMI* (A) EMI* (V) EMI* (A+V) DDD(R) DDI(R) DVI(R) VDD(R) VVI(R) AAI(R) DDT DDI/T DVT VDT VDI VVT AAT DVD(R) DVI(R) --- VVI(R) --- AO.
134 Stratos LV/LV-T Technical Manual.
Stratos LV/LV-T Technical Manual 135 7. Product Storage and Handling 7.1 Sterilization and Storage Stratos CRT-Ps are shipped in a cardboard box, equipped with a quality control seal and product information label.
136 Stratos LV/LV-T Technical Manual C AUTION FOR SINGLE USE ONLY - Do not re-sterilize the CRT-P or accessories packaged with the CRT-P, they are intended for one-time use. Device Packaging – Do not use the device if the packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised.
Stratos LV/LV-T Technical Manual 137 Peel off the sealing paper of the outer container as indicated by the arrow. Take out the inner sterile container by the gripping tab and open it by peeling the sealing paper as indicated by the arrow.
138 Stratos LV/LV-T Technical Manual C AUTION Muscle or Nerve Stimulation – Inappropriate muscle or nerve stimulation may occur with unipolar pacing when using a non-coated Stratos CRT-P.
Stratos LV/LV-T Technical Manual 139 8. Lead Connection 8.1 Lead Configuration The Stratos CRT-Ps allows programming of separate lead polarities for pacing and sensing. Lead polarity can also be programmed separately in both the atrial and ventricular channels.
140 Stratos LV/LV-T Technical Manual Table 28: Lead Configuration Configuration Description bipolar RV tip Æ RV ring Sensing * RV unipolar RV tip Æ Case bipolar RV tip Æ RV ring RV unipolar RV tip Æ Case bipolar LV tip Æ LV ring Pacing † LV unipolar LV tip Æ Case 8.
Stratos LV/LV-T Technical Manual 141 Lead Compatibility The Stratos CRT-Ps have been designed for connection with a bipolar lead in the atrium and two bi polar leads in the ventricle. All connections are IS-1 compatib le. Appropriate adapters (e.g., A1-A) should be fitted when using leads with a different connection.
142 Stratos LV/LV-T Technical Manual Connecting the Stratos LV w ith the IS-1 Connector In order to avoid programming errors with the Stratos LV, always connect the leads to the following ports: Figure 10. Connecting the Leads Stratos CRT-Ps have a self-sealing header.
Stratos LV/LV-T Technical Manual 143 1. Insert the enclosed torque wrench through the perforation in the self- sealing plug at an angle perpendicular to the lead connector until it is firmly placed in the setscrew.
144 Stratos LV/LV-T Technical Manual 6. Pass non-absorbable ligature through the hole in the connector receptacle to secure the CRT-P in the pocket. C AUTION Tightening Setscrew (s) – Do not overtighten the setscrew(s). Use only the BIOTRONIK supplied torque wrench.
Stratos LV/LV-T Technical Manual 145 9. Elective Replacement Indication (ERI) Service times for the Stratos CRT-Ps vary based on several factors, including battery proper ties, storage time, lead system impedance, programmed paramet ers, amount of pacing and sensing required, and circuit operat ing characteristics.
146 Stratos LV/LV-T Technical Manual The pacing rate decreases by 11% when programmed to DDD(R), DDT(R), D00(R), VDD(R) , VDI(R), VDT(R), VVI(R), VVT(R), AAI(R), AAT(R), or A00(R). In DDI(R), DDI/T(R), DVI(R), and DVT(R) modes, only the V-A delay is extended by 11%.
Stratos LV/LV-T Technical Manual 147 The follow ing functions remain activ e w hen the replacement indication is reached: • Mode switching • PMT detection and termination • Biventricular synchronization N OTE : The statistics are frozen when ERI is reached.
148 Stratos LV/LV-T Technical Manual Table 32 shows the mean * expected time intervals (in months) from ERI to EOS at standard program for Stratos CRT-Ps.
Stratos LV/LV-T Technical Manual 149 10. Explantation Explanted devices and accessories may not be reused. Explanted CRT-Ps can be deliver ed to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal.
150 Stratos LV/LV-T Technical Manual.
Stratos LV/LV-T Technical Manual 151 11. Technical Data 11.1 Available Pacing Modes DDDR, DDTRA, DDTR, DDIR, DDI TR, DVIR, DVTR, DOOR, VDDR, VDTR, VDIR, VVIR, VVTR, VOOR, AAIR, AATR, AOOR DDD DDTA, DDT, DDI, DDIT, DVI, DV T, DOO, VDD, VDT, VDI, VVI, VVT, VOO, AAI, AAT, AOO, OFF VV synchronization for the Stratos CRT-Ps: BiV RV RV-T, OFF 11.
152 Stratos LV/LV-T Technical Manual Dynamic AV Delay (Dual chamber only) low ; medium; high; individual; fixed AV Delay Values (Dual chamber modes only ) 15… (5)…300 AV Hysteresis Off ; 10… (10.
Stratos LV/LV-T Technical Manual 153 Pulse Width 0.1; 0.2; 0.3; 0.4 ; 0.5…(0.25)…1.5 ms (3 channels separately programmable) Sensitivity A 0.1... (0.
154 Stratos LV/LV-T Technical Manual Intervention Rate 100… (10)…250 ppm X-out-of-8 Activation Criterion 3… (1)…8 Z-out-of-8 Termination Criterion 3… (1)…8 DDI(R) Basic Rate 32… (1)…88.
Stratos LV/LV-T Technical Manual 155 Rate Fading Rate Increase 0.5; 1; 2… (1)…6 ppm/cycle Rate Fading Rate Decrease 0.25; 0.5… (0.25)…1.25 ppm/cycle Lead Configuration Pacing for the Stratos L.
156 Stratos LV/LV-T Technical Manual 11.3 Diagnostic Memory Functions IEGM Recoding AF OFF; 3… (1)…31 count AF Detection Rate 100… (10)…300… (20)…400 ppm AF End Rate 100… (10)…300… (.
Stratos LV/LV-T Technical Manual 157 Patient-Triggered Messages ON, OFF Time of Trend Message 00:00... (00:10)...23:50 11.5 Additional Functions N OTE : Availability of the following functions is dependent upon pulse generator configuration.
158 Stratos LV/LV-T Technical Manual NIPS Specifications Burst Mode Burst Chamber Atrium, Ventricle Coupling Interval /ms None… 2000 Burst Type Pushbutton, Ramp Burst stimulation Burst Range / ppm 30…800 S1-S1 S1-S2, S2-S3, S3-S4, S4-S5 Cycles 0…10 Pause / ms Stop… 50 No.
Stratos LV/LV-T Technical Manual 159 11.7 Default Programs Stratos LV / LV-T Parameter/ Function Factory settings/ Standard Program Safe Program Mode DDD VVI VV Synchronization BiV RV RV-T - AV delay 150 ms at 60 ppm 120ms at 130 ppm First Chamber Paced RV - VV delay after pace 5 ms - VV delay after sense 5 ms - Pulse Amplitude 3.
160 Stratos LV/LV-T Technical Manual Parameter Stratos LV Pace Unipolar/bipolar Pulse form Biphasic, asymmetric Polarity Cathodic Input impedance > 10k Ω (RV/LV) Power source Li/I 2 Battery voltage at BOS 2.8 V Conducting surface 37.4 2 Conducting Shape Flattened ellipsoidal 11.
Stratos LV/LV-T Technical Manual 161 12. Order Information Pulse Generator Type Order Number Stratos LV 338 200 Stratos LV-T 338 202.
162 Stratos LV/LV-T Technical Manual.
Stratos LV/LV-T Technical Manual 163 Appendix A Known Softw are Anomalies Anomaly Possible Effect on Patient or Implant Procedure General Programmer Issues If a long patient name is entered without bl.
Distributed by: BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by: BIOTRONIK GmbH & Co.
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