Stratos Family of Cardiac Resynchronization 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 3.2-mm configurations (e.g., the IS-1 and VS-1 standards), lead/ CRT-P compatibility should be confirmed with the CRT-P and/or lead manufacturer prior to the implantation of the system.
Stratos LV/LV-T Technical Manual i Contents 1. General ..............................................................................1 1.1 Device Description ........................................................1 1.2 Indications .....................................................................2 1.3 Contraindications ..........................................................3 1.4 Note to Physician ..........................................................3 1.5 Warnings and Precautions ...............
ii Stratos LV/LV-T Technical Manual 2.1.11 OFF (ODO)..........................................................69 2.2 Biventricular Synchronization of the Stratos CRT-Ps..69 2.3 Timing Functions .........................................................70 2.3.1 Basic Rate ...........................................................70 2.3.2 Rate Hysteresis ...................................................71 2.3.3 Scan Hysteresis...................................................72 2.3.4 Repetitive Hysteresis.
Stratos LV/LV-T Technical Manual iii 2.14.6 Maximum Activity Rate ........................................98 2.14.7 Rate Decay..........................................................98 2.15 Sensor Stimulation ......................................................98 2.16 Rate Fading.................................................................99 2.17 Home Monitoring (Stratos LV-T)................................100 2.17.1 Transmission of Information ..............................102 2.17.
iv Stratos LV/LV-T Technical Manual 5. Battery, Pulse and Lead Data ......................................123 5.1 Threshold Test - Testing the Pacing Function ...........123 5.2 P/R Measurement - Testing the Sensing Function....124 5.3 Testing for Retrograde Conduction ...........................125 5.4 Non-Invasive Programmed Stimulation (NIPS).........125 5.4.1 Description.........................................................125 5.4.2 Burst Stimulation ...............................................
Stratos LV/LV-T Technical Manual v 12. Order Information .........................................................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 Stratos CRT-Ps provide all standard bradycardia pacemaker therapy with 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 comprised 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 contraindicated for patients with an implanted cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy. • Single chamber atrial pacing is contraindicated for patients with impaired AV nodal conduction.
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. If the procedure must be used, constant monitoring is recommended, including monitoring the peripheral pulse. Rate Adaptive Pacing – Use rate adaptive pacing with care in patients unable to tolerate increased pacing rates.
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. • Place the TENS electrodes as far from the CRT-P/lead system as possible. • Monitor cardiac activity during TENS use.
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. 1.5.2 Storage and Sterilization Storage (temperature) – Recommended storage temperature range is 5° to 55°C (41°-131°F). Exposure to temperatures outside this range may result in CRT-P malfunction (see Section 7.1).
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 measures the lead impedance with every pace. Based on these measurements, the lead configuration will be set to either unipolar or bipolar. Refer to Section 2.5 for more details regarding this feature. Caution: Lead check will not lead to disabling of cardiac resynchronization therapy. It limits the use of the resynchronization features. 1.
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. [Reference ISO 58413:1992(E)]. Lead Configuration – The polarity of the implanted lead dictates what lead configuration can be programmed for the CRT-P. Pacing will not occur with a unipolar lead if the lead configuration of the respective channel is programmed to bipolar (see Section 8).
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. Sensing – The Stratos CRT-Ps do not sense in the left ventricle. AV Conduction – In patients with intact AV conduction, the intrinsic atrial tachycardia is conducted to the ventricle 1:1.
10 Stratos LV/LV-T Technical Manual Pacing thresholds – When decreasing programmed output (pulse amplitude and/or pulse width), 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”. 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 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. Programmed to Triggered Modes – When programmed to triggered modes, pacing rates up to the programmed upper limit may occur in the presence of either muscle or external interference.
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 1.5.6. Sources of EMI including cellular telephones, electronic article surveillance systems, and others are discussed therein.
Stratos LV/LV-T Technical Manual 13 1.5.6 Electromagnetic Interference (EMI) The operation of any implanted device may be affected by certain environmental sources generating signals that resemble cardiac activity. This may result in inhibition of pacing and/or triggering or in asynchronous pacing depending on the pacing mode and the interference pattern. In some cases (i.e.
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 directly 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 its previous state of operation. Because of the great variety of cellular phones and the wide variance in patient physiology, an absolute recommendation to cover all patients cannot be made.
16 Stratos LV/LV-T Technical Manual 1.
Stratos LV/LV-T Technical Manual 17 1.7 Clinical Studies The subsequent sections summarize the following three clinical studies that were used to support the safety and effectiveness of the Stratos LV/LV-T CRT-Ps. • The AVAIL CLS/CRT clinical study • The OVID clinical study (OUS) • The OPTION CRT/ATx clinical study Two of the studies, AVAIL CLS/CRT and OVID, collected significant safety data supporting use of the Stratos LV/LV-T CRT-P system.
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. During this study, the Protos DR/CLS devices were implanted with two ventricular leads: the right ventricular lead was connected to the ventricular port, and the left ventricular lead was connected to the atrial port.
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: • Meet the indications for therapy • Persistent (documented for more than 7 days), symptomatic AF with poorly controlled rapid ventricular rates or permanent, (documented for more than 30 days with failed cardioversion, or longstanding AF of 6 months or more) symptomatic AF with poorly controlled rapid ventri
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: • Meet one or more of the contraindications • Have a life expectancy of less than six months • Expected to receive heart transplantation within six months • Enrolled in another cardiovascular or pharmacological clinical investigation • Patients with an ICD, or being considered for an ICD • Patients with p
Stratos LV/LV-T Technical Manual 21 Clinical Endpoints Primary Endpoint: Complication-free Rate (Safety) The safety of the Stratos LV was evaluated based on complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Stratos LV, the right ventricular, the left ventricular lead, lead ventricular lead adapters (if used) and the implant procedure. The target complication-free rate at six months is 85%.
22 Stratos LV/LV-T Technical Manual Enrolled and Randomized Group 1 Group 2 Group 3 Patients 43 50 25 Implant Attempted Group 1 39 Group 2 44 Group 3 21 Successful implant Group 1 33 Group 2 42 Group 3 18 Completed 6-Month Follow-up Group 1 23 Group 2 30 Group 3 15 No implant Attempted Withdrawal of Consent Group 1 2 Group 2 4 Group 3 3 Not Meeting Inclusion Criteria Group 1 2 Group 2 2 Group 3 1 Unsuccessful implant Withdrawal of IC before 2nd Attempt Group 1 4 Group 2 2 Group 3 3 Follow-up to failed
Stratos LV/LV-T Technical Manual 23 Table 1: Patient Demographics at Enrollment Characteristic Group1 Group 2 Group 3 Age @ 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 Gender Male Female N=42 18 (42.9%) 24 (57.1%) N=50 19 (38.0%) 31 (62.0%) N=25 13 (52.0%) 12 (48.0%) N=42 262.7 ± 15.1 78 to 420 N=50 283.6 ± 13.8 37 to 438 N=25 267.8 ± 22.9 23 to 420 N=42 23 (54.8%) 19 (45.2%) N=50 18 (36.0%) 32 (64.0%) N=25 10 (40.0%) 15 (60.
24 Stratos LV/LV-T Technical Manual Table 1: Patient Demographics at Enrollment Characteristic Other Medical History Diabetes Chronic Lung Disease Thyroid Disease Chronic Kidney Disease Prior Ischemic Stroke or TIA Prior Embolic Events (non- Group1 Group 2 Group 3 P-value N=29 13 (44.8%) 7 (24.1%) N=36 9 (25.0%) 16 (44.4%) N=17 4 (23.5%) 7 (41.2%) 0.287** 0.211** 12 (41.4%) 4 (13.8%) 12 (33.3%) 5 (13.9%) 5 (29.4%) 1 (5.9%) 0.791** 0.836** 7 (24.1%) 10 (27.8%) 6 (35.3%) 0.726** 1 (2.
Stratos LV/LV-T Technical Manual 25 Table 2: Atrial Fibrillation Demographics at Enrollment Characteristic Classification of Atrial Fibrillation Persistent AF Permanent AF Classification of Symptoms Related to AF Palpitations Chest Pain Dyspnea or shortness of breath Fatigue Lightheadedness or syncope Other Previous AF Ablation No Yes Past Medications for Rate or Rhythm Control Amiodarone Digoxin Diltiazem Disopyramide Dofetilide Flecanide Ibutilide Procainamide Propafenone Sotolol Verapamil Metoprolol Pro
26 Stratos LV/LV-T Technical Manual Table 2: Atrial Fibrillation Demographics at Enrollment Characteristic Rate Control Medication, Reasons for Discontinuation Ineffective Not tolerated Other Rhythm Control Medication, Reasons for Discontinuation Ineffective Not tolerated Other Cardioversion History Successful prior electrical cardioversion Transthoracic Transvenous Unsuccessful prior electrical cardioversion Transthoracic Transvenous No electrical cardioversion attempted Successful prior pharmacological c
Stratos LV/LV-T Technical Manual 27 Table 3: Current Cardiac Medications at Enrollment Group 1 Group 2 Group 3 N=42 N=50 N=25 12 (28.6%) 10 (20.4%) 4 (16.0%) Pvalue* Rate Control Medications 32 (76.2%) 43 (87.8%) 20(80.0%) 0.462 Drug Category Anti-Arrhythmics Anti-thrombic Agents Anti-Coagulants ACE Inhibitors Angiotensin-Receptor Blockers Diuretics Inotropes 0.480 17 (40.5%) 19(38.8%) 11 (44.0%) 0.863 36 (85.7%) 40 (81.6%) 22 (88.0%) 0.686 16 (38.1%) 16 (32.7%) 8 (32.0%) 0.848 10 (23.8%) 7 (14.
28 Stratos LV/LV-T Technical Manual • The study was designed to enroll 265 patients. However, the study was terminated early due to slow patient enrollment. There were no safety issues involved in the termination decision. Due to the lack of patient data, the AVAIL CLS/CRT study alone was insufficient to support CRT pacing effectiveness or an ablate and pace indication. • The cumulative enrollment duration was 416.7 months with a mean duration of 9.7 months for Group 1, 522.
Stratos LV/LV-T Technical Manual 29 Primary Endpoint—Complication-free Rate (Safety) The safety of the Stratos LV was evaluated based on complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Stratos LV, the right ventricular, the left ventricular lead, lead ventricular lead adapters (if used) and the implant procedure. The target complication-free rate at six months is 85%.
30 Stratos LV/LV-T Technical Manual Table 4: AVAIL CLS/CRT Complication-Free Rate at 6 months – Stratos LV Category Number Complications % of Number of of per patientPatients Complications Patients year Device-Related Pocket Infection/Pain Total High Threshold No Capture Diaphragmatic Stimulation Dislodgement Total High Threshold / No Capture Total Pneumothorax User error Hematoma Total Total Lead and Procedure Related 1 1 1.3% 2 0.03 1.3% 2 LV Lead Related 0.03 1 1.3% 1 0.02 1 1.3% 1 0.
Stratos LV/LV-T Technical Manual 31 Table 4: AVAIL CLS/CRT Complication-Free Rate at 6 months – Stratos LV Category Number Complications % of Number of of per patientPatients Complications Patients year Other Medical Worsening CHF Repeat Ablation Non-CHF cardiac symptoms Other Medical Total Total—All Patients and Categories 2 2.7% 2 0.03 3 4.0% 3 0.05 3 4.0% 3 0.05 3 10 4.0% 13.3% 3 11 0.05 0.17 19 25.3% 24 0.37 Number of Patients = 75 Number of Patient-Years = 64.
32 Stratos LV/LV-T Technical Manual Complications and observations for 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 individual 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 Complications % of Number of of per patientPatients Complications Patients year Device-Related Pocket Infection or Pain Total High Threshold / No Capture Diaphragmatic Stimulation Dislodgement Total High Threshold / No Capture Total Pneumothorax User error Hematoma Total Total Lead and Procedure Related 2 2 2.7% 3 0.05 2.7% 3 LV Lead-Related 0.05 1 1.3% 1 0.02 1 1.3% 1 0.02 2.7% 2 5.
34 Stratos LV/LV-T Technical Manual Table 5: Summary of Complications – Stratos LV Category Number Complications % of Number of of per patientPatients Complications Patients year Repeated ablation Lead addition Other medical Total Total—All Patients and Categories 3 4.0% 3 0.05 1 3 12 1.3% 4.0% 16.0% 1 3 14 0.02 0.05 0.22 20 26.7% 28 0.43 Number of Patients = 75, Number of Patient-Years = 64.
Stratos LV/LV-T Technical Manual 35 Table 6: Summary of Observations – Stratos LV Number Observations % of Number of of per patientPatients Complications Patients year Category Dizziness Other Medical Worsening CHF Ventricular arrhythmias Shortness of Breath Stroke / TIA Non-CHF cardiac symptoms Total Total—All Patients and Categories 3 24 8 Other Medical 4.0% 3 32.0% 34 10.7% 8 0.05 0.53 0.12 2 2.7% 2 0.03 5 6.7% 5 0.08 1 1.3% 1 0.02 1 1.3% 1 0.02 35 46.7% 54 0.84 45 60.
36 Stratos LV/LV-T Technical Manual Primary Endpoint: (Effectiveness) Six Minute Walk Test & QOL 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 Effectiveness (Group 2 compared to Group 3): The average composite rate for Group 2 (N=30) was 48.1% with a standard error of 12.3%.
Stratos LV/LV-T Technical Manual 37 Table 8: Composite of Six Minute Walk Test and QOL (Effectiveness) CRT (Group 1 & 2) Category (N = 53) Mean ± SE * RV only Group 3 (N = 15) Mean ± SE p value (student’s t-test, 2-sided) Distance Walked at Baseline 262.8 ± 13.7 288.5 ± 22.4 0.369* Distance Walked at Six-Months 312.8 ± 14.6 345.8 ± 30.0 0.303* ∆ Distance Walked (meters) 50.0 ± 12.2 57.2 ± 26.7 0.790* ∆ Distance Walked (%) 39.0% ± 13.1% 25.7% ± 15.0% 0.610* QOL Score at Baseline 58.
38 Stratos LV/LV-T Technical Manual Primary Effectiveness Endpoint Analysis and Conclusions The primary effectiveness endpoint evaluated CRT effectiveness (Groups 1 and 2) compared to RV only effectiveness (Group 3), as measured by the composite rate of the six minute walk test and QOL improvement from Baseline to the Six-Month follow-up (Table 8). For this analysis, both six minute walk test and QOL were equally weighted at 50%.
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 (57.2% versus 42.7% male). There were no significant differences in the primary safety or effectiveness endpoints between the male and female population. 1.7.2 Stratos LV Clinical Study – OVID study The OVID clinical study collected significant safety data supporting the Stratos LV/LV-T CRT-P system.
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: • Meet the indications for bi-ventricular pacing • Age ≥ 18 years • Receiving optimal drug therapy for Congestive Heart Failure treatment • Give informed consent Clinical Exclusion Criteria To support the objectives of this investigation, the exclusion criteria at the time of patient enrollment included
Stratos LV/LV-T Technical Manual 41 Clinical Endpoints The safety of the Stratos LV was evaluated based on complications (adverse events that require additional invasive intervention to resolve) related to the implanted CRT system which includes the Stratos LV device, the atrial lead, the right ventricular lead the left ventricular lead and the implant procedure. The target complication-free rate at six months was 85%.
42 Stratos LV/LV-T Technical Manual Table 9: Patient Demographics Characteristic Age at Implant (Years) Mean ± SD Range Gender Male Female QRS-width (ms) Mean ± SD Range Etiology of Heart Failure Ischemic Non-Ischemic New York Heart Association (NYHA) Classification Class III Class IV Atrial Tachyarrhythmias None Atrial flutter Paroxysmal atrial fibrillation Results n=88 68 ± 10 34 to 84 n=89 66 (74%) 23 (26%) n=70 160 ± 23 110 to 210 n=87 32 (37%) 55 (63%) n=87 73 (84%) 14 (16%) N=87 48 (55%) 5 (5.
Stratos LV/LV-T Technical Manual 43 Safety and Effectiveness 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 for the Stratos LV CRT-P was 100% (89 out of 89). The implant success of the Stratos LV CRT-P in combination with the Corox OTW/Steroid LV lead was 94.4% (84 out of 89). • The mean LV pacing threshold at implant was 0.9 and at 6-months was 0.
44 Stratos LV/LV-T Technical Manual The freedom from Stratos LV system-related and procedurerelated complications was 88.76% with a one sided lower 95% confidence bound of 81.69%. Therefore, the null hypothesis was rejected, and it was concluded that the complication-free rate at 6 months is equivalent to 85% within 10% (p = 0.0014). Observed Adverse Events Adverse events are classified as either observations or complications.
Stratos LV/LV-T Technical Manual 45 Table 10: Summary of Complications at 6 months Category Number Complications % of Number of of per patientPatients Complications Patients year Device Related Pocket infection Total Total System Related Arrhythmias Total Overall Complication Totals 1 1.1% 1 0.02 1 1.1% 1 0.02 10 11.2% 10 0.16 Other Medical 1.1% 1 1.1% 1 0.02 0.02 1 1 10 11.2% 11 0.17 Number of Patients = 89; Number of Patient-Years = 63.
46 Stratos LV/LV-T Technical Manual Table 11: Summary of Observations at 6 months Category Number of % of Number of Patients Patients Observations Observations per patientyear Device Related Pocket infection/ Pericardial Effusion Total Total System Related Arrhythmias Shortness of breath, palpitations Total Malfunction of hemostatic valve Improper Lead preparation Total Overall Observation Totals 1 1.1% 1 0.02 1 1.1% 1 0.02 12 13.5% 13 0.21 2 Medical 2.2% 2 0.03 1 1.1% 1 0.02 3 0.
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 Complications % of Number of of per patientPatients Complications Patients year Device Related Pocket Infection Total Pneumothorax User error Hematoma Total Total Lead, Device and Procedure Related Arrhythmias Repeated ablation Worsening CHF Other Medical Non-CHF cardiac symptoms Total Total—All Patients and Categtories 2 1.2% 3 0.02 2 3 0.02 1 1 1 3 1.2% Procedure 0.6% 0.6% 0.6% 1.
Stratos LV/LV-T Technical Manual 49 The freedom from Stratos LV system-related and procedurerelated complications was 87.2% with a one sided lower 95% confidence bound of 82.09%. Therefore, the null hypothesis was rejected, and it was concluded that the complication-free rate at 6 months is equivalent to 85% within 10% and the primary safety endpoint was met (p = 0.0002)*. 1.7.
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). Relevant measurements were completed twice for each patient: once at the Baseline evaluation (two-week post implant follow-up) and again at a six-month follow-up evaluation.
Stratos LV/LV-T Technical Manual 51 • Ability to tolerate the surgical procedure required for implantation • Ability to complete all required testing including the sixminute walk test and cardiopulmonary exercise testing • Available for follow-up visits on a regular basis at the investigational site • Age greater than or equal to 18 years Clinical Exclusion Criteria To support the objectives of this investigation, the exclusion criteria at the time of patient enrollment included the following: • • •
52 Stratos LV/LV-T Technical Manual Follow-Up Schedule After successful enrollment, all patients were randomly assigned to either the study group or the control group.
Stratos LV/LV-T Technical Manual 53 Enrolled and Randomized Patients Study 133 Control 67 No implant Attempted Withdrawal of Consent Study 2 Control 1 Not Meeting Inclusion Criteria Study 1 Control 1 Implant Attempted Study 130 Control 65 Unsuccessful implant Withdrawal of IC before 2nd Attempt Study 1 Control 0 Expired before Second Attempt Study 0 Control 1 Successful implant Study 129 Control 64 Patients completed 6-Month Follow-up Study 100 Control 49 6-Month Follow-up Data Patient Death before 6-
54 Stratos LV/LV-T Technical Manual Table 13: Patient Demographics at Pre-Enrollment Study N=133 Control N=67 Pvalue 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 (69.9%) 40 (30.1%) 51 (76.1%) 16 (23.9%) 0.407** Underlying Heart Disease 100 (75.2%) Ischemic Cardiomyopathy Nonischemic Cardiomyopathy 34 (25.6%) 54 (80.6%) 15 (22.4%) 0.
Stratos LV/LV-T Technical Manual 55 Table 14 provides a summary of cardiac medications patients were taking at the time of enrollment. Some categories may be more than 100% as several categories allow more than one response. Table 14: Cardiac Medications at Pre-Enrollment Drug Study Control PCategory (N=133) (N=67) value Specific CHF Medications 89 (66.9%) 45 (67.2%) 1.000** ACE inhibitors Angiotensin receptor blockers 21 (15.8%) 16 (23.9%) 0.180** Beta blockers 111 (83.5%) 55 (82.1%) 0.
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 the lead and patient anatomy. The Tupos LV/ATx CRT-D was implanted with 7 endocardial and 4 epicardial lead models from 6 different manufacturers. There were no adverse events reported attributable to lead-generator incompatibility. • The cumulative implant duration is 1240.
Stratos LV/LV-T Technical Manual 57 Table 15: Composite of Six Minute Walk Test and QOL (Effectiveness) Study Group (N = 74) Mean ± SE Control Group (N = 38) Mean ± SE P-value* 310.51 ± 10.89 288.76 ± 15.37 0.249 340.77 ± 12.32 301.84 ± 17.02 0.067 30.26 ± 10.40 17.27% ± 5.59% 13.08 ± 13.05 8.71% ± 5.26% 0.322 0.326 QOL Score at Baseline 44.39 ± 2.78 45.53 ± 4.13 0.817 QOL Score at Six-Months 28.68 ± 2.66 33.95 ± 4.35 0.279 ∆ in QOL Score† 15.72± 2.83 19.08% ± 12.21% 11.58 ± 3.45 -13.
58 Stratos LV/LV-T Technical Manual Primary Effectiveness 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%. The mean difference in the composite rate between study and control group was 20.53% with an associated one-sided, 95% confidence bound of (-6.10%).
Stratos LV/LV-T Technical Manual 59 There are no clinically relevant differences in the six minute walk test results between the study and the control group. 2. The purpose of this secondary endpoint is to evaluate the improvement in the patient’s NYHA classification. Table 17 summarizes the average improvement in NYHA from Baseline to Six-Months for 140 patients that were able to complete both NYHA classification evaluations.
60 Stratos LV/LV-T Technical Manual Multi-site Poolability and Gender Analysis The OPTION CRT/ATx clinical report includes data from multiple centers with centralized coordination, data processing, and reporting at BIOTRONIK. All of the clinical centers followed the requirements of an identical clinical protocol, and all of the clinical centers used the same methods to collect and report the clinical data. In order to justify pooling of the data from multiple centers, several analyses were completed.
Stratos LV/LV-T Technical Manual 61 1.7.5 Conclusions Drawn from Studies The clinical study results support the safety and effectiveness of the Stratos LV CRT-P device. • The OPTION CRT/ATx clinical study completed and reviewed under P050023 provided a reasonable assurance that bi-ventricular pacing is effective in NYHA class III/IV heart failure patients with a prolonged QRS and a left ventricular ejection fraction <35%.
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 Stratos CRT-Ps, see Section 11. 2.1 Pacing Modes For a complete list of pacing modes available in each Stratos CRT-P configuration, see Section 11.1. 2.1.1 Rate-adaptive Modes The rate-adaptive modes are designated with an “R” in the fourth position of the NBG pacemaker code on the programmer screen.
64 Stratos LV/LV-T Technical Manual In the case of ventricular sensed 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. To protect the atrium from retrograde conduction, an extended PMT protection window is started at the same time as the basic interval.
Stratos LV/LV-T Technical Manual 65 Timing Interval AV delay Safety AV delay Interference interval (A) Interference interval (V) Blanking time (A) after Ap Blanking time (V) after RVp Atrial upper rate (AUR) Far-field Protection (A) PMT Protection (A) PMT protection extension (A) Table 18: Timing Intervals Event Ap As As Vp Vsp (PMT) X X VS VES X X X X X X X X X X X X X X X X X Trigger Pacing The triggered pacing modes are identical to the respective demand modes except that the sensing o
66 Stratos LV/LV-T Technical Manual In the DDI/T and DVT pacing modes, the basic interval is not restarted if ventricular sensing occurs within the AV delay. C AUTION Programmed to Triggered Modes – When programmed to triggered modes, pacing rates up to the programmed upper limit may occur in the presence of either muscle or external interference.
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. The VA delay is started together with the basic interval. If atrial or ventricular sensing does not occur during the VA delay, the atrial pacing occurs at the end of the VA delay. Atrial pacing starts the AV delay.
68 Stratos LV/LV-T Technical Manual 2.1.6 AAI and VVI The pacing modes AAI and VVI provide atrial and ventricular demand pacing. The lower rate timer is started by a sense or pace event. A sense event outside of the refractory period inhibits pacing and resets the lower rate timer; in the absence of a sense event, a pulse generator pulse will be emitted at the end of the lower rate interval. 2.1.7 AAI, VVI The AAI and VVI single-chamber pacing modes are used in atrial and demand pacing.
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 evaluate the morphology of an intrinsic rhythm. With external pulse control, the OFF mode is used for electrophysiological studies. The OFF mode can be programmed temporarily. C AUTION OFF Mode – The OFF mode can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous rhythm. (see Section 2.1.11). 2.
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. N OTE : While ventricular pacing and sensing events are synchronized, synchronization does not occur during ventricular extrasystoles.
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. Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm. 2.3.2 Rate Hysteresis Rate Hysteresis can be programmed in DDD(R), DDT(R), DDT(R)/A, DDI(R), VDD(R), VDT(R), VDI(R), VVI(R), VVT(R), AAI(R) and AAT(R) modes.
72 Stratos LV/LV-T Technical Manual The rate hysteresis is deactivated 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. Otherwise, stimulation in the absence of spontaneous activity occurs at the hysteresis rate instead of the lower rate. Hysteresis is suspended during the Night Mode activated 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. Scan Hysteresis is only available when Hysteresis is selected on. Magnet application (closing of reed switch) suspends 180 consecutive event counter independent of the magnet effect.
74 Stratos LV/LV-T Technical Manual 2.3.4 Repetitive Hysteresis Repetitive hysteresis is expanded programmability of the Hysteresis feature. Repetitive hysteresis searches for an underlying intrinsic cardiac rhythm, which may exist slightly below the programmed lower rate (or sensor-indicated rate) of the patient. Following 180 consecutive sensed events, this feature allows the intrinsic rhythm to drop to or below the hysteresis rate.
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. There is one Standard Hysteresis interval which occurs before the programmable number of Repetitive Hysteresis occurs. The repetitive rate hysteresis is deactivated in the standard setting, but can be programmed to 1… (1) …15 cycles. 2.3.
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. These atrial or ventricular sensed events are classified as “unused” for normal CRT-P timing. In the Stratos CRT-Ps, the total atrial refractory period has been subdivided into an atrial refractory period (ARP), atrial far-field protection (FFP) and a PMT protection window (PMT). In terms of priority FFP is first, ARP second and PMT third.
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. 2.3.6.2 Atrial Far-Field Protection In all dual chamber modes with atrial sensing, the Stratos CRT-Ps start an atrial FFP window upon each ventricular event to prevent sensing of far-field potentials in the ventricle.
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 ventricular refractory period after each ventricular event, using a standard value of 250 ms (programmable as 150…(35)…500 ms). 2.3.9 AV Delay 2.3.9.
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. It also serves for automatic prevention/termination of “circus movement” pacemaker mediated tachycardia and for prevention of reentrant supraventricular tachycardia (see PMT Management section). 2.3.9.
80 Stratos LV/LV-T Technical Manual 2.3.9.4 AV Scan Hysteresis 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. If an intrinsic rhythm is not detected within the number of scan cycles, the original AV delay value resumes. 2.3.
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 sensing of the atrial pacing pulse (“crosstalk”). The blanking time shall be as short as possible in order to provide ventricular sensing when a ventricular depolarization could occur.
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. The programmed pulse amplitude determines the voltage applied to the heart during each pacing pulse. The pulse amplitude is independently programmable for the atrial and ventricular channels up to 7.2 volts.
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 7.2 V or higher is programmed and high pacing rates are reached, output amplitudes may differ from programmed values. Programming Modifications – Extreme programming changes should only be made after careful clinical assessment.
84 Stratos LV/LV-T Technical Manual The Stratos CRT-Ps have a specially designed header that allows the CRT-Ps to simultaneously sense and pace in both the right and left ventricles. Biventricular pacing therapy requires programming of a bipolar pacing configuration in the ventricle. Refer to Section 8.1 for a summary of the sensing and pacing configurations in the ventricle. If a bipolar lead is connected to the CRT-P, unipolar or bipolar configuration can be programmed for pacing and sensing.
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. 2. Lead check works only when the pacing voltages are programmed between 2.4 and 4.8 V. The lead check feature can be programmed OFF in patients that require cardiac resynchronization therapy.
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 2.6.
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 occurs at the end of the upper tracking interval. 2:1 Behavior If the high-rate atrial event occurs in the ARP, the FFP or PMT protection window, an AV delay is not started. In Wenckebach mode, the CRT-P switches to ventricular timing.
88 Stratos LV/LV-T Technical Manual 2.8 Mode Switching Mode switching prevents the conduction of paroxysmal atrial tachycardias to the ventricle. Therefore, after sensing an atrial tachycardia while in activated mode switching, the CRT-P automatically switches to an atrial-controlled Rmode. Like the programmed atrial-controlled P-mode, the corresponding R-modes can be programmed: Table 21.
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 consecutive atrial intervals (p-p) are slower than the programmed mode switch intervention rate (Z out of 8), the device will revert back to the permanently programmed parameters. Z is programmable from 3 to 8.
90 Stratos LV/LV-T Technical Manual To prevent occurrence of a PMT, Stratos CRT-Ps start an atrial PMT protection interval after each ventricular paced event (right or left). If an atrial even is sensed within this PMT protection interval, this will neither start an AV delay nor a basic interval. The length of the PMT protection can be set to automatic (Auto). In this case, the PMT protection window can be automatically extended after the PMT is detected and terminated.
Stratos LV/LV-T Technical Manual 91 Confirmation When the suspicion criterion has been met, the Stratos CRT-Ps slightly modify the AV delay interval (+ 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. Once the PMT algorithm has confirmed a PMT, the cycle is terminated. The upper interval limit range must be shorter than the limit of the VA delay (350 ms, for example).
92 Stratos LV/LV-T Technical Manual When the PMT is detected and terminated, the PMT protection interval is extended by 50 ms. If no additional PMTs arise within two days, the length of the PMT protection interval is reduced by another 50 ms. If additional PMTs occur, the PMT protection interval is increased by another 50 ms. This occurs until no more PMTs are detected. In the absence of PMTs, the PMT protection interval is successively reduced.
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). If the intrinsic rate does not continue to rise after the programmable number of cycles (overdrive pacing plateau), the overdrive pacing rate is reduced in steps of 1 ppm. In each instance, the rate drop occurs after the programmed number of cycles has been completed.
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. 2.
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". The duration of the post-AES interval is equal to the coupling interval of the Post-AES plus the "decrement step size" (programmable 5 ... (5) ... 40 ppm). After the post AES interval has expired, pacing occurs in the atrium.
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 slope of the linear function between exertion and pacing rate. It designates a factor by which the electric signal of the sensor is amplified prior to the signal processing stages. The programmable amplification permits adaptation of the individually programmed sensor gain to the desired rate response.
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. The sensor gain will be increased by one step if for 7 consecutive days; the time recorded at maximum sensor rate is less than 90 seconds each day. 2.14.
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. This smooth drop in pacing rate is designed to prevent symptoms such as dizziness, light headedness, lack of energy and fainting spells.
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 0.25…1.25 ppm per cycle If the Target Rate is less than the current Back Up Rate. Target Rate The Target Rate is either the current detection rate minus 10 ppm, or the sensor or basic rate.
Stratos LV/LV-T Technical Manual 101 C AUTION Patient’s Ability - Use of the Home Monitoring system requires the patient and/or caregiver to follow the system instructions and cooperate fully when transmitting data. 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.
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. Not for Conclusive Diagnosis - Because not all information available in the implant is being transmitted, the data transmitted by Home Monitoring should be evaluated in conjunction with other clinical indicators (i.e., in-office follow-up, patient symptoms, etc.) in order to make a proper diagnosis.
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. The patient can carry the mobile unit during his or her occupational and leisure activities. The patient device is rechargeable, allowing for an approximate operational time of 24 hours.
104 Stratos LV/LV-T Technical Manual Table 24: System Requirements / Recommendations System System Requirements Recommendations (for Optimal Usage) Screen 800 x 600 ≥ 1024 x 768 Resolution Internet 56 kB/sec ≥ 128 kB/sec Bandwidth (DSL, cable modem) PC 600 MHz, 128 MB N/A RAM Internet MS Internet ≥ MS Internet Browser Explorer 5.0 Explorer 5.5 - or - or Netscape ≥ Netscape 7/Mozilla Navigator 4.
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 report (Cardio Report) from the implant can be triggered as follows: • Trend report – the time period (daily) initiates the report • Event report – the pulse generator detects certain events, which initiate a report • Patient report – the patient initiates the report 2.17.4.
106 Stratos LV/LV-T Technical Manual The length of the time interval (monitoring 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. 2.17.4.2 Event Report When certain cardiac and technical events are detected by the implant, a report transmission is automatically triggered. This is described as an “event message”.
Stratos LV/LV-T Technical Manual 107 N OTE : The attending physician must notify 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. The attending physician must inform the patient in detail about operating the device and about the physical symptoms which would warrant a magnet application by the patient.
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) • Number of Mode Switches / 24 hours • Duration of Mode Switching / 24 hours [%] Ventricular Rhythm • Mean Ventricular Rate at Mode Switching [ppm] • Number of Ventricular Episodes (>8 consecutive VES) • Number of Ventricular Runs (4…8 consecutive VES) • PMTs Detected AV Conduction • With Intrinsic Rhythm
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. 2.18.1 Timing • Event Counters • Event Episodes • A / V Rate Histogram • A / V Rate Trend 2.18.2 Arrhythmia • Tachy Episode Trend • AF Classification • AES Classification • AES vs.
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. • The counters within the statistic features do not operate when a magnet is applied to the CRT-Ps • The counters within the statistic features are reset each time the Stratos CRT-Ps are permanently programmed. • Event counters are displayed as bar charts showing the event totals expressed as a percentage.
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 classify ventricular sensed events that were preceded by an atrial event such as extrasystoles via the AVES discrimination function after As. In Stratos CRT-Ps: • RVs followed by LVp. • RVp followed by LVp • LVp followed by RVp A total counter that records grand total of all conductions is located below the conduction counters. 2.20.
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. 2.21 Arrhythmia Statistics 2.21.1 Tachy Episode Trend The Tachy Episode trend can only be selected when Mode Switching has been programmed ON and for events that occur at less than 1 minute intervals are combined in the tachy episode and stored.
114 Stratos LV/LV-T Technical Manual In addition to the detection rate, an AF is classified using X-outof-8 algorithm of mode switching. If mode switching is not programmed, the standard setting of 5-out-of-8 is used. In the statistics, the AF duration (1 min, 10 min, 60 min 4 h, 12 h, 24 h, 48 h, > 48 h) as well as the AF start time (0-3 hours, 3-6 hours, 6-9 hours, 9-12 hours, 12-15 hours, 15-18 hours, 18-21 hours, 21-24 hours) are shown in the histograms. 2.21.
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 different rate ranges (< 40 ppm to > 180 ppm). The atrial rate of the last interval before the AES serves to classify the AES. Two sequential AES are saved as a couplet, and three sequential AES are saved as a triplet.
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 classes of < 40 to 180 ppm. The graphic display shows the percentage values of the individual classes in the form of a bar chart and the total number of events. Subsequent VES’ (couplets, triplets) are recorded as one event. VES Coupling Interval The VES coupling interval shows in which millisecond range the prematurity has occurred.
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 divided into three ranges: • No Activity • Activity • MAR (Maximum Activity Rate) This data can assist in the analysis of heart and sensor activity. For example, a high value for the activity may indicate that the sensor gain is set too high.
118 Stratos LV/LV-T Technical Manual R-Wave Trend This is the sensitivity of the ventricles displayed over time. The R-wave trend is displayed in the form of a line chart. The Rwave trend is a rolling, long-term trend with a fixed resolution of 36 hours. Therefore, the 240 time windows with 36 hour recording periods result in actual recordings of approximately one year. The R-wave trend can record amplitudes from 0.0 to 20 mV.
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. The follow-up intervals are, therefore, primarily determined by medical judgment, taking possible pacemaker dependency into consideration.
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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 electrogram (IEGM). In the Stratos devices, it is possible to simultaneously transmit the IEGM from all three channels as well as the IEGM marker channel. The IEGM simultaneously recorded in the four channels at a scan rate of 256 Hz. All the markers from the three channels are also transmitted together with the IEGM.
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. An exception is the first recording and those with the longest duration for each event. These are not over-written. N OTE : The total length of each recording can be up to 10 seconds.
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. Measurable Parameters of Analog Telemetry Parameters Measuring Unit Battery voltage V Battery impedance kΩ Battery current µA Pulse voltage V Pulse current mA Pulse energy µJ Pulse charge µC Lead impedance Ω 5.
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 medical literature for specific recommendations regarding necessary safety margins. N OTE : With successful biventricular pacing of patients with congestive heart failure, the QRS complex should be visibly shortened. 5.
Stratos LV/LV-T Technical Manual 125 5.3 Testing for Retrograde Conduction Retrograde conduction from the ventricle to the atrium can be assumed when a 1:1 relationship between the ventricular stimulation and atrial depolarization has been obtained with a constant coupling interval during ventricular stimulation. The Stratos CRT-Ps feature a test for measuring retrograde conduction time.
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 burst is as long as the burst key on the programmer is touched. When the burst key is no longer touched, the program reverts to the backup program. Should the wand be removed, the pulse generator reverts to the permanent program.
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. In addition, before NIPS is performed in the Ventricle, the user must acknowledge that delivering NIPS into the Ventricle may induce dangerous arrhythmias.
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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. 6.1 Temporary Programming C AUTION OFF Mode – The OFF mode can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous rhythm. (see Section 2.1.11). A temporary program is a pacing program which remains activated while the programming head is positioned over the CRT-P.
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 following are stored: • Patient name • Patient index (how the patient name is coded) • Implantation date • Symptoms • Etiology • ECG indication • QRS width • LV ejection fraction • Lead polarity 6.
Stratos LV/LV-T Technical Manual 131 6.4 Magnet Effect Automatic Magnet Effect: After magnet application the pulse generator paces at 90 ppm for 10 cycles asynchronously. Thereafter, the pulse generator paces synchronously at the programmed basic rate. During asynchronous pacing, the AV interval is reduced to 100 ms. Asynchronous Magnet Effect: When programmed to asynchronous operation, magnet application results in asynchronous pacing.
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. A sensed event occurring during the interference interval will continuously reset that interval for the corresponding chamber without resetting the basic interval.
Stratos LV/LV-T Technical Manual 133 MODE DDD(R) DDI(R) DVI(R) VDD(R) VVI(R) AAI(R) DDT DDI/T DVT VDT VDI VVT AAT Table 27: Response to EMI EMI* (A) EMI* (V) DVD(R) DAD(R) DVI(R) DAI(R) --DOO(R) VVI(R) VAT(R) --VOO(R) AOO(R) --DVT DAT DVT DAT --DOO VVT VAT VVT VOO --VOO AOO --- * EMI = Electromagnetic Interference EMI* (A+V) DOO(R) DOO(R) --VOO(R) ----DOO DOO --VOO VOO -----
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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. The label contains the model specifications, technical data, serial number, expiration date, and sterilization and storage information for the particular CRT-P. The box contains a double blister container with the CRT-P and product documentation.
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. Return the device to BIOTRONIK.
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. Myopotential Sensing – The filter characteristics of BIOTRONIK implantable devices have been optimized to sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing skeletal myopotentials.
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. C AUTION Lead Configuration – The polarity of the implanted lead dictates what lead configuration can be programmed for the CRT-P.
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 Pacing† RV unipolar RV tip Æ Case bipolar LV tip Æ LV ring LV unipolar LV tip Æ Case 8.2 Lead Connection Stratos CRT-Ps have been designed and are recommended for use with bipolar or unipolar leads having an IS-1 connector.
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 bipolar leads in the ventricle. All connections are IS-1 compatible. Appropriate adapters (e.g., A1-A) should be fitted when using leads with a different connection. N OTE : Connecting systems with a 3.
142 Stratos LV/LV-T Technical Manual Connecting the Stratos LV with the IS-1 Connector In order to avoid programming errors with the Stratos LV, always connect the leads to the following ports: Bipolar lead in right atrium Bipolar lead in right ventricle Unipolar and/or Bipolar lead in left ventricle Figure 10. Connecting the Leads Stratos CRT-Ps have a self-sealing header. Refer to the following steps when connecting a lead(s) to the CRT-P.
Stratos LV/LV-T Technical Manual 143 1. Insert the enclosed torque wrench through the perforation in the selfsealing plug at an angle perpendicular to the lead connector until it is firmly placed in the setscrew. 2. Insert the lead connector pin into the connector receptacle of the CRT-P without bending the lead until the connector pin becomes visible behind the setscrew. Hold the connector in this position. 3.
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. Sealing System – Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle. Failure to do so may result in damage to the plug and its self-sealing properties.
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 properties, storage time, lead system impedance, programmed parameters, amount of pacing and sensing required, and circuit operating characteristics. Service time is the time from beginning of service (BOS) to the end of service (EOS).
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%. This reduces the pacing rate by 4.5-11%, depending on the programmed AV delay.
Stratos LV/LV-T Technical Manual 147 The following functions remain active when the replacement indication is reached: • Mode switching • PMT detection and termination • Biventricular synchronization N OTE : The statistics are frozen when ERI is reached. W ARNING High Output Settings – High output settings combined with extremely low lead impedance may reduce the life expectancy of the Stratos CRT-Ps. Programming of pulse amplitudes, higher than 4.
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. All service intervals, including the above-cited nominal longevity, are based on the battery discharge behavior and the hybrid circuit properties including current consumption and replacement indicator. The statistical calculations are based on 500 ohm lead impedances, 100% pacing, and data supplied by the battery manufacturer.
Stratos LV/LV-T Technical Manual 149 10. Explantation Explanted devices and accessories may not be reused. Explanted CRT-Ps can be delivered to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal. If possible, the explanted devices should be cleaned with a sodium-hyperchlorine solution of at least 1% chlorine and, thereafter, washed with water prior to shipping. All implantable electronic devices should be explanted before cremation of a deceased patient.
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Stratos LV/LV-T Technical Manual 151 11. Technical Data 11.1 Available Pacing Modes DDDR, DDTRA, DDTR, DDIR, DDITR, DVIR, DVTR, DOOR, VDDR, VDTR, VDIR, VVIR, VVTR, VOOR, AAIR, AATR, AOOR DDD DDTA, DDT, DDI, DDIT, DVI, DVT, DOO, VDD, VDT, VDI, VVI, VVT, VOO, AAI, AAT, AOO, OFF VV synchronization for the Stratos CRT-Ps: BiV RV RV-T, OFF 11.2 Pulse- and Control Parameters Basic Rate 32... (1)...60... (1)...88... (2)...122... (3)...140... (5)...180 ppm Night Rate Off, 32... (1)...88... (2)...122... (3)...140.
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)…100 ms Repetitive AV Hysteresis Off; 1… (1)…10 Scan AV Hysteresis Off; 1… (1)…10 Sense Compensation Off; -10… (-10)…-120 ms Safety AV Delay 100 ms Ventricular Blanking Time 30… (5)…70 ms Magnet effect Automatic; Auto; asynchronous; synchronous Asynchronous Magnet Effect: paces at 90 ppm.
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... (0.1)...1.0… (0.1)…1.5… (0.5)...7.5 mV RV 0.5... (0.5)...2.5... (0.5)...7.
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… (2)…122… (3)…140… (5)…180 ppm Overdrive Modes: Off; On Available in the modes DDD, DDTA, AAI, AAT with and without rate adaptation Maximum Overdrive Pacing Rate 90… (5)…160 ppm Overdrive Pacing Increment (Rate Increase) 2… (2)…10 ppm Overpacing Level (Rate Drop After) 1… (1) …32 cycles Post-AES Pacing Off; On AES Increment
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.
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… (20)…400 ppm Mode Switching Recording Off; 3… (1)…31 count High Ventricular Rate Recording OFF; 3… (1)…31 count Ventricular Sense Rate 100… (10)…250 ppm Patient Activated Recording OFF; 1… (1)…31 count Pre-trigger Recording 0… (10)…80% Recording when Switching off Off; On 11.
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 stimulation Programmed Stimulation Back-up Pacing Burst Chamber Coupling Interval /ms Burst Type Burst Range / ppm S1-S1 Cycles Pause / ms No. of intervals Decrement ms Modes Rate / ppm Amplitude / V Pulse width / ms Pace Polarity 11.6 Programmers ICS 3000 Implant Control System Atrium, Ventricle None… 2000 Pushbutton, Ramp 30…800 S1-S2, S2-S3, S3-S4, S4-S5 0…10 Stop… 50 4 0…100 VOO,VVI, SOO, SSI, OSO, OOO,OVO 30…180 0.1…8.4 0.
Stratos LV/LV-T Technical Manual 159 11.7 Default Programs Stratos LV / LV-T Parameter/ Function Mode Factory settings/ Standard Program DDD Safe Program VVI VV BiV RV RV-T - AV delay 150 ms at 60 ppm First Chamber Paced VV delay after pace VV delay after sense Pulse Amplitude Sensing A/RV RV 120ms at 130 ppm - 5 ms - 5 ms - 3.6 V (A); 3.6 V (RV); 3.6 V (LV) UNIP 4.8 V Refractory Period Auto (A); 250 ms (V) A: N/A V: 300 ms Synchronization UNIP (RV) 11.
160 Stratos LV/LV-T Technical Manual Parameter Stratos LV Pace Pulse form Polarity Input impedance Power source Battery voltage at BOS Conducting surface Unipolar/bipolar Biphasic, asymmetric Cathodic > 10kΩ (RV/LV) Li/I2 2.8 V 37.42 Conducting Shape Flattened ellipsoidal 11.10 Mechanical Data Model Stratos Leads IS-1 Size 6.4 x 50.3 x 57 mm Mass Volume 30.85 14.
Stratos LV/LV-T Technical Manual 161 12.
162 Stratos LV/LV-T Technical Manual
Stratos LV/LV-T Technical Manual 163 Appendix A Known Software Anomalies Anomaly Possible Effect on Patient or Implant Procedure General Programmer Issues If a long patient name is entered The last letters of the patient without blank spaces, it may be name may be missing from cut off in the printout under the the printout. However, the section 'Patient Data' patient name is not a therapyrelevant parameter.
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