Implantable cardioverter defibrillator with cardiac resynchronization therapy CRT-D models Implant manual
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TABLE OF CONTENTS 1. General description................................................................................................................ 5 2. Indications............................................................................................................................... 6 3. Contraindications.................................................................................................................... 7 4. 4.1. 4.2. 4.3. 4.4. 4.5. Warnings and precautions...............
15.3. Response in the presence of disturbance...............................................................................37 15.4. Detection characteristics in the presence of electromagnetic fields........................................37 15.5. Protection against short-circuits..............................................................................................39 16. 16.1. 16.2. 16.3. 16.4. 16.5. 16.6. 16.7. Main functions........................................................................
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION PLATINIUM CRT-D is an implantable cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation, with ventricular resynchronization, in patients with spontaneous or inducible tachyarrhythmias. PLATINIUM CRT-D is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity.
2. INDICATIONS 2. INDICATIONS PLATINIUM CRT-D is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of PLATINIUM CRT-D is contraindicated in patients: ─ whose ventricular tachyarrhythmias may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes, ─ who present incessant tachyarrhythmia, ─ who have an internal pacemaker, ─ whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias.
4. WARNINGS AND PRECAUTIONS 4. WARNINGS AND PRECAUTIONS The patient should be warned of the potential risks of defibrillator malfunction if he is exposed to external magnetic, electrical, or electromagnetic signals. These potential interference sources may cause conversion to inhibited mode (because of noise detection), erratic delivery of VT or VF therapies, nominal programming, or much more rarely, irreversible damage to the device’s circuits.
4. WARNINGS AND PRECAUTIONS 4.1. RISKS RELATED TO MEDICAL ENVIRONMENT It is advisable to carefully monitor defibrillator operation prior to and after any medical treatment during which an electrical current from an external source passes through the patient's body. Magnetic Resonance Imaging: MRI is strictly contraindicated in cardiac defibrillator patients. Radiofrequency ablation: A radiofrequency ablation procedure in a patient with a generator may cause device malfunction or damage.
4. WARNINGS AND PRECAUTIONS Diagnostic ultrasound (echography): The defibrillator is not affected by ultrasound imaging devices. Scales with body fat monitors and electronic muscle stimulators: A patient with an implanted PLATINIUM CRT-D should not use these devices. 4.2. STERILIZATION, STORAGE AND HANDLING Resterilization: Do not resterilize and re-implant explanted ICDs. "Use Before" Date: A "Use Before" date is printed on the outer storage package and on the sterile package.
4. WARNINGS AND PRECAUTIONS In the event of a warning on a low shock impedance, and after lead replacement or reconnection: it is recommended to check the system integrity (sensing and pacing thresholds and the impedance of the shock electrodes) It is recommended that a security margin of at least 10 J be demonstrated between the effective shock energy and maximum programmable energy.
4. WARNINGS AND PRECAUTIONS Do not place the patch lead over nerve tissue as this may cause nerve damage. Place the patch lead with the conducting coil side facing the heart to ensure delivery of energy to the heart. Place the sutures well outside the coil of the patch lead or in the area between the coils to avoid possible coil fracture. If countershock is unsuccessful using external paddles, adjust the external paddle position (e.g.
5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the MSP clinical study. PLATINIUM CRT-Dis similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to PLATINIUM CRT-D. 5.1. MSP STUDY orin conducted an international, multi-center, randomized clinical trial of its cardiac resynchronization therapy system. Investigators attempted to implant study devices in 190 patients.
5. ADVERSE EVENTS Worsening CHF/CHF decompensation 24 12.6 42 2.1 Atrial fibrillation/flutter 14 7.4 14 0.7 Not Serious events not related to the system 58 30.5 121 7.4 Pain (in back, arms, chest, shoulder, groin, head, other) 10 5.3 13 0.7 Worsening CHF/CHF decompensation 13 6.8 16 0.8 Atrial fibrillation/flutter 7 3.7 8 0.4 Ventricular tachycardia 5.2. 7 3.7 7 0.
5. ADVERSE EVENTS ─ Fear that shocking capability may be lost, ─ Imagined shocking (phantom shock).
6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the MSP clinical study. PLATINIUM CRT-D is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to PLATINIUM CRT-D. 6.1. MSP CLINICAL STUDY OVATIO CRT-D and earlier models were evaluated clinically in an international, multi-center, randomized clinical trial of Sorin’s cardiac resynchronization therapy (CRT-D) system.
6. CLINICAL STUDIES Six-month system complication-free rate 6.1.4. Number of patients contributing to analysis Kaplan-Meier six-month complication-free estimate One-sided lower 95% confidence bound for sixmonth complication-free estimate 190 89.5 % 84.1 % Absolute Differences in Peak VO2 and QOL The tables below show the absolute differences between the control and test groups’ peak VO2 and QOL over the 6 month follow-up period in the clinical trial.
6. CLINICAL STUDIES 6.1.5. Clinical Results V-V timing V-V programmable settings were available for the clinical study devices as follows: ALTO MSP model 617 (not programmable for V-V delay), ALTO 2 MSP model 627 values (0, 31, 39, 47, 55 and 63 ms) and OVATIO CRT-D 6750 values (0 to 63 ms in steps of 8 ms). The graph below shows the programmed V-V settings at randomization by percentage of patients programmed to each combination of Synchronous BiV pacing and V-V delay.
6. CLINICAL STUDIES Trial, a uniform protocol was used for V-V programming. This protocol required all patients to undergo echo-guided V-V delay optimization before randomization (2 to 14 days postimplant). The optimal V-V delay was determined by finding the programmable V-V delay and ventricular chamber pacing order (RV then LV, or LV then RV) providing the maximum time velocity integral (TVI or VTI) across the left ventricular outflow tract (LVOT).
7. PATIENT SELECTION AND TREATMENT 7. PATIENT SELECTION AND TREATMENT 7.1. INDIVIDUALIZATION OF TREATMENT Exercise stress testing: If the patient’s condition permits, use exercise stress testing to: ─ Determine the maximum rate of the patient’s normal rhythm, ─ Identify any supraventricular tachyarrhythmias, ─ Identify exercise-induced tachyarrhythmias. The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of programmable parameters.
7. PATIENT SELECTION AND TREATMENT 7.2. SPECIFIC PATIENT POPULATIONS Pregnancy: If there is a need to image the device, care should be taken to minimize radiation exposure to the foetus and the mother. Nursing Mothers: Although appropriate biocompatibility testing has been conducted for this implant device, there has been no quantitative assessment of the presence of leachables in breast milk. Pediatric Patients: This device has not been studied in patients younger than 18 years of age.
8. PATIENT COUNSELLING INFORMATION 8. PATIENT COUNSELLING INFORMATION The physician should consider the following points in counselling the patient about this device: ─ Persons administering CPR may experience tingling on the patient’s body surface when the patient’s ICD system delivers a shock. ─ Advise patients to carry Sorin ID cards and/or ID bracelets documenting their ICD system.
9. DECLARATION OF CONFORMITY 9. DECLARATION OF CONFORMITY Sorin declares that this device is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, with the mutual recognition of their conformity (R&TTE). Federal Communication Commission Interference Statement 47 CFR Section 15.19 and 15.
9. DECLARATION OF CONFORMITY This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada.
10. PHYSICIAN GUIDELINES 10. PHYSICIAN GUIDELINES 10.1. PHYSICIAN TRAINING Physicians should be familiar with sterile pulse generator and left ventricular pacing lead implant procedures. They must apply these procedures according to professional medical training and experience. Physicians should be familiar with follow-up evaluation and management of patients with an implantable defibrillator (or referral to such a physician).
10. PHYSICIAN GUIDELINES ─ Its storage package has been pierced or altered, because this could have rendered it non-sterile. ─ It has been stored or transported outside the environmental temperature limits: 32 °F (0 °C) to 122 °F (50 °C) as an electrical reset condition may occur. ─ "Use Before" date has expired, because this can adversely affect pulse generator longevity or sterility.
11. PATIENT INFORMATION 11. PATIENT INFORMATION Information for the patient is available in the patient booklet, contained in the outer storage package. Additional copies can be obtained by contacting your Sorin representative. This information should be given to each patient with their first ICD and offered to the patient on each return visit or as deemed appropriate.
12. HOW SUPPLIED 12. HOW SUPPLIED 12.1. STERILITY The PLATINIUM defibrillators are supplied one per package in a sterile package. 12.2. WARRANTY AND REPLACEMENT POLICY Sorin warrants its defibrillators. Refer to the section "Warranty" for additional information. Please see the following labelling sections for information concerning the performance of this device: Indications, Contraindications, Warnings and Precautions, and Adverse Events.
13. DEVICE DESCRIPTION 13. DEVICE DESCRIPTION The PLATINIUM CRT-D ICD device and programming system. The programming system includes the Sorin dedicated programmer with the SMARTVIEW programming software connected to a CPR3 programming head. The programming system is configured and furnished by Sorin. The PLATINIUM CRT-D can serve as a defibrillation electrode (active housing) with a total surface area of 63 cm².
13. DEVICE DESCRIPTION ─ Programmer-controlled VF inductions (30 Hz rapid pacing or shock on T), ─ Programmable electrogram vectors (A / RV coil-CAN / SVC coil-CAN /RV coil-SVC coil / LV bip / LV tip-RV ring / A ring-CAN / RV tip-CAN / RV ring-CAN / LV tip-CAN / LV ring-CAN) and RV EGM, ─ Real-time annotations displayed with the markers and indicating the majority rhythm, ─ Manual ATP sequences, ─ Manual shocks.
14. IMPLANT PROCEDURE 14. IMPLANT PROCEDURE 14.1.
14. IMPLANT PROCEDURE 14.4. BEFORE OPENING THE PACKAGE Before opening the package, check the "Use Before" date printed on the labels on the box and on the sterile package. Defibrillators that have not been implanted before that date should be returned to Sorin. Interrogate the device: ─ if a warning is displayed, do not implant the device and contact your Sorin representative. ─ if battery voltage is below 3V, and if the last reforming/charge occurred more than one week ago, do not implant the device.
14. IMPLANT PROCEDURE defibrillation coils ─ one unipolar or bipolar left ventricular pacing lead The choice of leads and their configuration is left to the implanting physician’s judgment. NOTE1: Please note that DF-1 standard compliant lead is not compatible with DF4 connector. In the reverse, DF4 standard compliant lead is not compatible with DF-1 connector. In case of defibrillator replacement, choose the appropriate device compatible with DF-1 or DF4 leads.
14. IMPLANT PROCEDURE 14.9. MEASUREMENT OF THRESHOLDS AT IMPLANT Pacing and sensing thresholds should be measured at implant. Pacing thresholds: Acute thresholds should be lower than 1 V (or 2 mA) for a 0.35 ms pulse width, in both ventricles and in the atrium. Sensing thresholds: For appropriate right ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. For appropriate atrial sensing, the amplitude of the P-wave should be greater than 2 mV.
14. IMPLANT PROCEDURE As a matter of fact, when the lead port is filled with a liquid, the physics piston effect can give the feeling the lead is properly tightened. 4. One single set screw is located on the side of the connection header. 5. Use only the screwdriver provided with the defibrillator. Keep the screwdriver's shaft perpendicular to the plane of the defibrillator (see figure below). 6.
14. IMPLANT PROCEDURE 14.12. TESTS AND PROGRAMMING During the implant testing procedure: It is recommended that a security margin of at least 10 J be demonstrated between the effective shock energy and maximum programmable energy. Enable shock therapies, then program the defibrillator. Verify that the defibrillation lead impedance for each shock delivered is within the range of 30 to 150 ohms. Check the lead connection if the values are outside these boundaries.
15. SPECIAL MODES 15. SPECIAL MODES 15.1. SAFETY MODE (NOMINAL VALUES) Nominal values may be rapidly restored by pressing the following button on the programming head or programmer keyboard: or via the Emergency button on the SMARTVIEW screen. In safety mode, the defibrillator operates with the parameters underlined in the table of programmable parameters. 15.2.
15. SPECIAL MODES For DF4 models: ─ Common mode rejection ratio: For DF-1 Models: 16.6 Hz 50 Hz 60 Hz Atrial channel ≥74 dB ≥74 dB ≥74 dB Ventricular channel ≥68 dB ≥68 dB ≥68 dB 16.6 Hz 50 Hz 60 Hz Atrial channel ≥74 dB ≥74 dB ≥74dB Ventricular channel ≥68 dB ≥68 dB ≥68dB For DF4 Models: For atrial sensitivity settings below 0.4mV, the ICD may detect noise lower than the level specified in clause 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz.
15. SPECIAL MODES 15.5. PROTECTION AGAINST SHORT-CIRCUITS The defibrillator can undergo a short-circuit if the anode and cathode are not adequately separated. In this case, the shock is aborted to prevent damaging the defibrillator and a warning will indicate that a short circuit (shock impedance < 20 ohms) was detected during the last shock.
16. MAIN FUNCTIONS 16. MAIN FUNCTIONS 16.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on atrial and ventricular leads every 6 hours. The daily mean impedance is stored for each chamber. Automatic coil impedance measurement: A continuity measurement is automatically performed on defibrillation coil(s) once per day. The continuity is stored for each coil.
16. MAIN FUNCTIONS Defibrillation threshold (DFT): Be aware that the changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT) which may result in non-conversion of the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively. 16.4.
16. MAIN FUNCTIONS 16.6. FOLLOW-UP FUNCTION Storage of memory data: AIDA+ (Automatic Interpretation for Diagnosis Assistance) software provides access up to 6 months of patient follow-up with day by day data collection, or up to 24 hours with hourly data collection. Episodes of ventricular tachyarrhythmia are recorded with one programmable EGM channel which can be selected, in addition to RV EGM.
16. MAIN FUNCTIONS 16.7.3. Data transmitted The data transmitted are identical to the data available during a standard interrogation with the dedicated programmer.
16. MAIN FUNCTIONS WARNING: The use of remote monitoring does not replace regular follow-up. Therefore, when using remote monitoring, the time period between follow-ups visits may not be extended.
17. PATIENT FOLLOW-UP 17. PATIENT FOLLOW-UP 17.1. FOLLOW-UP RECOMMENDATIONS Before the patient is discharged and at each subsequent follow-up visit, it is advisable to: ─ check the occurrence of system warnings ─ check the battery status, NOTES: If the last reforming, charge or shock occurred during the week preceding the interrogation, the last battery value may be still impacted by the event. One week post event, the battery will recover its steady state value.
17. PATIENT FOLLOW-UP Stored Tachyarrythmia Episodes: PLATINIUM CRT-D stores up to 16 episodes (VF, VT, Slow VT, SVT/ST, non-sustained) with a total of 25.6 min of high resolution EGM.
17. PATIENT FOLLOW-UP ─ The Recommended Replacement Time (RRT) point is reached ─ Confirmed malfunction ─ Burial of the patient (for environmental reasons, the local regulation may require the explantation of the devices containing a battery supply) ─ Cremation of the patient (the defibrillator may explode if placed in an incinerator) The explanted defibrillator should not be reused in another patient.
18. SUPPLEMENTAL INFORMATION 18. SUPPLEMENTAL INFORMATION Clinical data presented in this section are from the SafeR (AAI <> DDD) clinical study. SafeR (AAI <> DDD) operation in PLATINIUM is similar to that in the Symphony pacemaker. The data provided are applicable to PLATINIUM CRT-D. 18.1. ADVERSE EVENTS IN THE SAFER (AAI <> DDD) STUDY Clinical study of the SafeR (AAI <> DDD) included 45 Symphony 2550 devices implanted in 45 patients. No serious adverse events were device- or feature-related.
18. SUPPLEMENTAL INFORMATION refractory period, and disagreement in the statistics for swuitches to DDD. No patient symptoms were associated with these events. 18.2. SAFER (AAI <> DDD) CLINICAL STUDY SafeR (AAI <> DDD) mode in PLATINIUM is similar to that in Symphony. The differences in SafeR (AAI <> DDD) mode between the two devices are: ─ To prevent long RR intervals during VT/VF, SafeR (AAI <> DDD) has no effect during VT/VF therapy, electrophysiologic studies, and post-shock recovery.
18. SUPPLEMENTAL INFORMATION The graph shows that many patients programmed to SafeR (AAI <> DDD) had less than 1% ventricular pacing: ─ 84 % of patients without AV block at implant. ─ 63 % of patients with AV block at implant. In a representative reference group(1) of patients programmed to DDD, none had less than 1 % ventricular pacing and only 10 % had less than 90 % ventricular pacing regardless of AV block indication at implant.
19. PHYSICAL CHARACTERISTICS 19. PHYSICAL CHARACTERISTICS 1711 MODEL: Dimensions 73 x 54.3 x 11.1 mm Weight 86 g Volume 33 cm3 Active surface area of casing 62.7cm2 Connector Atrium: IS-1 bipolar. Right ventricle: IS-1 bipolar, 2*DF-1. Left ventricle: IS-1 bipolar (unipolar compatible). 1741 MODEL: 19.1. Dimensions 72.3 x 54.3 x 11.1 mm Weight 87 g Volume 33 cm3 Active surface area of casing 62.8cm2 Connector Atrium: IS-1 bipolar. Right ventricle: DF4.
20. ELECTRICAL CHARACTERISTICS 20. ELECTRICAL CHARACTERISTICS Atrial input impedance 80 kilohms ± 30 % Ventricular input impedance 80 kilohms ± 30 % D.C. capacitance 149 µF ± 8 % Capacitor reformation No reformation required Rate limit 192 ppm ± 10 ppm Pacing waveform Defibrillation waveform 20.1.
20. ELECTRICAL CHARACTERISTICS 20.3. Total capacity 2192 mAh Usable capacity Between BOS and RRT: 1530 mAh. Between BOS and EOS: 1910 mAh. Voltage BOS: 3.24 V. RRT: 2.62 V. EOS: 2.5 V. LONGEVITY The longevities are calculated by taking into account 6 months storage with the following conditions: ─ Mode: DDD ─ Basic rate: 60 ppm ─ Pulse width (A, RV, LV): 0.
20. ELECTRICAL CHARACTERISTICS A pacing (%) 100 100 1 15 1 30 0 BiV pacing (%) 100 100 100 100 100 100 0 A, RV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 - LV Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 3.0 - Sensor OFF ON ON ON OFF OFF OFF Max shocks (42J) per year 4 4 4 4 0 3 4 Longevity (years) 8.2 8.0 9.2 7.6 13.3 11.3 13.
21. PROGRAMMABLE PARAMETERS 21. PROGRAMMABLE PARAMETERS Measured at 37 °C under a 500 ohm load Legend: Value in bold: "as shipped" value Underlined value: nominal value 21.1.
21. PROGRAMMABLE PARAMETERS Pacing/Sensing Values Atrial sensitivity (mV) (1) From 0.2 to 4 by steps of 0.2 ; 0.4 (± 50 %) Atrial amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) Atrial pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) Ventricular sensitivity (mV) (1) From 0.4 to 4 by steps of 0.2 ; 0.4 (± 50 %) RV amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) RV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) LV amplitude (V) (2) 0.10-0.25-0.
21. PROGRAMMABLE PARAMETERS 1,75* 1,89 1,60 1,85* 2,02 1,71 2,00 2,10 1,78 2,10* 2,21 1,87 2,25* 2,34 1,98 2,35* 2,47 2,09 2,50 2,60 2,20 2,60* 2,73 2,31 2,75* 2,87 2,42 2,85* 3,00 2,53 3,00 3,15 2,67 3,10* 3,26 2,76 3,25* 3,39 2,87 3,35* 3,52 2,98 3.
21. PROGRAMMABLE PARAMETERS 5,60* 5,86 4,96 5,75* 5,99 5,07 5,85* 6,12 5,18 6,00 6,30 5,33 6,10* 6,38 5,40 6,25* 6,51 5,51 6,35* 6,64 5,62 6,50* 6,77 5,73 6,60* 6,90 5,84 6,75* 7,03 5,95 6,85* 7,16 6,06 7,00 7,35 6,22 * For left ventricular amplitude only.
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21. PROGRAMMABLE PARAMETERS 21.2. 60 SafeR parameters Values AVB I switch Rest+Exercise-Exercise Long PR: max (ms) From 200 to 500 by steps of 50 ; 450 Long PR: min (ms) From 200 to 500 by steps of 50 ; 250 Max.
21. PROGRAMMABLE PARAMETERS 21.3.
21. PROGRAMMABLE PARAMETERS 21.3.1.
21. PROGRAMMABLE PARAMETERS 21.3.2.
21. PROGRAMMABLE PARAMETERS 21.3.3.
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22. NON PROGRAMMABLE PARAMETERS 22.
23. LIMITED WARRANTY 23. LIMITED WARRANTY The PLATINIUM implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. The terms of the limited warranty are available upon request from your Sorin representative or on the CD-ROM of the package content.
24. PATENTS 24.
25. EXPLANATION OF SYMBOLS 25.
25. EXPLANATION OF SYMBOLS Temperature limitation Torque wrench Consult instructions for use Instructions for use in the CD-ROM This icon is used to call your attention to a particularly important point. This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon.
BACKCOVER CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN 2015-03 U459A © 2015 Sorin CRM SAS
