PHYSICIAN’S TECHNICAL MANUAL VALITUDE™, VALITUDE™ X4, INTUA™, INVIVE™ CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER Model U125, U128, V272, V273, V172, V173 CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures.
Table of Contents Additional Information..................................................................................................................... Device Description.......................................................................................................................... Related Information ........................................................................................................................ Indications and Usage ..................................................
Implanting the Pulse Generator.................................................................................................... Step A: Check Equipment ................................................................................................ Step B: Interrogate and Check the Pulse Generator ........................................................ Step C: Implant the Lead System .....................................................................................
ADDITIONAL INFORMATION For additional reference information, go to www.bostonscientific.com/ifu. DEVICE DESCRIPTION This manual contains information about the VALITUDE, INTUA, and INVIVE families of cardiac resynchronization therapy pacemakers (CRT-Ps) (specific models are listed in "Mechanical Specifications" on page 31). NOTE: Specific features discussed in this manual may not apply to all models. References to names of non-quadripolar devices also apply to the corresponding quadripolar devices.
• • One IS-1 unipolar or bipolar left ventricular lead One compatible IS42 quadripolar left ventricular lead3 The pulse generator and the leads constitute the implantable portion of the pulse generator system.
• Save patient data You can program the pulse generator using two methods: automatically using Indications-Based Programming (IBP) or manually. RELATED INFORMATION Refer to the lead’s instruction manual for implant information, general warnings and precautions, indications, contraindications, and technical specifications. Read this material carefully for implant procedure instructions specific to the chosen lead configurations.
INTENDED AUDIENCE This literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures. INDICATIONS AND USAGE Boston Scientific cardiac resynchronization therapy pacemakers (CRT-Ps) are indicated for patients with moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥ 120 ms and remain symptomatic despite stable optimal pharmacological therapy (OPT) for heart failure.
WARNINGS General • Labeling knowledge. Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. Such damage can result in patient injury or death. • For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.
• Handling the lead without Connector Tool. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps.
Post-Implant • Protected environments. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. • Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI scanning.
Sterilization and Storage • If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas before final packaging. When the pulse generator and/or lead is received, it is sterile provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the pulse generator and/or lead to Boston Scientific. • If device is dropped. Do not implant a device which has been dropped while outside of its intact shelf package.
• Lead compatibility. Prior to implantation, confirm the lead-to-pulse generator compatibility. Using incompatible leads and pulse generators can damage the connector and/or result in potential adverse consequences, such as undersensing of cardiac activity or failure to deliver necessary therapy. • Telemetry wand. Make sure a sterile telemetry wand is available should loss of ZIP telemetry occur. Verify that the wand can easily be connected to the programmer and is within reach of the pulse generator.
• Electrode connections. Do not insert a lead into the pulse generator connector without taking the following precautions to ensure proper lead insertion: • Insert the torque wrench into the preslit depression of the seal plug before inserting the lead into the port, to release any trapped fluid or air. • Visually verify that the setscrew is sufficiently retracted to allow insertion. Use the torque wrench to loosen the setscrew if necessary.
• Biventricular pacing therapy. This device is intended to provide biventricular pacing therapy. Programming the device to provide RV-only pacing, or programming the RV pace amplitude below the pacing threshold (resulting in LV-only pacing), is not intended for the treatment of heart failure. The clinical effects of LV-only or RV-only pacing for the treatment of heart failure have not been established. • Pacing and sensing margins.
• Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate pacing is not limited by refractory periods. A long refractory period programmed in combination with a high MSR can result in asynchronous pacing during refractory periods since the combination can cause a very small sensing window or none at all. Use Dynamic AV Delay or Dynamic PVARP to optimize sensing windows. If you are programming a fixed AV Delay, consider the sensing outcomes. • MTR/MSR programming.
• Proper programming without an atrial lead. If an atrial lead is not implanted (port is plugged instead), or an atrial lead is abandoned but remains connected to the header, device programming should be consistent with the number and type of leads actually in use. • Atrial sensing programmed to Off. When atrial sensing is programmed to Off in a DDI(R) or DDD(R) mode, any atrial pacing that occurs will be asynchronous. Additionally, features that require atrial sensing may not function as expected.
• Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the maximum LV pacing rate and may inhibit CRT at higher pacing rates. • Sensing adjustment. Following any Sensitivity parameter adjustment or any modification of the sensing lead, always verify appropriate sensing. Programming Sensitivity to the highest value (lowest sensitivity) may result in undersensing of cardiac activity.
Environmental and Medical Therapy Hazards • Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI. The pulse generator may inhibit pacing due to oversensing, or may switch to asynchronous pacing at the programmed pacing rate or at the magnet rate in the presence of EMI. Moving away from the source of the EMI or turning off the source usually allows the pulse generator to return to normal operation.
• • 16 Conducted electrical current. Any medical equipment, treatment, therapy, or diagnostic test that introduces electrical current into the patient has the potential to interfere with pulse generator function. • External patient monitors (e.g., respiratory monitors, surface ECG monitors, hemodynamic monitors) may interfere with the pulse generator’s impedance-based diagnostics (e.g., Respiratory Rate trend).
• External defibrillation. It can take up to 15 seconds for sensing to recover after an external shock is delivered. In non-emergency situations, for pacemaker dependent patients, consider programming the pulse generator to an asynchronous pacing mode and programming the Respiratory Sensor to Off prior to performing external cardioversion or defibrillation. External defibrillation or cardioversion can damage the pulse generator.
• Electrical interference. Electrical interference or “noise” from devices such as electrocautery and monitoring equipment may interfere with establishing or maintaining telemetry for interrogating or programming the device. In the presence of such interference, move the programmer away from electrical devices, and ensure that the wand cord and cables are not crossing one another.
• Magnetic fields. Advise patients that extended exposure to strong (greater than 10 gauss or 1 mTesla) magnetic fields may trigger the magnet feature. Examples of magnetic sources include: • • • • • Industrial transformers and motors MRI scanners Large stereo speakers Telephone receivers if held within 1.27 cm (0.5 inches) of the pulse generator Magnetic wands such as those used for airport security and in the Bingo game • Electronic Article Surveillance (EAS) and Security Systems.
• Follow-up considerations for patients leaving the country. Pulse generator follow-up considerations should be made in advance for patients who plan to travel or relocate post-implant to a country other than the country in which their device was implanted. Regulatory approval status for devices and associated programmer software configurations varies by country; certain countries may not have approval or capability to follow specific products.
• Reviewing real-time EGMs • Testing the leads (threshold, amplitude, and impedance) • Reviewing respiratory sensor-based diagnostics • Verifying battery status • Programming any permanent brady parameter to a new value and then reprogramming it back to the desired value • Saving all patient data • Verifying the appropriate final programming prior to allowing the patient to leave the clinic Minimizing Pacemaker/S-ICD Interaction These pulse generators are compatible for use with a Subcutaneous
In Safety Mode, these pulse generators use a unipolar pacing and sensing configuration. Safety Mode is compatible for use with an S-ICD because the configured parameters mitigate the potential pacemaker and S-ICD interactions as follows: • Sensing is AGC at 0.25 mV. The AGC sensing is able to effectively sense an intrinsic rhythm faster than the Safety Mode LRL of 72.5 bpm. As a result, pacing is inhibited and does not interfere with S-ICD tachyarrhythmia detection.
• Ventricular fibrillation and all of the patient’s ventricular tachycardias should be induced while the S-ICD is activated and the pacemaker is programmed to an asynchronous mode at maximum Amplitude and Pulse Width. This should provide the greatest opportunity for inhibition of arrhythmia detection due to detection of pacemaker pacing pulses. The pacemaker leads might have to be repositioned to eliminate detection of the pacing pulses by the S-ICD.
• Do not change TENS settings until you have verified that the new settings do not interfere with pulse generator function. If TENS is medically necessary outside the clinical setting (at-home use), provide patients with the following instructions: • Do not change the TENS settings or electrode positions unless instructed to do so. • End each TENS session by turning off the unit before removing the electrodes.
If electrocautery or RF ablation is medically necessary, observe the following to minimize risk to the patient and device: • Depending on the pacing needs of the patient, enable the Electrocautery Protection Mode, program to an asynchronous pacing mode, or use a magnet to switch to asynchronous pacing. An option for patients with intrinsic rhythm is to program the Brady Mode to VVI at a rate below the intrinsic rate to avoid competitive pacing.
Ionizing Radiation CAUTION: It is not possible to specify a safe radiation dosage or guarantee proper pulse generator function following exposure to ionizing radiation. Multiple factors collectively determine the impact of radiation therapy on an implanted pulse generator, including proximity of the pulse generator to the radiation beam, type and energy level of the radiation beam, dose rate, total dose delivered over the life of the pulse generator, and shielding of the pulse generator.
Elevated Pressures The International Standards Organization (ISO) has not approved a standardized pressure test for implantable pulse generators that experience hyperbaric oxygen therapy (HBOT) or SCUBA diving. However, Boston Scientific developed a test protocol to evaluate device performance upon exposure to elevated atmospheric pressures. The following summary of pressure testing should not be viewed as and is not an endorsement of HBOT or SCUBA diving.
Table 1. Pressure Value Equivalencies (continued) Pressure value equivalencies Bar 5.0 kPa Absolute 500 a. b. All pressures were derived assuming sea water density of 1030 kg/m3. Pressure as read on a gauge or dial (psia = psig + 14.7 psi). Prior to SCUBA diving or starting an HBOT program, the patient’s attending cardiologist or electrophysiologist should be consulted to fully understand the potential consequences relative to the patient’s specific health condition.
• • • • • • • • • • • • • • • • • • • • • • • Cardiac tamponade Chronic nerve damage Component failure Conductor coil fracture Death Electrolyte imbalance/dehydration Elevated thresholds Erosion Excessive fibrotic tissue growth Extracardiac stimulation (muscle/nerve stimulation) Fluid accumulation Foreign body rejection phenomena Formation of hematomas or seromas Heart block Inability to pace Inappropriate pacing Incisional pain Incomplete lead connection with pulse generator Infection including endocardit
• • • • • • • • • • • • • • • • • • • • • Lead tip deformation and/or breakage Local tissue reaction Loss of capture Myocardial infarction (MI) Myocardial necrosis Myocardial trauma (e.g.
• • • Depression Fear of premature battery depletion Fear of device malfunction Additionally, potential adverse events associated with the implantation of a coronary venous lead system include: • • • • Allergic reaction to contrast media Breakage/failure of implant instruments Prolonged exposure to fluoroscopic radiation Renal failure from contrast media used to visualize coronary veins MECHANICAL SPECIFICATIONS The following mechanical specifications and material specifications apply to VALITUDE device
Table 2. Mechanical Specifications - VALITUDE CRT-Ps Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type U125 4.45 x 6.13 x 0.75 30.6 16.2 RA: IS-1; RV: IS-1; LV: IS-1 U128 4.45 x 6.17 x 0.75 33.0 17.6 RA: IS-1; RV: IS-1; LV: IS4 VALITUDE devices include ZIP telemetry operating with a transmit frequency of 402 to 405 MHz.
Table 3. Table 4. Mechanical Specifications - INTUA CRT-Ps Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type V272 4.45 x 6.10 x 0.75 34.0 15.0 RA: IS-1, RV: IS-1, LV: LV-1 V273 4.45 x 6.10 x 0.75 34.0 15.0 RA: IS-1, RV: IS-1, LV: IS-1 Mechanical Specifications - INVIVE CRT-Ps Model Dimensions W x H x D (cm) Mass (g) Volume (cm3) Connector Type V172 4.45 x 6.10 x 0.75 34.0 15.0 RA: IS-1, RV: IS-1, LV: LV-1 V173 4.45 x 6.10 x 0.75 34.0 15.
ITEMS INCLUDED IN PACKAGE The following items are included with the pulse generator: • • One torque wrench Product literature NOTE: Accessories (e.g., wrenches) are intended for one-time use only. They should not be resterilized or reused. SYMBOLS ON PACKAGING The following symbols may be used on packaging and labeling (Table 5 on page 34): Table 5.
Table 5.
