Indications, Safety, and Warnings
Indications
The Attain™ Ability™ 4196, 4296, and 4396 steroid eluting, dual electrode, IS-1 transvenous leads are indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic cardiac resynchronization therapy (CRT) system. Extended bipolar pacing is available using these leads in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead. Unipolar pacing is available using the leads in combination with a compatible CRT-P system. The Attain™ Performa™ 4298, 4398, 4598 steroid eluting, quadripolar electrode, IS4 transvenous leads are indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used with a compatible Medtronic cardiac resynchronization therapy (CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead.
The Attain™ Ability™ MRI SureScan™ and Attain™ Performa™ MRI SureScan™ leads are part of the Medtronic SureScan™ implantable cardioverter defibrillator with cardiac resynchronization (CRT-D) system. A complete SureScan™ CRT-D system is required for use in the MR environment and includes a Medtronic SureScan™ device connected to Medtronic SureScan™ leads.
Contraindications
The Attain™ Ability™ leads are contraindicated for:
Coronary vasculature — These leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
Steroid use — Do not use in patients for whom a single dose of 232 μg of dexamethasone acetate cannot be tolerated.
The Attain™ Performa™ leads are contraindicated for:
Coronary vasculature — These leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.
Steroid use — Do not use in patients for whom a single dose of 288 μg of dexamethasone acetate may be contraindicated.
Warnings and precautions
Diathermy is a treatment that involves the therapeutic heating of body tissues. Diathermy treatments include high frequency, short wave, microwave, and therapeutic ultrasound. Except for therapeutic ultrasound, do not use diathermy treatments on cardiac device patients. Diathermy treatments may result in serious injury or damage to an implanted device and lead system. Therapeutic ultrasound (including physiotherapy, high intensity therapeutic ultrasound, and high intensity focused ultrasound) is the use of ultrasound at higher energies than diagnostic ultrasound to bring heat or agitation into the body. Therapeutic ultrasound is acceptable if treatment is performed with a minimum separation distance of 15 cm (6 in) between the applicator and the implanted device and lead system, as long as the ultrasonic beam is pointing away from the device and lead system.
A complete SureScan™ CRT-D system is required for use in the MR environment. Before performing an MRI scan, refer to the SureScan™ MRI technical manual for important information about procedures and MRI-specific warnings and precautions. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; for patients with multiple MR-Conditional devices present, the MR labeling conditions for all implants are satisfied; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the SureScan™ CRT-D system is implanted in the left or right pectoral region; the CRT-D device is operating within the projected service life; no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan™ is programmed to "on.” For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. A higher pacing capture threshold may indicate an issue with the implanted lead.
Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T MRI system with operating frequency of 64 MHz, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. Scanner must be operated in normal operating mode (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg). 3T scanners must be operated in first level controlled operating mode or normal operating mode. B1+RMS must be ≤ 2.8 μT when the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be performed without B1+RMS restriction when the isocenter is at or superior to the C7 vertebra.
The Models 4196, 4296, and 4396 leads were designed for optimal pacing when used in a unipolar or extended bipolar configuration. The standard bipolar configuration may result in markedly elevated pacing thresholds or produce anodal stimulation.
Potential complications
Potential complications related to the use of transvenous leads include, but are not limited to, the following patient-related conditions: air embolism; avulsion or other damage to the endocardium, valve, or vein (particularly in fragile hearts); cardiac dissection; cardiac perforation; cardiac tamponade; coronary sinus dissection; death; endocarditis; erosion through the skin; extracardiac muscle or nerve stimulation; fibrillation or other arrhythmias; heart block; heart wall or vein wall rupture; hematoma/seroma; infection; lead conductor fracture or insulation failure; lead dislodgement; myocardial irritability; myopotential sensing; pericardial effusion; pericardial rub; pericarditis; pneumothorax; rejection phenomena (local tissue reaction, fibrotic tissue formation); threshold elevation or exit block; thrombosis; thrombotic embolism.
Potential MRI complications for the SureScan™ system include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan™ is programmed to “on”; potential for VT/VF induction when the patient is programmed to an asynchronous pacing mode during MRI SureScan™; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; or damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer.
See the MRI SureScan™ mechnical manual before performing an MRI scan and the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.
Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.
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