Medtronic 459888 Technical Manual
ATTAIN PERFORMA™ S MRI SURESCAN™ 4598
Steroid-eluting, quadripolar electrode, transvenous, over-the-wire, cardiac vein pacing lead
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks
are the property of their respective owners.
AccuRead, Attain, Attain Hybrid, Medtronic, Performa, SureScan
Contents
1 Description 3
2 Drug component description 4
3 Indications 4
4 Contraindications 4
5 Warnings and precautions 4
6 Potential adverse events 6
7 Drug information 7
8 Clinical study 8
9 Implant procedure 8
10 Specifications 15
11 Medtronic warranty 16
12 Service 16
1 Description
The Medtronic Attain Performa S MRI SureScan 4598
steroid-eluting, quadripolar electrode, transvenous, over-the-wire
LV lead is designed for pacing via a cardiac vein. The lead has
been tested for use in the Magnetic Resonance Imaging (MRI)
environment. All lead lengths for this lead model are MR
Conditional. This lead contains 4 electrodes designed to function
as cathodes or anodes, depending on how the device LV pacing
polarity is programmed:
●
electrode LV1, the distal electrode, positioned near the distal
tip of the lead
●
electrode LV2, positioned 21 mm proximal to electrode LV1
●
electrode LV3, positioned 1.3 mm proximal to electrode LV2
●
electrode LV4, the proximal electrode, positioned 21 mm
proximal to electrode LV3
See Section 9.10, “Taking electrical measurements”, page 11
for information about LV pacing polarity selections.
The Medtronic IS4-LLLL1 four-pole inline connector on the lead
facilitates device connection during implant. The tip of the
connector pin has a white band indicator that can be used for
visual confirmation of proper lead connection to the device.
The connector contacts align with the lead electrodes LV1 to LV1,
LV2 to LV2, and so on:
●
connector contact LV1, the connector pin, positioned at the
proximal tip of the lead (aligns to electrode LV1)
●
connector contact LV2, positioned distal to connector pin LV1
(aligns to electrode LV2)
●
connector contact LV3, positioned distal to connector contact
LV2 (aligns to electrode LV3)
●
connector contact LV4, positioned distal to connector contact
LV3 (aligns to electrode LV4)
See Section 10.2, “Specifications drawing (nominal)”, page 16
for an illustration of the lead electrodes and connector contacts.
The distal tip of the lead allows a guide wire to pass through to aid
in cardiac vein selection. The tip contains a silicone rubber
membrane, which seals the lead inner lumen to reduce blood
ingress.
Each electrode contains a Monolithic controlled release device
(MCRD) for elution of steroid to reduce inflammatory response
within the cardiac vein. The MCRDs contain a combined-total
target dosage of 288 µg of dexamethasone acetate steroid. The
target dose of the steroid is 72 µg at each MCRD. Upon exposure
to body fluids, the steroid elutes from the MCRDs. The steroid
suppresses the inflammatory response that is believed to cause
threshold rise typically associated with implanted pacing
electrodes.
The electrodes are positioned relative to the 3 distal curves of the
lead to facilitate contact with the cardiac veins.
The outer insulation of the lead is polyurethane and the inner
insulation is SI-polyimide (SI-PI)2. The SI-PI is applied as a
coating to the conductor wire before coiling.
The Attain Performa S MRI SureScan 4598 LV lead can be
positioned with the aid of a guide wire, a stylet, an inner catheter,
or an inner catheter plus a guide wire or a stylet.
To implant the lead in a selected cardiac vein, a compatible
delivery system is required. A compatible delivery system
includes a guide catheter and either a hemostasis valve or an
introducer valve that can be removed or that allows passage over
the lead connector. Contact a Medtronic representative for further
information regarding compatible delivery systems.
1.1 Medtronic SureScan system
The Model 4598 lead is part of the Medtronic SureScan system.
The SureScan system includes a Medtronic SureScan device
connected to Medtronic SureScan leads. Labeling for SureScan
system components displays the SureScan logo and the MR
Conditional symbol. To verify that components are part of a
SureScan system, visit http://www.mrisurescan.com.
SureScan logo
MR Conditional symbol. The Medtronic SureScan system is MR Conditional and is designed to allow implanted patients to undergo an MRI scan under the specified MRI conditions for use.
1
IS4-LLLL refers to an International Connector Standard (ISO 27186:2010) whereby pulse generators and leads so designated are assured of a basic mechanical fit.
LLLL defines the lead connector contacts as low voltage (L).
2
Technology developed by NASA.
3
The MRI SureScan feature permits a mode of operation that
allows a patient with a SureScan device to be safely scanned by
an MRI machine while the device continues to provide appropriate
pacing. When programmed to On, MRI SureScan operation
disables arrhythmia detection, magnet mode, and all
user-defined diagnostics. Before performing an MRI scan,
refer to the SureScan MRI technical manual for important
information about procedures and MRI-specific warnings
and precautions.
1.2 Contents of package
Leads and accessories are supplied sterile. Each package
contains the following items:
●
1 lead with anchoring sleeve
●
1 guide wire insertion tool
●
1 guide wire clip
●
1 guide wire steering handle
●
4 stylets
●
2 AccuRead 2.0 analyzer cable interface tools
●
product documentation
1.3 Accessory descriptions
Dispose of all single-use accessories according to local
environmental requirements.
AccuRead 2.0 tool – The AccuRead 2.0 analyzer cable interface
tool guides the connection of analyzer cable terminals to the lead
connector contacts. This connection facilitates accurate electrical
measurements during implant and prevents possible connector
damage.
Anchoring sleeve – An anchoring sleeve secures the lead to
prevent it from moving and protects the lead insulation and
conductors from damage caused by tight sutures.
Guide wire clip – A guide wire clip secures the excess guide wire
and helps to protect and maintain the sterility of the guide wire.
Guide wire insertion tool – A guide wire insertion tool provides
additional control when inserting a guide wire into the lead
connector pin or the lead tip.
Guide wire steering handle – A guide wire steering handle is
used only with guide wires 0.46 mm (0.018 in) or less in diameter.
The steering handle provides additional guide wire steering and
rotation control.
Stylet – A stylet provides additional stiffness and controlled
flexibility for maneuvering the lead into position. Each stylet knob
is labeled with the stylet diameter and corresponding lead length.
2 Drug component description
The active ingredient in the Attain Performa S MRI SureScan 4598
LV lead is dexamethasone acetate [21-(acetyloxy)-9-fluoro-11β,
17-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione]. The
structural formula for this steroid is as follows:
Dexamethasone acetate (DXAC) - C24H31FO
6
Figure 1.
The target dosage of dexamethasone acetate is 288 µg per lead.
Cautions:
●
Drug interactions of dexamethasone acetate with this lead
have not been studied.
●
Before implanting this lead, consider total patient exposure to
dexamethasone acetate.
3 Indications
The Attain Performa S MRI SureScan 4598 steroid-eluting,
quadripolar electrode, IS4 transvenous lead is indicated for
chronic pacing 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.
4 Contraindications
Before performing an MRI scan, refer to the SureScan MRI
technical manual for MRI-specific contraindications.
The Model 4598 lead is contraindicated as follows:
Coronary vasculature – This lead is contraindicated for patients
with coronary venous vasculature that is inadequate for lead
placement, as indicated by venogram.
Steroid use – The lead is contraindicated in patients for whom a
single dose of 288 µg of dexamethasone acetate may
be contraindicated.
5 Warnings and precautions
A complete SureScan system is required for use in the MRI
environment. Before performing an MRI scan, refer to the
SureScan MRI technical manual for MRI-specific warnings
and precautions.
Note: Medical procedure warnings and precautions that pertain
to the Medtronic implanted system are provided in the manual that
is packaged with the device or on the Medtronic Manual Library
website (www.medtronic.com/manuals).
4
Inspecting the sterile package – Inspect the sterile package
with care before opening it.
●
If the seal or package is damaged, contact a Medtronic
representative.
●
Store at 25 °C (77 °F). Excursions from this storage
temperature are permitted in the range of 15 to 30 °C (59 to
86 °F). (See USP Controlled Room Temperature.) According
to USP excursion conditions, transient spikes up to 40 °C
(104 °F) are permitted as long as they do not exceed 24 hours.
●
Do not use the product after its expiration date.
Sterilization – Medtronic has sterilized the package contents
with ethylene oxide before shipment. This lead is for single use
only and is not intended to be resterilized.
Single use – The lead and accessories are for single use only.
Necessary hospital equipment – Keep external defibrillation
equipment nearby for immediate use during acute lead system
testing, the implant procedure, or whenever arrhythmias are
possible or intentionally induced during post-implant testing.
External defibrillation and cardioversion – External
defibrillation and cardioversion are therapies that deliver an
electrical shock to the heart to convert an abnormal heart rhythm
to a normal rhythm.
Medtronic cardiac devices are designed to withstand exposure to
external defibrillation and cardioversion. While damage to an
implanted system from an external shock is rare, the probability
increases with increased energy levels. These procedures may
also temporarily or permanently elevate pacing thresholds or
temporarily or permanently damage the myocardium. If external
defibrillation or cardioversion are required, consider the following
precautions:
●
Use the lowest clinically appropriate energy.
●
Position the patches or paddles a minimum of 15 cm (6 in)
away from the device.
●
Position the patches or paddles perpendicular to the device
and lead system.
●
If an external defibrillation or cardioversion is delivered within
15 cm (6 in) of the device, use a Medtronic programmer to
evaluate the device and lead system.
Line-powered and battery-powered equipment – An
implanted lead forms a direct current path to the myocardium.
During lead implant and testing, use only battery-powered
equipment or line-powered equipment specifically designed for
this purpose to protect against fibrillation that may be caused by
alternating currents. Line-powered equipment used in the vicinity
of the patient must be properly grounded. Lead connector pins
must be insulated from any leakage currents that may arise from
line-powered equipment.
Concurrent devices – Output pulses, especially from unipolar
devices, may adversely affect device sensing capabilities. If a
patient requires a separate stimulation device, either permanent
or temporary, allow enough space between the leads of the
separate systems to avoid interference in the sensing capabilities
of the devices. Previously implanted pulse generators and
implantable cardioverter defibrillators should generally be
explanted.
Steroid use – It has not been determined whether the warnings,
precautions, or complications usually associated with injectable
dexamethasone acetate apply to the use of this highly localized,
controlled-release device. For a list of potential adverse effects,
refer to the Physicians’ Desk Reference.
Handling steroid monolithic controlled release devices
(MCRDs) – Avoid reducing the amount of steroid available before
implanting the lead. Reducing the available amount of steroid may
adversely affect low-threshold performance.
●
Do not allow the electrode surfaces to come in contact with
surface contaminants.
●
Do not wipe or immerse the electrodes in fluid, except blood,
at the time of implant.
Bipolar pacing – If the surface area of the selected anode
electrode is equal to or less than the surface area of the selected
cathode, higher pacing thresholds or anodal stimulation may
result. This lead uses 4 equal-sized electrodes; therefore, bipolar
pacing configurations may result in higher pacing thresholds or
anodal stimulation.
If therapy cannot be delivered via the LV1 electrode, the LV2, LV3,
and LV4 electrodes are available for use with specific Medtronic
devices. Refer to the appropriate Medtronic Cardiac
Resynchronization Therapy (CRT-D) system manual for use of
available LV lead pacing polarity options.
Handling the stylet – Handle the stylet with care at all times.
●
To minimize the likelihood of trauma to the vein and to
maintain lead flexibility while advancing the lead through the
vein, keep the stylet withdrawn 1 to 2 cm or select a more
flexible stylet.
●
Do not use excessive force or surgical instruments when
inserting a stylet.
●
Avoid overbending, kinking, or blood contact on stylets.
●
Use a new stylet when blood or other fluids accumulate on the
stylet. Accumulated fluids may cause damage to the lead or
difficulty in passing the stylet through the lead.
●
Curving the distal end of the stylet prior to insertion into the
lead will achieve a curvature at the distal end of the lead. Do
not use a sharp object to impart a curve to the distal end of the
stylet.
Handling the guide wire – Handle the guide wire with care at all
times.
●
Do not insert the proximal end of the guide wire through the
lead tip seal without using the guide wire insertion tool.
Inserting the guide wire without the guide wire insertion tool
may damage the lead.
●
Damage to a guide wire may prevent the guide wire from
performing with accurate torque response and control and
may cause vessel damage. For additional information about
vessel damage and other potential adverse events, refer to
the technical manual packaged with the appropriate guide
wire.
5
●
If the distal end of the guide wire becomes severely kinked or
twisted, it may be difficult to withdraw it back through the lead.
Therefore, if there is an indication that the distal end of the
guide wire has become damaged, or if there is significant
resistance in guide wire passage, remove the lead and guide
wire together as a unit. Remove the guide wire from the lead
and insert a new guide wire into the lead. Do not use excessive
force to retract the guide wire from the lead.
Refer to the product documentation packaged with the guide
wire for additional information.
Handling the lead – Handle the lead with care at all times.
●
Rust stylets are not recommended with this lead due to the
risk of conductor coil or insulation perforation.
●
If a stylet is used for lead positioning, use only the stylets
packaged with the lead or in a stylet kit (downsized knob).
Other stylets may extend beyond the lead tip causing patient
injury.
●
If the lead is damaged, do not implant it. Return the lead to a
Medtronic representative.
●
Protect the lead from materials that shed particles such as lint
and dust. Lead insulators attract these particles.
●
Handle the lead with sterile surgical gloves that have been
rinsed in sterile water or a comparable substance.
●
Do not severely bend, kink, or stretch the lead.
●
Do not use surgical instruments to grasp the lead or connector
pin.
●
Do not immerse leads in mineral oil, silicone oil, or any other
liquid, except blood, at the time of implant.
●
Use an anchoring sleeve with all leads. Ensure that the
anchoring sleeve is positioned close to the lead connector
pin, to prevent inadvertent passage of the sleeve into the vein.
If it is necessary to wipe the lead before insertion, ensure that
the anchoring sleeve remains in position.
●
Do not force the guide catheter or leads if significant
resistance is encountered. Use of guide catheters or leads
may cause trauma to the heart.
Chronic repositioning or removal – Chronic repositioning or
removal of leads may be difficult because of fibrotic tissue
development. The clinical study was not designed to evaluate the
removal of left ventricular leads from the coronary venous
vasculature. If a lead must be removed or repositioned, proceed
with extreme caution. Return all removed leads to Medtronic.
●
Rust stylets are not recommended with this lead due to the
risk of conductor coil/insulation perforation.
●
Verify lead length on the lead label on the connector to choose
an appropriate stylet kit (downsized knob) length when
repositioning. Always choose a stylet kit (downsized knob)
3 cm (1.2 in) shorter than the lead length. For example,
choose a stylet kit (downsized knob) with stylets 75 cm long
for a lead 78 cm long.
●
Lead removal may result in avulsion of the endocardium,
valve, or vein.
●
Lead junctions may separate, leaving the lead tip and bare
wire in the heart or vein.
●
Chronic repositioning may adversely affect the low-threshold
performance of a steroid-eluting lead.
●
Cap abandoned leads to avoid transmitting electrical signals.
●
For leads that have been severed, seal the remaining lead end
and suture the lead to adjacent tissue.
●
If a lead is removed and repositioned, inspect it carefully for
insulator or conductor coil damage before repositioning.
Magnetic resonance imaging (MRI) – An MRI is a type of
medical imaging that uses magnetic fields to create an internal
view of the body. If certain criteria are met and the warnings and
precautions provided by Medtronic are followed, patients with an
MR Conditional device and lead system are able to undergo an
MRI scan; for details, refer to the SureScan MRI technical manual
that Medtronic provides for an MR Conditional device.
Diathermy treatment (including therapeutic ultrasound) –
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.
6 Potential adverse events
The potential adverse events (listed in alphabetical order) related
to the use of transvenous leads include, but are not limited to, the
following conditions:
●
Air embolism
●
Avulsion or other damage to the endocardium, valve, or vein
(particularly in fragile hearts)
●
Cardiac dissection or perforation
●
Cardiac tamponade
●
Coronary sinus dissection
●
Death
●
Endocarditis or pericarditis
●
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 or rub
●
Pneumothorax
●
Rejection phenomena (local tissue reaction, fibrotic tissue
formation)
6
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