Medtronic 419478 Technical Manual
ATTAIN® BIPOLAR OTW 4194
Steroid eluting, transvenous, bipolar, left ventricular, 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.
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other trademarks are the property of their respective owners.
Attain, InSync, Medtronic
Contents
1 Required physician training 3
2 Device description 3
3 Indications for use 4
4 Contraindications 4
5 Warnings and precautions 4
6 Potential adverse events 5
7 Clinical trials 6
8 Directions for use 9
9 Detailed device description 15
10 Medtronic warranty 17
11 Service 17
1 Required physician training
In order to implant a Medtronic Attain Bipolar OTW 4194 lead,
physicians are required to:
●
Thoroughly read this manual, and all associated device
technical manuals.
●
Provide a copy of the patient manual to the patient and
discuss it with him or her and any other interested parties.
●
Be trained on the following topics
– Indications for use
– Device operation to ensure therapy delivery
– Measuring and managing biventricular thresholds
– Assembly and use of LV lead implant tools
– Placement of the LV lead
– Patient management and system follow-up
Prior to implanting the system, Medtronic will certify that
physicians received training.
2 Device description
The Medtronic Attain Bipolar OTW 4194 steroid eluting,
transvenous, bipolar, left ventricular, over the wire, cardiac vein
pacing lead is designed for pacing and sensing via a cardiac vein,
as part of a Medtronic biventricular pacing system. The tip to
anode spacing is 11 mm.
The lead features a tapered annular platinum alloy electrode tip
and a platinum/iridium anode coil. The electrode tip contains a
molded silicone rubber seal. This molded tip provides a fluid seal
which allows guide wire passage and reduces blood ingress. The
lead also features nickel alloy conductors, polyurethane outer
insulation, silicone inner insulation, and an IS-11 Bipolar (BI) lead
connector.
The lead’s distal tip contains a maximum of 1.0 mg
dexamethasone sodium phosphate. Upon exposure to body
fluids, the steroid elutes from the lead tip. The steroid is known to
suppress the inflammatory response that is believed to cause
threshold rises typically associated with implanted pacing
electrodes.
The Model 4194 lead can be positioned with the aid of a guide wire
or with a stylet. If a stylet is used, use only the stylets packaged
with the lead or in a stylet kit (downsized knob).
Note: To implant the Model 4194 lead in a cardiac vein, a
compatible delivery system is required, such as a Medtronic
delivery system. A compatible delivery system includes a guide
catheter and a hemostasis/introducer valve which allows
passage through or removal from an IS-1 connector. Contact your
Medtronic representative for further information regarding
compatible delivery systems.
2.1 Contents of package
The lead and accessories are supplied sterile. Each package
contains the following items:
●
1 lead with stylet and anchoring sleeve
●
2 guide wire insertion tools
●
1 guide wire clip
●
1 guide wire steering handle
●
Extra stylets
●
Product documentation
2.2 Accessory descriptions
Dispose of all single-use accessories according to local
environmental requirements.
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 control and steerability of
the guide wire.
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.
1
IS-1 BI refers to an International Connector Standard (ISO 5841–3) whereby pulse generators and leads so designated are assured of a basic mechanical fit.
3
3 Indications for use
The lead has application as part of a Medtronic biventricular
pacing system.
4 Contraindications
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 1.0 mg of dexamethasone sodium phosphate may
be contraindicated.
5 Warnings and precautions
For single use only – Do not resterilize and reimplant an
explanted lead.
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.
Backup pacing should be readily available during implant. Use of
the delivery system or leads may cause heart block.
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.
Diathermy – People with metal implants such as pacemakers,
implantable cardioverter defibrillators (ICDs), and accompanying
leads should not receive diathermy treatment. The interaction
between the implant and diathermy can cause tissue damage,
fibrillation, or damage to the device components, which could
result in serious injury, loss of therapy, and/or the need to
reprogram or replace the device.
Inspecting the sterile package – Carefully inspect the package
prior to opening.
●
If the seal or package is damaged, contact your local
Medtronic representative.
●
Do not use the product after its expiration date.
●
The lead has been sterilized with ethylene oxide prior to
shipment. If the integrity of the sterile package has been
compromised prior to the expiration date, resterilize the lead
using ethylene oxide.
Ethylene oxide resterilization – If the sterile package seal is
broken, resterilize the device using a validated ethylene oxide
process. Avoid resterilization techniques that could damage the
lead.
●
Refer to sterilizer instructions for operating instructions.
●
Use an acceptable method to determine sterilizer
effectiveness, such as biological indicators.
●
Before resterilization, place the device in an ethylene oxide
permeable package.
●
Do not exceed temperatures of 55 °C (131 °F).
●
Do not resterilize more than one time.
●
Allow proper aeration of ethylene oxide residues prior to
implant.
Steroid use – It has not been determined whether the warnings,
precautions, or complications usually associated with injectable
dexamethasone sodium phosphate 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 the steroid tip – Reducing the available amount of
steroid may adversely affect low-threshold performance. Avoid
reducing the amount of steroid available prior to lead implant.
●
Do not allow the electrode surface to come in contact with
surface contaminants.
●
Do not wipe or immerse the electrode in fluid, except blood, at
the time of implant.
Handling the lead – Leads should be handled with care at all
times:
●
Do not withdraw the lead through a non-adjustable
hemostasis/introducer valve. This action could cause
distortion of the coil electrode and result in potential injury to
the patient.
●
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 lead tip
seal damage or 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 wiping the lead is necessary prior to 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.
4
Handling the guide wire – Handle the guide wire with care at all
times.
●
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.
●
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 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.
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.
Chronic repositioning or removal – Chronic repositioning or
removal of leads may be difficult because of fibrotic tissue
development. Studies have not specifically evaluated 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.
●
Verify lead length on the IS-1 label on the connector to choose
an appropriate stylet kit (downsized knob) length when
repositioning. Always choose a stylet kit (downsized knob)
3 cm shorter than the lead length listed on the IS-1 connector
label. 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 of a lead may adversely affect a steroid
eluting lead’s low-threshold performance.
●
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 prior to repositioning.
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:
●
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
●
myocardial irritability
●
myopotential sensing
●
pericardial effusion
●
pericardial rub
●
pneumothorax
●
rejection phenomena (local tissue reaction, fibrotic tissue
formation, pulse generator migration)
●
threshold elevation
●
thrombosis
●
thrombotic or air embolism
●
valve damage (particularly in fragile hearts)
Additional potential adverse events related to the lead and the
programmed parameters include, but are not limited to, the
following:
Potential adverse
event
Lead dislodgementaIntermittent or contin-
Lead dislodgementaIntermittent or contin-
Indicator of potential adverse event
uous loss of capture
or sensing
a
uous oversensing
Corrective action to
be considered
Reposition the lead.
Reposition the lead.
5
Potential adverse
event
Lead conductor fracture or insulation failure
Threshold elevation
or exit block
a
Transient loss of capture or sensing may occur following surgery until
lead stabilization takes place. If stabilization does not occur, lead
dislodgement may be suspected.
Indicator of potential adverse event
Intermittent or continuous loss of capture
or sensing
Loss of capture
a
a
Corrective action to
be considered
Replace the lead.
Adjust the implantable device output.
Replace or reposition
the lead.
Implant techniques that may damage the lead include, but are not
limited to, the following:
Implant techniques
that may damage
the lead
Forcing the lead
through the introducer/delivery system
Use of too medial of
an approach with
venous introducer
resulting in clavicle &
first rib binding
Puncturing the periosteum and/or tendon
when using subclavian introducer
approach
Advancing the lead
through the veins
without the stylet or
guide wire fully inserted
Inserting the proximal
end of the guide wire
through the lead tip
seal without using the
guide wire insertion
tool
Advancing a stylet tip
beyond the distal end
of the lead tip seal
Possible effects on
the lead
Electrode, conductor
coil, and/or insulation
damage
Conductor coil fracture, insulation damage
Conductor coil fracture, insulation damage
Tip distortion and/or
insulation perforation
Lead tip seal damage Replace the lead.
Lead tip seal damage Replace the lead.
Corrective action to
be considered
Replace the lead.
Replace the lead.
Replace the lead.
Replace the lead.
7 Clinical trials
7.1 Attain Bipolar OTW Model 4194 left-heart lead study
A prospective, multi-center trial conducted at 22 investigative
sites in the United States and Canada evaluated the safety and
effectiveness of the Medtronic Attain Bipolar OTW Model 4194
left-heart lead in heart failure patients.
An investigational protocol pre-specified the performance criteria
for both safety and effectiveness based on previous studies. For
this study, patients who satisfied inclusion and exclusion criteria
underwent a baseline evaluation to determine study eligibility and
then underwent a cardiac resynchronization system implant
attempt, which could include the Model 4194 left heart lead.
Key study inclusion criteria included patients with the following:
●
Patient provides written informed consent
●
Patients 18 years of age or older
●
Patient is diagnosed with New York Heart Association
functional classification three (NYHA III) or New York Heart
Association functional classification four (NYHA IV) despite
optimal medical therapy which is defined as:
– ACE inhibitor or Angiotensin Receptor Blocker (ARB), if
tolerated, for at least 1 month prior to implant
– Beta-blockers for at least 3 months preceding implant, if
tolerated, and stable for 1 month. Stable is defined as no
upward titration of beta-blockers.
●
Demonstrated intrinsic QRS duration ≥ 130 ms (test
documented within 6 months of baseline)
●
Left ventricular ejection fraction (EF) ≤ 35% (test documented
within 12 months of baseline)
●
Patient is expected to remain available for follow-up visits
●
Patient is willing and able to comply with the protocol
●
Patient is indicated for ICD implantation for the treatment of
life threatening ventricular arrhythmias (required only if a
patient will receive an ICD)
Key study exclusion criteria included patients with the following:
●
Patients with a previous complete atrial based biventricular
CRT system
●
Patients with a previous LV lead implanted or previous
implant attempt within 30 days of implant or ongoing adverse
events from previous unsuccessful attempt
●
Patients contraindicated for < 1.0 mg dexamethasone sodium
phosphate
●
Patients with unstable angina or who have experienced an
acute myocardial infarction (MI) within the past month
●
Patients who have had a coronary artery revascularization
(CABG) or coronary angioplasty (PTCA) within the past 3
months
●
Patients on more than 2 inotropic infusions per week within 1
month of implant
●
Patients with contraindications for standard transvenous
cardiac pacing (for example, mechanical right heart valves)
●
Patients with chronic (permanent) atrial arrhythmias
●
Post heart transplant patients (patients waiting for heart
transplant are allowed in the study)
●
Patients enrolled in any concurrent drug and/or device study
that may confound the results of this study
●
Patients with a terminal illness who are not expected to
survive more than 6 months
6
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