®
Attain
Transvenous, bipolar, coronary sinus/cardiac vein pacing
lead
OTW 4193
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.
Attain, InSync, Medtronic
Contents
Required physician training 5
Device description 5
Contents of package 6
Accessory descriptions 6
Indications for use 6
Contraindications 6
Warnings and precautions 7
Potential adverse events 10
Clinical trials 11
Attain OTW Model 4193 left-heart lead study 11
Objectives 13
InSync Registry study 18
Directions for use 18
Placing the right ventricular lead 19
Preparing the delivery system 19
Accessing the subclavian vein 19
Inserting the guide catheter assembly 20
Obtaining venograms 20
Inserting the lead into the delivery system 20
Selecting the lead placement method 21
Placing the lead using a stylet 22
Preparing the guide wire 24
Placing the lead using a guide wire 26
Fixating the lead 28
Taking electrical measurements 28
Removing the guide catheter from the lead 29
Anchoring the lead 29
Connecting the lead 30
Placing the device and leads into the pocket 30
Post-implant evaluation 31
Detailed device description 32
Specifications (nominal) 32
Specifications drawing (nominal) 33
Medtronic warranty 34
Service 34
4193 Technical Manual 3
Required physician training
In order to implant a Medtronic Attain OTW Model 4193 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 bi-ventricular 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.
Device description
The Medtronic Attain OTW Model 4193 steroid eluting, transvenous,
unipolar, left ventricular, over the wire, cardiac vein pacing lead is
designed for pacing and sensing via a cardiac vein.
The lead features a tapered annular platinum alloy electrode with a
molded silicone rubber tip. This molded tip provides a fluid seal which
allows guide wire passage and reduces blood ingress. The lead also
features nickel alloy conductors, polyurethane insulation, and an
1
Unipolar (UNI) lead connector.
IS-1
The distal tip of the lead contains a maximum of 1.0 mg
dexamethasone sodium phosphate. Upon exposure to body fluids,
the steroid elutes from the lead tip. The steroid suppresses the
inflammatory response that is believed to cause threshold rises
typically associated with implanted pacing electrodes.
The Model 4193 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 4193 in a cardiac vein, a compatible
delivery system is required. 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.
1
IS-1 UNI refers to an International Connector Standard (ISO 5841-3) whereby
pulse generators and leads so designated are assured of a basic
mechanical fit.
4193 Technical Manual English 5
Contents of package
The lead and accessories are supplied sterile. Each package
contains the following items:
■
One lead with stylet and anchoring sleeve
■
Two guide wire insertion tools
■
One guide wire clip
■
One guide wire steering handle
■
Extra stylets
■
Product literature
Accessory descriptions
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 length.
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.
Anchoring sleeve – An anchoring sleeve secures the lead from
moving and protects the lead insulation and conductors from damage
caused by tight ligatures.
Guide wire steering handle – A guide wire steering handle is used
only with guide wires 0.018” in diameter or less. The steering handle
provides additional control and steerability of the guide wire.
Guide wire clip – A guide wire clip secures the excess guide wire
and helps to protect and maintain the sterility of the guide wire.
Indications for use
The lead has application as part of a Medtronic biventricular
pacing system.
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 – Do not use steroid eluting leads in patients for whom
a single dose of 1.0 mg of dexamethasone sodium phosphate may
be contraindicated.
6 English 4193 Technical Manual
Warnings and precautions
For single use only – Do not resterilize and reimplant an
explanted lead.
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 for determining 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 Physician’s 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.
■
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 and/or patient injury.
■
If the lead is damaged, do not implant it. Return the lead to your
Medtronic representative.
■
Protect the lead from materials that shed particles such as lint
and dust. Lead insulators attract these particles.
4193 Technical Manual English 7
■
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’s 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 and/or leads if significant
resistance is encountered. Use of guide catheters and/or leads
may cause trauma to the heart.
Handling the guide wire – Use care when handling guide wires.
■
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 product.
■
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 a lot of
resistance in guide wire passage, remove the lead and guide
wire. Remove the guide wire from the lead and re-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 literature packaged with the guide wire for
additional information.
Handling the stylets – Use care when handling stylets.
■
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 1-2 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.
8 English 4193 Technical Manual
Necessary hospital equipment – Keep external defibrillation
equipment nearby for immediate use during the acute lead system
testing, implant procedure, or whenever arrhythmias are possible or
intentionally induced during post-implant testing. Back-up pacing
should be readily available during implant. Use of the delivery system
and/or leads may cause heart block.
Line-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.
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.
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. 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.
4193 Technical Manual English 9
■
If a lead is removed and repositioned, inspect it carefully for
insulator or conductor coil damage prior to repositioning.
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 patient-related 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
■
Thrombolytic and air
embolism
■
Thrombosis
■
Transvenous lead-related
thrombosis
■
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 dislodgment
Lead dislodgment
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 dislodgment may
be suspected.
Indicator of potential
adverse event
a
Intermittent or continuous
loss of capture or sensing
a
Intermittent or continuous
oversensing
Intermittent or continuous
loss of capture or sensing
Loss of capture
Corrective action
to be considered
Reposition the lead.
a
Reposition the lead.
Replace the lead.
a
a
Adjust the implantable
device output. Replace
or reposition the lead.
10 English 4193 Technical Manual
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.
Clinical trials
Attain OTW Model 4193 left-heart lead study
A prospective, multi-center trial conducted at 28 investigative sites in
the United States evaluated the safety and effectiveness of the
Medtronic InSync III cardiac resynchronization device and the
Attain OTW Model 4193 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 an implant attempt of the InSync III cardiac
resynchronization system including an Attain OTW Model 4193 lead.
Key study inclusion criteria included patients with the following:
■
Symptomatic congestive heart failure (NYHA classification III
or IV).
■
QRS duration of ≥ 130 ms.
■
Left ventricular end diastolic diameter of ≥ 55 mm.
■
Left ventricular ejection fraction ≤ 35%.
■
A stable pharmacological medical regimen prior to implant of
the cardiac resynchronization system. This included ACE-I or
substitute for at least one month and a beta blocker for at least
three months if tolerated.
4193 Technical Manual English 11
Key study exclusion criteria included patients with the following:
■
Prior pacing systems or indications or contraindications for
standard cardiac pacing.
■
Patients with an existing implantable cardioverter defibrillator
(ICD) or indications for an ICD.
■
Chronic atrial arrhythmias or a paroxysmal atrial event within
the previous month.
■
Unstable angina or myocardial infarction (MI), or received
coronary artery revascularization (CABG), or coronary
angioplasty (PTCA), within the past 3 months.
Successfully implanted patients were programmed to VDD as
required per the protocol. They were followed at pre-hospital
discharge (PHD), one-month, three-months, six-months, and every
six months thereafter until approval of the InSync III system.
All patients who underwent an InSync III/Attain OTW system implant
attempt were included in the Attain OTW Model 4193 safety results.
Of the 301 patients attempted with an InSync III/Attain OTW system,
289 were successfully implanted for a 96.0% cardiac
resynchronization system implant success rate. Of those
successfully implanted, 280 patients received the Attain OTW
Model 4193, 8 patients received the Attain LV Model 2187, and
1 patient received the Attain CS Model 2188. Table 1 summarizes
the reasons for unsuccessful implants. These reasons are not
mutually exclusive.
Table 1. Reasons for unsuccessful cardiac resynchronization
Reason N
Dislodgement/unstable position 7
Unable to access coronary os 4
Dissection/perforation 3
Unable to obtain adequate distal location 3
Unacceptable pacing thresholds 2
Patient venous anatomy 2
Coronary vein too small 1
a
Categories are not mutually exclusive.
implant procedures (N = 12)
a
Of the 280 patients successfully implanted with the Attain OTW
Model 4193, 149 have completed the six-month follow-up visit. All
patients successfully implanted with the Attain OTW Model 4193 lead
are included in the effectiveness analysis. Refer to Figure 1 for an
overview of patient accountability and disposition.
12 English 4193 Technical Manual
Figure 1. Enrollment and follow-up for 301 patients attempted
InSync III
patien ts attemped
301
Successful patient
implants
289
Unsuccessful
patient implants
12
Successful
Model 4193
implants
280
Successful
Model 2187
implants
8
Successful
Model 2188
implants
1
6 Month
follow-ups
149
Objectives
There were two primary study objectives and two secondary study
objectives for the Attain OTW Model 4193 lead. Pre-established
performance criteria for each of the primary objectives were
documented in the protocol prior to study start based on experience
with the use of the Model 2187 and 2188 leads as part of the
MIRACLE study.
Primary objective – Estimate the rate of survival from complications
related to the Attain OTW Model 4193 lead.
■
Performance criteria: Lower 95% confidence limit ≥ 75%.
■
Results:
– Estimated survival: 95.1%
– Lower limit of 1-sided 95% confidence interval at
6-months: 89.5%
– Objective met.
4193 Technical Manual English 13
There were 13 Model 4193 related complications reported in
Attain OTW Model 4193 Left Ventricular
Voltage Threshold Data at 0.5 ms
Note: Mean ±1 standard deviation
Implant PHD 1 Month
3 Month
6 Month
Visit
Threshold @ 0.5 ms (V)
11 patients. These are summarized in Table 2.
Tabl e 2. Model 4193 lead-related complications and treatments
Complication event/treatment Occurrence of event
Lead dislodgement
Lead replaced 5
Lead repositioned 3
Lead explanted 1
No treatment 1
Diaphragmatic stimulation
Lead repositioned 1
Failure to capture, loss of capture
Lead replaced 1
Cardiac vein perforation
Patient monitored, no treatment required,
successfully implanted at later date 1
Tota l
13 events
(in 11 patients)
Primary objective – Estimate the mean voltage pacing threshold for
the Attain OTW Model 4193 lead.
■
Performance criteria: Upper 95% confidence limit ≤ 2.5 volts.
■
Results:
– Mean voltage threshold: 1.5 volts ± 1.2.
– Upper limit of 1-sided 95% confidence interval at: 1.6 volts.
– Objective met.
14 English 4193 Technical Manual
Figure 2.
Secondary objective – To demonstrate the implantability of the
Attain Model 4193, Model 2187, and Model 2188 leads.
■
Results:
– Attain implant success: 96.0% (289 patients successfully
implanted with an Attain lead out of 301 patients attempted
with an Attain OTW lead)
– Attain OTW implant success: 93.0% (280 patients
successfully implanted with the Attain OTW lead out of
301 patients attempted with the Attain OTW lead)
Implant time information is provided in Table 3.
Tabl e 3. Implant time (minutes)
N Median Mean Std.
Total operative time 277 138.0 151.8 67.9 54.0 450.0
Fluoroscopic time 275 27.1 36.4 30.0 1.3 174.5
Dev.
Min. Max.
The final LV lead electrode location for the 280 patients (as reported
by the implanting physician) successfully implanted with the
Attain OTW Model 4193 lead is summarized in Table 4.
Tabl e 4. Model 4193 lead electrode location
Location N %
Basal anterior 18 6
Basal lateral 37 13
Basal posterior 8 3
Mid anterior 16 6
Mid lateral 157 56
Mid posterior 32 12
Apical 12 4
Tota l 280 10 0
Table 5 provides a summary of the 14 reported implant dissection
and perforation events related to placing the left-heart lead
(complications and observations) in the 301 patients attempted with
the Model 4193 lead. A complication is an adverse event that is
resolved invasively or resulted in an unsuccessful implant (regardless
of treatment). An observation is an adverse event that is resolved
with non-invasive means. Of the 14 events, 11 were implant tool
related, and 3 were Model 4193 lead related.
Tabl e 5. Implant dissection/perforation adverse events
Event Complications
Coronary sinus/vein dissection 2 (0.7%) 9 11
Coronary sinus/vein perforation 2 (0.7%) 1 3
Tota l 4 ( 1. 3% ) 10 14
N (%)
Observations NTot al
N
4193 Technical Manual English 15
Of the three Model 4193 related events, two were CS dissections
which required no treatment and the patients were successfully
implanted with the InSync III system, and one was a CS perforation
complication that resulted in an unsuccessful implant, the patient was
monitored and required no treatment (the patient was successfully
implanted with an InSync III system at a later date).
Table 6 presents a summary of all implant tool related adverse
events. The implant tools include the Attain venogram balloon
catheter Model 6215, Attain LDS Model 6216, Attain Access
Model 6218, and “other implant tools” (introducer, introducer guide
wire, other catheters). The coronary sinus/vein dissections and
coronary sinus/vein perforations presented in Table 6 are also
included in Table 5.
Tabl e 6. Implant tool related adverse events
Event Complications
Attain Venogram balloon catheter Model 6215
Coronary sinus/vein
dissection
Cornary sinus/vein perforation 0 1 1
Attain LDS Model 6216
Coronary sinus/vein
dissection
Coronary sinus/vein
perforation
Atrial fibrillation 1 (0.3%) 0 1
Lead dislodgement 0 2 2
Attain Access Model 6218
Coronary sinus dissection 0 1 1
Other implant tools
Heart block 0 2 2
Air embolism 0 1 1
Total 4 (1.3%) 13 17
N (%)
044
2 (0.7%) 2 4
1 (0.3%) 0 1
Observations NTota l
N
16 English 4193 Technical Manual
Secondary objective – To characterize the electrical performance
Attain OTW Model 4193 R-wave Amplitude (mV)
Note: Mean ±1 standard deviation
Implant PHD 1 Month
3 Month
6 Month
Visit
R-wave Amplitude (mV)
Attain OTW Model 4193 Impedance (Ohms)
Note: Mean ±1 standard deviation
Implant PHD 1 Month
3 Month
6 Month
Visit
Impedance (Ohms)
of the Attain OTW Model 4193 lead.
■
Results:
– The mean six-month R-wave amplitude of the Attain
Model 4193 lead is 18.5 mV ± 7.3.
Figure 3.
– The mean six-month impedance of the Attain Model 4193
lead is 751 Ohms ± 169.
Figure 4.
4193 Technical Manual English 17
InSync Registry study
The InSync Registry clinical study document is available at
www.medtronic.com/manuals. The following is a synopsis of the
study:
InSync Registry condition-of-approval clinical study – This
observational study was required as a condition of approval for the
InSync Model 8040 and InSync III Model 8042 devices, the Attain LV
lead models 2187 and 2188, and the Attain OTW models 4193 and
4194 left ventricular leads. The findings of the InSync Registry
condition-of-approval clinical study demonstrate that the InSync and
InSync III systems with Attain LV lead models 2187, 2188, and OTW
lead models 4193 and 4194, are safe and effective as part of a
cardiac resynchronization therapy (CRT) system.
Directions for use
Warning: Do not force the guide catheter and/or leads if significant
resistance is encountered. Use of guide catheters and/or leads may
cause trauma to the heart.
Note: To implant the Model 4193 in a cardiac vein, a compatible
delivery system is required. 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.
Proper surgical procedures and sterile techniques are the
responsibility of the medical professional. The implant procedures
described in this manual are provided for information only. Each
physician must apply the information in these instructions according
to professional medical training and experience.
The implant procedure generally includes the following steps:
■
Placing the right ventricular lead
■
Preparing the delivery system
■
Accessing the subclavian vein
■
Inserting the guide catheter assembly
■
Obtaining venograms
■
Inserting the lead into the delivery system
■
Selecting the lead placement method
■
Placing the lead using a stylet
■
Preparing the guide wire
■
Placing the lead using a guide wire
■
Fixating the lead
■
Taking electrical measurements
■
Removing the guide catheter from the lead
■
Anchoring the lead
18 English 4193 Technical Manual
■
Connecting the lead
■
Placing the device and leads into the pocket
Placing the right ventricular lead
Note: When deciding which ventricular lead to place first, consider
the ease of coronary sinus cannulation and the need for back
up pacing.
■
When a left ventricular lead is implanted first:
– It may be easier to cannulate the coronary sinus without
other leads already implanted.
– Additional hospital equipment may be necessary to provide
back up pacing.
■
When a right ventricular lead is implanted first:
– A right ventricular lead may be used to provide back
up pacing.
– It may be more difficult to cannulate the coronary sinus with
a right ventricular lead already implanted.
Preparing the delivery system
Prepare the delivery system for lead implant according to the
instructions in the product literature packaged with the
delivery system.
Accessing the subclavian vein
Access the subclavian vein:
1. Use a preferred method, based on professional experience, to
access the subclavian vein.
Caution: Certain anatomical abnormalities, such as thoracic
outlet syndrome, may precipitate pinching and subsequent
fracture of the lead.
Caution: Insertion should be done as far lateral as possible to
avoid clamping the lead body between the clavicle and the first
rib (Figure 5).
Figure 5.
2. Introduce a J-shaped introducer guide wire and percutaneous
introducer sheath.
4193 Technical Manual English 19
Inserting the guide catheter assembly
Warning: Back-up pacing should be readily available during implant.
Use of the delivery system and/or leads may cause heart block.
Access the coronary sinus:
1. Insert the guide catheter assembly.
2. Advance the guide catheter to the right atrium.
3. Achieve entry into the coronary sinus by rotating the guide
catheter tip posteriorly and to the patient’s left.
See the delivery system product literature for complete details.
Obtaining venograms
Before placing a lead in the coronary sinus, obtain venograms.
Venograms are recommended to assess a route for passage and a
site for final placement based on the size, shape, location, and
tortuosity of the veins. Also, venograms may be useful in identifying
suspected coronary sinus trauma. For information on obtaining a
venogram by using a venogram balloon catheter, see the product
literature packaged with an appropriate venogram balloon catheter.
Inserting the lead into the delivery system
Warning: 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 and/or patient injury.
Warning: Do not force the lead if significant resistance is
encountered during lead passage.
Caution: Use care when handling the lead during insertion:
■
Do not severely bend, kink, or stretch the lead.
■
Do not use surgical instruments to grasp the lead or
connector pin.
■
Do not force the lead if significant resistance is encountered
during lead passage.
Insert the lead:
1. Remove and discard the stylet packaged with the lead.
2. Insert a straight stylet into the lead to vary the shape of the
lead’s distal end (Figure 6).
Note: When the stylet is fully inserted, the distal tip of the stylet
does not reach the distal tip of the lead (Figure 6b).
20 English 4193 Technical Manual
Figure 6.
a) Stylet fully
withdrawn
b) Stylet fully
inserted
Coronary sinus
Cardiac vein
3. Insert the lead into the delivery system. See the delivery
system product literature for details.
Selecting the lead placement method
The Model 4193 lead can be placed with the aid of stylet or with a
guide wire.
To determine the placement method:
1. Review the venogram to determine if stylet or guide wire
delivery should be used.
Stylet delivery: If the patient’s anatomy features gentle vein
angulation off of the coronary sinus and the cardiac vein branch
is less tortuous (Figure 7) use a stylet for lead delivery. See
“Placing the lead using a stylet” for more information.
Figure 7.
Guide wire delivery: If the patient’s anatomy features acute vein
angulation off of the coronary sinus and the cardiac vein branch
is more tortuous (Figure 8) use a guide wire for lead delivery.
See “Preparing the guide wire” for more information.
4193 Technical Manual English 21
Figure 8.
b) More tortuous
cardiac vein branch
with acute angulation
from the coronary
sinus
a) More tortuous
cardiac vein branch
with gentle angulation
from the coronary
sinus
Placing the lead using a stylet
Warning: Do not force the lead if significant resistance is
encountered during lead passage.
Warning: 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 1-2 cm or select a more flexible stylet.
Note: If it is difficult to advance the stylet around a bend, consider
changing the stylet. More flexible stylets are recommended for
tortuous anatomies. Firmer stylets are recommended where
additional support is needed.
There are two techniques that may be used to advance the lead into
a cardiac vein. The choice of technique is left to the discretion of
the physician.
First technique to advance the lead into a cardiac vein
Advance the lead into a cardiac vein:
1. Advance the lead up to, but not past, the cardiac vein ostium
(Figure 9).
2. Use one or more of the following actions to direct the lead tip
into the cardiac vein:
■
22 English 4193 Technical Manual
Withdraw the stylet
■
Advance the lead off of the stylet
Figure 9.
■
Remove the straight stylet. Manually shape the stylet into a
curve. Insert the curved stylet into the lead. Rotate the lead
body and stylet together.
■
Rotate the curved tip of the lead into the vein.
3. Advance the lead into the cardiac vein (Figure 10).
Figure 10.
4. Advance the lead, with the stylet inserted, further into the
cardiac vein. See “Fixating the lead” for additional information.
Second technique to advance the lead into a cardiac vein
Advance the lead into a cardiac vein:
1. Advance the lead past the ostium of the cardiac vein
(Figure 11).
Figure 11.
2. Refer to one of the following procedures according to the type
of stylet used:
Straight stylet: If using a straight stylet, withdraw the stylet
1- 2 cm and rotate the lead to align the curved lead tip with the
cardiac vein ostium.
Curved stylet: If using a curved stylet, withdraw the stylet
1- 2 cm and rotate the stylet and lead body together to align the
curved lead tip with the cardiac vein ostium.
3. Withdraw the lead and drag the curved lead tip over the ostium
of the cardiac vein until the lead turns into the vein (Figure 12).
4193 Technical Manual English 23
Figure 12.
Reinsert the stylet slightly to advance the lead into the
cardiac vein.
4. Advance the lead, with the stylet inserted, further into the
cardiac vein. See “Fixating the lead” for additional information.
Preparing the guide wire
Warning: 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 product.
Caution: Use care when positioning the guide wire. Refer to the
product literature packaged with the guide wire for additional
information.
Note: Medtronic recommends using guide wires 0.014 inch to
0.018 inch (0.36 mm to 0.46 mm) in diameter. Contact a Medtronic
representative for further information about recommended
guide wires.
Prepare the guide wire for use:
1. Select a guide wire. A more flexible guide wire is recommended
if the patient has tortuous anatomy. If additional support is
needed, use a firmer guide wire.
Note: Guide wire firmness is determined by two factors: guide
wire diameter and guide wire core design. A larger guide wire
diameter may be firmer than a smaller guide wire diameter.
However, guide wires with the same diameter may have
different degrees of firmness.
A “J” shaped guide wire or angled tip guide wire are
recommended to aid in sub-selecting the cardiac vein and
where more steerability is desired.
Note: Consider soaking the guide wire in a heparin solution
prior to insertion to minimize the risk of thrombus formation
during use.
2. Remove the stylet.
3. Insert the guide wire into the lead by placing the distal (flexible)
end of the guide wire into the lead connector pin using the
guide wire insertion tool included in the package (Figure 13).
24 English 4193 Technical Manual
Caution: To minimize the risk of damaging the guide wire, be
sure the flexible section of the guide wire is fully inserted into
the lead before removing the guide wire insertion tool from
the lead.
Figure 13.
4. Disengage the guide wire insertion tool from the lead
connector pin.
5. Remove the guide wire insertion tool using the slit on the tool
or by sliding the tool off the end of the guide wire.
6. Position the guide wire steering handle:
a. Advance the guide wire steering handle over the proximal
(rigid) end of the guide wire (Figure 14a).
b. Tighten the guide wire steering handle onto the guide wire
near the lead connector pin (Figure 14b).
Figure 14.
7. Position the guide wire clip. Medtronic recommends securing
the guide wire clip to the patient’s sterile surgical drape. Attach
the guide wire clip to the guide wire and secure within the
sterile field.
Alternate approach: In situations where the guide wire is already in
place, the lead can be loaded over the guide wire using the guide wire
insertion tool.
Insert the guide wire into the lead by placing the proximal (rigid) end
of the guide wire into the distal lead tip using the guide wire insertion
tool included in the package (Figure 15).
Note: There may be slight resistance as the guide wire passes
through the lead tip seal.
Note: Be sure to remove the guide wire insertion tool prior to
lead implant.
Figure 15.
4193 Technical Manual English 25
Placing the lead using a guide wire
Warning: Do not force the lead if significant resistance is
encountered during lead passage.
Caution: 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 a lot of resistance in guide wire
passage, remove the lead and guide wire. Remove the guide wire
from the lead and re-insert a new guide wire into the lead. Do not use
excessive force to retract the guide wire from the lead.
Note: If the lead is not advancing, or if the lead and guide wire seem
to be sticking together, there may be thrombus on the guide wire at
the lead tip. Remove and inspect the lead and guide wire. Consider
using a new guide wire. Reinsert the lead and the guide wire as
described in previous steps.
Note: If it is difficult to advance the guide wire around a bend,
consider changing the guide wire. More flexible guide wires are
recommended for tortuous anatomies. Firmer guide wires are
recommended where additional support is needed.
There are two techniques that may be used to advance the lead into
a cardiac vein. The choice of technique is left to the discretion of
the physician.
First technique to advance the lead into a cardiac vein
Advance the lead into a cardiac vein:
1. Using venogram images as reference, advance the lead into
the coronary sinus. Keep the distal tip of the guide wire beyond
the distal tip of the lead during passage and placement
(Figure 16).
Figure 16.
2. Rotate the guide wire and advance the guide wire into the
cardiac vein (Figure 17). Pass the lead over the guide wire and
into the cardiac vein.
26 English 4193 Technical Manual
Figure 17.
3. Advance the lead further into the cardiac vein by advancing the
lead along the guide wire or by advancing the lead and guide
wire together. See “Fixating the lead” for additional information.
Second technique to advance the lead into a cardiac vein
Advance the lead into a cardiac vein:
1. Using venogram images as reference, advance the lead into
the cardiac vein. The lead’s curved distal tip may be used to aid
in subselecting cardiac veins within the coronary sinus by
slightly retracting the guide wire inside the lead lumen
(Figure 18).
Figure 18.
2. If retracted, reinsert the guide wire through the lead tip seal and
more distally into the cardiac vein. Advance the lead over the
guide wire into the cardiac vein (Figure 19).
Figure 19.
3. Advance the lead further into the cardiac vein by advancing the
lead along the guide wire or by advancing the lead and guide
wire together. See “Fixating the lead” for additional information.
4193 Technical Manual English 27
Fixating the lead
Fixation is achieved the same way regardless of whether a stylet or
a guide wire is used.
Using fluoroscopy for guidance, fixate the lead by wedging both
curves of the lead tip into the cardiac vein (Figure 20).
Figure 20.
Note: If the cardiac vein is large, it may be necessary to position the
lead in a smaller cardiac vein in order to achieve lead tip fixation.
Taking electrical measurements
Caution: Prior to taking electrical or defibrillation efficacy
measurements, move objects made of conductive materials, such as
guide wires or stylets, away from all electrodes.
Note: For the Model 4193, initial electrical measurements should be
taken with the stylet or guide wire retracted a minimum of 4 cm inside
the lead lumen.
Take electrical measurements:
1. Attach a surgical cable to the lead connector pin.
Note: A unipolar lead requires the use of an indifferent
electrode.
2. Use an implant support instrument, such as a pacing system
analyzer, for obtaining electrical measurements (Table 7). For
information on the use of the implant support instrument,
consult the product literature for that device.
Satisfactory lead placement is indicated by low stimulation
thresholds and adequate sensing of intracardiac
signal amplitudes:
■
A low stimulation threshold provides for a desirable safety
margin, allowing for a possible rise in thresholds that may
occur within two months following implant.
■
Adequate sensing amplitudes ensure that the lead is
properly sensing intrinsic cardiac signals. Minimum signal
requirements depend on the sensitivity capabilities of the
device. Acceptable acute signal amplitudes for the lead
must be greater than the minimum device sensing
capabilities including an adequate safety margin to account
for lead maturity.
28 English 4193 Technical Manual
Table 7. Recommended measurements at implant
Measurements required Left ventricle
Maximum acute stimulation thresholds
Minimum acute sensing amplitudes 4.0 mV
a
at pulse duration setting of 0.5 ms.
(Assumes 500 Ω resistance)
a
3.0 V
3. If electrical measurements do not stabilize to acceptable levels,
it may be necessary to reposition the lead and repeat the
testing procedure.
4. Check for diaphragmatic stimulation by pacing at 10 V and a
pulse width setting greater than 0.5 ms. Then observe for
diaphragmatic contracting either by fluoroscopy or direct
abdominal palpitation. Further testing may include patient
positional changes to simulate upright chronic conditions. If
diaphragmatic pacing occurs, reduce the voltage until a
diaphragmatic pacing threshold is determined. Diaphragmatic
stimulation usually necessitates repositioning of the lead.
Removing the guide catheter from the lead
Once the lead is in the final position:
1. If used, remove the guide wire and replace the guide wire with
a straight stylet (downsized knob). Insert the straight stylet into
the lead to the mid-coronary sinus.
2. Remove the guide catheter from the lead. See the delivery
system product literature for details.
3. Carefully and completely remove the stylet. When removing
the stylet, grip the lead firmly just below the connector pin; this
will help prevent possible lead tip dislodgement.
4. Repeat electrical measurements, see the section “Taking
electrical measurements.”
Anchoring the lead
Caution: Use care when anchoring the lead.
■
Use only nonabsorbable sutures to anchor the lead.
■
Do not attempt to remove or cut the anchoring sleeve.
■
Do not use the anchoring sleeve tabs for suturing.
■
During anchoring, take care to avoid dislodging the lead tip.
■
Do not secure ligatures so tightly that they damage the vein,
lead, or anchoring sleeve (Figure 21).
■
Do not tie a ligature directly to the lead body (Figure 21).
4193 Technical Manual English 29
Figure 21.
Anchor the lead using all three grooves:
1. Position the anchoring sleeve against or near the vein.
2. Secure the anchoring sleeve to the lead body by tying a suture
firmly in each of the three grooves (Figure 22).
Figure 22.
3. Use at least one additional suture in one of the grooves to
secure the anchoring sleeve and lead body to the fascia.
Connecting the lead
Caution: Always remove the stylet before connecting the lead to
the implantable device. Failure to remove the stylet may result in
lead failure.
Connect the lead to an implantable device:
1. Take final electrical measurements.
2. Insert the lead connector into the connector block. Consult the
product literature packaged with the implantable device for
instructions on proper lead connections.
Placing the device and leads into the pocket
Caution: Use care when placing the device and leads into
the pocket.
■
Ensure that the leads do not leave the device at an acute angle.
■
Do not grip the lead or device with surgical instruments.
■
Do not coil the lead. Coiling the lead can twist the lead body and
may result in lead dislodgment (Figure 23).
Figure 23.
30 English 4193 Technical Manual
Place the device and leads into the pocket:
1. Rotate the device to loosely wrap the excess lead length.
Caution: To prevent undesirable twisting of the lead body,
wrap the excess lead length loosely under the implantable
device and place both into the subcutaneous pocket
(Figure 24).
Figure 24.
2. Suture the pocket closed using a preferred surgical technique.
Post-implant evaluation
After implant, monitor the patient’s electrocardiogram until the patient
is discharged. If a lead dislodges, it usually occurs during the
immediate postoperative period.
4193 Technical Manual English 31
Detailed device description
Specifications (nominal)
Parameter Model 4193
Type Unipolar
Chamber paced Ventricle
Length 20-110 cm
Connector IS-1 UNI
Materials Conductor: MP35N
Insulator: Polyurethane
Electrode tip: Platinum alloy
Connector pin: Titanium
Connector ring: Titanium
Molded tip seal: Silicone rubber
Electrode configuration Tapered annular, platinized
Diameter Lead body: 1.3 mm
Electrode: 1.8 mm
Medtronic delivery system
(recommended inner diameter) 7 French (2.3 mm)
Diagnostic guide wire
(recommended diameter)
Electrode surface
area
Resistance Unipolar: 52 Ω at 78 cm
Steroid Dexamethasone sodium phosphate
Amount of steroid 1.0 mg maximum
0.36 mm (0.014 in) to
0.46 mm (0.018 in)
Tip: 5.8 mm
2
32 English 4193 Technical Manual
Specifications drawing (nominal)
Tip electrode
Diameter: 1.8 mm
Surface area: 5.8 mm
2
Anchoring sleeve
IS-1 UNI connector
Total lead length:
20-110 cm
4193 Technical Manual English 33
Medtronic warranty
For complete warranty information, see the accompanying
warranty document.
Service
Medtronic employs highly trained representatives and engineers
located throughout the world to serve you and, upon request, to
provide training to qualified hospital personnel in the use of Medtronic
products. Medtronic also maintains a professional staff to provide
technical consultation to product users. For medical consultation,
Medtronic can often refer product users to outside medical
consultants with appropriate expertise. For more information, contact
your local Medtronic representative, or call or write Medtronic at the
appropriate address or telephone number listed on the back cover.
34 English 4193 Technical Manual
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Medtronic USA, Inc.
Toll-free in the USA (24-hour
technical consultation for
physicians and
medical professionals)
Bradycardia: +1 800 505 4636
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© Medtronic, Inc. 2014
A00805001B
2014-04-07
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