Transcript CRT Implant Steps

CRT Essentials Program
CRT Implant Steps
Left-Heart Lead Implant Procedure
Left-Heart Lead Implant Procedure
CRT Essentials Program
Implant Procedure
► Six-Step Implant Process
1. Cannulate coronary sinus
2. Perform venograms
3. Select target vein and leads
4. Place leads
5. Remove implant tools
6. Measure final electricals and program device
Left-Heart Lead Implant Procedure
CRT Essentials Program
Left-Heart Lead Implant Procedure
Implant Procedure: Getting Started
► Backup pacing should be readily available
 (LBBB + RBBB = complete heart block)
► RV lead first
 Can be used to provide backup pacing
 May also provide a landmark for coronary sinus ostium (proximal end of
distal coil is a good marker for CS)
 Helps to visualize tricuspid valve, which can help locate CS ostium
 May be more difficult to cannulate the CS with the lead implanted
► LV lead first (alternate option)
 May be easier to cannulate the CS
 Additional method may be necessary to provide backup pacing
 May be more likely to dislodge when going to place RV lead
CRT Essentials Program
Left-Heart Lead Implant Procedure
Implant Procedure: Getting Started
► Use preferred method to access subclavian vein
 May need longer wire ( 100 cm) to advance the guide catheter into
the heart
• packaged in Attain Command™ system kits
► Use lead introducer ( 9.0 Fr) to maintain access
 The Attain Command CS Guide Catheter (9.0 Fr O.D.) is placed
through this introducer
► Prepare all delivery system components before procedure begins
 Flush all lumens with heparinized saline
 Flush and test the venogram balloon catheter
 Wet the guide wire with heparinized saline
CRT Essentials Program
Left-Heart Lead Implant Procedure
Goal: Place left-heart lead in the target branch vein
Venogram
Final Bipolar Lead Placement
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step #1:
Cannulate the Coronary Sinus
CRT Essentials Program
Right Atrial Anatomical Features
► Tricuspid annulus
► Fossa ovalis
► Eustachian ridge
► Coronary sinus
► Thebesian valve
► Eustachian fossa
► Inferior vena cava
Left-Heart Lead Implant Procedure
CRT Essentials Program
Left-Heart Lead Implant Procedure
CS Cannulation Catheters
► Fixed Shape Catheters are most
commonly used
 Curve shapes accommodate varying
anatomy (see following slides)
► Attain Command™ catheter is the
only catheter family to feature a
hydrophilic coating for deep seating
into the coronary sinus
Attain Command
CRT Essentials Program
Left-Heart Lead Implant Procedure
Suggested Use: Curve Shape Selection
CS Cannulation: Curve Shape Suggested Use
Straights
Various CS takeoffs
Upon cannulation,
advance Model 6250
straight catheter into
the vein over
cannulation catheter
Multipurpose
Right
Right side venous
access curve helps
cradle catheter
against the freewall
of the RA
CRT Essentials Program
Left-Heart Lead Implant Procedure
Suggested Use: Curve Shape Selection
MB2
Standard or high
takeoffs of the CS
Multipurpose
Standard or high
takeoffs of the CS
Curve allows
cradling in a medium
to large size RA
CRT Essentials Program
Left-Heart Lead Implant Procedure
Suggested Use: Curve Shape Selection
Extended Hook
Vertical takeoff
of CS
Use with an inner
catheter (Attain
Select® II) to reach
across a large
dilated RA
Extended
Hook Extra
Large
Vertical takeoffs
of
CS with a large
dilated RA
Use with an inner
catheter (Attain
Select II) to reach
across a large
dilated RA
CRT Essentials Program
Left-Heart Lead Implant Procedure
Suggested Use: Curve Shape Selection
Amplatz
Bypasses
Eustachian Ridge or
Thebesian valve
near or blocking CS
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step 1: CS Cannulation with Fixed Shape Catheters
► Obtain venous access
► Flush components with heparanized saline
► Attach valve to catheter hub
► Insert dilator through valve/catheter
► Pass guide catheter assembly over long introducer guide wire through
introducer sheath, to the atrium
 It is recommended to use a guide wire when advancing into the heart
► Remove dilator
► Locate the CS by rotating the guide catheter tip posteriorly and to the
patient’s left (typically a counter-clockwise rotation)
► Advance the guide catheter 2-3 cm over guide wire to engage the CS
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step 1: Cannulate Coronary Sinus
► Use care when passing
the guide catheter through
vessels
► Due to the relative
stiffness of the catheter,
damage to the walls of the
vessels may include
dissections or perforations
CRT Essentials Program
Left-Heart Lead Implant Procedure
Alternative Option: CS Cannulation with Straight Catheters
► Obtain venous access
► Assemble system components
► Load guide catheter assembly onto steerable
EP catheter
► Insert steerable EP catheter into right atrium
Marinr® MCXL steerable
EP catheter
► Access CS with steerable catheter
► Advance guide catheter over steerable catheter into the CS
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step #2:
Perform Venogram
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step 2: Perform Venogram
► Balloon occludes most coronary sinuses – inflates to 10 mm
(pre-measure 1.25 cc syringe)
► Lead with a guide wire
► Balloon can be inflated and deflated several times
► Contrast solution can be injected through catheter
Attain® 6215
Venogram Balloon
CRT Essentials Program
Cardiac Venous Anatomy: AP View
Left-Heart Lead Implant Procedure
CRT Essentials Program
Cardiac Venous Anatomy: LAO View
Left-Heart Lead Implant Procedure
CRT Essentials Program
Cardiac Venous Anatomy: RAO View
Left-Heart Lead Implant Procedure
CRT Essentials Program
Left-Heart Lead Implant Procedure
Lead in Lateral Cardiac Vein
Atrial Lead
Left
Ventricular
Lead
Right Ventricular
Lead
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step #3:
Select Target Vein and Left
Ventricular Lead
CRT Essentials Program
Left-Heart Lead Implant Procedure
Selecting Vein for LV Lead Placement
► Target: Left ventricular free wall
(Lateral, Poster-lateral, Antero-lateral)1,2,3
A. Lateral (marginal) cardiac vein
B. Postero-lateral cardiac vein
C. Posterior cardiac vein
E
A
A
D
BB
C
C
E
► Sub-optimal lead location:
D. Middle cardiac vein
E. Great cardiac vein
D
LAO View
1 Ansalone
G, et al. JACC. 2002;39:489-499.
C, et al. Circulation. 2001;104:3026-3029.
3 Auricchio A, et al. Am J Cardiol. 1999;83:136D-142D.
2 Butter
CRT Essentials Program
Left-Heart Lead Implant Procedure
Select the Left-Heart Lead for the Anatomy
Leads
Lead Body
Size
Polarity
Attain® OTW
Model 4193
4 Fr (1.3 mm)
Unipolar
Placement in smaller
veins with moderate
to great tortuosity
Attain OTW
Model 4194
6.2 Fr (2.0 mm)
True
bipolar
Easy trackability and
pushability in
medium to large
veins
Attain Starfix
Model 4195
5 Fr (1.7 mm)
Unipolar
Placement in a
variety of vein
positions with active
fixation (deployable
lobes)
Attain Ability
Model 4196
4 Fr (1.3 mm)
Bipolar
•
Improved
trackability into
smaller veins
•
Programmable
repositioning of
pacing vectors
4194
4193
Attain
Ability®
Attain
StarFix®
Designed for:
(dual
electrode)
CRT Essentials Program
Left-Heart Lead Implant Procedure
Attain StarFix®
► First active fixation left-heart lead
► More placement options
 Vein sizes
 Vein locations
► Soft, polyurethane deployable lobes
► 5 Fr lead body, 5.3 Fr electrode with tip seal
CRT Essentials Program
Left-Heart Lead Implant Procedure
Attain Ability®
► The first 4 Fr bipolar left-heart lead
► Flexible, tapered distal end for navigating difficult anatomies
► Compatible with the Attain Select® II for direct-to-vein delivery*
► Compatible with the Attain Hybrid® guide wire
Polyurethane 55D
outer insulation
The first implantable
to feature NASA
insulation technology
Co-radial design
*Leads >= 88cm length
Multiple
layers SI-PI3232-layers
SI-Polyimide
filarcoating
coating
layers filar
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step #4:
Place Left-Heart Lead
CRT Essentials Program
Left-Heart Lead Implant Procedure
Fully Integrated CRT Implant System
Compatible Tools
► Advance lead through CS
cannulation catheter or through
Attain Select II catheter*
Attain Ability
left-heart lead
Attain Select II
sub-selection catheter
 Attain Ability® lead is the first bipolar
LV lead that allows delivery through a
7 Fr sub-selection catheter
► Compatible with Attain Hybrid®
Guide Wire
 Combines the benefits of a guide wire
and stylet in one tool for improved
trackability, steerability, and control
for placement
► Implant lead in target branch vein
Hybrid®
Attain
guide wire
*4
Fr, 88 cm Attain Ability and Attain® 4193 models
are compatible with Attain Select II sub-selection catheter
Attain Command™
CS cannulation
catheter
CRT Essentials Program
Left-Heart Lead Implant Procedure
Implant Tools: Attain Hybrid® Guide Wire
► Select a guide wire or stylet for the lead
 Attain Hybrid Guide Wire features the agility of a guide wire with the
stability of a stylet in one tool
CRT Essentials Program
Left-Heart Lead Implant Procedure
Implant Tools: Direct to Vein 4 Fr Lead Delivery
with Attain Select® II Sub-selection Catheter
► Insert Attain Select II catheter inside of
the CS cannulation catheter
CS cannulation
catheter tip
► Sub-select branch with Attain Select II
delivery catheter
 Tip: A soft, flexible inner catheter comes
packaged with Attain Select and can be used
to enhance trackability in tortuous anatomy
► Advance 4 Fr lead over wire, through
Attain Select II delivery catheter, into
branch vein
Attain Select II
tip
4 Fr lead tip
electrode
CRT Essentials Program
Implant Attain Ability® LV Lead
Placement Recommendations
► Both curves at least 1 cm
within target vein
► Both electrodes have
contact with vein
► Test thresholds at LV tip
and LV ring at implant
Left-Heart Lead Implant Procedure
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step #5:
Remove Implant Tools
CRT Essentials Program
Left-Heart Lead Implant Procedure
Remove Catheter: Slitting Procedure
Medtronic Universal II and Adjustable Slitters
Lead Securement
► Universal II – secure with thumb pressure
► Adjustable – mechanically secure in lead
channel
Control Grip
Universal II Slitter
► Larger grip with ergonomic hand position
Slit Twice
► Sharp blade to slit two Medtronic
catheters in same procedure
Adjustable Slitter
CRT Essentials Program
Left-Heart Lead Implant Procedure
Step #6:
Measure Final Electricals
CRT Essentials Program
Left-Heart Lead Implant Procedure
Measure Final Electricals
► Test RA, RV, LV leads independently
► Test at 10 V for phrenic/diaphragmatic stimulation
► Acceptable thresholds for LV lead
 Dependent upon difficulty of lead placement and target vessel
options
 2X’s safety margin not required for LV setting
CRT Essentials Program
Left-Heart Lead Implant Procedure
Pacing Vector Programmability
► For CRT-D devices, the available LV pace polarities are:
 LV tip to LV ring1
 LV tip to RV coil
 LV ring to RV coil2
► For CRT-P devices, the available LV pace polarities are:
 LV tip/RV ring
 Unipolar (LV tip/Can)
 Bipolar (LV tip/LV ring)
1 The
2 For
Attain Ability® lead was designed for optimal pacing when used in a unipolar or extended bipolar configuration.
CRT-D devices, starting with Concerto® CRT-D.
CRT Essentials Program
Implant Considerations
CRT + ICD Lead Connection
Evaluate ICD ports:
► Ensure the setscrew has not
settled down into the port
during shipping
► If setscrew is seen, back it out
with wrench before insertion of
the lead into the port
► Always have wrench in
setscrew before inserting lead
Left-Heart Lead Implant Procedure
CRT Essentials Program
Left-Heart Lead Implant Procedure
Ability®
Brief Statement: Medtronic Attain
4196 Lead
Steroid eluting, dual electrode, transvenous, over the wire, cardiac vein pacing lead
Indications
The Attain Ability 4196 steroid eluting, dual electrode, IS-1 transvenous lead has application 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 this lead in
combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead.
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 232 µg of dexamethasone acetate may be contraindicated.
Warnings and Precautions
The Model 4196 was 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.
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.
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.
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.
Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to the lead connector
pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending, kinking, stretching, handling with surgical
instruments, or excessive force when inserting a stylet may cause permanent damage to the lead. When using Model 4196, only use compatible stylets (stylets with
downsized knobs and are 3 cm shorter than the lead length). Other sytlets may extend beyond the lead tip causing lead tip seal damage or injury or perforation of
the cardiac vein or heart. Rust stylets are not recommended with this lead due to the risk of conductor coil or insulation perforation.
Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control and may cause
vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the literature packaged with the guide wire for additional information on
guide wires.
Do not use magnetic resonance imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads, potentially causing tissue
damage and the induction of tachyarrhythmias.
For the Model 4196 lead, total patient exposure to dexamethasone acetate should be considered. Drug interactions of dexamethasone acetate with this lead have
not been studied. 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 lead. For a list of potential adverse effects, refer to the Physicians’ Desk Reference.
Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters and/or leads may cause trauma to the heart.
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 the post-implant testing.
CRT Essentials Program
Left-Heart Lead Implant Procedure
Warnings and Precautions, continued
Backup pacing should be readily available during implant. Use of the delivery system or leads may cause heart block.
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 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 could cause damage to the lead tip seal or to the conductor core or insulation.
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.
Potential Complications
Potential complications 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, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
CRT Essentials Program
Brief Statement: Medtronic Attain
StarFix®
Left-Heart Lead Implant Procedure
4195 Lead
Indications
The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobes is intended for chronic pacing and sensing of the left ventricle via a cardiac vein,
when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator.
Contraindications
This lead is contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. Do not use in patients for
whom a single dose of 30 μg (micrograms) of beclomethasone dipropionate (BDP) cannot be tolerated.
Warnings/Precautions
Leads, stylets, and guide wires should be handled with great care at all times. When using the Model 4195 lead, only use compatible stylets (stylets with downsized
knobs and are 3 cm shorter than the lead length). Verify that the stylet does not extend beyond the lead tip prior to inserting the lead in the delivery system. Implanting
the lead with the stylet extending beyond the lead tip could cause injury or perforation of the cardiac vein or heart. Output pulses, especially from unipolar leads, may
adversely affect device sensing capabilities.
Backup pacing should be readily available during implant. Use of leads may cause heart block.
For the Attain StarFix Model 4195 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug
interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21 dipropionate with the Model 4195 lead
have not been studied.
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, or the need to reprogram or replace the device.
Do not use magnetic resonance imaging (MRI) on patients who have this device. MRI can induce currents on implanted leads, potentially causing tissue dmage and
the induction of tachyarrhythmias.
Always use an acute retention clip to reposition or remove the lead. Always attempt to undeploy the lobes before repositioning or removing the lead. If a lead must be
removed or repositioned, consider referring the case to an experienced extraction center. Do not implant the acute retention clip. Previously implanted pulse
generators, implantable cardioverter defibrillators, and leads should generally be explanted.
Potential Complications
Potential clinical complications resulting from the use of transvenous leads include, but are not limited to, the following: air embolism, avulsion of the endocardium,
valve, or vein, cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis and 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, myocardial
irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic embolism, and
valve damage.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
CRT
Essentials Program
Brief Statement: Medtronic Attain OTW Leads, Models 4193 and 4194
®
Left-Heart Lead Implant Procedure
Indications
The Attain OTW Model 4193 and Attain Bipolar OTW Model 4194 leads have application as part of a Medtronic biventricular pacing system.
Contraindications
The leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. Do not use steroid
eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.
Warnings/Precautions
Leads should be handled with great care at all times. Use care when handling stylets. Any severe bending, kinking, stretching, handling with surgical instruments, or
excessive force when inserting a stylet, may cause permanent damage to the lead. When using Model 4193 and 4194 leads, only use compatible stylets (stylets with
downsized knobs and are 3 cm shorter than the lead length).
Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control and may cause vessel
damage. Do not use excessive force to remove a guide wire from a lead. Refer to the literature packaged with the guide wire for additional information on guide wires.
Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. The clinical studies were not designed to evaluate the removal of left
ventricular leads from the coronary venous vasculature.
Patients should avoid diathermy.
Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities. Previously implanted pulse generators, implantable cardioverter
defibrillators, and leads should generally be explanted.
Keep external defibrillation equipment nearby for immediate use during the acute lead system testing, implantation procedure, or whenever arrhythmias are possible or
intentionally induced during post-implant testing. Backup pacing should be readily available during implant. Use of leads may cause heart block.
Do not force the guide catheter and/or leads if significant resistance is encountered. Use of the guide catheters or leads may cause trauma to the heart.
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 1-2cm or select a
more flexible stylet.
During lead implantation 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.
It has not been determined if 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.
Potential Complications
Potential complications 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, epicardial rub,
pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
CRT Essentials Program
Left-Heart Lead Implant Procedure
www.medtronic.com
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Medtronic, Inc.
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