CRT Essentials Program Left-Heart Lead Implant Procedure CRT Implant Steps Left-Heart Lead Implant...

CRT Essentials Program Left-Heart Lead Implant Procedure

CRT Implant StepsLeft-Heart Lead Implant Procedure


Implant Procedure 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


Implant Procedure: Getting StartedImplant 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


Implant Procedure: Getting StartedImplant 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


Goal: Place left-heart lead in the target branch veinGoal: Place left-heart lead in the target branch vein

Final Bipolar Lead PlacementVenogram


Step #1:Step #1:Cannulate the Coronary SinusCannulate the Coronary Sinus


Right Atrial Anatomical FeaturesRight Atrial Anatomical Features

► Tricuspid annulus

► Fossa ovalis

► Eustachian ridge

► Coronary sinusCoronary sinus

► Thebesian valve

► Eustachian fossa

► Inferior vena cava


CS Cannulation CathetersCS 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


CS Cannulation: Curve Shape Suggested UseCS Cannulation: Curve Shape Suggested UseSuggested Use: Curve Shape SelectionSuggested Use: Curve Shape Selection

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


Suggested Use: Curve Shape SelectionSuggested 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



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



Amplatz

Bypasses Eustachian Ridge or Thebesian valve near or blocking CS


Step 1: CS Cannulation with Fixed Shape CathetersStep 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


Step 1: Cannulate Coronary SinusStep 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


Alternative Option: CS Cannulation with Straight CathetersAlternative 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

► Access CS with steerable catheter

► Advance guide catheter over steerable catheter into the CS

Marinr® MCXL steerable EP catheter


Step #2:Step #2:Perform VenogramPerform Venogram


Step 2: Perform VenogramStep 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


Cardiac Venous Anatomy:Cardiac Venous Anatomy: AP ViewAP View


Cardiac Venous Anatomy:Cardiac Venous Anatomy: LAO ViewLAO View


Cardiac Venous Anatomy:Cardiac Venous Anatomy: RAO ViewRAO View


Lead in Lateral Cardiac VeinLead in Lateral Cardiac Vein

Atrial Lead

Right Ventricular Lead

Left Ventricular Lead


Step #3:Step #3:Select Target Vein and Left Select Target Vein and Left

Ventricular LeadVentricular Lead


Selecting Vein for LV Lead PlacementSelecting Vein for LV Lead Placement

A. Lateral (marginal) cardiac vein

B. Postero-lateral cardiac vein

C. Posterior cardiac vein

AB

C

D

E

► Target: Left ventricular free wall (Lateral, Poster-lateral, Antero-lateral)1,2,3

1 Ansalone G, et al. JACC. 2002;39:489-499. 2 Butter C, et al. Circulation. 2001;104:3026-3029. 3 Auricchio A, et al. Am J Cardiol. 1999;83:136D-142D.

A

B

CD

E

LAO View

► Sub-optimal lead location:

D. Middle cardiac vein

E. Great cardiac vein


Select the Left-Heart Lead for the AnatomySelect the Left-Heart Lead for the Anatomy

Attain StarFix®

Attain Ability®

4193

4194Leads Lead Body

SizePolarity Designed for:

Attain® OTW Model 4193

4 Fr (1.3 mm) Unipolar Placement in smallerveins with moderate to great tortuosity

Attain OTW Model 4194

6.2 Fr (2.0 mm) True bipolar

Easy trackability andpushability in medium to large veins

Attain Starfix

Model 41955 Fr (1.7 mm) Unipolar Placement in a

variety of vein positions with active fixation (deployable lobes)

Attain Ability

Model 41964 Fr (1.3 mm) Bipolar

(dual electrode)

• Improved trackability into smaller veins

• Programmable repositioning of pacing vectors


Attain StarFixAttain 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


Attain AbilityAttain 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

The first implantable to feature NASA insulation technology

Polyurethane 55D outer insulation 32-layers SI-PI32-

layers filar coating

Co-radial design

Polyurethane 55D outer insulation 32-layers SI-PI32-

layers filar coating

Co-radial design

Multiple layers SI-Polyimide filar coating

*Leads >= 88cm length


Step #4:Step #4:Place Left-Heart LeadPlace Left-Heart Lead


► Advance lead through CS cannulation catheter or through Attain Select II 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

Fully Integrated CRT Implant SystemFully Integrated CRT Implant System Compatible ToolsCompatible Tools

*4 Fr, 88 cm Attain Ability and Attain® 4193 models are compatible with Attain Select II sub-selection catheter

Attain Select IIsub-selection catheter

Attain Hybrid® guide wire

Attain Ability left-heart lead

Attain Command™ CS cannulation catheter


Implant Tools: Attain HybridImplant Tools: Attain Hybrid®® Guide Wire 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


Implant Tools: Direct to Vein 4 Fr Lead Delivery Implant Tools: Direct to Vein 4 Fr Lead Delivery with Attain Selectwith Attain Select®® II Sub-selection Catheter II Sub-selection Catheter

4 Fr lead tip electrode

Attain Select II tip

CS cannulation catheter tip

► Insert Attain Select II catheter inside of the CS cannulation catheter

► 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


► 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

Implant Attain AbilityImplant Attain Ability®® LV Lead LV Lead Placement RecommendationsPlacement Recommendations


Step #5:Step #5:Remove Implant Tools Remove Implant Tools


Remove Catheter: Slitting ProcedureRemove Catheter: Slitting Procedure Medtronic Universal II and Adjustable SlittersMedtronic Universal II and Adjustable Slitters

Lead Securement

► Universal II – secure with thumb pressure

► Adjustable – mechanically secure in lead channel

Control Grip

► Larger grip with ergonomic hand position

Slit Twice

► Sharp blade to slit two Medtronic catheters in same procedure

Universal II Slitter

Adjustable Slitter

Hold slit

ter s

teady

Pull cath

eter b

ack

Pull cath

eter b

ack

Hold slit

ter s

teady


Step #6:Step #6:Measure Final Electricals Measure Final Electricals


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


► 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 Attain Ability® lead was designed for optimal pacing when used in a unipolar or extended bipolar configuration.

2 For CRT-D devices, starting with Concerto® CRT-D.

Pacing Vector ProgrammabilityPacing Vector Programmability


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

Implant Considerations Implant Considerations CRT + ICD Lead ConnectionCRT + ICD Lead Connection

CRT Essentials Program Left-Heart Lead Implant Procedure Brief Statement: Medtronic Attain Ability® 4196 LeadSteroid 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.


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 ComplicationsPotential 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 Left-Heart Lead Implant Procedure Brief Statement: Medtronic Attain StarFix® 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.


Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

CRT Essentials Program Left-Heart Lead Implant Procedure Brief Statement: Medtronic Attain® OTW Leads, Models 4193 and 4194

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.


Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.


UC201000552 EN© Medtronic, Inc.Minneapolis, MNAll Rights Reserved 03/2010

www.medtronic.com

World HeadquartersMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USATel: (763) 514-4000Fax: (763) 514-4879

Medtronic USA, Inc.Toll-Free: 1 (800) 328-2518(24-hour technical support for physiciansand medical professionals)

CRT Essentials Program Left-Heart Lead Implant Procedure CRT Implant Steps Left-Heart Lead Implant...

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