CRT Essentials Program CRT Implant Steps LeftHeart Lead

CRT Essentials Program CRT Implant Steps 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: 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: Getting Started ► Use preferred method to access subclavian vein n 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 n The Attain Command CS Guide Catheter (9. 0 Fr O. D. ) is placed through this introducer ► Prepare all delivery system components before procedure begins n Flush all lumens with heparinized saline n Flush and test the venogram balloon catheter n 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 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 MB 2 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 D A BB C C E A ► 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: 136 D-142 D. 2 Butter

CRT Essentials Program Left-Heart Lead Implant Procedure Select the Left-Heart Lead for the Anatomy Leads 4194 4193 Attain Ability® 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 Attain Star. Fix® (dual electrode) Designed for: trackability into smaller veins • Programmable repositioning of pacing vectors

CRT Essentials Program Left-Heart Lead Implant Procedure Attain Star. Fix® ► First active fixation left-heart lead ► More placement options n Vein sizes n 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 Multiple layers SI-Polyimide filar coating The first implantable to feature NASA insulation technology *Leads >= 88 cm length

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 n 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 n 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 n 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 tip ► Sub-select branch with Attain Select II delivery catheter n 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 er et h at c l ck a b y ad te rs e itt l Pu ld sl Ho Universal II Slitter ► Larger grip with ergonomic hand position y Slit Twice ► Sharp blade to slit two Medtronic catheters in same procedure ad te k ac b r rs e itt te l ul e th ca P Adjustable Slitter H d ol sl

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 < 2 X’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: n LV tip to LV ring 1 n LV tip to RV coil n LV ring to RV coil 2 ► For CRT-P devices, the available LV pace polarities are: n LV tip/RV ring n Unipolar (LV tip/Can) n 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 Star. Fix® Left-Heart Lead Implant Procedure 4195 Lead Indications The Attain Star. Fix 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 Star. Fix 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 -2 cm 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 World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 -5604 USA Tel: (763) 514 -4000 Fax: (763) 514 -4879 Medtronic USA, Inc. Toll-Free: 1 (800) 328 -2518 (24 -hour technical support for physicians and medical professionals) UC 201000552 EN © Medtronic, Inc. Minneapolis, MN All Rights Reserved 03/2010