1. CRT Implant Steps
Left-Heart Lead Implant Procedure

2. Six-Step Implant Process
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

3. 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
When using any Attain® lead as part of a biventricular pacing system, decide which ventricular lead to use first. Consider the ease of coronary sinus cannulation and the need for backup pacing.
When a right ventricular lead is implanted first:
A right ventricular lead may be used to provide backup pacing.
It may be more difficult to cannulate the coronary sinus with a right ventricular lead already implanted.”
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 backup pacing.

4. 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
Key Points:
PLI (Percutaneous Lead Introducer) is useful for maintaining lead access during implant. This may permit smoother movement around the venotomy site. The Attain Command guide catheter fits into any Medtronic introducer  9 Fr.

5. Goal: Place left-heart lead in the target branch vein
Venogram
Final Bipolar Lead Placement
Student Notes
In order to gain stability, both lead cants should be within the target vein.

6. Step #1: Cannulate the Coronary Sinus

7. Right Atrial Anatomical Features
Tricuspid annulus
Fossa ovalis
Eustachian ridge
Coronary sinus
Thebesian valve
Eustachian fossa
Inferior vena cava
This slide reviews the various anatomical structures and sites of the right atrium that are deemed necessary knowledge for the success of the procedure.

8. 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 8

9. CS Cannulation: Curve Shape Suggested Use
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

10. 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

11. 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

12. Suggested Use: Curve Shape Selection
Amplatz
Bypasses Eustachian Ridge or Thebesian valve near or blocking CS

13. 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
Implanter may use a Medtronic 9 French introducer kit. If a different manufacturer’s kit is preferred, use a 9.5 French introducer.

14. 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
Engage the CS 2 – 3 cm, leading with a guide wire or a fixed shape catheter to minimize the chance of dissection.
Achieving a good placement of the guide catheter in the ostium of the coronary sinus provides support for passing the venogram balloon and lead(s) to the appropriate branch cardiac vein.
It is recommended that the implanter pull back and inject a PROOF SHOT (a small puff or bump of contrast) to make sure that the catheter is free in the CS.

15. 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
Access CS with steerable catheter
Advance guide catheter over steerable catheter into the CS
Marinr® MCXL steerable EP catheter
Again, if Medtronic introducer is preferred, use a 9 French introducer kit; otherwise use 9.5 French.

16. Step #2: Perform Venogram

17. 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
The Attain Model 6215 Venogram Balloon
80 cm.
6 Fr.
0.025 inch inner lumen diameter
A venogram is recorded for future reference regarding lead placement. Generally an AP, LAO and RAO view are recorded to fully understand:
Venous anatomy
Access to left lateral wall
The size and tortuosity of the veins
A venogram is critical to the success of the Left Heart Lead implant!
Provides a “road map” of the venous anatomy.
Two or more views are necessary to capture more than just an “aerial” view; additional views give the third dimension (tell you about the “bumps” in the road).
The venogram image of the patient’s anatomy assists in determining the LV lead choice.

18. Cardiac Venous Anatomy: AP View

19. Cardiac Venous Anatomy: LAO View
LAO view is best for cannulation and for visualization of lead separation.

20. Cardiac Venous Anatomy: RAO View
RAO view usually used for visualization of the take off of the branches.

21. Lead in Lateral Cardiac Vein
Atrial Lead
Left Ventricular Lead
Note the location of the leads in relation to each other. Note specifically the physical separation of the RV and LV leads.
Right Ventricular Lead

22. Step #3: Select Target Vein and Left Ventricular Lead

23. 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
Sub-optimal lead location:
One of the important elements in a successful implantation is selecting the most appropriate vein to cannulate for CRT lead placement. The best performance for LV pacing is thought to occur in a lateral or posterior lateral position. Three different studies have approached various targets to determine the best method in lead placement. The three studies are discussed briefly.
1Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Fedele F, Santini M. Doppler myocardial imaging to evaluate the effectiveness of pacing sites in patients receiving biventricular pacing. J Am Coll Cardiol. 2002;39:
Study to compare efficacy of biventricular pacing (BIV) at most delayed wall of LV and at other LV walls. In all pts after BIV, LVEDV and LVESV decreased, LVEF increased, QRS narrowed, NYHA decreased, 6-min walk distance increased, interval between closure and opening of mitral valve (CO) and isovolumic contraction time (ICT) decreased, diastolic time and Q-P2 interval increased, while Q-A2 interval and mean performance index (MPI) did not change. Group A showed greater improvement over group B in LVESV, LVEF, bicycle stress test work and time capacity, CO, and ICT. Concluded that BIV improved LV performance in all pts; however, greatest improvement in pts paced at most delayed site.
2Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation 2001;104:
Acute study in 30 pts (mean NYHA class 2.7, mean QRS duration 152 ms, mean PR interval 194 ms, mean EF 23%) from PATH-CHF-II study. LV freewall pacing (in either LV only or BIV modes) showed significantly greater changes in dP/dt and aortic pulse pressure compared with anterior wall pacing.
3Auricchio A, Klein H, Tockman B, Sack S, Stellbrink C, Neuzner J, Kramer A, Ding J, Pochet T, Maarse A, Spinelli J. Transvenous biventricular pacing for heart failure: can the obstacles be overcome? Am J Cardiol. 1999;83:136D-142D.
Article describes the Guidant EASYTRAK lead including acute testing in 12 pts. Also included is a retrospective analysis of the PATH-CHF study acute pacing results from the first 25 patients showing an association of magnitude of pulse pressure and left ventricular +dP/dt increases and left ventricular pacing site. The percent increases in pulse pressure and left ventricular +dP/dt averaged over all atrioventricular delays were significantly larger at mid-lateral epicardial pacing sites compared with any other left ventricular region and increases at the middle-anterior sites were smaller than other sites.” A
D. Middle cardiac vein
E. Great cardiac vein B B C D E C D
LAO View
1 Ansalone G, et al. JACC. 2002;39:
2 Butter C, et al. Circulation. 2001;104:
3 Auricchio A, et al. Am J Cardiol. 1999;83:136D-142D.

24. Select the Left-Heart Lead for the Anatomy
Leads
Lead Body Size
Polarity
Designed for:
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)
Placement in a variety of vein positions with active fixation (deployable lobes)
Attain Ability Model 4196
Bipolar
(dual electrode)
Improved trackability into smaller veins
Programmable repositioning of pacing vectors
4194
4193
Attain Ability®
Attain StarFix®
Attain 4193:
4 Fr (1.33 mm), unipolar lead
Lead lengths – 78 cm and 88 cm
Steroid - Dexamethasone Sodium Phosphate
Purpose: Smaller veins with moderate to great tortuosity
Attain 4194:
6 Fr (2.0 mm), bipolar lead
Purpose: Medium to large veins with moderate tortuosity
Attain StarFix 4195:
5 Fr (1.67 mm), unipolar lead
Lead lengths – 78 cm, 88 cm, and 103 cm
Steroid Eluting - Beclomethasone
Purpose: Increased stability with deployable lobes
Attain Ability 4196:
4 Fr (1.3 mm), bipolar (dual electrode) lead
Fixation – Compound cants
Steroid – Dexamethasone acetate
Purpose: Programmable repositioning with the ability to get into a small vein

25. First active fixation left-heart lead More placement options
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

26. The first 4 Fr bipolar left-heart lead
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 >= 88cm length

27. Step #4: Place Left-Heart Lead

28. Fully Integrated CRT Implant System Compatible Tools
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
Attain Select II sub-selection catheter
Attain Ability left-heart lead
The Attain Ability lead can be inserted through the Attain Select II catheter with a guide wire or Attain Hybrid guidewire to track to the desired position within the sub-selected branch.
Attain Command™ CS cannulation catheter
Attain Hybrid® guide wire
*4 Fr, 88 cm Attain Ability and Attain® 4193 models are compatible with Attain Select II sub-selection catheter

29. 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

30. CS cannulation catheter tip
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
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
CS cannulation catheter tip
NOTES:
You can opt to cannulate CS ostium with the Attain Select II delivery catheter through an outer CS cannulation catheter
The Attain Select II delivers a 4 Fr lead > 88 cm, such as Attain Ability model 4196.
Suggested Procedure:
Place a valve on the Attain Select II delivery catheter
Insert inner catheter into the Attain Select II delivery catheter / valve assembly
Advance the Attain Select II delivery catheter / inner catheter assembly over guide wire, through outer CS cannulation catheter
Sub-select target cardiac vein with the Attain Select II delivery catheter
Leading with guide wire, sub-select target vein with Attain Select II delivery catheter / inner catheter assembly
Pull back inner catheter, as necessary, to sub-select
Remove inner catheter, after sub-selecting
Deliver 4 Fr lead to sub-selected cardiac vein
Backload 4 Fr lead over guide wire
Advance lead through the Attain Select II delivery catheter and into target cardiac vein
Pull the Attain Select II delivery catheter and guide wire back enough to allow lead shape to make full contact with tissue
Perform electrical measurements
Remove valve from Attain Select II delivery catheter
Slit Attain Select II delivery catheter first
Remove valve from outer CS cannulation catheter
Slit outer CS cannulation catheter
Attain Select II tip
4 Fr lead tip electrode 30

31. 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
Lead Placement
Position both curves at least 1 cm within the target vein
Verify that both electrodes have contact with the vein to confirm acceptable thresholds at both cathode locations during implant. This will ensure programmable repositioning as an option post-implant.
Confirm Both Electrodes Have Contact with Vein
Via fluoro: Verifying the position of both cants are at least 1 cm within the target vein
The analyzer: Test thresholds in both LVtip to RVcoil and LVring to RVcoil configuration
Testing Both Electrodes with the Analyzer is Important
Confirming acceptable thresholds at both cathode locations during implant will ensure programmable repositioning as an option post-implant

32. Step #5: Remove Implant Tools

33. 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
Larger grip with ergonomic hand position
Slit Twice
Sharp blade to slit two Medtronic catheters in same procedure
Pull catheter back
Hold slitter steady
Universal II Slitter
Hold slitter steady
Pull catheter back
Adjustable Slitter

34. Step #6: Measure Final Electricals

35. 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

36. 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)
The dual electrode design of the Attain Ability lead provides programmable repositioning as an option for the clinician. This is available during an implant or follow-up through device programming. The electrode which optimizes the pacing threshold and avoids extra-cardiac stimulation can be chosen by programming the appropriate LV Pace Polarity.
Currently, Medtronic does not have a low power CRT device with programmable repositioning capabilities.
The LVring/RVcoil pacing option is available on Medtronic CRT-D devices, starting with Concerto and moving forward.
The Attain Abilitylead was designed for optimal pacing when used in a unipolar or extended bipolar configuration. While standard bipolar configuration is a valid pacing option, it may result in
- elevated pacing thresholds or
- anodal stimulation
because the electrodes have the same surface area.
Definition: Extended bipolar refers to programming the pacing vector in one of the following configurations:
- For CRT-D devices, LVtip/RVcoil or LVring/RVcoil
- For CRT-P devices, LVtip/RVring
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.

37. 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
This slide provides the technical hints in evaluating ICD ports and connections.

38. Brief Statement: Medtronic Attain Ability® 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.

39. 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) and/or consult Medtronic’s website at
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

40. 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.
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) and/or consult Medtronic’s website at
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

41. 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.
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) and/or consult Medtronic’s website at
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Tel: (763)
Fax: (763)
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and medical professionals)
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