Medtronic 419478 Technical Manual

Download

Page 1

ATTAIN® BIPOLAR OTW 4194

Steroid eluting, transvenous, bipolar, left ventricular, over the wire, cardiac vein pacing lead

Technical Manual

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

Page 2

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.

Attain, InSync, Medtronic

Page 3

1 Required physician training 3 2 Device description 3 3 Indications for use 4 4 Contraindications 4 5 Warnings and precautions 4 6 Potential adverse events 5 7 Clinical trials 6 8 Directions for use 9

9 Detailed device description 15 10 Medtronic warranty 17 11 Service 17

1 Required physician training

In order to implant a Medtronic Attain Bipolar OTW 4194 lead, physicians are required to:

●

Thoroughly read this manual, and all associated device technical manuals.

●

Provide a copy of the patient manual to the patient and discuss it with him or her and any other interested parties.

●

Be trained on the following topics – Indications for use – Device operation to ensure therapy delivery – Measuring and managing biventricular thresholds – Assembly and use of LV lead implant tools – Placement of the LV lead – Patient management and system follow-up

Prior to implanting the system, Medtronic will certify that physicians received training.

2 Device description

The Medtronic Attain Bipolar OTW 4194 steroid eluting, transvenous, bipolar, left ventricular, over the wire, cardiac vein pacing lead is designed for pacing and sensing via a cardiac vein, as part of a Medtronic biventricular pacing system. The tip to anode spacing is 11 mm.

The lead features a tapered annular platinum alloy electrode tip and a platinum/iridium anode coil. The electrode tip contains a molded silicone rubber seal. This molded tip provides a fluid seal which allows guide wire passage and reduces blood ingress. The lead also features nickel alloy conductors, polyurethane outer insulation, silicone inner insulation, and an IS-11 Bipolar (BI) lead connector.

The lead’s distal tip contains a maximum of 1.0 mg dexamethasone sodium phosphate. Upon exposure to body fluids, the steroid elutes from the lead tip. The steroid is known to suppress the inflammatory response that is believed to cause threshold rises typically associated with implanted pacing electrodes.

The Model 4194 lead can be positioned with the aid of a guide wire or with a stylet. If a stylet is used, use only the stylets packaged with the lead or in a stylet kit (downsized knob).

Note: To implant the Model 4194 lead in a cardiac vein, a compatible delivery system is required, such as a Medtronic delivery system. A compatible delivery system includes a guide catheter and a hemostasis/introducer valve which allows passage through or removal from an IS-1 connector. Contact your Medtronic representative for further information regarding compatible delivery systems.

2.1 Contents of package

The lead and accessories are supplied sterile. Each package contains the following items:

●

1 lead with stylet and anchoring sleeve

●

2 guide wire insertion tools

●

1 guide wire clip

●

1 guide wire steering handle

●

Extra stylets

●

Product documentation

2.2 Accessory descriptions

Dispose of all single-use accessories according to local environmental requirements.

Anchoring sleeve – An anchoring sleeve secures the lead to prevent it from moving and protects the lead insulation and conductors from damage caused by tight sutures.

Guide wire clip – A guide wire clip secures the excess guide wire and helps to protect and maintain the sterility of the guide wire.

Guide wire insertion tool – A guide wire insertion tool provides additional control when inserting a guide wire into the lead connector pin or the lead tip.

Guide wire steering handle – A guide wire steering handle is used only with guide wires 0.46 mm (0.018 in) or less in diameter. The steering handle provides additional control and steerability of the guide wire.

Stylet – A stylet provides additional stiffness and controlled flexibility for maneuvering the lead into position. Each stylet knob is labeled with the stylet diameter and corresponding lead length.

IS-1 BI refers to an International Connector Standard (ISO 5841–3) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

Page 4

3 Indications for use

The lead has application as part of a Medtronic biventricular pacing system.

4 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 1.0 mg of dexamethasone sodium phosphate may be contraindicated.

5 Warnings and precautions

For single use only – Do not resterilize and reimplant an

explanted lead.

Necessary hospital equipment – 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 post-implant testing. Backup pacing should be readily available during implant. Use of the delivery system or leads may cause heart block.

Line-powered and battery-powered equipment – An implanted lead forms a direct current path to the myocardium. During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.

Diathermy – People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.

Inspecting the sterile package – Carefully inspect the package prior to opening.

●

If the seal or package is damaged, contact your local Medtronic representative.

●

Do not use the product after its expiration date.

●

The lead has been sterilized with ethylene oxide prior to shipment. If the integrity of the sterile package has been compromised prior to the expiration date, resterilize the lead using ethylene oxide.

Ethylene oxide resterilization – If the sterile package seal is broken, resterilize the device using a validated ethylene oxide process. Avoid resterilization techniques that could damage the lead.

●

Refer to sterilizer instructions for operating instructions.

●

Use an acceptable method to determine sterilizer effectiveness, such as biological indicators.

●

Before resterilization, place the device in an ethylene oxide permeable package.

●

Do not exceed temperatures of 55 °C (131 °F).

●

Do not resterilize more than one time.

●

Allow proper aeration of ethylene oxide residues prior to implant.

Steroid use – It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone sodium phosphate apply to the use of this highly localized, controlled-release device. For a list of potential adverse effects, refer to the Physicians’ Desk Reference.

Handling the steroid tip – Reducing the available amount of steroid may adversely affect low-threshold performance. Avoid reducing the amount of steroid available prior to lead implant.

●

Do not allow the electrode surface to come in contact with surface contaminants.

●

Do not wipe or immerse the electrode in fluid, except blood, at the time of implant.

Handling the lead – Leads should be handled with care at all times:

●

Do not withdraw the lead through a non-adjustable hemostasis/introducer valve. This action could cause distortion of the coil electrode and result in potential injury to the patient.

●

If a stylet is used for lead positioning, use only the stylets packaged with the lead or in a stylet kit (downsized knob). Other stylets may extend beyond the lead tip causing lead tip seal damage or patient injury.

●

If the lead is damaged, do not implant it. Return the lead to a Medtronic representative.

●

Protect the lead from materials that shed particles such as lint and dust. Lead insulators attract these particles.

●

Handle the lead with sterile surgical gloves that have been rinsed in sterile water or a comparable substance.

●

Do not severely bend, kink, or stretch the lead.

●

Do not use surgical instruments to grasp the lead or connector pin.

●

Do not immerse leads in mineral oil, silicone oil, or any other liquid, except blood, at the time of implant.

●

Use an anchoring sleeve with all leads. Ensure that the anchoring sleeve is positioned close to the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. If wiping the lead is necessary prior to insertion, ensure that the anchoring sleeve remains in position.

●

Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters or leads may cause trauma to the heart.

Page 5

Handling the guide wire – Handle the guide wire with care at all times.

●

Damage to a guide wire may prevent the guide wire from performing with accurate torque response and control and may cause vessel damage. For additional information about vessel damage and other potential adverse events, refer to the technical manual packaged with the appropriate guide wire.

●

If the distal end of the guide wire becomes severely kinked or twisted, it may be difficult to withdraw it back through the lead. Therefore, if there is an indication that the distal end of the guide wire has become damaged, or if there is significant resistance in guide wire passage, remove the lead and guide wire together as a unit. Remove the guide wire from the lead and insert a new guide wire into the lead. Do not use excessive force to retract the guide wire from the lead. Refer to the product documentation packaged with the guide wire for additional information.

Handling the stylet – Handle the stylet with care at all times.

●

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 use excessive force or surgical instruments when inserting a stylet.

●

Avoid overbending, kinking, or blood contact on stylets.

●

Use a new stylet when blood or other fluids accumulate on the stylet. Accumulated fluids may cause damage to the lead or difficulty in passing the stylet through the lead.

●

Curving the distal end of the stylet prior to insertion into the lead will achieve a curvature at the distal end of the lead. Do not use a sharp object to impart a curve to the distal end of the stylet.

Concurrent devices – Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators should generally be explanted.

Chronic repositioning or removal – Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. Studies have not specifically evaluated the removal of left ventricular leads from the coronary venous vasculature. If a lead must be removed or repositioned, proceed with extreme caution. Return all removed leads to Medtronic.

●

Verify lead length on the IS-1 label on the connector to choose an appropriate stylet kit (downsized knob) length when repositioning. Always choose a stylet kit (downsized knob) 3 cm shorter than the lead length listed on the IS-1 connector label. For example, choose a stylet kit (downsized knob) with stylets 75 cm long for a lead 78 cm long.

●

Lead removal may result in avulsion of the endocardium, valve, or vein.

●

Lead junctions may separate, leaving the lead tip and bare wire in the heart or vein.

●

Chronic repositioning of a lead may adversely affect a steroid eluting lead’s low-threshold performance.

●

Cap abandoned leads to avoid transmitting electrical signals.

●

For leads that have been severed, seal the remaining lead end and suture the lead to adjacent tissue.

●

If a lead is removed and repositioned, inspect it carefully for insulator or conductor coil damage prior to repositioning.

6 Potential adverse events

The potential adverse events (listed in alphabetical order) related to the use of transvenous leads include, but are not limited to, the following conditions:

●

cardiac dissection

●

cardiac perforation

●

cardiac tamponade

●

coronary sinus dissection

●

death

●

endocarditis

●

erosion through the skin

●

extracardiac muscle or nerve stimulation

●

fibrillation or other arrhythmias

●

heart block

●

heart wall or vein wall rupture

●

hematoma/seroma

●

infection

●

myocardial irritability

●

myopotential sensing

●

pericardial effusion

●

pericardial rub

●

pneumothorax

●

rejection phenomena (local tissue reaction, fibrotic tissue formation, pulse generator migration)

●

threshold elevation

●

thrombosis

●

thrombotic or air embolism

●

valve damage (particularly in fragile hearts)

Additional potential adverse events related to the lead and the programmed parameters include, but are not limited to, the following:

Potential adverse event

Lead dislodgementaIntermittent or contin-

Indicator of potential adverse event

uous loss of capture or sensing

uous oversensing

Corrective action to be considered

Reposition the lead.

Page 6

Potential adverse event

Lead conductor fracture or insulation failure

Threshold elevation or exit block

Transient loss of capture or sensing may occur following surgery until lead stabilization takes place. If stabilization does not occur, lead dislodgement may be suspected.

Indicator of potential adverse event

Intermittent or continuous loss of capture or sensing

Loss of capture

Corrective action to be considered

Replace the lead.

Adjust the implantable device output. Replace or reposition the lead.

Implant techniques that may damage the lead include, but are not limited to, the following:

Implant techniques that may damage the lead

Forcing the lead through the introducer/delivery system

Use of too medial of an approach with venous introducer resulting in clavicle & first rib binding

Puncturing the periosteum and/or tendon when using subclavian introducer approach

Advancing the lead through the veins without the stylet or guide wire fully inserted

Inserting the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool

Advancing a stylet tip beyond the distal end of the lead tip seal

Possible effects on the lead

Electrode, conductor coil, and/or insulation damage

Conductor coil fracture, insulation damage

Tip distortion and/or insulation perforation

Lead tip seal damage Replace the lead.

Corrective action to be considered

Replace the lead.

7 Clinical trials

7.1 Attain Bipolar OTW Model 4194 left-heart lead study

A prospective, multi-center trial conducted at 22 investigative sites in the United States and Canada evaluated the safety and effectiveness of the Medtronic Attain Bipolar OTW Model 4194 left-heart lead in heart failure patients.

An investigational protocol pre-specified the performance criteria for both safety and effectiveness based on previous studies. For this study, patients who satisfied inclusion and exclusion criteria underwent a baseline evaluation to determine study eligibility and then underwent a cardiac resynchronization system implant attempt, which could include the Model 4194 left heart lead.

Key study inclusion criteria included patients with the following:

●

Patient provides written informed consent

●

Patients 18 years of age or older

●

Patient is diagnosed with New York Heart Association functional classification three (NYHA III) or New York Heart Association functional classification four (NYHA IV) despite optimal medical therapy which is defined as: – ACE inhibitor or Angiotensin Receptor Blocker (ARB), if

tolerated, for at least 1 month prior to implant

– Beta-blockers for at least 3 months preceding implant, if

tolerated, and stable for 1 month. Stable is defined as no upward titration of beta-blockers.

●

Demonstrated intrinsic QRS duration ≥ 130 ms (test documented within 6 months of baseline)

●

Left ventricular ejection fraction (EF) ≤ 35% (test documented within 12 months of baseline)

●

Patient is expected to remain available for follow-up visits

●

Patient is willing and able to comply with the protocol

●

Patient is indicated for ICD implantation for the treatment of life threatening ventricular arrhythmias (required only if a patient will receive an ICD)

Key study exclusion criteria included patients with the following:

●

Patients with a previous complete atrial based biventricular CRT system

●

Patients with a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing adverse events from previous unsuccessful attempt

●

Patients contraindicated for < 1.0 mg dexamethasone sodium phosphate

●

Patients with unstable angina or who have experienced an acute myocardial infarction (MI) within the past month

●

Patients who have had a coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 3 months

●

Patients on more than 2 inotropic infusions per week within 1 month of implant

●

Patients with contraindications for standard transvenous cardiac pacing (for example, mechanical right heart valves)

●

Patients with chronic (permanent) atrial arrhythmias

●

Post heart transplant patients (patients waiting for heart transplant are allowed in the study)

●

Patients enrolled in any concurrent drug and/or device study that may confound the results of this study

●

Patients with a terminal illness who are not expected to survive more than 6 months

Page 7

●

Implant attempted (incision made)

Model 4194 lead implant NOT attempted Model 4194 lead implant attempted

No LV lead implanted

Model 4194 lead

successfully

implanted

Three-month

follow-ups

Model 4193 lead

successfully

implanted

Model 4193 lead successfully

implanted

Competitor (not

Medtronic) LV lead

successfully

implanted

No LV lead

implanted

201

195 6

190

162

10 1 12

185

Successful CS cannulation

Unsuccessful CS cannulation

Implant not attempted

Patients enrolled (informed consent form signed)

Women who are pregnant, or have a positive pregnancy test within 7 days of implant, or with child bearing potential and who are not on a reliable form of birth control (all women of child bearing potential must undergo a pregnancy test within 7 days of implant)

●

Patients unable to tolerate an urgent thoracotomy

Patients successfully implanted with a Model 4194 lead were followed at pre-hospital discharge (PHD), 1 month, 3 months, 6 months and every 6 months thereafter. Patients attempted with a Model 4194 lead who did not ultimately have a successful Model 4194 implant were followed for 1 month or until all relevant adverse events were resolved.

All patients who underwent a Model 4194 lead attempt were included in the analysis of the safety results. Those patients who were successfully implanted with a Model 4194 lead were included in the analysis of the efficacy results. Of the 201 patients who were enrolled in the study, 195 underwent a cardiac resynchronization implant attempt. One hundred sixtytwo (162) of those patients were successfully implanted with a Model 4194 lead and 13 patients were successfully implanted with a Model 4193 lead, resulting in an OTW lead success rate of 89.7%. Ninety-five (95) of the Model 4194 lead patients have completed the 3-month follow-up visit. Figure 1 illustrates an overview of patient accountability and disposition at the time of data analysis. Table 1 summarizes the reasons for unsuccessful Model 4194 lead implants.

Figure 1. Implant status for the 201 patients enrolled in the study

Table 1. Reasons for unsuccessful Model 4194 implant attempts

(N = 23)

Reason N

Unacceptable pacing thresholds 6

Coronary vein too small 6

Unable to obtain adequate distal location 5

Diaphragmatic stimulation 5

Unable to access coronary vein 4

Dislodgement/unstable location 2

Unable to negotiate curve 1

Categories are not mutually exclusive.

7.1.1 Objectives

There were 2 primary study objectives and 4 secondary objectives for the Model 4194 lead clinical study. Pre-established performance criteria for each of the primary objectives were documented in the protocol prior to study start. The secondary objectives were descriptive in nature and were designed to obtain additional information about the Model 4194 lead.

Primary objective – Evaluate the complication-free survival from lead-related complications at 3 months.

●

Performance criteria: Lower 95% confidence bound limit ≥ 80%

●

Results: – Observed survival from Model 4194 lead-related

complications: 96.3%

– Lower limit of 1-sided 95% confidence interval at 3 months:

89.7%

– Objective met.

There were 8 Model 4194 lead-related complications in 8 patients, all of which resolved. Six (6) of these complications had occurred by 3 months. All 8 are summarized in Table 2.

Table 2. Model 4194 lead-related complications and treatments

Complication event/treatment N

Lead dislodgement

Lead repositioned 4

Lead replaced with Model 4193 lead 2

Elevated pacing threshold

Lead repositioned 1

Diaphragmatic muscle stimulation

Lead replaced with Model 4193 lead 1

Total 8

Two (2) of the lead dislodgements treated by repositioning occurred after the 3-month time point.

Primary objective – Evaluate the mean bipolar voltage threshold for the Model 4194 lead at 3 months.

●

Performance criteria: Upper 95% confidence limit ≤ 2.5 V.

Page 8

●

1.41

1.62

1.49

1.59

1.51

0.5

1.5

2.5

3.5

Implant

(N=162)

PHD

(N=159)

1 Month (N=149)

3 Month

(N=93)

6 Month

(N=23)

Visit

Threshold @ 0.5 ms (V)

13.86

12.40

13.93

16.00

14.19

Implant

(N=162)

PHD

(N=153)

1 Month (N=141)

3 Month

(N=89)

6 Month

(N=23)

Visit

R-Wave Amplitude (mV)

963.7

752.5

718.7

793.0

745.9

200

400

600

800

1000

1200

1400

Implant

(N=162)

PHD

(N=141)

1 Month (N=131)

3 Month

(N=82)

6 Month

(N=18)

Visit

Impedance (Ohms)

Results: – Mean bipolar voltage threshold (@ 0.5 ms) at 3 months:

1.5 V ± 1.05 – Upper limit of 1-sided 95% confidence interval: 1.68 V – Objective met.

Figure 2. Model 4194 lead bipolar threshold data at 0.5 ms (mean ± one standard deviation)

Table 4. Model 4194 lead implant times (minutes)

N Mean Std. Dev. Range

Cannulation time 162 8.9 13.3 <1.0 - 90.0

Fluoroscopy time 161 24.0 15.8 5.1 - 101.0

Model 4194 lead

162 12.0 11.8 1.0 - 100.0

placement time

Total implant time 161 117.1 58.4 39.0 - 380.0

Secondary objective – To evaluate the electrical performance (sensing, impedance, phrenic nerve stimulation, and atrial anodal stimulation) of the Model 4194 lead.

There was no anodal stimulation reported at the Pre-Hospital Discharge and one instance (2.4%) at the 3-month follow-up visit (5.0 V). Overall, electrical measurements were within expected ranges and stable over time. Figure 3 and Figure 4 illustrate the Model 4194 lead R-wave amplitude and impedance over time.

Figure 3. Model 4194 lead R-wave amplitude (mean ± one standard deviation)

Secondary objective –

●

The overall Attain lead family

●

The Attain lead family after successful coronary sinus cannulation

●

The Model 4194 lead

To evaluate the implant success rates of:

The overall Attain lead family implant success rate was 89.7%. The Attain lead family success after successful coronary sinus cannulation was 93.1%. The overall Model 4194 implant success rate was 87.6%. These rates are presented in Table 3.

Table 3. Lead implant success rates

Lead Group

implants

Attain lead family 195 175 89.

Attempted

Attain lead family after cannula-

188

tion

Model 4194 lead 185 162 87.

This number includes all patients who were successfully cannulated less the 2 patients who were cannulated but had no lead attempts.

Secondary objective – To evaluate the total implant, fluoroscopy, cannulation, and LV placement time for the Model 4194 lead.

Table 4 summarizes the implant-related times for successful Model 4194 lead implants. Cannulation time, fluoroscopy time, lead placement time, and total implant time were all within expected ranges.

Successful

implants

175 93.

cce

ss rat

Figure 4. Model 4194 lead impedance (mean ± one standard deviation)

Table 5 summarizes the phrenic nerve stimulation observed at implant. Five (5) patients experienced phrenic nerve stimulation in all 3 configurations. An additional 6 patients experienced phrenic nerve stimulation at 1 of the 3 configurations (2 patients at each).

Page 9

Table 5. Model 4194 Phrenic nerve stimulation at implant (volts)

Per-

UTC

N Mean Std Dev Range

Unipolar 7 5.90 2.49 2.20 -

LV tip / LV anode

LV tip / RV anode

7 6.24 2.52 2.30 -

7 6.81 2.72 3.20 -

10.0

cent

(N)

(%)

152 95.6%

155 95.7%

154 95.7%

Secondary objective – To evaluate all adverse events occurring during the clinical study (excluding unavoidable adverse events).

A total of 224 adverse events in 107 patients were reported in this patient cohort. Seventy-nine (79) of the events (in 53 patients) were classified as complications and 145 (in 79 patients) were classified as observations. A complication was defined as an adverse event which was resolved invasively or which directly resulted in the death of or serious injury to the patient, or the termination of significant device function regardless of other treatments. An observation was defined as an adverse event which was resolved by non-invasive means such as medically or by reprogramming the device or which resolved spontaneously. Table 6 provides an overview of all the adverse events.

Table 6. Summary of all adverse events

Relatedness Complications Observations

Model 4194 left ventricular lead

Right atrial lead 7 0

Right ventricular lead 0 1

Cardiac resynchronization device

Cardiac resynchronization system

Implant tool 7 4

Procedure 16 30

Unrelated to cardiac resynchronization system

Total 79 145

8 16

0 8

0 1

41 85

The Model 4194 lead-related adverse events are presented in Table 7. Complications related to the Model 4194 lead included lead dislodgements, diaphragmatic muscle stimulation, and an elevated pacing threshold.

Table 7. Model 4194 lead-related adverse events

Event

Muscle stimulation - diaphragm

Lead dislodgement 6 0 6

Compli-

cations

Observa-

tions

1 13 13

Total number

of patients

Table 7. Model 4194 lead-related adverse events (continued)

Event

Elevated pacing threshold 1 2 3

Muscle stimulation - pectoral

Total 8 16 22

Note: The 24 events occurred in 22 patients.

Compli-

cations

Observa-

tions

0 1 1

Total number

of patients

Table X summarizes the implant tool-related adverse events.

Table 8. Implant tool-related adverse events

Event

Coronary sinus dissection 3 3 6

Coronary sinus perforation 1 1 2

Air embolism 1 0 1

Cardiac perforation 1 0 1

Ventricular tachycardia 1 0 1

Total 7 4 10

Note: The 11 events occurred in 10 patients.

Compli-

cations

Observa-

tions

Total number

of patients

7.2 InSync Registry study

The InSync Registry clinical study document is available at www.medtronic.com/manuals. The following is a synopsis of the study:

InSync Registry condition-of-approval clinical study – This observational study was required as a condition of approval for the InSync Model 8040 and InSync III Model 8042 devices, the Attain LV lead models 2187 and 2188, and the Attain OTW models 4193 and 4194 left ventricular leads. The findings of the InSync Registry condition-of-approval clinical study demonstrate that the InSync and InSync III systems with Attain LV lead models 2187, 2188, and OTW lead models 4193 and 4194, are safe and effective as part of a cardiac resynchronization therapy (CRT) system.

8 Directions for use

Warning: Do not force the guide catheter or lead if significant

resistance is encountered. Use of guide catheters or leads may cause trauma to the heart.

Note: To implant the Model 4194 lead in a cardiac vein, a compatible delivery system is required, such as a Medtronic delivery system. A compatible delivery system includes a guide catheter and a hemostasis valve or introducer valve which allows passage through or removal from an IS-1 connector. Contact a Medtronic representative for further information regarding compatible delivery systems.

Page 10

Proper surgical procedures and sterile techniques are the

responsibility of the medical professional. The implant procedures described in this manual are provided for information only. Each physician must apply the information in these instructions according to professional medical training and experience.

The implant procedure generally includes the following steps:

●

Placing the right ventricular lead

●

Preparing the delivery system

●

Accessing the subclavian vein

●

Inserting the guide catheter assembly

●

Obtaining venograms

●

Inserting the lead into the delivery system

●

Selecting the lead placement method

●

Placing the lead using a stylet

●

Preparing the guide wire

●

Placing the lead using a guide wire

●

Fixating the lead

●

Taking electrical measurements

●

Removing the guide catheter from the lead

●

Anchoring the lead

●

Connecting the lead

●

Placing the device and leads into the pocket

8.1 Placing the right ventricular lead

Note: When deciding which ventricular lead to place first,

consider the ease of coronary sinus cannulation and the need for backup pacing.

●

When a left ventricular lead is implanted first: – It may be easier to cannulate the coronary sinus without

other leads already implanted.

– Additional hospital equipment may be necessary to

provide 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.

8.2 Preparing the delivery system

Prepare the delivery system for lead implantation according to the instructions in the product literature packaged with the delivery system.

8.3 Accessing the subclavian vein

Access the subclavian vein:

1. Use a preferred method, based on professional experience, to access the subclavian vein. Caution: Certain anatomical abnormalities, such as thoracic outlet syndrome, may precipitate pinching and subsequent fracture of the lead. Caution: Insertion should be done as far lateral as possible to avoid clamping the lead body between the clavicle and the first rib (Figure 5).

Figure 5.

1 Suggested entry site

2. Introduce a J-shaped introducer guide wire and percutaneous introducer sheath.

8.4 Inserting the guide catheter assembly

Warning – Back-up pacing should be readily available during

implant. Use of the delivery system or leads may cause heart block.

Access the coronary sinus:

1. Insert the guide catheter assembly.

2. Advance the guide catheter to the right atrium.

3. Achieve entry into the coronary sinus by rotating the guide catheter tip posteriorly and to the patient’s left.

See the delivery system product documentation for additional information.

8.5 Obtaining venograms

Before placing a lead in the coronary sinus, obtain venograms. Venograms are recommended to assess a route for passage and a site for final placement based on the size, shape, location, and tortuosity of the veins. Also, venograms may be useful in identifying suspected coronary sinus trauma. For information on obtaining a venogram by using a venogram balloon catheter, see the product documentation packaged with an appropriate venogram balloon catheter.

8.6 Inserting the lead into the delivery system

Warning: Use only the stylets packaged with the lead or in a stylet

kit (downsized knob). Other stylets may extend beyond the lead tip causing lead tip seal damage and/or patient injury.

Warning: Do not force the lead if significant resistance is encountered during lead passage.

Caution: Use care when handling the lead during insertion.

●

Do not severely bend, kink, or stretch the lead.

●

Do not use surgical instruments to grasp the lead or connector pin.

Insert the lead:

1. Remove and discard the stylet packaged with the lead.

2. Insert a straight stylet into the lead to vary the shape of the lead’s distal end.(Figure 6).

Page 11

Note: When the stylet is fully inserted, the distal tip of the

stylet does not reach the distal tip of the lead (Figure 6).

Figure 6.

1 Stylet fully withdrawn 2 Stylet fully inserted

3. Insert the lead into the delivery system. See the delivery system product documentation for additional information.

8.7 Selecting the lead placement method

The Model 4194 lead can be placed with the aid of a stylet or with a guide wire.

To determine the placement method, review the venogram to determine if stylet or guide wire delivery should be used.

Stylet delivery – If the patient’s anatomy features gentle vein angulation off of the coronary sinus and the cardiac vein branch is not tortuous (Figure 7), use a stylet for lead delivery. See Section 8.8 for more information.

Figure 7.

Figure 8.

1 Tortuous cardiac vein branch with gentle angulation from the

coronary sinus

2 Tortuous cardiac vein branch with acute angulation from the coronary

sinus

8.8 Placing the lead using a stylet

Warning: Do not force the lead if significant resistance is

encountered during lead passage.

Warning: To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein, keep the stylet withdrawn 1 to 2 cm or select a more flexible stylet.

Caution: To avoid damage to the stylet, do not use a sharp object to impart a curve at the distal end of a stylet (Figure 9).

Figure 9.

1 Coronary sinus 2 Cardiac vein

Guide wire delivery – If the patient’s anatomy features acute vein angulation off of the coronary sinus and the cardiac vein branch is tortuous (Figure 8), use a guide wire for lead delivery. See Section 8.9 for more information.

Note: If it is difficult to advance the stylet around a bend, consider changing the stylet. More flexible stylets are recommended for tortuous anatomies. Firmer stylets are recommended where additional support is needed.

There are 2 techniques that may be used to advance the lead into a cardiac vein. The choice of technique is left to the discretion of the physician.

8.8.1 First technique to advance the lead into a cardiac vein using a stylet

Advance the lead into a cardiac vein:

1. Advance the lead up to, but not past, the cardiac vein ostium (Figure 10).

Page 12

Figure 10.

2. Use 1 or more of the following actions to direct the lead tip into the cardiac vein:

●

Withdraw the stylet

●

Advance the lead off of the stylet

●

Remove the straight stylet. Manually shape the stylet into a curve. Insert the curved stylet into the lead. Rotate the lead body and stylet together.

●

Rotate the lead’s curved tip into the cardiac vein.

3. Advance the lead into the cardiac vein (Figure 11).

Figure 11.

4. Advance the lead, with the stylet inserted, further into the cardiac vein. See Section 8.11, “Fixating the lead”, page 14 for additional information. Note: The anode should be placed in the selected vein, not in the coronary sinus.

8.8.2 Second technique to advance the lead into a cardiac vein using a stylet

Advance the lead into a cardiac vein:

1. Advance the lead past the ostium of the cardiac vein (Figure 12).

Figure 12.

2. Refer to 1 of the following procedures according to the type of stylet used.

●

Straight stylet: If using a straight stylet, withdraw the stylet 1 to 2 cm and rotate the lead to align the curved lead tip with the cardiac vein ostium.

●

Curved stylet: If using a curved stylet, withdraw the stylet 1 to 2 cm and rotate the stylet and lead body together to align the curved lead tip with the cardiac vein ostium.

3. Withdraw the lead and drag the curved lead tip over the ostium of the cardiac vein until the lead turns into the vein.

Reinsert the stylet slightly to advance the lead into the cardiac vein (Figure 13).

Figure 13.

8.9 Preparing the guide wire

Warning: Damage to a guide wire may prevent the guide wire

from performing with accurate torque response and control and may cause vessel damage. For additional information about vessel damage and other potential adverse events, refer to the technical manual packaged with the appropriate guide product.

Caution: Use care when positioning the guide wire. Refer to the product documentation packaged with the guide wire for additional information.

Note: Medtronic recommends using guide wires 0.36 mm to

0.46 mm (0.014 in to 0.018 in) in diameter. Contact a Medtronic representative for further information about recommended guide wires.

Prepare the guide wire for use:

1. Select a guide wire. A more flexible guide wire is recommended if the patient has tortuous anatomy. If additional support is needed, use a firmer guide wire. Note: Guide wire firmness is determined by 2 factors: guide wire diameter and guide wire core design. A larger guide wire diameter may be firmer than a smaller guide wire diameter. However, guide wires with the same diameter may have different degrees of firmness. A “J” shaped guide wire or angled tip guide wire are recommended to aid in sub-selecting the cardiac vein and where more steerability is desired. Note: Consider soaking the guide wire in a heparin solution prior to insertion to minimize the risk of thrombus formation during use.

2. Remove the stylet.

3. Insert the guide wire into the lead by placing the distal (flexible) end of the guide wire into the lead connector pin using the guide wire insertion tool included in the package (Figure 14). Caution: To minimize the risk of damaging the guide wire, be sure the flexible section of the guide wire is fully inserted into the lead before removing the guide wire insertion tool from the lead.

Page 13

Figure 14.

4. Disengage the guide wire insertion tool from the lead connector pin.

5. Remove the guide wire insertion tool using the slit on the tool or by sliding the tool off the end of the guide wire.

6. Position the guide wire steering handle (Figure 15) :

a. Advance the guide wire steering handle over the

proximal (rigid) end of the guide wire.

b. Tighten the guide wire steering handle onto the guide

wire near the lead connector pin.

Figure 15.

1 Guide wire steering handle 2 Lead connector pin

7. Attach the guide wire clip to the guide wire and secure it within the sterile field. Medtronic recommends securing the guide wire clip to the patient’s sterile surgical drape.

Alternate approach: In situations where the guide wire is already in place, the lead can be loaded over the guide wire using the guide wire insertion tool.

Insert the guide wire into the lead by placing the proximal (rigid) end of the guide wire into the distal lead tip using the guide wire insertion tool included in the package (Figure 16).

Note: There may be slight resistance as the guide wire passes through the lead tip seal.

Note: Be sure to remove the guide wire insertion tool prior to lead implant.

Figure 16.

8.10 Placing the lead using a guide wire

Warning: Do not force the lead if significant resistance is

encountered during lead passage.

Caution: If the guide wire’s distal end becomes severely kinked or twisted, it may be difficult to withdraw it back through the lead. Therefore, if there is an indication that guide wire’s distal end has become damaged, or if there is a lot resistance in guide wire passage, remove the lead and guide wire. Remove the guide wire from the lead and insert a new guide wire into the lead. Do not use excessive force to retract the guide wire from the lead.

Note: If the lead is not advancing, or if the lead and guide wire seem to be sticking together, there may be thrombus on the guide wire at the lead tip. Remove and inspect the lead and guide wire. Consider using a new guide wire. Reinsert the lead and the guide wire as described in previous steps.

Note: If it is difficult to advance the guide wire around a bend, consider changing the guide wire. More flexible guide wires are recommended for tortuous anatomies. Firmer guide wires are recommended where additional support is needed.

There are 2 techniques that may be used to advance the lead into a cardiac vein. The choice of technique is left to the discretion of the physician.

8.10.1 First technique to advance the lead into a cardiac vein using a guide wire

Advance the lead into a cardiac vein:

1. Using venogram images as reference, advance the lead into the coronary sinus. Keep the distal tip of the guide wire beyond the distal tip of the lead during passage and placement (Figure 17).

Figure 17.

2. Rotate the guide wire and advance the guide wire into the cardiac vein. Pass the lead over the guide wire and into the cardiac vein (Figure 18).

Figure 18.

3. Advance the lead further into the cardiac vein by advancing the lead along the guide wire or by advancing the lead and guide wire together. See Section 8.11, “Fixating the lead”, page 14 for additional information. Note: The anode should be placed in the selected vein, not in the coronary sinus.

Page 14

8.10.2 Second technique to advance the lead into a cardiac vein using a guide wire

Advance the lead into a cardiac vein:

1. Using venogram images as reference, advance the lead into the cardiac vein (Figure 19). The lead’s curved distal tip may be used to aid in subselecting cardiac veins within the coronary sinus by slightly retracting the guide wire inside the lead lumen.

Figure 19.

2. If retracted, reinsert the guide wire through the lead tip seal and more distally into the cardiac vein. Advance the lead over the guide wire into the cardiac vein (Figure 20).

Figure 20.

8.11 Fixating the lead

Fixation is achieved the same way regardless of whether a stylet or a guide wire is used.

Fixate the lead:

Using fluoroscopy for guidance, fixate the lead by wedging both curves of the lead tip into the cardiac vein (Figure 21).

Figure 21.

Note: If the cardiac vein is large, it may be necessary to position

the lead in a smaller cardiac vein in order to achieve lead tip fixation.

8.12 Taking electrical measurements

Caution: Prior to taking electrical or defibrillation efficacy

measurements, move objects made of conductive materials, such as guide wires or stylets, away from all electrodes.

Note: For the Model 4194 initial electrical measurements should be taken with the stylet or guide wire retracted a minimum of 4 cm inside the lead lumen.

Take electrical measurements:

1. Attach a surgical cable to the lead connector pin. Note: A unipolar lead requires the use of an indifferent electrode.

2. Use an implant support instrument, such as a pacing system analyzer, for obtaining electrical measurements (Table 9). For information on the use of the implant support instrument, consult the product documentation for that device. Satisfactory lead placement is indicated by low stimulation thresholds and adequate sensing of intracardiac signal amplitudes.

●

A low stimulation threshold provides a desirable safety margin, allowing for a possible rise in thresholds that may occur within 2 months following implant.

●

Adequate sensing amplitudes ensure that the lead is properly sensing intrinsic cardiac signals. Minimum signal requirements depend on the sensitivity capabilities of the device. Acceptable acute signal amplitudes for the lead must be greater than the minimum device sensing capabilities. Be sure to include an adequate safety margin to account for lead maturity.

Table 9. Recommended measurements at implant (Assumes 500 Ω resistance)

Measurement recommended Left ventricle

Maximum acute stimulation thresholdsa3.0 V

Minimum acute sensing amplitudes 4.0 mV

At a pulse duration setting of 0.5 ms.

3. If electrical measurements do not stabilize to acceptable levels, it may be necessary to reposition the lead and repeat the testing procedure.

4. Check for diaphragmatic stimulation by pacing at 10 V and a pulse width setting greater than 0.5 ms. Then observe for diaphragmatic contracting either by fluoroscopy or direct abdominal palpitation. Further testing may include patient positional changes to simulate upright chronic conditions. If diaphragmatic pacing occurs, reduce the voltage until a diaphragmatic pacing threshold is determined. Diaphragmatic stimulation usually necessitates repositioning of the lead.

Page 15

8.13 Removing the guide catheter from the lead

Once the lead is in the final position, perform the following steps:

1. If used, remove the guide wire and replace the guide wire with a straight stylet (downsized knob). Insert the straight stylet into the lead to the mid-coronary sinus.

2. Remove the guide catheter from the lead. See the delivery system product documentation for details.

3. Carefully and completely remove the stylet. When removing the stylet, grip the lead firmly just below the connector pin; this will help prevent possible lead tip dislodgement.

4. Repeat the electrical measurements. See Section 8.12, “Taking electrical measurements”, page 14.

8.14 Anchoring the lead

Caution: Use care when anchoring the lead.

●

Use only nonabsorbable sutures to anchor the lead.

●

Do not attempt to remove or cut the anchoring sleeve.

●

Do not use the anchoring sleeve tabs for suturing.

●

During lead anchoring, take care to avoid dislodging the lead tip.

●

Do not secure sutures so tightly that they damage the vein, lead, or anchoring sleeve (Figure 22).

●

Do not tie a suture directly to the lead body (Figure 22).

Figure 22.

Anchor the lead using all 3 grooves:

1. Position the anchoring sleeve against or near the vein.

2. Secure the anchoring sleeve to the lead body by tying a suture firmly in each of the 3 grooves (Figure 23).

Figure 23.

1. Take final electrical measurements.

2. Insert the lead connector into the connector block. Consult the product documentation packaged with the implantable device for instructions on proper lead connections.

8.16 Placing the device and lead into the pocket

Caution: Use care when placing the device and leads into

the pocket.

●

Ensure that the leads do not leave the device at an acute angle.

●

Do not grip the lead or device with surgical instruments.

●

Do not coil the lead. Coiling the lead can twist the lead body and may result in lead dislodgement (Figure 24).

Figure 24.

Place the device and leads into the pocket:

1. Rotate the device to loosely wrap the excess lead length. Caution: To prevent undesirable twisting of the lead body, wrap the excess lead length loosely under the implantable device and place both into the subcutaneous pocket (Figure 25).

Figure 25.

2. Suture the pocket closed using a preferred surgical technique.

8.17 Post-implant evaluation

3. Use at least 1 additional suture in 1 of the grooves to secure the anchoring sleeve and lead body to the fascia.

8.15 Connecting the lead

Caution: Always remove the stylet and stylet guide before

connecting the lead to the device. Failure to remove the stylet may result in lead failure.

Connect the lead to an implantable device.

After implant, monitor the patient’s electrocardiogram until the patient is discharged. If a lead dislodges, it usually occurs during the immediate postoperative period.

9 Detailed device description

9.1 Specifications (nominal)

Parameter Model 4194

Type Bipolar

Chamber paced Ventricle

Length 20–100 cm

Page 16

Parameter Model 4194

Connector IS-1 BI

Materials Conductors: MP35N

Insulators: Polyurethane (outer)

Silicone (inner)

Electrode tip: Platinum alloy

Anode coil: Platinum alloy

Connector pin: Stainless steel

Connector

Stainless steel

ring:

Molded tip

Silicone rubber

seal:

Tip electrode configuration Tapered annular, plati-

nized

Diameter Lead body: 6 French (2.0 mm)

Tip electrode: 5.4 French (1.8 mm)

Medtronic delivery sys-

7 French (2.3 mm) tem (recommended inner diameter)

Diagnostic guide wire (recommended diame-

0.36 mm to 0.46 mm

(0.014 in to 0.018 in) ter)

Tip electrode surface

5.8 mm

area

Anode coil surface area 38 mm

Resistance Unipolar: 67 Ω at 78 cm

Bipolar: 126 Ω at 78 cm

Distance between elec-

11 mm trodes

Steroid Dexamethasone sodium

phosphate

Amount of steroid 1.0 mg maximum

9.2 Specifications drawing

Figure 26.

1 Anode coil diameter: 5.4 French (1.8 mm); surface area 38 mm

2 Tip electrode diameter: 5.4 French (1.8 mm); surface area 5.8 mm 3 Anchoring sleeve 4 Total lead length: 20-110 cm 5 IS-1 BI connector

Page 17

10 Medtronic warranty

For complete warranty information, see the accompanying warranty document.

11 Service

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products. Medtronic also maintains a professional staff to provide technical consultation to product users. For more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate telephone number or address listed on the back cover.

Page 18

Page 19

Page 20

Medtronic, Inc.

*A04287001*

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636

Europe/Middle East/Africa

Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland +41 21 802 7000

Technical manuals

www.medtronic.com/manuals