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Cardiac Rhythm Management // Tachyarrhythmia Therapy // Kainox VCS ICD Leads
Kainox VCS
Technical Manual
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the order of,
a physician (or properly licensed practitioner).
© 2014 BIOTRONIK, Inc., all rights reserved.
Table of Contents
Kainox VCS Leads Systems Manual
Contents
1. Device Description................................................................................................................1
2. Indications for Use................................................................................................................3
3. Contraindications..................................................................................................................5
4. Warnings and Precautions��������������������������������������������������������������������������������������������������7
4.1 Sterilization, Storage, and Handling..................................................................................7
4.2 Implantation and Programming.........................................................................................7
4.3 Lead Evaluation and Connection......................................................................................8
4.4 Follow-up Testing...............................................................................................................9
4.5 Pulse Generator Explant and Disposal.............................................................................9
4.6 Hospital and Medical Hazards...........................................................................................9
4.7 Home and Occupational Hazards...................................................................................10
5. Adverse Events...................................................................................................................13
5.1 Observed Adverse Events...............................................................................................13
5.1.1 Kainox RV-S and Kainox VCS.....................................................................................13
5.2 Potential Adverse Events................................................................................................14
6. Clinical Studies...................................................................................................................15
6.1 Kainox RV-S and Kainox VCS.........................................................................................15
6.1.1 Study Objectives.........................................................................................................15
6.1.2 Results........................................................................................................................15
7. Sterilization and Storage���������������������������������������������������������������������������������������������������17
8. Implant Procedure..............................................................................................................19
8.1 Implant Preparation.........................................................................................................19
8.2 Product Inspection...........................................................................................................20
8.3 Opening the Sterile Container.........................................................................................20
8.4 Package Contents and Accessories ...............................................................................21
8.5 Kainox VCS Lead Insertion.............................................................................................21
8.6 Baseline Measurements .................................................................................................22
8.7 Lead Fixation...................................................................................................................22
8.8 Defibrillation Testing........................................................................................................22
8.9 Lead to Device Connection.............................................................................................23
8.10 Final Implant Steps........................................................................................................24
9. Follow-Up Procedures........................................................................................................25
9.1 ICD Patient Follow-Up.....................................................................................................25
9.2 Explantation.....................................................................................................................25
10. Disclaimer..........................................................................................................................27
11. Technical Data....................................................................................................................29
12. Glossary.............................................................................................................................31
PAGE i
Table of Contents
Kainox VCS Leads Systems Manual
PAGE ii
Chapter 1 Device Description
Kainox VCS Leads Systems Manual
1. Device Description
The Kainox VCS lead is an implantable, transvenous lead for use with BIOTRONIK’s implantable
cardioverter defibrillators (ICDs). Defibrillation shocks are delivered by a shock coil(s) that is comprised
of a platinum/iridium alloy base. The lead is designed for use in conjunction with an ICD that allows
defibrillation to include the housing of the ICD.
The Kainox VCS is composed of a silicone-insulated lead body that is terminated at the distal end by
a single platinum/iridium shocking coil. The proximal end consists of a standard DF-1 connector for
attachment to any BIOTRONIK ICD. This lead is intended to augment the shock pathway of other
single coil lead systems.
Use of this lead provides an alternate shock vector when implanted together with a single-coil lead
system. The lead is positioned such that the high-voltage electrode is located in the superior vena cava.
The Kainox VCS has a total length of 60 cm and is designated as Kainox VCS 60.
DF‑1 refers to the international standard for defibrillation lead connectors [Reference ISO 11318:1993].
Please refer to Section 11 for technical specifications.
PAGE 1
Chapter 1 Device Description
Kainox VCS Leads Systems Manual
PAGE 2
Chapter 2 Indications for Use
Kainox VCS Leads Systems Manual
2. Indications for Use
The Kainox Lead Systems are indicated for use in conjunction with a BIOTRONIK ICD. Currently, data
is not available regarding the use of this lead system with ICDs of other manufacturers. Use of other
ICDs may adversely affect sensing and/or therapy delivery.
PAGE 3
Chapter 2 Indications for Use
Kainox VCS Leads Systems Manual
PAGE 4
Chapter 3 Contraindications
Kainox VCS Leads Systems Manual
3. Contraindications
Do not use the Kainox Lead Systems in patients with severe tricuspid valve disease or patients who
have a mechanical tricuspid valve implanted.
PAGE 5
Chapter 3 Contraindications
Kainox VCS Leads Systems Manual
PAGE 6
Chapter 4 Warnings and Precautions
Kainox VCS Leads Systems Manual
4. Warnings and Precautions
MRI (Magnetic Resonance Imaging) - Do not expose a patient to MRI device scanning. Strong
magnetic fields may damage the device and cause injury to the patient.
Electrical Isolation - Electrically isolate the patient from potentially hazardous leakage current to
prevent inadvertent arrhythmia induction.
Lead Systems - The use of another manufacturer’s ICD lead system may cause potential adverse
consequences such as under-sensing of cardiac activity and failure to deliver necessary therapy.
Resuscitation Availability - In order to implant the ICD system, it is necessary to induce and convert
the patient’s ventricular tachyarrhythmias. Do not perform induction testing unless an alternate source
of patient defibrillation such as an external defibrillator is readily available.
Unwanted Shocks - Prior to handling the device during the implant procedure, program the detection
status of the device to OFF to prevent the delivery of unwanted shocks to the patient or the person
handling the device.
4.1 Sterilization, Storage, and Handling
Device Packaging - Do not use the device if the device’s packaging is wet, punctured, opened or
damaged because the integrity of the sterile packaging may be compromised. Return the device
to BIOTRONIK.
Re-sterilization - Do not re-sterilize and re-implant explanted devices.
Storage (temperature) - Store the device between 5° to 55° C (41° - 131° F) because temperatures
outside this range could damage the device.
Storage (magnets) - Store the device in a clean area, away from magnets, kits containing magnets,
and sources of electromagnetic interference (EMI) to avoid damage to the device.
Temperature Stabilization - Allow the device to reach room temperature before programming or
implanting the device because temperature extremes may affect initial device function.
Use Before Date - Do not implant the device after the USE BEFORE DATE because the device may
have reduced longevity.
4.2 Implantation and Programming
Capacitor Reformation - Infrequent charging of the high voltage capacitors may extend the charge
times of the ICD. The capacitors may be manually reformed, or the ICD may be programmed to
reform the capacitors automatically. For further information, please refer to the appropriate ICD
technical manual.
Connector Compatibility - ICD and lead system compatibility should be confirmed prior to the implant
procedure. Consult your BIOTRONIK representative regarding lead/pulse generator compatibility prior
to the implantation of an ICD system
ERI (Elective Replacement Indicator) - Upon reaching ERI, the battery has sufficient energy
remaining to continue monitoring for at least three months and to deliver a minimum of six 30-joule
shocks. After this period, all tachyarrhythmia detection and therapy is disabled.
Intrusion of Blood – Avoid intrusion of blood into the lead lumen from the connector.
PAGE 7
Chapter 4 Warnings and Precautions
Kainox VCS Leads Systems Manual
Lead Positioning – If the ICD is implanted underneath the pectoral muscle, ensure that no parts of
the lead lie between the ribs and clavical or between the housing of the implant and the ribs/clavical.
Chafing and pressure on the lead between the housing of the ICD and the ribs/clavical could damage
the lead’s insulation and thus cause premature failure.
Magnets - Positioning of a magnet or the programming wand over the ICD will suspend tachycardia
detection and treatment.
Pacemaker/ICD Interaction - In situations where an ICD and a pacemaker are implanted in the same
patient, interaction testing should be completed. If the interaction between the ICD and the pacemaker
cannot be resolved through repositioning of the leads or reprogramming of either the pacemaker or the
ICD, the pacemaker should not be implanted (or explanted if previously implanted).
Programmed Parameters - Program the device parameters to appropriate values based on the
patient’s specific arrhythmias and condition.
Programmers - Use only BIOTRONIK programmers to communicate with the device.
Repositioning or Explanting – If, due to repeated repositioning of the lead tip, the stylet sticks, the
lead should be removed and replaced with a new one by following these measures:
Sealing System - Failure to properly insert the torque wrench into the perforation at an angle
perpendicular to the connector receptacle may result in damage to the sealing system and its selfsealing properties.
Shock Impedance - Never implant the device with a lead system that has a measured shock
impedance of less than thirty ohms. Damage to the device may result. If the shock impedance is less
than thirty ohms, reposition the lead system to allow a greater distance between the electrodes.
System Compatibility – Do not use this lead with a DF-4 system. This lead is intended for use with an
ICD with DF-1 connectors.
4.3 Lead Evaluation and Connection
Capping Leads - If a lead is abandoned rather than removed, it must be capped to ensure that it is not
a pathway for currents to or from the heart.
Gripping Leads - Do not grip the lead with surgical instruments or use excessive force or surgical
instruments to insert a stylet into a lead.
Kinking Leads - Do not kink leads. This may cause additional stress on the leads that can result in
damage to the lead.
Stylet Insertion - To avoid damage to the lead, do not insert the stylet too rapidly nor use excessive
force when inserting the stylet into the lead.
Stylet Compatibility - To ensure compatibility, use only the stylets that are packaged with the lead.
Other stylet types may result damage to the lead and/or patient injury.
Kainox VCS Stylet - The maximum stylet diameter for the Kainox VCS lead is 0.36 mm.
Liquid Immersion - Do not immerse leads in mineral oil, silicone oil, or any other liquid.
Short Circuit - Ensure that none of the lead electrodes are in contact (a short circuit) during delivery of
shock therapy as this may cause current to bypass the heart or cause damage to the ICD system.
Suturing Leads - Do not suture directly over the lead body as this may cause structural damage. Use
the appropriate lead fixation sleeve to immobilize the lead and protect it against damage from ligatures.
Tricuspid Valve Bioprothesis - Use ventricular transvenous leads with caution in patients with a
tricuspid valvular bioprosthesis.
PAGE 8
Chapter 4 Warnings and Precautions
Kainox VCS Leads Systems Manual
Anchoring Sleeve - Always use an anchoring sleeve (lead fixation sleeve) when implanting a
lead. Use of the anchoring sleeve, which is provided with the lead will lessen the possibility of lead
dislodgement and protect the lead body from damage by the securing ligature.
Blind Plug - A blind plug must be inserted and firmly connected into any unused header port to prevent
chronic fluid influx and possible shunting of high-energy therapy.
Setscrew(s) - Failure to back off the setscrew(s) may result in damage to the lead(s), and/or difficulty
connecting the lead(s).
Cross-Threading - To prevent cross-threading the setscrew, do not back the setscrew completely out
of the threaded hole. Leave the screwdriver in the slot of the setscrew while the lead is inserted.
Over-Tightening - Do not over-tighten the setscrew(s). Use only a torque wrench that automatically
prevents over-tightening.
4.4 Follow-up Testing
Defibrillation Threshold - Be aware that the changes in the patient’s condition, drug regimen, and
other factors may change the defibrillation threshold (DFT) which may result in nonconversion of the
arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia
during arrhythmia conversion testing is no assurance that conversion will occur post-operatively
Resuscitation Availability - Ensure that an external defibrillator and medical personnel skilled in
cardiopulmonary resuscitation (CPR) are present during post-implant device testing should the patient
require external rescue.
4.5 Pulse Generator Explant and Disposal
Device Incineration - Never incinerate the ICD due to the potential for explosion. The ICD must be
explanted prior to cremation.
Explanted Devices - Return all explanted devices to BIOTRONIK.
Unwanted Shocks - Prior to explanting the ICD, program the detection status of the device to OFF to
prevent unwanted shocks.
4.6 Hospital and Medical Hazards
Electromagnetic interference (EMI) signals present in hospital and medical environments may
affect the function of any ICD or pacemaker. The ICD is designed to selectively filter out EMI noise.
However, due to the variety of EMI signals, absolute protection from EMI is not possible with this or any
other ICD.
Diathermy - Diathermy therapy is not recommended for ICD patients due to possible heating effects of
the pulse generator and at the implant site. If diathermy therapy must be used, it should not be applied
in the immediate vicinity of the pulse generator or lead system. Following the procedure, proper ICD
function should be checked and monitored.
Electrocautery - Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or
may cause device malfunction or damage. If use of electrocautery is necessary, the current path and
ground plate should be kept as far away from the pulse generator and leads as possible.
Excessive Pressure – Excessive pressure and hyperbaric oxygen therapy should be avoided, as it
may cause damage to the implant.
PAGE 9
Chapter 4 Warnings and Precautions
Kainox VCS Leads Systems Manual
External Defibrillation - The device is protected against energy normally encountered from external
defibrillation. However, any implanted device may be damaged by external defibrillation procedures. In
addition, external defibrillation may also result in permanent myocardial damage at the electrode-tissue
interface as well as temporarily or permanently elevated pacing thresholds. When possible, observe
the following precautions:
• Position the adhesive electrodes or defibrillation paddles of the external defi­brillator
anterior‑posterior or along a line perpendicular to the axis formed by the implanted device and
the heart.
• Set the energy to a level not higher than is required to achieve defibrillation.
• Place the paddles as far as possible away from the implanted device and lead system.
• After delivery of an external defibrillation shock, interrogate the ICD to confirm device status and
proper function.
Lithotripsy - Lithotripsy treatment should be avoided, since electrical and/or mechanical interference
with the ICD is possible and may damage the ICD. If this procedure must be used, the greatest
possible distance from the point of electrical and mechanical strain should be chosen in order to
minimize a potential interference with the implant.
Medical Procedures - For any medical procedures that may affect the device (e.g., therapeutic
ultrasound, external defibrillation, electrophysiological ablation, HF surgery, lithotripsy, perform a
complete follow-up after the procedure.
MRI (Magnetic Resonance Imaging) - Do not expose a patient to MRI device scanning. Strong
magnetic fields may damage the device and cause injury to the patient.
Radiation - High radiation sources such as cobalt 60 or gamma radiation should not be directed at the
pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead
shielding over the device to prevent radiation damage and confirm its function after treatment.
Radio Frequency Ablation - Prior to performing an ablation procedure, deactivate the ICD. Avoid
applying ablation energy near the implanted lead system whenever possible. The ICD system should
be checked for proper operation after the procedure.
Therapeutic Ultrasound - Therapeutic ultrasound is not recommended due to possible heating effects
of the device at the implant site. If therapeutic ultrasound must be considered, it should not be applied
in the immediate vicinity of the implant.
Transcutaneous Electrical Nerve Stimulation (TENS) - Transcutaneous Electrical Nerve Stimulation
should be avoided, as it may lead to unintended heart stimulation.
4.7 Home and Occupational Hazards
Patients should be directed to avoid devices that generate strong electromagnetic interference (EMI).
EMI could cause device malfunction or damage resulting in non-detection or delivery of unneeded
therapy. Moving away from the source or turning it off will usually allow the ICD to return to its normal
mode of operation.
The following equipment (and similar devices) may affect normal ICD operation: electric arc or
resistance welders, electric melting furnaces, radio/television and radar transmitters, power‑generating
facilities, high‑voltage transmission lines, and electrical ignition systems (of gasoline‑powered devices)
if protective hoods, shrouds, etc., are removed.
PAGE 10
Chapter 4 Warnings and Precautions
Kainox VCS Leads Systems Manual
Cellular Phones - Testing has indicated there may be a potential interaction between cellular phones
and BIOTRONIK ICD systems. Potential effects may be due to either the cellular phone signal or
the magnet within the telephone and may include inhibition of therapy when the telephone is within 6
inches (15 centimeters) of the ICD, when the ICD is programmed to standard sensitivity.
Patients having an implanted BIOTRONIK ICD who operate a cellular telephone should:
• Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular
telephone and the implanted device.
• Set the telephone to the lowest available power setting, if possible.
• Patients should hold the phone to the ear opposite the side of the implanted device. Patients
should not carry the telephone in a breast pocket or on a belt over or within 6 inches (15
centimeters) of the implanted device as some telephones emit signals when they are turned ON,
but are not in use (i.e., in the listen or stand-by mode). Store the telephone in a location opposite
the side of implant.
Based on results to date, adverse effects resulting from interactions between cellular telephones and
implanted ICDs have been transitory. If electromagnetic interference (EMI) emitting from a telephone
does adversely affect an implanted ICD, moving the telephone away from the immediate vicinity of the
ICD should restore normal operation.
Electronic Article Surveillance (EAS) - equipment such as retail theft prevention systems may
interact with ICDs. Patients should be advised to walk directly through and not to remain near an EAS
system longer than necessary.
Home Appliances - Home appliances normally do not affect ICD operation if the appliances are
in proper working condition and correctly grounded and shielded. There have been reports of the
interaction of electric tools or other external devices (e.g. electric drills, older models of microwave
ovens, electric razors, etc.) with ICDs when they are placed in close proximity to the device.
A recommendation to address every specific interaction of EMI with implanted ICDs is not possible due
to the disparate nature of EMI.
PAGE 11
Chapter 4 Warnings and Precautions
Kainox VCS Leads Systems Manual
PAGE 12
Chapter 5 Adverse Events
Kainox VCS Leads Systems Manual
5. Adverse Events
5.1 Observed Adverse Events
5.1.1 Kainox RV-S and Kainox VCS
The clinical study involved 32 patients implanted with the Kainox RV-S ICD lead and 12 patients
implanted with the Kainox VCS lead.
There were a total of two patient deaths reported during the course of the trial: none of the deaths were
judged by the clinical studies investigator to be device related. One death was due to cardiogenic
shock and one death was related to cardiorenal system failure.
Two Kainox RV-S leads were explanted during the trial. One lead was explanted secondary to
insulation damage during lead repositioning. One lead was explanted secondary to ICD system
infection. In addition, three Kainox RV-S leads were tested at the implant procedure, but were
not implanted chronically. Two leads were tested during one implant procedure but not implanted
secondary to high pacing thresholds. One lead was not implanted secondary to inability to pace and
sense in the bipolar configuration.
Table 1 and Table 2 provide a summary of the adverse events that were reported during the clinical
study regardless of whether or not the event was related to the ICD system. A complication is defined
as a clinical event that requires additional invasive intervention to resolve. An observation is defined as
a clinical event that does not require additional invasive intervention to resolve.
Table 1: Reported Adverse Events (Complications)
Number of Patients
with Complications
(% of Patients)
Number of
Complications
Complications
per patient-year
Lead Repositioning
4 (12.5%)
4
0.32
Medical (Infection)
1 (3.1%)
2
0.16
Sensing and Pacing
1 (3.1%)
1
0.08
All Events
6 (18.8%)
7
0.56
Complication
Total Number of Patients = 32, Number of Patient Years = 12.6
Table 2: Reported Adverse Events (Observations)
Number of Patients
Number of
Observations
Observation
with Observations
Observations
per patient-year
(% of Patients)
T-wave Oversensing
5 (15.6%)
5
0.40
Sensing and Pacing
5 (15.6%)
5
0.40
Atrial Arrhythmia
1 (3.1%)
1
0.08
Delayed Detection
1 (3.1%)
1
0.08
Medical
1 (3.1%)
1
0.08
Programmer Software
1 (3.1%)
1
0.08
11 (34.4%)
14
1.12
All Events
Total Number of Patients = 32, Number of Patient Years = 12.6
PAGE 13
Chapter 5 Adverse Events
Kainox VCS Leads Systems Manual
5.2 Potential Adverse Events
Adverse events (in alphabetical order) associated with ICD systems include:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Acceleration of arrhythmias (caused by device)
Air embolism
Bleeding
Chronic nerve damage
Erosion
Excessive fibrotic tissue growth
Extrusion
Fluid accumulation
Formation of hematomas or cysts
Inappropriate shocks
Infection
Keloid formation
Lead abrasion and discontinuity
Lead migration/dislodgement
Myocardial damage
Pneumothorax
Shunting current or insulating myocardium during defibrillation with internal or external paddles
Potential mortality due to inability to defibrillate or pace
Thromboemboli
Venous occlusion
Venous or cardiac perforation
Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop
psychological intolerance to an ICD system that may include the following:
•
•
•
•
•
•
Dependency
Depression
Fear of premature battery depletion
Fear of shocking while conscious
Fear that shocking capability may be lost
Imagined shocking (phantom shock)
PAGE 14
Chapter 6 Clinical Studies
Kainox VCS Leads Systems Manual
6. Clinical Studies
6.1 Kainox RV-S and Kainox VCS
The Kainox RV-S and Kainox VCS clinical evaluation included 32 patients implanted with the Kainox
RV-S ICD lead and 12 patients implanted with the Kainox VCS lead.
6.1.1 Study Objectives
The objective of the clinical evaluation was to gather information about the function and performance of
the Kainox RV-S and Kainox VCS ICD leads in patients with standard ICD indications.
6.1.2 Results
The mean implant duration was 4.7 months with cumulative implant duration of 151.2 patient months.
No unanticipated adverse device effects were reported during the evaluation. A summary of the results
obtained during the evaluation is provided in Table 5.
Table 3: Clinical Study Results
Evaluation
Data
Results
DFT Safety Margin Evaluation-Kainox RV-S Alone,
Two Successes at 20J or Less
Number of Evaluations:
Mean:
16
16.9 J
DFT Safety Margin Evaluation-Kainox RV-S Alone,
Step-down DFT Testing
Number of Evaluations:
Mean:
7
6.9 J
DFT Safety Margin Evaluation- Kainox RV-S & VCS,
Two Successes at 20J or Less
Number of Evaluations:
Mean:
14
15.1 J
DFT Safety Margin Evaluation- Kainox RV-S & VCS,
Step-down DFT Testing
Number of Evaluations:
Mean:
1
10 J
R-Wave Amplitudes (millivolts)
Implant (n=36):
Three-month (n=15):
11.0 mV
12.5 mV
Pacing Threshold (volts) at 0.5 ms.
Implant (n=36):
Three-month (n=15):
0.5 V
1.4 V
Pacing Impedance (Ohms)
Implant (n=34):
Three-month (n=14):
537
553
Appropriate Ventricular Sensing
Number of evaluations:
Appropriate result:
133
97.7%
Appropriate Ventricular Pacing
Number of evaluations:
Appropriate result:
134
96.3%
Appropriate Ventricular Tachyarrhythmia Detection
and Conversion
Number of evaluations:
Appropriate result:
217
100.0 %
PAGE 15
Chapter 6 Sterilization and Storage
Kainox VCS Leads Systems Manual
PAGE 16
Chapter 7 Sterilization and Storage
Kainox VCS Leads Systems Manual
7. Sterilization and Storage
This lead is shipped in packaging equipped with a quality control seal and product information label.
The label contains the model specifications, technical data, serial number, expiration date, sterilization,
and storage information. The lead and its accessories have been sealed in a container and gas
sterilized with ethylene oxide.
PAGE 17
Chapter 7 Sterilization and Storage
Kainox VCS Leads Systems Manual
PAGE 18
Chapter 8 Implant Procedure
Kainox VCS Leads Systems Manual
8. Implant Procedure
8.1 Implant Preparation
Prior to beginning an implant of the Kainox VCS lead, ensure that all of the necessary equipment
is available. The implant procedure requires the ICD device, the lead system, a programmer, other
external testing equipment, and the appropriate cables and accessories. Additional sterile equipment
and devices should be available in the event of accidental contamination or damage.
CAUTION
Capping Leads - If a lead is abandoned rather than removed, it must be capped to
ensure that it is not a pathway for currents to or from the heart.
Gripping Leads - Do not grip the lead with surgical instruments or use excessive
force or surgical instruments to insert a stylet into a lead.
Kinking Leads - Do not kink leads. This may cause additional stress on the leads
that can result in damage to the lead.
Liquid Immersion - Do not immerse leads in mineral oil, silicone oil, or any
other liquid.
Short Circuit - Ensure that none of the lead electrodes are in contact (a short circuit)
during delivery of shock therapy as this may cause current to bypass the heart or
cause damage to the ICD system.
Suturing Leads - Do not suture directly over the lead body as this may cause
structural damage. Use the appropriate lead fixation sleeve to immobilize the lead
and protect it against damage from ligatures.
CAUTION
Tricuspid Valve Bioprothesis - Use ventricular transvenous leads with caution in
patients with a tricuspid valvular bioprosthesis.
Device Packaging - Do not use the device if the device’s packaging is wet,
punctured, opened or damaged because the integrity of the sterile packaging may be
compromised. Return the device to BIOTRONIK.
Use Before Date - Do not implant the device after the USE BEFORE DATE because
the device may have reduced longevity.
PAGE 19
Chapter 8 Implant Procedure
Kainox VCS Leads Systems Manual
8.2 Product Inspection
The lead and its accessories have been sealed in a container and gas sterilized with ethylene oxide.
To assure sterility, inspect the packaging and check for integrity prior to opening. Do not use products
in which the lead or packaging appears damaged. Should a breach of sterility be suspected, return the
lead to BIOTRONIK.
CAUTION
Storage (temperature) - Store the device between 5° to 55° C (41° - 131° F)
because temperatures outside this range could damage the device.
Should a replacement lead be required, contact your local BIOTRONIK representative.
WARNING
Resuscitation Availability - In order to implant the ICD system, it is necessary
to induce and convert the patient’s ventricular tachyarrhythmias. Do not perform
induction testing unless an alternate source of patient defibrillation such as an
external defibrillator is readily available.
8.3 Opening the Sterile Container
The lead is packaged in two plastic trays, one within the other. Each tray is individually sealed and
sterilized with ethylene oxide.
The inner tray is sterile and can be removed from the outer tray using standard aseptic technique.
Peel off the sealing paper of the outer unsterile
container as indicated by the arrow.
Take out the inner sterile container by the gripping
tab and open it by peeling the sealing paper as
indicated by the arrow.
PAGE 20
Chapter 8 Implant Procedure
Kainox VCS Leads Systems Manual
8.4 Package Contents and Accessories
The Kainox VCS lead and contents of the inner package are sterile.
Each Kainox VCS package contains:
1 - Kainox VCS
2 - 0.36 mm, soft, tapered stylets (1 pre-inserted)
1 - stylet guide
2 - lead fixation sleeves (attached to lead)
1 - vein lifter
1 - vial of silicone oil
NOTE:
Additional stylets also are available as separately packaged sterile accessories.
8.5 Kainox VCS Lead Insertion
NOTE:
The Kainox leads are intended for use with BIOTRONIK ICDs. Currently, there are no data available
regarding the use of the Kainox leads with other manufacturers’ ICD systems. Use of other ICD
systems may adversely affect sensing and/or therapy delivery.
The following procedure is recommended for implanting of the Kainox VCS leads.
1. Prior to lead placement, inspect the lead to ensure that the fixation sleeves are positioned close
to the junction near the connector portion of the lead.
2. Venous access may be obtained through a standard cut-down or introducer technique. If the
introducer method is used, select an appropriate introducer for the lead. The recommended
introducer size (without guide wire) for the Kainox VCS leads is 9 French. A vein lifter is supplied
inside the sterile packaging for use, if needed.
3. The lead should be inserted into the vein and advanced under fluoroscopic guidance. Two
stylets are included in the sterile package. Additional stylets are available in separate packaging,
if required. Do not shape the stylet while it is inserted in the lead body. When changing stylets,
care should be taken to keep the stylet free of blood to help ensure easy insertion and removal.
NOTE:
BIOTRONIK stylets are designed to be 1 to 2 cm longer than the stylet lumen of the lead body.
CAUTION
Stylet Insertion - To avoid damage to the lead, do not insert the stylet too rapidly nor
use excessive force when inserting the stylet into the lead.
Kainox VCS Stylet - The maximum stylet diameter for the Kainox VCS lead is 0.36 mm.
Stylet Compatibility - To ensure compatibility, use only the stylets that are packaged
with the lead. Other stylet types may result damage to the lead and/or patient injury.
4. Advance the lead through the superior vena cava until it is in the desired position.
5. Once adequate lead placement is achieved, the stylet should be carefully withdrawn under
fluoroscopy so as not to dislodge the lead.
6. Anchor the lead at the venous entry site using the supplied lead fixation sleeves to prevent
dislodgement. Adequate slack should be allowed so that the lead will not be under tension later
when the patient is mobile.
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Chapter 8 Implant Procedure
Kainox VCS Leads Systems Manual
8.6 Baseline Measurements
Standard baseline lead measurements should be performed before connecting the lead to a
BIOTRONIK ICD. Medical judgment should be used in cases where optimal lead signals cannot be
reliably obtained.
Refer to the appropriate BIOTRONIK ICD manual for the configuration of the ports prior to connecting
the leads.
8.7 Lead Fixation
An Omega-shaped (W) strain relief loop at the lead insertion site may assist in maintaining the chronic
stability of the lead. Place and secure one of the lead fixation sleeves at the base of each side of the
Omega.
CAUTION
Suturing Leads - Do not suture directly over the lead body as this may cause
structural damage. Use the appropriate lead fixation sleeve to immobilize the lead
and protect it against damage from ligatures.
8.8 Defibrillation Testing
After connecting the lead to a BIOTRONIK ICD, test the function of the lead and ICD system to ensure
that pacing, sensing, and defibrillation efficacy is adequate and sufficient.
Before induction testing, a synchronized low energy test shock into sinus rhythm is recommended to
confirm the defibrillator electrode integrity. Typical shock impedance is 30 - 100 Ohms.
Between fibrillation inductions, sufficient time should be allocated for recovery of hemodynamic status.
This manual is intended to be used in conjunction with other appropriate BIOTRONIK technical
manuals (i.e., BIOTRONIK ICD manual).
CAUTION
Defibrillation Threshold - Be aware that the changes in the patient’s condition, drug
regimen, and other factors may change the defibrillation threshold (DFT) which may
result in nonconversion of the arrhythmia post-operatively. Successful conversion of
ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing
is no assurance that conversion will occur post-operatively.
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Chapter 8 Implant Procedure
Kainox VCS Leads Systems Manual
8.9 Lead to Device Connection
The dedicated bipolar Kainox VCS lead may only be connected to a BIOTRONIK ICD. This connection
may be configured several different ways (See Table 4). The connectors are marked as “IS‑1 BI”
for the ventricular sensing and pacing connector, “Atrium IS‑1 BI” for the atrial sensing connector,
“Ventricle HV1” for the distal coil defibrillation connector, and “Atrium HV2” for the proximal coil
defibrillation connector. The Kainox VCS has one DF-1 connector.
Table 4: Active Housing ICD with Kainox Leads
Port
Connector pin
RV
DF‑1 pin of the ventricular coil
SVC
DF-1 pin of the SVC coil or VCS lead or
P/S ATR
IS‑1 pin of a separate atrial pace/sense lead
P/S VENT
IS‑1 pin of the ventricular pace/sense electrode
BIOTRONIK ICDs have self-sealing setscrew covers. Refer to the following steps when connecting the
lead to the ICD.
• Withdraw the stylet and stylet guide before connecting the lead to the ICD.
• To retract a setscrew, insert the enclosed torque wrench through the perforation in the self-sealing
plug at a 90º angle to the lead connector until it is firmly placed in the setscrew. Rotate the wrench
counter-clockwise until the receptacle is clear of obstructions.
• Insert the lead connector into the receptacle of the ICD header, without bending the lead, until the
connector pin becomes visible beyond the connector block. Hold the connector in this position.
• Insert the enclosed torque wrench and securely tighten the setscrew by rotating the wrench in a
clockwise direction until torque transmission is limited by the wrench.
• After removing the torque wrench, the silicone sealing plug will self-seal.
CAUTION
Blind Plug - A blind plug must be inserted and firmly connected into any unused header
port to prevent chronic fluid influx and possible shunting of high-energy therapy.
Setscrew(s) - Failure to back off the setscrew(s) may result in damage to the
lead(s), and/or difficulty connecting the lead(s).
Cross-Threading - To prevent cross-threading the setscrew, do not back the
setscrew completely out of the threaded hole. Leave the screwdriver in the slot of
the setscrew while the lead is inserted.
Over-Tightening - Do not over-tighten the setscrew(s). Use only a torque wrench
that automatically prevents over-tightening.
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Chapter 8 Implant Procedure
Kainox VCS Leads Systems Manual
8.10 Final Implant Steps
The ICD and/or lead system may be placed in the pocket at this time. The following steps will help
ensure appropriate chronic Kainox VCS lead function:
•
•
•
•
Carefully coil any excess lead length loosely around the ICD housing.
Place the device into the pocket with the etched side facing anteriorly.
Evaluate the pacing and sensing functions of the device.
It is recommended that at least one induction and device conversion be done prior to closing the
pocket. This will ensure that the lead system has been properly connected to the ICD.
• Close the device pocket using standard surgical technique. Ensure the ICD detection status has
been deactivated prior to using electrocautery.
• If the Kainox VCS lead is being implanted without an ICD at this time, the lead connector must be
capped with an appropriate lead cap and carefully laid in a subcutaneous pocket. Ensure that the
lead system is carefully coiled and not twisted.
• Complete the implant form provided with the Kainox VCS lead and return it to BIOTRONIK for
patient and device registration.
CAUTION
Lead Positioning – If the ICD is implanted underneath the pectoral muscle, ensure
that no parts of the lead lie between the ribs and clavical or between the housing
of the implant and the ribs/clavical. Chafing and pressure on the lead between the
housing of the ICD and the ribs/clavical could damage the lead’s insulation and thus
cause premature failure.
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Chapter 9 Follow-Up Procedures
Kainox VCS Leads Systems Manual
9. Follow-Up Procedures
9.1 ICD Patient Follow-Up
Follow the instructions described in the appropriate BIOTRONIK ICD technical manual.
9.2 Explantation
An explanted lead may not be reused. Please complete the appropriate explant form and return the
form to BIOTONIK with the explanted lead system. Explanted devices should be sent to BIOTRONIK
for analysis and/or disposal. Contact BIOTRONIK if you are in need of assistance with returning any
explanted devices. If possible, the explanted devices should be cleaned with a sodium‑hypochlorite
solution of at least 1% chlorine and, thereafter, washed with water prior to shipping.
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Chapter 9 Follow-Up Procedures
Kainox VCS Leads Systems Manual
PAGE 26
Chapter 10 Disclaimer
Kainox VCS Leads Systems Manual
10. Disclaimer
BIOTRONIK leads, lead extensions, adapters and accessories used in connection with these devices
(referred to as: leads and accessories) have been qualified, manufactured and tested in accordance
with well proven and accepted standards and procedures. The physician should be aware, however,
that leads and accessories may be easily damaged by improper handling or use. Except as set forth in
BIOTRONIK’s Lead Limited Warranty, BIOTRONIK makes no express or implied warranties for its leads
and accessories.
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Chapter 10 Technical Data
Kainox VCS Leads Systems Manual
PAGE 28
Chapter 11 Technical Data
Kainox VCS Leads Systems Manual
11. Technical Data
Kainox VCS
General
Overall Length
60 cm
Lead Insulation
Silicone Rubber
Lead Connectors
1 x 3.2 mm DF‑1
Fixation
None
SVC Shock Coil
Length
7.0 cm
Diameter
2.6 mm (7.9 F)
Electrode Surface area
4.0 cm2
Electrode Material
80% Platinum / 20% Iridium
Conductor Style
Coil
Conductor Material
MP35N + 28% Ag core
Number of Filaments
8
Conductor Resistance
≤ 0.8 W
Accessories
Introducer
9F
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Chapter 11 Glossary
Kainox VCS Leads Systems Manual
PAGE 30
Chapter 12 Glossary
Kainox VCS Leads Systems Manual
12. Glossary
Arrhythmia. Any abnormality of the cardiac rhythm. The heart rhythm may be too fast, too slow, or
irregular in its pattern. Also known as dysrhythmia.
Asystole. The absence of cardiac contraction; also referred to as standstill.
Atria. The upper chambers of the heart. These act as receiving chambers for blood from the body.
The sinus node is found in the right atrium.
Bradycardia. Refers to a slow heart rate, usually below 60 bpm. Bradycardia may be caused by the
sinus node not functioning properly, heart block, or medications.
Cardiac Arrest. A decrease in the blood supply to the body due to ventricular tachycardia, ventricular
fibrillation, or asystole.
Cardioversion. The use of minimally necessary shock energy to convert the arrhythmia to a normal
rhythm. This energy is delivered at the same time as the heart beat.
Defibrillation. The delivery of a high energy shock to restore a normal heart beat.
Defibrillator. An external or internal device used to terminate an extremely fast or irregular rhythm.
Electrocardiogram (ECG, EKG). A picture of the electrical activity of the heart that shows the heart
rate and the rhythm. This is recorded using surface electrodes.
Electrogram. A picture of the electrical activity of the heart as seen from within the heart chamber.
Electromagnetic Interference (EMI). Produced by invisible line of force called an electromagnetic
field. If the force is strong enough, it may interfere with the BIOTRONIK ICD system. This happens on
rare occasions.
Electrophysiology Test or Study (EPS). An electrical recording and stimulation test used to evaluate
the heart’s electrical system.
Endocardial. The inside surface of the heart. Endocardial leads are inserted through veins into
the heart.
Epicardial. Refers to the outside surface of the heart. Epicardial lead is usually placed during open
chest surgery.
Heart Rhythm. Another term for heart beat. Refers to the rate and regularity of the heart beat.
Implantable Cardiac Defibrillator (ICD). A device used to treat arrhythmias that is implanted in the
body. The BIOTRONIK ICD consists of a battery and electronic circuitry.
Implanted. To be placed inside the body. The BIOTRONIK ICD is a system that is implanted.
Lead. An insulated wire that is used both to receive signals from the heart and to send electrical
impulses to the heart. The lead is connected to the BIOTRONIK ICD.
Myocardial Infarction. Occurs when an artery that supplies heart muscle with blood becomes
blocked. Blood does not get to the tissue and the tissue dies. Symptoms include nausea, shortness of
breath, and/or pain in the chest, jaw, or arms.
Myocardium. Refers to the muscle of the heart.
Noise. Current or voltage that can interfere with an electrical device or system.
Programmer. A computerized device that allows the physician to communicate with the BIOTRONIK
ICD. With the programmer, the doctor can reprogram the device to fit your needs and to help
determine when the device needs to be replaced.
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Chapter 12 Glossary
Kainox VCS Leads Systems Manual
Sinoatrial Node. A small area of tissue in the upper right atrium from where the normal heart beat
originates. This is referred to as the “natural pacemaker of the heart”.
Syncope. A loss of consciousness with recovery after a period of time. Syncope may occur suddenly
or over a period of time. It may or may not be cardiac in origin.
Tachycardia. An abnormal fast heart rate, inappropriate for the tissue involved. Tachycardia rates are
usually faster than 100 bpm.
Transvenous. Placed in the heart through a vein.
Ventricle. One of the two lower chambers of the heart. Blood from the right ventricle is pumped to the
lungs to receive oxygen. Blood from the left ventricle is pumped to the body.
Ventricular Fibrillation. Chaotic contraction of the ventricles that results in little or no blood being
pumped to the body. This is a life-threatening rhythm if left untreated.
Ventricular Pacing. Pacing in the ventricle to prevent the heart rate from becoming too slow.
Ventricular Standstill. Failure of the ventricles to contract due to a lack of a stimulus. Immediate
intervention is required.
Ventricular Tachycardia. A fast heart beat that originates in a single area in the ventricle. The rate is
usually faster than 120 bpm.
Wand. The portion of the programmer that facilitates commu­nication between the BIOTRONIK ICD
and computer of the programmer.
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Chapter 12 Glossary
Kainox VCS Leads Systems Manual
PAGE 33
Kainox VCS
Technical Manual
Manufactured by:
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin Germany
M4087-B 10/14
©2014 BIOTRONIK, Inc. All rights reserved.
MN036 10/10/14
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
(800) 547-0394 (24-hour)
(800) 291-0470 (fax)
www.biotronik.com