ELC Lead
Epicardial Sutureless Lead
IS-1-UP Connector
Technical Manual
C AUTION
CAUTION: Federal (U.S.A.) law restricts this device to sale
by, or on the order of, a physician.
1997 BIOTRONIK, Inc., all rights reserved.
ELC Lead Technical Manual i
Contents
1. General Description ............................................................1
2. Contraindications................................................................3
3. Warnings ..............................................................................5
4. Precautions..........................................................................7
5. Potential Complications .....................................................9
6. Disclaimer ..........................................................................11
7. General Information on Product Handling .....................13
7.1 Sterilization and Storage ...................................................13
7.2 Opening the Sterile Container...........................................14
7.3 Package Content and Accessories ...................................15
8. Implantation .......................................................................17
8.1 Suggested Lead Placement Procedure ............................17
8.2 Lead Repositioning ...........................................................20
8.3 Measurement of the Stimulation Threshold and
Intracardiac Potential .........................................................21
8.4 Lead Connection to the Pacemaker .................................22
9. Technical Data ...................................................................23
ii ELC Lead Technical Manual
ELC Lead Technical Manual 1
1. General Description
The ELC xx-UP is a unipolar, active fixation sutureless epicardial
lead, available in either 35 or 54 cm lengths. It provides pacing and
sensing capabilities through a spiral screw tip composed of 70%
platinum and 30% iridium with an iridium fractal surface structure.
A disc of LARS mesh cardiovascular fabric is located at the base
of the screw, facilitating tissue ingrowth of the lead into the
epicardium. The body of the ELC is insulated with silicone; it is
connected to the device by means of an IS-1 (3.2 mm) unipolar
connector, of dimensions as specified in ISO 5841-3:1992.
The ELC lead is sterilized and shipped in a PETG blister
package contained within a Stericlin® bag, along with the
following accessories: a screw-in introducer tool (sometimes
referred to as an applicator tool), a tunneling tool, and a
connector pin cap. The lead is shown below as shipped, with the
flexible lead (bottom) attached to the introducer tool used for lead
placement.
The ELC lead (bottom) is packaged with a screw-in introducer
tool (top), a tunneling tool, and a pin connector cap.
2 ELC Lead Technical Manual
The ELC xx-UP epicardial sutureless screw-in lead is indicated
for pacing and sensing in the ventricle when an epicardial lead is
preferred, or when a transvenous lead cannot provide
satisfactory results or is contraindicated. Epicardial leads are
well suited for situations where heart stimulation is necessary,
for example, after open heart surgery, or based upon the
patient’s age or heart condition (e.g., in young patients who have
not reached full physical maturity and risk potential lead
dislodgement). Epicardial leads are also indicated in situations
where transvenous access is not available or contraindicated.
C AUTION
Because of the numerous available 3.2 mm configurations,
e.g., the IS-1 and VS-1 standards, lead/pulse generator
compatibility should be confirmed with the pulse generator
and/or lead manufacturer prior to the implantation of a pacing
system.
NOTE: IS-1 unipolar, wherever stated in this manual, refers to
the international standard, whereby leads and generators
from different manufacturers are assured a basic fit.
[Reference ISO 5841-3:1992(E)].
ELC Lead Technical Manual 3
2. Contraindications
Epicardial leads are contraindicated for use in patients who have
very complicated heart disease such as coronary heart disease
in advanced stages, for weak and elderly debilitated patients, as
well as patients with pulmonary disease and/or renal
dysfunction.
The application of epicardial leads is not
recommended if the myocardium is heavily infarcted, thin-walled,
or suffused with fatty or fibrotic tissue.
4 ELC Lead Technical Manual
ELC Lead Technical Manual 5
3. Warnings
Performance of a cardiac pacing system depends on proper
interaction of its three components – the pulse generator, the
lead(s), and the patient. Abnormalities or changes in the
electrical properties of any of the three components, or their
interfaces with each other, will directly affect system function.
Correct lead implantation is critical to safe and effective pacing
system performance. The pacing system may cease to function
at any time due to medical complications as well as lead-related
problems, including, but not limited to, displacement, wire
fracture, loss of insulation integrity, fibrotic tissue formation and
elevated thresholds.
Medical Complications
Medical complications of the pacemaker treatment may include,
but are not limited to: fibrotic tissue formation, thrombosis,
embolism, elevated thresholds, body rejection phenomena,
cardiac tamponade, muscle/nerve stimulation, myocardial
perforation, infection, erosion of pulse generator/lead through
skin, and pacemaker-induced dysrhythmia (some of which could
be life-threatening such as ventricular fibrillation).
Technical Complications
Incorrect operation of the pacing system may be caused by, but
is not limited to: improper lead placement, lead dislodgement,
wire fracture, loss of insulation integrity, battery depletion, or
electrical component failure.
Potentially Harmful Therapeutic and Diagnostic Procedures
An implanted pacing lead is a direct, low resistance path to the
myocardium for electrical current, which requires observance of
high electrical safety standards. Electrosurgical instruments, for
example, could generate voltages of such amplitude that a direct
coupling between the tip of the electrocautery and the implanted
lead may result, possibly inducing myocardial lesions or serious
cardiac arrhythmias (e.g., fibrillation).
6 ELC Lead Technical Manual
Some therapeutic and diagnostic procedures (e.g., diathermy,
MRI, electrocautery) may result in latent damage to the pacing
system. This damage may not be detected when testing the
pacemaker function after the procedure, but may become
evident at a later time, resulting in pacing system malfunction or
failure. For a detailed description of these procedures and the
appropriate precautions which must be taken, please consult the
appropriate section of this technical manual and the pacemaker
technical manual.
Prevention of Leakage Current Conduction
Pulse generators and testing equipment connected to the lead
must be battery-powered. Proper grounding of line-powered
devices in the vicinity of the patient is essential to prevent
leakage currents arising from such devices to be conducted via
the lead’s terminal or any other uninsulated part.
ELC Lead Technical Manual 7
4. Precautions
Ancillary Equipment Necessary for Implantation
During implantation the surface ECG should be monitored, and a
temporary pacemaker/analyzer and defibrillation equipment
should always be readily available. Accessories which are
provided with the lead are addressed in the section “Package
Content and Accessories”.
Handling the Lead
The lead should be handled very carefully at all times. Any
application of force (bending, stretching, crimping, etc.) may
permanently damage the lead.
8 ELC Lead Technical Manual
ELC Lead Technical Manual 9
5. Potential Complications
Potential complications resulting from the use of epicardial leads
include, but are not limited to: thrombosis, embolism, body
rejection phenomena, cardiac tamponade, muscle/nerve
stimulation, fibrillation, and infection. Lead perforation through
the myocardium has been rarely observed. The table below
summarizes some of the potential symptoms indicating a
complication and possible corrective actions:
Table 1.
Symptom
Loss of
pacing or
sensing
Increase/
decrease in
threshold
Potential Complication
Potential Corrective
Action
• Electrode dislodgement
• Lead fracture
• Setscrew penetration of
lead insulation
• Improper lead/pulse
generator connection
• Reposition lead
• Replace lead
• Replace lead
• Fibrotic tissue
formation
• Adjust pulse generator
output; Replace lead
• Reconnect lead to
pulse generator
10 ELC Lead Technical Manual
ELC Lead Technical Manual 11
6. 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. Regardless of cause of failure, there is no
warranty, express or implied, for leads or accessories.
Leads and accessories are sold in an “as is” condition. The
entire risk as to the quality and performance of leads and
accessories is with the buyer.
BIOTRONIK disclaims all
warranties, express or implied, with respect to leads and
accessories including but not limited to, any implied warranty of
merchantability or fitness for a particular purpose. BIOTRONIK
or its distributor shall not be liable for any loss, damage or injury
of any nature, whether direct, indirect or consequential in
connection with, or resulting from, the use of the leads and
accessories. No person is authorized to bind BIOTRONIK or its
distributor to any representation or warranty with respect to its
leads or accessories.
12 ELC Lead Technical Manual
ELC Lead Technical Manual 13
7. General Information on
Product Handling
The following remarks apply in principle to all epicardial implantable leads and do not attempt to describe all procedures to be
followed, precautions to be taken or contraindications to be
considered.
7.1 Sterilization and Storage
The lead is shipped in an outer box, equipped with a quality
control seal and product information label. The label contains
the model specifications, technical data, serial number,
expiration date, and sterilization and storage information of the
lead.
The lead and its accessories have been sealed in a plastic
container contained in a sealed bag and gas sterilized with
ethylene oxide. To assure sterility, the package should be
checked for integrity prior to opening
C AUTION
Recommended storage temperature range is 5°− 55° C
(41°−131° F). Exposure to temperatures outside this range
may result in lead malfunction.
If a replacement lead is needed, contact your local BIOTRONIK
representative.
14 ELC Lead Technical Manual
7.2 Opening the Sterile Container
The lead is packaged in a plastic container that is sealed within a
Stericlin® bag. Each is individually sealed and then sterilized
with ethylene oxide. Due to the double packaging, the outside of
the inner container is sterile and can be removed using standard
aseptic technique and placed on the sterile field.
1. Open the outer unsterile bag by peeling the ends of the bag
apart at the arrow on the package.
2. Remove the inner sterile container.
3. Open the container by peeling the
sealing paper as indicated by the
arrow.
ELC Lead Technical Manual 15
7.3 Package Content and Accessories
The ELC lead is delivered sterile and is contained by the screwin introducer tool (ELT). The introducer is used to easily and
securely screw the ELC lead into the myocardium. The
introducer is cylindrical and is exposed at the distal end. On this
end it contains a split, tapered cavity with a locking mechanism
for holding and placing the screw tip of the ELC lead. The
locking mechanism can be locked or opened by rotating the
handle of the introducer from the RELEASE to LOCK position.
Introducer/Screw-in Lead
Tunneling Tool
Additional accessories which are included with the ELC lead are
a tunneling tool and a pin connector cap (BK-IS). The tunneling
tool is intended for creating a subcutaneous pathway for the lead
to the pacemaker pocket. The proximal end of the tunneling tool
has a unipolar socket which holds the lead pin connector. The
distal end of the tool is tapered to facilitate tunneling.
16 ELC Lead Technical Manual
ELC Lead Technical Manual 17
8. Implantation
8.1 Suggested Lead Placement Procedure
Selection of a preferred surgical procedure is left to the
implanting physician.
•
A subxiphoid, median sternotomy or limited thoracotomy
approach may be used for access to the epicardial surface
for application of one or more electrodes.
•
After opening the pericardial sac, an avascular site of the
heart having suitable thickness which is free of infarcts,
fibrosis or fatty tissue should be chosen for attachment of
the electrode(s). If more than one electrode is implanted,
they should be placed no closer than 2.5 cm apart.
•
Position the electrode tip over the selected site. To attach
the electrode, hold the introducer perpendicular to the
surface of the epicardium and rotate, making only 2
clockwise turns.
LOCK
NOTE:
Only light pressure is required on the introducer. Two
clockwise turns of the introducer will attach the electrode
properly. Do not exceed this maximum number of turns.
18 ELC Lead Technical Manual
•
To release the lead from the introducer, hold the introducer
with one hand. With the other hand, rotate the grip of the
introducer to the “RELEASE” position. The entire lead can
now be completely released from the introducer.
RELEASE
•
Adequate and stable values for ventricular capture
threshold, R-wave amplitude, and lead impedance should be
obtained using a pacing system analyzer as described in
section “Measurement of the Stimulation Threshold and
Intracardiac Potential.”
•
If those values are not satisfactory, refer to the “Electrode
Repositioning” section.
•
When the electrode is in the final position, a partial loop of
the lead within the pericardial sac is suggested, to eliminate
tension on the electrode lead.
•
The lead may be passed subcutaneously to the pacemaker
pocket after firmly inserting the lead connector pin into the
proximal end of the tunneling tool.
ELC Lead Technical Manual 19
•
Follow the directions with the pulse generator for completion
of the procedure, as noted in the corresponding technical
manual and in the “Lead Connection to the Pacemaker”
section within this manual.
NOTE:
Immediately after fixation, threshold values may be high.
This condition may be caused by transient irritation in and
around the area of fixation, and under normal circumstances
will improve with time. Within approximately fifteen minutes,
threshold values will normally decrease.
•
Additional information may be obtained through the use of
an external ECG recorder or the PMS 1000 programming
system as diagnostic tools. These tools may be used to
record intracardiac electrograms in order to verify
appropriate signal detection.
Care should be taken to avoid surface contact which could
perforate lead insulation or cause other damage (e.g., via
clamping or use of surgical instruments).
NOTE:
Special care should be taken not to damage the sealing
rings of the lead connector, particularly when making contact
with the connector pin of a unipolar lead by means of an
alligator clip.
20 ELC Lead Technical Manual
8.2 Lead Repositioning
If acute repositioning is necessary, the electrode may be
removed from the epimyocardium in the following manner.
•
Rotate the introducer’s handle to the ‘RELEASE” position.
•
Then carefully place the distal end of the introducer onto the
silicone base at the tip of the lead, making certain that the
large notch in the tubular portion of the introducer is aligned
with the lead body.
RELEASE
•
Rotate the introducer’s handle to the “LOCK” position and
turn the entire assembly counter clockwise until the lead is
unscrewed from the epimyocardium.
LOCK
Prior to reinsertion into the epimyocardium (refer to section
“Suggested Lead Placement Procedure”), the lead may be
reloaded into the introducer to provide a convenient means of
controlling the lead body.
ELC Lead Technical Manual 21
8.3 Measurement of the Stimulation
Threshold and Intracardiac Potential
The BIOTRONIK ERA 20 or ERA 300 Analyzer should be used
to accurately determine current and voltage stimulation
thresholds, as well as intracardiac potentials, in accordance with
the characteristics of implantable pacemakers.
The filter
characteristics of the input circuits of the pacemaker and the
measurement device should be the same when the measured
intracardiac potential is correlated with the sensitivity of the
pacemaker to be implanted.
When measuring the stimulation threshold, the pacing rate
should be higher than the patient’s intrinsic rate. The lowest
voltage or current required to consistently stimulate the heart
represents the stimulation threshold with respect to the set pulse
width.
C AUTION
Pacing is interrupted during the measurement of the
intracardiac potentials.
The measured value (P-wave or R-wave) will be digitally
displayed on the BIOTRONIK Analyzer. Generally, the electrode
position is regarded acceptable if the values for stimulation and
sensing threshold meet the following limits:
Ventricular
Maximum acute stimulation threshold at pulse
duration setting 0.5 ms
Minimum acute sensing amplitudes
Pacing Impedance
1.0 V
5 mV
300-1200 Ω
22 ELC Lead Technical Manual
8.4 Lead Connection to the Pacemaker
C AUTION
Failure to back out the setscrew(s) may result in damage to
the lead(s), and/or difficulty connecting the lead(s).
1. Lubricate the sealing rings of the lead with silicone oil to
facilitate insertion of the lead’s connector into the receptacle
of the pacemaker without bending the lead.
2. Retract the setscrew(s) slightly to ensure unimpeded
insertion of the lead connector(s) into the port(s).
3. Insert the lead connector into the header receptacle
following the pacemaker manufacturer’s directions for lead
insertion. The method of insertion depends upon the header
configuration of the pacemaker (self-sealing or with sealing
caps).
4. Securely tighten the setscrew(s) of the pacemaker
connector. Sterile lubricant and a hex wrench are contained
within the BIOTRONIK pacemaker package.
5. Assure correct insertion of the
connector pin by verifying that
the tip of the pin is visible as
illustrated.
6. Visually and mechanically
check the safety of the
connection after tightening the
setscrew.
ELC Lead Technical Manual 23
9. Technical Data
ELC xx-UP Implantable Epicardial Sutureless
Lead
Models:
ELC 54-UP
115 606
ELC 35-UP
116 015
Connection System:
IS-1
Polarity:
unipolar
Tip Electrode
Surface Area
Material
Surface structure
Shape
Diameter of screw
Penetration depth
10 mm2
70% Platinum, 30% Iridium
Iridium, fractal
spiral screw
4.3 mm
3.5 mm
Lead Body
Insulation
Diameter
Coil material1)
No. of filaments
Length
Resistance
1
Silicone
1.7 mm or 5 F
MP 35 N
4
35/54 cm
1.0 Ω/ cm
MP 35 N is the trademark for a special cobalt-chromium-nickel alloy.
Inside back cover
Distributed by:
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
(800) 547-0394 (24-hour)
(503) 635-9936 (FAX)
Manufactured by:
M3075-A 8/97
BIOTRONIK GmbH & Co.
Woermannkehre 1
D-12359 Berlin
Germany