Accessing The Vein And Inserting The Lead; Probing The Ostium Of The Coronary Sinus And Venogram; Positioning The Lead In The Coronary Venous System; Fixating The Lead In The Target Vein - BIOTRONIK Sentus ProMRI OTW BP L Manuel Technique

How to open the package
To open, proceed as follows:
Step Figure Action
1 In the non-sterile area:
open the outer blister by peeling
off the paper seal in the direction
of the arrow.
W CAUTION
Risk to sterility
The inner blister must not come into contact with non-sterile instruments or be
touched by persons who are not wearing sterile gloves.
Step Figure Action
2 In the sterile area:
• Remove the sterile inner
blister by using the gripping
tab.
• Open the inner blister by
peeling off the paper seal in
the direction of the arrow.

Accessing the Vein and Inserting the Lead

Two methods of accessing the vein
There are 2 options for inserting the lead into the vein:
Either Method A Incision of the cephalic vein
Or Method B Puncturing the subclavian vein
Method A
Through the cephalic vein:
Step Action
1 Prepare the cephalic vein.
2 Open the vein.
3 Carefully insert the tip of the vein lifter provided into the lumen of the
vein.
4 Raise the vein lifter carefully.
5 Guide the lead or the guiding catheter of the LV lead delivery system
through the opening into the vein.
Method B
Through the subclavian vein:
• Use a suitable lead introducer set.
Stop the procedure if the lead cannot be easily inserted into the introducer sheath
and check whether the lead introducer set is appropriate for the lead.
• Please consult the technical manual included with the lead introducer set.
After having established access to the vein using the lead introducer set, insert the lead
or the guiding catheter of the LV lead delivery system into the vein through the intro-
ducer sheath.
en • English

Probing the Ostium of the Coronary Sinus and Venogram

Probing with the CS guiding catheter
BIOTRONIK provides appropriate LV lead delivery systems for probing the ostium of the
coronary sinus and positioning an LV lead in the coronary venous system.
A CS guiding catheter of these LV lead delivery systems can be guided directly to the
coronary sinus via the vein opening (e.g. via the introducer sheath).
Handling of the CS guiding catheter and the other implant accessories of these LV lead
delivery systems is described in the accompanying technical manual.
Probing with an EP catheter
Probing can be simplified by the supplementary use of a suitable EP catheter.
For this purpose, a CS guiding catheter is pushed almost to the ostium of the coronary
sinus and a suitable EP catheter is pushed through the CS guiding catheter.
Once the entrance of the coronary sinus has been passed using the EP catheter, the CS
guiding catheter can be pushed into the coronary sinus via the EP catheter and then the
EP catheter can be removed.
Observe the technical manual accompanying the EP catheter.
Venogram
The preliminary creation of a venogram of the coronary vessels can facilitate the
selection of a suitable coronary target vein and make subsequent lead positioning
easier.
To do this, insert a suitable venogram balloon catheter through the CS guiding catheter
into the coronary sinus.
Once the blood flow in the coronary vein has been temporarily blocked using the
balloon catheter, a contrast medium can be introduced via the balloon catheter.
Observe the technical manuals for the balloon catheter and the LV lead delivery
system.

Positioning the Lead in the Coronary Venous System

Two possible approaches
The LV leads can be positioned in the target vein using either of the following methods:
• With a guide wire (over-the-wire)
• With a stylet
W CAUTION
Stylet or guide wire
Either a guide wire or a stylet, but not both, can be placed in the lead.
The chosen technique (over-the-wire or stylet) determines the tool.
W CAUTION
Stylet technique
The use of unsuitable stylets or improper handling of the stylet can result in damage
to the lead.
This would result in malfunction or failure of the lead.
Moreover, the stylet could protrude from the lead tip and injure the patient.
Over-the-wire technique
To position the lead tip with the aid of a guide wire in the target vein, proceed as
follows:
Step Action
1 Insert the TVI (transvalvular insertion tool) provided into the proximal
opening of the hemostatic valve of the CS guiding catheter.
The TVI makes it easier to introduce the guide wire through the valve
and into the CS guiding catheter.
2 Insert the guide wire through the TVI into the CS guiding catheter
Note: Use only guide wires with a diameter of max. 0.36 mm (0.014 inches).
BIOTRONIK offers suitable guide wires in the Streamer product family with various
levels of stiffness.
Step Action
3 Position the guide wire in the desired target vein.
4 Remove the TVI.
Note: The included torque tool can be mounted onto the guide wire to achieve optimal
maneuverability of the guide wire.
Guide the torque tool over the proximal end of the wire and tighten by turning it.
The torque tool must be removed before guiding the lead over the guide wire.
Step Action
5 Guide the distal end of the lead over the proximal end of the guide wire
and advance the lead to its target position.
3
Stylet technique
To position the lead tip with the aid of a stylet in the target vein, proceed as follows:
Step Action
1 Use the stylet to apply mechanical tension to the lead.
Note: To maintain the mechanical prestress, you can anchor the pre-formed part
near the handle of the stylet in the lead connector.
When the stylet has been anchored in the lead, rotations of the stylet handle are
directly transmitted to the lead tip.
Note: A defined pre-formed lead tip is sometimes desirable to facilitate maneuvering
of the lead in the coronary venous system.
To do this, shape the stylet appropriately prior to insertion, and then carefully insert
the stylet into the lead.
Step Action
2 Use X-ray monitoring to advance the lead through the CS guiding
catheter into a position suitable for fixation in the coronary venous
system.

Fixating the Lead in the Target Vein

Various procedures
The procedure for fixating the lead in the coronary vein differs depending on the type of
distal fixation.
Fixation with distal pre-shaped form
Proceed as follows to fixate an LV lead with distal preshaped helix or S-curve or 
J-curve in the target vein:
Step Action
1 Withdraw the guide wire or stylet.
After about 7 to 10 cm, the distal pre-shaped form unfolds two-dimen-
sionally or three-dimensionally in the vessel and fixates the distal lead
area.
Note: This procedure changes the position of the lead tip.
This means that the lead tip has reached its final position after fixation.
Step Action
2 Gently pull on the lead to check that the fixation is secure.
Fixation with silicone thread
Proceed as follows to fixate an LV lead with a silicone thread in the target vein:
Step Action
1 If there is a guide wire in the lead, it has to be replaced with a stylet.
2 The stylet must put the lead under mechanical prestress so that it can
be advanced in the coronary vessel by applying the force required for
this fixation method.
3 Advance the lead with the stylet until the threads of the lead lodge in
the coronary vessel.
Note: Despite the shape of the silicone thread, no rotation of the lead in the vessel is
required or intended.
Step Action
4 Withdraw the stylet a little.
5 Gently pull on the lead to check that the fixation is secure.

Intraoperative Measurements and Tests

Objective
For a qualitative evaluation of the lead position, it is necessary to measure pacing
thresholds and intracardiac potentials.
Note: Use suitable patient cables and adapters when temporarily connecting the lead
to an intraoperative test system. The stylet or guide wire must be removed prior to
measurement.
Temporary contact with the lead
To obtain short-term measurements of the pacing thresholds and the intracardiac
signal amplitudes, you can contact the connector pin and the contact ring with an
alligator clip.