Introduce guiding catheter up to the atrium
1 Using X-ray monitoring, introduce the included guide wire through the cannula into
the vein and advance it up to the atrium.
2 Remove the cannula.
Note: You can also use a peel-away introducer sheath with a dilator. A lead introducer
with an inner diameter of at least 9 F is suitable for this purpose.
• With the dilator fully in place, push the introducer sheath over the guide wire into
the vessel.
• Then remove the dilator. The introducer sheath remains in the vessel.
3 Introduce the selected outer guiding catheter and dilator through the guide wire.
Advance the guiding catheter up to the atrium.
Caution! Carefully advance the guiding catheter to prevent damage to the vessel walls!
4 Remove the dilator and the guide wire. The guiding catheter resumes its preshaped
form (except for curve shapes Straight and Straight L), thus facilitating access to the
coronary sinus.
Probing of the coronary sinus, introduce catheter into coronary sinus
The decisive step during the implantation of a lead into the coronary venous system is
the introduction of the catheter into the coronary sinus. Different approaches to do this
are provided by using the Selectra CS lead introducer system and possibly further
accessories.
Connecting syringe with side port (introduction of contrast media)
The side ports of the inner and outer guiding catheters are identical, as is the process
of introducing contrast media for each type.
The syringe includes a Luer lock thread, which can be screwed into the Luer lock
thread of the bidrectional valve or one-way stopcock.
If a sealing cap has been covering the catheter's side port, this must be replaced by a
bidirectional valve or one-way stopcock.
The one-way stopcock can be opened or closed manually at any given time.
The bidirectional valve can be opened by screwing the Luer lock thread of the syringe.
It closes automatically when the syringe is removed.
Probing of the coronary sinus directly with the outer guiding catheter
1 Push the guiding catheter into the coronary sinus through the ostium (except curve
shapes Straight and Straight L).
A one-way stopcock or check valve can be connected to the side port of the guiding
catheter and used to funnel in contrast media.
Probing of the coronary sinus with a straight outer catheter and steerable
EP catheter
A straight guiding catheter (Straight or Straight L) can only be formed or guided in
the coronary sinus using a steerable EP guiding catheter (e.g., ViaCath NG 4/S/5 mm
(not available in the U.S)).
1 Introduce the steerable EP catheter into the straight guiding catheter.
2 Probe the coronary sinus with the steerable EP catheter and push the EP catheter
into the coronary sinus.
3 Push the straight guiding catheter into the coronary sinus using the steerable
EP catheter. A one-way stopcock or check valve can be connected to the side port of
the guiding catheter and used to funnel in contrast media.
Probing the coronary sinus with inner guiding catheters or diagnostic catheters
Probing of the coronary sinus can be facilitated using the Selectra inner guiding
catheter or a suitable diagnostic catheter (e.g., HyperFlow MPA2 or AL1).
Selectra inner and outer catheters make up a telescopic system.
Observe the respective manuals for use of a diagnostic catheter.
A one-way stopcock or check valve can be connected to the side port of the inner and
outer Selectra guiding catheter and used to funnel in contrast media if necessary.
Note: The main port of the inner Selectra guiding catheter also has a Luer lock,
so the syringe with a Luer lock thread can be fixed directly to the main port. Therefore,
the inner catheter can be steered single-handedly and a contrast medium can be
injected at the same time.
1 Advance the probing catheter (diagnostic catheter or Selectra inner catheter) to
the atrium through the implanted (outer) guiding catheter.
2 Probe the coronary sinus with the probing catheter and introduce the probing
catheter into the coronary sinus.
3 Advance the guiding catheter over the probing catheter into the coronary sinus or
further advance both catheters together.
Probing of a lateral target vein for the lead using the inner catheter
Carefully insert the tip of the inner catheter into the target vein and then advance it.
Insert a suitable guide wire for the designated OTW lead (max. diameter 0.36 mm or
0.014 inch) through the inner guiding catheter into the target vein and, if needed,
advance it further.
The outer Selectra catheter can now be advanced further via the inner catheter.
Angiography
To obtain a better overview of the coronary venous system, a coronary angiography may
be carried out.
en • English
A contrast medium can be injected directly through a lateral inner catheter. However,
the contrast medium spreads out better when the venous blood flow is temporarily
interrupted using a balloon catheter.
• Remove inner catheter or EP diagnostic catheter.
• Insert a suitable venogram balloon catheter (e.g., Corodyn P1 (not available in the
U.S) into the coronary sinus using the guiding catheter.
Please consult the user manual provided with the venogram balloon catheter.
Keep the interruption of the blood flow as short as possible.
Transvalvular insertion tool (TVI)
The transvalvular insertion tool (TVI) is guided into the integrated hemostatic valve to
allow or facilitate the process of steering 0.36 mm guide wires for OTW leads through
the valve.
Use the transvalvular insertion tool for optimal valve effectiveness. Prior to moving the
lead forward, remove the transvalvular insertion tool using the peel-away technique.
Inserting the lead
Positioning of an OTW lead with a diameter less than 5 F
• An OTW lead with an outer diameter less than 5 F can be steered directly through
the inner guiding catheter.
The rest of this process is described in the manual of the respective CS OTW lead.
In order to then remove the inner and outer guiding catheter, the procedure with the
slitter tool described below needs to be carried out twice in a row (first for the inner,
and then for the outer catheter).
Positioning of an OTW lead with a diameter greater than 5 F
• Remove the inner guiding catheter, at the same time hold the guide wire in its
position.
• Position OTW lead over the guide wire through the outer catheter into the target
vein.
The rest of this process is described in the manual of the respective CS OTW lead.
Note: The implantation accessories for the Selectra CS lead introducer system can
only be used in combination with suitable leads with polyurethane coating or a coating
with comparable gliding properties and a diameter of 4.6 to 5.8 F.
Remove guiding catheter using slitter tool
Note: The guiding catheters for BIOTRONIK's Selectra CS lead introducer system
must be slit open and removed with a slitter tool.
1 Take the slitter tool in one hand, and the lead with the catheter that is to be removed
in the other - see Figure 2.
Note: The slitter tool is suitable for both left-handed and right-handed use.
Fig. 2: Holding the slitter tool, clamp not open
Legend:
1
Grip plate of the slitter tool
2
Blade
3
Clamp for the lead
2 To open the clamp, press and hold the release button.
3 With the other hand, insert the lead into the clamp.
3
Fig. 3: Insert the lead into the open clamp
4 Disengage the release button - the lead is held in the clamp.
5 Position the handle of the guiding catheter on the blade of the slitter tool.
6 Support the hand that is holding the slitter tool - if possible -, holding the catheter
handle level with the slitter tool. Pull the guiding catheter against the slitter tool slitting
it open.
Fig. 4: Hold the slitter tool level with the catheter handle.
Pull the catheter parallel to the edge of the slitter tool against the blade.
If the lead is part of a telescope system consisting of an inner and an outer catheter,
first the inner and then the outer catheter is removed using the slitter tool.
The slitter tool is suitable for slitting up to three catheters.
Note: When using the slitter tool, make sure that the guiding catheter moves straight
along the slitter tool (Fig. 4). If the slitting procedure requires an unusual amount of
effort or other signs of problems occur while slitting the catheters, resume slitting or
reclamp the lead or replace the slitter tool with a new one and then continue slitting.
7 If present, remove the introducer sheath appropriately.