Johnson & Johnson Biosense Webster THERMOCOOL SMARTTOUCH SF Mode D'emploi page 10

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15. For RF application and flow settings refer to Table 1.
Table 1: RF and Flow Settings when using Stockert's RF generators
RECOMMENDED RF APPLICATION PARAMETERS
Power Range
Temperature Monitoring
Irrigation Flow Rate During
RF Application
Application Time
* Power levels exceeding 30 Watts may be used when transmural lesions
cannot be achieved at lower energy levels. For power settings > 30 Watts,
the recommended irrigation flow rate is 15 ml/min.
** The temperature displayed on the RF generator does not represent tissue
temperature or electrode tissue interface temperature.
Additional recommendation:
For isthmus dependent flutter ablation, power applications exceeding 30
watts and up to 50 watts should only be used if conduction block cannot be
achieved at lower power levels.
16. Recommendation for irrigation when using Stockert's RF generators:
Increase the irrigation to high flow rate starting up to 5 seconds before the
onset of RF energy delivery and maintaining this higher flow rate until 5
seconds after termination of the energy application. For power levels up to
30 watts, a high flow rate of 8 ml/min should be used. For power levels
between 31-50 watts, a high flow rate of 15 ml/min should be used. Do not
use catheter without irrigation flow.
17. The application of RF energy must not be initiated until the increase in
irrigation flow rate is confirmed by a minimum of 2°C decrease in tip
electrode temperature.
18. Monitor the catheter tip temperature throughout the procedure to ensure
adequate irrigation. If temperature increases to 40°C during RF energy
delivery, power delivery should be interrupted. The irrigation system must be
rechecked prior to restarting RF delivery. Note: the displayed temperature
represents the temperature of the electrode only, not the temperature of the
tissue.
19. Start a procedure at 15-20 Watts. After 15 seconds, power may be
increased by 5-10 W increments as needed, until a transmural lesion is
achieved, defined by > 80% reduction in unipolar atrial electrogram
amplitude, or emergence of double potentials of equal and low amplitude. It
is recommended that power not exceed 50 W when the catheter is parallel
to the tissue and 35 W if the catheter is perpendicular to the tissue. The
duration of each RF ablation should not exceed 120 seconds. Dragging the
catheter to the next location is permissible during the 120-second energy
application. RF current may be reapplied to the same or alternate sites
using the same catheter.
20. RF current may be reapplied to the same or alternate sites using the same
catheter. However, in the event of a generator cutoff (impedance or
temperature), the catheter must be withdrawn and the tip electrode
inspected for coagulum before RF current is reapplied. To remove any
coagulum, if present, a sterile gauze pad dampened with sterile saline may
be used to gently wipe the tip section clean; do not scrub or twist the tip
electrode as damage to the tip electrode bond may occur and loosen the tip
electrode or damage may also occur to the contact force sensor and affect
measurement accuracy. Prior to reinsertion, ensure that the irrigation holes
are not plugged as follows:
If irrigation hole occlusion occurs:
a) Fill a 1 or 2 ml syringe* with sterile saline and attach to the stopcock
or sidearm.
b) Carefully inject the saline from the syringe into the catheter. A stream
of fluid should be visible from the tip of the catheter.
c) Repeat steps a and b, if necessary until the holes are cleared.
d) Flush catheter and tubing per standard technique to ensure purging
of trapped air bubbles and to verify that the irrigation holes are patent.
e) The catheter can now be introduced into the patient.
f) Zero catheter following re-insertion into patient.
WARNING: Do not continue use of the catheter if still occluded or if
it is not functioning properly.
*NOTE: A small syringe provides sufficient pressure to produce a visible
stream of fluid.
Adverse Reactions
A number of serious adverse reactions have been documented for catheter
ablation procedures including pulmonary embolism, myocardial infarction, stroke,
cardiac tamponade, and death.
The following complications were also noted to have occurred during prior
studies or have been reported in the literature:
Catheterization/catheter procedure related: vascular bleeding/local
•
hematomas, thrombosis, arteriovenous (AV) fistula, pseudoaneurysm,
thromboembolism and vasovagal reactions, cardiac perforation, pericardial
effusion/tamponade, thrombi, air embolism, arrhythmias and valvular
damage, pneumothorax and hemothorax, pulmonary edema, hypoxia,
pleural effusion, acute respiratory distress syndrome (ARDS), congestive
heart failure, aspiration pneumonia, pneumonia, asthmatic attack,
hypotension, implantable cardioverter-defibrillator (ICD) lead malfunction,
anemia, thrombocytopenia, disseminated intravascular coagulation,
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Figure 3
ATRIAL
ABLATION
15 W to 30 W*
< 40°C**
8 ml/min
30 to 120 seconds
VENTRICULAR
ABLATION
31 W to 50 W
< 40°C**
15 ml/min
60 to 120 seconds
M-5276-785B