Bringing Hemofiltration Cartridges On Line - Delcath Systems CHEMOSTAT Mode D'emploi

Significant decreases in blood pressure will occur within two (2) to five (5) minutes.
Thus, the vasoactive agents must be continued to maintain mean blood pressures
above 65 mmHg. Vasopressor agents are typically not required after the conclusion of
the procedure.
(a) Perfusionist must carefully monitor the flow rate during the balloon inflation.
(b) Maximum balloon inflation volumes:
• C ephalad Balloon: 38 mL of dilute contrast medium
• C audal Balloon: 38 mL of dilute contrast medium
WARNING
Do NOT Overinflate The Balloons. Overinflation Of The Balloons Could
Cause The Balloons To Burst Which Could Result Serious Injury or Death.
(c) Under fluoroscopy, partially inflate the cephalad balloon with approximately 15-
25 mL of dilute contrast media (e.g., 35% dilution) within the right atrium (the
balloon will have a rounded appearance).
(d) With the caudal balloon still deflated, slowly retract the Isofuse catheter until
the cephalad balloon is at the junction of the right atrium and inferior vena
cava. If needed, further inflate the cephalad balloon until indentation of the
diaphragmatic hiatus is visible at the inferior margin (the balloon will acquire
an acorn shaped appearance). Do not inflate balloons beyond required volume
to achieve an adequate seal. Never advance or retract the Isofuse catheter when
both balloons are inflated. If resistance is met during manipulation, determine the
cause of the resistance before proceeding.
(e) Under fluoroscopy, inflate the caudal balloon with dilute contrast medium until
the lateral edges of the inflated balloon start to become effaced by the inferior
vena cava wall.
(f) With balloons inflated, perform a limited (retro-hepatic) inferior vena cavagram
(using digital subtraction angiography technique) through the fenestrations. Prior
to injection of contrast medium, reduce the pump speed to 1000 RPM and clamp
off the circuit. Inject iodinated contrast medium through the fenestration port
to confirm that the catheter properly isolates hepatic venous flow between the
balloons. The cephalad balloon must occlude the inferior vena cava just above the
highest (closest to right atrium) hepatic vein, and the caudal balloon must occlude
the inferior vena cava just below the lowest hepatic vein (above the renal veins) as
shown in the radiographic image below.
WARNING
Blood Flow Through the Hemofilltration Circuit Should Never Be
Stopped For More than 30 Seconds.
R e-establish flow through the hemofiltration circuit by unclamping the circuit and
returning pump RPM to deliver previous flow rate.
(g) If the Isofuse catheter is not in the proper position, deflate both balloons (caudal
balloon first) and then reposition the catheter, while maintaining flow in the
hemofiltration circuit.
WARNING
Never Adjust the Position of the Double Balloon Catheter
Unless Both Balloons are Fully Deflated.
(h) Once satisfactory position is attained (i.e., the isolated segment is well sealed),
gently hold the proximal end of the Isofuse catheter to prevent upward migration
of the catheter into the right atrium. The catheter must be held and its position
checked for the duration of the procedure (approximately 60 minutes).
CAUTION: Check Isofuse catheter balloon positions fluoroscopically every
four (4) to five (5) minutes during drug administration and
filtration to ensure continued hepatic venous isolation.

18. Bringing Hemofiltration Cartridges on Line

(a) Continuously monitor and check the patient's blood pressure as required (see
"Blood Pressure Control").
(b) Leaving the bypass line open, open clamps on the left cartridge (5 and 7), and
allow blood to displace the saline into the patient.
(c) After the saline in the left cartridge and its lines are is fully replaced with blood,
wait approximately 30 seconds and open clamps on the right cartridge (clamps
6 and 8), while keeping the bypass line open, and once the saline in the right
cartridge and its lines are fully replaced with blood, wait approximately 30
seconds and then close the bypass line by securely closing clamp 4. Add a
reusable tube clamp as a redundant bypass closure mechanism high on the bypass
line in clear view of the team.
WARNING
Bypass Line Must Be Closed
Prior To Infusion of Drug.
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