Anticoagulation; Connection Of Catheter To Hemofiltration (Chemofiltration) Circuit; Establishing Hemofiltration Circulation; Inflation Of Balloons - Delcath Systems CHEMOSTAT Mode D'emploi

13. Anticoagulation

(a) Obtain the baseline activated clotting time value.
(b) H eparin must be administered AFTER percutaneous placement of all introduction
sheaths is completed, BUT PRIOR to the insertion of the double balloon catheter
into the inferior vena cava.
(c) An initial intravenous bolus of 300 units/kg of heparin must be administered.
Heparin dose should be adjusted to achieve a minimum activated clotting time of
400 seconds prior to initiation of veno-venous bypass and balloon inflation.
(d) Initially activated clotting time should be determined as frequently as necessary
(approximately every 5 minutes) until adequate anti-coagulation is established
(activated clotting time > 400 seconds). Activated clotting time should then be
maintained at > 400 seconds throughout the procedure, by checking it every 15-
30 minutes depending on the patient's response, and administering intravenous
heparin as needed.
NOTE: TIMING OF CHEMOTHERAPEUTIC AGENT DELIVERY TO IR SUITE
The Request For Delivery Of The Chemotherapeutic Agent (Melphalan
Hydrochloride) To The IR Suite Should Be Timed So That The Start Of The IA Infusion
Of The Drug Solution Is Within Thirty Minutes Of Its Preparation. Since Preparation
And Delivery Times Vary, Depending Upon Local Practices, The Timing Of The
Request Is Critical And Should Be Pre-Arranged With The Pharmacist. Typically, The
Time To Request Chemotherapeutic Agent From The Pharmacy Would Be When The
Isofuse Isolation Catheter Is Being Positioned In The Inferior Vena Cava. .
14. Insertion of the Isofuse Isolation Aspiration Catheter
(a) Flush catheter with heparinized saline.
(b) I ntroduce the Isofuse catheter through the 18F sheath. Under fluoroscopic
guidance advance it over a guidewire into the inferior vena cava and position the
catheter tip at the level of diaphragmatic hiatus. Do NOT inflate balloons.
(c) Upon successful placement, remove guidewire and create a heparin lock within
the " OTW" lumen to maintain patency.

15. Connection of Catheter to Hemofiltration (Chemofiltration) Circuit

(a) R emove sterile wrap from Isofuse catheter line while maintaining sterility, and
transfer sterile end to interventional radiologist.
(b) Open saline line clamp to allow for a " wet connection" of the hemofiltration
(chemofiltration) circuit to the Isofuse catheter. After connection is made, close
saline line clamp. Ensure that all air is removed from the Isofuse catheter.
(c) R emove the venous return line from the pouch while maintaining sterility, and
transfer sterile end to the interventional radiologist and flush saline to fill the line.
(d) Connect the venous return line to the sheath stopcock, flush saline through the
line. When all air is removed and line is completely filled with saline turn stopcock
to close the side port. Ensure the stopcock handle (at the venous return line to
sheath connection) is centered over the side port female luer to minimize back
pressure and maximize flow through the stopcock.
9
Double Balloon
Catheter

16. Establishing Hemofiltration Circulation

(a) S tart pump and slowly increase RPM control to achieve a maximum allowable
flow rate which does not cause flow induce vibration or exceed the 0.80 L/min
flow rate or −250 mmHg pre-pump pressure.
• F low rates of approximately 0.40 to 0.75 liters/minute are typical; however,
0.80 L/min is the maximum allowable flow rate for this system.
• I n-line pressure transducers should be used to monitor pressures:
o Pre pump pressure (suction side) should not be more negative than −250
mmHg, as lower pressures indicate possible catheter collapse or kink.
o Pre-cartridge pressures (pre-filter) should not exceed 200 mmHg, as
higher pressures indicate increasing filter resistance potentially due to
thrombus or a kinked return line. Check filters to assure free flow and
return line for kinks.
(b) T he hemofiltration circuit is now established. Venous blood is aspirated from the
central lumen through the fenestrations in the Isofuse catheter. This blood flows
through the Isofuse catheter to the pump, through the bypass line, and returns to the
patient through the venous return sheath.
CAUTION: Continously monitor any perfusion related events including:
• Blood flow-rate as displayed by the Medtronic Bio-Console.
• Systolic, diastolic and mean arterial blood pressure.
• Heart rate and vital signs.
• Activated clotting times.
• Bubble-trap for entrapped air.
• Leaks from any part of the circuit.

17. Inflation of Balloons

Vasopressor Agents Response Testing: Prior to inflation of either balloon (occlusion
of inferior vena cava), phenylephrine is to be administered to assess patient
responsiveness to this agent. After inflation of the balloons, patients must be assessed
for two (2) to five (5) minutes for changes in blood pressure before proceeding.
14
Systemic Venous
Return Sheath
Introducer
Sheaths
5F Infusion
Catheter