Hepatic Vascular Mapping; Procedure; Preparation: Prior To Treatment - Delcath Systems CHEMOSTAT Mode D'emploi

System risks and coordinating with other oncologists and key health care
professionals responsible for patient follow-up care and monitoring for post-
procedure toxicities.
• A qualified interventional radiologist with the knowledge, skills, experience,
and hospital privileges required to perform advanced vascular interventional
procedures.
• A qualified perfusionist to establish, monitor, and control the extracorporeal pump
and veno-venous bypass circuit.
• A qualified anesthetist (anesthesiologist) and/or nurse anesthetist responsible for
the management of sedation, analgesia, respiratory and cardiovascular support.
• A qualified pharmacist, on call during the procedure, to reconstitute the
chemotherapeutic agent (melphalan hydrochloride), using national and local safety
guidelines. The pharmacist should be aware of the rapid preparation time required
for the preparation and administration of melphalan for use with the CHEMOSAT
System.
• A qualified chemotherapy healthcare professional certified by the site to deliver
chemotherapy.
• A qualified intensivist, or appropriately qualified critical care specialist, responsible
for providing medical management of the patient in the immediate post-procedure
period during which the patient is in the intensive care unit or step down unit.
The procedure team is required to complete the Delcath training program.

HEPATIC VASCULAR MAPPING

Angiography and Embolization
A thorough search for any variant anatomy must be conducted in order to avoid
inadvertent infusion of the gastrointestinal or visceral branches. In addition,
embolization of certain branches supplying the gastro-intestinal tract may be
necessary.
• P rior to performing the procedure using the CHEMOSAT System, a complete
visceral angiogram (celiac artery and superior mesenteric artery) must be
performed. The presence of a replaced or accessory hepatic artery should be
specifically addressed. The portal vein must be evaluated for patency with late
imaging during celiac and superior mesenteric arteriography. The arterial supply
to the liver must be completely examined, and its impact on chemotherapy
infusion assessed and understood. A thorough search for any variant anatomy
must be conducted in order to avoid inadvertent infusion of gastrointestinal or
visceral branches. Embolization of critical branches supplying the gastrointestinal
tract may be required. Use of a selective micro-catheter may be beneficial for
both embolization and subsequent drug infusion.
• A ngiographic mapping of the hepatic arterial circulation with embolization
of gastrointestinal branches arising from hepatic arteries is required to avoid
inadvertent infusion of the chemotherapeutic agent into gastrointestinal arterial
branches. Completion of embolization is recommended at least one week prior
to treatment for eligible patients to allow the arterial puncture site to heal.
Embolization on the same day as procedure is discouraged since the intense anti-
coagulation required for percutaneous hepatic perfusion may not allow stable
thrombotic occlusion of the coil-embolized vessels.
• A ssess tumor blood supply and formulate a strategy for catheter placement to
ensure adequate drug infusion to the tumor.
• E mbolization of the gastroduodenal artery is frequently necessary, but depends
on its origin relative to the branches of the distal proper hepatic artery. If the
infusion catheter tip can be placed sufficiently distally to avoid retrograde reflux
into the gastroduodenal artery, then the latter may not need to be embolized.
• F or patients with supply of the left lobe of the liver from the left gastric artery,
selective embolization of left gastric artery branches will be necessary.
• T he origin of the right gastric artery and/or supra-duodenal branches, and need
for their embolization, must be assessed individually.
• I n some patients (~15%), the liver receives arterial blood supply from two (2)
different arteries: the right lobe from the superior mesenteric artery (replaced
right hepatic artery) and the left lobe of the liver from the celiac artery.
For such patients, the delivery of chemotherapeutic agent to the entire liver may
be accomplished by either:
o Temporary balloon occlusion (or permanent coil embolization) of one artery
while infusing the remaining patent hepatic artery. Potential risks of this
method are ischemia and/or delayed re-perfusion of the occluded lobe.
Infusion and filtration periods remain unchanged.
o Simultaneous infusion of each hepatic artery through two separate catheters
introduced by bilateral femoral artery catheterizations. Using a 50/50
distribution, the infusion time will become 15 minutes, instead of the usual
30 minutes, but post-infusion washout filtration period of 30 minutes must
remain unchanged.
o S equential volume-adjusted infusion of each branch (60% to right; 40% to
left). Infusion times will be different for each lobe, but total infusion and
filtration times remain unchanged.
• I f the risk assessment is unfavorable or the anatomic variation is too complex to
allow selective catheterization for safe delivery of chemotherapy, the procedure
must not be performed.
• D uring the infusion procedure described below, a single optimal angiographic
projection of the hepatic artery should be used to periodically document hepatic
arterial patency and flow.
• R eview computed tomography or magnetic resonance imaging to assess venous
anatomy. Select kit (balloon spacing) based on patient anatomy.

PROCEDURE

PREPARATION: PRIOR TO TREATMENT

All medications and supportive measures must be determined and administered in
accordance with each institution's policies, guidelines, procedures, the CHEMOSAT
System Instructions for Use and chemotherapeutic agent (melphalan hydrochloride)
prescribing information.
Coagulation Studies
• C oagulation studies pre-, peri- and post-procedure are performed then repeated
daily until normalized. Parameters tested must include:
- Partial Thromboplastin Time
- Prothrombin Time / International Normalized Ratio
Blood Products
Type and cross-match for :
• 4 units packed red blood cells
8