INDICATIONS
The TITAN-PORT LARGE Systems ensure repeated access to the vascular system for example for the following indications:
- Llong-term treatment with cytostatic agents and other “aggressive” medications
- regional chemotherapeutic treatment of liver tumors, metastases, tumors of the head and extremities. And; tumors of other organs
- patients with poor peripheral veins
- infusion therapy
- parenteral nutrition
- HIV patients
- venous blood sampling
- blood transfusions *see note
- special labeled systems are appropriate to high-pressure injection
Besides, some systems may be used for the following indications:
- TITAN-PORT LARGE A (arterial): for direct perfusion of organs, and; for inoperable hepatic metastases via the gastroduodenal artery, also; via the coeliac trunk for pancreatic and the aorta and internal iliac arteries for pelvic neoplasms
- D: for dialysis venous <-> venous
- P: for pediatrics
- F: fetal
- S: for peridural pain therapy or anesthesia
- PD: for peritoneal dialysis
- PC: for peritoneal chemotherapy
- APH: for apheresis
- AS/PT: for ascites- and peritoneal therapy
- UA: side port
CONTRAINDICATIONS
The TITAN-PORT LARGE systems should not be used in:
- extremely rare cases of hypersensitivity to silicone, polyurethane or titanium
- suspected bacteremia or sepsis
- disseminated intravascular coagulation (DIC)
COMPLICATIONS and potential ADVERSE REACTIONS
The following complications or adverse reactions can occur:
- technical intraoperative complications
- tissue incompatibility
- local reactions (inflammation, edema, hematoma)
- infection
- disconnection or dislocation
- thrombosis/thromboembolism
- breakage of the catheter between the clavicle and first rib
- breakage of catheter or damage to catheter
- perforation of catheter
- drug extravasation due to improper handling of the system
- damage to neighboring tissues by the pharmaceutical agents (In the event of leakage of portal components)
INSTRUCTIONS FOR USE / PORT IMPLANTATION
Caution: During implantation, sterile handling is mandatory!
- various techniques are available for implantation of port and catheter, including the Seldinger technique
- the choice depends on the surgeon’s preference
- the implantation of TITAN-PORT LARGE A/V, P and S is usually possible under local anesthesia, TITAN-PORT LARGE D, PD, PC under general anesthesia (see special instructions for use)
- recommended sites for venous catheter placement include the cephalic vein, subclavian vein, or internal and external jugular veins.
- use a 10 ml syringe and only special non-coring needles for puncturing the septum. The intention of needles are only for single use.
- should insert the needle into the silicon membrane carefully and always vertically to avoid bending the tip.
- if the situation is unclear or thrombotic obstruction is suspected a radiographic or Doppler sonographic control is necessary.
To achieve greater flow rates the port membrane may be accessed simultaneously with up to three needles.
- a venous implantation should be flushed with 20 ml 0,9% saline solution once every 3 months if the system is not used
- an arterial implantation requires flushing once every 2 weeks.
- for sampling venous blood 3 ml of blood, you should initially aspirate and discard. A minimum of 20 G needle should be used and the required amount of blood aspirated slowly (to avoid falsification of the results) * note: 18 G or 19 G needle is recommended for blood transfusion! Afterward; the system must be flushed immediately with at least 20-50 ml 0,9% saline solution. During the flushing procedure; the needle may be rotated in different directions to ensure uniform rinsing of the chamber interior
- to avoid interactions between various drugs (cytostatic agents in particular) the system must be flushed with at least 10 ml 0,9% saline when repeated infusions are required
- you must flush the system must after each use. Most importantly, remove the needle with gentle force
- when using needles with tube activate the lock to avoid getting blood into the system
- catheter obstruction injecting Streptokinase/Urokinase can clear the thrombus formation (e.g. 5000 IE/ml physiologic saline with 10 ml syringe, small amounts should be injected at intervals, allowed time to take effect and the patency checked)
(The above-mentioned concentrations are recommendations and physicians must always adapt to the patient’s coagulation status as they monitored. The product description of all pharmaceuticals used should always be consulted.)
- reduce the complication rate of thrombus formation in the catheter in patients at risk by low-dose heparinization
- in arterial portal systems; by the administration of a platelet aggregation inhibitor (e.g. acetylsalicylic acid).
CAUTION: The physician confirmed the high-pressure injections, not unless patency of the system (aspiration, manual
injection). In case of any doubt, injection should be avoided!
Causes of abnormally high resistance to access needle may include
- Incorrect placement of the access needle in the portal chamber
- bending and kinking of the catheter
- fibrin deposition or thrombotic occlusion of catheter or port.
Blood deposits in the system generally indicate one of the following causes:
- leakage of the system
- defective septum
- faulty handling
INDICATIONS FOR EXPLANTATION
- remove the port under local anesthesia at the end of treatment (explantation is possible under local anesthesia)
- irreversible obstruction of the portal system
- breakage of catheter or damage to catheter
- membrane leakage
- poor patient compliance
- massive thrombosis of the major vessels (subclavian vein, v.cava)
- uncontrollable infection (port removal only under general anesthesia
WARNINGS
While; Using Titan-Port:
- secure the port to surrounding subcutaneous tissue by sutures or place in the smallest of portal pockets to prevent port migration
- secure the catheter to the vein with a firm, but; not constricting suture
- confirm the proper connection of the catheter to the port
PRECAUTIONS
Sterility
Meticulous hygiene and sterile handling technique are mandatory for the safe usage of TITAN-PORT Systems. This includes:
- implantation in sterile OR setting
- proper disinfection of hands and skin
- sterile gloves when initiating treatment
- use of sterile products
AFTERCARE AND MONITORING
Regular treatment sessions and associated care of the port system are coincidental with monitoring of the port system.
Physicians/health care personnel who are not familiar with all aspects of the product and its potential complications should not use the port system. Complications can occur at any time during and after implantation.
CARE OF THE SYSTEM AND SPECIAL RECOMMENDATION
Before each access; the correct position of the portal chamber must be checked by palpation. Also; any signs of infection must be excluded. Without complications, the TITAN-PORT Systems is usable only for one day after implantation.
PREPARATION
- before placement, fill the catheter with 0,9% saline solution
- puncture the portal chamber with the access needle; then; filled with 0,9% saline solution and purged of air. And; for this purpose the outlet pipe should be held upright when filling to allow air to escape. Futher to this; Use the enclosed needle.
