Thoratec Vectra Manual Del Usuario página 3

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Vectra Vascular Access Graft
Potential Complications with the Use of a Vascular Prosthesis
Potential complications that may occur with any surgical procedure involving a vascu-
lar prosthesis include, but are not limited to: aneurysm; anastomotic disruption or
tearing of the suture line and/or host vessel; embolic events; infection; bleeding;
occlusion; stenosis; thrombosis; kinking/compression; swelling of the implanted limb;
formation of hematomas or pseudoaneurysms; steal syndrome; and/or skin erosion.
Warnings
AVOID EXCESSIVE AXIAL ELONGATION OR STRETCHING OF THE GRAFT (>10%)
DURING HANDLING AT IMPLANTATION. Cut the graft long enough to prevent stress
on the anastomoses and/or allow for a full range of body movements. Excessive elon-
gation or stretching of the graft may result in damage to the graft microporous layers
or anastomotic disruption that could lead to hematoma, bleeding, pseudoaneurysm,
ischemia, or loss of limb or limb function.
Do NOT use product if package has been damaged or opened, as sterility may be compromised.
Do NOT resterilize the graft.
Precautions
1. When using a balloon angioplasty or embolectomy catheter within the lumen of the Vec-
tra VAG, match the inflated balloon size to the inner diameter size of the VAG. Over-infla-
tion of the balloon or use of an inappropriately sized balloon catheter may damage the
graft. Care must be exercised to avoid causing excessive axial elongation of the graft dur-
ing retraction.
2. Preclotting this graft is not necessary.
3. It is necessary to hydrate the graft in a sterile solution of normal physiologic saline
prior to implantation. The inner and outer luminal walls of the graft are micropo-
rous and the voids in these surfaces contain air that must be displaced. See "Oper-
ative Techniques" for more information.
4. Use of the Vectra sheath tunneler is necessary to minimize subcutaneous trauma
and to minimize the force required to position the graft during implant. Tunneling
permits graft placement without pulling that can produce excessive force that could
result in damage to the graft microporous layers.
5. If clamping is necessary, use only atraumatic or appropriate vascular smooth-jawed
or shod clamps to avoid damage to the graft wall during implantation.
6. Because of the monofilament reinforcement, only an end-to-end, not an end-to-
side, anastomosis of the revision graft to the implanted graft is recommended.
7. Guideline 17 from the Clinical Practice Guidelines from the Final Report from the
Vascular Access Work Group of the National Kidney Foundation (US) – Dialysis
Outcomes Quality Initiative, recommends the following for infected AV grafts:
"When infected, a dialysis graft should be treated surgically. An untreated access
infection may lead to bacteremia, sepsis, hemorrhage, and death. Surgical explora-
tion and removal of any infected graft or graft segment is necessary for resolution of
the infection because the graft material acts as a foreign body unless eliminated."
Patients receiving grafts in the femoral location are known to have more infections
and thrombosis complications, and should be monitored for signs of infection and
attended to promptly if any are identified.
Summary of the Vectra
Purpose: The Thoratec Vectra VAG was compared to ePTFE grafts in a prospective
randomized study to establish equivalency in the safety and effectiveness for the Vec-
tra and ePTFE grafts when used as subcutaneous arteriovenous conduits.
1. Taylor et al. Results and complications of arteriovenous access dialysis grafts in the lower extremity: A
five year review. Am. Surg. 1996 Mar;62(3):188-91.
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VAG Clinical Experience
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