Patient Selection; Treatment And Follow-Up - Jotec E-vita OPEN NEO Gebrauchsanweisung

• The E-vita OPEN NEO must be implanted under sterile conditions ideally in a hybrid operating suite.
• The E-vita OPEN NEO is a single use product that has been sterilized with ethylene oxide. It must
not be re-sterilized or reused. Risks arising from re-sterilization and reuse include loss of function,
infection, hemolysis and allergic reaction in the patient.
• For emergency cases a selection of the E-vita OPEN NEO should be available to the physician.
4.2

Patient selection

• Clinical experience indicates that contrast-enhanced spiral computed tomographic angiography
(CTA) with 3‑D reconstruction is the strongly recommended imaging modality to accurately assess
patient anatomy prior to treatment. In hemodynamically unstable patients with a suspicion of acute
aortic syndromes, transesophageal echocardiography (TEE) should be used.
• Do not attempt to implant the E-vita OPEN NEO in patients unable to undergo or not compliant
with the necessary pre‑ and postoperative imaging. Patients with preexisting renal insufficiency
may have an increased risk of renal failure postoperatively.
• The E-vita OPEN NEO is not recommended in patients who cannot tolerate contrast agents
necessary for pre- and postoperative follow-up imaging.
• Care should be taken to determine whether a patient has sensitive or allergic reactions to heparin.
Systemic anticoagulation should be used during the implantation procedure based on the preferred
protocol of the hospital and physician. If heparin is contraindicated, an alternative anticoagulation
should be considered.
• Do not use the E-vita OPEN NEO in patients with sensitivities or allergies to nitinol, polyester,
platinum-iridium, polypropylene.
• Patient must be able to tolerate general anesthesia.
• Do not use the E-vita OPEN NEO in patients who have systemic infection or who are suspected to
have systemic infection. Patients with endocarditis or active infection of the aorta may also have
an increased risk of implant infection.
• Patients with history of bleeding diathesis or coagulopathy, may have an increased risk of severe
bleeding or hematoma.
• Severe angulation, circumferential thrombus or severe calcification in the distal landing zone may
increase the risk of migration or endoleak formation. In case of aneurysm the distal aortic neck
length of at least two distal springs of the stent graft part is required. The coverage of large re-entries
inhibits retrograde perfusion and thus favors thrombosis of the false lumen and aortic remodeling.
• Severe atherosclerosis at the distal landing zone may result in increased risk of spinal cord ischemia
as a consequence of thromboembolism of intercostal arteries or branch vessels.
• In chronic aortic dissections the origin of the visceral and renal arteries should be assessed
preoperatively. In the case that vessel perfusion depends on a patent false lumen the treatment
using the FET technique may cause renal or visceral ischemia or infarction.
• Extensive exclusion of the intercostal arteries by the stent graft may lead to spinal cord ischemia.
Coverage of the descending thoracic aorta distal to T8 should be avoided.
• The length of the stent graft portion must always be measured at the outer curvature, otherwise
there is the risk of endoleak in the distal landing zone.
• Care should be taken if the distal anastomosis is performed distal to the left subclavian artery
(LSA) to avoid laryngeal nerve damage.
• Covering the left subclavian artery heightens the risk of stroke and spinal cord injury. In case that
the anastomosis is performed proximal to the LSA, LSA bypassing is recommended.
• When performing distal anastomosis in zone 0, make sure that the diameter of the curvature of the
inner aortic arch is more than 50 mm. Otherwise there is a risk of stent graft kinking.
• Severe calcification at the sites of the anastomosis may lead to bleeding.
• Patients with aortic disease usually require life-long surveillance, regardless of the initial treatment
strategy. For Patients treated with endografts life-long imaging follow up on a regular basis should
be considered to exclude the presence of complications, such as endoleaks or aortic enlargement.
4.3

Treatment and follow-up

• The product must not be used if the package is damaged or if the package has been opened
outside of the sterile area.
• Insufficient anticoagulation during the implantation procedure may result in thrombosis and embo-
lism. Leakages through the graft fabric (endoleak type IV) which can be visualized during or
immediately after the implantation may be caused by intraoperative anticoagulation. Any endoleak
must be carefully monitored after implantation.
• In order to enhance organ protection during the surgery using the frozen elephant trunk technique,
the following key elements should be carefully considered:
- hypothermic circulatory arrest and degrees of hypothermia
- cerebral perfusion (retrograde, unilateral or bilateral antegrade, varying flow rates)
- antegrade perfusion of left subclavian artery (LSA)
- distal body perfusion
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