Potential Adverse Events; Treatment And Sizing; Patient Selection - Jotec E-vita OPEN NEO Gebrauchsanweisung

EN
The perioperative management is crucial to achieve an optimal procedural outcome and is
performed at the discretion of the physician.
• If any resistance is felt during the insertion of the E-vita OPEN NEO delivery system do not advance
further. Stop and assess the cause of resistance, otherwise the risk of trauma to the vessel or
catheter damage may occur. Additional care must be taken in case of acute dissection to avoid
entering the false lumen.
• Clamping may damage the prosthesis. Atraumatic clamps, ideally with soft shod jaws, should be
used with a minimum application of force. Excessive force should be avoided as it will damage
the polyester fibers.
• Transesophageal echocardiography (TEE) or intravascular ultrasound (IVUS) may be helpful to
confirm the correct placement of the guide wire in the true lumen in case of aortic dissection and
to verify the suitability of distal landing zone.
• The anastomosis should be done very accurately to avoid bleeding and re-exploration. Use a
common surgical anastomosis needle of a suitable size and a non‑absorbable mono‑filament
suture material. The sewing collar should be used for a safe distal anastomosis.
• Care should be taken to include all dissected membranes of the aortic wall in the anastomosis. In
case of very arteriosclerotic and friable tissue the use of an external felt support to minimize the
risk of bleeding may be helpful.
• Excessive tension on the anastomosis and the graft material should be avoided to prevent strain
on the suture line.
• If deairing is required, the smallest needle possible should be used. Do not use cutting needles
that may result in blood leakage.
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Potential adverse events

• Allergic reaction (to contrast media, antithrombotic agents, prosthesis material)
• Amputation
• Aortic enlargement (e.g. aneurysm, false lumen)
• Aortic rupture
• Cardiac failure (e.g. arrhythmia, tachycardia, congestive heart failure, myocardial infarction)
• Death
• Dissection, perforation, or rupture of the aortic vessel & surrounding vasculature
• Embolism (e.g. thromboembolism, microembolism)
• Endoleaks
• Fistula (e.g. aorto-esophageal, aorto-tracheal, aorto-bronchial)
• Gastrointestinal complications (e.g. bleeding, visceral ischemia/infarction)
• Hemorrhage/bleeding
• Hepatic failure
• Hypotension/hypertension
• Prosthesis material failure (including breakage of metal portion of device, collapse, extrusion,
erosion and prosthesis rupture)
• Infection (e.g. local, systemic, prosthesis) or fever
• Ischemia or infarction (e.g. cerebral, visceral, renal, organ, peripheral)
• Laryngeal nerve palsy
• Neurological complications (e.g. transient ischemic attack (TIA), stroke)
• Occlusion (venous or arterial, incl. prosthesis occlusion)
• Pulmonary complication (e.g. edema, embolism, pneumonia, respiratory failure)
• Renal insufficiency
• Spinal cord ischemia (SCI) incl. paraparesis and paraplegia
• Stenosis (arterial or venous)
• Stent graft migration (retrograde in case of aneurysm)
• Thrombosis (incl. prosthesis thrombosis)
• Tissue necrosis
• Wound healing complications (e.g. dehiscence, bleeding, infection, sepsis)
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Treatment and sizing

6.1

Patient selection

Before use of the E‑vita OPEN NEO, the benefits and risks should be carefully considered for each
patient (refer to Chapter 4, Warnings and Precautions). A selection of implants necessary to perform
the procedure should be available to the physician, especially when preoperative case planning
measurements (treatment diameters/lengths) are not certain. Size selection is described in Chapter
6.4. and is the responsibility of the treating physician.
Additional considerations for patient selection include, but are not limited to:
• Patient age and life expectancy.
• Comorbidities (e.g. cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity, etc.).
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