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2.0 Indications
1. The Edwards SAPIEN 3 system is indicated for use in patients with heart
disease due to native calcific aortic stenosis at any or all levels of
surgical risk for open heart surgery.
2. The Edwards SAPIEN 3 system is indicated for use in patients with
symptomatic heart disease due to a failing aortic bioprosthetic valve or
a failing mitral surgical bioprosthetic valve (stenosed, insufficient, or
combined) who are judged by a heart team to be at high or greater risk
for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8%
at 30 days, based on the Society of Thoracic Surgeons (STS) risk score
and other clinical co-morbidities unmeasured by the STS risk
calculator).
3.0 Contraindications
Use of the Edwards SAPIEN 3 system is contraindicated in patients with:
• Evidence of intracardiac mass, thrombus, vegetation, active infection or
endocarditis.
• Inability to tolerate anticoagulation/antiplatelet therapy.
4.0 Warnings
• The devices are designed, intended, and distributed STERILE for single use
only. Do not resterilize or reuse the devices. There are no data to
support the sterility, nonpyrogenicity, and functionality of the devices
after reprocessing.
• Correct sizing of the THV is essential to minimize the risk of paravalvular
leak, migration, and/or annular rupture.
• The physician must verify correct orientation of the THV prior to its
implantation.
• Accelerated deterioration of the THV may occur in patients with an altered
calcium metabolism.
• Observation of the pacing lead throughout the procedure is essential to
avoid the potential risk of pacing lead perforation.
• The THV must remain hydrated at all times and cannot be exposed to
solutions, antibiotics, chemicals, etc. other than its shipping storage
solution and sterile physiologic saline solution to prevent leaflet damage
that may impact valve functionality. THV leaflets mishandled or damaged
during any part of the procedure will require replacement of the THV.
• Patients with hypersensitivities to cobalt, nickel, chromium,
molybdenum, titanium, manganese, silicon, and/or polymeric materials
may have an allergic reaction to these materials.
• Do not use the THV if the tamper evident seal is broken, as sterility may
be compromised.
• Do not use the THV if the temperature indicator has been activated, as
valve function may be compromised.
• Do not use the THV if the expiration date has elapsed, as either sterility or
valve function may be compromised.
• Do not mishandle the delivery system or use the delivery system and
accessory devices if the packaging sterile barriers and any components
have been opened or damaged, cannot be flushed, or the expiration date
has elapsed.
• Access characteristics such as severe obstructive or circumferential
calcification, severe tortuosity, vessel diameters less than 5.5 mm
(for size 20, 23 and 26 mm SAPIEN 3 transcatheter heart valve) or
6.0 mm (for 29 mm SAPIEN 3 transcatheter heart valve) may preclude
safe placement of the sheath and should be carefully assessed prior to the
procedure.
5.0 Precautions
• Glutaraldehyde may cause irritation of the skin, eyes, nose and throat.
Avoid prolonged or repeated exposure to, or breathing of, the solution.
Use only with adequate ventilation. If skin contact occurs, immediately
flush the affected area with water; in the event of contact with eyes, seek
immediate medical attention. For more information about
glutaraldehyde exposure, refer to the Material Safety Data Sheet available
from Edwards Lifesciences.
• The safety and effectiveness of the THV implantation has not been
established in patients who have:
•
Congenital unicuspid aortic valve
•
Pre-existing prosthetic ring in any position
•
Severe ventricular dysfunction with ejection fraction < 20%
•
Hypertrophic cardiomyopathy with or without obstruction
•
Aortic stenosis characterized by a combination of AV low flow, low
gradient
• If a significant increase in resistance occurs when advancing the catheter
through the vasculature, stop advancement and investigate the cause of
resistance before proceeding. Do not force passage, as this could increase
the risk of vascular complications.
• Appropriate antibiotic prophylaxis is recommended post-procedure in
patients at risk for prosthetic valve infection and endocarditis.
• THV recipients should be maintained on anticoagulant/antiplatelet
therapy to minimize the risk of valve thrombosis or thromboembolic
events, as determined by their physicians.
• Long-term durability has not been established for the THV. Regular
medical follow-up is advised to evaluate valve performance.
• Based on the treating physician's consideration of risks and benefits, the
SAPIEN 3 valve may be implanted in relatively young patients, although
the longer-term durability is still the subject of ongoing clinical research.
• Do not overinflate the deployment balloon, as this may prevent proper
valve leaflet coaptation and thus impact valve functionality.
• Patients with pre-existing mitral valve devices should be carefully
evaluated before implantation of the THV to ensure proper THV
positioning and deployment.
• The risks of subclavian/axillary access are low and acceptable, but
subclavian/axillary access should be considered when the physician
determines there is an increased risk associated with transfemoral access.
• For left axillary approach, a left subclavian takeoff angle ~ ≥90° from the
aortic arch causes sharp angles, which may be responsible for potential
sheath kinking, subclavian/axillary dissection and aortic arch damage.
• For left / right axillary approach, ensure there is flow in the Left Internal
Mammary Artery (LIMA) / Right Internal Mammary Artery (RIMA),
respectively, during procedure and monitor pressure in homolateral radial
artery.
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