Biomedical Engineering Reference
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of evidence that supports PVR as a realistic and clinically effi cient
alternative.
The inclusion criteria for this study were as follows:
age
18 years;
native or bioprosthetic aortic valve disease of either endocarditic or
non-endocarditic origin, defi ned as valve regurgitation
≥
≥
3 and/or valve
1 cm
2
by echocardiographic measure;
stenosis with an aortic valve area
<
aortic valve annulus diameter
≥
20 mm and
≤
23 mm by echocardio-
graphic measure;
eligibility for an open-heart surgical aortic valve replacement;
documented left ventricular ejection fraction
≥
30%;
signed informed consent.
The exclusion criteria were as follows:
known hypersensitivity or contraindication to aspirin, heparin, ticlo-
pidine, clopidogrel, or nitinol, or sensitivity to contrast media that
cannot be adequately premedicated; any sepsis state, including active
endocarditis;
uncontrolled atrial fi brillation;
any condition considered as a contraindication for extracorporeal
assistance;
any femoral, iliac, or aortic vascular condition (stenosis or tortuosity)
that precludes insertion and endovascular access to the aortic valve;
symptomatic carotid or vertebral artery narrowing disease;
abdominal or thoracic aortic aneurysm;
bleeding diathesis or coagulopathy, or refusal of blood transfusion;
severe renal failure (creatinine
≥
2.5 mg/dl);
pregnancy;
enrolment in another investigational device study.
The primary endpoints for this study were safety and feasibility. Safety is
determined in terms of clinical outcome: composite major adverse cardiac,
cerebral, and vascular events (MACCVE) and death at discharge.
MACCVE include:
major arrhythmia;
myocardial infarction;
cardiac tamponade;
valve non-structural dysfunction or structural deterioration;
emergent aortic valve replacement surgery, coronary bypass surgery, or
percutaneous coronary intervention;
cardiogenic shock;
endocarditis;
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