Biomedical Engineering Reference
In-Depth Information
stroke or transient ischemic attacks (TIA);
aortic dissection;
access site vessel dissection;
vessel perforation;
acute vessel occlusion;
major bleeding.
Procedure feasibility was defi ned by device functionality based on an inves-
tigator evaluation rating and the rate of procedural success at discharge.
The rating evaluated the system's (including the user) ability to:
load the valve on the delivery catheter, using the loading system;
access the aortic valve with the delivery catheter;
deploy the valve accurately across the aortic native or bioprosthetic
valve;
remove the intact delivery system.
The rate of procedural success at discharge was defi ned as valve success
without MACCVE or death at discharge. Valve success was defi ned as
adequate device placement and functionality as assessed by angiography at
the end of the procedure.
Secondary endpoints were defi ned as:
patient's functional status evaluated by NYHA functional class at 15
days, 30 days and 3 months;
patient's left ventricular ejection fraction measured by Doppler echocar-
diography at 15 days, 30 days and 3 months;
valve performance (including valve surface area, transvalvular gradient,
and valve regurgitation grade) measured by control Doppler echocar-
diography at 15 days, 30 days and 3 months;
incidence of valve migration at 15 days, 30 days and 3 months, as dem-
onstrated by echocardiography;
incidence of paravalvular leak at 15 days, 30 days and 3 months, as
measured by Doppler echocardiography;
incidence of composite MACCVE and death at discharge, 15 days and
3 months;
incidence of valve endocarditis at 15 days and 3 months;
rate of access site complications requiring treatment;
incidence of surgical cardiovascular intervention;
incidence of overall adverse events.
5.6.1 Clinical experience to date
It must be borne in mind that PVR is a new technique and, although there
is increasing experience with it in the clinical setting, the outcome data are
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