This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
General anesthesia by standard endotracheal intubation.
Conscious sedation
Time-on-table
* time to patient on table to surgical drapes down * time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
Time frame: <1 day
Number of patients with serious adverse events
* deaths * conversion from sedation to intubation * hypersensitivity reactions
Time frame: within 30 days
Length of stay
* ICU length of stay (days) * Hospital length of stay (days)
Time frame: within 30 days
Readmissions
Number of patients readmitted within 30 days of initial procedure
Time frame: within 30 days
Number of Patients with Valve Complications
* paravalvular leak on echocardiogram * pacemaker requirement * vascular complications requiring reintervention * post-procedure requiring valve dilation
Time frame: within 30 days
Contrast usage
Amount of contrast used in mL for procedure
Time frame: <1 day
Fluoroscopy time
Amount of time fluoroscopy used
Time frame: <1 day
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