The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
411
St Paul's Hospital
Vancouver, British Columbia, Canada
The composite of all-cause mortality or stroke
Time frame: 30 days post-procedure
The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day
Time frame: Next day
All-cause mortality
Time frame: 30 days post-procedure
Stroke
Time frame: 30 days post-procedure
30-day major vascular complications
Time frame: 30 days post-procedure
30-day major/life-threatening bleed
Time frame: 30 days post-procedure
Any readmission to hospital within 30 days
Time frame: 30 days post-procedure
> mild paravalvular regurgitation
Time frame: Post-procedure/discharge
New permanent pacemaker
Time frame: 30 days post-procedure
Conversion to general anesthetic/intubation
Time frame: Peri-procedure
Myocardial infarction
Time frame: Peri-procedure
Repeat procedure for valve-related dysfunction
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Time frame: 30 days post-procedure
Stage 3 acute kidney injury (need for dialysis)
Time frame: 30 days post-procedure
Patient-centred outcomes including health related quality of life as measured by KCCQ and SF-12 at baseline, 2 weeks, 30 days, and 1 year
Time frame: Baseline, and 2 weeks, 30 day and 1 year post procedure
Economic evaluation including health resource utilization, and cost effectiveness
Time frame: Peri- and post-procedure
Death or stroke at one year
Time frame: 1 year post-procedure