Aortic Valve Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Replacement
Brief summary
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.
Interventions
OTHERVancouver 3M Clinical Pathway
Sponsors
University of British Columbia
BC Centre for Improved Cardiovascular Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a balloon expandable transcatheter heart valve 1. Considered at increased surgical risk by the Multidisciplinary Heart Team. 2. Informed written consent
Exclusion criteria
1. Non -cardiovascular co-morbidity reducing life expectancy to \< 3 years 2. Any factor precluding 1 year follow-up 3. Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures) 4. Predicted inability to perform uncomplicated percutaneous vascular access and closure 5. Iliofemoral diameter \< 6 mm for SAPIEN XT or \<5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head) 6. Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons. 7. Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions 8. MMSE \< 24/30 (unless language barrier or limited formal education), 5-metre gait \> 7 seconds (unless chronic mobility impairment not affecting ability to perform ADLs), and ADL \< 6/6 9. Insufficient social support to facilitate next day discharge 10. Airway unfavourable for emergent intubation 11. Inability to lay supine without conscious sedation or general anesthetic 12. Not receiving a balloon expandable transcatheter heart valve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of all-cause mortality or stroke | 30 days post-procedure |
| The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day | Next day |
Secondary
| Measure | Time frame |
|---|---|
| 30-day major/life-threatening bleed | 30 days post-procedure |
| Any readmission to hospital within 30 days | 30 days post-procedure |
| > mild paravalvular regurgitation | Post-procedure/discharge |
| New permanent pacemaker | 30 days post-procedure |
| Conversion to general anesthetic/intubation | Peri-procedure |
| Myocardial infarction | Peri-procedure |
| Repeat procedure for valve-related dysfunction | 30 days post-procedure |
| Stroke | 30 days post-procedure |
| 30-day major vascular complications | 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 | Baseline, and 2 weeks, 30 day and 1 year post procedure |
| Economic evaluation including health resource utilization, and cost effectiveness | Peri- and post-procedure |
| Death or stroke at one year | 1 year post-procedure |
| All-cause mortality | 30 days post-procedure |
| Stage 3 acute kidney injury (need for dialysis) | 30 days post-procedure |
Countries
Canada
Outcome results
None listed