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 self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.
Interventions
OTHERVancouver Clinical Pathway
Vancouver 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 self-expanding 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. Illiofemoral diameter \<6 mm (for 23 and 25 mm valves) and \<6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head 6. Surgical prosthesis \<23 mm (labelled size) for valve-in-valve procedure 7. In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons) 8. Language barriers (inability to understand peri-procedural and discharge instructions) 9. Insufficient social support post procedure to allow next day discharge 10. Airway unfavourable for emergent intubation 11. Inability to lay supine without conscious sedation or general anaesthetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day | Discharge 1 day after procedure |
| The composite of all-cause mortality or stroke | 30 days post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Stroke | 30 days post-procedure |
| Major vascular complications | 30 days post-procedure |
| Major/Life-threatening bleed | 30 days post-procedure |
| Any hospital readmission | 30 days post-procedure |
| >mild paravalvular regurgiation | Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure |
| Patient is converted from local to general anaesthetic/receives intubation during procedure | This happens during the procedure |
| Myocardial infarction | This happens during the procedure |
| Repeat procedure for valve-related dysfunction | 30 days post-procedure |
| Stage 3 acute kidney injury (need for dialysis) | 30 days post-procedure |
| Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year | Baseline, and 30 days and 1 year post-procedure |
| New permanent pacemaker | 30 days post-procedure |
| All-cause mortality | 30 days post-procedure |
Other
| Measure | Time frame |
|---|---|
| Death or stroke | 1 year post-procedure |
Contacts
Primary ContactDavid A Wood, MD
Backup ContactShirley C Wong, PhD
Outcome results
None listed