Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
Not Applicable
- Conditions
- Aortic Valve Stenosis
- Interventions
- Other: Vancouver Clinical Pathway
- Registration Number
- NCT03600935
- Lead Sponsor
- BC Centre for Improved Cardiovascular Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 315
Inclusion Criteria
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve
- Considered at increased surgical risk by the Multidisciplinary Heart Team
- Informed written consent
Exclusion Criteria
- Non-cardiovascular co-morbidity reducing life expectancy to <3 years
- Any factor precluding 1 year follow-up
- 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)
- Predicted inability to perform uncomplicated percutaneous vascular access and closure
- 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
- Surgical prosthesis <23 mm (labelled size) for valve-in-valve procedure
- In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
- Language barriers (inability to understand peri-procedural and discharge instructions)
- Insufficient social support post procedure to allow next day discharge
- Airway unfavourable for emergent intubation
- Inability to lay supine without conscious sedation or general anaesthetic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vancouver Clinical Pathway Vancouver Clinical Pathway The Vancouver Clinical Pathway utilizes objective anatomical and functional screening criteria as well as strict peri-procedural guidelines to determine if next day discharge home is appropriate.
- Primary Outcome Measures
Name Time Method The composite of all-cause mortality or stroke 30 days post-procedure The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day Discharge 1 day after procedure
- Secondary Outcome Measures
Name Time Method 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 All-cause mortality 30 days post-procedure Stroke 30 days post-procedure Major vascular complications 30 days post-procedure New permanent pacemaker 30 days post-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