Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: Vancouver Clinical Pathway


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancouver Clinical Pathway<br>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. | Other: Vancouver Clinical Pathway<br>* Vancouver Clinical Pathway<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Clinical Pathway, who are discharged the next day |  | Discharge 1 day after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days post-procedure | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Replacement