The Multidisciplinary, Multimodality, But Minimalist Approach to 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 balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.

Official Title
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The Vancouver Multidisciplinary, Multimodality, But Minimalist Clinical Pathway Facilitates Safe Next Day Discharge Home at Low, Medium, and High Volume Transfemoral Transcatheter Aortic Valve Replacement Centres: The 3M TAVR Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: Vancouver 3M 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 balloon expandable 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 Iliofemoral diameter < 6 mm for SAPIEN XT or <5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head) Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons. Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions 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 Insufficient social support to facilitate next day discharge Airway unfavourable for emergent intubation Inability to lay supine without conscious sedation or general anesthetic Not receiving a balloon expandable transcatheter heart valve
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 3M Clinical Pathway<br>The Vancouver 3M 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 3M Clinical Pathway<br> <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 3M Clinical Pathway, who are discharged the next day |  | Next day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days post-procedure | 
| Stroke |  | 30 days post-procedure | 
| 30-day major vascular complications |  | 30 days post-procedure | 
| 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 | 
| 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 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 | 

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