The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement (3MTAVR)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: Vancouver 3M Clinical Pathway

• Study Type: Interventional
• Enrollment (Anticipated): 411
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vancouver 3M Clinical Pathway; 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: BC Centre for Improved Cardiovascular Health
• Collaborators: University of British Columbia

Publications and helpful links

General Publications

• Butala NM, Wood DA, Li H, Chinnakondepalli K, Lauck SB, Sathananthan J, Cairns JA, Magnuson EA, Barker M, Webb JG, Welsh R, Cheung A, Ye J, Velianou JL, Wijeysundera HC, Asgar A, Kodali S, Thourani VH, Cohen DJ; 3M-TAVR Investigators. Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study. Circ Cardiovasc Interv. 2022 Oct;15(10):e012168. doi: 10.1161/CIRCINTERVENTIONS.122.012168. Epub 2022 Oct 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis