Clinical trial NCT02287662: The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Replacement
Lead sponsor: BC Centre for Improved Cardiovascular Health
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2014-11-11
Enrollment: 411
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The composite of all-cause mortality or stroke
timeFrame: 30 days post-procedure
measure: The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day
timeFrame: Next day
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days post-procedure
measure: Stroke
timeFrame: 30 days post-procedure
measure: 30-day major vascular complications
timeFrame: 30 days post-procedure
measure: 30-day major/life-threatening bleed
timeFrame: 30 days post-procedure
measure: Any readmission to hospital within 30 days
timeFrame: 30 days post-procedure
measure: > mild paravalvular regurgitation
timeFrame: Post-procedure/discharge
measure: New permanent pacemaker
timeFrame: 30 days post-procedure
measure: Conversion to general anesthetic/intubation
timeFrame: Peri-procedure
measure: Myocardial infarction
timeFrame: Peri-procedure
measure: Repeat procedure for valve-related dysfunction
timeFrame: 30 days post-procedure
measure: Stage 3 acute kidney injury (need for dialysis)
timeFrame: 30 days post-procedure
measure: 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
timeFrame: Baseline, and 2 weeks, 30 day and 1 year post procedure
measure: Economic evaluation including health resource utilization, and cost effectiveness
timeFrame: Peri- and post-procedure
measure: Death or stroke at one year
timeFrame: 1 year post-procedure
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: David A Wood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: John A Webb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.