Aortic Stenosis, Cardiac Valve Replacement Complication, Fragility
Conditions
Keywords
Aortic stenosis, Aortic valve replacement, Transcatheter aortic valve implantation, Outcomes, Frailty, Elderly
Brief summary
Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.
Interventions
None listed
Sponsors
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Duke University
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Massachusetts General Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre
McMaster University
Montreal Heart Institute
Royal Victoria Hospital, Canada
St. Boniface Hospital
Unity Health Toronto
St. Paul's Hospital, Canada
Ottawa Heart Institute Research Corporation
Jewish General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years) 2. Severe AS 3. Referred for surgical or transcatheter AVR (with or without concomitant revascularization) 4. Signed informed consent
Exclusion criteria
1. Emergency surgery 2. Clinical instability: decompensated heart failure, active ischemia, unstable vital signs 3. Severe neuropsychiatric impairment 4. Not English or French speaking 5. Replacement of \>1 valve or aortic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-procedural mortality or major morbidity | 30 days | Mortality is defined as death from any cause. Major morbidity is defined as an aggregate of the Society of Thoracic Surgeons (STS) and Valve Academic Research Consortium (VARC) composite endpoints. Additionally, the individual components of this composite endpoint will be examined. |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | 6-12 months |
| Functional status | 6-12 months |
| Length of stay | 30 days |
Other
| Measure | Time frame |
|---|---|
| Readmission | 6-12 months |
| Cost analysis and resource use | 30 days |
| Cognitive function | 6-12 months |
| Longitudinal recovery of physical and cognitive functioning | Monthly (1-12 months) |
| Echocardiographic function of ventricles and valves | 30 days |
| Mood disturbance | 6-12 months |
| Delirium | 30 days |
| Disposition | 30 days |
Countries
Canada, France, United States
Outcome results
None listed