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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Duke University | OTHER |
| Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic valve replacement | Patients aged ≥70 years referred for surgical or transcatheter aortic valve replacement. |
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| Measure | Description | Time Frame |
|---|---|---|
| Post-procedural mortality or major morbidity | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 6-12 months | |
| Functional status | 6-12 months | |
| Length of stay |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | 6-12 months | |
| Mood disturbance | 6-12 months | |
| Delirium |
Inclusion Criteria:
Exclusion Criteria:
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In-patients and out-patients referred for surgical or transcatheter aortic valve replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Afilalo, MD MSc | Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham & Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30882905 | Derived | Shi SM, Sung M, Afilalo J, Lipsitz LA, Kim CA, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Lee J, Marcantonio ER, Kim DH. Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement. J Am Geriatr Soc. 2019 Jul;67(7):1393-1401. doi: 10.1111/jgs.15867. Epub 2019 Mar 18. | |
| 28693934 | Derived |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Massachusetts General Hospital | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| McMaster University | OTHER |
| Montreal Heart Institute | OTHER |
| Royal Victoria Hospital, Canada | OTHER |
| St. Boniface Hospital | OTHER |
| Unity Health Toronto | OTHER |
| St. Paul's Hospital, Canada | OTHER |
| Ottawa Heart Institute Research Corporation | OTHER |
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Tissue specimens
| 30 days |
| 30 days |
| Disposition | 30 days |
| Readmission | 6-12 months |
| Cost analysis and resource use | 30 days |
| Echocardiographic function of ventricles and valves | 30 days |
| Longitudinal recovery of physical and cognitive functioning | Monthly (1-12 months) |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | Canada |
| Hamilton General Hospital | Hamilton | Ontario | Canada |
| Ottawa Heart Institute | Ottawa | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Universite de Montreal | Montreal | Quebec | Canada |
| Montreal Heart Institute | Montreal | Quebec | Canada |
| Royal Victoria Hospital | Montreal | Quebec | Canada |
| Hôpital Jacques Cartier | Massy | 91300 | France |
| Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7. |
| D014694 |
| Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |