Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Jewish General Hospital800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Aortic Stenosis Cardiac Valve Replacement Complication Fragility

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (14)

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, 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, Canada

...and 4 more locations

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

All-cause mortality

Time frame: 6-12 months

Functional status

Time frame: 6-12 months

Length of stay

Time frame: 30 days