Disability, Perioperative Myocardial Infarction, Perioperative/Postoperative Complications
Conditions
Brief summary
Major adverse cardiac events (MACE) are a leading cause of mortality in patients undergoing noncardiac surgery. Patients with perioperative myocardial injury (PMI), defined as either myocardial infarction and lower elevations in cardiac troponin, are also at substantially increased risk of additional cardiac and noncardiac complications. Accordingly, it is plausible to assume that PMI negatively affects quality of life in terms of disability. The aim of this study is to investigate and compare the independent prognostic effects of the different PMI phenotypes (myocardial infarction and non-infarct troponin elevations) and noncardiac complications on disability in patients undergoing elective noncardiac surgery.
Interventions
None listed
Sponsors
University Health Network, Toronto
UMC Utrecht
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 60 years old; * Major noncardiac surgery defined as all noncardiac surgical procedures requiring an expected hospital stay of at least 24 hours; * Elective surgery, defined as surgery that that has been preceded by a preoperative consultation at the anesthesia preoperative screening outpatient clinic.
Exclusion criteria
* Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch or English). * Patients with an American Society of Anesthesiologists (ASA) Physical status 5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 6 months after surgery | Disability is expressed by the World Health Organization Disability Assessment Score 2.0 (WHODAS 2.0), which is based on difficulties experienced by the respondent in different functional domains including, cognition, mobility, self-care, getting along, life activities and participation during the previous 30 days. Disability is defined as a decrement in each functioning domain corresponding to score between 0% and 100%, in which no disability stands for a score of 0% and full disability represents a score of 100%, including death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability free survival | 6 months after surgery | Disability free survival is defined as being alive with a WHODAS 2.0 score ≤ 25% and no increase of the pre-operative score ≥ 25% at 6 months after surgery. |
| Major adverse cardiovascular event (MACE) | 1 week after surgery | MACE is defined as a composite outcome consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal ventricular fibrillation, ventricular arrhythmia with hemodynamic compromise, atrial fibrillation requiring cardioversion, pulmonary embolism, stroke |
| Noncardiac major adverse postoperative events (MAPE) | 1 week after surgery | Noncardiac MAPE is a composite outcome consisting of respiratory failure (including pneumonia and hypoxia or hypercapnia leading to ICU admission for respiratory support), sepsis, renal failure, unplanned ICU admission, unplanned medium care admission, reoperation |
| Length of hospital stay | 1 week after surgery | the number of days from the end of surgery until day of discharge |
| All-cause mortality | 1 week after surgery | — |
Countries
Canada, Netherlands
Contacts
Primary ContactWilton A van Klei, MD, PhD
Backup ContactLisette M Vernooij, Msc
Outcome results
None listed