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An international prospective cohort study evaluating major vascular complications among patients undergoing noncardiac surgery: the VISION Pilot Study.

VISION Pilot Study InvestigatorsDevereaux PJ, Bradley D, Chan MT, Walsh M, Villar JC, Polanczyk CA, Seligman BG, Guyatt GH, Alonso-Coello P, Berwanger O, Heels-Ansdell D, Simunovic N, Sch√ľnemann H, Yusuf S - Open Med (2011)

Bottom Line: We recruited 432 patients across 5 hospitals in Canada, China, Italy, Colombia, and Brazil.The observed event rate was increased 6-fold compared with the event rate expected from the RCRI.These results underscore the need for a large international prospective cohort study.

View Article: PubMed Central - PubMed

Affiliation: Population Health Research Institute, David Braley Cardiac, Vascular, and Stroke Research Institute, RoomC1-116, Perioperative Medicine and Surgical Research Unit, c/o Hamilton General Hospital, 237 Barton Street East, Hamilton, ON, Canada, L8L2X2. philipj@mcmaster.ca

ABSTRACT

Objectives: among patients undergoing noncardiac surgery, our objectives were to: (1) determine the feasibility of undertaking a large international cohort study; (2) estimate the current incidence of major perioperative vascular events; (3) compare the observed event rates to the expected event rates according to the Revised Cardiac Risk Index (RCRI); and (4) provide an estimate of the proportion of myocardial infarctions without ischemic symptoms that may go undetected without perioperative troponin monitoring.

Design: An international prospective cohort pilot study.

Participants: Patients undergoing noncardiac surgery who were >45 years of age, receiving a general or regional anesthetic, and requiring hospital admission.

Measurements: Patients had a Roche fourth-generation Elecsys troponin T measurement collected 6 to 12 hours postoperatively and on the first, second, and third days after surgery. Our primary outcome was major vascular events (a composite of vascular death [i.e., death from vascular causes], nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) at 30 days after surgery. Our definition for perioperative myocardial infarction included: (1) an elevated troponin T measurement with at least one of the following defining features: ischemic symptoms, development of pathologic Q waves, ischemic electrocardiogram changes, coronary artery intervention, or cardiac imaging evidence of myocardial infarction; or (2) autopsy findings of acute or healing myocardial infarction.

Results: We recruited 432 patients across 5 hospitals in Canada, China, Italy, Colombia, and Brazil. During the first 30 days after surgery, 6.3% (99% confidence interval 3.9-10.0) of the patients suffered a major vascular event (10 vascular deaths, 16 nonfatal myocardial infarctions, and 1 nonfatal stroke). The observed event rate was increased 6-fold compared with the event rate expected from the RCRI. Of the 18 patients who suffered a myocardial infarction, 12 (66.7%) had no ischemic symptoms to suggest myocardial infarction.

Conclusions: This study suggests that major perioperative vascular events are common, that the RCRI underestimates risk, and that monitoring troponins after surgery can assist physicians to avoid missing myocardial infarction. These results underscore the need for a large international prospective cohort study.

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Related in: MedlinePlus

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figure1: Patient flow chart

Mentions: Patients were recruited over a 1- to 2-month period at each participating site. Sites joined the pilot study over a 4-year period. The first site started recruiting patients on 30 March 2005, and the last patient was recruited at the final site on 19 May 2009. We recruited 432 patients who met the eligibility criteria into the VISION Pilot Study, 17 (3.9%) of whom consented during the first 24 hours after surgery. The patient flow chart for recruitment across all sites is shown in Figure 1. A comparison of the study log with operating room surgical records, and, where available, hospital computer systems, demonstrated that study personnel approached 85.0% of all potentially eligible patients. Missed patients were primarily elective patients who were rescheduled on short notice, elective patients with the same booking time as many other elective cases, and some urgent/emergent patients who underwent weekend surgery and were missed by the weekend study personnel. Forty-eight patients refused to participate (10.0% refusal rate).


An international prospective cohort study evaluating major vascular complications among patients undergoing noncardiac surgery: the VISION Pilot Study.

VISION Pilot Study InvestigatorsDevereaux PJ, Bradley D, Chan MT, Walsh M, Villar JC, Polanczyk CA, Seligman BG, Guyatt GH, Alonso-Coello P, Berwanger O, Heels-Ansdell D, Simunovic N, Sch√ľnemann H, Yusuf S - Open Med (2011)

Patient flow chart
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3345376&req=5

figure1: Patient flow chart
Mentions: Patients were recruited over a 1- to 2-month period at each participating site. Sites joined the pilot study over a 4-year period. The first site started recruiting patients on 30 March 2005, and the last patient was recruited at the final site on 19 May 2009. We recruited 432 patients who met the eligibility criteria into the VISION Pilot Study, 17 (3.9%) of whom consented during the first 24 hours after surgery. The patient flow chart for recruitment across all sites is shown in Figure 1. A comparison of the study log with operating room surgical records, and, where available, hospital computer systems, demonstrated that study personnel approached 85.0% of all potentially eligible patients. Missed patients were primarily elective patients who were rescheduled on short notice, elective patients with the same booking time as many other elective cases, and some urgent/emergent patients who underwent weekend surgery and were missed by the weekend study personnel. Forty-eight patients refused to participate (10.0% refusal rate).

Bottom Line: We recruited 432 patients across 5 hospitals in Canada, China, Italy, Colombia, and Brazil.The observed event rate was increased 6-fold compared with the event rate expected from the RCRI.These results underscore the need for a large international prospective cohort study.

View Article: PubMed Central - PubMed

Affiliation: Population Health Research Institute, David Braley Cardiac, Vascular, and Stroke Research Institute, RoomC1-116, Perioperative Medicine and Surgical Research Unit, c/o Hamilton General Hospital, 237 Barton Street East, Hamilton, ON, Canada, L8L2X2. philipj@mcmaster.ca

ABSTRACT

Objectives: among patients undergoing noncardiac surgery, our objectives were to: (1) determine the feasibility of undertaking a large international cohort study; (2) estimate the current incidence of major perioperative vascular events; (3) compare the observed event rates to the expected event rates according to the Revised Cardiac Risk Index (RCRI); and (4) provide an estimate of the proportion of myocardial infarctions without ischemic symptoms that may go undetected without perioperative troponin monitoring.

Design: An international prospective cohort pilot study.

Participants: Patients undergoing noncardiac surgery who were >45 years of age, receiving a general or regional anesthetic, and requiring hospital admission.

Measurements: Patients had a Roche fourth-generation Elecsys troponin T measurement collected 6 to 12 hours postoperatively and on the first, second, and third days after surgery. Our primary outcome was major vascular events (a composite of vascular death [i.e., death from vascular causes], nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) at 30 days after surgery. Our definition for perioperative myocardial infarction included: (1) an elevated troponin T measurement with at least one of the following defining features: ischemic symptoms, development of pathologic Q waves, ischemic electrocardiogram changes, coronary artery intervention, or cardiac imaging evidence of myocardial infarction; or (2) autopsy findings of acute or healing myocardial infarction.

Results: We recruited 432 patients across 5 hospitals in Canada, China, Italy, Colombia, and Brazil. During the first 30 days after surgery, 6.3% (99% confidence interval 3.9-10.0) of the patients suffered a major vascular event (10 vascular deaths, 16 nonfatal myocardial infarctions, and 1 nonfatal stroke). The observed event rate was increased 6-fold compared with the event rate expected from the RCRI. Of the 18 patients who suffered a myocardial infarction, 12 (66.7%) had no ischemic symptoms to suggest myocardial infarction.

Conclusions: This study suggests that major perioperative vascular events are common, that the RCRI underestimates risk, and that monitoring troponins after surgery can assist physicians to avoid missing myocardial infarction. These results underscore the need for a large international prospective cohort study.

Show MeSH
Related in: MedlinePlus