Clinical Trial

. 2017 Jan 9;7(1):e013510.

doi: 10.1136/bmjopen-2016-013510.

External validation of the Revised Cardiac Risk Index and update of its renal variable to predict 30-day risk of major cardiac complications after non-cardiac surgery: rationale and plan for analyses of the VISION study

Pavel S Roshanov^{1

2}, Michael Walsh^{2

3

4}, P J Devereaux^{2

3

4}, S Danielle MacNeil^{5

6}, Ngan N Lam⁷, Ainslie M Hildebrand⁷, Rey R Acedillo¹, Marko Mrkobrada⁸, Clara K Chow^{9

10}, Vincent W Lee^{11

12}, Lehana Thabane^{2

13

14}, Amit X Garg^{6

8

15}

Affiliations

¹ Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre, London, Ontario, Canada.
² Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
³ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
⁴ Population Health Research Institute, Hamilton, Ontario, Canada.
⁵ Department of Otolaryngology Head & Neck Surgery and Department of Oncology, Western University, London, Ontario, Canada.
⁶ Institute for Clinical Evaluative Sciences, London, Ontario, Canada.
⁷ Division of Nephrology, University of Alberta, Edmonton, Alberta, Canada.
⁸ Department of Medicine, Western University, London, Ontario, Canada.
⁹ The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
¹⁰ Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia.
¹¹ Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, New South Wales, Australia.
¹² Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney, Westmead, New South Wales, Australia.
¹³ Centre for Evaluation of Medicines and Biostatistics Unit, St Joseph's Healthcare, Hamilton, Ontario, Canada.
¹⁴ Departments of Paediatrics and Anaesthesia, McMaster University, Hamilton, Ontario, Canada.
¹⁵ Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.

PMID: 28069624
PMCID: PMC5223708
DOI: 10.1136/bmjopen-2016-013510

Clinical Trial

External validation of the Revised Cardiac Risk Index and update of its renal variable to predict 30-day risk of major cardiac complications after non-cardiac surgery: rationale and plan for analyses of the VISION study

Pavel S Roshanov et al. BMJ Open. 2017.

. 2017 Jan 9;7(1):e013510.

doi: 10.1136/bmjopen-2016-013510.

Authors

Affiliations

¹ Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre, London, Ontario, Canada.
² Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
³ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
⁴ Population Health Research Institute, Hamilton, Ontario, Canada.
⁵ Department of Otolaryngology Head & Neck Surgery and Department of Oncology, Western University, London, Ontario, Canada.
⁶ Institute for Clinical Evaluative Sciences, London, Ontario, Canada.
⁷ Division of Nephrology, University of Alberta, Edmonton, Alberta, Canada.
⁸ Department of Medicine, Western University, London, Ontario, Canada.
⁹ The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
¹⁰ Department of Cardiology, Westmead Hospital, Sydney, New South Wales, Australia.
¹¹ Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District, Sydney, New South Wales, Australia.
¹² Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney, Westmead, New South Wales, Australia.
¹³ Centre for Evaluation of Medicines and Biostatistics Unit, St Joseph's Healthcare, Hamilton, Ontario, Canada.
¹⁴ Departments of Paediatrics and Anaesthesia, McMaster University, Hamilton, Ontario, Canada.
¹⁵ Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.

PMID: 28069624
PMCID: PMC5223708
DOI: 10.1136/bmjopen-2016-013510

Abstract

Introduction: The Revised Cardiac Risk Index (RCRI) is a popular classification system to estimate patients' risk of postoperative cardiac complications based on preoperative risk factors. Renal impairment, defined as serum creatinine >2.0 mg/dL (177 µmol/L), is a component of the RCRI. The estimated glomerular filtration rate has become accepted as a more accurate indicator of renal function. We will externally validate the RCRI in a modern cohort of patients undergoing non-cardiac surgery and update its renal component.

Methods and analysis: The Vascular Events in Non-cardiac Surgery Patients Cohort Evaluation (VISION) study is an international prospective cohort study. In this prespecified secondary analysis of VISION, we will test the risk estimation performance of the RCRI in ∼34 000 participants who underwent elective non-cardiac surgery between 2007 and 2013 from 29 hospitals in 15 countries. Using data from the first 20 000 eligible participants (the derivation set), we will derive an optimal threshold for dichotomising preoperative renal function quantified using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) glomerular filtration rate estimating equation in a manner that preserves the original structure of the RCRI. We will also develop a continuous risk estimating equation integrating age and CKD-Epi with existing RCRI risk factors. In the remaining (approximately) 14 000 participants, we will compare the risk estimation for cardiac complications of the original RCRI to this modified version. Cardiac complications will include 30-day non-fatal myocardial infarction, non-fatal cardiac arrest and death due to cardiac causes. We have examined an early sample to estimate the number of events and the distribution of predictors and missing data, but have not seen the validation data at the time of writing.

Ethics and dissemination: The research ethics board at each site approved the VISION protocol prior to recruitment. We will publish our results and make our models available online at http://www.perioperativerisk.com.

Trial registration number: ClinicalTrials.gov NCT00512109.

Keywords: Risk prediction; SURGERY; cardiac events; perioperative medicine.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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Conflict of interest statement

Conflicts of Interest: None declared.

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References

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External validation of the Revised Cardiac Risk Index and update of its renal variable to predict 30-day risk of major cardiac complications after non-cardiac surgery: rationale and plan for analyses of the VISION study

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External validation of the Revised Cardiac Risk Index and update of its renal variable to predict 30-day risk of major cardiac complications after non-cardiac surgery: rationale and plan for analyses of the VISION study

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Conflict of interest statement

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