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. 2021 Dec 21;2021(12):CD013139. doi: 10.1002/14651858.CD013139.pub2

Valentijn 2012.

Study characteristics
General information Objective 
  • Added biomarkers


Journal
  • American Journal of Cardiology


Country
  • The Netherlands


Study design
  • Prospective cohort study

Participants Number of included patients
  • 1172


Surgical specialty
  • Vascular surgery


Age
  • Mean 68 years (SD 10 years)


Male sex
  • 74%


High‐risk surgery
  • Not reported  


Insulin‐dependent diabetes mellitus
  • Not reported


History of ischaemic heart disease
  • 40.4%


History of congestive heart failure
  • 9.4%


History of cerebrovascular events
  • 33.5%


Elevated creatinine
  • 5.3%


0 to 1 RCRI factors
  • 57.3%


1 RCRI factor
  • Not reported


2 RCRI factors
  • 27%


3 or more RCRI factors
  • Not reported

Predictors Predictor 1:
Aortic value function (aortic valve sclerosis)
  • Objective: added biomarker 

  • Category: imaging

  • Scale: dichotomous

  • Threshold: defined by the presence of thickening and/or calcium of 1 cusp of a tricuspid valve not inducing stenosis (i.e. with a maximal velocity < 2.5 m/s)

  • Assay/device: portable Acuson Cypress ultrasound system (Acuson, A Siemens, Mountain View, California) with a 7V3c transducer or a portable Vivid‐I ultrasound System (Vivid‐I, GE Healthcare, Solingen, Germany) with a 3S‐RS transducer


 
Predictor 2:
Aortic value function (aortic valve stenosis)
  • Objective: added biomarker 

  • Category: imaging

  • Scale: dichotomous

  • Threshold: defined as a jet velocity > 2.5 m/s

  • Assay/device: portable Acuson Cypress ultrasound system (Acuson, A Siemens, Mountain View, California) with a 7V3c transducer or a portable Vivid‐I ultrasound System (Vivid‐I, GE Healthcare, Solingen, Germany) with a 3S‐RS transducer

Outcome Outcome category
  • All‐cause mortality


Full outcome definition
  • Not applicable


Prediction horizon
  • 4 years after surgery

Analysis Domain 1: Participant selection
  • Low


Justification: 
Domain 2: Predictors
  • High


Justification: some of the echocardiographies were performed in the 30 days after surgery
Domain 3: Outcome
  • High


Justification: outcome is all‐cause mortality and not MACE
PROBAST: Applicability Domain 1: Participant selection
  • Low


Justification: patient selection was appropriate and generalisable to the population used in the RCRI development study
Domain 2: Predictors
  • High


Justification: some of the echocardiographies were performed in the 30 days after surgery
Domain 3: Outcome
  • High


Justification: outcome is all‐cause mortality and not MACE
Overall judgement
  • High


Justification: patients selected were generalisable to the patient population used in the RCRI development study. However, some predictors were measures after surgery and outcome definition was different compared to the development study.
Notes
 
Item Authors' judgement Support for judgement
Domain 1: Participant selection Yes Although only patients undergoing vascular surgery were included, participant selection was appropriate and the RCRI model can be applied in these patients. 
Domain 2: Predictors No Some of the echocardiographies were performed in the 30 days after surgery.
Domain 3: Outcome Yes Clearly defined outcome definitions and appropriate adjudication of outcomes.
Domain 4:  Analysis No Categorisation of predictors; no performance measures for additive predictive performance are reported; complete case analysis.
Overall judgement No Patient selection was appropriate. Outcomes were clearly defined and assessed. However, some predictors were not preoperatively available. Furthermore, predictors were categorised, complete case analysis was performed and no reclassification measures were reported.