met-repair: screening - inclusion form€¦ · met : reevaluation for perioperative cardiac risk...

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MET : REevaluation for Perioperative cArdIac Risk MET-REPAIR Appendix 5A Screening / Inclusion form Final Version 1.0 dated 6 Feb 2017 Page 1 of 1 Appendix 5A MET-REPAIR: Screening - Inclusion Form Inclusion criteria - Planned as inpatients after surgery Yes No - Non-cardiac surgery Yes No - Age (at time of operation) 45 years AND NSQIP MICA percentage 1% OR - Age (at time of operation) ≥ 45 years AND Revised Cardiac Risk Index 2 OR - Age (at time of operation) ≥ 65 years AND intermediate or high risk procedure Yes No - Consent Mandatory? Yes No Mandatory unless the centre has an explicit and written exemption from IRB If consent mandatory - Consent obtained Yes No Exclusion criteria - Non-Elective surgery planned to occur ≤ 72 hours after diagnosis of the acute condition that makes the procedure necessary No Yes - Acute coronary syndrome or uncontrolled congestive heart failure within the last 30 days of planned day of surgery No Yes - Stroke within the last 7 days of planned day of surgery No Yes - Long-standing inability to perform ambulation e.g. paraplegics, polio, etc.; NOT joint or pain problems No Yes - Unable to complete the questionnaire No Yes - Unable to consent or unwilling to participate No Yes - Previous enrolment in MET-REPAIR No Yes IF all items confirm patient can be included, THEN, Paper CRF and electronic CRF should be completed. IF patient does not comply with any inclusion criteria, THEN, DO NOT INCLUDE patient in the study Paper CRF and electronic CRF should NOT be completed.

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Page 1: MET-REPAIR: Screening - Inclusion Form€¦ · MET : REevaluation for Perioperative cArdIac Risk MET-REPAIR Appendix 5A Screening / Inclusion form – Final Version 1.0 dated 6 Feb

MET : REevaluation for Perioperative cArdIac Risk

MET-REPAIR Appendix 5A Screening / Inclusion form – Final Version 1.0 dated 6 Feb 2017 Page 1 of 1

Appendix 5A

MET-REPAIR: Screening - Inclusion Form

Inclusion criteria

- Planned as inpatients after surgery Yes No

- Non-cardiac surgery Yes No

- Age (at time of operation) ≥ 45 years AND NSQIP MICA percentage ≥ 1%

OR

- Age (at time of operation) ≥ 45 years AND Revised Cardiac Risk Index ≥ 2

OR

- Age (at time of operation) ≥ 65 years AND intermediate or high risk procedure

Yes No

- Consent Mandatory? Yes No

Mandatory unless the centre has an explicit and written exemption from IRB

If consent mandatory - Consent obtained

Yes

No

Exclusion criteria

- Non-Elective surgery planned to occur ≤ 72 hours after diagnosis of the acute condition that makes the procedure necessary

No Yes

- Acute coronary syndrome or uncontrolled congestive heart failure within the last 30 days of planned day of surgery

No Yes

- Stroke within the last 7 days of planned day of surgery No Yes

- Long-standing inability to perform ambulation

e.g. paraplegics, polio, etc.; NOT joint or pain problems

No Yes

- Unable to complete the questionnaire No Yes

- Unable to consent or unwilling to participate No Yes

- Previous enrolment in MET-REPAIR No Yes

IF all items confirm patient can be included,

THEN, Paper CRF and electronic CRF should be completed.

IF patient does not comply with any inclusion criteria,

THEN, DO NOT INCLUDE patient in the study

Paper CRF and electronic CRF should NOT be completed.

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MET : REevaluation for Perioperative cArdIac Risk

MET-REPAIR Appendix 5B CRF Confidential Identification Coversheet – Final Version 1.0 dated 6 Feb

2017

Page 1 of 1

Appendix 5B

MET-REPAIR: Patient Confidential Identification CRF Coversheet

This coversheet is intended to help site staff and local investigator link local patient data to the study-specific study patient code. This sheet is used to facilitate this task for investigators; it can be filled to your convenience. After completing follow-up, this coversheet should be saved separately from the CRF and filed in a secure place. The information on this coversheet will NOT be collected in the CRF. It is for local use ONLY.

IDENTIFYING DATA

A Date paper CRF created |__|__| / |__|__|__| / |__|__|__|__| (dd/Mmm/YYYY)

B Date of birth |__|__| / |__|__|__| / |__|__|__|__| (dd/Mmm/YYYY)

C1 Patient Code (OpenClinica eCRF

ID number) |__|__|__|-|__|__|__|-|__|__|__| (xxx-xxx-xxx 3 digit code for the

country, 3 digit code for the hospital and 3 digit individual patient number)

C2

Identification

fill in with available data – only for local follow-up use:

Patient Hospital/local Identification Number (handwritten or sticker):

First name:

Last name:

Completion progress of the study forms: Paper CRF OpenClinica electronic CRF

CRF1: PREOPERATIVE CHARACTERISTICS - Patient Data and Planned Surgery (1.1-1.10) - Preoperative Comorbidities (1.11-1.28) - Functional Capacity Questionnaire (1.29-1.35)

CRF2: ANAESTHESIA DATA - Intraoperative data (2.1-2.5)

CRF3: POST SURGERY DATA - Postoperative Data (3.1-3.7) - Adjudicated Outcomes (3.8-3.15)

CRF4: NTproBNP SUBSTUDY (4.1-4.3) (only for centres participating to this substudy)

CRF5: PREOPERATIVE CARDIOLOGY CONSULTATION AND PREOPERATIVE CARDIAC TESTING - 5.1. Preoperative Cardiology Consultation - 5.2. Preoperative Ergometry - 5.3. Preoperative Echocardiography (rest) - 5.4. Preoperative Stress-Echocardiography - 5.5. Myocardial perfusion study

- 5.6. Coronary Angiogram (within 12 months prior to surgery)

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MET : REevaluation for Perioperative cArdIac Risk

MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 1 of 10

Appendix 5C

MET-REPAIR Case Report Form

CRF 1: PREOPERATIVE CHARACTERISTICS

PATIENT DATA AND PLANNED SURGERY

1.1

Study Subject ID: |__|__|__|-|__|__|__|-|__|__|__| Enter Study Subject ID in this format xxx-xxx-xxx 3 digit code for the country, 3 digit code for the hospital and 3 digit individual patient number

1.2

Informed consent applicable?

Yes No choose no only if consent process has been confirmed in writing as not needed by local Ethics

1.2.1 If yes, was consent obtained? Yes No

1.2.1.1 If obtained, date of informed consent |__|__|- |__|__|__| -|__|__|__|__| in this format dd-Mmm-YYYY (Month in English starting with capital letter)

1.3 Year of birth:

|__|__|__|__| (e.g. 1971)

patient must be ≥ 45 years of age on the inclusion date

1.4 Gender: Male Female

1.5 Weight:

|__|__||__| kg [40-120]

1.6 Height:

|__|__||__| cm [140-210]

1.7 Preoperative functional status

☐ fully independent ☐ partially dependent ☐ fully dependent

1.8 Planned type of surgery Low risk Moderate risk High risk

see Appendix 5D CRF Instructions

1.9

Planned intrathoracic, intra-abdominal, or suprainguinal vascular surgery?

Yes No

1.10

Planned procedure site (as per NSQIP MICA)

Anorectal Aortic Bariatric Brain Breast ENT (not thyroid/parathyroid) Foregut/Hepatopancreatobiliary Gallbladder, appendix, adrenal and

spleen Hernia (ventral, inguinal, femoral) Intestinal

Neck (thyroid/parathyroid) Obstetric/Gynecologic Orthopedic and non-vascular

extremity Other abdominal Peripheral vascular Skin Spine Non-esophageal thoracic Vein Urology

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MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 2 of 10

PREOPERATIVE COMORBIDITIES

1.11 ASA Physical Status: I II III IV V

Choose single most appropriate

1.12

Diabetes mellitus

diagnosis of diabetes mellitus reported in preoperative clinical documentation or corresponding medication

No Diet Oral antidiabetics Insulin

1.13 History of Hypertension

Yes No

yes, if diagnosis reported in any preoperative clinical documentation of if history of correspondent treatment

1.14 History of Congestive Heart Failure

Yes No

yes, if diagnosis reported in any preoperative clinical documentation of if history of correspondent treatment

1.15 History of Coronary Artery Disease

Yes No

yes, if diagnosis reported in any preoperative clinical documentation or if history of myocardial infarction (1.16), correspondent interventions (1.17-1.18), or medical treatment

1.16 Previous Myocardial infarction?

Yes No

1.16.1 If yes, date of last MI: |__|__| - |__|__|__| - |__|__|__|__|

1.17

Previous percutaneous coronary intervention?

Yes No

1.17.1 If yes, date of last PCI: |__|__| - |__|__|__| - |__|__|__|__|

1.18

Previous coronary artery bypasss grafting?

Yes No 1.18.1 If yes, date of last CABG: |__|__| - |__|__|__| - |__|__|__|__|

1.19 History of peripheral vascular disease

Yes No yes, if diagnosis reported in any preoperative clinical documentation of if Hx of correspondent interventions (e.g. PTA, vascular surgery)

1.20 History of Stroke or TIA

Yes No yes, if diagnosis reported in any preoperative clinical documentation of if Hx of correspondent interventions

1.21

Creatinine Preop:

preoperative creatinine (closest to operation date and ≤3 months)

|__|__|__|__|.|__| 1.21.1 μmol/L [1.0-3000.0]

mg/dL [0.1-30.0]

1.22 Preoperative Dialysis Yes No

yes, if diagnosis reported in any preoperative clinical documentation

1.23

History of severe valvular stenosis

if reported in any preoperative clinical documentation or refer to CRF Instructions (App. 5D) for echocardiographic definitions

Yes No

1.23.1 If yes, check all that apply : Mitral valve Aortic valve Tricuspid valve Pulmonary valve

1.24

History of severe valvular regurgitation

if reported in any preoperative clinical documentation or refer to CRF Instructions (App. 5D) for echocardiographic definitions

Yes No

1.24.1 If yes , check all that apply : Mitral valve Aortic valve Tricuspid valve Pulmonary valve

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MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 3 of 10

1.25

Chronic Obstructive Pulmonary Disease ?

COPD diagnosis reported in preoperative clinical documentation or corresponding medication

Yes No

1.26

Smoking

as reported in clinical documentation

Yes Stopped (≥ 1 month prior to

preoperative data collection) No (never smoked)

1.26.1 Total lifetime pack years |__|__|__| See App 5D CRF instruction

1.27 Active cancer

Yes No

undergoing surgery for cancer OR known metastatic disease OR patient has received active treatment for their cancer (e.g., chemotherapy, radiation, or surgery) within the last 6 months

1.28

Preoperative medication

last intake up to 7 days before surgery; check all that apply

Aspirin ADP-inhibitors Vit K-antagonits NOAK B-Blocker Inhibitors of renin angiotensin system (ACE-inhibitors, ADII Antagonists,

renin inhibitors, Angiotensin receptor neprilysin inhibitors) CA-blockers Statins Nitrate Diuretics Mineralocorticoid/aldosterone receptor antagonists PDE-Inhibitors or Endothelin-Inhibitors Bronchodilators (Anticholinergics or beta2-agonists or combinations)

or steroid for COPD Oral antidiabetics Insulin None of the above

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MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 4 of 10

FUNCTIONAL CAPACITY QUESTIONNAIRE (as filled out by the patient)

1.29 Date of Completion |__|__|- |__|__|__| -|__|__|__|__| [>=01-Jan-2017]

enter date in this format dd-Mmm-YYYY (Month in English starting with capital letter)

1.30 Answers to “Yes/no” questions of questionnaire

as filled out by patient

YES NO N/A

1.30.1.Stair climbing at rapid pace; Carrying upstairs a suitcase (10-20kg); Running ☐ ☐ ☐

1.30.2 Moving furniture, household items; Lifting light loads; Running, playing with children or animals at vigorous effort; Swimming (recreational)

☐ ☐ ☐

1.30.3 Carrying groceries upstairs; Jogging; Recreational soccer or tennis ☐ ☐ ☐

1.30.4 Descending stairs; Making beds; Vacuuming or sweeping floors; Walking the dog for pleasure; Playing with children at moderate effort

☐ ☐ ☐

1.30.5 Stair climbing at slow pace; Hanging wash; Cleaning the bathroom; Mowing lawn (power mower); Raking lawn or sweeping outside the house; Leisure bicycling; Walking for exercise, level, moderate pace

☐ ☐ ☐

1.30.6. Sitting, reading, watching TV, listening to music ☐ ☐ ☐

1.30.7. Moving household items upstairs carrying boxes; Climbing hills carrying ≥ 20 kg; Swimming fast

☐ ☐ ☐

1.30.8 Hiking cross country; Walking for exercise uphill; Biking to/from work at self-selected pace; Scrubbing floors on hands and knees, vigorous effort; Mowing lawn (hand mower); Shoveling snow; Chopping wood vigorous effort

☐ ☐ ☐

1.30.9 Walk indoors, such as around your house; Dressing/undressing ☐ ☐ ☐

1.30.10. Carrying loads ≥ 25 kg (e.g. furniture, 2 suitcases) upstairs; Running 10 km/h Please notice: 10km/h is faster than a bicycle at leisure pace

☐ ☐ ☐

1.31

How many floors can you continuously climb without having to stop to rest?

Single choice

<1 1 2 3 4 >4

1.32 Self-reported Preoperative functional status Single choice

Totally Independent Partially Independent Totally Dependent

1.33 How do you rate your cardiorespiratory fitness compared to your peers? Single choice

Lower Same Higher

1.34

Choose one activity category that best describes your usual pattern of daily physical activities, (including activities related to house and family care, transportation, occupation, exercise and wellness and leisure or recreational purposes).

as filled out by patient.Single choice

Inactive or little activity other than usual daily activities

Regularly (≥ d/wk) participate in physical activities requiring low levels of exertion that result in slight increases in breathing and heart rate for at least 10 minutes at a time

Brisk walking, jogging or running, cycling, swimming, or vigorous sports at a comfortable pace or other activities requiring similar levels of exertion for 20 to 60 minutes per week

Brisk walking, jogging or running, cycling, swimming, or vigorous sports at a comfortable pace or other activities requiring similar levels of exertion for 1 to 3 hours per week

Brisk walking, jogging or running, cycling, swimming, or vigorous sports at a comfortable pace or other activities requiring similar levels of exertion for over 3 hours per week.

1.35 Do bone, muscle, or neurological disorders/diseases impair your physical activity? (tick all that apply)

Yes Bone/Muscle Yes Neurological No

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MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 5 of 10

CRF 2: ANAESTHESIA DATA

INTRAOPERATIVE DATA

2.1

Date and time of incision

2.1.1 Date |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

[>=Date of questionnaire completion] 2.2 2Time |__|__| : |__|__| (hh:mm) [0-23] hrs [0-59] min

2.2 Type of anaesthesia

General General combined with regional

2.2.1 neuraxial peripheral Regional-peripheral Regional-neuraxial Regional-combined peripheral and neuraxial

2.3 Performed Type of Surgery

Low-risk Moderate-risk High-risk See CRF instructions (App 5D)

2.4

Performed intrathoracic, intra-abdominal, or suprainguinal vascular surgery?

Yes No

2.5

Performed procedure site

NSQIP-MICA

Anorectal Aortic Bariatric Brain Breast ENT (not thyroid or parathyroid) Foregut/Hepatopancreatobiliary Gallbladder Appendix Adrenal and spleen Hernia (ventral, inguinal, femoral)

Intestinal Neck (thyroid / parathyroid) Obstetric/Gynaecologic Orthopaedic and non-vascular

extremity Other abdominal Peripheral vascular Skin Spine Non-oesophageal thoracic Vein Urology

2.6 Date and Time of End of operation

(skin closure completed)

2.6.1 Date |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

[>=Date of time incision] 2.6 2Time |__|__| : |__|__| (hh:mm) [0-23] hrs [0-59] min

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CRF 3: POST SURGERY DATA

POSTOPERATIVE DATA

3.1

Type of first ICU admission?

No ICU admission

Planned, i.e. decision of ICU admission prior to anesthesia induction

Unexpected, i.e. decision of ICU admission

during/after anaesthesia induction

3.2

Date Arrival ICU

|__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

[>=Date of skin closure]

3.3 Date Discharge ICU

|__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

3.4

Was Patient readmitted to ICU (second stay in ICU) ? Yes No

3.4.1 If readmitted, date? |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY) [>=Date of Discharge 3.3] 3.4.2 Second Discharge date |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY) [>=Date of readmission]

3.5

Was Patient readmitted to ICU (Third stay in ICU)? Yes No

3.5.1 If readmitted, date? |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY) [>=Date of 2nd Discharge] 3.5.2 Third discharge from ICU |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY) [>=Date of 3rd readmission]

3.6

Was Patient readmitted to ICU (Fourth stay in ICU)?? Yes No

3.6.1 If readmitted, date? |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY) [>=Date of 3rd Discharge] 3.6.2 Final discharge from ICU |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY) [>=Date of 4th readmission]

3.7 Does the centre implement a routine perioperative troponin monitoring?

Yes No

3.7.1. If yes, did the patient suffer MINS?

Myocardial injury after noncardiac surgery, as defined in relevant Appendix to the protocol-

Yes No

3.7.1.1 Date of MINS |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

3.7.1.2. Type Troponin assay (single choice)

Troponin I high-sensitivity Troponin I

Troponin T high-sensitivity Troponin T

3.7.1.3 Highest postoperative troponin for MINS |__|__|__|__| ng/L Please be aware of unit

3.8

Grade of most severe complication

according to Clavien-Dindo class (single choice)

None I II IIIa IIIb IVa IVb V

3.8.1 If any, organ system of most severe complication

Organ system affected by the complication with the highest Clavien Dindo class, if several with the same class check all that apply

Cardiovascular, non-MACE Respiratory Neurological, non-stroke Gastrointestinal Renal Other

3.82 If any, date of most severe complication

Date of diagnosis/detection If several with the same class please report the first occurrence/diagnosis

|__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

3.9 Date Hospital Discharge |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

[>=Date of skin closure]

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MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 7 of 10

ADJUDICATED OUTCOMES

3.10 When was follow-up performed? |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

[>=Date of skin closure]

3.11 How was follow-up performed? Inhospital, at discharge or at day 30, whichever came first By phone or by mail, at Day 30 or up to 14 days after day 30.

3.12 Did the patient die? Yes No

3.12.1. If yes, date of death |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

3.12.2. If yes, cardiovascular cause of death?

as defined in Protocol

No Fatal myocardial infarction Cardiac arrest Fatal heart failure or cardiogenic shock Fatal stroke Fatal complications of cardiac revascularisation procedure Death of unknown cause

3.13 Did the patient suffer MACE?

as defined in relevant Appendix to the protocol

None Non-fatal STEMI Non-fatal NSTEMI Non-fatal cardiac arrest Non-fatal heart failure or cardiogenic shock Non-fatal stroke

3.13.1. If yes, date of MACE |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

3.14 Did patient suffer second MACE?

None Non-fatal STEMI Non-fatal NSTEMI Non-fatal cardiac arrest Non-fatal heart failure or cardiogenic shock Nonfatal Stroke

3.14.1. If any, date of second MACE |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

3.15 Did patient suffer third MACE?

None Non-fatal STEMI Non-fatal NSTEMI Non-fatal cardiac arrest Non-fatal heart failure or cardiogenic shock Nonfatal Stroke

3.15.1. If any, date of third MACE |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

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MET-REPAIR Appendix 5C: Data acquisition sheets/CRF-Final Version 1.0 dated 7 Feb 2017 Page 8 of 10

CRF 4: NTproBNP SUBSTUDY

4.1

Does the centre participate to the NTproBNP substudy

Yes No; if no, do not complete CRF4 and proceed to CRF5 if applicable

4.2 If yes, was consent obtained?

Yes No

4.2.1. Date of Informed Consent |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY) format dd-Mmm-YYYY (Month in English starting with capital letter)

4.3. NTproBNP |__|__|__|__|__|ng/L [0-5000]

4.3.1. Date of NTproBNP sampling |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

CRF 5. PREOPERATIVE CARDIOLOGY CONSULTATION AND PREOPERATIVE CARDIAC TESTING

5.1 Preoperative Cardiology Consultation

5.1

Cardiology consultation

Evaluation by a cardiologist or a resident affiliated to a Cardiology Service; within 6 months prior to surgery

Yes - If yes, please complete sections below

No

5.1.1 Date of most recent cardiology consultation : |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

5.1.2

Recommendation for cardiac testing

Please check all that apply

No

Ergometry

Echocardiography at rest

Stress Echocardiography

Myocardial Perfusion study Coronary angiogram

5.1.3

Recommendation for new medication

Please check all that apply

No Aspirin ADP-inhibitors Vit K-antagonits NOAK B-Blocker Inhibitors of renin angiotensin system

(ACE-inhibitors, ADII Antagonists, renin inhibitors, Angiotensin receptor neprilysin inhibitors)

CA-blockers Statins Nitrate Diuretics Mineralocorticoid/aldosterone

receptor antagonists PDE-Inhibitors or Endothelin-

Inhibitors

Preoperative Ergometry

5.2 Preoperative Ergometry within 6 months prior to surgery?

Yes => please fill items below

No => please go to item 5.3

5.2.1 Date of most recent ergometry : |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

5.2.2 MAX workload ergometry

|__|__|__| Watt

5.2.3 Clinically positive ergometry

Yes No

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5.2.4

Electrically positive ergometry Check all that apply

No Anterior Septal Lateral

Inferior

Preoperative Echocardiography (rest)

5.3 Preoperative Echocardiography within 6 months prior to surgery?

Yes => please fill items below

No => please go to item 5.4

5.3.1 Date of most recent echocardiography: |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

5.3.2 New diagnosis of severe stenosis Check all that apply

No Mitral valve Aortic valve Tricuspid valve Pulmonary valve

5.3.3 New diagnosis of severe regurgitation Check all that apply

No Mitral valve Aortic valve Tricuspid valve Pulmonary valve

5.3.4 Regional wall motion abnormality Check all that apply

No Anterior Septal Lateral Inferior

5.3.5 Estimated EF echocardiography |__|__| %

5.4. Preoperative Stress-Echocardiography

5.4 Preoperative Stress-Echocardiography within 6 months prior to surgery?

Yes => please fill items below

No => please go to item 5.5

5.4.1 Date of most recent stress echocardiography:

|__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

5.4.2 New diagnosis of severe stenosis Check all that apply

No Mitral valve Aortic valve Tricuspid valve Pulmonary valve

5.4.3 New diagnosis of severe regurgitation Check all that apply

No Mitral valve Aortic valve Tricuspid valve Pulmonary valve

5.4.4

Regional wall motion abnormality at rest

Check all that apply (e.g. for anteroseptal location check anterior AND septal)

No Anterior Septal Lateral Inferior

5.4.5

Regional wall motion abnormality during stress Check all that apply (e.g. for anteroseptal location check anterior AND septal)

No Anterior Septal Lateral Inferior

5.4.6 Estimated EF stress echocardiography |__|__| %

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Myocardial perfusion study

5.5 Myocardial perfusion study within 6 months prior to surgery?

Yes => please fill items below

No => please go to item 5.6

5.5.1 Date of most recent myocardial perfusion study:

|__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

5.5.2 Scar tissue myocardial perfusion study Check all that apply

No Anterior Septal

Lateral Inferior

5.5.3

Ischemia location in myocardial perfusion study

Check all that apply

No Anterior Septal Lateral Inferior

5.5.4 Estimated EF myocardial perfusion study |__|__| %

Coronary Angiogram

5.6 Myocardial perfusion study within 12 months prior to surgery?

Yes => please fill items below

No

5.6.1 Date of most recent coronary angiogram: |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

5.6.2 Stenosis Location and degree Report stenosis ≥ 50%, check all that apply

None Left main |__|__| % Proximal LAD |__|__| % LAD non-proximal |__|__| % RCX |__|__| % RCA |__|__| %

5.6.3 Estimated EF ventriculogram if applicable |__|__| %

5.6.4 Type of revascularisation

None PCI ballon angioplasty PCI bare metal stent PCI drug eluting stent

CABG

5.6.4.1 Location of revascularisation

Check all that apply

None Left main Proximal LAD LAD non-proximal RCX

RCA

5.6.4.2 Date of revascularisation: |__|__| - |__|__|__| - |__|__|__|__| (dd/Mmm/YYYY)

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MET-REPAIR: CRF INSTRUCTIONS This document is intended to aid in the completion of the CRF. Should you have any questions or should uncertainties arise, please do not hesitate to contact the ESA Secretariat at [email protected] Frequently Asked Questions and answers will be made available on esahq.org/met-repair

CONTENTS

1. General instructions: .............................................................................................................................. 2

2. Screening –Inclusion Form (App 5A) ..................................................................................................... 3

2.1. Inclusion Criteria section ............................................................................................................... 3

2.2. Exclusion criteria Section: ............................................................................................................. 4

3. Patient Confidential Identification CRF Coversheet (App.5B) ............................................................... 5

4. Case Report Form (CRF – App?5C) ..................................................................................................... 6

1.5. Weight ............................................................................................................................................. 6

1.6. Height .............................................................................................................................................. 6

1.7. Preoperative functional status ........................................................................................................ 6

1.8 Planned type of surgery ................................................................................................................... 6

1.10 Planned procedure site .................................................................................................................. 6

1.11 ASA Physical Status ...................................................................................................................... 7

1.23 and 1.24 severe valvular disease: ................................................................................................. 7

1.26 Smoking ......................................................................................................................................... 9

1.26.1 Smoking time: ............................................................................................................................. 9

1.30 Questionnaire ................................................................................................................................. 9

2.2. Type of anesthesia.......................................................................................................................... 9

2.3 Performed type of surgery ............................................................................................................. 10

2.4. Performed intrathoracic, intraabdominal or suprainguinal vascular surgery ................................ 10

2.5 Performed procedure site .............................................................................................................. 10

3.1. Type of ICU admission ................................................................................................................. 10

3.7.1 Myocardial injury after noncardiac surgery (MINS) .................................................................... 10

3.8 Clavien-Dindo Classification [8] ..................................................................................................... 10

3.9. How was follow-up performed? .................................................................................................... 11

3.12. Did the patient die? ..................................................................................................................... 11

30.12.2.Cardiovascular Cause of Death .............................................................................................. 11

3.13. MACE .......................................................................................................................................... 11

5. Table of Abbreviations: ........................................................................................................................ 13

6. References ........................................................................................................................................... 14

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1. General instructions:

- The date format for all fields is dd-Mmm-YYYY (e.g. 06-Jan-1978) - Data will be collected directly from source documents into the encoded paper CRF and secondarily

entered into the eCRF. A copy of the original source documents will be stored within a locked cabinet/office accessible to authorised personnel only in accordance with local and national regulations. The Patient Confidential Identification CRF Coversheet (page 2) and assigned patient identification code will be stored separately also in a locked cabinet/office (accessible to authorised personnel only) in order to record inhospital outcomes, supply missing data points, and to allow potential monitoring visits by National Coordinating Investigators, Sponsor, IRB, or regulatory authorities. Signed ICF to document that written informed consent was obtained prior to enrolment will be stored as described above. All study documents will be archived as required by local legislation. Blood samples (NTproBNP substudy) will not be stored after measurement of NTproBNP and will be destroyed locally as per local practice by the laboratory.

- The paper CRF should be completed at patient inclusion. Data from the paper CRF should be entered electronic CRF no more than 8 weeks after patient inclusion.

- After the end of the study, if there are queries on data entered in the electronic CRF, centres may receive a Data Clarification Form (DCF). The DCF must be completed, signed and returned within 1 week to the study team.

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2. Screening –Inclusion Form (App 5A)

2.1. Inclusion Criteria section

NSQIP MICA [1]

Calculated on the basis of age, creatinine, ASA class, preoperative functional status, and site of surgery.

This may be calculated online: https://qxmd.com/calculate/gupta-perioperative-cardiac-risk

rRCI [2]

Calculated on the basis of

Creatinine ≥2 mg/dL = 177 mmol/L

History of heart failure

Insulin-dependent diabetes mellitus

Intrathoracic, intra-abdominal, or suprainguinal vascular surgery

History of cerebrovascular accident or TIA

Ischemic heart disease Patients are eligible if they present at least 2 of the mentioned risk factors.

Low risk procedure Intermediate Risk Procedures High risk procedures

Vascular asymptomatic Carotid

Carotid symptomatic (CEA or CAS)

OPEN abdominal aortic aneurysm repair

Hemodialysis access procedure

Endovascular abdominal aortic aneurysm repair

OPEN Major vascular surgery (suprainguinal)

Endovascular infrainguinal Vascular reconstruction

OPEN lower limb revascularisation

Peripheral arterial angioplasty Embolectomy/Thrombectomy

Renal transplant Amputation

Abdominal Rectal/ anal surgery Hiatal hernia repair Exploratory laparotomy

Hernia OPEN Nissen fundoplasty Repair of perforated bowel

Laparascopic hernia Splenectomy Stomach surgery

Laparascopic cholecystectomy Laparoscopic splenectomy Enterostomy

Laparascopic appendectomy

Laparoscopic colectomy or small bowel resection Colectomy

Appendectomy Repair of enteric fistula Small bowel resection

Laparascopic fundoplication OPEN Cholecystectomy Bile duct surgery

Laparascopic gastric bypass Laparoscopic liver procedure Liver resection

Gastric bypass Duodeno-pancreatic surgery

Laparoscopic procedure, stomach Pancreatic resection

Laparascopic adrenal OPEN Adrenal resection

Liver transplantat

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Low risk procedure Intermediate Risk Procedures High risk procedures

Head and neck surgery Thyroid, Parathyroid major _

Neurological or orthopaedic

Arthroscopy, Laminectomy, total knee replacement major (hip and spine surgery) _

Intra-thoracic non-major Pneumonectomy

Esophagectomy

Lung transplantat

Urological

Transurethral resection of the prostate major OPEN Adrenal resection

minor, e.g. other transurethral Total cystectomy

Gynecolo-gical

Breast surgery, hysterectomy (including open for benign pathologies), Ovary - salpingectomy, curettage major

Other

Lymph node, vein ligation, soft tissue excision _ _

Eye, dental

reconstructive

2.2. Exclusion criteria Section:

- “Acute coronary syndrome”: if documented physician´s diagnosis in the clinical records or if documented lab, clinical, and ECG evidence [4]

- “Uncontrolled congestive heart failure”: if documented physician´s diagnosis in the clinical records or if heart failure requiring hospitalization or transfer to a higher level of care

- “Stroke”: if documented physician´s diagnosis in the clinical records or if documented radiological evidence

- “Long-standing inability to perform ambulation”: e.g. papaplegics, polio, muscular dystrophy,… Please notice that this does NOT refer to impairment resulting from bone/joint problems, e.g resulting in hip or knee replacement or spinal surgery or from claudicatio due to vascular cause

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3. Patient Confidential Identification CRF Coversheet (App.5B) Please note: this sheet is intended as an aid in local site organization and will help you keep track of CRF still pending completion. The columns are not exclusive: one column tracks completion of the paper CRF, the other of the eCRF.

The Patient Confidential Identification CRF Coversheet should be stored separately from the CRF and data from this sheet is not collected in the eCRF.

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4. Case Report Form (CRF – App?5C) Please note that numbering refers to CRF items.

1.5. Weight: in kg

1.6. Height: in cm

1.7. Preoperative functional status: fully independent, partially dependent, fully dependent

American College of Surgeons http://riskcalculator.facs.org/RiskCalculator/PatientInfo.jsp

1.8 Planned type of surgery: Low risk, moderate risk, high-risk [5]. Please notice that this refers to the planned procedure and may differ from the actually performed procedure (to be recorded in CRF 2, 2.3)

1.9. Planned intrathoracic, intraabdominal or suprainguinal vascular surgery: please notice this is required for rCRI calculation and is not redundant with point 1.8. Please notice that this refers from the planned procedure and may differ to the actually performed procedure (to be recorded in CRF 2, 2.4)

1.10 Planned procedure site (as per NSQIP MICA) [1]

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List available CRF and in NSQIP MICA risk calculator: https://qxmd.com/calculate/gupta-perioperative-cardiac-risk. Please notice that this refers to the planned procedure and may differ from the actually performed procedure (to be recorded in CRF 2, 2.5).

1.11 ASA Physical Status:

ASA PHYSICAL STATUS CLASSIFICATION SYSTEM Last approved by the ASA House of Delegates on October 15, 2014

Current definitions (NO CHANGE) and Examples (NEW)

ASA PS Classification

Definition Examples, including, but not limited to:

ASA I A normal healthy patient Healthy, non-smoking, no or minimal alcohol use

ASA II A patient with mild systemic disease

Mild diseases only without substantive functional limitations. Examples include (but not limited to): current smoker, social alcohol drinker, pregnancy, obesity (30 < BMI < 40), well-controlled DM/HTN, mild lung disease

ASA III A patient with severe systemic disease

Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of MI, CVA, TIA, or CAD/stents.

ASA IV A patient with severe systemic disease that is a constant threat to life

Examples include (but not limited to): recent ( < 3 months) MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, DIC, ARD or ESRD not undergoing regularly scheduled dialysis

ASA V A moribund patient who is not expected to survive without the operation

Examples include (but not limited to): ruptured abdominal/thoracic aneurysm, massive trauma, intracranial bleed with mass effect, ischemic bowel in the face of significant cardiac pathology or multiple organ/system dysfunction

ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

1.23 and 1.24 severe valvular disease:

If reported as such in any preoperative clinical record or if echocardiographic documentation as defined in Table 4 and Table 5 of the ESC guidelines on valvular disease [6]

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1.26 Smoking: “stopped” refers to cessation of ≥ 1 month prior to preoperative data collection

1.26.1 Smoking time: Please report lifetime pack years for smokers AND for previous smokers (stopped)

1.30 Questionnaire: Please instruct patients to check

YES if they are able to performANY of the activities listed in each section; e.g. for 1.30.1. YES if able to rapidly climb stairs but unable to carry a suitcase upstairs and unable to run and vice versa

NO only if they are unable to perform all listed activities, e.g. for 1.30.1. NO requires inability to walk rapidly upstairs AND inability to carry suitcase AND inability to run

2.2. Type of anesthesia:

- “regional-peripheral” includes any combination of peripheral single-shot and/or catheters of one or more nerves, e.g. single-shot popliteal blockade and femoral catheter

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- “regional-neuroaxial” includes combined spinal-epidural technique

2.3 Performed type of surgery: Low risk, moderate risk, high-risk [5]. Please notice that this refers to the performed procedure and may differ from the initially planned procedure (to be recorded in CRF 1, 1.8)

2.4. Performed intrathoracic, intraabdominal or suprainguinal vascular surgery: please notice this is required for rCRI calculation and is not redundant with point 2.3. Please notice that this refers from the performed procedure and may differ to the initially planned procedure (to be recorded in CRF 1, 1.19).

2.5 Performed procedure site (as per NSQIP MICA) [1]

List available CRF and in NSQIP MICA risk calculator: https://qxmd.com/calculate/gupta-perioperative-cardiac-risk. Please notice that this refers to the performed procedure and may differ from the initially planned procedure (to be recorded in CRF 1, 1.20).

3.1. Type of ICU admission

ICU refers to units with continuous monitoring of vitals, possibility of noninvasive and/or invasive ventilation and of administration of iv-inotropes and vasopressors; ICU admission does not include stay overnight in the postanesthesia care unit

3.7.1 Myocardial injury after noncardiac surgery (MINS)

Troponin elevation >99 percentile upper limit of the norm presumably of cardiac origin [7]. Please notice: this should be reported only if your centre is conducting a perioperative troponin monitoring.

3.8 Clavien-Dindo Classification [8]

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3.15.1 If any, organ system of most severe complication

Organ system affected by the complication with the highest Clavien Dindo class, if several with the same class check all that apply. For class IVb ( multiorgan dysfunction) please check the affected organs. For death, please check the organ initially affected, e.g. death resulting from pneumonia

3.15 Grade of most severe complication

according to Clavien-Dindo class None I-II IIIa IIIb IVa IVb V

3.15.1 If any, organ system of most severe complication

Organ system affected by the complication with the highest Clavien Dindo class, if several with the same class check all that apply

Cardiovascular, non-MACE Respiratory Neurological, non-stroke Gastrointestinal Renal Other

3.9. How was follow-up performed?

Some centres collect in addition to inhospital outcome, data on events occurring after discharge from the index hospitalization up to day 30 after surgery. Follow-up after discharge can be conducted by phone or by mail. Please acquire relevant source documentation for events occurring after discharge, e.g. from the family physician or relevant institutions.

3.12. Did the patient die?

Any inhospital death up to day 30 after surgery if still hospitalized at day 30 after surgery or up to day 30 in centres conducting followup after discharge.

30.12.2.Cardiovascular Cause of Death

Any death presumably of cardiac or vascular origin, defined as fatal myocardial infarction, cardiac arrest, heart failure or cardiogenic shock, fatal stroke, fatal complications of cardiac revascularization procedure, death of unknown cause.

3.13. MACE

- non-fatal cardiac arrest successful resuscitation from documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, pulseless electrical activitiy requiring cardiopulomarycardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation or documented physician´s diagnosis of nonfatal cardiac arrest in the clinical records.

- acute myocardial infarction according to third universal definition, i.e. evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Under these conditions any one of the following criteria meets the diagnosis for MI:

• Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischemia; New or presumed new significant ST-segment–T wave (ST–T) changes or new left bundle branch block; Development of pathological Q waves in the ECG; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Identification of an intracoronary thrombus by angiography or autopsy.

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• Cardiac death with symptoms suggestive of myocardial ischemia and presumed new ischemic ECG changes or new left bundle branch block, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased.

• Percutaneous coronary intervention (PCI) related MI is arbitrarily defined by elevation of cTn values (>5 × 99th percentile URL) in patients with normal baseline values (≤99th percentile URL) or a rise of cTn values >20% if the baseline values are elevated and are stable or falling. In addition, either (i) symptoms suggestive of myocardial ischemia or (ii) new ischemic ECG changes or (iii) angiographic findings consistent with a procedural complication or (iv) imaging demonstration of new loss of viable myocardium or new regional wall motion abnormality are required.

• Stent thrombosis associated with MI when detected by coronary angiography or autopsy in the setting of myocardial ischemia and with a rise and/or fall of cardiac biomarker values with at least one value above the 99th percentile URL.

• Coronary artery bypass grafting (CABG) related MI is arbitrarily defined by elevation of cardiac biomarker values (>10 × 99th percentile URL) in patients with normal baseline cTn values (≤99th percentile URL). In addition, either (i) new pathological Q waves or new LBBB, or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality [1] or documented physician´s diagnosis of myocardial infarction in the clinical records.

ST-Elevation is defined as below

- congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU of at least one clinical sign (i.e. elevated jugular venous pressure, respiratory rales/crackles, crepitations, or presence of S3) and one radiographic finding (i.e. vascular redistribution, interstitial/alveolar pulmonary edema) or the documented physician´s diagnosis of congestive heart failure AND clinical records indicating that heart failure was a main trigger for ICU or intermediate care transfer and for prolonged ICU stay, respectively. ICU or intermediate care unit refer to units with continuous monitoring of vitals, possibility of noninvasive and/or invasive ventilation and of administration of iv-inotropes and vasopressors. Prolonged refers to an extension of ≥ 24h of expected ICU/IMC duration after specific surgical procedures according to local standards.

- stroke ar in origin with signs and symptoms lasting > 24h or documented physician´s diagnosis of stroke in the clinical records.

5.3.2-3. New diagnosis of severe stenosis /regurgitation in rest echocardiography

If reported as such in echocardiography summary comment or if echocardiographic documentation as defined in Table 4 and Table 5 of the ESC guidelines on valvular disease (see p.14) [6] of a previously unknown severe stenosis/regurgitation or of a progressing stenosis/regurgitation (i.e. previously described as less then severe)

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5.4.2-3. New diagnosis of severe stenosis / regurgitation in stress echocardiography

If reported as such in echocardiography summary comment or if echocardiographic documentation as defined in Table 4 and Table 5 of the ESC guidelines on valvular disease [6] of a previously unknown severe stenosis/regurgitation or of a progressing stenosis/regurgitation (i.e. previously described as less then severe)

5. Table of Abbreviations: ADP-inhibitors Adenosine diphosphate-inhibitor

ASA American Society of Anesthesiologists

CABG Coronary Artery Bypass Grant

CAD Coronary Artery Disease

CHF Congestive Heart Failure

COPD Chronic Obstructive Pulmonary Disease

CRF Case Report Form

EF Ejection Fraction

ENT Ears, Nose, Throat

ICU Intensive Care Unit

MACE Major Adverse Cardiac Event

MI Myocardial Infarction

MINS Myocardial Injury After Non-Cardiac Surgery

NOAC New Oral Anticoagulant

NSQIP MICA National Surgical Quality Improvement Program-Myocardial Infarction or Cardiac Arrest

NSTEMI Non-ST-Segment Elevation Infarction

NTproBNP N-Terminal pro B-Type Natriuretic Protein

PCI Percutaneous Coronary Intervention

PVD Peripheral Vascular Disease

rCRI Revised Cardiac Risk Index (aka Lee-Index)

STEMI ST-Segment Elevation Infarction

TIA Transient Ischemic Attack

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6. References

1. Gupta, S., et al., Cardiorespiratory fitness and classification of risk of cardiovascular disease mortality. Circulation, 2011. 123(13): p. 1377-83.

2. Lee, T.H., et al., Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation, 1999. 100(10): p. 1043-9.

3. Kristensen, S.D., et al., 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol, 2014. 31(10): p. 517-73.

4. Thygesen, K., et al., Third universal definition of myocardial infarction. J Am Coll Cardiol, 2012. 60(16): p. 1581-98.

5. Kristensen, S.D., et al., 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol, 2014.

6. Vahanian, A., et al., Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg, 2012. 42(4): p. S1-44.

7. Botto, F., et al., Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes. Anesthesiology, 2014. 120(3): p. 564-78.

8. Clavien, P.A., et al., The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg, 2009. 250(2): p. 187-96.