Staying Alive After Surgery - Health Quality & Safety ... · MI/IHD 9.9 25.7 Other 29.6 20.0 Main...

Staying Alive After Surgery: The Second POMRC Report

Prof Kate Leslie Royal Melbourne Hospital and ANZCA

Scope of this Talk

Death and health in New Zealand

The Second POMRC report

International mortality data

International outcome studies

Conclusions and future directions

Life Expectancy in New Zealand

http://en.wikipedia.org/wiki/List_of_countries_by_life_expectancy

Human Development Index

Composite statistic of life expectancy, education, and income indices

UN Development Programme

Long and Healthy Lives

Peri

nata

l care

Imm

un

isati

on

Fo

od

/wate

r

Gu

n l

aw

s

Wo

rkp

lace law

s

Un

ivers

al h

ealt

hcare

Co

mm

un

ity c

are

To

bacco

law

s

Ro

ad

law

s

Ed

ucati

on

0

5000

10000

15000

0-

1-

2-

3-

4-

5-

10-

15-

20-

25-

30-

35-

40-

45-

50-

55-

60-

65-

70-

75-

80-

85+

Deat

hs

in N

Z

2009

Age (years) www.stats.govt.nz

Maori and Non-Maori Health

1202.5

1045.81016.6

1047.7

972.0

897.8

974.2 983.9

911.3

857.4897.2 899.6

792.6827.9

864.2

763.3

705.1732.4

708.0 691.7 706.8679.7 671.6

646.5 659.5630.9

649.4624.9

685.3645.7

599.7 612.6577.5 579.2

558.0532.9 523.7

482.6 483.9 475.7 474.9455.3440.9

406.2384.5 401.3

365.3 375.3 372.6 361.2 363.7332.9 338.4 329.8 330.7 321.2

0

200

400

600

800

1000

1200

1400

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Year

Māori males

Māori females

Non-Māori males

Non-Māori females

Rate

Rates per 100,000 population, age-standardised to WHO World Standard Population

Life Expectancy Gap

0

5

10

15

20

25

Mexico Panama New Zealand Guatemala Canada Nepal Australia

Lif

e E

xp

ecta

ncy G

ap

(years

)

www.un.org

World Healthcare Systems

http://www.kaiserhealthnews.org/Graphics/2010/020410Spending-By-Public-And-Private-Sectors.aspx

Scope of this Talk






Data Collection in New Zealand

National Minimum Dataset (NMDS)

Public and private hospital discharge information

for inpatients and day patients

Limitations

Incomplete for privately-funded patients

No unifying code for ‘operation’

Surrogate marker of ‘GA/neuraxial block’ excludes

significant procedures under regional/local block

and/or sedation (e.g. cataract surgery)

Data Collection in New Zealand

Mortality Collection (MORT)

Classifies underlying cause of death for all deaths

and all stillbirths registered in New Zealand

ICD-10-AM 6th Edition and the WHO Rules and

Guidelines for Mortality Coding

Proximate cause of death not recorded

Underlying cause of death masks proximate causes

of death associated with surgery/anaesthesia

Cholecystectomies

0

1000

2000

3000

4000

5000

6000

0-44 45-64 65-79 80+

Deat

hs

per

100,0

00 a

dm

issi

ons Acute Elective

Age (years)

Cholecystectomies

Cause Acute Electives

Malignancy 23.5 40.0

Gallbladder calculi 22.2 14.3

GB, biliary & pancreas 14.8 -

MI/IHD 9.9 25.7

Other 29.6 20.0

Main underlying cause of death

% of deaths in category

• What is the mechanism of death from “GB calculi”? • How was myocardial infarction diagnosed?

ASA 1-2 Electives

0

100

200

300

400

500

600

700

800

0-24 25-44 45-64 65-79 80+

Deat

hs

per

100,0

00 a

dm

issi

ons

Age (years)

ASA 1-2 Electives

Cause 45-64 years 80+ years


MI/IHD/CVS 20.7 30.6

Respiratory 5.2 6.7

Other 20.7 21.3



• Was anaesthetic/surgical mishap a factor?

Patients aged 80+ years

0

10000

20000

30000

40000

50000

60000

1-2 3 4 5 Not stated

Acute Elective

Deat

hs

per

100,0

00 a

dm

issi

ons

ASA Physical Status


0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

Acute Elective

Deat

hs

per

100,0

00 a

dm

issi

ons

Data from 1st (2005-9) and 2nd (2006-10) POMRC reports


Cause Acute Elective

Falls 19.8 -


MI/IHD/CVS 35.9 41.9

Respiratory 5.2 7.8

Other 23.9 19.8



• How was myocardial infarction diagnosed? • Were all falls preoperative?

Pulmonary Embolism

0

20

40

60

80

100

120

140

0-24 25-44 45-64 65-79 80+

Associated Attributed

Deat

hs

per

100,0

00 a

dm

issi

ons

Age (years)

• How was pulmonary embolism diagnosed? • Was thromboprophylaxis adequate?

Coronial Data

Majority of relevant information to mortality

review is obtainable from hospital records

Coronial files add important information when

Cause of death uncertain

Expert opinion is available

When death occurred out of hospital

In either case more contextual information

and/or case studies would add richness and

readability to POMRC reports

Scope of this Talk






Mortality Events Weighted events per

million (95% CI)

Anaesthetic sole 151/8,610,720 25 (21-30)

Anaesthetic contributory 275/5,641,048 85 (75-96)

Total perioperative 1,723/934,781 1,982 (1,891-2,078)

Mortality audits with sample size over 3,000

87 studies included with >21,000,000 patients under GA

Most reported immediate (24-48 h) mortality

That’s 0.2%

Baseline risk INCREASED over the period 1937-2007 as per ASA scores

Australian Mortality Reporting

Anaesthesia- and surgery-related

mortality reported separately

National reports by College

mortality committees

State/territory sub-committees

undertake detailed review

Data collection methods vary

between reports

Incomplete data an issue for both

Public/private

States/territories

Anaesthesia Mortality 2003-5

1994-6 1997-9 2000-2 2003-5

Population (million) 12.57 13.40 13.75 13.68

Anaesthesia-related death (n) 116 99 122 112

Anaesthesia-related death ratio (pa) 3.08 2.46 2.96 2.73


0

5

10

15

20

25

30

35

40

<11 11-20 21-30 31-40 41-50 51-60 61-70 71-80 81-90 >90

Num

ber

of deat

hs

Age (years)


Factor N (%) (n = 112)

Preoperative management 31 (27)

Anaesthetic technique 41 (37)

Anaesthetic drug 36 (32)

Anaesthetic management 25 (22)

Postoperative management 17 (15)

Organisational factors 27 (13)

No correctable factor 37 (33)

Condition of patient significant factor 65 (58)

Death frequently multi-factorial with patient factors contributing

Surgical Mortality 2011

Surgical M

ortality 2

011

Scope of this Talk






Collaboration

J McNeil A Forbes

P Myles

D Story

T Short M Chan

S Poustie

K Leslie M Paech

PJ Devereaux

The ANZCA Trials Group

Established in 2005 by ANZCA Council

Full-time ANZCA-supported co-ordinator

Additional co-ordinators supported by

peer-reviewed funding

Located at DEPM, Monash University

Annual workshop and education sessions

Survey research support

Pilot grant scheme

Trial initiation and update meetings

A/Prof Tim Short Trials Group Chair

2012-

Support by ANZCA

• Project grant funding >$800,000 per annum

• Novice investigator, senior investigator and pilot grants

Council

Foundation Committee

Investment Committee

Research Committee

Trials Group Executive

Prospective cohort study at three Melbourne hospitals

Austin, Alfred and Royal Melbourne

1,102 non-cardiac surgery patients aged ≥70 years

70% had pre-existing co-morbidities

At day 30 postoperatively

6% had died (>1 in 20)

20% at least one night in ICU

19% had suffered a major complication

Predictor Mortality OR (95% CI) P value

Age per year >70 1.1 (1.0-1.1) <0.001

Albumin <30 g/dl 17% 4.0 (2.2-7.3) <0.001

Emergency surgery 10% 2.8 (1.7-4.7) <0.001

ASA 1-2 1% -

ASA 3 5% 4.6 (1.4-15.1) 0.01

ASA 4 14% 14.6 (4.3-49.4) <0.001

ASA 5 23% 26.4 (4.8-147.5) <0.001

Preoperative variables

Predictor Mortality OR (95% CI) P value

Myocardial infarction 30% 8.0 (3.1-20.9) <0.001

Acute kidney injury 16% 4.0 (2.1-7.7) <0.001

Sepsis 20% 5.1 (2.6-10.1) <0.001

Unplanned ICU 21% 5.4 (2.6-10.9) <0.001

Postoperative variables

Funded by ANZCA

Prospective cohort study at 23 hospitals

4,158 non-cardiac surgery patients aged ≥70 years

68% had pre-existing co-morbidities

At day 30 postoperatively

5% had died (1 in 20)

9% had an unscheduled ICU admission

20% had suffered a major complication

Lessons from REASON

Elderly patients are at high risk of perioperative

morbidity and mortality

Patient factors more important than surgical factors

Albumin should be used in preoperative risk assessment

Improved postoperative surveillance and care required

ASA status and ICU admission should be collected

routinely in surgical and anaesthetic audits

This information should be used to guide preoperative

discussions with patients

Survival in our large studies

Trial ASA 3-5

(%)

30-day

Mortality (%)

Master (Epidural) 100* 4.7

B-Aware (BIS monitoring) 75 4.3

ENIGMA-1 (Nitrous oxide) 25 0.9

POISE-1 (Metoprolol) 100* 5.0

REASON (≥70 years) 66 5.0

* Imputed from inclusion criteria and/or baseline characteristics

Surgical Patient Safety

More than 200 million patients

have surgery annually worldwide

proportion are elderly and at

risk of perioperative morbidity

No proven primary or secondary

prevention measures

Resources for monitoring and

treating complications inadequate

More action is required

THE MASTER TRIAL

25 centres in Australia, East Asia and Middle East

988 high-risk patients having non-cardiac surgery

Randomization Intra- and postoperative epidural analgesia

Intra- and postoperative intravenous analgesia

Primary endpoint Death or major morbidity at 30 days

Funding ANZCA, Health Department of WA and NHMRC

% Control (n = 441)

Epidural (n = 447)

P value

Death 4.3 5.2 0.67

Respiratory failure 30.2 23.3 0.02

Cardiovascular event 24.0 25.7 0.61

Renal failure 8.2 7.4 0.75

Inflammation/sepsis 46.7 42.7 0.26

Death or morbidity 60.7 57.1 0.29

A multi-centre, randomized, double-blind controlled trial of BIS

monitoring to prevent awareness during general anaesthesia

The B-Aware Trial

Funded by ANZCA, Alfred Hospital Research Trust, Royal Hobart

Hospital Research Foundation and the Centre for Encouragement of

Philanthropy in Australia and supported by Aspect Medical Systems

Lancet 2004; 363; 1757-63

Group n Aware

All cases 2,463 13 (0.53%)

All BIS monitored 1,225 2 (0.16%)

All Routine care 1,238 11 (0.89%)

Risk ratio = 0.18 (95% CI: 0.02-0.83); P = 0.022

Anesth Analg 2010; 110:816-22

Total

2,463 patients

BIS

1,225 patients (50%)

Optimal BIS

354 patients (14%)

No BIS

1,238 patients (50%)

Low BIS

871 patients (36%)

Long-term* mortality (n = 548; 22%)

Predictor HR (95% CI) P value

Age >70 years 3.10 (2.37-4.07) <0.0001

ASA 4 2.59 (1.87-3.60) <0.0001

Severe hypotension 1.27 (1.03-1.55) 0.02

Low BIS vs. No BIS 0.93 (0.78-1.12) 0.46

Optimal BIS vs. No BIS 0.66 (0.50-0.87) 0.003

Low BIS vs. Optimal BIS** 1.41 (1.02-1.95) 0.04

Anesth Analg 2010; 110:816-22

*median follow-up 4.1 (0-6.5 years) **propensity adjusted

N2O – A Historical Relic?

• Widespread use worldwide for >150 years

• Contemporaries and successors obsolete

• Proud record of safety relative to historical agents

• Does N2O still have role in anaesthesia today?

Joseph Priestley Humphrey Davy Horace Wells

NHMRC &

ANZCA

Funding

ENIGMA-I

1000 Patients O2 30% & N2O 70%

1000 Patients O2 80% & N2 20%

2000 Non-Cardiac Patients Surgery > 2 hours duration

Randomised, Controlled Double-blind Trial

Primary Outcome Variable = Length of Hospital Stay

N2O – based

n (%)

N2O – free

n (%)

P value

Severe PONV 229 (23%) 104 (10%) <0.001

Wound infection 106 (10%) 77 (7.7%) 0.03

Pulmonary complication 132 (13%) 78 (7.8%) <0.001

Risk of MI 13 (1.3%) 7 (0.7%) 0.19

Death 9 (0.9%) 3 (0.3%) 0.26

Long-term* mortality (n = 380; 19%)

Predictor HR (95% CI) P value

Age >65 years 1.45 (1.09-1.91) 0.01

ASA physical status 3-4 1.12 (0.87-1.45) 0.36

MAC <0.75 1.59 (1.22-2.08) 0.0007

Duration of anaesthesia >4 h 2.03 (1.44-2.87) 0.0001

Nitrous oxide 0.98 (0.80-1.20) 0.82

* follow-up 3.5 (0-5.7 years) Anesth Analg 2011;112:387–93

RCT of metoprolol versus placebo

Non-cardiac surgery

With or at risk of IHD

Planned sample size

10,000 patients

Primary outcome

30 day cumulative risk of cardiac death, nonfatal MI

and non-fatal cardiac arrest

Dr PJ Devereaux

PHRI Canada

Metoprolol

(n = 4174)

Placebo

(n = 4177)

HR

(95% CI)

P

value

Primary outcome 243

(5.8%)

290

(6.9%)

0.83

(0.70-0.99)

0.04

Non-fatal MI 151

(3.6%)

215

(5.1%)

0.70

(0.56-0.86)

0.0008

Death 129

(3.1%)

97

(2.3%)

1.33

(1.02-1.74)

0.03

Stroke 41

(1.0%)

19

(0.5%)

2.17

(1.26-3.73)

0.005

Perioperative MI is common

5% of POISE patients within 30 days of surgery

74% within 48 h of surgery

66% asymptomatic

NSTEMI more common than STEMI

Perioperative MI has a poor prognosis

11.6% with PMI died within 30 days

Median time to death 48 h

Asymptomatic (12.5%) and symptomatic (9.7%)

MO

RT

AL

ITY

Isolated biomarker elevation in 8% of patients

Associated with worse outcomes than ‘normal’ patients

Median time to death 8 days (c.f. 48 h in PMI patients)

The VISION Study

Prospective cohort study

40,000 patients aged ≥45 years

Non-cardiac surgery with ≥ 1 night admission

30-day and 1-year follow-up

Objectives

Incidence of major perioperative vascular events

Optimal clinical model to predict events

MIs detected without cTnT monitoring

Relationship between cTnT and 1-year survival

Clinicaltrials.gov NCT00512109

PJ Devereaux

1st 15,000 patients monitored with 4th generation cTnT

1%

4%

9.3%

16.9%

Lessons from VISION

Risk of increased mortality rises at cTNT levels in

‘normal range’

Elevated cTNT associated with poor outcome

independent of other diagnostic features of MI

50% of deaths deemed non-vascular

Myocardial injury may decrease likelihood of surviving

non-vascular complication

Risk may be modifiable with cardiovascular Mx

ANZCA Trials Group Studies

l ENIGMA-2 POISE-2 Balanced RELIEF

N 6,457/7,000 7,610/10,000 50/6,5000 0/2,4000

Intervention Nitrous oxide

or nitrogen

Aspirin and/or

clonidine

Deep or light

volatile GA

Restricted or

liberal IV fluid

Age (years) ≥45 ≥45 ≥60 ≥18

Type of surgery Non-cardiac

≥2 h

Non-cardiac

Cardiac & non-

cardiac ≥2 h

Major

abdominal

Inclusions With or at risk

of IHD

With or at risk

of IHD

With or at risk

of M&M

With or at risk

of M&M

Exclusions Bowels, brains High risk of

thrombosis or

bleeding

Brains, TIVA Liver, thoracic,

renal failure

Primary

outcome

30-day CVS

M&M

30-day CVS

M&M

1-year

survival

1-year disability

free survival

The Balanced Study

Endorsed by the ANZCA Trials Group

Supported by ANZCA, NZ HRC ($1.1M) and Australian NHMRC ($2.8M)

Due to commence in December 2012

Tim

Short

Kate

Leslie

Matthew

Chan

Paul

Myles

Michael

Paech

Chief Investigators

Tomas

Corcoran

The Balanced Study

6,600-patient randomized controlled trial

Patients: Aged >60 years, ASA 3, major surgery

Anaesthesia: Volatile-based general anaesthesia >2 h

Intervention: BIS 35 vs. BIS 50

Primary outcome: One-year mortality

Sample size based on 20% mortality reduction (from 10%)

125-patient pilot study has been completed

Seven centres in New Zealand, Australia and HK

Balanced Pilot Results

BIS 35 BIS 50

Number 61 64

Age (year) 74 (61-92) 72 (60-87)

Sex (male) 36 (59%) 44 (69%)

BIS 39 (5) 48 (6)

MAC 0.95 (0.23) 0.63 (0.19)

MAP (mmHg) 86 (11) 89 (10)

Mortality (1 year) 12% 9%

Composite complications (1 year) 28% 17%

Scope of this Talk






Conclusions & Future Directions

Perioperative mortality in New Zealand is very low

and consistent with other high HDI countries

The New Zealand system for data collection is

national, consistent and increasingly complete

Data collection in New Zealand could be improved

Private as well as public hospitals

Unifying code for ‘operation’

Full documentation of ASA status

Recording of proximate cause of death

Conclusions & Future Directions

Analysis of data by POMRC could be improved

Annual reporting of total perioperative mortality

Attribution of death to anaesthetic and surgical causes

More lessons for anaesthetists and surgeons

More work is needed to ensure compliance with safe

surgery checklists (antibiotics & VTE prophylaxis)

More research is needed to improve outcomes for

ASA 1-2 patients having surgery

Patients with acute cholecystitis

Patients aged over 80 years of age

Thank You

RMH Hokkaido Trauma Conference – on again in 2014!

Staying Alive After Surgery - Health Quality & Safety ... · MI/IHD 9.9 25.7 Other 29.6 20.0 Main...

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