Mortalità in anestesia

Claudio Melloni

Anestesia e Rianimazione

Ospedale di Faenza(RA)

What lessons have the ASA closed claims

teached to us?

What is a claim?

Claim is a demand for financial compensation by an individual who has sustained an injury from medical care.

Once a claim is resolved the file is closed

Che cosa sono gli ASA Closed claims?

Collection of 35 USA insurance companies

14500 anesthesiologists covered 50-55% of all USA practicing

anesthesiologists

Closed claim

Medical records Narrative statement by the

involved health care personnel Deposition summaries Outcome and follow up reports Cost of the settlement or jury award

Utilità dei closed claims

Collection of “ sentinel” events

Identification of areas of risk(and litigation….)

Provides direction for further analysis

Demography and general characteristics

Adults(91%>16 years) Generally healthy:asa 1 & 2 69% Non emergency surgery 75% GA 67% The database is not a collection of medically or

surgically compromised patients in whom the underlying disease plays a major role in the outcome;for this reason the closed claim database offers the unique opportunity to discern how the process of care contributes to the genesis of adverse outcomes…..

Problemi nella interpretazione dei dati

Data collected to resolve claims Not collected for outcome research Total number of anesthesia and patients unknown Unknown denominator for risk calculation Retrospective Lag time in

publication;closure,availability,study,calculations…publication

Geographic imbalance ? Interrater reliability;bias… Claims selectivity;only 30-33% of claims available are

evaluated….

Definizioni

Complication;adverse outcome or injury sustained by the patient

Damaging event:the specific incident or mechanism that led to the adverse outcome(e.g.airway obstruction)

Risarcimenti (*1000 $) Outcome median range

Death(1725) 216 260-14700 Brain damage adults(676) 673 2750-23200

Brain damage newborns(129) 499 3333-6800

Relationships associated with

payment

Appropriateness /unappropriateness

of caregravity of injury standard of care

Frequency of paymentmagnitude of paymentBetter

monitoring

Relationships emerged form studies of closed claims:

Frequency of payment linked to appropriateness of care,but not to severity of injury

magnitude of payment linked to both severity of injury and to standard of care

adverse outcome judged preventable with better monitoring were far costlier than those which were not considered preventable with better monitoring.

Cheney FW et al. Standard of care and anesthesia liability. JAMA 1989;261:1599‑1603 Tinker JH et al. Role of monitoring devices in prevention of anesthetic mishaps: a closed claims analysis. 1999;71:535‑540.

Effect of outcome on physician judgements

Examination of the Closed Claims database suggests the presence of a recurrent association between the severity of an adverse outcome and accompanying judgments of appropriateness of care.

Caplan RA.Effect of outcome on physician judgement of appropriateness of care.JAMA 1991;265:1957-1960.

Severity of Severity of adverse outcomeadverse outcome

judgments ofjudgments of appropriatenessappropriateness of care. of care.

Effect of outcome on physician judgements:2

Specifically, non disabling iniuries are more often associated with ratings of appropriate care, while disabling injuries and death are more often associated with ratings of less than appropriate care.

Effect of outcome on physician judgements:3

This raises the possibility that highly unfavorable outcomes may predispose (bias) peer reviewers towards harsher judgments,while minor injuries may elicit less critical responses.

Study of peer review:1 cases from the Closed Claims database study of peer review with 112 practicing anesthesiologists

volunteered to judge appropriateness of care involving adverse anesthetic outcomes.

The original outcome in each case was either temporary or permanent.

For each original case, a matching alternate case was devised. The alternate case was identical to the original in every respect,

except that a plausible outcome of opposite severity was substituted. The original and alternate cases were randomly divided into two sets

and assigned to reviewers. The reviewers were blind to the intent of the study.

Study of peer review:2 The care in each case was independently rated by the

reviewers based upon the conventional criterion of reasonable

and prudent practice at the time of the event. Knowledge of the severity of injury produced a

significant inverse effect on judgments of appropriateness of care.

the proportion of ratings for appropriate care by 31 percentage points when the outcome was changed from temporary to permanent, and increased by 28 percentage points when the outcome was changed from permanent to temporary.

Effect of outcome on judgements of appropriate

care

0

10

20

30

40

50

60

70

actuallytemporary

changed topermanent

actuallypermanent

changed totemporary

% of appr

opriat

eness of

care

Schroeder SA et al. Do bad outcomes mean bad care? JAMA

199 1; 265:1995.

non disabling iniuries = appropriate care

disabling injuries and death = less than appropriate care.

Concern about peer review and bias

obstacle to objective evaluation of major medical risks….

Frequency and size of payments!!

Foster practices which result in minor but avoidable injuries….

If such injuries are pervasive…» Aggregate cost

Incidence % of claims related to the most common adverse

outcomes

0

5

10

15

20

25

30death

nerve damage

brain damage

airway trauma

pnx

eye injury

fetal/newborn injury

headache

stroke

awareness

aspiration

bckpain

myocardial infarction

burns

Most common damaging events:%

resp

cardiovasc

equipment

reg block techn.

surg.techn.

wrong drug dose

1382

717591

372278

209

Conclusioni Damaging events and adverse outcome show tight

clustering in a small number of specific categories; Damaging events:3 categories account for almost half of

claims;resp, equipment & cardiovascular account for 46% of claims:

Adverse outcome:death,nerve damage,brain damage account for almost 65% of claims

This clustering of damaging events and adverse outcome is of fundamental importance since suggests that research and risk management strategies directed at just a few areas of clinical practice could result in large improvements in professional liability.

Most common adverse outcomes Range of payments($*1000)

0

5000

10000

15000

20000

25000

deathnerve dam

age

brain damage

airway traum

a

eye in.

pnxfetal/new

born in,.

stroke

aspiration

back pain

headache

MI

burns

awareness

min

med

max

Most common adverse outcomes Median Payment:$*1000

0

100

200

300

400

500

600

700

median payment

deathnerve damagebrain damageairway traumaeye injurypnxfetal7newborn injurystrokeaspirationback painheadacheMIburnsawareness

Claims differ in different populations;

»FOR INCIDENCE

»FOR SERIOUSNESS

Morray J, Geiduschek J, Caplan R, Posner K, Gild W, Cheney FW: A comparison of

pediatric and adult anesthesia malpractice claims. ANESTHESIOLOGY 78:461-7, 1993

Chadwick,HS,Posner,K,Kaplan,RA,Ward,RJ,Cheney FW.A comparison of obstetric and

nonobstetric anesthesia malpractice claims.Anesthesiology 1991;74:242-249.

ob vs non ob:190 vs 1351» ob cases 67% CS,33% vaginal» 65% associati a anest reg,33% con

GA» 2 claims per non disponibilità

dell’anestesista!

ASA closed claims project Malpractice claims against

anesthesiologists:OB VS NON OB

0

5

10

15

20

25

30

35

40

%

ob nonob

morte (materna)danno cerebrale neonatalecefaleamorte neonataledolore dur.anestdanno neuraledanno cerebrale paz.distress emotivodolore dorso

Claims ostetrici:regionale vs GA.

0

5

10

15

20

25

30

35

40

45

%

reg GA

morte materna

danno cerebrale neonatale

cefalea

morte neonatale

dolore dur.anest

danno neurale

danno cerebrale paz

distress emoz

dolore dorso

*

*

*

*

Patogenesi del danno neonatale

45% attribuiti a cause anestetiche:

GA:4» 1 broncospasmo» 1 intub esofagea» 1 aspir polm» 1 ritardo anest.

» Regionale:13» 9 convuls da iniez

intravasc» 1 eclampsia» 1 ritardo disponibilità» 3 spinali alte

37% a probl ostetrici o congeniti,

13% con probl di rianimaz.

Dati relativi ai pagamenti:OB VS NON OB

claims non ob claims ob Claims obregionale generale

non pagati(%) 32 38 43 27

pagati(%) 59 53 48 63

pagamento mediano($) 85000 203000 91000 225000

range di pagamento($) 15000-6 milioni 675000-5.4 milioni 675-2.5 mil 750-5.4 mil

GA pagata il 63% vs 48% delle reg.

Conclusioni dai closed claims obs

Danno cerebrale neonatale è il claim più frequente,anche se solo il 50% è LEGATO ALL’ANESTESIA!.

Pagamento mediano per il danno cerebr. Neonatale:500.000 $ ,vs 120.000 $ dei danni ob;

Cefalea è il III problema: e risulta in pagamento il 56% delle volte……...

RESPIRATORY related events

Characteristics of respiratory related

claims high frequency of severe

outcomes:85% death or brain damage Costly payments($ 200.000 and +) 72% judged preventable by monitoring

(pulse oximetry and etCO2) Monitoring helpful in reducing

inadequate ventilation and inadeq.oxygenation

Classification of the most common respiratory system damaging events:% of 1382

cases.

diff intub

inadeq vent/O2

esoph intub

airway obstruct

aspiration

premat extub

bronchospasm

Trends in death and brain damage according to the basic

damaging event

05

101520253035404550

%

1980 1990

Resp eventcardiovasc eventequipment probl

Most common respiratory events associated with death and brain

damage

inadequate ventilationesophag intubdifficult intubother resp eventsadv resp events

inadequate ventilationesophag intubdifficult intubother resp events

1980

1990

Adv resp events

Other respiratory damaging events associated with death or

brain damage

0

2

4

6

8

10

12

%

1980 1990

air obsbronchospasmpremat extubaspir

Which is the impact of pulse oxymetry and

end tidal CO2 monitoring in death and brain damage?

Respiratory damaging events associated with death or brain damage by monitoring group

0

5

10

15

20

25

30

35

%

inadeq ventil esophag intub diff.intub

noneSpO2 onlySpO2+etCO2

799

102167

Cardiovascular damaging events associated with death or brain

damage

0

10

20

30

40

50

60

unexp./othercv event

neuraxcardiac arrest

inadeq fluid blood loss

19801990

Unexplained/other damaging cardiovascular events in the 90’s(137)(death and brain

damage)

arrhythMIpulm embstroke path abnormmultifactorial

How do end tidal CO2 and SpO2 monitoring affect the occurrence

of cardiovascular damaging events as the mechanism of brain damage or

death?

Cardiovascular damaging events associated with death or brain damage by monitoring group

0102030405060

none

SpO2 only

SpO2+etCO2

72194

192??

Conclusions from the data about the

future role of monitoring in the

prevention of severe anesthesia

related injury?

Better monitoring would have

prevented death or brain damage

Better monitoring would have prevented death or brain damage

in the 90’s

no

yes

Resp events:221

Cardiovascular events judged preventable by better monitoring

no

yes

Respiratory and cardiovascular events contribution to deaths and brain

damage(Cheney,FW Anesthesiology 1999;91:552-6)

0

10

20

30

40

50

60

70

80

%

'70 '80 '90

respcardiovascinadeq ventesoph.intub<standard of careplaintiff payment

Trends in death and brain damage

0

10

20

30

40

50

60

70

80

%

'70-79 '80-89 '90-94

nerve injurybrain damagedeath

“The fact that professional liability premiums for anesthesiologists have decreased significantly since the mid-1980s would imply an overall reduction in severe injuries.”

Emerging trends Claims fro death and permanent brain damage are

decreasing injuries attributed to inadequate ventilation and

oxygenation are decreasing;SpO2 and etCO2 monitoring are the most likely causes

relative increase in the proportion of cardiovascular damaging events and respiratory events not prevented by monitoring

better monitoring would not lead to further reductions in death and brain damage

Death associated with Regional anesthesia in the 90’s(97

cases):etiology

pain management

neuraxial block

notblock related

intravascinjectionother blockrelated

Neuraxial cardiac arrest

Sudden and unexpected severe bradycardia and /or

asystole occurring during neuraxial block with relatively stable

haemodynamics preceding the event.

Cardiac arrest associated with neuraxial block

900 cases in claims 1988; 14 cases of neuraxial cardiac arrest…..,all pts

were resuscitated,8 survived but only 1 regained a sufficient neurologic function…..

Hypothesis: poor cerebral perfusion pressures

engendered by closed chest cardiac massage in the presence of high sympathetic blockade.

Sudden cardiac arrest during regional anesthesia

Cardiac arrest during spinal anesthesia

Closed claim database:14/1000 (1978-86) Features consistent with a sentinel event:

» Young healthy adults for relatively minor surgery» Standard anesthetic techniques and monitoring» Arrest followed by prompt & brief CPR» All resuscitation successful» Death/severe brain damage;13/14 !!» Up tp the year 2000 other 41 cases were reported in the

literature(26 spi + 15 epid);but outcome much better…..

Risk factors for cardiac arrest during spinal anesthesia

Advanced age & high ASA physical status(Auroy)

baseline HR < 60 (Carpenter et al). ASA physical status I patients(ASA closed claims)

Current therapy with b-blockers block height >T6 patients who are <50 years old (Tarkkila)

patients with first-degree heart block (Liu)

Conclusions from cases of sudden bradycardia or asystole associated with

spinal anesthesia:

Cases do occur There are no clear clinical

predictors… Prompt recognition and treatment

keys to injury prevention.

Incidence of anesthesia related cardiac arrest/per 10.000

anesthetics

0

1

2

3

4

5

6

7

incidence mortality

BibouletOlssonAuroyNewland:directNewland: relatedNewland anesth.attribAubasAubas reg onlyTarkkilaGeffin

spinal

*10 !!

GA

GA