slightly old,not updated.

1. Mortalità in anestesia
Claudio Melloni
Anestesia e Rianimazione
Ospedale di Faenza(RA)

2. What lessons have the
ASA closed claims
teached to us?

3. 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

4. Che cosa sono gli ASA
Closed claims?
Collection of 35 USA insurance
companies
14500 anesthesiologists covered
50-55% of all USA practicing
anesthesiologists

5. 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

6. Utilità dei closed claims
Collection of “ sentinel”
events
Identification of areas of
risk(and litigation….)
Provides direction for
further analysis

7. 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…..

8. 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….

9. 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)

10. Risarcimenti (*1000 $)
Outcome
median
Death(1725)
216
Brain damage adults(676)
673
Brain damage newborns(129)
499
range
260-14700
2750-23200
3333-6800

11. Relationships associated
with payment
Appropriateness /
unappropriateness
of care
gravity of injury standard of care
Frequency of paymentmagnitude of payment
Better
monitoring

12. 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.

13. 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.

14. Severity of
adverse outcome
judgments of
appropriateness
of care.

15. 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.

16. 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.

17. 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.

18. 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.

19. Effect of outcome on judgements of
appropriate care
70
% of 60
appro
50
priate
ness 40
of 30
care 20
10
0
actually
temporary
changed to
permanent
actually
permanent
changed to
temporary

20. 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.

21. 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

22. Incidence % of claims related to the
most common adverse outcomes
30
25
20
15
10
5
0
death
nerve damage
brain damage
airway trauma
pnx
eye injury
fetal/newborn injury
headache
stroke
awareness
aspiration
bckpain
myocardial infarction
burns

23. Most common damaging
events:%
209
372
278
1382
591
717
resp
cardiovasc
equipment
reg block techn.
surg.techn.
wrong drug dose

24. 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.

25. Most common adverse outcomes Range
of payments($*1000)
25000
20000
min
med
max
15000
10000
5000
0
e
en
ar
aw
s
rn
bu
ss
I
M he
ac
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in
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ck
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as
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ke
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ew
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.
a
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e
um
ey
tra
ay
e
ag
rw
ai
m
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n
ag
ai
m
br
da
e
rv
ne
h
at
de

26. Most common adverse outcomes
Median Payment:$*1000
700
600
500
400
300
200
100
0
median payment
death
nerve damage
brain damage
airway trauma
eye injury
pnx
fetal7newborn injury
stroke
aspiration
back pain
headache
MI
burns
awareness

27. Claims differ in different
populations;
»FOR INCIDENCE
»FOR SERIOUSNESS

28. 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

29. 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!

30. ASA closed claims project
Malpractice claims against anesthesiologists:
OB VS NON OB
40
35
morte (materna)
danno cerebrale neonatale
cefalea
morte neonatale
dolore dur.anest
danno neurale
danno cerebrale paz.
distress emotivo
dolore dorso
30
25
% 20
15
10
5
0
ob
nonob

31. Claims ostetrici:regionale vs GA.
45
*
40
morte materna
danno cerebrale neonatale
cefalea
morte neonatale
dolore dur.anest
danno neurale
danno cerebrale paz
distress emoz
dolore dorso
35
30
20
15
*
*
*
%
25
10
5
0
reg
GA

32. 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.

33. Dati relativi ai pagamenti:OB VS
NON OB
claims non ob claims ob
Claims ob
regionale generale
non pagati(%)
pagati(%)
pagamento mediano($)
range di pagamento($)
32
38
43
27
59
53
48
63
85000
203000
91000
225000
15000-6 milioni
675000-5.4 milioni
GA pagata il 63% vs 48% delle reg.
675-2.5 mil 750-5.4 mil

34. 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……...

35. RESPIRATORY
related events

36. 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

37. 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

38. Trends in death and brain damage
according to the basic damaging event
50
45
40
35
30
% 25
20
15
10
5
0
Resp event
cardiovasc event
equipment probl
1980
1990

39. Most common respiratory events
associated with death and brain damage
inadequate ventilation
esophag intub
difficult intub
other resp events
adv resp events
1980
1990
Adv resp events
inadequate ventilation
esophag intub
difficult intub
other resp events

40. Other respiratory damaging events
associated with death or brain damage
12
10
8
air obs
bronchospasm
premat extub
aspir
% 6
4
2
0
1980
1990

41. Which is the impact of pulse
oxymetry and end tidal CO2
monitoring in death and
brain damage?

42. Respiratory damaging events associated
with death or brain damage by
monitoring group
35
30
25
%
20
799
102
none
SpO2 only
SpO2+etCO2
15
10
167
5
0
inadeq ventil
esophag intub
diff.intub

43. Cardiovascular damaging events
associated with death or brain damage
60
50
40
30
1980
1990
20
10
0
unexp./other
neurax
inadeq fluid
cv event cardiac arrest
blood loss

44. Unexplained/other damaging
cardiovascular events in the 90’s(137)
(death and brain damage)
arrhyth
MI
pulm emb
stroke
path abnorm
multifactorial

45. How do end tidal CO2 and
SpO2 monitoring affect the
occurrence of cardiovascular
damaging events as the
mechanism of brain damage
or death?

46. Cardiovascular damaging events
associated with death or brain damage
by monitoring group
60
50
40
30
20
10
0
192??
72
194
none
SpO2 only
blo
l
od
oss
lui
qf
ds
st
n
eve
e
arr
r cv
iac
e
ot h
d
ca r
/
ec t
rax
de
ina
neu
exp
un
SpO2+etCO2
t

47. Conclusions from the
data about the future
role of monitoring in
the prevention of
severe anesthesia
related injury?

48. Better monitoring
would have prevented
death or brain damage

49. Better monitoring would have prevented
death or brain damage in the 90’s
Resp events:221
no
yes

50. Cardiovascular events judged
preventable by better monitoring
no
yes

51. Respiratory and cardiovascular events contribution to
deaths and brain damage(Cheney,FW Anesthesiology
1999;91:552-6)
80
70
60
resp
cardiovasc
inadeq vent
esoph.intub
<standard of care
plaintiff payment
50
%
40
30
20
10
0
'70
'80
'90

52. Trends in death and brain
damage
“The fact that professional
liability premiums for anesthesiologi
have decreased significantly since th
mid-1980s would imply an overall
reduction in severe injuries.”
80
70
60
50
nerve injury
brain damage
death
% 40
30
20
10
0
'70-79
'80-89
'90-94

53. 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

54. Death associated with Regional
anesthesia in the 90’s(97 cases):etiology
pain management
neuraxial block
notblock related
intravasc
injection
other block
related

55. Neuraxial cardiac arrest
Sudden and unexpected
severe bradycardia and /or
asystole
occurring during neuraxial
block
with relatively stable
haemodynamics preceding
the event.

56. 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.

57. Sudden cardiac arrest during
regional anesthesia

58. 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…..

59. 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)

60. 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.

61. Incidence of anesthesia related cardiac
arrest/per 10.000 anesthetics
7
6
GA
Biboulet
Olsson
Auroy
Newland:direct GA
Newland: related
Newland anesth.attrib
Aubas
Aubas reg only
Tarkkila
Geffin
spinal
5
4
*10 !!
3
2
1
0
incidence
mortality