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 ca...
Che cosa sono gli ASA
Closed claims?
Collection of 35 USA insurance
companies
14500 anesthesiologists covered
50-55% of al...
Closed claim
Medical records
Narrative statement by the
involved health care personnel
Deposition summaries
Outcome and fo...
Utilità dei closed claims
Collection of “ sentinel”
events
Identification of areas of
risk(and litigation….)
Provides dire...
Demography and general
characteristics
Adults(91%>16 years)
Generally healthy:asa 1 & 2 69%
Non emergency surgery 75%
GA 6...
Problemi nella
interpretazione dei dati
Data collected to resolve claims
Not collected for outcome research
Total number o...
Definizioni
Complication;adverse outcome or
injury sustained by the patient
Damaging event:the specific
incident or mechan...
Risarcimenti (*1000 $)
Outcome

median

Death(1725)
216
Brain damage adults(676)
673
Brain damage newborns(129)
499

range...
Relationships associated
with payment
Appropriateness /
unappropriateness
of care

gravity of injury standard of care

Fre...
Relationships emerged form studies of
closed claims:
Frequency of payment linked to appropriateness of
care,but not to sev...
Effect of outcome on
physician judgements
Examination of the Closed Claims database
suggests the presence of a recurrent
a...
Severity of
adverse outcome

judgments of
appropriateness
of care.
Effect of outcome on
physician judgements:2
Specifically, non disabling iniuries are

more often associated with ratings o...
Effect of outcome on
physician judgements:3
This raises the possibility that highly
unfavorable outcomes may predispose (b...
Study of peer review:1
cases from the Closed Claims database
study of peer review with 112 practicing anesthesiologists
vo...
Study of peer review:2
The care in each case was independently rated by the
reviewers
based upon the conventional criterio...
Effect of outcome on judgements of
appropriate care
70

% of 60
appro
50
priate
ness 40
of 30
care 20
10
0

actually
tempo...
Schroeder SA et al. Do bad outcomes
mean bad care? JAMA 199 1; 265:1995.

non disabling iniuries = appropriate
care
disabl...
Concern about peer review
and bias
obstacle to objective
evaluation of major
medical risks….
Frequency and size of
payment...
Incidence % of claims related to the
most common adverse outcomes
30
25
20
15
10
5
0

death
nerve damage
brain damage
airw...
Most common damaging
events:%

209
372

278

1382

591
717

resp
cardiovasc
equipment
reg block techn.
surg.techn.
wrong d...
Conclusioni
Damaging events and adverse outcome show tight
clustering in a small number of specific categories;
Damaging e...
Most common adverse outcomes Range
of payments($*1000)
25000

20000

min
med
max
15000

10000

5000

0

e
en
ar
aw
s
rn
bu...
Most common adverse outcomes
Median Payment:$*1000
700
600
500
400
300
200
100
0

median payment

death
nerve damage
brain...
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 ...
Chadwick,HS,Posner,K,Kaplan,RA,Ward,RJ,Cheney
FW.A comparison of obstetric and nonobstetric
anesthesia malpractice claims....
ASA closed claims project
Malpractice claims against anesthesiologists:

OB VS NON OB
40
35

morte (materna)
danno cerebra...
Claims ostetrici:regionale vs GA.
45

*

40

morte materna
danno cerebrale neonatale
cefalea
morte neonatale
dolore dur.an...
Patogenesi del danno neonatale
45% attribuiti a
cause
anestetiche:
GA:4
»
»
»
»

1 broncospasmo
1 intub esofagea
1 aspir p...
Dati relativi ai pagamenti:OB VS
NON OB
claims non ob claims ob

Claims ob
regionale generale

non pagati(%)
pagati(%)
pag...
Conclusioni dai closed
claims obs
Danno cerebrale neonatale è il claim più
frequente,anche se solo il 50% è LEGATO
ALL’ANE...
RESPIRATORY
related events
Characteristics of
respiratory related claims
high frequency of severe
outcomes:85% death or brain
damage
Costly payments(...
Classification of the most common
respiratory system damaging
events:% of 1382 cases.

diff intub
inadeq vent/O2
esoph int...
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
cardio...
Most common respiratory events
associated with death and brain damage
inadequate ventilation
esophag intub
difficult intub...
Other respiratory damaging events
associated with death or brain damage
12
10
8

air obs
bronchospasm
premat extub
aspir

...
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
35
30
25
%

20

799

102

none
SpO2 ...
Cardiovascular damaging events
associated with death or brain damage
60
50
40
30

1980
1990

20
10
0

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

arrhyth
MI
pulm emb
stroke
pat...
How do end tidal CO2 and
SpO2 monitoring affect the
occurrence of cardiovascular
damaging events as the
mechanism of brain...
Cardiovascular damaging events
associated with death or brain damage
by monitoring group
60
50
40
30
20
10
0

192??
72
194...
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

Resp events:221

no
yes
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)
80
7...
Trends in death and brain
damage

“The fact that professional
liability premiums for anesthesiologi
have decreased signifi...
Emerging trends
Claims fro death and permanent brain damage
are decreasing
injuries attributed to inadequate ventilation a...
Death associated with Regional
anesthesia in the 90’s(97 cases):etiology
pain management
neuraxial block
notblock related
...
Neuraxial cardiac arrest
Sudden and unexpected
severe bradycardia and /or
asystole
occurring during neuraxial
block
with r...
Cardiac arrest associated
with neuraxial block
900 cases in claims 1988;
14 cases of neuraxial cardiac arrest…..,all pts
w...
Sudden cardiac arrest during
regional anesthesia
Cardiac arrest during
spinal anesthesia
Closed claim database:14/1000 (1978-86)
Features consistent with a sentinel event:...
Risk factors for cardiac arrest
during spinal anesthesia
Advanced age & high ASA physical status (Auroy)
baseline HR < 60 ...
Conclusions from cases of sudden bradycardia or
asystole associated with spinal anesthesia:

Cases do occur
There are no c...
Incidence of anesthesia related cardiac
arrest/per 10.000 anesthetics
7
6

GA

Biboulet
Olsson
Auroy
Newland:direct GA
New...
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Mortalità in anestesia

  1. 1. Mortalità in anestesia Claudio Melloni Anestesia e Rianimazione Ospedale di Faenza(RA)
  2. 2. What lessons have the ASA closed claims teached to us?
  3. 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. 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. 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. 6. Utilità dei closed claims Collection of “ sentinel” events Identification of areas of risk(and litigation….) Provides direction for further analysis
  7. 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. 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. 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. 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. 11. Relationships associated with payment Appropriateness / unappropriateness of care gravity of injury standard of care Frequency of paymentmagnitude of payment Better monitoring
  12. 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. 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. 14. Severity of adverse outcome judgments of appropriateness of care.
  15. 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. 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. 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. 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. 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. 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. 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. 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. 23. Most common damaging events:% 209 372 278 1382 591 717 resp cardiovasc equipment reg block techn. surg.techn. wrong drug dose
  24. 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. 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 ad he in pa ck n ba ti o ra pi ,. as in rn ke ro bo st ew l /n ta fe x pn . a in e um ey tra ay e ag rw ai m da e n ag ai m br da e rv ne h at de
  26. 26. Most common adverse outcomes Median Payment:$*1000 700 600 500 400 300 200 100 0 median payment death nerve damage brain damage airway trauma eye injury pnx fetal7newborn injury stroke aspiration back pain headache MI burns awareness
  27. 27. Claims differ in different populations; »FOR INCIDENCE »FOR SERIOUSNESS
  28. 28. Morray J, Geiduschek J, Caplan R, Posner K, Gild W, Cheney FW: A comparison of pediatric and adult anesthesia malpractice claims. ANESTHESIOLOGY 78:461-7, 1993
  29. 29. Chadwick,HS,Posner,K,Kaplan,RA,Ward,RJ,Cheney FW.A comparison of obstetric and nonobstetric anesthesia malpractice claims.Anesthesiology 1991;74:242-249. ob vs non ob:190 vs 1351 » ob cases 67% CS,33% vaginal » 65% associati a anest reg,33% con GA » 2 claims per non disponibilità dell’anestesista!
  30. 30. ASA closed claims project Malpractice claims against anesthesiologists: OB VS NON OB 40 35 morte (materna) danno cerebrale neonatale cefalea morte neonatale dolore dur.anest danno neurale danno cerebrale paz. distress emotivo dolore dorso 30 25 % 20 15 10 5 0 ob nonob
  31. 31. Claims ostetrici:regionale vs GA. 45 * 40 morte materna danno cerebrale neonatale cefalea morte neonatale dolore dur.anest danno neurale danno cerebrale paz distress emoz dolore dorso 35 30 20 15 * * * % 25 10 5 0 reg GA
  32. 32. Patogenesi del danno neonatale 45% attribuiti a cause anestetiche: GA:4 » » » » 1 broncospasmo 1 intub esofagea 1 aspir polm 1 ritardo anest. » Regionale:13 » 9 convuls da iniez intravasc » 1 eclampsia » 1 ritardo disponibilità » 3 spinali alte 37% a probl ostetrici o congeniti, 13% con probl di rianimaz.
  33. 33. Dati relativi ai pagamenti:OB VS NON OB claims non ob claims ob Claims ob regionale generale non pagati(%) pagati(%) pagamento mediano($) 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. 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. 35. RESPIRATORY related events
  36. 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. 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. 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. 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. 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. 41. Which is the impact of pulse oxymetry and end tidal CO2 monitoring in death and brain damage?
  42. 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. 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. 44. Unexplained/other damaging cardiovascular events in the 90’s(137) (death and brain damage) arrhyth MI pulm emb stroke path abnorm multifactorial
  45. 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. 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. 47. Conclusions from the data about the future role of monitoring in the prevention of severe anesthesia related injury?
  48. 48. Better monitoring would have prevented death or brain damage
  49. 49. Better monitoring would have prevented death or brain damage in the 90’s Resp events:221 no yes
  50. 50. Cardiovascular events judged preventable by better monitoring no yes
  51. 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. 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. 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. 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. 55. Neuraxial cardiac arrest Sudden and unexpected severe bradycardia and /or asystole occurring during neuraxial block with relatively stable haemodynamics preceding the event.
  56. 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. 57. Sudden cardiac arrest during regional anesthesia
  58. 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. 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. 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. 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
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