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STSegment Elevation Myocardial Infarction Challenges in Diagnosis & Current Measures of Quality James M. McCabe, MD, FACC, FAHA Cath Lab Director, University of Washington

UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

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Page 1: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

ST-­‐Segment  Elevation  Myocardial  InfarctionChallenges  in  Diagnosis

&Current  Measures  of  Quality

James  M.  McCabe,  MD,  FACC,  FAHACath Lab  Director,  University  of  Washington

Page 2: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Disclosures

• I,  James  McCabe,  have  no  relevant  financial  disclosures  

Page 3: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

V1

II

V5

DONNELLY, EILEEN ID:002653467 02-JAN-2010 22:27:29 BRIGHAM & WOMEN'S/FAULKNER HOSP.

Normal sinus rhythm with sinus arrhythmiaMinimal voltage criteria for LVH, may be normal variantCannot rule out Anterior myocardial infarction , age undeterminedAbnormal ECGNo previous ECGs available

25mm/s 10mm/mV 150Hz 8.0.1 12SL 239 CID: 1

Referred by: PETER LIBBY, M.D. Confirmed By: DALE ADLER M.D.

BPM62Vent. ratems202PR intervalms76QRS durationmsQT/QTc 468/475-28025P-R-T axes

03-AUG-1925 (84 yr)Female Unknown

Room:904Loc:206 Option:1

Technician: Test ind:410.12

Page 1 of 1 EID:12 EDT: 15:12 05-JAN-2010 ORDER: ACCOUNT: 002653467

Page 4: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

ECG�  51

Analysis of intermediate risk ECGs alone for STEMI diagnosis

• 36  ECGs  for  which  a  cath lab  activation  had  occured

• 124  physicians  at  various  levels  surveyed• All  cases  described  as  ”moderate  risk  of  acute  coronary  syndrome”  without  further  clinical  details  provided

• Q:  Is  there  a  blocked  coronary  artery  present  causing  a  STEMI?  (please  provide  your  best  guess)

McCabe  et  al.  JAHA.  2013.  

Page 5: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Reader  Performance  by  Experience

Sens Spec PPV NPV Kappa C  

Computer  Algorithm 45.8 83.3 84.6 43.5 n/a 0.65

Sens Spec PPV NPV Kappa C  

Computer  Algorithm 45.8 83.3 84.6 43.5 n/a 0.65

All  Participants 65.4 79.1 86.3 53.3 0.35 0.72

Sens Spec PPV NPV Kappa C  

Computer  Algorithm 45.8 83.3 84.6 43.5 n/a 0.65

All  Participants 65.4 79.1 86.3 53.3 0.35 0.72

By  Training  Level

All  Residents 61.3 72.5 81.7 48.2 0.27 0.67

All  Fellows 62.9 86.1 90 53.7 0.41 0.74

All  Attendings 70.3 79.2 87.1 57.1 0.39 0.75

McCabe et al. JAHA . 2013

Page 6: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Accuracy  of  ECG  Read  for  STEMI

OR 95%  CI p  Value

Residents -­‐-­‐ -­‐-­‐ -­‐-­‐

Fellows 1.26 1.02-­‐1.56 0.03

Attendings 1.45 1.19-­‐1.77 <0.01

Experience  (per  year) 1.01 1.00-­‐1.02 0.01

ED  &  IM  Physicians* -­‐-­‐ -­‐-­‐ -­‐-­‐

Non-­‐invasive  Cardiologists* 0.91 0.67-­‐1.22 0.53

Interventional  Cardiologists* 1.06 0.73-­‐1.53 0.77

* Attendings only

Experience  Matters!6%  increased  odds  of  accuracy  for  every  5  years  since  medical  school

Statistical methods: generalized estimatingequations to account for repeated measures

Page 7: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Sensitivity  &  Specificity  by  ECG  Characteristics

4%  éodds  of  accuracy  per  ECG  lead  with  diagnostic  STE  (p  =  0.03,  95%CI  1.00-­‐1.08)

Maximal  height  of  STE  (per  mm)  doesn’t  improve  accuracy  (p  0.59,  95%CI  .95-­‐1.03)

Lateral  and  posterior  STE  more  often  inaccurate  (vs  anterior)  – small  samples

Page 8: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

V1

II

V5

DONNELLY, EILEEN ID:002653467 02-JAN-2010 22:27:29 BRIGHAM & WOMEN'S/FAULKNER HOSP.

Normal sinus rhythm with sinus arrhythmiaMinimal voltage criteria for LVH, may be normal variantCannot rule out Anterior myocardial infarction , age undeterminedAbnormal ECGNo previous ECGs available

25mm/s 10mm/mV 150Hz 8.0.1 12SL 239 CID: 1

Referred by: PETER LIBBY, M.D. Confirmed By: DALE ADLER M.D.

BPM62Vent. ratems202PR intervalms76QRS durationmsQT/QTc 468/475-28025P-R-T axes

03-AUG-1925 (84 yr)Female Unknown

Room:904Loc:206 Option:1

Technician: Test ind:410.12

Page 1 of 1 EID:12 EDT: 15:12 05-JAN-2010 ORDER: ACCOUNT: 002653467

Page 9: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

PRE-­‐

POST-­‐

Page 10: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

I

II

III

aVR

aVL

aVF

V1

V2

V3

V4

V5

V6

V1

II

V5

DONNELLY, EILEEN ID:002653467 02-JAN-2010 22:27:29 BRIGHAM & WOMEN'S/FAULKNER HOSP.

Normal sinus rhythm with sinus arrhythmiaMinimal voltage criteria for LVH, may be normal variantCannot rule out Anterior myocardial infarction , age undeterminedAbnormal ECGNo previous ECGs available

25mm/s 10mm/mV 150Hz 8.0.1 12SL 239 CID: 1

Referred by: PETER LIBBY, M.D. Confirmed By: DALE ADLER M.D.

BPM62Vent. ratems202PR intervalms76QRS durationmsQT/QTc 468/475-28025P-R-T axes

03-AUG-1925 (84 yr)Female Unknown

Room:904Loc:206 Option:1

Technician: Test ind:410.12

Page 1 of 1 EID:12 EDT: 15:12 05-JAN-2010 ORDER: ACCOUNT: 002653467

NOT  COUNTED  BY  CMS

Page 11: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Measuring  Quality  of  Care  in  STEMIIn-­‐hospital  Mortality• primary  outcomemeasure  of  quality

– Public  Reporting  (eg COAP)  and  national  registries  (NCDR)– CMS  began  tracking  30  day post-­‐MI  mortality  as  part  of  Value  Based  Purchasing  in  2014  

• Typically  ‘risk-­‐adjusted’• Crude  in-­‐hospital  mortality  ~5-­‐6%Massachusetts’  Crude  In-­‐Hospital  Mortality  following   PCI  for  STEMI  or  Shock  2003-­‐2010

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Measuring  Quality  of  Care  in  STEMI  Cont’d

Time  to  Reperfusion• primary  process measure  of  quality• “Door-­‐to-­‐Balloon”  time• Should  maintain  relationship  with  outcome  measure• Easily  measured• Allows  for  systemic  changes  targeting  controllable  processes– D2B  time  should  be  within  our  control,  mortality  may  not  be.  – Why  mortality  is  risk-­‐adjusted  and  D2B  time  is  not.  

Page 13: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Mr.  C.• 59  yo man  with  no  significant  PMHx (former  tobacco  and  +FHx early  CAD)  presented  to  the  ED  with  chest  discomfort.

• Felt  well  in  AM. Went  skydiving  for  first  time.– “Queasy  and  nervous”  in  plane  (approx  1  PM).– Jumped  and  developed  chest  pain  as  parachute  deployed.

• Returned  home  by  2  PM.    Continued  chest  discomfort.    Took  nap  for  approx  until  approximately  5:30  PM.    On  waking  continued  discomfort.

• Girlfriend  drove  him  to  UW  ED.    Arrived  at  6  PM  with  continued  chest  discomfort.

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18:05

Page 15: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Mr.  C• Code  STEMI  activated  within  6  mins of  ECG.• STAT  chest  CTA  to  evaluate  for  aortic  dissection  was  ordered  in  ED.

• Left  ED  and  arrived  in  cath lab  at  18:50.

Page 16: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

Mr.  C.• PMHx:  Erectile  dysfunction• NKA• Meds:  Tadalafil PRN• SHx:  divorced.    Long-­‐term  girlfriend.   35  pack  year  tobacco  history   (quit  20  years  

ago)• FHx:  Father  with  MI  at  age  48.  Mother  alive  with  HTN,  depression.    No  children.  

• Exam:– 114/56,  HR  65,  RR  18,  96%  RA– Uncomfortable  and  diaphoretic.– JVP  6  cm.  Normal  PMI.  RRR.  normal  s1,  s2.  No  gallops  or  murmurs.  No  rub.  – Normal  radial,  femoral,  DP/PT  pulses  bilaterally.    – Lungs  CTA  b/l.– Abdomen   soft/non-­‐tender.– Alert,  non-­‐focal

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Mortality  and  D2B  Time  Relationship2nd National  Registry  of  Myocardial  Infarctions  

(NRMI-­‐2)• 1474  Hospitals  (only  661  could  perform  PTCA)• 6/1994-­‐3/1998  • All  acute  MI’s  (by  ECG  and  CK-­‐MB)• Observational• Angioplasty  only

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NRMI  2

Cannon  CP.  JAMA.  2000;283:2941.

Symptom  Duration  to  Balloon  Time

Door-­‐to-­‐Balloon  Time

120  Minutes

Page 19: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

NRMI  3&4:  Confirmed  Findings  of  NRMI  2

McNamara  RL.    J  Am  Coll Cardiol.  2006;47:2180

1999-­‐200229,222  STEMIs  at  395  hospitals

P  <0.001  for  trend

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DBT  and  1  year  mortality

DeLuca  G  et  al.    Circulation.  2004;109:1223

Regression  Model  of  TOTAL  ISCHEMIC  TIME vs mortality

• 1994-­‐2001• 1700  patients• Angioplasty  only  

Introduced  the  notion  of  per  minute  increases  in  mortality

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D2B  Alliance  Hospitals

Bradley  EH.  J  Am  Coll Cardiol.  2009;54:2423

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CMS  Codified  D2B  Time

Centers  for  Medicaid  and  Medicare  Services  (CMS)  arguably  most  important  in  altering  care  delivery  for  STEMI  patients• Began  tracking  D2B  in  2005

– Original  target  120  min  mean  D2B  per  hosp– 2006  changed  to  90  min  median  D2B  per  hosp

• Reimbursement  was  tied  to  performance

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Improvements in D2B in U.S. 2005-2010

Krumholz, et al. Circulation. 2011;124:1038-1045

Review of 973 U.S. hospitals providing Primary PCI for STEMI demonstrated dramatic improvement in proportion of patient treated within 90 minutes of emergency department arrival.

48% absolute Δ

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What  drives  DTB  time?

McCabe  JM.  Circ  Cardiovasc Qual Outcomes.  2012;5:672

Door-­‐to-­‐activation  ≤  20  min  – 89%  achieved  D2B  <90  minDoor-­‐to-­‐activation  >  20  min  – 28%  achieved  D2B  <  90  min

r =  0.97

Page 25: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

ED  Crowding  – Important  Predictor  of  D2B

Adjusted   for  time  of  day  and  physician  staffing  

p  =  0.013

McCabe,  unpublished

Page 26: UCSF CME STEMI Diaganosis McCabe UCSF... · guidelines&insetting&of&LVH? Armstrong & McCabe et al. AJC, 2012.110(7), 977–983. • Goal: create a simple ECG rule to improve specificity

What  drive  DTB  time:Can  We  Skip  the  ED?

Bagai A.  Circulation.  2013;128:352

• Action-­‐GWTG  registry,  2008-­‐2011• 83,461  STEMI  patients

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ED  Bypass

Bagai A.  Circulation.  2013;128:352

Median  times

In  hospitals  with  >25  STEMI/year

• Unadjusted  mortality  lower  in  patient  who  had  ED  bypass.• Adjusted  mortality  was  similar.

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The Price  of  Doing  Business  When  Focus  is  Solely  on  Expedience

Barnes  GD.  Am  J  Man  Care.  2013;19:671

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The  confusing  semantics  of  STEMI  (mis)diagnoses

False  PositiveActivation Over-­‐activation

Inappropriate  Activation

“[activation] for patients who do not ultimately require emergent catheterization or performing angiography on patients who are ultimately found not to require coronary intervention.” 4

Weighs cases against criteria available at the time of activation; not directly related to outcomes. 5,6

Generally a surrogate for diagnostic accuracy but variously defined in relationship to available angiography, clinical history, and biomarker assays. 1,2,3

1. Larson. JAMA, 20072. Kontos. Am J Em Med,

20113. McCabe. Arch Int Med,

20124. Garvey. Circ, 20125. Rokos. Am Heart J, 20106. Mixon. Circ Qual, 2012

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14% No culprit on angio

11% Negative biomarkers

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The  confusing  semantics  of  STEMI  (mis)diagnoses

False  PositiveActivation Over-­‐activation

Inappropriate  Activation

36% 39%

N/A

McCabe et al. JAMA Int Med. 2012;172, 864–871

1. Larson. JAMA, 20072. Kontos. Am J Em Med, 20113. McCabe. JAMA Int Med, 20124. Garvey. Circ, 20125. Rokos. Am Heart J, 20106. Mixon. Circ Qual, 2012

Generally a surrogate for diagnostic accuracy but variously defined in relationship to available angiography, clinical history, and biomarker assays. 1,2,3

“[activation] for patients who do not ultimately require emergent catheterization or performing angiography on patients who are ultimately found not to require coronary intervention.” 4

Weighs cases against criteria available at the time of activation; not directly related to outcomes. 5,6

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Factors  Independently  Associated  with  False  Positives

Multivariate  AnalysisAOR 95%CI p  value

BMI  (per  unit  kg/m2) 0.91 .86-­‐.97 0.004Anginal  chief  complaint   0.28 .14-­‐.57 <0.001Known  coronary  disease     1.93 1.04-­‐3.59 0.037Illicit  Drug  Abuse 2.67 1.13-­‐6.26 0.024Left  Ventricular  Hypertrophy  by  ECG  Criteria 3.15 1.55-­‐6.40 0.001

Known CAD, prior drug abuse, and presence of LVH are strongly associated with false positive diagnoses

Heavier weight and a “classic angina” chief complaint associated with diminished false positive rates

McCabe et al. Arch Int Med, 2012.172, 864–871

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Adjudicated Admission Diagnoses for False Positives

%  false  PositivesN=  146

Structural/valvular  heart  disease  +/-­‐ CHF  exacerbation 19

Non-­‐specific  chest  pain,  including   soft  tissue  ailments 17

Demand  ischemia  and  severe  concomitant  illness 14

Primary  rhythm  disturbance 10

Metabolic  derangements  (including   toxins/drugs) 10

Out  of  hospital  cardiac  arrest 6

Myocarditis/Pericarditis 6

Known  CAD  &  stable  symptoms 4

Abdominal   pathologic  condition 3

Hypertensive  urgency/emergency 3

Takotsubo 1

Other  diagnoses 6

McCabe. Arch Int Med, 2012. 172(11), 864–871

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Can  we  do  better  than  ACC/AHA  guidelines  in  setting  of  LVH?

Armstrong & McCabe et al. AJC, 2012.110(7), 977–983.

• Goal: create a simple ECG rule to improve specificity while preserving sensitivity for STEMI dx

• 79 of first 411 cases in registry had criteria for LVH (by any standard criteria) and underwent angiography; study cohort

• Assessed test characteristics of multiple schemes against angiographic outcome (reference standard)

REF

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Recursive  PartitioningAlgorithm

Sensitivity = 77%Specificity = 91%NRI 37%

Armstrong & McCabe et al. AJC, 2012.110(7), 977–983.

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LVH

3 29

3/29 = 10%Not a STEMI

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Primary  Limitation  to  LVH  Algorithm

It  has  not  been  validated  against  an  external  cohort

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Does the attention on Door-to-Balloon time and diagnostic

specificity matter?

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•CathPCI data  from  2005-­‐2009•96,738  STEMI  admissions  at  515  hospitals

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Menees DS.  N  Engl J  Med.  2013;369:901

•No  significant  association  between  annual  decreases  in  DTB  time  and  in-­‐hospital  mortality  (odds   ratio  for  10  min  reduction   in  DTB  time:  1.04,  95%  CI:  0.99  – 1.14).

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Improvements in D2B in U.S. 2005-2010

Krumholz, et al. Circulation. 2011;124:1038-1045

Review of 973 U.S. hospitals providing Primary PCI for STEMI demonstrated dramatic improvement in proportion of patient treated within 90 minutes of emergency department arrival.

48% absolute Δ

CMS Specifications Manual: 9 exclusion criteria for case reporting. Updated 2006.

#9: “Patients who did not receive PCI within 90 minutes and had a reason for delay documented by a physician/APN/PA (e.g., social, religious, initial concern or refusal, cardiopulmonary arrest, balloon pump insertion, respiratory failure requiring intubation)”

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Is  D2B  Time  Just  a  Game?

McCabe  JM.  Circulation.  2014.  129:194-­‐202    

Patients  excluded  from  national  registries  are  large,  un-­‐measured  piece  of  puzzle

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“Gaming”  the  system?

McCabe  JM.  Circulation.  2014.  129:194-­‐202    

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Different  Registry,  Same  Result:“non-­‐system”  delays  Patients  in  NCDR

Swaminathan RV.  J  Am  Coll Cardiol.  2013;61:1688

•CathPCI Registry  2009-­‐2011

•82,678  STEMIs  (12,146  non-­‐system  delay  patients)

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D2B  Time  as  Quality

• 10+  years  as  the  primary  process  measure  of  quality  in  pPCI

• Functioned  as  a  surrogate  for  mortality  risk• Have  we  eroded  the  D2B-­‐mortality  relationship  by  studying  only  ‘idealized’  patients?

• More  fundamentally,  is  risk-­‐adjusted  mortality  even  capable  of  determining  quality?  

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Fundamental  Challenges  of  Risk  Adjusted  Mortality  (RAM)  and  Quality

Thomas  TJ  &  Hoffer  TP.  Med  Care.  1999.  37(1):  83-­‐92

Sensitivity  for  poor  performers  <20%

60-­‐70%  of  identified  outliersNot  poor  performers

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The  Multiple  Axes  of  Quality  in  PCI

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Other  Process  Measures:  The  radial  vs.  femoral  example.

Wimmer NJ.  Am  Heart  J.  2014.  in  press.

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Conclusions:  How  do  we  move  forward?

• Focus  on  a  single  axes  of  quality  (like  ED  bypass  or  DTB  time)  is  useful  but  not  sufficient  to  enhance  the  overall  system  of  care  for  STEMI  patients.

• Greater  coordination  among  the  many  pre-­‐hospital  systems  in  the  care  of  STEMI  patients  is  crucial  and  would  be  facilitated  if  STEMI  was  a  reportable  public  health  condition.  

• Focus  on  total  ischemic  time  in  the  care  of  patients  with  STEMI  important.    Patient  education  is  paramount  in  this  endeavor.

• Other  advances  (hemodynamic  support,  pharmacologic  targeting,  cooling  [arrest  patients],  technical  innovations)  in  PCI  are  likely  to  provide  the  next  major  steps  forward  in  STEMI  care.

Antman EM.  Circulation.  2013;128:322Grines CL  and  Schreiber  T.  J  Am  Coll Cardiol.  2013;61:1696

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Thank  you!