Download ST-Elevation Myocardial Infarction

ST-Elevation Myocardial Infarction
Which Patients Do Quality Assurance Programs Include?
Alex R. Campbell, MD*; Daniel Satran, MD*; David M. Larson, MD; Ivan J. Chavez, MD;
Barbara T. Unger, RN; Barbara P. Chacko, RN; Christopher Kapsner, MD; Timothy D. Henry, MD
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Background—In the United States, efforts are underway to improve timely access to percutaneous coronary intervention
in ST-elevation myocardial infarction (STEMI). The Joint Commission (TJC) and the American College of Cardiology
National Cardiovascular Data Registry (NCDR) have developed standardized definitions and clinical performance
measures for STEMI. The purpose of this study was to determine differences in 3 quality-assurance registries for STEMI
patients.
Methods and Results—STEMI patients presenting to the Minneapolis Heart Institute at Abbott Northwestern Hospital
(Minneapolis, Minn) are tracked by 3 distinct quality assurance programs: NCDR, TJC, and the level 1 MI registry (a
regional system for percutaneous coronary intervention in STEMI which includes transfer patients). Over 1 year, we
examined consecutive STEMI patients in level 1 and compared them with individuals meeting NCDR and TJC inclusion
criteria. Of 501 STEMI patients treated using the level 1 MI protocol, 422 patients had a clear culprit (402 percutaneous
coronary intervention, 13 coronary artery bypass grafting, 7 medical management). In the same period, 282 patients met
inclusion criteria for NCDR (56% of the level 1 population), and 66 met inclusion criteria for TJC (13% of the level
1 population). Transfer patients (n⫽380) accounted for 87% of the discrepancy between level 1 and TJC.
Pharmacoinvasive percutaneous coronary intervention (n⫽102) accounted for 47% of the discrepancy between level 1
and NCDR.
Conclusions—Current inclusion criteria for enrollment in STEMI registries are not uniform. This may lead to variable
quality assurance outcomes for the same patient cohort and has important implications for standardized quality
measurement. (Circ Cardiovasc Qual Outcomes. 2009;2:648-655.)
Key Words: myocardial infarction 䡲 quality assurance, health care
Q
uality of care in ST-elevation myocardial infarction
(STEMI) has become a focus for physicians, hospitals,
payers, and medical organizations. Door-to-balloon time has
emerged as the standard metric of clinical performance for
percutaneous coronary intervention (PCI) in STEMI because
of its association with patient outcome.1,2 The American
College of Cardiology (ACC) D2B Alliance has focused on
reducing door-to-balloon time in PCI hospitals.3 The American Heart Association (AHA) “Mission: Lifeline” initiative
has been launched to improve timely access to reperfusion in
STEMI.4 Integrated systems of care for STEMI including
transfer from non-PCI hospitals represent one strategy to
achieve this goal.5 The ACC/AHA have developed standardized definitions and clinical performance measures for
STEMI and have recently published a statement which
includes recommendations for additional performance measures for reperfusion therapy.6,7 The National Cardiovascular
Data Registry (NCDR) is intended to serve as a means of
internal STEMI program quality improvement.8 The Joint
Commission (TJC) and the Center for Medicare and Medicaid Services (CMS) track door-to-balloon time as the key
clinical performance measure specific to STEMI at institutions performing primary PCI.9
Pay for performance programs, which link financial incentives to physician and hospital performance on specific
quality measures, have been proposed as a method to improve
healthcare quality and efficiency.10 –14 Door-to-balloon time
benchmarks are currently being incorporated in public reporting and federal pay-for-performance initiatives.10 Accurate
and reproducible inclusion criteria for enrollment in STEMI
registries are necessary to achieve uniform performance
measurement and are implicit in standardized quality assurance. Despite the implications of performance measurement
for physicians and hospitals, the ability of quality-assurance
registries to identify cohorts of patients with STEMI has not
been evaluated. The level 1 MI program is a regional system
for STEMI care using a standardized protocol and integrated
transfer system for 31 non-PCI hospitals to a PCI center.15,16
Received February 27, 2009; accepted July 27, 2009.
From the Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minn.
*The first 2 authors contributed equally to this work.
Correspondence to Timothy D. Henry, MD, Minneapolis Heart Institute Foundation, 920 E 28th St, Suite 100, Minneapolis, MN 55407. E-mail
[email protected]
© 2009 American Heart Association, Inc.
Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org
648
DOI: 10.1161/CIRCOUTCOMES.109.861484
Campbell et al
Table 1.
Inclusion Criteria in STEMI Registries
649
Three STEMI Registries, 3 Different Inclusion Criteria for Enrollment
Level 1
ACC-NCDR
TJC
Data abstracted retrospectively
Data abstracted retrospectively
Inclusion:
Inclusion:
Any patient (direct admit or transfer)
presenting with ischemic symptoms ⬍24 h
from onset AND:
Patients for whom PCI indication includes STEMI within
24 h of the index event as evidenced by:
Patients ⱖ18 y of age with an ICD-9-CM principal
diagnosis code of AMI
1. New ST-elevation on ECG in 2 or more
contiguous leads
Elevated troponin T, troponin I, or CK-MB and 1 of the
following:
an ICD-9-CM principal and other procedure code
for PCI performed within 24 h of hospital arrival
1. New ST elevation in 2 or more contiguous leads OR
2. Development of any Q wave in leads V1–V3 OR
ST-segment elevation or LBBB on the ECG
performed closest to hospital arrival
Data collected prospectively
Inclusion:
AND
OR
AND
2. New LBBB on 12-lead ECG
3. Development of Q waves ⱖ30 ms in any other 2
contiguous leads OR
4. New LBBB on 12-lead ECG
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Determined by:
The emergency room physician at the
presenting facility
Exclusions:
None
Determined by:
Determined by:
The cardiologist at the PCI facility
Independent abstractors
Exclusions:
Exclusions:
Fibrinolytic administration
Outside transfers
Comfort care patients
Patients with ECG exclusionary criteria (See Table 2)
Fibrinolytic administration
Any PCI other than primary
AMI indicates acute myocardial infarction.
We examined consecutive STEMI patients in the level 1
Registry over a 1-year period and compared them to patients
meeting current inclusion criteria for TJC and NCDR.
Methods
Abbott Northwestern Hospital is a 619-bed tertiary care hospital in
Minneapolis, Minn. Three STEMI registries—with 3 separate inclusion criteria—track patient quality assurance data (Table 1).
Level 1 MI Program
The level 1 MI program is a regional system for STEMI care using
a standardized protocol and integrated transfer system for 31
non-PCI hospitals to a PCI center.15,16 Non-PCI hospitals are
stratified into 2 zones based on distance from the PCI center: zone 1
(up to 60 miles) and zone 2 (between 60 and 210 miles). Treatment
protocols are identical except zone 2 patients receive half-dose
fibrinolytics before transfer. Regardless of whether or not they
undergo PCI, patients who present within 24 hours of typical
ischemic symptoms with ST-elevation or new left bundle-branch
block (LBBB) on ECG are included in a prospectively maintained
Registry with detailed time to treatment measures. A cardiologist
(T.D.H.) and emergency medicine physician (D.M.L.) independently review all cases to insure that inclusion criteria are met.
National Cardiovascular Data Registry
The NCDR maintains a voluntary cardiac catheterization laboratory
registry at more than 600 institutions in the United States.8 STEMI
patients are eligible for door-to-balloon time measurement if they
meet the ACC/AHA inclusion criteria (Table 1). Baseline patient
characteristics and door-to-balloon times are collected retrospectively and submitted to the ACC. Confidential outcome reports for
participating institutions are generated as a means of internal quality
improvement. At Abbott Northwestern, a registered nurse (B.C.)
completes NCDR data for all cases, and an interventional cardiologist is available for oversight review (I.J.C.).
The Joint Commission
TJC defines STEMI as any patient discharged with an ICD-9 code
for acute myocardial infarction with appropriate ECG changes based
on abstraction algorithms.9 TJC abstractors do not interpret ECGs:
computerized ECG wording is analyzed for specific inclusion and
exclusion phrases indicating ST-segment elevation or new LBBB. If
computerized wording is inadequate to adjudicate STEMI, abstractors may use physician documentation, but only if the initial ECG is
specifically referenced by time and date with appropriate inclusion
phrases. Inclusion and exclusion criteria for ST-elevation and LBBB
are periodically updated and have changed frequently since 2002
(Table 2). TJC tracks door-to-balloon time data for STEMI patients
meeting inclusion criteria (Table 1). Data obtained by the independent abstractors were reviewed by a cardiologist (T.D.H.).
For a 1-year period, we examined consecutive STEMI patients in
the level 1 Registry and compared them to patients who met
inclusion criteria for NCDR and TJC. Median door-to-balloon times
and in-hospital mortality were determined for each quality assurance
program. For the 63 individuals in all 3 registries, registries were
compared according to door-to-balloon time using repeatedmeasures ANOVA.
Results
From October 2005 to September 2006, 501 patients with
STEMI were treated using the level 1 MI standardized
protocol. Although all patients had STEMI based on emergency room physician diagnosis, 422 (84.2% of 501) had a
clear culprit on angiography. Of the 79 without a clear culprit,
25 (5.0% of 501) had elevated cardiac biomarkers consistent
with myocardial infarction. Therefore, 54 (10.8% of 501)
650
Table 2.
Circ Cardiovasc Qual Outcomes
November 2009
Chronological Changes to TJC Guidelines for the ECG Interpretation
7/2002– 6/2003
Inclusion
Exclusion
ST-segment elevation
ST-segment elevation
AMI or MI with any mention of location (anterior, apical,
inferior, lateral, posterior, or combination)
Non–Q-wave MI
Q-wave AMI
Non-STEMI
Q wave MI
ST elevation attributable to early repolarization, LVH, normal variant, pericarditis,
or Printzmetal variant
ST elevation
ST-segment elevation, or any of the other ST segment elevation inclusion terms,
described as old or previously seen
ST consistent with injury, infarct, or acute MI
ST-segment elevation, or any of the other ST segment elevation inclusion terms,
described using one of the following qualifiers: cannot rule out, may have, may
have had, may indicate, possible, suggestive of, suspect, or suspicious
ST changes consistent with injury, infarct, ischemia, or
MI
STEMI
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ST segment noted as ⱖ0.10 mV
Transmural AMI
Transmural MI
7/2003–6/2004
LBBB
LBBB
Intermittent LBBB
Incomplete LBBB
Intraventricular conduction delay of LBBB type
Intraventricular conduction delay
Variable LBBB
LBBB, or any of the other LBBB inclusion terms, described using one of the
following qualifiers: cannot rule out, may have, may have had, may indicate,
possible, suggestive of, suspect, or suspicious
Added
Added
ST abnormality consistent with injury, infarct, or acute
MI
ST abnormality, ST changes, or ST segment described as consistent with
ischemia
LBBB described as old
ST elevation or LBBB with the qualifier “cannot exclude”
Changed
Removed
MI with any mention of location or combinations of
locations (anterior, apical, basal, inferior, lateral,
posterior, or combination), if described as acute (eg.
“posterior AMI”)
ST segment elevation, or any of the other ST-segment elevation inclusion terms,
described as old or previously seen
Q-wave MI, if described as acute
Transmural MI, if described as acute
7/2004–12/2004
No Changes
1/2005–12/2005
Changed
No Changes
Added
MI with any mention of location or combinations of
locations (anterior, apical, basal, inferior, lateral,
posterior, or combination), if described as acute (eg.
“posterior AMI”) or evolving
MIs specified as old or noted as previously seen
Q-wave MI if described as acute or evolving
MIs where the age is documented as undetermined or is not addressed
ST changes/abnormalities consistent with injury, infarct,
acute or evolving MI
Transmural MI, if described acute or evolving
Removed
LBBB described as old
1/2006–6/2006
Added
Added
ST segment noted as ⱖ1 mm
ST elevation, or any of the other ST segment elevation inclusion terms, with
mention of pacemaker/pacing (unless atrial only)
LBBB, or any of the other LBBB inclusion terms, with mention of
pacemaker/pacing (unless atrial only)
(Continued)
Campbell et al
Table 2.
Inclusion Criteria in STEMI Registries
651
Continued
Inclusion
7/2006 –12/2006
Exclusion
Removed
Added
Intermittent LBBB
ST elevation clearly described as confined to one lead
ST elevation described as minimal, ⬍0.1 mv, ⬍1 mm, nondiagnostic, or
nonspecific in all leads noted to have ST elevation
Removed
MIs where the age is not addressed
ST segment elevation with the qualifier possible
ST abnormality, ST changes, or ST segment described as consistent with
ischemia
AMI indicates acute myocardial infarction; LVH, left ventricular hypertrophy.
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were false-positive cardiac catheterization laboratory activations.17 Of 422 patients with a clear culprit, 402 (80.2% of
501) underwent PCI, 13 underwent coronary artery bypass
grafting, and 7 were managed medically. In the same period,
282 patients met inclusion criteria for NCDR (56% of the
level 1 population), and 66 met inclusion criteria for TJC
(13% of the level 1 population).
Level 1 Compared With TJC
Level 1 reported 501 patients with STEMI, whereas TJC
reported 66. Of 501 patients presenting per the level 1
protocol, 380 were transferred for PCI and excluded by TJC
criteria. Of 121 patients presenting directly to the PCI center,
97 underwent PCI (19 had no clear angiographic culprit and
5 underwent coronary artery bypass grafting, excluding them
by TJC criteria). Of the 97 patients who underwent PCI, only
66 were included in TJC’s door-to-balloon time metric.
Figure 1 shows the discrepancies between the 2 registries.
Figure 2 shows an example of TJC’s ECG wording exclusions in a confirmed STEMI.
Level 1 Compared With NCDR
Level 1 reported 501 patients with STEMI, whereas NCDR
reported 282 with 274 patients common to both registries.
Figure 3 shows discrepancies between the 2 registries. Of 501
patients in level 1, 227 were excluded by NCDR criteria: 99
received fibrinolytics from zone 2, 3 received fibrinolytics
from zone 1 (2 weather delay, 1 time delay), 88 had no
angiographic culprit, 13 underwent coronary artery bypass
grafting, 7 were managed medically, and 1 transfer with cardiac
arrest died before angiography. NCDR did not capture 16
patients with STEMI who underwent PCI and met NCDR
criteria. Level 1 did not capture 8 patients included by NCDR
with confirmed STEMI (all transferred in from emergency
departments not participating in the level 1 Program).
NCDR Compared With TJC
NCDR reported 282 patients with STEMI, whereas TJC
reported 66 with 63 patients common to both registries.
Figure 4 shows discrepancies between the 2 registries. Of 282
patients in NCDR, 194 were transferred for PCI and excluded
by TJC criteria. Of the remaining 88 patients presenting
directly to the PCI center who underwent PCI, TJC included
63 with 25 excluded for reasons outlined in Figure 4. NCDR
did not capture 3 patients included by TJC with confirmed
STEMI who met criteria for both registries.
Door-to-Balloon Times and Mortality
Overall, median door-to-balloon time in TJC’s registry (62
minutes) was lower than either NCDR (92 minutes) or level
1 (96 minutes) because of exclusion of transfer patients.
Considering only patients common to all 3 registries (n⫽63),
the door-to-balloon time was similar in all 3 registries despite
subtle differences in inclusion criteria (P⫽0.96 from
repeated-measures ANOVA; median times in this subset
were level 1, 62 minutes; NCDR, 58 minutes; TJC, 61
minutes). 23 patients (4.6%) in the level 1 cohort and 13
Figure 1. Discrepancies in reported STEMI between the level 1 and TJC registries.
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Circ Cardiovasc Qual Outcomes
November 2009
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Figure 2. Example of an ECG excluded from TJC’s STEMI population based on the presence of “age undetermined” on the electronic
readout.
patients (4.6%) in the NCDR cohort died in the hospital.
There were no in-hospital deaths in TJC’s cohort.
Discussion
Our results indicate current inclusion criteria for enrollment
in STEMI registries are not uniform and can lead to variable
quality assurance outcomes for the same patient cohort. Of
501 STEMI patients in level 1 (402 who underwent primary
PCI), only 282 (56%) were recognized by NCDR and only 66
(13%) by TJC. The specific inclusion criteria for enrollment
in a STEMI registry has important implications for quality of
care measurement, and by extension, pay for performance:
87% of STEMI patients presenting to a facility recognized for
high quality STEMI care15–18 were not eligible for inclusion
in TJC’s door-to-balloon time performance metric.
The development of an “ideal” system for STEMI identification, quality of care process, and performance measurement is challenging.6,7,19,20 Theoretically, all STEMI patients
would be included in process measurement: patients who
undergo PCI; patients who undergo coronary artery bypass
grafting or are managed medically; false-positive cardiac
catheterization laboratory activations6,7,19,20; patients who
receive fibrinolytics and are transferred for rescue PCI;
patients who receive fibrinolytics but remain at a non-PCI
center; and eligible but untreated patients who receive neither
fibrinolytics nor PCI. Important time to treatment measures
beyond door-to-balloon time (eg, chest pain onset to first
medical contact, first medical contact to hospital arrival,
hospital arrival to ECG, in-door/out-door at community
hospital, transfer time, chest pain onset to balloon/needle) and
Figure 3. Discrepancies in reported STEMI between the level 1 and ACC-NCDR registries.
Campbell et al
Inclusion Criteria in STEMI Registries
653
Figure 4. Discrepancies in reported STEMI between the ACC-NCDR and TJC registries.
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outcome measures (adjunctive medication use, bleeding,
recurrent ischemia, recurrent revascularization, stroke, myocardial infarction, mortality) would also be tracked.19,20 Currently, the exact definitions for door-to-balloon time differ for
NCDR and TJC (the level 1 registry uses NCDR definitions),
and there continues to be controversy regarding the appropriate measure for reperfusion (wire, first device, balloon,
Thrombolysis in Myocardial Infarction grade 3 flow). The
recently published ACC/AHA statement on performance
measurement and reperfusion therapy recommends a focus on
time of first device rather than time of restoration of flow or
time to first angiography.6,7 Finally, a single comprehensive
data collection system would avoid the economic and human
resource burden of multiple quality assurance programs: the
ACC/AHA statement also encourages “alignment” of data
registries in an effort to reduce “measurement fatigue.”6,7
Currently, the accuracy of quality assurance outcomes in
STEMI depends on inclusion criteria for enrollment used by
a particular registry. The level 1 registry attempts to use
comprehensive inclusion criteria. However, patients transferred to other PCI centers and those treated exclusively at
community hospitals (individuals not transferred and “eligible but untreated”) are still not captured. The NCDR registry
includes only those patients with STEMI who undergo PCI.
TJC’s registry—with the most specific inclusion criteria—
tracks data exclusively from the PCI center with specific
ECG eligibility criteria. From one perspective in our study,
the ability of TJC criteria to track patients with STEMI is
excellent (66/66, 100%): this actually exceeds the accepted
accuracy of the acute myocardial infarction ICD-9 code and
TJC/CMS margin of error for abstraction using that ICD-9
code.21–24 Viewed from another perspective, the ability of
TJC criteria to track patients with STEMI is incomplete: for
all individuals presenting directly to the PCI center who
underwent PCI, TJC identified only 66/97 (68%). When
transfer patients who underwent PCI are included, the ability
of TJC criteria to track STEMI patients is poor (66/402,
16%), and it is important to recognize that a significant
number of patients with STEMI who do not undergo PCI
remain excluded from this denominator. Numerators and
denominators in the setting of performance measurement are
complex in that there is no “standard” registry, and the
concept of sensitivity and specificity in this setting have been
partially addressed by the ACC/AHA.6,7 The wide variation
in quality assurance outcomes in our patient cohort illustrates
implications for both quality-of-care measurement and pay
for performance.25 In TJC’s registry—where a small number
of adverse events can dramatically alter a program’s overall
outcomes—the potential exists to “game the system” at the
expense of overall quality of care. Concern for higher
mortality rates in the context of public reporting has previously been highlighted as a possible reason for case-mix
differences between New York and Michigan PCI registries
and reluctance to treat high-risk patients.26,27 Definitionbased discrepancies in door-to-balloon time measurement
have also recently been recognized: in 2005, agreement in
door-to-balloon measures between the Hospital Quality Alliance and NCDR was only fair to moderate across 241
matched hospitals.28 This difference resulted in discrepant
quality of care rankings for individual hospitals based on the
data source.
In our study, the majority of the discrepancy between TJC
and level 1 is attributable to patients transferred for primary
PCI. Timely transfer of STEMI patients in the United States
continues to be an important issue, and studies have recently
demonstrated the feasibility of efficient and integrated transfer systems for primary PCI.16,29,30 As regional STEMI
systems become more widely incorporated, the establishment
of uniform registry inclusion criteria to define quality of care
will be increasingly important. The opportunity to include
transfer patients allows STEMI registries to reflect the efforts
of the entire network of care providers. This has the potential
to address reimbursement gaps in STEMI care by acknowledging non-PCI transfer facilities.31 Increasing timely access
to PCI with a coordinated transfer system may dramatically
decrease numbers of eligible but untreated patients yet
increase overall door-to-balloon times. Therefore, wellintegrated systems of STEMI care may substantially impact
the “eligible but untreated” population and decrease overall
mortality in STEMI, but paradoxically risk higher publicly
reported mortality rates. This concept also applies to registries that include high risk patient cohorts (cardiogenic shock
and out-of-hospital cardiac arrest), who stand to benefit the
most from early PCI. The ACC/AHA has endorsed including
transfer patients in performance measurement6,7; however,
TJC has not accepted these recommendations and there are no
plans for inclusion in the near future.23
In our study, the majority of the discrepancy between
NCDR and level 1 is attributable to pharmacoinvasive PCI.
Pharmacoinvasive PCI is a broad term that requires rigorous
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Circ Cardiovasc Qual Outcomes
November 2009
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definition based on dose and type of fibrinolytic, glycoprotein
2B3A inhibitor, and antiplatelet agent.32 Controversy remains
regarding a facilitated/pharmacoinvasive approach when considering transfer for primary PCI. Recently, the CARESS-inAMI trial demonstrated immediate transfer for PCI in highrisk patients with STEMI treated with half-dose reteplase and
abciximab was superior to fibrinolytic plus rescue PCI.33 The
TRANSFER-AMI trial showed similar results with immediate PCI after full-dose tenecteplase.34 The use of a pharmacoinvasive strategy and the optimal pharmaceutical regimen—particularly for patients transferred from a substantial
distance to the PCI hospital—are a matter of ongoing debate.35 However, it should be acknowledged that for certain
“hub-and-spoke” systems, a pharmacoinvasive strategy continues to be used and may be clinically beneficial.35 Indeed, a
substantial percentage of patients from both the Mayo regional29 and North Carolina statewide30 systems of STEMI care
underwent rescue PCI after full-dose fibrinolytics. As we
look to the future with a goal of extending the reach of
primary PCI systems, it seems reasonable to account for these
patients in an organized fashion. Neither the ACC/AHA nor
TJC has recommended that patients who receive fibrinolytics
(in any form) be included in future performance measures,
and thus these patients remain “uncaptured” by any current
quality measure.
In conclusion, current registry inclusion criteria in STEMI
are neither uniform nor straightforward: 3 quality-assurance
registries (level 1, NCDR, TJC) at a single facility identified
vastly different numbers of patients in the same cohort over a
1-year period. Ongoing efforts to improve STEMI care must
recognize that registry inclusion criteria vary, with significant
implications for quality of care process and performance
measurement.
Acknowledgments
We thank James S. Hodges, PhD, of the Division of Biostatistics,
University of Minnesota, for assistance with statistical analysis.
Disclosures
None.
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ST-Elevation Myocardial Infarction: Which Patients Do Quality Assurance Programs
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Circ Cardiovasc Qual Outcomes. 2009;2:648-655; originally published online October 6, 2009;
doi: 10.1161/CIRCOUTCOMES.109.861484
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