Percutaneous left ventricular assist device for

high-risk percutaneous coronary interventions:

Real-world versus clinical trial experience
Mauricio G. Cohen, MD, a Ray Matthews, MD, b Brij Maini, MD, c Simon Dixon, MD, d George Vetrovec, MD, e
David Wohns, MD, f Igor Palacios, MD, g Jeffrey Popma, MD, h E. Magnus Ohman, MD, i Theodore Schreiber, MD, j
and William W. O’Neill, MD k Miami, FL; Los Angeles, CA; Harrisburg, PA; Royal Oak, MI; Richmond, VA; Grand
Rapids, MI; Boston, MA; Durham, NC; and Detroit, MI

Background High-risk percutaneous coronary intervention (PCI) supported by percutaneous left ventricular assist
devices offers a treatment option for patients with severe symptoms, complex and extensive coronary artery disease, and
multiple comorbidities. The extrapolation from clinical trial to real-world practice has inherent uncertainties. We compared the
characteristics, procedures, and outcomes of high-risk PCI supported by a microaxial pump (Impella 2.5) in a multicenter
registry versus the randomized PROTECT II trial (NCT00562016).
Methods The USpella registry is an observational multicenter voluntary registry of Impella technology. A total of 637
patients treated between June 2007 and September 2013 were included. Of them, 339 patients would have met enrollment
criteria for the PROTECT II trial. These were compared with 216 patients treated in the Impella arm of PROTECT II.
Results Compared to the clinical trial, registry patients were older (70 ± 11.5 vs 67.5 ± 11.0 years); more likely to have
chronic kidney disease (30% vs 22.7%), prior myocardial infarction (69.3% vs 56.5%), or prior bypass surgery (39.4% vs.
30.2%); and had similar prevalence of diabetes, peripheral vascular disease, and prior stroke. Registry patients had more
extensive coronary artery disease (2.2 vs 1.8 diseased vessels) and had a similar Society of Thoracic Surgeons predicted risk
of mortality. At hospital discharge, registry patients experienced a similar reduction in New York Heart Association class III to
IV symptoms compared to trial patients. Registry patients had a trend toward lower in-hospital mortality (2.7% vs 4.6, P = .27).
Conclusions USpella provides a real-world and contemporary estimation of the type of procedures and outcomes of
high-risk patients undergoing PCI supported by Impella 2.5. Despite the higher risk of registry patients, clinical outcomes
appeared to be favorable and consistent compared with the randomized trial. (Am Heart J 2015;170:872-9.)

Coronary revascularization, in association with optimal
medical therapy, is the mainstay therapy for a defined
subset of patients with coronary artery disease (CAD)
based on appropriateness use criteria. A significant
proportion of CAD patients present with high-risk
features including clinical instability, multiple comorbid
conditions, severe left ventricular dysfunction, and
From the aUniversity of Miami Hospital, Miami, FL, bKeck School of Medicine, University of
Southern California, Los Angeles, CA, cPinnacle Health System, Harrisburg, PA, dWilliam
Beaumont University Hospital, Royal Oak, MI, ePauley Heart Center, Virginia Commonwealth
University, Richmond, VA, fSpectrum Health, Grand Rapids, MI, gMassachusetts General
Hospital, Boston, MA, hBeth Israel Deaconess Medical Center, Harvard Medical School,
Boston, MA, iDuke Clinical Research Institute, Durham, NC, jHarper University Hospital,
Detroit, MI, and kHenry Ford Hospital, Detroit, MI.
Clinical trial registration: ClinicalTrials.gov no. NCT00562016.
Submitted May 31, 2015; accepted August 8, 2015.
Reprint requests: Mauricio G. Cohen, MD, University of Miami Hospital, 1400 NW 12th
Avenue, Suite 1179, Miami, FL 33136.
E-mails: mgcohen@med.miami.edu, mauricio.cohen@gmail.com
0002-8703
© 2015 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ahj.2015.08.009
extensive CAD. 1 Current clinical practice guidelines as well
as appropriate use documents support the use of
revascularization in patients with high-risk clinical presen-
tation. 2-5 However, revascularization options are limited
due to the extreme surgical risk of this population. The
development of percutaneous left ventricular assist devices
(PLVADs) to support high-risk percutaneous coronary
interventions (PCI) has been an important step to facilitate
the care of these high-risk patients. The use of PLVAD
increased in the United States after the inception of a
microaxial rotational pump device (Impella, Abiomed,
Danvers, MA) in the market in 2008. 6 The randomized trial
PROTECT II demonstrated that the use of Impella 2.5 in
patients undergoing high-risk PCI resulted in a significant
reduction in adverse outcomes at 90 days, compared to
intraaortic balloon pumps (IABP). 7 It has been demonstrat-
ed that cardiac patients enrolled in clinical trials tend to be
at lower risk for adverse events but are more likely to be
managed with more evidence-based treatments. 8 A large
series of “real-world” data that analyze how PLVADs are
being used in routine clinical practice is lacking.
American Heart Journal
Volume 170, Number 5
Cohen et al 873

Figure 1

All USpella Patients

Excluded (n = 685)
(n = 1,322)
Cardiogenic shock (n = 408)
Support initiated after start of PCI or post-
PCI (n = 87)
Hemodynamic support only (no PCI)
(n = 39)
Emergent PCI without shock (n = 24)
Other indications (high risk valvuloplasty,
or interventional electrophysiology
procedures) (n = 23)
support prior to CABG (n = 10)
Enrollment in PROTECT II (n = 1)
Incomplete data (n = 1)
Use of other devices
Impella CP (n = 51)
High-Risk PCI supported Impella 5.0 (n = 41)
with Impella 2.5
(n = 637)

High-Risk PCI supported with

Impella 2.5 that met PROTECT II
eligibility criteria
(n = 339)

Flow chart of the USpella Registry high-risk PCI data.

To better understand the practice pattern of PLVAD
use, we sought to characterize the type of high-risk PCI
patients currently treated with Impella in the United
States and to compare these patients with the Impella
arm of the PROTECT II trial. The comparisons focused
on baseline variables, procedure characteristics, and
hospital outcomes.
Methods
We performed a retrospective observational analysis of
the USpella registry, an observational ongoing multicenter
voluntary registry of Impella technology with participation
of 47 sites in the United States and 2 sites in Canada. Sites
were asked to report all of their consecutive Impella 2.5,
Impella CP, and Impella 5.0/LD cases without preselection
of indication or patients. Between June 13, 2007, and
September 4, 2013, a total of 1,322 patients were entered
into the USpella registry. Of these, 637 patients were
supported for high-risk PCI with Impella 2.5 and serve as the
study population for this analysis. The remaining 635
patients were supported for other indications or with
other Impella devices and were not part of this analysis. Of
the 637 patients undergoing supported high-risk PCI, we
further identified a subset of 339 patients included in the
USpella registry that would have met eligibility for the
PROTECT II trial (NCT00562016). These patients had
severely reduced left ventricular ejection fraction
(≤35%) and intervention to the last patent conduit or
an unprotected left main coronary artery or left
ventricular ejection fraction ≤30% and 3-vessel disease.
Patients with ST-segment elevation myocardial infarction
(MI) within 24 hours of Impella implant, cardiogenic
shock, renal failure with serum creatinine ≥4 mg/dL, and
abnormal coagulation defined as platelets count
≤75,000/mm 3 were excluded. 7 Figure 1 depicts the
selection of registry patients included in our study. All
high-risk PCI patients (n = 637) and the PROTECT
II–“like” patients (n = 339) from USpella registry were
compared with the patients randomized to the Impella
arm from the PROTECT II trial (n = 216).
In the USpella registry, outcomes were collected only
during hospitalization. Adjudication of adverse events, for
causality and relatedness to the device and procedure, was
performed by an independent clinical event committee,
consisting of 2 interventional cardiologists and 1 cardiovas-
cular surgeon with prior experience in event adjudication,
high-risk interventions, and circulatory support.
 American Heart Journal
874 Cohen et al November 2015

Table I. Baseline characteristics

USpella Registry
PROTECT II
All HRPCI patients PROTECT II–“like” patients Impella arm
(n = 637) (n = 339) (n = 216) P⁎ P†

Age (mean ± SD) 70.2 ± 11.5 69.6 ± 10.9 67.5 ± 11.0 .003 .03
Male gender 73.5% 79.1 % 80.6% .04 .67
Diabetes mellitus 50.5% 49.4% 53.2% .49 .38
PVD 30.2% 31.7% 25.4% .18 .14
Previous stroke 9.7% 8. 7% 12.0% .356 .253
Chronic kidney disease 31.3% 30.0% 22.7% .02 .06
Dialysis 20.9% 6.5% N/A – –
COPD 25.1% 25.0% 26.0% .78 .79
CHF NYHA class III or IV 70.3% 77.6% 67.4% .53 .04
History of angina 43.6% 49.8% 70.1 % b.001 b.001
Prior MI 51.6% 56.5% 69.3% b.001 .003
Pacemaker/ICD 24.4% 30.0% 35.6% .001 .17
Prior PCI 46.6% 50.6% 40.9% .154 .03
Prior CABG 29.6% 30.2% 39.4% .008 .03
Surgical consultation requested 48.8% 50.8% 45.4% .38 .22
Reason for not performing CABG
Extreme risk 14.0% 10.5% 21.9% .029 .004
Patient refusal 86.0% 89.5% 78.1% .029 .004
LVEF (mean ± SD) 30.1 ± 16.1 21.6 ± 7.7 23.4 ± 6.3 b.001 .004
STS PROM 5.9 ± 6.4 6.0 ± 6.0 5.8 ± 6.0 .86 .64

Abbreviations: HRPCI, High-risk PCI; PVD, peripheral vascular disease; COPD, chronic pulmonary obstructive disease; ICD, implantable cardioverter defibrillator.
⁎ P value comparing all USpella patients to the Impella 2.5 arm of the PROTECT II trial.
† P value comparing the subset of USpella patients who met PROTECT II eligibility criteria to the patients in the Impella 2.5 arm of the PROTECT II trial.

The registry protocol was reviewed and approved by Results

the institutional review board at each participating site.
Patient data were extracted from deidentified patient
medical records into a standardized paper case report
form up to December 2011, after which the data were
collected with the electronic case report form of an
electronic data capturing system. To maintain consistency
and to allow for study results comparability, adverse event
definitions in the USpella registry were identical to those
used in the PROTECT II trial. Data were monitored against
source documents in 77% of cases. The authors are solely
responsible for the design and conduct of this study, all
study analyses, the drafting and editing of the manuscript,
and its final contents. The current analysis, the USpella
Registry, and the PROTECT II trial were funded by
Abiomed, Inc (Danvers, MA).
Statistical analysis
Continuous data are presented as means (±SD) and
compared using the Student t test. Discrete data are
presented as frequencies with their respective percentages
and compared using the χ 2 test or the Fisher exact test as
appropriate. All statistical analyses were performed at the
Harvard Clinical Research Institute using Statistical Analysis
System version 9.2 (SAS Institute, Inc, Cary, NC). The
authors are solely responsible for the design and conduct of
this study, all study analyses, the drafting and editing of the
manuscript, and its final contents. A 2-tailed P value N.05
was considered significant.
Overall, all patients were high risk for PCI. Baseline
characteristics of the populations are compared and
displayed in Table I. All patients had advanced age, severe
congestive heart failure (CHF) symptoms, low left
ventricular ejection fraction (LVEF), high prevalence of
renal insufficiency, and an elevated Society of Thoracic
Surgeons predicted risk of mortality (STS PROM). The
baseline risk of the subset of USpella patients who met
PROTECT II criteria and the actual PROTECT II popula-
tion was comparable. However, USpella patients were
older, had higher prevalence of renal insufficiency, were
less likely to have prior coronary artery bypass graft but
more likely to have prior PCI, presented with more
severe CHF symptoms, and had lower LVEF.
In terms of coronary anatomy, most patients had
3-vessel disease, and 16% had left main disease. The
extent of coronary disease (no. of diseased vessels and
number of lesions) was higher in USpella patients
compared with PROTECT II patients (Table II). However,
the number of treated lesions and number of stents was
significantly higher in the PROTECT II trial likely due to a
specific requirement to perform the most complete
revascularization as possible in a single procedure.
About a fifth of USpella patients underwent rotational
atherectomy, similar to the Impella arm of the PROTECT
II trial. However the average of 2.56 ± 2.20 passes per
lesion observed in USpella was significantly lower than in
the PROTECT II trial, with 3.47 ± 1.89 passes per lesion.
American Heart Journal
Volume 170, Number 5
Cohen et al 875

Table II. Angiographic and procedural characteristics

USpella Registry
PROTECT II
All HRPCI patients PROTECT II–“like” patients Impella arm
(n = 637) (n = 339) (n = 216) P⁎ P†

Diseased vessels (mean ± SD) 2.20 ± 0.91 2.22 ± 0.86 1.78 ± 0.72 b.001 b.001
Significant lesions (mean ± SD) 3.10 ± 1.65 3.07 ± 1.52 2.73 ± 1.42 .002 .009
Vessels involved
Left main 16.1% 14.0% 11.5% .008 .16
Left anterior descending 33.2% 33.3% 34.2% .67 .71
Left circumflex 29.3% 28.5% 28.5% .72 .98
Right coronary artery 17.1% 19.3% 19.0% .288 .898
SVG 3.7% 4.4% 6.8% .002 .038
Treated vessels (mean ± SD) 1.82 ± 0.59 1.82 ± 0.60 1.81 ± 0.67 .82 .75
No. of vessels treated .82 .75
1 vessel 28.4% 28.2% 33.8% .14 .17
2 vessels 61.5% 61.3% 51.9% .01 .03
3 vessels 10.1% 10.5% 14.4% .09 .18
Lesions treated (mean ± SD) 2.47 ± 1.25 2.48 ± 1.23 2.88 ± 1.44 b.001 b.001
Stents placed (mean ± SD) 2.21 ± 1.14 2.24 ± 1.10 3.08 ± 1.78 b.001 b.001
SVG intervention 10.3% 11.3% 12.5% .37 .66
Rotational atherectomy use 18.1% 16.4% 14.8% .280 .630
Duration of support (mean ± SD) 2.24 ± 6.19 2.35 ± 6.91 1.86 ± 2.71 .384 .327

Abbreviation: SVG, Saphenous vein graft.

⁎ P value comparing all USpella patients to the Impella 2.5 arm of the PROTECT II trial.
† P value comparing the subset of USpella patients who met PROTECT II eligibility criteria to the patients in the Impella 2.5 arm of the PROTECT II trial.

Saphenous vein graft interventions were attempted in
approximately 10% of cases. In average, the duration of
support was slightly N2 hours. As depicted in Figure 2,
blood pressure increased significantly during support,
and device malfunction was uncommon (0.16%).
In a subset of 128 patients of the USpella Registry,
New York Heart Association (NYHA) class was assessed at
baseline and upon discharge. There was a significant
improvement in CHF symptoms with a substantial 42%
reduction in patients who had NYHA class III to IV
symptoms after high-risk PCI. Similarly, in 87 patients
enrolled in PROTECT II, there was a 28% reduction in class
III to IV symptoms after PCI (Figure 3). In the 164 patients
in whom their left ventricular function was assessed at
baseline and discharge, there was a significant increase in
LVEF from 21.4% ± 7.5% to 28.4% ± 11.6% (P b .0001).
In-hospital outcomes are displayed in Table III. The
mortality of 2.8% in all USpella patients and 2.7% in
“PROTECT II–like” patients was numerically lower than
the mortality of 4.6% in the Impella arm of PROTECT II
trial. In addition, MI and repeat revascularization rates
were significantly lower in registry patients. There were
no incidents of stroke or transient ischemic attacks,
emergency coronary artery bypass graft (CABG), acute
aortic regurgitation, or valve injury in the registry. Other
adverse events including vascular complications, blood
transfusions, acute kidney injury, groin hematoma, and
transient hypotension during support were similar in the
registry and the clinical trial. It is important to note that
although the total rate of blood transfusions in the registry
was relatively high (11%), there was a significant decline
in transfusion rates over the enrollment period. Transfu-
sion rates were 12.2%, 7.4%, and 6.1% in 2009, 2010, and
2011, respectively.
Discussion
Our study represents the largest cohort of patients
undergoing complex high-risk PCI supported by a
microaxial flow pump PLVAD (Impella 2.5) both in
real-world practice and in clinical trials. Our results
showed that interventional cardiologists were able to
identify a high-risk group of patients, with similar
characteristics compared to the population enrolled in
the PROTECT II trial, in whom they felt a PLVAD would
be needed to support PCI. Significant overlap of baseline
characteristics between clinical trial and registry patients
was observed. Moreover, STS PROM was almost identical
in both groups. However, patients included in the USpella
Registry were older and had more severe CHF symptoms
and lower left ventricular function compared to those in
the PROTECT II trial. Coronary artery bypass graft was
not considered a treatment option in about two-thirds of
patients in the trial and registry reflecting real-world
experience. Interventional procedures were complex
including left main and/or multivessel interventions in
N65% of cases. In terms of outcomes, the in-hospital
mortality observed in USpella was similar to that of IABP
arm and numerically lower than that of the Impella arm of
the PROTECT II trial. 7
 American Heart Journal
876 Cohen et al November 2015

Figure 2

Blood pressure pre-Impella 2.5 versus on-Impella 2.5 support in the USpella Registry and the Impella arm of the PROTECT II trial.

Figure 3

Improvement in NYHA class after Impella-supported PCI in the USpella Registry and the Impella arm of the PROTECT II trial.

In the past, concerns have been raised in regard to
the extrapolation of clinical trial results to real-world
practice. Clinical trial patients are usually highly
selected with significant less risk than those treated
in practice. 9 However, within the context of high-risk
PCI, the results of the USpella Registry are certainly
reassuring because operators selected and treated in
their practice a similar population compared to the
PROTECT II trial. More than 50% of patients in USpella
met inclusion criteria for the PROTECT II trial, and the
predicted mortality risk was almost identical between
the registry and the trial.
A paradox in the utilization of cardiac catheterization
and revascularization has been observed among patients
American Heart Journal
Volume 170, Number 5
Cohen et al 877

Table III. Hospital outcomes

USpella Registry
PROTECT II
All HRPCI patients PROTECT II–“like” patients Impella arm
Outcome, % (95% CI) (n = 637) (n = 339) (n = 216) P⁎ P†

Death 2.83 (1.5-4.1) 2.65 (0.9-4.4) 4.6 (1.8-7.4) .19 .27

MI 1.26 (0.4-2.1) 0.29 (0.0-0.9) 15.3 (10.4-20.1) b.001 b.001
Stroke/TIA 0.0 0.0 0.5 (0.0-1.4) .09 .21
Repeat revascularization 0.78 (0.1-1.5) 0.29 (0.0-0.9) 2.3 (0.3-4.3) .07 .02
Vascular complications
Requiring surgery 2.51 (1.3-3.7) 2.36 (0.7-4.0) 1.4 (0.0-3.0) .33 .42
Not requiring surgery 5.18 (3.5-6.9) 5.60 (3.1-8.1) 9.3 (5.4-13.1) .03 .10
Blood transfusion 10.99 (8.6-13.4) 9.14 (6.1-12.2) 12.5 (8.1-16.9) .55 .21
Acute kidney injury 5.81 (4.0-7.6) 7.96 (5.1-10.8) 6.5 (3.2-9.8) .71 .52
Hemolysis 0.16 (0.0-0.5) 0.0 0.9 (0.0-2.2) .10 .08
Transient hypotension during support 7.06 (5.1-9.1) 6.78 (4.1-9.5) 10.2 (6.2-14.2) .14 .15
Cardiopulmonary resuscitation or ventricular arrhythmia 4.40 (2.8-6.0) 5.90 (3.4-8.4) 6.9 (3.6-10.3) .14 .62

All results are expressed as percentages (95% CIs). Abbreviation: TIA, transient ischemic attack.
⁎ P value comparing all USpella patients to the Impella 2.5 arm of the PROTECT II trial.
† P value comparing the subset of USpella patients who met PROTECT II eligibility criteria to the patients in the Impella 2.5 arm of the PROTECT II trial.

with severe CAD and multiple comorbidities who would
benefit the most from revascularization. 10 Patients with
the highest probability of having severe CAD (3-vessel
diseased and/or left main disease), such as those with
more advanced age, renal dysfunction, and CHF, are the
least likely to undergo coronary angiography and
revascularization. 11,12 Patients with all these comorbidi-
ties usually have extensive and complex coronary lesions
with elevated SYNTAX scores and are the ones who may
particularly benefit from complete and surgical revascu-
larization. 13 However, because of their elevated mortality
risk, these patients are often turned down for CABG and
end up being treated medically.
More contemporary observational data have shown
that between 1999 and 2011, patients treated with PCI
had increasing number of comorbid conditions and more
extensive and complex CAD and underwent more
complex interventions. It was also noticed that PCI
success increased and adverse procedural outcomes
decreased over time. 14 Enhancements to PCI technology,
better understanding of interventional technique, and the
availability of more effective antithrombotic agents may
have led to improved PCI outcomes despite an increasing
population risk. In fact, in the current era, PCI is offered
to patients with complex and extensive CAD who have
comorbid conditions that disproportionately increase
surgical risk, such as immobility, frailty, prior stroke,
oxygen-dependent pulmonary disease, prior CABG, and/or
a hostile chest. 15,16
New and relatively simple-to-insert PLVAD, including
Impella 2.5 and TandemHeart, became available in practice
during the past decade. A recent study showed a steep
increase in the use of short-term mechanical circulatory
support by 1,500% over a 4-year period, from 2007 to 2011.
Not only the use of support increased but also the
utilization pattern changed from bail-out use in patients
who had already developed circulatory collapse to a more
prophylactic use in patients deemed at high risk for
complications. Of note, a reduction in mortality and costs
were observed during the study period. 6
The PROTECT II trial demonstrated that a high-risk
group of patients with multiple comorbidities, severe
symptoms, and complex and extensive CAD can be
treated with PCI supported by either Impella 2.5 or IABP;
however, the former resulted in better hemodynamic
support, providing greater cardiac power output, and
was associated with a reduction in adverse events at
90 days, mostly driven by decreased repeat revasculari-
zation procedures. 7 It is worth mentioning that hemody-
namics in USpella mimicked the trial findings with
increased blood pressure after initiation of support.
Our results showed a substantial overlap in the
occurrence of major outcomes between the USpella
Registry and the PROTECT II trial. Interestingly, transfu-
sions decreased significantly over time possibly reflecting
a learning curve effect. A similar effect was observed in
the PROTECT II trial, with decreased occurrence of
complications during the period the study lasted. 7 As
operators familiarize with the device and become more
proficient in the use of percutaneous closure techniques
for large access, vascular complications and transfusions
decrease. However, the learning curve may have had a
more favorable impact in the outcomes observed in the
registry, which is still ongoing, whereas treatment within
the clinical trial was limited to a given period when the
learning curve was evolving. This may explain to a certain
extent the lower rates of complications and adverse
outcomes, such as MI, severe hypotension on support, or
repeat revascularization observed in the registry. Another
explanation for the low occurrence of adverse events was
inconsistent documentation in registry patients, in
particular for those events defined by temporal changes

878 Cohen et al
in biomarker levels, such as periprocedural MI. Serial
assessments of biomarkers may not be performed as
frequently (if at all) during routine care in comparison
with clinical trials, and only overt, symptomatic MI events
may have been captured in the registry. In addition,
events that are transient in nature, such as hypotension,
may not be properly documented in the medical record,
and therefore, their occurrence may be underestimated.
Conversely, the rigorous requirement in the trial to
perform femoral and iliac angiograms to evaluate if the
device can be accommodated may have played a role in
the lower rates of vascular complications observed in
the trial.
The present study is mainly limited by the retrospective
and observational design of the registry, and patient
selection bias cannot be excluded. As data were collected
retrospectively, only major exclusion criteria of the
PROTECT II trial could be assessed, which makes the
interpretation of the results somewhat limited.
In conclusion, our results provide a real-world and
contemporary estimation of the type of procedures and
outcomes of high-risk patients undergoing PCI supported
by Impella 2.5. In-hospital mortality in the USpella
Registry was numerically lower than in the Impella arm
of the PROTECT II trial. There is an identifiable
population with multiple comorbidities and extensive
coronary disease that would benefit from myocardial
revascularization but have prohibitive surgical risk. In this
extreme-risk population, the use of percutaneous revas-
cularization supported by a microaxial flow pump left
ventricular assist device is feasible with a relatively low
incidence of adverse events.
Disclosures
Mauricio G. Cohen: Speaker honoraria and consultant
for Abiomed.
Brij Maini: Speaker honoraria, proctorship, and con-
tracted research for Medtronic, Boston Scientific, Abbott
Vascular, Abiomed, and St Jude Medical; advisory board
for Medtronic, Abbott Vascular, and Abiomed.
Ray Matthews: Consultant for Abiomed.
Simon Dixon: Institutional research support from Abiomed.
Jeffrey Popma: Institutional research support from
Abiomed.
George Vetrovec, David Wohns, Igor Palacios, E. Magnus
Ohman, Theodore Schreiber, and William O’Neill have no
conflicts to disclose.
References
1. Cummings DM, Letter AJ, Howard G, et al. Medication adherence
and stroke/TIA risk in treated hypertensives: results from the
REGARDS study. J Am Soc Hypertens 2013;7:363-9.
2. O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA
guideline for the management of ST-elevation myocardial infarction:
American Heart Journal
November 2015
a report of the American College of Cardiology Foundation/
American Heart Association Task Force on Practice Guidelines.
Circulation 2013;127(4):e362-25.
3. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/
PCNA/SCAI/STS Guideline for the diagnosis and management of
patients with stable ischemic heart disease: a report of the American
College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines, and the American College of Physicians,
American Association for Thoracic Surgery, Preventive Cardiovascular
Nurses Association, Society for Cardiovascular Angiography and
Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol
2012;60:e44-164.
4. Jneid H, Anderson JL, Wright RS, et al. 2012 ACCF/AHA focused
update of the guideline for the management of patients with unstable
angina/non–ST-elevation myocardial infarction (updating the 2007
guideline and replacing the 2011 focused update): a report of the
American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guidelines. J Am Coll Cardiol
2012;60:645-81.
5. Patel MR, Bailey SR, Bonow RO, et al. ACCF/SCAI/AATS/AHA/ASE/
ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 appropriate use
criteria for diagnostic catheterization: a report of the American College of
Cardiology Foundation Appropriate Use Criteria Task Force, Society for
Cardiovascular Angiography and Interventions, American Association for
Thoracic Surgery, American Heart Association, American Society of
Echocardiography, American Society of Nuclear Cardiology, Heart
Failure Society of America, Heart Rhythm Society, Society of Critical Care
Medicine, Society of Cardiovascular Computed Tomography, Society for
Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.
J Am Coll Cardiol 2012;59:1995-2027.
6. Stretch R, Sauer CM, Yuh DD, et al. National trends in the utilization of
short-term mechanical circulatory support: incidence, outcomes, and
cost analysis. J Am Coll Cardiol 2014;64:1407-15.
7. O'Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized
clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic
balloon pump in patients undergoing high-risk percutaneous coronary
intervention: the PROTECT II study. Circulation 2012;126:1717-27.
8. Kandzari DE, Roe MT, Chen AY, et al. Influence of clinical trial enrollment
on the quality of care and outcomes for patients with non–ST-segment
elevation acute coronary syndromes. Am Heart J 2005;149:474-81.
9. Hordijk-Trion M, Lenzen M, Wijns W, et al. Patients enrolled in coronary
intervention trials are not representative of patients in clinical practice:
results from the Euro Heart Survey on Coronary Revascularization. Eur
Heart J 2006;27:671-8.
10. Smith PK, Califf RM, Tuttle RH, et al. Selection of surgical or
percutaneous coronary intervention provides differential longevity
benefit. Ann Thorac Surg 2006;82:1420-8. [discussion 1428–9].
11. Cohen MG, Filby SJ, Roe MT, et al. The paradoxical use of cardiac
catheterization in patients with non–ST-elevation acute coronary
syndromes: lessons from the Can Rapid Stratification of Unstable Angina
Patients Suppress Adverse Outcomes With Early Implementation of the
ACC/AHA Guidelines (CRUSADE) Quality Improvement Initiative. Am
Heart J 2009;158:263-70.
12. Bhatt DL, Roe MT, Peterson ED, et al. Utilization of early invasive
management strategies for high-risk patients with non–ST-seg-
ment elevation acute coronary syndromes: results from the
CRUSADE Quality Improvement Initiative. JAMA 2004;292:
2096-104.
13. Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary
intervention versus coronary-artery bypass grafting for severe
coronary artery disease. N Engl J Med 2009;360:961-72.
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14. Bortnick AE, Epps KC, Selzer F, et al. Five-year follow-up of patients
treated for coronary artery disease in the face of an increasing burden
of co-morbidity and disease complexity (from the NHLBI Dynamic
Registry). Am J Cardiol 2014;113:573-9.
15. Farooq V, van Klaveren D, Steyerberg EW, et al. Anatomical and
clinical characteristics to guide decision making between coronary
artery bypass surgery and percutaneous coronary intervention for
Cohen et al 879
individual patients: development and validation of SYNTAX score II.
Lancet 2013;381:639-50.
16. Serruys PW, Farooq V, Vranckx P, et al. A global risk approach to
identify patients with left main or 3-vessel disease who could safely
and efficaciously be treated with percutaneous coronary intervention:
the SYNTAX Trial at 3 years. JACC Cardiovasc Interv 2012;5:
606-17.