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Editor’s Perspective
High-Risk Percutaneous Coronary Interventions
in Modern Day Clinical Practice
Current Concepts and Challenges
Theodore A. Bass, MD
A
t its inception, all percutaneous coronary interventions
(PCI) were considered high risk. The initial US experience published by the National Heart, Lung, and Blood
Institute Registry reported procedural success to be <60%
and the need for emergent coronary bypass surgery occurring 6% of the time.1 It was mandatory to have a cardiothoracic surgeon immediately available and an operating room
open and ready to go. These outcomes involving a far less
complex, lower risk population compared with patients we
currently treat would be completely unacceptable today. The
evolution of coronary interventions has been remarkable
during the past decades attributable to the refinement and
development of new device technologies, imaging capabilities, adjunctive pharmacotherapies and the explosive growth
in physician and catheterization laboratory team experience.
This has resulted in a greatly expanded population who can
now be treated by PCI, including sicker patients often with
more complex anatomic lesions. Overall reported procedural
success rates are now expected to approach 100% and complication rates continue to trend toward or <1%. With this history and in our current environment of expanding databases,
public reporting, cost-sensitive resource use, and increased
patient expectations, the concept and reality of high-risk PCI
continues to evolve.
First and foremost, it is helpful to differentiate complex
PCI from high-risk PCI. The interventional cardiovascular
community has spent a great deal of effort defining, classifying, and attempting to understand how to best treat patients
presenting for complex PCI. The term complex PCI is a
descriptor applied to patients presenting with complex, anatomic coronary lesions. These lesions may have a variety of
defining characteristics such as severe calcification, extensive thrombotic burden, extreme tortuosity or length, or
might be chronically, totally occluded. The lesion location
might be located at a coronary bifurcation or in a degenerated
saphenous venous bypass graft. Analysis derived from large
The opinions expressed in this article are not necessarily those of the
American Heart Association.
From the Department of Cardiology, University of Florida College of
Medicine, Jacksonville.
Correspondence to Theodore A. Bass, MD, Department of Cardiology,
University of Florida College of Medicine, 655 W 8th St, Jacksonville, FL
32209. E-mail [email protected]
(Circ Cardiovasc Interv. 2015;8:e003405.
DOI: 10.1161/CIRCINTERVENTIONS.115.003405.)
© 2015 American Heart Association, Inc.
Circ Cardiovasc Interv is available at
http://circinterventions.ahajournals.org
DOI: 10.1161/CIRCINTERVENTIONS.115.003405
registries have consistently demonstrated that PCI involving
these anatomically complex lesions results in expected lower
procedural success rates with an increased risk of procedural
complications when compared with PCI of less anatomically
complex coronary lesions.2 We have successfully developed
both the technology and interventional techniques to facilitate
optimally treating these lesions.
An example of a complex PCI might be a middle-aged
male with normal left ventricular (LV) function and increasing angina presenting for PCI with a heavily calcified bifurcation lesion involving the left anterior descending-first diagonal
bifurcation. This is indeed different from what should be
considered as a high-risk PCI, which might involve the same
angiographic lesion, but occurring in an elderly male with
a chronically occluded right coronary artery and a severely
decreased LV ejection fraction. Therefore, the approach, skill
sets, and support systems required to do these interventions
with similar anatomic target lesions might be drastically
different.
Currently, the definition of high-risk PCI is evolving.
There is a growing consensus that this group of patients
involves a confluence of characteristics, including complex
coronary artery disease (multivessel or left main disease
and anatomically complex coronary lesions), hemodynamic
compromise (shock or severely depressed LV function), and
clinical comorbidities such as advanced age, diabetes mellitus, peripheral vascular disease, heart failure, acute coronary
syndromes, or previous cardiac surgery. The Food and Drug
Administration (FDA) recently approved the Impella, a temporary percutaneous ventricular assist device to treat patients
presenting for high-risk PCI. This recommendation was based
a randomized clinical trial involving symptomatic high-risk
patients with 3-vessel disease or unprotected left main coronary disease and severely depressed LV function presenting
for nonemergent high-risk PCI. The study found that a strategy
using percutaneous ventricular assist device compared with
using intra-aortic balloon pump counterpulsation for hemodynamic support when performing PCI in this high-risk population offered clinical benefit.3 This clearly expands the concept
of high-risk PCI beyond patients presenting emergently with
acute myocardial infarction and cardiogenic shock.
Coronary revascularization appropriateness guidelines
similarly acknowledge the broadening concept of high-risk
PCI. Many high-risk patients presenting with increasing ischemic symptoms such as angina refractory to medical treatment
or heart failure are thought to be appropriate candidates for
coronary revascularization.4 Strategies to achieve the most
complete revascularization are critically important in this
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2 Bass High-Risk PCI in Modern Day Clinical Practice
cohort of patients who often may not be surgical bypass candidates. The concept of attempting more complete revascularization in patients with reduced LV function is not new. A
recent quantitative echocardiographic analysis examined the
possible benefit of achieving more complete revascularization
in high-risk PCI patients presenting with multivessel coronary
artery disease and low LV ejection fraction.5 Patients undergoing more complete revascularization were found to have
more reverse LV remodeling, increased LV ejection fraction,
and a decrease in end systolic LV volume. Patients with echocardiographic evidence of reverse remodeling were found to
have significantly fewer subsequent clinical events, including
a decrease in composite myocardial infarction, death, stroke
and transient ischemic attack, and less severe heart failure.
PCI, especially multivessel PCI in this population frequently
requires the use of short-term hemodynamic support to provide the safety backup needed to achieve optimal procedural
results. Frequently intra-aortic balloon pump counterpulsation
does not provide sufficient hemodynamic support during PCI
in these patients and newer more robust ventricular support is
required.6 Currently, 2 FDA approved percutaneous ventricular
assist devices, the Impella and the Tandem Heart, are available
offering superior hemodynamic support compared with traditional intra-aortic balloon pump counterpulsation.7,8 Both these
devices present their own benefits and challenges, each requiring expertise in vascular access and deployment. Physician and
support team expertise is also required to manage these devices
during the PCI and in the postprocedural time period.
Challenges
As new technologies continue to develop allowing us the treat
an expanding high-risk population with PCI, the interventional
community will be required to address important challenges.
It is essential that we more clearly define high-risk PCI. Clinical, anatomic, and cardiovascular functional characteristics all
come into play in this heterogeneous population ranging from
patients presenting in extremis with acute myocardial infarction and cardiogenic shock to clinically much more stable
patients presenting with heart failure or angina with markedly
reduced LV function and complex coronary artery disease.
Without better formed definitions, it is impossible to develop
robust databases needed to track, risk adjust, standardize
patient selection protocols and investigate optimal treatment
strategies required to move this process forward. We currently
attempt to get at this information indirectly such as analyzing
the use of short-term mechanical support circulatory devices
from national databases such as the National Cardiovascular
Data registry Cath PCI Registry or the Nationwide Inpatient
Sample, Healthcare Cost and Utilization Project, which however are not designed to provide much guidance about highrisk PCI.8–10
Similar to our experience with percutaneous valve
therapies, high-risk PCI involves a multidisciplinary team
approach. Many of the patients sent to our practice are turned
down for coronary artery bypass grafting or repeat coronary
artery bypass grafting by cardiac surgeons. An experienced
interventional cardiologist and cardiac surgeon are essential as are catheterization laboratory technician and nursing
personnel with the knowledge and experience required to
handle mechanical circulatory support devices and the skill
sets needed to treat often unstable patients. Hospital administration should be part of this team with full transparency
about the potential healthcare risks, benefits, and economics
involved with developing and maintaining a high-risk PCI
program. How to best train physicians and staff to assure competencies when performing these procedures will be a serious
question that needs to be addressed.
The economic challenges involved with developing and
maintaining a high-risk PCI program are considerable. This
not only involves the recruitment and maintenance of a seasoned, competent medical team but also involves the expenses
of providing the continuous training, monitoring, and quality
assurance required to assure best clinical practice. Many of
these high-risk patients are resource depleting from a hospital
perspective. The personnel and equipment are costly. Initial
cost benefit data support that the realized increased up front
expenses are offset by shorter index admission length of stay
and lower 90-day episode of care costs compared with intraaortic balloon pump counterpulsation–treated patients. This is
attributed to fewer subsequent readmissions for revascularization procedures and shorter, less expensive readmission length
of stay noted in the high-risk PCI population. Importantly, an
increase in quality-adjusted life years is noted further supporting clinical benefit in this high-risk PCI population. Regulators
and payers will certainly be interested in more data addressing
cost benefit issues.11,12
A further challenge relates to the distribution of care for
high-risk PCI. Economic models breakdown at safety net
hospitals with a significant amount of unfunded or underfunded care.13,14 Medical legal concerns when treating this
high-risk population might drive practitioners and hospital
systems away from participating in a high-risk PCI program.
Transparency in public reporting further complicates the issue
as we learned from some of the observed unintended consequence of state registry PCI reporting systems. Risk-adjusted
mortality would be difficult for this heterogeneous, high-risk
population, which includes the clinical spectrum from cardiogenic shock to more elective multivessel, low-LV function
PCI.15
Often it is the patient with the highest risk for PCI (complex left main disease or cardiogenic shock) who might realize
the greatest potential benefit from the procedure. We now have
the skill sets and have developed the tools to more safely and
effectively treat these patients. The challenge will be how to
provide these services in the most effective and efficient ways
possible.
Disclosures
None.
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Key Words: acute coronary syndrome ◼ coronary artery bypass ◼ heart
failure ◼ percutaneous coronary intervention ◼ peripheral vascular diseases
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High-Risk Percutaneous Coronary Interventions in Modern Day Clinical Practice:
Current Concepts and Challenges
Theodore A. Bass
Circ Cardiovasc Interv. 2015;8:
doi: 10.1161/CIRCINTERVENTIONS.115.003405
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