JACC: CARDIOVASCULAR INTERVENTIONS
VOL. 8, NO. 2, 2015
ª 2015 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 1936-8798/$36.00
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http://dx.doi.org/10.1016/j.jcin.2014.07.030
STATE-OF-THE-ART REVIEW
Percutaneous Circulatory Assist Devices for High-Risk Coronary Intervention Aung Myat, MBBS,* Niket Patel, MBBS,y Shana Tehrani, MD,z Adrian P. Banning, MD, PHD,y Simon R. Redwood, MD,* Deepak L. Bhatt, MD, MPHx
JACC: INTERVENTIONS CME This article has been selected as this issue’s CME activity, available online
Author Disclosures: Dr. Myat is supported by the Department of
at http://interventions.onlinejacc.org/ by selecting the CME tab on the
Health via the National Institute for Health Research (NIHR)
top navigation bar.
Comprehensive Biomedical Research Centre award to Guy’s & St. Thomas’ NHS Foundation Trust in partnership with King’s College
Accreditation and Designation Statement
London and King’s College Hospital NHS Foundation Trust; and also receives financial support from the British Heart Foundation via a
The American College of Cardiology Foundation (ACCF) is accredited by
Clinical Research Training Fellowship (grant no. FS/11/70/28917). Dr.
the Accreditation Council for Continuing Medical Education (ACCME) to
Banning is partially funded by the National Institute for Health
provide continuing medical education for physicians.
Research (NIHR) Oxford Biomedical Research Centre. Dr. Redwood has received unrestricted grant support for the BCIS-1 Trial; and
The ACCF designates this Journal-based CME activity for a maximum of
travel support from Maquet. Dr. Bhatt is on the advisory board of
1 AMA PRA Category 1 Credit(s) . Physicians should only claim credit
Elsevier Practice Update Cardiology, Medscape Cardiology, Regado
commensurate with the extent of their participation in the activity.
Biosciences; is on the Board of Directors of Boston VA Research
Method of Participation and Receipt of CME Certificate
Institute and the Society of Cardiovascular Patient Care; is Chair of the American Heart Association Get With the Guidelines Steering
To obtain credit for this CME activity, you must:
Committee; is on Data Monitoring Committees of Duke Clinical
1. Be an ACC member or JACC: Cardiovascular Interventions subscriber.
Research Institute, Harvard Clinical Research Institute, Mayo Clinic,
2. Carefully read the CME-designated article available online and in this issue of the journal. 3. Answer the post-test questions. At least 2 out of the 3 questions provided must be answered correctly to obtain CME credit.
and Population Health Research Institute; has received honoraria from the American College of Cardiology (Editor of Clinical Trials and Cardiosource), Belvoir Publications (Editor-in-Chief of the Harvard Heart Letter), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), and Slack Publications (Chief
4. Complete a brief evaluation.
Medical Editor, Cardiology Today’s Intervention); is Associate Editor
5. Claim your CME credit and receive your certificate electronically by
of Clinical Cardiology; is Section Editor of Journal of the American
following the instructions given at the conclusion of the activity.
College of Cardiology; is on the clinical trial steering committees of Duke Clinical Research Institute, Harvard Clinical Research
CME Objective for This Article: At the completion of this article, the
Institute, and Population Health Research Institute; is on the CME
learner should be able to: 1) consider the patient, anatomical and pro-
steering committee of WebMD; and has received research grants
cedural characteristics that can elevate percutaneous coronary inter-
from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon,
vention to a high-risk procedure; 2) discuss the physiology underpinning
Medtronic, Roche, Sanofi, and The Medicines Company. All other
the application of percutaneous circulatory assist devices for high risk
authors have reported that they have no relationships relevant to
percutaneous coronary intervention; and 3) determine which patients
the contents of this paper to disclose.
may benefit most from the utilization of the intra-aortic balloon pump, Impella, TandemHeart or extracorporeal membrane oxygenation. CME Editor Disclosure: JACC: Cardiovascular Interventions CME Editor
CME Term of Approval
Olivia Hung, MD, PhD, has received research grant support from NIH T32,
Issue Date: February 2015
Gilead Sciences. and Medtronic Inc.
Expiration Date: January 31, 2016
From the *King’s College London BHF Centre of Research Excellence, The Rayne Institute, Cardiovascular Division, St. Thomas’ Hospital, London, United Kingdom; yDepartment of Cardiology, Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford, United Kingdom; zHatter Cardiovascular Institute, University College London, London, United Kingdom; and the xBrigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. Dr. Myat is supported by the Department of Health via the National Institute for Health Research (NIHR) Comprehensive Biomedical Research
230
Myat et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 8, NO. 2, 2015 FEBRUARY 2015:229–44
Hemodynamic Support for High-Risk PCI
Percutaneous Circulatory Assist Devices for High-Risk Coronary Intervention ABSTRACT A unifying definition of what constitutes high-risk percutaneous coronary intervention remains elusive. This reflects the existence of several recognized patient, anatomic, and procedural characteristics that, when combined, can contribute to elevating risk. The relative inability to withstand the adverse hemodynamic sequelae of dysrhythmia, transient episodes of ischemia-reperfusion injury, or distal embolization of atherogenic material associated with coronary intervention serve as a common thread to tie this patient cohort together. This enhanced susceptibility to catastrophic hemodynamic collapse has triggered the development of percutaneous cardiac assist devices such as the intra-aortic balloon pump, Impella (Abiomed Inc., Danvers, Massachusetts), TandemHeart (CardiacAssist, Inc., Pittsburgh, Pennsylvania), and extracorporeal membranous oxygenation to provide adjunctive mechanical circulatory support. In this state-of-the-art review, we discuss the physiology underpinning their application. Thereafter, we examine the results of several randomized multicenter trials investigating their use in high-risk coronary intervention to determine which patients would benefit most from their implantation and whether there is a signal to delineate whether they should be used in an elective pre-procedure, standby, rescue, or routine post-procedure fashion. (J Am Coll Cardiol Intv 2015;8:229–44) © 2015 by the American College of Cardiology Foundation.
T
he evolution
coronary
complete the procedure. In this review, we highlight
intervention (PCI) has witnessed unprece-
the criteria that elevate PCI to the high-risk category.
dented advances in the past 2 decades. In
Thereafter, we compare and contrast the physiology
the wake of such progress, interventional cardiolo-
and evidence base underpinning MCS use to deter-
gists are now attempting revascularization of more
mine where these devices sit in the wider context of
complex
high-risk PCI.
coronary
of
percutaneous
anatomy
in
patients
often
declined for surgical intervention. Yet with greater complexity comes greater risk, hence the develop-
WHAT DEFINES HIGH-RISK PCI?
ment of percutaneous mechanical circulatory support (MCS) devices. Borne from a sound physiological plat-
A universally accepted definition of high-risk PCI
form, in theory they serve to maintain coronary perfu-
remains elusive. This reflects the myriad adverse
sion pressure and reduce myocardial workload,
clinical, anatomic, and hemodynamic factors that, if
allowing the operator sufficient time to optimally
taken in isolation, are potentially surmountable but
Centre award to Guy’s & St. Thomas’ NHS Foundation Trust in partnership with King’s College London and King’s College Hospital NHS Foundation Trust; and also receives financial support from the British Heart Foundation via a Clinical Research Training Fellowship (grant no. FS/11/70/28917). Dr. Banning is partially funded by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre. Dr. Redwood has received unrestricted grant support for the BCIS-1 Trial; and travel support from Maquet. Dr. Bhatt is on the advisory board of Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; is on the Board of Directors of Boston VA Research Institute and the Society of Cardiovascular Patient Care; is Chair of the American Heart Association Get With the Guidelines Steering Committee; is on Data Monitoring Committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and Population Health Research Institute; has received honoraria from the American College of Cardiology (Editor of Clinical Trials and Cardiosource), Belvoir Publications (Editor-inChief of the Harvard Heart Letter), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), and Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention); is Associate Editor of Clinical Cardiology; is Section Editor of Journal of the American College of Cardiology; is on the clinical trial steering committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, and Population Health Research Institute; is on the CME steering committee of WebMD; and has received research grants from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Roche, Sanofi, and The Medicines Company. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received July 8, 2014; accepted July 17, 2014.
Myat et al.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 8, NO. 2, 2015 FEBRUARY 2015:229–44
when combined, will significantly increase the chance
KEY FUNDAMENTALS OF MECHANICAL
ABBREVIATIONS
of periprocedural, subacute, medium- and long-term
CIRCULATORY SUPPORT
AND ACRONYMS
Once Kantrowitz et al. (5) had performed the
infarction
major adverse cardiac and cerebrovascular events occurring.
first-in-human
intra-aortic
balloon
pump
HIGH-RISK CRITERIA USED IN
(IABP) implantation in 1968, the following 4
THE CURRENT EVIDENCE BASE
basic characteristics for an MCS device to have a therapeutic impact on CS management
The diversity of criteria adopted by investigators to
had already been proposed: effective inser-
study the performance of percutaneous circulatory
tion
with
minimal
surgical
application;
assist devices (PCADs) (Table 1, Online Appendix)
simplicity of initiation and maintenance for
would suggest a lack of consensus on what defines
widespread use by minimally trained profes-
high-risk PCI. This makes robust intertrial compari-
sional personnel; capability for aiding the
son speculative at best and standardization prob-
coronary and peripheral circulation inter-
lematic, especially when patient characteristics,
mittently or continuously for hours or days;
procedural adjuncts, timing of hemodynamic sup-
significant support for the ischemic myocar-
port, and metrics of risk are largely heterogeneous
dium by reducing its work (Figures 1 and 2).
(1,2).
To
this
end,
the
definition
of
high-risk
PCI becomes somewhat arbitrary, reflecting a need to pigeonhole the population under investigation to satisfy inclusion criteria rather than corresponding to universally accepted parameters. This also limits our ability to recommend one model of risk stratification over another. Moreover, risk scores may identify who might benefit from MCS, but they do not, as yet, inform the operator as to which PCAD to use or whether it should be used in an elective pre-procedure, standby, rescue, or routine postprocedure fashion. Despite these inconsistencies, there is a common thread. It is the relative inability of the high-risk patient to withstand the deleterious hemodynamic consequences of dysrhythmia, transient intervals of ischemia-reperfusion injury, or the distal embolization of atherogenic material (i.e., the no-reflow phenomenon) associated with PCI. A highrisk patient may have significantly attenuated cardiovascular reserve and be increasingly susceptible to post-ischemic stunning. The onus falls on the heart team to recognize this patient subset, anticipate potential difficulties that may occur during the procedure, and decide whether MCS is an appropriate intervention. Otherwise, a chain of deleterious events may ensue, leading to further reduction in cardiac output (CO) and an amplification of ischemia, culminating in cardiogenic shock (CS) or malignant ventricular arrhythmia. Conversely, the patient may already be in CS on presentation, a diagnosis based on
evidence
of
231
Hemodynamic Support for High-Risk PCI
hypotension
(systolic
blood
pressure