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Anesthesia Outside the Operating Room

Foreword

Lee A. Fleisher, MD, FACC


Consulting Editor

Increasingly, we are being asked to provide anesthesia or heavy sedation for patients
undergoing procedures outside of the operating room. This represents a clinical, staff-
ing, and financial challenge to most anesthesiology departments. While provision of
anesthesia services within an operating room environment has been associated with
increasing safety over the past several decades, settings outside of the operating
room may present unique challenges. For these reasons, it is important the Anesthe-
siology Clinics address this important topic. In this issue, three major areas of care
are addressed: financial implications, optimal care paradigms for specific patients,
and locations and priorities with respect to all out-of-operating-room settings.
In choosing editors for this issue, it became important to identify forward thinkers
from different locations to obtain a broad perspective of optimal care. Both Wendy
Gross, MD, and Barbara Gold, MD, are such individuals. Dr. Gross is currently assis-
tant professor of Anesthesia at Harvard Medical School and an attending anesthesiol-
ogist at the Brigham and Women’s Hospital. She is currently the medical director of the
Procedural Sedation Service and the Peri-Procedural Services in Cardiovascular Medi-
cine and director of Non-OR Anesthesia Services at her hospital. Dr. Gold is currently
associate professor of Anesthesiology and vice chair for Education at the University of
Minnesota and medical director of anesthesia at Fairview Hospital. She has been
a leader in the area of ambulatory anesthesia and a former president of the Society
of Ambulatory Anesthesia. Together, they have produced an issue which will help us
deal with new challenges in our practice.

Lee A. Fleisher, MD, FACC


Department of Anesthesiology and Critical Care
University of Pennsylvania School of Medicine
6 Dulles, 3400 Spruce Street
Philadelphia, PA 19104, USA
E-mail address:
[email protected] (L.A. Fleisher)

Anesthesiology Clin 27 (2009) xiii


doi:10.1016/j.anclin.2009.02.001 anesthesiology.theclinics.com
1932-2275/09/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
Anesthesia Outside the Operating Room

Preface

Wendy L. Gross, MD, MHCM Barbara Gold, MD


Guest Editors

For the most part, anesthesiologists practice their specialty in the controlled setting of
the operating room (OR). However, improved technology, escalating financial
constraint, limited OR resources, and growing numbers of acutely ill patients create
incentives for medical practitioners to perform procedures outside of the OR. Conse-
quently, the need for deeper sedation, general anesthesia, and hemodynamic moni-
toring in non-OR venues has grown dramatically. In many hospitals, the non-OR
caseload is equal to that of the OR. Many non-OR procedures are performed with
minimal to moderate intravenous sedation administered by registered nurses,
however, an increasing number require more extensive medications and regimens
administered by anesthesiologists. Not only is the volume of non-OR cases increasing,
but the scope of non-OR procedures requiring anesthesia care is increasing as well.
This evolution generates new challenges for medical interventionalists, anesthesiolo-
gists, and patients alike.
As the practice of anesthesiology moves beyond the familiar domain of the OR, it
enters the venue of medical specialists—such as invasive cardiologists, interventional
radiologists, gastroenterologists, and oncologists. There are new obstacles to over-
come as the landscape changes. The articles herein have been compiled to help the
practioner navigate the new landscape by examining the issues from multiple perspec-
tives. This issue of Anesthesiology Clinics is divided into three sections, each of which
scrutinizes the practice of anesthesiology in non-OR locations.

SECTION 1: FINANCIAL CONSIDERATIONS


This section discusses the context for major financial considerations that drive the
practice of anesthesiology as it expands outward from the traditional perioperative
area. These considerations include budget neutrality, new innovation, the cost of poorly
integrated care, and financial implications of potential modifications to resource
management in the OR. In the current reimbursement environment, anesthesia service

Anesthesiology Clin 27 (2009) xv–xvii


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xvi Preface

provided outside of the OR is poorly reimbursed. Opportunity costs for anesthesia


departments are enormous since coverage outside of the OR often requires a ratio
of 1:1 staffing. The demand for comprehensive and reliable anesthesiology services
outside of the OR is growing, but the benefits accrue to other departments and to hospi-
tals as a whole. Just as surgical procedures in the OR often require an integrative and
interdisciplinary approach to patient care and strategic management of reimburse-
ments, so, too, do many of the emerging minimally invasive procedures performed
outside of the OR. Creative financing and alternative staffing models may need to be
considered.

SECTION 2: PRACTICE PARAMETERS


The authors review anesthesiology practice needs and methods as they evolve outside
of the OR in three rapidly growing areas: cardiology, endoscopy, and radiology. Many
non-OR procedures are new and innovative. Often, interventionalists perform novel
procedures and employ new techniques that are unique or unfamiliar to them and to
the anesthesiologists attending to their patients. Delivering anesthetic care to those
who are acutely ill, elderly, and/or poorly prepared for the procedure is always chal-
lenging; performing this work during a procedure that is either ill-defined or poorly ex-
plained/communicated to the anesthesiologist adds another layer of complexity. A
fundamental understanding of the types of cases performed and types of patients
commonly treated in non-OR locations is critical.
Many non-OR areas have physical characteristics that are unwelcoming for anes-
thesiologists and their equipment. Often proceduralists are unfamiliar with the basic
needs of anesthesiologists and the equipment needed to ensure patient safety. The
necessary anesthesia equipment is usually expensive and may be incompatible with
that of the interventional suite in terms of space or patient positioning. More impor-
tantly, sick patients require intense and complex anesthetic care even if the procedure
itself is not complicated. Section 2 considers what medical specialists and anesthesi-
ologists in cardiology, radiology, and endoscopy see as important practice guidelines
and future goals for their respective practices.

SECTION 3: TRANSITIONAL PRIORITIES


Here, the authors discuss critical features of OR practice that must become standard in
non-OR sites to insure consistency, patient safety, and best practice outside of the OR.
The characteristics of consultative practice and the application of OR standards to non-
OR locations are considered in this section. There is no question that anesthesiology
stands at the forefront of promoting and developing increased patient safety. Perioper-
ative morbidity and mortality have declined as anesthesia practice has evolved. In
addition, surgical procedures have grown less invasive. Outside of the OR, however,
the opposite is true. Whereas non-OR procedures were previously small and relatively
simple, they are now as broad in scope as many surgeries, even though they may be
less ‘‘invasive.’’
Percutaneous procedures often accomplish the same process and purpose as
open surger. ‘‘Minimally invasive’’ percutaneous procedures introduce a different
type of risk, however, because fixing a problem may be more difficult without expo-
sure, necessitating urgent transfer of the patient to the OR. Nonsurgical practitioners
may find it hard to understand why patients require invasive monitors or any monitors,
or even the presence of an anesthesiologist until the unexpected happens in the
Preface xvii

middle of a procedure. In Section 3, the need for portability of standard OR practice


parameters is discussed in terms of patient evaluation, monitoring, and safety.

In the final article, the future of anesthesiology as a medical specialty is discussed


using the evolution of ICU practice as a template. In addition, strategies for the future
are discussed in the context of emerging medical, political, and financial challenges.
The future of the specialty now includes an array of practices in non-OR locations.
We face the question of how to incorporate a new venue into the practice of anesthe-
siology and how to do so in a way that makes medical, political, and financial sense for
the future of the specialty and medicine. The future of anesthesiology as a medical
specialty is discussed. The financial and political challenges we face are summarized.
An account of the new concerns we face, the changing practice parameters we
encounter, and a review of what we know to be essential to the delivery of safe
care concludes this issue. We discuss the need for our specialty to develop strategies
that stimulate us to keep in step with the rhythm of modern medicine for the benefit of
patients and practitioners.

Wendy L. Gross, MD, MHCM


Department of Anesthesia, Perioperative and Pain Medicine
Brigham and Women’s Hospital
75 Francis St.
Boston, MA 02115
Barbara Gold, MD
Department of Anesthesiology
University of Minnesota Medical Center
Minneapolis, MN
E-mail addresses:
[email protected] (W.L. Gross)
[email protected] (B. Gold)
I ntro d uc tion :
The Challenge of
Anesthesia Outside
the Op erating Room
Anthony Dunster Whittemore, MD

There is little doubt that the burgeoning array of minimally invasive procedures
provides substantial advantages over traditional open surgical alternatives. Because
significant complications have become low-frequency events, an aura of compla-
cency is frequently notable in interventional suites. Yet such procedures, however
minimally invasive they may be, are associated with potential hazard.
At the Brigham and Women’s hospital in Boston, more than 30,000 operations are
carried out annually in the setting of the conventional operating room, but an equal
number of interventions are conducted in remote locations where the availability of
anesthesia personnel is less predictable. This reflects a national trend with regard to
the interventional endoscopy, radiology, and cardiology areas, most of which are
associated with a low risk of anesthetic and procedural complications.
As the comorbidities of patients inevitably become more significant, however, the
inherent risks of major cardiopulmonary complications, along with perforation and
hemorrhage, remain real hazards. Patients are not always evaluated before non–oper-
ating room procedures with the standards or rigor insisted on for operating room
cases. Anesthesia consults are often sought spontaneously at the last minute, or
the need is not recognized at all. Practitioners administering sedation not infrequently
provide inadequate analgesia and sedation for fear of inducing complications from
overmedication; less frequently, respiratory distress or worse may occur. It is hoped
that allocation of additional anesthesia resources results in a safer and more comfort-
able experience for patients and for all health care providers involved.

Department of Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston,
MA, USA
E-mail address: [email protected]

Anesthesiology Clin 27 (2009) 1


doi:10.1016/j.anclin.2009.01.001 anesthesiology.theclinics.com
1932-2275/09/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
I ntrod uc tion to Se ction 1:
Fina nc ial Considerations
AlexanderA. Hannenberg, MD

KEYWORD
 Procedural sedation

This section on financial considerations is intended to provide the tools and perspec-
tive needed to intelligently structure a service providing high-quality anesthetic care
for patients undergoing procedures outside the traditional operating room environ-
ment. Dr. Siegrist’s outline of analytic approaches to the cost of such services con-
tains well-established principles and techniques that are essential to understanding
and explaining the economic impact and requirements for this care. Dr. Kane’s discus-
sion of emerging payment issues should make the reader aware that ‘‘the times they
are a’changing’’ and that models of payment for health care will evolve rapidly in an
effort to cope with the affordability challenges.
It is fair to say that all the ‘‘W’s’’ of traditional journalism (who, what, where, why,
when, and how) are in flux with respect to procedural sedation and anesthesia. Anes-
thesia providers involved in gastrointestinal endoscopy procedures are living through
the resulting turmoil. Last year’s controversy surrounding Aetna’s limitations on pay-
ment for anesthesia care during endoscopy1 is an excellent example of the fundamen-
tal challenges faced by everyone involved in expanding the scope of anesthetic care
outside the operating room. Left unsettled in this dispute are the key questions of who
needs what kind of sedation administered by whom! When is anesthetic care medi-
cally necessary, and when is it a convenience for the patient or operator? The author
estimates that if all endoscopy procedures in the United States were attended by an
anesthesiologist, the total cost would exceed $5 billion annually at current rates. Such
figures predictably will provoke a reaction like Aetna’s, and providers must anticipate
future demands from payers and purchasers.
There undoubtedly will continue to be a place for sedative administration by trained
nurses. The range of settings and conditions in which these services are optimal will be
debated. The role of anesthesiologists in setting standards and in training and clini-
cally supporting these non-anesthesia providers will advance the quality, safety,
and efficiency of the care provided. Who better to direct—at an institutional level
and an individual patient level—the use of hypnotics, sedatives, and analgesics?
The failure of the payment system to recognize this type of physician leadership
creates an obstacle to building multidisciplinary teams to meet the growing needs
in procedural sedation.

Newton-Wellesley Hospital, Newton, MA 02462, USA


E-mail address: [email protected]

Anesthesiology Clin 27 (2009) 5–6


doi:10.1016/j.anclin.2008.10.008 anesthesiology.theclinics.com
1932-2275/08/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
6 Hannenberg

These challenges are likely to provoke new models of payment, many of which are
described in the article by Dr. Kane. In the Acute Care Episode2 demonstration pro-
ject, Medicare is revisiting bundled payments that lump together institutional and pro-
vider payments for certain orthopedic and cardiac procedures. In such models, the
providers involved—rather than Medicare’s fee schedules—make decisions about
the value of each provider’s contribution to the care of the patient. What judgments
will they make, for example, about the anesthesiologist’s service in the catheterization
laboratory? These considerations clearly are uncharted territory but, just as clearly, will
bring the physicians in touch with cost–benefit considerations from which existing
payment systems substantially isolate them.
The emerging need to provide compelling evidence of the value of a professional
service demands systematic aggregation of outcomes data and a steady stream of
scholarly work to assess the justification, clinical benefit, and economic underpinnings
of anesthesiologists’ services, especially for those new to the clinical arena.
Boston, September 2008.

REFERENCES

1. Feder BJ. Aetna to end payment for a drug in colonoscopies. NY Times Dec 28,
2007. Available at: http://www.nytimes.com/2007/12/28/business/28.colon.html.
Accessed December 11, 2008.
2. Centers for Medicare and Medicaid Services. Medicare Acute Care Episode Demon-
stration. Available at: http://www.cms.hhs.gov/demoprojectsevalrpts/md/itemdetail.
asp?filterType5none&filterByDID5-99&sortByDID53&sortOrder5descending&
itemID5CMS1204388&intNumPerPage510. Accessed November 10, 2008.
Traditional Fee - for-
Ser vice Medic are
Payment Systems
a nd Fragmente d
Patient C are :
The Backdrop for
Non ^ Op erating Room
Proce dures a nd
Anesthesia Ser vices
Nancy M. Kane, DBA

KEYWORDS
 Medicare  Payment reform  Care fragmentation
 Bundling  Medical home

Medicare’s traditional method of paying for units of service, be they hospital admis-
sions, office visits, outpatient surgeries, or laboratory tests, evolved gradually from
a payment system that originated in the 1930s, when private insurance for hospitaliza-
tions and physician services first emerged in this country. At that time, hospitals were
just beginning to cure patients, emerging from their centuries-long primary function as
almshouses that provided housing and minimal comforts to the sick poor. Desperate
for capital resources, hospitals founded the first hospitalization insurance plans and
designed their largely cost-based, open-ended payment systems to favor their own
expansive growth. Physicians in the 1930s reluctantly joined private, largely
physician-controlled insurance schemes to stave off compulsory public insurance.
Fee-for-service was the payment system of choice for keeping insurers, with more
restrictive or prescriptive forms of payment, out of the practice of medicine. Hospital-
ization and physician payment systems were designed to entice providers into ac-
cepting them, not to ensure that the right care was delivered at the right place and
at the right time.

Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA
E-mail address: [email protected]

Anesthesiology Clin 27 (2009) 7–15


doi:10.1016/j.anclin.2008.10.009 anesthesiology.theclinics.com
1932-2275/08/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
8 Kane

TOO MANY PAYMENT SILOS

The delivery system has come a long way since the 1930s, when the hospital was the
physician’s private workplace. As capital costs and technological advances have ac-
celerated, hospitals, physicians, and other health care providers, willingly or not, have
become increasingly interdependent, but current payment systems and medical
culture do not reflect these changed relationships. Medicare’s 18 separate payment
systems for 16 different provider/supplier types, plus two types of private insurance
plan (medical and drug) represent an elaborate scheme of ‘‘silos’’ that frequently
pits the interest of one set of providers (eg, physicians) against the interests of another
(eg, hospitals), leaving the patient in a daze, looking for an ombudsman.

PROLIFERATION AND FRAGMENTATION IN THE SITES OF TREATMENT

Changes in the sites of treatment have exacerbated fragmentation. Medicare expen-


ditures for inpatient care have fallen from 50% of total traditional (non–managed care)
spending in 1996 to only 34.5% in 2006.1 In the same decade, Medicare spending for
outpatient care rose from 4.5% to 8.3% of total traditional spending, and spending for
‘‘other fee-for-service settings’’ including hospice, outpatient laboratory, ambulatory
surgical centers, and health clinics, grew from 11.2% to 15.5% of total traditional
spending. For surgical procedures, the shift from hospital-based to free-standing am-
bulatory surgical centers (ASCs) has been dramatic: Medicare payments to ASCs dou-
bled between 2000 and 2006, and the number of ASCs increased by more than 50% to
4707. Surgical care runs the risk of increased fragmentation with the proliferation of
hospitals specializing in cardiac, orthopedic, and general surgeries. The number of
such specialty hospitals grew from 46 to 89 between 2002 and 2004 and reached
130 in 2006 after the 2004–2005 moratorium on new specialty hospitals expired.2
Even within hospitals, new ‘‘noninvasive, nonsurgical’’ approaches to disease via
radiology and medical specialty clinics increase the likelihood of fragmentation by
adding a whole new cadre of providers with whom the patient and the primary
care-giver must interact, often without an infrastructure for doing so.

INCREASE IN THE NUMBER AND TYPES OF PHYSICIANS INVOLVED IN PROVIDING SERVICES

Even within the same payment silo (eg, physician services), the scope and number of
providers involved in specialty treatment has increased the need for better care coor-
dination. Within imaging services, for example, where growth in units of service per ben-
eficiary has exploded in the last decade, radiologists now receive 43% of Medicare
payments; the rest go to cardiologists (25%), surgical specialties (9%), independent di-
agnostic testing facilities (8%), internal medicine (6%), and other specialists (10%).
The average Medicare beneficiary sees five physicians a year. Nearly two thirds of
Medicare beneficiaries with three or more common chronic conditions (eg, coronary
artery disease, congestive heart failure, and diabetes) see 10 or more physicians in
a year.3 Yet fewer providers than ever are willing to spend the time, much of it
unreimbursed, to coordinate care or communicate with the patient or other providers
regarding the implications of the various tests and procedures provided.
Because of fragmentation, lack of coordination, and the fee-for-service incentives of
Medicare payment, there is enormous variation in resource use and adherence to rec-
ognized quality standards and outcomes within severity-adjusted episodes. For in-
stance, for similar severity-adjusted hypertensive patients, a high-cost cardiologist
in Boston spends 1.74 times more on evaluation and management, 1.56 times more
on imaging, and 1.39 times more on tests than the average Boston cardiologist. Similar
Medicare Payment Systems 9

variation occurs across metropolitan areas: in 2002, physicians in Boston treating Medi-
care patients for hypertension used 96% of the national average resource use per ep-
isode, whereas physicians in Houston and Miami used 120%, and those in Minneapolis
used only 87% of the national average. Clinical quality measures show similar variation
within and across cities, and they are not correlated highly with relative resource use.

OVERPAYMENT OF HIGHER-TECHNOLOGY CARE AT THE EXPENSE


OF LOW-TECHNOLOGY CARE

Besides paying in silos that fail to align incentives across provider types (eg, hospital
and physician) or within provider types (eg, radiologist and cardiologist, or procedur-
alist and anesthesiologist), Medicare also has an imperfect process for recognizing the
impact of new technology on treatment cost and outcome. This deficiency affects care
delivery in at least two ways. First, payment recognition for new technology involving
physician services lags behind the appearance of that technology by several years,
thereby slowing its adaptation. Second, payment adjustments for new technology
that has been disseminated fully into practice, with the associated improvements in
technique and scale, also are slow in coming, leaving in place incentives to overpro-
vide newer technologies at the expense of equally or even more effective alternative
treatments. The rapid migration of technically intensive procedures from operating
rooms to non–operating room areas under the auspices of competing nonsurgical
medical practitioners has strained the capabilities of payment systems to keep up
with the proliferation of new service sites and types of practitioners.
The Resource-Based Relative Value System (RBRVS) assigns weights to physician
service units (eg, office visit, diagnostic test, surgical procedure) based on the relative
costliness of the inputs used to provide services: physician work, practice expense,
and professional liability expenses. The relative weights for roughly 6700 distinct ser-
vices in the Health care Common Procedural Coding System, the coding system for
outpatient care under Medicare, are supposed to be updated at least every 5 years
to reflect changes in medical practice, coding changes, new data, and the addition
of new services. The minimum lead time for a new code can be several years; for in-
stance, it is 18 months for new laboratory tests, but the service must be already
‘‘widely used’’ before the American Medical Association’s Current Procedural Termi-
nology Committee that supervises the coding system for insurance billing will consider
it. Thus a test may be in the market for up to 2 years before it even can be submitted.4
On the other hand, Medicare has been slow to adjust relative weights downward
once a new technology is well integrated into practice. Thus input costs generally
are higher in the early years (when physician work may be more intensive or longer
per treatment, patients involved may be more severely ill, and/or equipment or supply
expenses may be higher because of lower volumes) than in later years when the
service is well established and is being applied in higher volumes to less severely ill
patients. The relative weights, however, are not lowered automatically to reflect the re-
duced input costs. A sign that Medicare has not done a good job of adjusting for the
‘‘experience curve’’ and impact of volume on new technology is the number of codes
whose relative weights are reduced in 5-year reviews, relative to those that are in-
creased. In 1996, for the first 5-year review following the 1992 introduction of the
RBRVS system, the Resource Use Committee (RUC) of the American Medical Asso-
ciation, responsible for recommending relative weight changes to the Centers for
Medicare and Medicaid Services, recommended increased weights for 296 codes,
no change for 650 codes, and decreased weights for only 107 codes. At the second
5-year review in 2001, the RUC recommended increased weights for 469 codes, no
10 Kane

change for 311 codes, and decreases for only 27. The Centers for Medicare and Med-
icaid Services accepted more than 90% of the RUC’s recommendations.5
Because adjustments to relative weights are budget-neutral within the physician
payment silo, increases in payment weights distribute the ‘‘fixed’’ resources more
into the higher-weighted services while reducing the share of the pie paid to lower-
weighted services. This system creates very strong incentives (overpayments) for phy-
sicians to provide more services with higher relative weights (services with newer
technologies) and to avoid providing services with lower relative weights (services
that do not use new technologies, such as evaluation and management or care
coordination).
This ‘‘fee-for-service-on-steroids’’ phenomenon is responsible, at least in part, for
fueling the enormous growth in the volume of high-technology services provided to
Medicare beneficiaries in recent years. Between 2000 and 2005, the cumulative vol-
ume of physician services per beneficiary increased 30%, with the greatest increases
in imaging (61%) and tests (46%). These volume increases have fueled large, politi-
cally unpopular increases in Medicare Part B premiums and are largely responsible
for the negative updates in the physician fee schedule that are required by current
law. At the same time, evaluation and management services, which include vital but
underprovided services such as care coordination and patient education, had the
lowest per-beneficiary rate of increase over the 5-year period—less than 20%.
Relatively poor payment for coordination and other primary care services has
contributed to a severe shortage of United States medical school graduates willing to en-
ter primary care residencies.6 Although foreign medical graduates have been willing to fill
the gap in recent years, the difference in income between primary and specialty practice
is growing, and this difference will aggravate a predicted shortage of primary care physi-
cians just as the baby-boomers reach Medicare age with a host of chronic care needs.7

IMPROVING INTEGRATION OF CARE ACROSS AND WITHIN PAYMENT SYSTEMS:


POTENTIAL REFORMS
The Problem of the Sustainable Growth Rate Formula Is Absorbing Policy Attention
with no Remedy in Sight
Much of the recent policy debate about physician payment involves eliminating the
Sustainable Growth Rate (SGR) constraint on physician fees. The SGR was imposed
by Congress in the Balanced Budget Act of 1997, limiting growth in Medicare physi-
cian expenditures per beneficiary to inflation plus the per capita growth in gross
domestic product using 1996 as the base year. Total physician expenditures have ex-
ceeded this limit since 2001, thereby mandating across-the-board cuts in physician
fees since 2002. As of 2008, however, Congress has overridden its own mandate in
all but one of the last 7 years; each delay in implementing the law creates an ever-
deeper deficit to be recovered out of future years’ physician expenditures. The cumu-
lative SGR deficit has grown so large (more than $60 billion as of 2007) that at least
9 years of 5% fee cuts each year would be needed to comply with the law. Trustees
of the Medicare Trust Fund have called this projected series of negative updates ‘‘un-
realistically low,’’ but Congress has not yet come up with an alternative, budget-neu-
tral way to address the problem. Meanwhile, the fees not cut do not keep up with
inflation and encourage even greater volume growth, although the greater volume
per beneficiary does not seem to be related to better outcomes or better patient sat-
isfaction with care.8 Finally, although the fee-for-service system strongly encourages
more volume, which is not needed, it does not reward care coordination or high-qual-
ity care, which is urgently needed.
Medicare Payment Systems 11

It is Time to Focus on Alternatives to Fee-for-Service in Provider Silos


Although there is some truth in the popular joke that the most expensive piece of tech-
nology in a hospital is the physician’s pen, the reality is that other parties are encour-
aged by their payment systems to provide a greater volume of service without regard
to quality of care, overall cost, or health care maintenance. Hospitals have strong in-
centives to admit patients and to increase the care they provide in the less constrained
outpatient setting, as well as to discharge patients early. Postacute providers have
strong incentives keep patients Medicare-eligible even if that means re-admitting
them to acute hospitals for the requisite 3-day stay for conditions that otherwise might
have been treated more effectively in a community-based or long-term care setting.
Equipment and pharmaceutical suppliers are paid only if their products are used, so
they engage in direct-to-consumer advertising and marketing campaigns directed
at physicians. One of the biggest problems in traditional Medicare is that no one is
held accountable for the quality or cost of the entire package of services delivered
to a beneficiary during an episode of illness or a year of chronic disease. Worse still,
no one is held responsible for keeping Medicare beneficiaries healthy.
The Medicare Payment Advisory Commission (MedPAC) has recommended to
Congress a number of reforms that would begin to address provider accountability
for services outside the provider’s service and/or payment silo. Two of these reforms
are described here, because they reflect the most recent discussions and recommen-
dations to Congress in the spring of 2008. A third concept described here is not yet at
the recommendation stage but is complementary to the other two. The three would
represent significant change in the way delivery systems are structured and operated.
Their potential impact, if enacted, could be much more far reaching than the 1983
payment reform that replaced retrospective cost-based reimbursement with prospec-
tive diagnosis-related group payments for inpatient care. That reform contributed to
a 20-year decline in inpatient days (and related inpatient capacity), as well as to an
explosion in the development and use of outpatient and postacute providers. Given
the potential impact of these possible reforms, it is likely that their implementation,
if passed, would take several years. Even with a phased-in implementation, however,
it is likely that some institutions will adapt and thrive, and others will not.

Bundling Parts A and B for High-Cost, High-Volume Inpatient Admissions


MedPAC’s April 2008 recommendation to Congress, unanimously adopted, reads as
follows:9

To encourage providers to collaborate and better coordinate care, the Congress


should direct the Secretary (of HHS) to reduce payments to hospitals with rela-
tively high readmission rates for select conditions and also allow shared account-
ability between physicians and hospitals. The Congress should also direct the
Secretary to report within two years on the feasibility of broader approaches
such as virtual bundling for encouraging efficiency across hospitalization epi-
sodes. The Congress should require the Secretary to create a voluntary pilot pro-
gram to test the feasibility of actual bundled payments for services around
hospitalization episodes for select conditions. The pilot must have clear and
explicit thresholds for determining if it can be expanded into the full Medicare
program, or discontinued entirely.

Under bundled payment, Medicare would pay a single entity (one in which all pro-
viders involved were represented) an amount that would cover the expected costs
of providing all services for the hospitalization and related postacute period. This
proposal could be implemented on a pilot/voluntary basis for organizations with an
12 Kane

infrastructure already capable of receiving and allocating bundled payments. For


those lacking such an infrastructure, a phased approach could include, first, a confi-
dential information-only strategy and eventually incorporate mandatory bonuses and
penalties within a fee-for-service withhold system (‘‘virtual’’ bundling).
Bundled payment might begin by focusing primarily on holding hospitals, physicians,
and postacute providers responsible for 30-day readmission rates, which vary from 13%
to 24% depending on the state.10 This plan would encourage hospitals to work with phy-
sicians and postacute providers to re-engineer the care process, addressing mortality,
morbidity, readmission rates, and costs throughout the patient’s hospitalization and re-
covery experience. A bundled payment system would encourage providers to do a better
job of coordinating and communicating through hand-offs of patients through the pro-
cess of care and across the traditional payment silos. Focusing on inpatient admissions
as the trigger for bundling also targets the most costly Medicare beneficiaries; the most
costly 20% of Medicare beneficiaries average 1.7 admissions per year.

Medical Homes
In the same April 2008 meeting, MedPAC Commissioners also unanimously supported
the following recommendations to Congress:10

Congress should initiate a medical home pilot project in Medicare. Eligible med-
ical homes must meet stringent criteria, including at least the following: Furnish
primary care, including coordinating appropriate preventive, maintenance and
acute health services; use health information technology for active clinical deci-
sion support; conduct care management; maintain 24-hour patient communi-
cation and rapid access; keep up to-date records of patient’s advanced
directives; have a formal quality improvement program; maintain a written under-
standing with beneficiary designating the provider as a medical home.
Medicare should provide medical homes with timely data on patient use. The
pilot should require a physician pay-for-performance program. Finally, the pilot
must have clear and explicit thresholds for determining if it can be expanded
into the full Medicare program, or discontinued entirely.

Under a medical home arrangement, the designated provider would be paid a monthly
capitation for providing comprehensive, continuous care and acting as a resource for
helping patients and families navigate through the health system to select optimal treat-
ments and providers. The provider would continue to be paid fee-for-service for providing
Part B services, subject to a pay-for-performance component reflecting the provider’s
clinical quality and efficient use of resources. Specialists could qualify as a medical
home when they sign up to manage specific chronic diseases of their patients, such as
a cardiologist managing patients who have congestive heart failure, or endocrinologists
managing the care of diabetics. The provider’s efficient and effective use of resources ul-
timately would affect participation and payment levels in the medical home program.
Eligibility might be limited at first to beneficiaries who have at least two chronic con-
ditions, and enrollment in a medical home would be voluntary. Beneficiaries still would
be free to see specialists without a referral from the medical home, although they
might have an obligation to inform the medical home of their use of a non–medical
home provider. There would be no beneficiary cost sharing for medical home fees.
Medical homes would begin to address the fact that beneficiaries with chronic condi-
tions do not receive recommended care and are sometimes hospitalized for events that
could have been prevented with better primary care. Researchers have found that adult
patients who have chronic conditions receive recommended care only 56% of the time.11
Avoidable Medicare hospitalizations related to congestive heart failure, chronic
Medicare Payment Systems 13

obstructive pulmonary disease, hypertension, and three forms of complications for un-
controlled diabetes are among the top 12 reasons for Medicare hospitalizations.12 One
study found that 38% of patients without chronic disease experienced medical mistakes,
that is, medication and laboratory errors caused by lack of coordination across care set-
tings. Even more patients (48%) reported similar mistakes when four or more doctors
were involved in their care.13 Although medical homes will not solve all the problems
caused by fragmentation, fee-for-service silos, and lack of incentives for physicians to
work collaboratively to improve patient care, they at least are headed in the right direction.

Accountable Care Organizations


Although MedPAC made no recommendations to Congress regarding accountable
care organizations (ACOs), the concept was discussed extensively as a means of con-
trolling excessive volume growth and addressing the uneven quality of care provided
to all Medicare beneficiaries, not just those who have chronic or acute conditions. An
ACO would be a group of physicians, possibly including a hospital, that is responsible
for quality and overall Medicare spending for their patients over the course of a year. It
could involve fee-for-service payment with withholds, penalties, and bonuses, or
could move into more bundled payment designs if an infrastructure is created to allo-
cate payments across provider types. ACOs would be responsible for all patients
within a geographic area who agree to participate, thus expanding the concept of bun-
dling beyond medical homes and bundled hospitalization care to include well-care,
prevention, and health maintenance. They could be voluntary groups of physicians
who choose to work together or who are within the same hospital’s primary service
area, or they could be already established multispecialty group practices.
Many philosophical and practical issues regarding the implementation of ACOs re-
main to be worked out, ranging from whether they should be voluntary (in which case
there could be selection bias) or mandatory (which would generate high resistance in
many unstructured markets), whether they should include hospitals, and whether non-
participating physicians would continue to have their fee updates subject to the SGR.
The direction of the policy discussion clearly is to encourage broader provider
accountability across the payment silos for patient cost, quality, and outcomes.

SUMMARY

The rising tide of uninsured and underinsured Americans is a sign that the health care
financing system is broken. Many policymakers, providers, and beneficiaries, how-
ever, believe that the health care delivery system is broken, too. To the extent that
the present payment systems contribute to the high cost, poor quality, and lack of ac-
countability that characterizes today’s health care delivery system, there is hope that
reforms are within reach. Medicare, as the largest payer in the country, can lead the
way, as it did with diagnosis-related groups and RBRVUs, to change fundamentally
the dynamics of health delivery in the United States. Already private insurers are ex-
perimenting with care coordination, provider accountability, and pay-for-performance
concepts on a smaller scale. Some are hampered in their efforts to distinguish high-
cost and poor-quality providers effectively because of the relatively small numbers
of patients per provider. Medicare could increase substantially the validity and cred-
ibility of the tools of provider accountability by combining its beneficiary population
data and its technical expertise with those of private-sector insurers. The technical
ability to identify episodes of acute and chronic illness and to link providers to clinical
measures of care and outcomes is improving every day, making payment reforms
linked to meaningful measures of performance increasingly possible.
14 Kane

The implications for providers are that payment incentives of the future are likely to fa-
vor care coordination; information systems; integration/collaboration across primary, in-
patient, and postacute sectors; performance measurement; and re-engineered
processes of care. Obviously a big challenge is timing; the old payment incentives to
provide ever-higher volumes of care continue, and they continue to punish those who
do ‘‘the right thing.’’ Physicians seeking to maximize volume and intensity of services
at the expense of appropriate, high-quality patient care will resist efforts to hold them ac-
countable for outcomes such as readmissions and unexpected complications. Hospitals
that fail to see the need to build a collaborative, interdisciplinary infrastructure that im-
proves patient care across the silos will struggle along the same path that led to the de-
mise of their predecessors who were unable to manage their lengths of stay in the 1980s.
Forward-looking hospital systems already are experimenting with integrated physician–
hospital care packages in the private sector (eg, Geisinger Health System’s extended
episode warranty on coronary bypass surgery)14 and in Medicare Demonstration pro-
jects (eg, the Acute Care Episode demonstration project and the Hospital Gainsharing
Project).15 Achieving fundamental reform of the health care system to improve patient
outcomes will take decades of effort and a major shift in financial, medical, and political
behaviors that have built up since the beginning of health insurance in the United States.
In retrospect, managing length of stay was a piece of cake!

REFERENCES

1. Medicare Payment Advisory Commission. Data Book. Washington, DC: Medicare


Payment Advisory Commission; 2007. p. 9, 116, 118, 104. Available at: http://
www.medpac.gov.
2. Medicare Payment Advisory Commission. Report to Congress specialty hos-
pitals revisited. Washington, DC: Medicare Payment Advisory Commission;
2006. p. 4.
3. Medicare Payment Advisory Commission. Report to the Congress, increasing the
value of medicare. Washington, DC: Medicare Payment Advisory Commission;
2006. p. 36, 107, 108.
4. Quinn B. Crossing the three chasms: complex molecular testing and Medicare
regulations. Foley Hoag LLP, Boston.
5. Medicare Payment Advisory Commission. Report to the congress medicare pay-
ment policy. Washington, DC: Medicare Payment Advisory Commission; 2006,
p. 142.
6. Bodenheimer. Primary care—will it survive? N Engl J Med 2006;355(9):861–4.
7. Tu HT, O’Malley AS. Exodus of male physicians from primary care drives shift
to specialty practice: tracking report no. 17. Center for Studying Health System
Change. Available at: http://www.hschange.org/CONTENT/934/. Accessed
November 29, 2008.
8. Fisher E. The implications of regional variations in medicare spending. Part 2:
health outcomes and satisfaction with care. Ann Intern Med 2003;138(4):273–87.
9. Meeting of the Medicare Payment Advisory Commission [transcript]. Washington,
DC, April 9, 2008. p. 300–1.
10. Cantor JC, Belloff D, Schoen C, et al. ‘‘Aiming higher’’ results from a state
scorecard on health system performance, commonwealth fund. Available at:
http://www.commonwealthfund.org/publications/publications_show.htm?
doc_id5494551; 2007; Accessed June 10, 2008.
11. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to
adults in the United States. N Engl J Med 2003;348(26):2635–45.
Medicare Payment Systems 15

12. Rich MW, Beckham V, Wittenberg C, et al. A multidisciplinary intervention to pre-


vent the reasmission of elderly patients with congestive heart failure. N Engl J
Med 1995;333(18):1190–5.
13. Schoen C, Osborn R, Huynh PT, et al. Taking the pulse of health care systems:
experiences of patients with health problems in six countries. Health affairs
web exclusive (not 3). Available at: http://www.healthaffairs.org. Accessed June
16, 2008.
14. Available at: http://www.nytimes.com/2007/05/17/business/17quality.html.
Accessed August 12, 2008.
15. Available at: http://www.cms.hhs.gov/demoprojectsevalrpts/md/list.asp?listpage52.
Accessed August 12, 2008.
Fina nc ial a nd
Op erational Analysis
of Non ^ Op erating
Ro om Anesthesia :
the Wrong Way Versus
the Rig ht Way
Richard B. Siegrist, Jr., MBA, MA, BA, CPA

KEYWORDS
 Full costing  Differential costing  Non-OR anesthesia
 Management control  Operations management
 Queuing theory  Urgency classification  Scheduling

Most financial analysis regarding the cost of non–operating room (non-OR) anesthesia
in hospitals is incorrect. This statement is strong, but this article indicates why this sit-
uation exists and suggests how to perform the cost analysis in the right way. It also re-
views financial and operational strategies that can result in more efficient scheduling of
anesthesia, thereby freeing up anesthesiologist time in the main OR for non-OR needs.

FULL COSTINGçTHE WRONG WAY FOR MOST DECISIONS

When performing cost analysis regarding non-OR anesthesia, most hospitals use
a costing approach referred to as ‘‘full costing.’’1 Full costing attempts to determine
all the costs of a particular cost object, in this case anesthesia performed outside
the OR, either in total (x dollars of anesthesia services provided to cardiac catheriza-
tion) or per unit (anesthesia services provided to cardiac catherization at a cost of x
dollars per catherization procedure). Full cost is measured as the combination of
the direct costs for the cost object plus a ‘‘fair share’’ of the overhead of the institution.
Direct costs are directly traceable to or caused by the cost object, such as non-OR
anesthesia services in the catherization laboratory, interventional radiology, ICU, or
other unit. The direct costs of anesthesia services provided during cardiac catheriza-
tion procedures typically would include the time of the anesthesia team, the supplies
and drugs needed during the administration of anesthesia, and any specialized equip-
ment devoted to cardiac catherization–based anesthesia.

Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02215, USA
E-mail address: [email protected]

Anesthesiology Clin 27 (2009) 17–23


doi:10.1016/j.anclin.2008.10.010 anesthesiology.theclinics.com
1932-2275/08/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
18 Siegrist

Indirect costs are not directly traceable to only one cost object and therefore must be
allocated to multiple cost objects, using a reasonable allocation base such as salary
dollars, square footage, or service hours. Typical indirect costs include the finance de-
partment, computer services, and administration. These indirect costs are allocated to
other departments using the allocation basis and statistics for each department,
employing either a step-down approach (in which a department can allocate costs
only to those departments below it in hierarchical structure) or a reciprocal approach
(departments can allocate cost to each other using simultaneous equations).1
Although full cost accounting is useful for indicating what non-OR anesthesia cost
on a fully loaded basis and for external/regulatory reporting, it can be highly misleading
for internal decision making involving non-OR anesthesia in matters such as expand-
ing/contracting, adding/dropping, or making/buying. An example may help illustrate
this analytical pitfall.
For example, assume that the cardiac catherization laboratory requires 80% of an
anesthesiologist’s time and 80% of an anesthesia technician’s time on an annual
basis, and annually 1000 catherization procedures require anesthesia. The full cost
of a catheterization procedure with anesthesia is shown in Table 1.
This calculation is useful for establishing the cost for the anesthesia component of
a catherization procedure, in this case $800 per procedure. This calculation, however,
does not help show what the cost would be if the volume of catherization procedures
requiring anesthesia increased by 10% (ie, 100 cases), whether money could be saved
by hiring an outside anesthesia service to take over anesthesia support for the cathe-
rization laboratory, or if one catherization room should be closed if the volume of cath-
eterizations dropped significantly. To answer these questions one needs to use the
differential cost.

DIFFERENTIAL COSTINGçTHE RIGHT WAY FOR MOST DECISIONS

Differential costing compares how costs actually would change for the institution after
implementation of a particular management decision.1,2 In other words, differential
costing shows how costs (and revenues) would change between situation A (often
the status quo) and situation B (the proposed change). A 10% or 100-case increase
in catherization volume requiring anesthesia support can serve as an example.
The full cost approach indicates that costs would increase by $800 per new proce-
dure times 100 more procedures, or $80,000. In reality, the direct costs for anesthesia
supplies and drugs would increase proportionately by 10% or $15,000 (10% of $50,000
1 $100,000). Anesthesiologist and technician expenses would increase between

Table 1
Analysis of the cost of anesthesia for a catheterization procedure

Expense Item Cost in Dollars


Anesthesiologist (80% of $300,000) 240,000
Anesthesia technician (80% of $100,000) 80,000
Anesthesia supplies 50,000
Anesthesia drugs 100,000
Total direct costs 470,000
Indirect allocations from step-down 330,000
Full cost in total 800,000
Full cost per unit ($800,000/1000 procedures) 800
Financial and Operational Analysis of Non–Operating Room Anesthesia 19

0% and 10%, depending on whether they have available time, paid overtime would be
incurred, or additional staff would be hired. Although more indirect costs may be
allocated, a volume increase of 10% probably will not result in an increase in adminis-
tration or information services. Accordingly, instead increasing by $80,000, the actual
costs would increase by between $15,000 and $47,000 ($15,000 plus 10% of
$240,000 1 $80,000), depending on how costs actually change—a big difference
that could lead to an incorrect decision if the full cost approach is used.
This example has illustrated how to use differential costing to evaluate alternative
choices. More completely, the steps in alternative choice decision making are to

1. Define the problem


2. Identify the likely alternatives (usually including the status quo)
3. Evaluate the quantitative factors (how costs and/or revenues will change)
4. Evaluate the nonquantitative or qualitative factors
5. Make a decision1

For step #3, a common approach is to look at the specific differences between
alternatives A and B in regards to revenue and costs, as follows:

Change in revenues (positive for increase, negative for decreases)


 Change in variable costs (positive for decreases, negative for increases)
 Change in fixed direct costs (positive for decreases, negative for increases)
 Change in indirect costs (positive for decreases, negative for increases)
5 Net benefit/loss (positive for net benefit, negative for net loss)
This simple approach enables clinical and financial managers to analyze the impact
on the organization of a variety of changes related to non-OR anesthesia.
This approach clearly involves a number of assumptions regarding how costs actu-
ally will behave if changes are made. These assumptions should be reasonable but do
not have to be exact to make informed decisions. Each assumption can be tested
using sensitivity analysis as follows:
 Would the decision change if the assumption changed by 10%? If so, that
assumption should be investigated in more detail.
 Would the decision change if the assumption changed by 50%? If not, it is not
necessary to spend any more time fine-tuning that assumption.
An alternative approach to sensitivity analysis is to determine how much an as-
sumption could change before a decision would change; this determination indicates
how comfortable the decision-maker is with that assumption.

POTENTIAL CONSEQUENCES OF INCORRECT DECISIONS

The beginning of this article indicated that most hospitals use the wrong information to
make decisions regarding non-OR anesthesia. What are the potential implications of
this oversight? First, the true incremental profitability of the expansion of services requir-
ing anesthesia support usually is understated because under full costing the costs are
overstated. This overstatement of costs may lead the institution to underinvest in new
services or to limit the expansion of existing services that would make economic sense.
Second, the value of the anesthesia department to the institution may be under-
stated because of the increased allocation of indirect costs to anesthesia as a result
of increased volume when in fact those indirect costs will not increase because
they are not differential. Third, negative incentives may be created for the anesthesia
20 Siegrist

service because the department is held responsible for costs that it does not control,
namely allocated indirect costs.
Finally, as demand for non-OR anesthesia continues to grow, administration may
not recognize what additional personnel and non-personnel resources will be needed
to meet that demand. In other words, the anesthesia department either will exceed
budget and be criticized for justifiable increases or will be stretched thin with potential
negative consequences for quality of care, staff satisfaction, and patient satisfaction.

ADDITIONAL QUESTIONS FOR DIFFERENTIAL ANALYSIS

Some of the additional pressing questions facing anesthesia could be addressed


using differential cost analysis in conjunction with operations management:
 What would be the differential financial impact of devoting separate anesthesiol-
ogists or anesthesia technicians exclusively to non-OR anesthesia during certain
times of the day or days of the weeks?
 What would be the differential financial impact of shifting certain services requir-
ing anesthesia support from an inpatient setting to an outpatient setting?
 How can anesthesia scheduling be adjusted using queuing theory or simulation
models to enhance productivity, staff satisfaction and profitability?

MANAGEMENT CONTROL IMPLICATIONS

Another important issue is the role anesthesiologists should play in this differential cost
analysis and alternative choice decision making. Should the analysis be left to finance
because of its expertise with numbers? The answer is a resounding no. Anesthesiolo-
gists usually are in a much better position to evaluate how things will change if a partic-
ular action is taken. Therefore, a joint effort or partnership between anesthesia and
finance in performing the differential analysis will produce the most accurate results.
Once decisions are made, who should be accountable for the ultimate results? If
anesthesia has been involved directly in the decisions and in formulating the assump-
tions and options regarding those decisions, anesthesia should be held accountable
for the results. If, however, anesthesia is not involved to a significant extent, then an-
esthesia should not be held accountable for something not under its control. Holding
someone accountable for something not under his or her control is a recipe for disil-
lusionment at best and dysfunctional behavior at worst.1

MORE EFFICIENT USE OF ANESTHESIA RESOURCES THROUGH OPERATIONS MANAGEMENT

An important cost to any hospital is the inefficient use of expensive resources such as
anesthesia. A common belief is that inevitably anesthesia resources will be underutil-
ized frequently because of the complexity and unpredictability of the OR schedule,
which dictates the use of anesthesia. This inefficient use of anesthesia resources
can be reduced greatly through the application of operations management tech-
niques, however.
In a normal OR situation, emergent/urgent cases wreak havoc on the productivity of
the OR and anesthesia staff. Typically, emergent/urgent cases are handled in one of
three different ways depending on the specific circumstances:

1. The OR schedule builds in holes during the day to accommodate emergent and
urgent cases.
Financial and Operational Analysis of Non–Operating Room Anesthesia 21

2. If a truly emergent case comes in and there is no hole to fit it in, an elective case is
canceled or delayed to perform surgery on the emergent case.
3. Urgent but not emergent cases are delayed until the end of the day, after prime time.

These three ways of handling emergent/urgent cases builds in inefficiency from having
holes in the schedule, creates physician/nurse/patient dissatisfaction and stress from
bumping elective surgeries, and results in wait times (sometimes longer than clinical
desirable) for urgent cases and boarding of these cases in the emergency department.
Anesthesiologists suffer from the unpredictability of the demand for their services
(they may be called into an emergent case at any time), from the need to spend un-
planned time after prime time to accommodate urgent cases at the end of the day,
and from inefficient utilization resulting from the downtime created by holes in the elec-
tive surgery schedule. As a result, the operating room department (and accordingly
anesthesia) typically operates at 70% to 75% utilization, but all the staff feel stressed
because of the unpredictability.
The science of operations management offers a solution to this chaotic situation—
the application of queuing theory to separate nonelective (emergent/urgent) from
elective (scheduled) surgeries.3 Nonelective cases, by their nature, are random in
occurrence. One cannot schedule when the victim of an automobile accident will
arrive for surgery or when a patient will present with a ruptured appendix. In contrast,
elective surgeries are nonrandom and therefore are under the control of the hospital/
surgery department through scheduling. When random and nonrandom patient flows
compete for scarce resources (ORs, surgeons, anesthesiologists, nurses, and staff),
unpredictability and inefficiency naturally result.
One solution that has been shown to be effective is to designate specific ORs on
certain days of the week and certain times of the day for nonelective surgery only. Ide-
ally, those ORs should be used only for nonelective cases, and all nonelective cases
should be done in those ORs. Those ORs should be fully staffed and available when
emergent/urgent cases arrive.
The number of ORs necessary for this purpose can be determined scientifically
using priority-based queuing models and historical arrival patterns/case times of non-
elective (emergent/urgent) cases. In this situation it is important to develop and apply
rigorously a clinically based urgency classification system to determine case priority
and maximum waiting times. For example, a truly emergent case that needs to be
in the OR within 30 minutes of booking would be an ‘‘A’’ case, an urgent case that
needs to be in the OR within 2 hours would be a ‘‘B’’ case, a case that clinically could
wait 24 hours would be an ‘‘E’’ case, and so forth. These nonelective ORs should op-
erate only at 40% to 60% utilization to accommodate the random arrival of emergent/
urgent cases and the need to begin surgery within a clinically defined time period.
What are the benefits of having such nonelective ORs? First, waiting times for emer-
gent/urgent cases typically decline by more than 20%, resulting in better patient care
and a decrease in emergency room boarding. Second, OR time after prime time de-
creases significantly because urgent cases are done during the regular day, rather
than after prime time. Third, elective cases rarely are delayed or canceled because of
emergent/urgent cases, because those emergent/urgent cases are done in the non-
elective rooms. Fourth, the elective OR rooms can be scheduled back-to-back with re-
sulting utilization rates of 90% or greater. Even though the nonelective ORs operate at
around 50% utilization, the overall OR utilization increases from 70% to 85% or more.
The ramifications of this separation of disparate patient flows potentially are enor-
mous for anesthesia. First, the reduction in OR time after prime time means that the
demand for after-hour anesthesia coverage is reduced substantially. Second, the
22 Siegrist

increased prime time OR utilization means that anesthesia is used more effectively
during the day, with lower downtime. Third, and most relevant for this article, anesthe-
sia gains additional time to cover non-OR anesthesia needs with existing staff and
existing resources.
The positive benefits described in this article can be illustrated best with a simplified
example. This example assumes a hospital has 20 ORs and currently is operating at
a 70% utilization rate during prime time. Looking at emergent/urgent arrival rates
and case times and applying queuing theory, the hospital determines that two ORs
should be designated as nonelective ORs, and the remaining 18 ORs should be
used only for elective cases.
Table 2 shows the freed-up capacity that is available for (1) moving cases done past
prime time into prime time, (2) accommodating new surgical cases if demand exists, or
(3) reducing OR staffing needs while handling the same number of cases.
In effect, such a change would enable the hospital to increase its surgical volume by
23% without adding any additional OR or anesthesia staff or any expenditure for new
capital expenses. This increase in capacity results from improving the utilization rate
from 70% to 86% (18 elective rooms at 90% utilization because of back-to-back
scheduling of elective cases plus two nonelective rooms at 50% utilization to reduce
wait times for emergent/urgent cases equals 86% overall utilization).
More relevantly to non-OR anesthesia, this change could free up 19% of anesthesia
time normally spent in the OR for performing anesthesia in other settings. This reduc-
tion in staffed rooms for anesthesia results from needing to staff only 16.3 rooms to
accommodate the existing volume of surgery (20 rooms at 70% utilization is mathe-
matically equivalent to 16.3 rooms at 86% utilization in terms of surgical capacity).
In most institutions this extra capacity probably would go a long way in addressing
the chronic shortage of anesthesia resources for demands outside the OR.
This analysis makes the implicit assumption that the demand for elective surgery is
relatively stable across the days of the week and that none of the low utilization can be
attributed to variations in utilization across the days of the week. Accordingly, to
achieve fully the benefits described in this example, an institution also would need

Table 2
Management of cases before and after dedicating two operating rooms for emergent cases

Non-Elective
Metric Comparison Elective Rooms Rooms Total
Number of staffed rooms Before 20 0
After 18 2
Operating room utilization Before 70% 0% 70%
(prime time 7:30–3:30) After 90% 50% 86%
Occupied rooms Before 14.0 0.0 14.0
After 16.2 1.0 17.2
Difference 2.2 1.0 17.2
Increase in capacity 23%
Number of staffed rooms Before 20 0 20
needed if assume no After 14.3 2 16.3
increase in prime-time
surgeries
Reduction in staffed rooms 19%
Financial and Operational Analysis of Non–Operating Room Anesthesia 23

to work on smoothing surgical demand across the days of the week by adjusting block
schedules and taking into account destination unit capacity for inpatient surgeries.
Because the elective schedule is under the control of the hospital/surgery depart-
ment, it should be possible to accomplish this smoothing of surgical demand with
the cooperation of the surgeons. The benefits to the hospital, the nurses, the anesthe-
siologists, the surgeons, and the patients should be compelling enough to bring about
these operational changes.
These improvements in utilization can translate into a significant opportunity for
increased revenue and profitability. A 23% growth in surgical volume with no incre-
mental staffing or capital costs related to OR or anesthesia equates to millions of dol-
lars of additional profitability for the hospital, the surgeons, and the anesthesiologists.
Applying the differential costing techniques described earlier makes quantifying these
benefits feasible.
In summary, the marriage of cost accounting and operations management can help
the anesthesia department (1) understand the true differential cost and benefits of
non-OR anesthesia and (2) free up anesthesia resources for use in non-OR settings.
The arguments for proper cost accounting, operations management, and optimized
utilization in the OR apply with equal validity to the non-OR setting. Elective and emer-
gent scheduling should be handled in the non-OR environment the same way that it is
handled in the OR. Understanding how to apply differential cost analysis and queuing
theory are the keys to making the right management decisions for the ORs, for proce-
dure areas, and for the organization.

REFERENCES

1. Anthony RN, Young DW. Management control in nonprofit organizations. 7th


edition. New York: McGraw Hill Irwin; 2003. p. 221–43, 272–95, 372–96.
2. Anthony RN, Welsch GA. Fundamentals of management accounting. 3rd edition.
Homewood (IL): Richard D. Irwin; 1981. p. 246–62.
3. Litvak E, Long MC, Prenney B, et al. Improving patient flow and throughput in Califor-
nia hospitals operating room services. Boston university program for management of
variability in health care delivery. California Healthcare Foundation 2007. Available
at: http://www.bu.edu/mvp/Library/CHCF%20Guidance%20document.pdf.
I ntro d uc tion to Se c tion 2 :
Prac tice Parameters
Barbara Gold, MD

The need for non-operating room (OR) anesthesia services continues to expand as
technology improves and the scope of procedures performed by cardiologists, radiol-
ogists, gastroenterologists, and other physicians grows. Indeed, the range of proce-
dures that can now be performed safely and comfortably outside the OR is
facilitated by many factors, not the least of which are improvements in sedation and
anesthesia care. However, each of these non-OR settings has different needs and
limitations.
Delivering anesthesia in an operating room is a consistently structured endeavor ir-
respective of the specialty; a given OR can accommodate a wide variety of cases
ranging from urologic surgery to neurosurgery. This is not the case in the non-OR
setting; delivering anesthesia in a GI suite is qualitatively different than doing so in
a cardiac catheterization lab—equipment is highly specialized, patient comorbidities
are often unique to the particular specialty, physical access to the patient may vary,
and the ‘‘culture’’ of the venue may make integration and communication difficult.
For example, in the cardiac catheterization or EP lab, imaging equipment is often
permanently affixed at the head of the bed, precluding easy access to the patient’s
airway. Given the myriad screens and equipment around patients, there may be inad-
equate space for anesthesia equipment, especially when tables move to permit fluo-
roscopy. There may also be confusion as to the handling of lab specimens as well as
communication of lab results to anesthesiologists if there is no standard protocol.
Again, coping with these situations may be straightforward in an OR setting; outside
the OR, however, basic work processes cannot be assumed.
Work spaces are frequently retrofitted to accommodate anesthesia providers (and
associated equipment) because procedural areas were not constructed with anes-
thesia delivery in mind. This often produces less-than-ideal working conditions for
the anesthesia team. For example, medical specialists often dim ambient lights to
accommodate digital images, making it difficult for the anesthesiologist to see equip-
ment or observe patients. In addition, moribund patients deemed too sick to undergo
an operation are often scheduled for a more limited procedure that nevertheless
requires an anesthetic. The mix of unfamiliar work environment and processes along
with a moribund patient can be especially problematic. However, anesthesia providers
can help improve their work environment by becoming involved in the design phase of
procedural facilities and also establishing working relationships with the subspecialty
physicians. Indeed, as facilities are remodeled to accommodate the growing number
of complex procedures performed outside the traditional confines of the OR, subspe-
cialists increasingly are seeking the input of anesthesia care providers.

Department of Anesthesiology, University of Minnesota Medical Center, Minneapolis, MN, USA

Anesthesiology Clin 27 (2009) 27–28


doi:10.1016/j.anclin.2008.12.001 anesthesiology.theclinics.com
1932-2275/08/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
28 Gold

Due to the complex nature of the procedures and the fragile state of many patients,
it is incumbent upon anesthesia providers to agree upon the ‘‘terms of engagement’’ in
non-OR settings before providing actual patient care. That is, the provision of equip-
ment, space, support services, and patient access needs to be addressed in detail
and as far in advance as possible. Those working with fragile patients will further
appreciate the need to address these issues as they learn about highly complex
procedures that are just on the horizon, such as those described by DeVilliers (ie,
natural orifice transluminal endoscopic surgery) or Faillace (ie, percutaneous ventric-
ular assist devices).
This section explores major non-OR procedures that require anesthesia services
from the vantage points of both the subspecialist performing the procedure and the
anesthesiologist. Areas of convergent and divergent opinion are quite clear, and it is
obvious that although the goals of both teams are similar, the focus of attention is
not. The potential for expanding procedures outside the OR appears exciting and
limitless, but the path to success requires both medical and diplomatic flexibility.
The nature of these procedures and their associated patient populations (ie, older,
medically compromised) could broaden the practice of anesthesiology and take our
specialty in another exciting, challenging, and rewarding direction.
The Role of the
Out - of - Op erating
Ro om Anesthesiolo gist
in the Care of the
Cardiac Patient
RobertT. Faillace, MD, ScM*, Raja’a Kaddaha, MD, Mahesh Bikkina, MD,
ThilYogananthan, MD, Rupen Parikh, MD, Pierre Casthley, MD

KEYWORDS
 Anesthesia  Invasive cardiology  Conscious sedation
 State-of-the-art cardiac interventions

Modern invasive cardiovascular procedures require patients to be both comfortable


and cooperative. In addition, these procedures demand the complete attention of
the attending cardiovascular specialist. To a large degree, outcomes of procedures
depend on the amount of focus and concentration the cardiovascular specialist can
give to performing the procedure itself. A team approach using the specialized skills
of a cardiologist and an anesthesiologist frequently is required to optimize results.
At present there are no established, discipline-directed guidelines for anesthesia
consultation or conscious sedation during cardiovascular procedures. The goals of
the cardiologist in involving an anesthesiologist during the performance of cardiovas-
cular procedures are to minimize physical discomfort, pain, and negative psychologic
response to treatment; to ensure some degree of amnesia; to gain the patient’s coop-
eration; to have minimal variation in the hemodynamic state; and to return the patient
to a state in which safe discharge is possible.1
It is important that patients who have comorbidities that increase the risk associated
with conscious sedation be recognized and assessed properly before initiating the pro-
cedure. The goal is to avoid complications during the procedure, especially complica-
tions related to maintenance of the patient’s airway and hemodynamic stability.
Patients at high risk include those who have morbid obesity, obstructive sleep apnea,
chronic obstructive lung disease, congestive heart failure, hemodynamic compromise,
an American Society of Anesthesia type III airway, and those taking medications that
complicate their sedation/anesthesia requirements. The selection of medications used
for conscious sedation/general anesthesia depends on the specific needs of the patient

St. Joseph’s Regional Medical Center, 703 Main Street, Paterson, NJ 07503, USA
* Corresponding author.
E-mail address: [email protected] (R.T. Faillace).

Anesthesiology Clin 27 (2009) 29–46


doi:10.1016/j.anclin.2008.10.006 anesthesiology.theclinics.com
1932-2275/08/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
30 Faillace et al

and on the complexity and duration of the procedure. Therefore, cardiologists and anes-
thesiologists need to have mutual understanding, common knowledge, and non-nego-
tiable mutual respect to work together as a team to provide optimal care to the patient.
Common diagnostic and therapeutic invasive procedures performed by cardiolo-
gists fall under the domain of the cardiac catheterization laboratory, the electrophysiol-
ogy laboratory, and the transesophageal echocardiography (TEE) laboratory. Specific
procedures performed in the cardiac catheterization laboratory or electrophysiology
laboratory that may benefit from the presence of an anesthesiologist include
Diagnostic cardiac catheterization
Percutaneous coronary interventions (PCIs)
Peripheral vascular diagnostic and therapeutic procedures
Use of percutaneous left ventricular assist devices for hemodynamic support in the
setting of cardiogenic shock and/or high-risk coronary interventions
Placement of septal device occluders
Radiofrequency ablation procedures
Implantation of biventricular pacing systems and cardioverter defibrillators; and
electrical cardioversion; percutaneous cardiac valve-related procedures
In addition, the performance of TEE may benefit from the input of an anesthesiolo-
gist, because it involves airway manipulation.
This article clearly delineates the procedures cardiologists perform that might
involve anesthesiologists. Close collaboration between the cardiovascular specialist
and the anesthesiologist is a fundamental requirement to optimize patient outcomes.

PROCEDURES PERFORMED IN THE CARDIAC CATHETERIZATION LABORATORY

It is estimated that more than 2 million Americans will undergo coronary arteriography
with left ventriculography in the United States this year alone.2 Diagnostic cardiac
catheterization is performed to assess the presence and severity of suspected under-
lying cardiac disease that cannot be evaluated sufficiently by noninvasive techniques.3
These conditions include coronary artery disease, valvular heart disease, congenital
heart disease, and cardiomyopathic disease.4 Cardiac catheterization laboratory–
based procedures most commonly include left and right heart catheterization with he-
modynamic measurements, left ventriculography with use of radio-iodinated contrast
medium, diagnostic coronary arteriography, and PCIs. Diagnostic cardiac catheteriza-
tion also may include the use of intracoronary ultrasound to assess the severity of lu-
minal narrowing caused by an atherosclerotic plaque.5 Patients who undergo cardiac
catheterization range from hemodynamically stable outpatients to critically ill and he-
modynamically unstable patients who have acute myocardial ischemia, severe heart
failure, or cardiogenic shock.3,6 The invasive cardiologist most commonly administers
conscious sedation for hemodynamically stable patients. However, patients who are
either critically ill, high risk, morbidly obese or patients who have severe obstructive
sleep apnea, advanced underlying pulmonary disease are in need of complex pro-
longed interventions benefit from the presence of an anesthesiologist.

Percutaneous Coronary Interventions


PCIs include coronary angioplasty, coronary stenting with use of either bare-metal stents
or drug-eluting stents, and atherectomy procedures. Percutaneous interventional proce-
dures commonly are performed on patients who have demonstrated myocardial ische-
mia and 70% or greater intracoronary luminal obstruction from coronary atherosclerosis.
The major benefit of PCI is to reduce or relieve symptoms and signs of ischemic heart
Anesthesiologist in the Care of the Cardiac Patient 31

disease.7 In unstable patients or in patients who have ST elevation myocardial infarction,


PCI may decrease mortality and subsequent myocardial infarction more effectively than
medical treatment.8–10 In patients who have stable coronary artery disease, however,
a recent large, multicentered study has suggested there are no significant differences
in total mortality, nonfatal myocardial infarction, and rate of hospitalization for acute cor-
onary syndrome between patients randomly assigned to aggressive medical therapy or
to aggressive medical therapy or bare-metal stenting.11 To the authors’ knowledge, no
randomized trials have compared aggressive medical therapy alone versus aggressive
medical therapy plus drug-eluting stents.
More recently, there has been an increase in PCIs and a concomitant decrease in
coronary artery bypass graft surgery for unprotected (in the absence of coronary artery
bypass grafts to the left anterior descending and left circumflex-marginal system) left
main coronary artery disease.12 Although at present at least five ongoing randomized,
controlled trials with an anticipated enrollment of more than 2400 patients are compar-
ing PCI and coronary artery bypass graft surgery for the treatment of unprotected left
main coronary artery disease, no randomized study data have been reported as
yet.13 A recent meta-analysis of 16 observational studies involving 1278 patients under-
going PCI with drug-eluting stents for unprotected left main coronary artery disease
demonstrated mortality of 2.3% during hospitalization and 5.5% at a median of 10
months’ follow-up.14 A recent registry study conducted in Korea in matched cohorts
of patients who had unprotected left main coronary artery disease followed on average
for 3 years demonstrated no difference in either death or a composite outcome of
death, Q-wave myocardial infarction, and/or stroke for patients who underwent either
PCI (with bare metal or drug-eluting stents) or coronary artery bypass graft surgery.15
Target-vessel revascularization was significantly higher in patients who received stents
(hazard ratio, 4.76; 95% confidence interval, 0.75–1.62), however.15 This study also
demonstrated a trend toward higher rates of death and the composite end point of
death, Q-wave myocardial infarction, and/or stroke in patients who received a drug-
eluting stent than in patients who received a bare-metal stent.15 This study further
shows the need for a adequately powered prospective, randomized trial of the two re-
vascularization strategies in this population of patients.13
Cardiac catheterization and PCI procedures are performed most commonly with
conscious sedation. In these patients the goal is to achieve a state of relaxation,
analgesia, and amnesia that allows a patient to respond appropriately to verbal
commands and maintain a patent airway. It is imperative that patients be able to
cough immediately after the injection of radio-iodinated contrast medium into the cor-
onary arteries to increase intrathoracic pressure and clear the dye from the arteries
and prevent complications of myocardial ischemia and bradycardia.
Although in the authors’ experience the invasive/interventional cardiologist admin-
isters conscious sedation for most diagnostic cardiac catheterization and PCI proce-
dures, the need for an anesthesiologist becomes greater as the patient complexity,
comorbidities and the procedural difficulty increase. These procedures may involve
patients who have chronic total coronary artery occlusions, saphenous vein PCI inter-
ventions, or in-stent restenosis or patients who have complex coronary anatomy, are
hemodynamically compromised, or who are in cardiogenic shock. In addition, patients
who undergo PCI atherectomy procedures typically have more complex anatomy that
requires the full attention of the interventional cardiologist. Atherectomy procedures
also are time consuming. Rotational atherectomy uses a rapidly rotating, diamond-
coated, olive-shaped burr and has been found to be useful for heavily calcified com-
plex lesions. The burr pulverizes the atherosclerotic plaque into pieces small enough
to pass through the distal myocardial capillary bed.16 One uncontrolled, multicenter
32 Faillace et al

registry study demonstrated that this technique successfully relieved the luminal cor-
onary artery obstruction in 94% of calcific lesions.17

Percutaneous Ventricular Assist Devices


Although intravenously administered positive inotropic medications and an intra-aortic
counterpulsation balloon are used routinely to support a failing heart, more recent pro-
cedures performed in the cardiac catheterization laboratory include use of percutane-
ously placed left ventricular support devices. These devices support patients who are
at high risk for a PCI procedure (eg, a patient with an unprotected left main lesion), pa-
tients who are hemodynamically compromised, and patients in cardiogenic shock.
Two percutaneous ventricular assist devices currently are available clinically, the Tan-
demHeart (Cardiac Assist, Inc., Pittsburg, Pennsylvania) and the Impella Recover LP
2.5 and 5.0 (Abiomed Inc., Danvers, Massachusetts).18–20 The TandemHeart is used
more frequently to support patients in cardiogenic shock (until a recovery occurs or
as a bridge to definitive therapy) or as a temporary hemodynamic support during
high-risk angioplasties.19 The TandemHeart is a percutaneously placed left atrial-to-
femoral bypass system. It comprises a transseptal cannula, arterial cannulae, and
an externally located centrifugal blood pump. At a maximum speed of 7500 rpm,
the pump can deliver flow rates up to 4.0 L/min.19 One center reported a 30-day sur-
vival rate of 61% in 18 patients (11 in cardiogenic shock and 7 undergoing high-risk
PCI) with use of the TandemHeart device. The cardiac index of patients in cardiogenic
shock improved from 1.57 L/min/m2 before support to 2.60 L/min/m2 with use of the
device.19 The mean duration of support was 88  74.3 hours (range, 4–264 hours).
High-risk patients undergoing PCI were supported by the device from 1 to 24 hours
(mean 5.5  8.3 hours).19
The Impella Recover LP 2.5 and 5.0 pump devices are similar percutaneous-based
left ventricular assist devices.21 One main difference between the Impella systems and
the TandemHeart is that the Impella Recover LP 2.5 and 5.0 pump systems use can-
nulae retrogradely inserted via the femoral artery into the left ventricle across the aortic
valve.22 The main advantages of the Impella Recover LP 2.5 and 5.0 devices, as com-
pared with the TandemHeart, are their ease of implantation, avoidance of the need for
a transseptal puncture, and smaller catheter size (13 F versus 17 F). In addition, the
microaxial pump is integrated directly into the catheter system, and there is no extra-
corporeal blood. The circulatory support of the Impella is either 2.5 L/min or 5.0 L/min.
Patients must be selected carefully, because the Impella Recover LP 2.5 device
requires the presence of at least some left ventricular function, whereas the Tandem-
Heart device may replace left ventricular function completely.22
Patients who require use of either the TandemHeart or the Impella LP 2.5 devices
definitely benefit from the services of a cardiac anesthesiologist. These patients are
at high risk for either a morbid or life-threatening event during the procedure. The an-
esthesiologist and the cardiovascular specialist need to maintain adequate conscious
sedation or general anesthesia and an adequate hemodynamic state. In addition, al-
though preliminary reports have not cited any major adverse effects from the use of
either device, cardiac surgical backup should be available during the performance
of these procedures, because significant blood loss may occur.23

Percutaneous Closure of Septal Defects


Another procedure that would benefit from the presence of a cardiac anesthesiologist
is placement of an intra-atrial septal occluder device for the treatment of either a patent
foramen ovale (PFO) or an atrial septal defect. In 2001 the Food and Drug Administra-
tion (FDA) approved two occluder devices, the CardioSEAL Septal Occlusion system
Anesthesiologist in the Care of the Cardiac Patient 33

(NMT Medical, Inc., Boston, Massachusetts) and the AMPLATZER Septal Occluder
(AGA Medical Corporation, Golden Valley, Minnesota).24 Other devices that currently
are available include the Helex implant (W.L. Gore & Associates, Flagstaff, Arizona);
the Premere PFO Closure System (St. Jude Medical, Inc., Maple Grove, Minnesota);
the Solysafe Septal Occluder (Swiss Implant AG, Solothurn, Switzerland); the Intrasept
occluder (Cardia, Inc., Burnsville, Minnesota); the Occlutech device (Occlutech, Jena,
Germany), the SeptRx Occlude (Secant Medical, Perkasie, Pennsylvania); the
BioSTAR septal occluder (NMT Medical), the first partially bioabsorbable septal repair
implant; the SuperStitich device (Sutura(R) Inc., Fountain Valley, California); and the
PFx Closure System (Cierra, Inc., Redwood City, California). The PFx Closure System
uses vacuum suction to hold the septum primum and secundum in place and radio-
frequency energy to close the PFO.25 Despite this plethora of available devices, there
has not been a prospective, randomized, controlled trial of percutaneous closure of
PFOs in patients who have suffered from a cryptogenic stroke. In addition, no device
has been approved by the FDA for the prevention of recurrent cryptogenic stroke.26
Here the authors describe the AMPLATZER and the CardioSEAL devices because
they are used commonly to close PFOs and atrial septic defects.
The AMPLATZER Septal Occluder consists of a percutaneous-based delivery sys-
tem and a two-sided permanent occluder implant that resembles a clamshell.26 The
AMPLATZER Septal Occluder clamshell consists of two flat discs with a middle or
‘‘waist.’’ The discs are made of nitinol (an alloy of nickel and titanium) wire mesh
with polyester fabric inserts. These fabric inserts help close a patent foramen ovale
or an atrial septal defect while providing a foundation for the growth of tissue over
the occluder after placement.27 It is claimed that the AMPLATZER Septal Occluder
has several advantages over other devices, including delivery through smaller cathe-
ters; easy repositioning with a self-centering mechanism; a smaller overall size; and
round retention discs extending radially beyond the defect that allow firmer contact
and thereby enhance endotheliazation that, in turn, reduces the risk of residual
shunting.28
The CardioSEAL device consists of two self-expanding Dacron-covered umbrellas
that attach to either side of the intra-atrial septum. The umbrellas are formed by four
radiating metal arms attached in the center. Because of arm fractures and protrusion
of the arm through the atrial septal defect, the device was re-engineered by adding
a self-centering mechanism made of nitinol springs. These springs connect the two
umbrellas and a flexible core wire with a pin-pivoting connection. This device, named
the ‘‘STARFlex,’’ has reduced the rate of arm fractures significantly.29,30
Although the FDA initially approved these devices for percutaneous closure of se-
cundum atrial septal defect in 2001, this approval was under the auspices of a human-
itarian device exemption (HDE). This HDE was withdrawn in October 2006 because the
devices were placed in more than 4000 patients, the limit set by the FDA.31 Therefore,
these devices now are available in the United States for investigational use only.28
Patients who meet the criteria for the approved HDE indication (treatment of patients
who have recurrent cryptogenic stroke caused by presumed paradoxical embolism
through a PFO and who have not responded to conventional drug therapy) have
access to these devices through an Investigational Device Exemption.31 In addition
to PFO and secundum atrial septal defect closure, these devices have been used to
close muscular and perimembranous ventricular septal defects (either congenital or
acquired).32–34 Closure of a perimembranous or a muscular ventricular defect has
been reported to be successful approximately 96% of the time, with a major compli-
cation rate of 2%.34 Success rates for closure of PFOs and atrial septic defects have
ranged from 79% to 100% after several years’ follow-up.23
34 Faillace et al

Complications related to the deployment of septal occluder devices require imme-


diate recognition, evaluation, and treatment to prevent permanent sequelae or min-
imize their impact.35 Complications include, but are not limited to, intraprocedure air
embolism; device embolization; device positioning; device thrombosis and emboli-
zation (cerebral embolization may occur from air, a piece of the device itself, or
thrombus) during or following the procedure; device-related arrhythmias (usually
atrial, but sudden death has occurred); and cardiac perforation with or without car-
diac tamponade.28,35 These devices are placed in the cardiac catheterization labo-
ratory with the aid of fluoroscopy and ultrasound guidance. Cardiac ultrasound may
either be performed with TEE or intracardiac echocardiography. TEE requires endo-
tracheal intubation and general anesthesia, because the patient must remain still to
allow precise placement of the occluder devices. Intracardiac ultrasound does not
require endotracheal intubation or general anesthesia but still demands the
presence of a cardiac anesthesiologist. The anesthesiologist/cardiologist team en-
sures optimal patient comfort and allows the cardiologist to devote attention wholly
to performing the procedure while remaining vigilant for any complication that may
arise.

Peripheral Arterial Disease


Approximately 8 million Americans are afflicted with lower-extremity peripheral arterial
disease.36 This disease is a result of atherosclerotic occlusion of the peripheral arteries
and increases in prevalence after 40 years of age.37 As in coronary artery disease, the
prevalence is slightly higher in men than in women.38 The principle symptom of occlu-
sive peripheral arterial disease is intermittent claudication. (The term ‘‘claudication’’ is
derived from the Latin term ‘‘claudicare,’’ meaning ‘‘to limp’’).39 Because of insufficient
arterial blood flow and leg ischemia, patients who suffer from intermittent claudication
may have symptoms of pain, aching, a sense of fatigue, or other discomfort that is ex-
perienced in the affected muscle group with exercise, especially walking, and is re-
lieved with rest.39 Symptoms usually are located in the muscle bed supplied by the
most proximal stenosis.39 Obstruction of the aorta or iliac flow typically results in but-
tock, hip, or thigh claudication. Femoral or popliteal arterial stenosis commonly results
in calf claudication, and ankle or pedal claudication occurs as a result of either tibial or
peroneal disease.39
The American College of Cardiology/American Heart Association and other guide-
lines suggest that percutaneous revascularization be considered in patients who
have intermittent claudication when40–42
Exercise rehabilitation and pharmacologic therapy have not been successful in
providing the patient with an adequate response
Claudication symptoms significantly disable the patient, resulting in an inability to
perform normal work or other important activities
The procedure carries a very favorable risk/benefit ratio and has a high likelihood of
initial and long-term success
The patient is able to benefit from an improvement in claudication (ie, exercise is
not limited by another cause, such as angina, heart failure, chronic obstructive
pulmonary disease, or orthopedic problems)
The characteristics of the lesion permit appropriate intervention at low risk with
a high likelihood of initial and long-term success
The patient has limb-threatening ischemia, as manifested by rest pain, ischemic
ulcers, or gangrene
Anesthesiologist in the Care of the Cardiac Patient 35

In lower-extremity stent procedures, epidural anesthesia may attenuate stress


responses and reduce the production of acute-phase reactants, leading to fewer com-
plications related to hypercoagulation.43 A major concern regarding regional blocks is
the risk for an epidural or a spinal hematoma, because most of these patients are tak-
ing antithrombotic medications (eg, clopidogrel, aspirin, warfarin, or heparin).44,45 The
anesthesiologist may be of great benefit to the interventional cardiologist during a pe-
ripheral vascular intervention. Many of these patients have resting claudication that
precludes them from lying still during the procedure. In addition, performance of en-
dovascular intervention, with or without stent implantation, frequently is associated
with transient painful leg ischemia that may lead to patient movement and further
increase the risk of complication.

Percutaneous Valve Repair and Replacement


Although percutaneous valvuloplasty for mitral, aortic, and pulmonic stenosis has
been performed for decades, newer percutaneous techniques for the treatment of mi-
tral regurgitation and percutaneous aortic valve replacement have been developed
only recently and are presently under investigation.46–48

Percutaneous mitral valve repair


Cardiac surgical mitral valve repair is currently the procedure of choice for the treat-
ment of symptomatic mitral regurgitation or mitral regurgitation with impaired left ven-
tricular ejection fraction (< 60%). Current techniques for percutaneous mitral valve
repair include coronary sinus annuloplasty, direct annuloplasty, leaflet repair, and
chamber plus annular remodeling.49
Because the coronary sinus runs parallel to the mitral annulus, a device can be
placed within the sinus to deform the annulus and decrease the annular circumfer-
ence.49 One device uses anchors or stents percutaneously placed in the coronary si-
nus ostium and the distal coronary sinus. These anchors are bridged by a connecting
spring (the Monarc device, Edwards Lifesciences Inc., Orange, California). Tension
develops as the spring shortens and the coronary sinus diminishes in diameter. The
Carillon mitral contour system (Cardiac Dimensions, Kirkland, Washington) is another
percutaneous coronary device system that uses a nitinol wire-shaping ribbon between
the proximal and distal anchors.50–52 The efficacy of these devices is being evaluated.
In many patients the coronary sinus does not directly parallel the mitral annulus, and
in about half of the patients the coronary sinus crosses over branches of the circumflex
coronary artery.53 Compression of the circumflex coronary artery may occur at the
time of implantation or, in the case of the Monarc device, later as the biodegradable
material in the spring spaces absorbs and the spring element shortens over a period
of weeks to months.49 Other complications of coronary sinus–based procedures may
include coronary sinus erosion or thrombosis. Therefore, the safety and the efficacy of
the coronary sinus approach remains to be determined.
In the early 1990s Alfieri54,55 demonstrated that suturing the free mitral valve leaflet
edges of the midpart of the line of mitral coaptation creates a mitral valve with a double
orifice. Although isolated edge-to-edge mitral valve repair may be durable in selected pa-
tients with 5-year 90% freedom from re-operation and mitral regurgitation more than 2 1
or moderate mitral regurgitation,56 this technique also has had mixed clinical results.57,58
The MitraClip (Evalve, San Francisco, California) is a percutaneously delivered de-
vice that duplicates the Alfieri edge-to-edge repair. After a transatrial septal puncture
is made, the clip is positioned in the mid-left atrium cavity above the mitral valve ori-
fice. The clip is positioned in the center of the valve orifice and is aligned above the
origin of the mitral regurgitant jet. The clip then is opened and passed into the left
36 Faillace et al

ventricular cavity and is drawn back so that the mitral valve leaflets are grasped. Once
the leaflets are grasped, the clip is closed to create a double-orifice mitral valve.59,60 In
a phase I clinical trial, the rate of 2-year freedom from death, mitral valve surgery, or
recurrent mitral regurgitation > 2 1 was 80% in patients undergoing successful clip
therapy.61 The success of the Evalve clip procedure in this phase I trial has led to a ran-
domized trial comparing this procedure with mitral valve surgery in selected patients,
the Endovascular Valve Edge to Edge Repair Study II trial.49
Presently, all patients undergoing percutaneous mitral valve repair using the Evalve
procedure receive general anesthesia. Placement of the device is guided by fluoros-
copy and TEE.23

Percutaneous aortic valve replacement


Cribier 47 developed the first percutaneous heart valve for humans based on the initial
animal work of Anderson and Pavcnik and colleagues.62 Presently, percutaneous aor-
tic valve replacement is performed in patients who have severe aortic stenosis, New
York Heart Association class IV symptoms related to aortic stenosis, and comorbid-
ities that exclude them from cardiac surgery because of excessive risk.63 Ongoing ran-
domized, controlled clinical trials are comparing surgical aortic valve replacement and
percutaneous aortic valve replacement using newer-generation percutaneous aortic
prosthetic valves in patients who are candidates for cardiac surgery.64 Some experts
in this field believe that, depending on the trial results and future technological ad-
vances, percutaneous aortic valve replacement may be a viable option for a patient
in need of a prosthetic aortic valve to avoid the concomitant complications inherent
in open heart surgery.64
The Cribier-Edwards aortic valve (Edwards Lifesciences, Irvine, California) consists
of three bovine pericardial leaflets sutured to a stainless steel balloon expandable
stent. The valve is crimped on an aortic valvuloplasty balloon that is expandable to
23 to 26 mm (NuMED Inc., Hopkinton, New York). This system is delivered through
a 24-F (8-mm) sheath with an antegrade approach using a transatrial septal puncture.
Once the sheath is positioned across the native aortic valve, the prosthetic aortic valve
is delivered and placed in the aortic position through rapid inflation and deflation of the
balloon. Antegrade flow is minimized temporarily by high-rate pacing.63 Cribier 65 re-
cently reported a series of 35 patients undergoing this procedure. Twenty-seven of
the 35 patients underwent a successful implantation with improvement of aortic valve
area and left ventricular function. Five patients developed moderately severe aortic in-
sufficiency. There were no device-related deaths in 9 to 26 months of follow-up.65
More recently an antegrade approach has been developed that is not as technically
demanding and may be safer.66
Currently, technological advances are occurring in the development of percutane-
ous delivered aortic valves. The CoreValve (CoreValve, Inc., Paris, France) is a percu-
taneous aortic valve that is self expanding and consists of a bioprosthetic pericardial
tissue valve sutured in a nitinol metal stent.63 Preliminary studies have demonstrated
that an advantage of this self-expanding stent-valve system is lack of significant aortic
regurgitation.63 Other percutaneously delivered aortic valves are being developed
(eg, by AorTx, Inc., Redwood City, California) that may be retrieved after deployment.
It is believed that these advances in technology will lead to valves that are more
deliverable and safer.63
On September 5, 2007 Edwards Lifesciences Corporation announced European
approval for commercial release of the Edwards SAPIEN transcatheter aortic valve
technology with the RetroFlex transfemoral delivery system.67 This bovine pericardial
tissue valve is constructed with a cobalt chromium alloy stent that reduces the profile
Anesthesiologist in the Care of the Cardiac Patient 37

of the system by 4 to 5 F as compared with the other systems described previously.


The reduced diameter of this delivery system allows easier access into and within the
patient’s vasculature through a smaller catheter and may lead to a lower risk of pro-
cedural complication.68 This valve presently is being studies in the Placement of Aortic
Transcatheter Valve trial in high-risk symptomatic patients who have severe aortic ste-
nosis.68 This valve also may be placed in the aorta via a transapical approach with the
Ascendra delivery system.68
The initial clinical experience with the transapical transcatheter approach for aortic
valve implantation in humans was reported in 2006.69 This approach uses a left an-
terolateral intercostals incision to expose the left ventricular apex. A hemostatic
sheath is introduced by direct needle puncture of the apex. The prosthetic valve is
crimped onto a valvuloplasty balloon and is passed over a wire into the left ventricular
cavity. Fluoroscopy, aortography, and echocardiography confirm proper positioning.
As in the percutaneous technique, rapid ventricular pacing is used to decrease cardiac
output while the balloon is inflated and the prosthesis is deployed within the annulus.
The initial experience was reported on seven patients. There were no procedural
deaths. One death occurred in the 7 patients during a mean follow-up of 87  56
days.69 Since the first report, other published reports have demonstrated safety
with good early results in high-risk patients.70,71
Cardiac anesthesiologists are needed for the performance of percutaneous aortic
valve replacement. These patients are extremely ill and frequently need endotracheal
intubation and general anesthesia. In addition, they often are hemodynamically unsta-
ble and are at high risk for cardiac death during the procedure.

ELECTROPHYSIOLOGY INTERVENTIONS

The current era of clinical electrophysiology that began in 1960s has evolved from sim-
ple diagnostic procedures to therapeutic interventions. In recent years, the number of
electrophysiology procedures has increased exponentially.
The complexity and length of these procedures also have evolved dramatically and
frequently mandate administration of different analgesics and moderate sedation.
Although electrophysiologists commonly administer a combination of narcotics and
benzodiazepine for conscious sedation, consultation with a cardiac anesthesiologist
frequently is required to manage and stabilize a spectrum of patient profiles ranging
from healthy young patients who have no significant cardiac history or comorbidities
to patients who have advanced heart failure and multisystem disease. Therefore, the
anesthesiologist’s understanding of electrophysiology procedures is key in determin-
ing the outcome. This section reviews current electrophysiology procedures.

Electrophysiology Studies
Electrophysiology studies are performed to evaluate specific arrhythmias, specific
symptoms, or events such as syncope, palpitation, or cardiac arrest that suggest
the occurrence of an arrhythmia.72 Catheters commonly are placed via femoral venous
access into the high right atrium, His bundle, coronary sinus, right ventricular apex, or
right ventricular outflow tract. Programmed stimulation is performed from the high
right atrium, right ventricular apex, or right ventricular outflow tract to induce ventric-
ular or supraventricular tachycardias as well as to help identify etiologies of bradyar-
rhythmias. These procedures usually are performed with conscious sedation and light
analgesics. Drugs that may affect the sympathetic and parasympathetic nervous sys-
tems should be avoided, because they commonly influence the function of the atrio-
ventricular node and sinus node and thus may affect inducibility of certain arrhythmias.
38 Faillace et al

Catheter Ablation
Catheter ablation is commonly used to treat supraventricular tachyarrhythmias such
as atrioventricular nodal re-entry tachycardia, tachycardias related to Wolf-Parkinson-
White syndrome, and atrial flutter. More recently, catheter ablation also has been used
to treat atrial fibrillation. Radiofrequency is the energy most commonly used.73 Radio-
frequency catheter ablation has been used as a first-line treatment for some arrhyth-
mias as well as a treatment for arrhythmias that are refractory to pharmacologic
therapy.72 The major arrhythmias that have been treated with radiofrequency ablation
include: A-V nodal re-entrant tachycardia; atrial ventricular re-entrant tachycardia as-
sociated with the Wolf-Parkinson-White syndrome and an atrial ventricular bypass
tract; atrial flutter; bundle branch re-entry ventricular tachycardia; and atrial fibrillation.
Radiofrequency ablation also has been used as an adjunctive therapy for recurrent
ventricular tachycardia caused by coronary artery disease or arrhythmogenic right
ventricular dysplasia.73 As in an electrophysiology study, in catheter ablation proce-
dures catheters are placed in different cardiac chambers, and programmed stimula-
tion is performed from different sites to induce tachyarrhythmias. In addition,
different medications (isoproterenol, epinephrine, dopamine, aminophylline, atropine,
adenosine, beta-blockers, ibutilide, verapamil, procainamide, and others) are used to
induce and terminate tachyarrhythmias.72
Radiofrequency ablation procedures require complex mapping techniques to iden-
tify the source of the arrhythmia and specify the exact location of radiofrequency
ablation. These mapping techniques include activation mapping; pace mapping;
entrainment mapping; anatomic fluoroscopy-based, three-dimensional (3D) electro-
anatomic mapping; 3D noncontact mapping, and intracardiac echo-guided anatomic
mapping. All these techniques and the application of radiofrequency ablation energy
require that patient lie still on the electrophysiology table for the accurate localization
of the arrhythmogenic focus. Patient comfort often becomes an issue, and deeper
sedation is necessary. Therefore the role of the anesthesiologist becomes crucial in
facilitating ablation procedures by maintaining a patient’s airway and ensuring hemo-
dynamic stability with minimal movement of the patient’s body.
Once an arrhythmia is diagnosed and localized, energy sources other than radiofre-
quency may be applied to destroy the arrhythmogenic focus. These energy sources
include cryothermic energy, ultrasound, laser, and microwave. Regardless of the
energy source delivered to specific targets, the patient may experience pain and
may require more sedation.
Radiofrequency ablation procedures are becoming more tedious and time consum-
ing. Patients who have atrial fibrillation may require a procedure time of 6 to 8 hours,
followed by a 30-minute observation time after ablation and repeat electrophysiology
testing to ensure success of the procedure.72

Electrical Cardioversion
Electrical cardioversion ideally requires an anesthesiologist. Cardiologists frequently
have administered conscious sedation with benzodiazepines alone, with suboptimal
results.74 The authors recommend that all patients who undergo elective electrical
cardioversion receive conscious sedation under the direction of an anesthesiologist
to minimize patient discomfort and promote rapid recovery.

Implantable Cardioverter Defibrillators


Large, prospective, multicenter, randomized trials in patients who had coronary and
noncoronary heart disease and a wide range of ventricular function have
Anesthesiologist in the Care of the Cardiac Patient 39

demonstrated the efficacy and safety of implantable cardioverter defibrillators


(ICDs).75 Indications for ICD implantation include both the primary and secondary pre-
vention of ventricular tachycardia and/or ventricular fibrillation to decrease the risk of
sudden cardiac death.75 With the advent of smaller biphasic transvenous ICDs and the
experience gained over the years, it now is feasible for electrophysiologists to implant
ICDs safely in the pectoral area without surgical assistance. Throughout the years,
general anesthesia has been the standard anesthesia technique used for these proce-
dures, but the use of local anesthesia combined with conscious sedation has facili-
tated and simplified these procedures further. It is feasible to use local anesthesia
for current ICD implants to expedite the procedure and avoid the cost and possible
complications related to general anesthesia. The role of anesthesiologist is crucial dur-
ing defibrillation threshold testing, when deeper sedation or occasionally general an-
esthesia is required in patients who generally have significant comorbidities and
significant left ventricular dysfunction.
Defibrillation threshold testing can be considered the most critical part of the ICD
implantation procedure. Although the risk associated with defibrillation threshold test-
ing usually is low, serious complications may occur as a consequence of this practice.
These complications include transient ischemic attack, stroke, cardiopulmonary
arrest caused by refractory ventricular fibrillation, pulseless electrical activity, cardio-
genic shock, embolic events, and death.76,77 In unstable patients or patients who have
untreated coronary artery disease, defibrillation threshold testing usually is omitted
because of the potential life-threatening risks of the procedure.

Biventricular Pacing and Defibrillation Lead Placement


Cardiac resynchronization therapy with defibrillation systems is prescribed for both
primary and secondary prevention of sudden cardiac death in patients who have heart
failure associated with an ischemic or a non-ischemic origin. The presently recom-
mended criteria for implantation of a biventricular pacemaker with defibrillation capa-
bility includes patients who have a left ventricular ejection fraction of less than 35%
with a wide (> 120 ms) QRS complex and drug-refractory New York Heart Association
class III or IV heart failure who are receiving optimal medical therapy for their heart
failure.76–78
These patients may be unable to lie flat on the electrophysiology table because of
their advanced heart failure and increased total lung water despite diuretic therapy.
Therefore, close monitoring of the patient’s blood pressure, heart rate, and oxygena-
tion is extremely important. The skill of an anesthesiologist is required to administer
conscious sedation gradually to avoid cardiac decompensation during these generally
long procedures. Positioning the left ventricular lead via the coronary sinus and great
cardiac vein can be a very complex and lengthy procedure because of distorted ven-
tricular anatomy. Generally these patients have severe right ventricular and left ven-
tricular dilatation and valvular regurgitation that may complicate lead positioning.
Lead dislodgement may occur immediately after lead placement, further prolonging
these procedures.
Procedure-related complications can include the development of refractory heart
failure. Therefore, the need for airway protection is critical, and the ability to intubate
the patient is crucial to the success of the procedure and survival of the patient. Other
complications can include pneumothorax and coronary sinus perforation related to
lead placement. Coronary sinus perforation may be recognized clinically by contrast
extravasation. Cardiac tamponade may occur as a result of perforation of the coronary
sinus or from cardiac perforation related to ventricular or atrial lead placement. The
40 Faillace et al

development of cardiac tamponade necessitates immediate pericardiocentesis upon


recognition.

TRANSESOPHAGEAL ECHOCARDIOGRAPHY

The clinical indications for TEE continue to be defined. In two large series, the clinical
indications for TEE were for cardiac sources of embolism (36%), endocarditis (14%),
prosthetic heart valve function (12%), native valvular disease, aortic dissection or an-
eurysm, intracardiac tumor, mass, or thrombus (6%–8% each), and congenital heart
disease (4%).79,80 In current practice, TEE commonly is performed with most major
cardiac surgical procedures to verify preoperative diagnoses, monitor ventricular
function, and assess the success of valve repair.81 The 2007 appropriateness criteria
from the American Society of Echocardiography include the following indications for
TEE as an initial test:82

Evaluation of suspected aortic dissection


Guidance during percutaneous interventions for structural heart disease
Determining suitability for valve repair
Diagnosis of endocarditis
Evaluation of persistent fever with an intracardiac device
Evaluation for left atrial thrombus or spontaneous echo contrast before cardiover-
sion or radiofrequency ablation
As compared with transthoracic echocardiography, TEE offers superior visualiza-
tion of posterior cardiac structures because of the close proximity of the esophagus
to the posteromedial heart with the absence of intervening lung and bone. This prox-
imity permits the use of high-frequency imaging transducers that afford superior spa-
tial resolution.83 TEE is contraindicated in the presence of the following conditions:
esophageal stricture or malignancy; surgical interposition of the esophagus; recent
esophageal ulcer or hemorrhage; Zenker’s diverticulum; altered mental status or an
uncooperative patient; and a history of odynophagia or dysphagia in the absence of
a screening endoscopy and or barium swallow.83
Risk of bleeding increases in patients who are taking anticoagulants, who have re-
ceived thrombolytic therapy before the procedure, who are thrombocytopenic, or who
have other bleeding disorders. The risk of bleeding in patients who have esophageal
varices is not known but probably is increased.83

Description of Procedure and the Role of Anesthesia


Although considered moderately invasive, the performance of a TEE requires the
focused attention of the cardiologist and is performed best in combination with an an-
esthesiologist. In patients who are difficult to intubate with the TEE probe, the anesthe-
siologist can visualize the glottis directly with a laryngoscope and facilitate an
uncomplicated successful esophageal intubation. In uncooperative patients, a greater
level of sedation and prophylactic tracheal intubation for airway protection also can be
helpful.
Careful attention to topical posterior pharyngeal anesthesia with Cetacaine spray
(Cetylite Industries, Inc., Pennsauken, New Jersey) and patient reassurance (‘‘verbal
anesthesia’’) helps minimize the degree of sedation that is required. Pulse oximetry
is used to monitor oxygen saturation. Intravenous glycopyrrolate can be administered
to decrease secretions during the procedure. Because of its anticholinergic proper-
ties, glycopyrrolate inhibits salivation and excessive pharyngeal secretions, reducing
the risk of aspiration pneumonia.
Anesthesiologist in the Care of the Cardiac Patient 41

Serious complications of TEE, including death, sustained ventricular tachycardia,


and severe angina, have been estimated at less than 1 in 5000.79,80 There is a low
risk of pharyngeal, esophageal, or stomach perforation. In a study of 10,000 consec-
utive patients undergoing TEE, there was one case of hypopharyngeal perforation, two
cases of cervical esophageal perforation, and no fatalities.84
Application of topical benzocaine and related agents that are used for posterior pha-
ryngeal anesthesia may be associated with the development of methemoglobinemia,
a potentially life-threatening complication. The development of cyanosis in the pres-
ence of normal arterial oxygen saturation is an indication of the development of met-
hemoglobinemia.85,86 Therefore, pulse oximetry cannot be used to make a diagnosis
of methemoglobinemia. Minor complications include transient bronchospasm,
transient hypoxia, nonsustained ventricular tachycardia, transient atrial fibrillation,
vomiting, pharyngeal abrasion, and pharyngeal hematoma.83

SUMMARY

As described throughout this article, modern invasive cardiovascular procedures are


complex and demand the full attention of the attending cardiologist and the complete
cooperation of the patient. In many, if not most, of the circumstances described here,
the anesthesiologist is a welcome addition to the cardiovascular team. The anesthe-
siologist’s knowledge, skills, abilities, and experience are invaluable in ensuring
optimal procedure results and good patient outcomes.

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Anesthesia in the
Cardiac
Catheterization
L ab orator y a nd
Ele ctrophysiolo gy
L ab orator y
Douglas C. Shook, MDa,*, Robert M. Savage, MDb,c

KEYWORDS
 Anesthesia  Catheterization  Electrophysiology
 Cardiac  Cardiology  Intervention

Procedures and interventions in the cardiac catheterization laboratory (CCL) and elec-
trophysiology laboratory (EPL) are more complex and involve acutely ill patients. Mod-
ern procedures take longer to perform, requiring technical precision and greater focus
by cardiologists for a successful result. In this new and changing arena, collaboration
and planning between cardiologists and anesthesiologists are required for both pa-
tient safety and procedural success.
The focus of this article is the transformation of that information into a safe and
effective anesthesia management plan for the CCL and EPL.

THE LABORATORY ENVIRONMENT

Becoming familiar with the laboratory workspace and personnel is imperative. Typi-
cally there is a control station and procedure room. The control station is shielded
from radiation and usually has a technician recording the progress of the procedure.
The technician communicates with the cardiologist frequently and controls many as-
pects of the case, including patient monitoring, video recording and editing, and digital
record keeping.

a
Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s
Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA
b
Department of Cardiothoracic Anesthesia and The Cleveland Clinic Foundation, Mail Code
G30, 9500 Euclid Avenue, Cleveland, OH 44195, USA
c
Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Mail Code G30,
9500 Euclid Avenue, Cleveland, OH 44195, USA
* Corresponding author.
E-mail address: [email protected] (D.C. Shook).

Anesthesiology Clin 27 (2009) 47–56


doi:10.1016/j.anclin.2008.10.011 anesthesiology.theclinics.com
1932-2275/08/$ – see front matter ª 2009 Elsevier Inc. All rights reserved.
48 Shook & Savage

The procedure room is where the cardiologist, anesthesiologist, nurses, and other
technicians care for the patient during the procedure. Equipment in the procedure
room includes fluoroscopy, the procedure table, screens for viewing the procedure,
a sterile table for the cardiologist, storage of various catheters and wires for the pro-
cedure, and blood analysis machines. The anesthesiologist should become familiar
with what each room contains, and particularly the location of gas outlets and suction,
monitors for vital signs, cardioverter/defibrillator, emergency medications, and any
airway equipment normally stored in the room. The anesthesiologist may need to
familiarize him/herself with different brands of equipment not found in the operating
room. Locations for a ventilator, anesthesia cart, and possibly a fiberoptic cart also
should be planned if needed. Other equipment regularly used during cases includes
ventricular assist devices and echocardiography.
Most CCLs and EPLs are designed for the cardiologist and not for the needs of the
anesthesiologist. Space always is an issue in complex cases. Collaboration and pre-
procedure planning are essential. The fluoroscopy table and fluoroscopy equipment
are controlled by the cardiologist and can move unexpectedly during the procedure.
Long intravenous lines, extra oxygen tubing, and long breathing circuits must be used
to allow movement of both the table and fluoroscopy equipment.
Basic monitoring equipment for sedation or regional or general anesthesia may not
be present in the CCL and EPL. Assisting with a sedation issue during a procedure can
be more difficult if end-tidal CO2 is not being monitored. Having end-tidal CO2 moni-
tors in all rooms is important for safe patient care. Because an anesthesia workroom
typically is not located near the CCL or EPL, stocking laboratories with airway equip-
ment and an emergency airway cart is essential. Having an anesthesia cart stocked
with extra intravenous (IV) lines, medications, and other items located in the CCL
and EPL helps during emergent consultations. All personnel in the laboratory should
know the location of this equipment, because the anesthesiologist will not have
time to gather the equipment if called emergently to a procedure area.

ANESTHESIA CONSULTATION

There are no established guidelines for anesthesia consultation in the CCL and EPL.
Many emergencies are avoided by preprocedure planning of patient sedation or advis-
ing that general anesthesia should be considered. Consultation is based either on pa-
tient factors or procedure complexity.
Patient airway factors that should trigger an anesthesia consultation include morbid
obesity, obstructive sleep apnea, inability to lie flat, and known or suspected difficult
airways (Mallampati class III or IV). Personnel in the preprocedure area should be
taught how to perform basic airway histories and examinations to establish whether
consultation should be obtained. Other patient factors that may trigger an anesthesia
consultation include chronic obstructive pulmonary disease, low oxygen saturation,
current congestive heart failure, hemodynamic instability, psychiatric disorders, and
any medications that could complicate the administration of sedative agents.
Procedure factors that may prompt a provider to seek an anesthesia consultation
include the potential for an outcome that requires immediate surgical back-up such
as unprotected left-main coronary artery stenting or investigational percutaneous
valve procedures. These procedures typically are longer and more complex, requiring
the focused attention of the cardiologist. Complex arrhythmia ablation procedures,
complicated lead extractions (laser lead extraction), and biventricular pacemaker pro-
cedures also should have anesthesia consultations. Any procedure that requires gen-
eral anesthesia needs preprocedure anesthesia evaluation.
Anesthesia in the CCL and EPL 49

Establishing criteria for anesthesia consultation eventually will lead to more efficient
and safer patient care. Better preprocedure planning can take place, such as route of
catheterization (radial versus femoral), avoiding oversedation in susceptible patients,
planned elevation of the patient’s head during the procedure to alleviate sedation-in-
duced airway obstruction, and having continuous positive airway pressure available
for patients who have known or suspected obstructive sleep apnea. Personnel deliv-
ering sedation will be more comfortable caring for the patient, cardiologists can focus
on the task at hand, and anesthesiologists are alerted to the possible complications
they may be called to manage.

THE PATIENT

If an anesthesia consultation is warranted, a comprehensive preprocedure evaluation


is essential. A complete history includes not only the typical evaluation questions but
also a comprehensive review of all previous cardiac interventions (diagnostic catheter-
izations, stent placement and location, left- and right-sided cardiac pressures,
surgical interventions, arrhythmia interventions and ablations), echocardiograms (ven-
tricular function and dimensions, valve disease), chest radiographs, and any recent
changes in the patient’s medication regimen.
Many patients arrive in the preprocedure area after failed interventions, recent myo-
cardial infarctions, acute exacerbations of heart failure, or with uncontrolled arrhyth-
mias. These patients are not the typical patient population cared for in the operating
rooms, because operations for most of these patients would be cancelled using the cur-
rent American College of Cardiology/American Heart Association guidelines for preop-
erative assessment.1 Awareness of the patient’s current state of health is imperative. In
some cases, the anesthesiologists may be the only care provider to be aware of recent
changes is health status, because of the urgency and focus of the intervention at hand.
Determining the urgency of the procedure in relation to anesthetic needs and
procedural complications requires communication with the CCL and EPL teams.
The condition of some patients can be optimized before the procedure to avoid gen-
eral anesthesia. For example, improving diuresis and adjusting medication regimens
to optimize respiratory function, thereby permitting the patient to lie flat comfortably
during the procedure, can increase the probability of a successful result. Radial artery
catheterization instead of a femoral approach may be a better option in some patients,
because this approach allows the patient to sit in a more upright position during the
procedure. Some patients need the procedure emergently, limiting options and requir-
ing the direct involvement of an anesthesiologist for sedation or general anesthesia.
Emergently managing an airway in a sedated patient in the CCL and EPL can be
difficult. The fluoroscopy table is different from an operating room table. The head
of the bed cannot be elevated, and the cardiologist has the table controls. In addition,
the fluoroscopy equipment usually surrounds the patient’s head, limiting access; the
patient may be hemodynamically unstable, further complicating airway management.
Finally, personnel in the CCL and EPL do not have training in advance airway manage-
ment and can be of little help in an emergency.
Therefore, airway assessment is critical in this environment. Ease of endotracheal
intubation should be assessed and also the ability to mask ventilate should be evalu-
ated, because mask ventilation can bridge a moment of oversedation during a proce-
dure. Langeron and colleagues2 identified five independent criteria associated with
difficult mask ventilation: age greater than 55 years, body mass index greater than
26, presence of a beard, lack of teeth, and history of snoring. The presence of two
of these factors indicates possible difficult mask ventilation. A history of difficult
50 Shook & Savage

intubation or possible difficult intubation does not preclude sedation but should be
a warning that oversedation can be dangerous, and communication with all personnel
involved in the procedure is warranted. Everyone should be alerted to the location of
airway supplies and early communication of sedation issues during the procedure.

SEDATION

Most procedures in the CCL and EPL are performed using mild to moderate sedation
administered by trained personnel and local anesthetic infiltration at the site of catheter
placement by the cardiologist. Non-anesthesia personnel administering mild to moder-
ate sedation should be trained in the pharmacology of commonly used agents and be
able to recognize and manage respiratory and hemodynamic indicators for mild, mod-
erate, and deep sedation.3 Personnel administering sedative agents should be able to
manage the next level of sedation safely. The possible synergistic drug interactions of
benzodiazepines, opioids, and other commonly administered sedatives such as di-
phenhydramine (given to patients who have IV contrast reactions) must be well under-
stood, especially in patients who have complicated airways or diminished respiratory
capacity. Anesthesiologists should take an active role in developing and maintaining
sedation standards for non-anesthesia personnel throughout the hospital.3
Patients in the CCL and EPL commonly are sedated with fentanyl and midazolam
because of the ease of drug titration and their shorter redistribution and elimination
half-lives. In patients who have complicated airways, obstructive symptoms, or respi-
ratory or hemodynamic compromise, minimal sedation usually is recommended with
liberal use of local anesthesia for patient comfort. Patient anxiety and fear can be
treated with verbal comfort, reassurance, and a small amount of midazolam. Avoiding
fentanyl eliminates the synergistic respiratory depressant effect, and most pain is
alleviated once local anesthesia has been administered.
The anesthesiologist has a greater medication arsenal available for complicated pa-
tients and procedures. Management of sedation requires a complete understanding of
the procedure, in addition to the patient’s comorbidities. Tachypnea and tachycardia
from light sedation can be just as dangerous as airway obstruction and snoring from
deep sedation. Both can make an intervention more difficult for the cardiologist. In
many instances, deep sedation, a situation that is ideally suited for the assistance of
an anesthesiologist, is necessary only for a couple of minutes during a procedure
(eg, testing an implantable cardioverter-defibrillator [ICD] after implantation).
Dexmedetomidine (an a2-agonist) may be ideal in certain patients in the CCL who
have complicated airways or mild respiratory compromise, because less respiratory
depression is associated with its administration.4 In patients in the EPL, dexmedeto-
midine may not be appropriate because it causes sympatholysis, which can be a prob-
lem when trying to induce arrhythmias for either diagnosis or treatment (ablation).
Sometimes, because of the complexity of the procedure and/or respiratory and air-
way compromise of the patient, sedation is not appropriate, and general anesthesia is
administered. In most instances, it is safer to start a procedure with general anesthesia
than to convert during the procedure.

MONITORING

Just as the room set-up in the CCL and EPL is designed for the cardiologist, so is
patient monitoring. The fluoroscopy screen and patient vital signs are easy for the car-
diologist to see but may be difficult for the anesthesiologist to see if he/she is at the
head of the bed. Establishing the best location to view the necessary monitors is
essential and may require changing the current room set-up. Being able to see the
Anesthesia in the CCL and EPL 51

fluoroscopy screen is helpful to monitor the progress of the procedure and anticipate
changes in hemodynamics or patient comfort.
Certain simple functions such as blood pressure cuff cycling and pulse oximetry
volume typically are controlled outside the actual procedure room; if so, the anesthe-
siologist may want to add his/her own equipment. In addition, for prolonged cases in
compromised patients, invasive arterial monitoring that is visible to the anesthesiolo-
gist may be important, because the blood pressure cuff may not function during fast or
erratic heart rhythms. Invasive arterial monitoring is available in many cases, because
arterial access is necessary to perform the procedure, but it may be difficult for the
anesthesiologist to see the waveform unless an effort is made to display it on the an-
esthesia machine or other equipment close to the anesthesiologist. Some CCLs and
EPLs may not have end-tidal CO2 monitoring readily available. End-tidal CO2 monitor-
ing is not required for sedation cases but is recommended, especially for patients who
will need deep sedation.3 The American Society of Anesthesiologists has established
monitoring guidelines for sedation by anesthesia and non-anesthesia personnel in
non–operating room locations.3,5
In many cases transesophageal echocardiography (TEE) is used to guide and mon-
itor the patient during the procedure. Familiarity with standard views and assessment
of cardiac function assists the anesthesiologist in determining the progress of the
case, including success and complications of the procedure. If hemodynamic instabil-
ity occurs, TEE provides instant assessment of contractility, volume status, and valve
function. Positioning the TEE screen so that it is visible to the cardiologist performing
the procedure as well as to the anesthesiologist performing the TEE can be helpful.

MEDICATIONS

In addition to the standard medications used for sedation and general anesthesia, the
anesthesiologist must be familiar with the pharmacokinetics and pharmacodynamics
of medications commonly used in both the CCL and EPL. Medications include hepa-
rin, glycoprotein IIb/IIIa platelet receptor inhibitors, clopidogrel, direct thrombin inhib-
itors such as bivalirudin, and vasoactive and inotropic medications. In addition, many
patients in the EPL are treated with antiarrhythmic agents of a variety of classes. Com-
mon medications include sodium-channel blockers (class 1: quinidine, lidocaine, fle-
cainide), b-blockers (class 2: metoprolol, sotalol), potassium-channel blockers (class
3: amiodarone, sotalol, ibutilide, dofetilide), and calcium-channel blockers (class 4:
verapamil, diltiazem).
Before the procedure, it must be made clear who will deliver medications to the
patient. The cardiologist usually has the nurse in the room administer drugs such as
heparin and vasoactive and inotropic medications. In addition, the cardiologist may
administer bolus medications such as nitroglycerine or calcium-channel blockers
directly into cardiac catheters; these medications can have a profound effect on the
patient’s hemodynamics. The anesthesiologist must be informed before the adminis-
tration of boluses so that subsequent hemodynamic effects can be anticipated.

SPECIFIC ANESTHETIC CONSIDERATIONS

As mentioned earlier, the anesthesiologist must understand the procedure completely


to be able to anticipate the patient’s anesthetic needs. This section describes some of
the anesthetic implications that should be anticipated. The considerations of room
set-up, availability of anesthesia equipment, patient evaluation, and medication
administration described earlier apply to each of these situations.
52 Shook & Savage

Percutaneous Coronary Interventions


Percutaneous coronary interventions commonly are performed using mild to moder-
ate sedation under the direction of the cardiologist. Anesthesia involvement typically
occurs in patients presenting with respiratory insufficiency, hemodynamic compro-
mise, or emergently during the procedure because of sedation complications or acute
patient decompensation. Close communication with the cardiologist is imperative, be-
cause management decisions usually need to be made expeditiously. Information
such as recently administered medications, IV access, invasive monitoring, and stage
of the procedure must be obtained. Access to the patient’s head can be difficult, as
mentioned previously. If an airway must be established, priority needs to be given
to the anesthesiologist, and the table and fluoroscopy equipment may need to be
moved temporarily. Placement of an endotracheal tube is preferred to a laryngeal
mask airway. In general, the use of a laryngeal mask airway is not recommended in
the CCL and EPL because it can be dislodged by the constant moving of the fluoros-
copy equipment and table. In addition, patients can become acutely unstable, and
having an endotracheal tube in place eliminates the need to manage an airway further
during a crisis.

Percutaneous Ventricular Assist Devices


Percutaneous ventricular assist devices (TandemHeart, Cardiac Assist, Inc., Pittsburg,
Pennsylvania, and Impella Recover LP 2.5 and 5.0, Abiomed Inc, Danvers, Massachu-
setts) are placed in patients undergoing high-risk percutaneous coronary interventions
(unprotected left main) or high-risk ablation procedures or who are hemodynamically
compromised (cardiogenic shock).6–8 The anesthesiologist usually is consulted for
these procedures because the patient already is unstable or because the procedure
can have both airway and hemodynamic complications. Depending on the procedure
and state of the patient, either sedation or general anesthesia can be used to care for
the patient safely. Communication with the cardiologist helps determine the type of
anesthetic most appropriate for the case.
The TandemHeart and Impella LP 5.0 can produce cardiac outputs that can com-
pletely replace left ventricular function. During this time, pulse oximetry and non-inva-
sive blood pressure cuffs may not work properly, because blood flow may not be
pulsatile. The Impella LP 2.5 uses a smaller cannula that achieves a maximum cardiac
output of 2.5 L/min. The patient must have some intrinsic cardiac function to maintain
hemodynamic stability.
Invasive monitoring is available because arterial cannulation is used during the
procedure. Large-bore IV access is desirable because a large amount of blood loss
is possible during the procedure.9 Blood loss is more likely with the TandemHeart or Im-
pella LP 5.0, because larger cannulas are used. Surgical back-up usually is necessary
during these procedures. The anesthesiologist should confirm that back-up is available.

Percutaneous Closure of Septal Defects


Percutaneous closure procedures are used to close patent foramen ovale, atrial septal
defects (ASD) and ventricular septal defects (VSD). Patient history is important to
determine the reason for closing the defect. Closure of a patent foramen ovale tends
to be simpler than closure of an ASD. In patients who have ASDs, it is important to
determine if right ventricular function and pulmonary arterial pressures are normal,
because the right side of the heart has been volume overloaded by the typical
left-to-right shunt through the ASD. In patients who have VSDs, the anesthesiologist
needs to determine if the VSD is congenital or acquired (post–myocardial infraction)
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