Although low, the risks from invasive cardiac procedures
are not zero. In addition to procedural-related complications,
occasional patients will become unstable during or after
the procedure. For this reason, other ancillary services
(Table 1) may be necessary
to support the laboratory. At present, there are 3 basic
environments in which invasive cardiac procedures are
performed: the in-hospital cardiac catheterization laboratory
with cardiac surgery capability, the in-hospital laboratory
without cardiac surgery capability in the same hospital,
and the freestanding laboratory. Certain patient subgroups
may be inappropriate for study in some of these environments.
The following outlines the current laboratory environments
and suggests patient populations appropriate for study
in each of these settings.
A. The Cardiac Catheterization Laboratory at a Hospital
With Cardiac Surgery Capability
The cardiac catheterization laboratory at a hospital
with cardiac surgery capability is the classical or
traditional type of cardiac catheterization laboratory
facility. It is located at a hospital that offers a
broad range of cardiovascular services, including cardiopulmonary
bypass and coronary, cardiothoracic, and vascular surgery
(i.e., full support services). The presence of on-site
cardiac surgery capability is the defining service because
it is unlikely that a cardiac surgical program would
exist in the absence of the other support services listed
in Table 1. If pediatric cardiac
catheterization services are provided, additional ancillary
services are necessary, and the availability of on-site
pediatric cardiac surgery is essential if complex congenital
heart diseases in infants and children are to be studied
and treated.
Fully trained personnel dedicated to the facility should
staff such a laboratory. This is the only setting in
which patients with poorly compensated heart failure,
severe left ventricular dysfunction (ejection fraction
<20%), acute coronary syndromes, or other conditions
that contribute to clinical instability can be studied
safely. Elective coronary interventions are best performed
in this setting. Physicians should have appropriate
credentials for performing both diagnostic and interventional
procedures or have ready access to interventional cardiologists
should an emergency arise.
Although the majority of cardiac catheterization laboratories
in this category are located within the main hospital
building, there may be special situations in which a
mobile laboratory is used temporarily at such a hospital
or where a laboratory may be in a different, but adjacent
building dedicated to outpatient services. Generally,
these latter situations may be considered similar to
a laboratory with full support services.
1. Patients Eligible for
Invasive Cardiac Procedures at a Hospital With Cardiac
Surgery Capability
A hospital with cardiac surgery capability provides
an environment in which all diagnostic and therapeutic
procedures can be performed on both stable and unstable
patients, provided the operators are physicians with
appropriate experience, adequate cumulative procedure
volumes, and satisfactory outcomes. Even though a hospital
may have cardiac surgery capability and is therefore
technically eligible to provide every type of invasive
procedure, patients requiring less commonly performed
procedures (e.g., transseptal catheterization and balloon
valvuloplasty) or patients with more complex conditions
(e.g., adults and children with complex congenital heart
disease) may be better served by referral to a more
highly specialized center.
Performance of invasive cardiac procedures in the pediatric
and especially neonatal age groups requires knowledge
and skills that go beyond catheter manipulations and
include the management of conscious sedation, administration
of intravenous (IV) fluids, regulation of body temperature,
and the postprocedural care of infants and children.
These issues are important to understand, not only for
the physician, but also for nurses and other paramedical
personnel who assist in the procedure. For these reasons,
pediatric procedures should only be performed if they
are within the competence of the operator and the experience
of the team supporting the physician in the invasive
procedure. Pediatric issues are summarized later in
this document.
B. The Cardiac Catheterization
Laboratory at a Hospital Without Cardiac Surgery Capability
The performance of diagnostic cardiac catheterization
in facilities without the capability for on-site cardiac
surgery is now common in the United States. About half
of the 2014 laboratories identified in 1996 had on-site
cardiac surgery capability (6).
The number of surgical programs has now increased, and
72% of the 2142 laboratories reported in 2001 have cardiac
surgical programs on-site (1).
Many hospitals without cardiac surgery have permanent,
in-house cardiac catheterization laboratories and provide
the majority of supporting services except for cardiac
surgery. Although cardiac surgery is the defining service,
the importance of the other services listed in Table
1 cannot be overemphasized. This is especially true
in situations in which a mobile cardiac catheterization
laboratory operates at a smaller rural hospital. In this
setting, support services such as vascular surgery and
comprehensive imaging techniques may not be available
should important complications develop. It is mandatory
that catheterization laboratories operating in this setting
have well-defined selection and exclusion criteria and
provision for identification of emergency situations requiring
immediate transfer to a tertiary facility and insertion
of an intra-aortic balloon pump. Written agreements should
be signed with a tertiary center for the timely (<60 min)
transfer and acceptance of patients in the event of a
crisis. In some settings, a physician using a mobile laboratory
may live in the local community and is available after
the laboratory leaves to assess complications or assist
in patient management. In other situations, however, the
physician performing the procedure may live in a distant
area and may leave the hospital after the procedure. In
this latter circumstance, it is essential that local physicians
and support staff have an understanding of the potential
complications of cardiac catheterization and be an integral
part of the management process.
It is possible for catheterization laboratories to
function with high quality and safety in hospitals without
a cardiac surgical program; however, services are necessarily
limited.
To further ensure safety, a formal arrangement between
the laboratory and a nearby institution with cardiac
surgical services must be made. Regulatory authorities
and third-party reimbursement agencies should demand
formal documentation and periodic review of such arrangements.
1. Patients Eligible for Diagnostic Cardiac Catheterization
at a Hospital Without Cardiac Surgery Capability
Patients undergoing invasive procedures in this
type of facility require a higher level of screening
to avoid situations that might require urgent cardiac
surgery or result in a complication that could not be
managed effectively with the inherent delays encountered
during transfer to another facility. Clinically, adults
at the greatest risk include the very elderly (>75 years
of age), those with New York Heart Association (NYHA)
functional class III or IV congestive heart failure,
those with acute coronary syndromes or recent MI, and
those in whom noninvasive testing demonstrates severe
ischemia. Patients with suspected or known left main
disease, markedly reduced left ventricular function
(ejection fraction <20%), or severe valvular dysfunction,
especially in association with poor left ventricular
performance, are also at increased risk. Patients at
increased risk for vascular complications should not
be studied in facilities without the capability to diagnose
and surgically treat such complications should they
arise. Such patients include those with known severe
peripheral vascular disease, severe systolic hypertension,
a bleeding diathesis, the need for continuous anticoagulant
therapy, or severe obesity. Pediatric patients should
not be studied. Patients receiving dialysis who may
decompensate after the procedure are generally best
studied at a facility with rapid access to a dialysis
center.
It is not feasible to list every possible situation
that could develop, but general exclusions for the performance
of invasive cardiac procedures at hospitals without
cardiac surgery are summarized in Table
2. It is important to emphasize that these recommendations
are based on the literature and the judgment and experience
of Committee members rather than extensive clinical
evidence developed from outcome measures.
2. Patients Eligible for Therapeutic Invasive Procedures
at a Hospital Without Cardiac Surgery Capability
Therapeutic invasive procedures primarily consist
of valvuloplasty, pericardiocentesis for tamponade,
and PCIs, as well as certain procedures specific for
the pediatric and adult congenital heart disease populations.
In evaluating the use of these procedures at hospitals
without cardiac surgery capability, it is important
to consider the clinical situation for which the procedure
is needed, and specifically whether it is an emergency
or elective procedure. Valvuloplasty is not required
on an emergency basis, and therefore it should not be
performed at hospitals without full support services,
including cardiac surgery. Moreover, because it requires
a unique knowledge base, special equipment, and technical
expertise, it is advisable to refer the patient to a
regional center with experience in this technique.
In the setting of pericardial tamponade, pericardiocentesis
can be a lifesaving therapeutic procedure, and the potential
benefits of the procedure far outweigh the risks. Although
commonly performed in catheterization laboratories as
a matter of convenience, ECG- or echocardiographic-guided
pericardiocentesis can be performed in other areas of
the hospital. In the setting of tamponade, therefore,
pericardiocentesis should be immediately available,
irrespective of the hospital status. In the absence
of tamponade, diagnostic pericardiocentesis only rarely
provides critical clinical information but can be performed
with minimal risk of ventricular puncture or coronary
laceration if the pericardial effusion is sizeable.
Therefore, assuming that the operator is skilled and
experienced, elective pericardiocentesis for large effusions
is acceptable in hospitals without immediate cardiac
surgery capability. Elective procedures in patients
with moderate or small pericardial effusions are better
performed at hospitals in which immediate cardiac surgery
is available should ventricular perforation or coronary
laceration occur.
The performance of coronary angioplasty and other PCIs
at hospitals without immediate surgical backup is controversial.
In simple terms, patients can be divided into 2 groups:
(1) those having the procedure as an alternative to
thrombolytic therapy within 12 h from the onset of acute
MI and (2) all others who are assumed to be undergoing
elective or semielective procedures. In the setting
of an acute MI, several small studies (7-9)
have suggested that patients presenting to hospitals
without cardiac surgery capability can be treated with
primary angioplasty without a measurable difference
in complications or outcomes when compared with hospitals
with on-site cardiac surgery capability. However, these
are not randomized trials, and none of these studies
are of sufficient size to detect a small difference
between groups. Recently reported data from the National
Registry of Myocardial Infarction Investigators have
revealed 28% less mortality among patients undergoing
primary angioplasty in high-volume hospitals than in
those undergoing the procedure in low-volume settings
(4).
Most hospitals without cardiac surgery capability perform
a relatively low volume of cardiac interventions.
Although some studies support the use of primary angioplasty
at hospitals without on-site cardiac surgery capability,
important operator, laboratory, and institutional requirements
must exist (9).
If it is accepted that it is possible to develop a program
of primary angioplasty for MI at a hospital without
on-site cardiac surgery capability, the important question
still remains whether this is an appropriate decision
based on a desire to provide the best possible care
for the local community. For example, is it really necessary
to offer primary angioplasty at a hospital without cardiac
surgery capability if a hospital with a cardiac surgical
program is <10 min away? Although it can be argued that
should an interventional complication occur, transport
time and delay to a surgical center would be inconsequential,
it is also appropriate to make certain that the motives
for offering this service at a hospital without on-site
cardiac surgery capability are not based purely on financial
considerations or physician convenience. Moreover, it
is unlikely that smaller hospitals performing only emergency
procedures on patients with acute MI can satisfy the
procedure volume requirements that now are associated
with better outcomes (3,4).
In the final analysis, this Committee endorses the
opinions and recommendations of the current ACC/AHA
Committee revising the 1993 PTCA guidelines (3).
In brief, primary angioplasty for reperfusion therapy
in the setting of acute myocardial infarction in hospitals
without onsite cardiac surgery capability must only
be performed in a setting where there is a proven plan
for rapid access (within 1hour) to a cardiac surgery
operating room in a nearby facility with appropriate
hemodynamic support capability for transfer. The procedure
should be limited to patients with ST-segment elevation
MI or new LBBB on ECG, and done in a timely manner (balloon
inflation within 90±30 min of admission) by persons
skilled in the procedure (those performing 
75
PCI’s per year) and only at facilities performing
a minimum of 36 PCIs per year (3).
Newer thrombolytic regimens, especially those combining
thrombolytic agents with glycoprotein (GP) IIb/IIIa
inhibitors, have higher reperfusion rates approaching
those achieved by mechanical means and could reduce
this as an issue (10,11).
Although the need for swift intervention drives the
argument for primary coronary intervention at hospitals
without on-site cardiac surgery capability, this does
not apply to elective coronary intervention. The risks
of coronary intervention have diminished with the increased
use of coronary artery stents and GP IIb/IIIa inhibitors.
Nevertheless, complications that require urgent bypass
surgery still occur, and there will always be some risk
related to the transfer between hospitals of patients
for whom an interventional procedure has failed. These
risks, however small, must be balanced against the proven
safety of performing the procedure at a hospital with
on-site cardiac surgery capability. The performance
of elective angioplasty in hospitals without such capability
has been reported from several centers outside the United
States (12,13)
where cardiac surgery is generally less available. However,
given the availability of cardiac surgery in the United
States, it seems quite unlikely that patients or their
families are significantly inconvenienced by referral
to a hospital with on-site cardiac surgery available.
Therefore, in agreement with the upcoming ACC/AHA PCI
guidelines (3),
it is the opinion of this Committee that the performance
of elective coronary interventions in hospitals without
on-site cardiac surgery capability cannot be endorsed
at this time. The Committee is aware that certain programs
that do perform interventions in this setting are affiliated
with a high-volume PCI/coronary artery bypass graft
(CABG) center and have a well-organized plan for emergency
transfer of patients, a sophisticated communication
system between the primary site and the tertiary center,
and a means for measuring and reporting patient complications
and outcomes. Such a strictly monitored and controlled
setting may allow for elective interventional procedures
without cardiac surgical backup on-site, but outcomes
from such programs have yet to be reported. This is
obviously a dynamic area that awaits further data regarding
the safety and outcomes of patients treated.
In addition, the desire for an interventional cardiac
catheterization program should not be used to justify
the development of a low-volume cardiac surgery program.
There is concern among Committee members that low-volume
cardiac surgery programs may be developed for the sole
purpose of allowing an interventional cardiac catheterization
program to be operative. The development of a cardiac
surgery program should reflect the need based on a high
volume of cardiac catheterization procedures.
C. Cardiac Catheterization and Diagnostic Procedures
in the Freestanding Laboratory
A freestanding laboratory is not physically attached
to a hospital. By definition, it is a laboratory in
which quick transportation of a patient to a hospital
by gurney is not possible. Although some hospitals build
such laboratories adjacent to their primary facility,
many are privately owned, and the physicians who use
the facility may also own it. In the 2001 Directory
of Cardiac Catheterization Laboratories assembled by
the Society for Cardiac Angiography and Interventions,
58 such laboratories submitted data (1),
but this number is clearly increasing. It is the responsibility
of each freestanding laboratory to have a formal relationship
with at least 1 tertiary referral hospital so that a
written established plan for the emergency transfer
of patients is in place. Furthermore, freestanding facilities
must have the necessary equipment for intubation and
ventilatory support. Physicians using these facilities
must be capable of performing endotracheal intubation
and inserting an intra-aortic balloon pump. Appropriate
QA and ongoing QI programs must be established in writing
and documented. Oversight has traditionally been provided
by a tertiary referral hospital, but alternatives that
comply with the maintenance of the highest concern for
patient care may be used if acceptable by local standards
and if a well-defined QA program is operative.
1. Patients Eligible for Cardiac Catheterization
in a Freestanding Laboratory
Patients undergoing cardiac catheterization procedures
in a freestanding facility require the highest level
of screening to avoid situations that might require
urgent cardiac surgery or result in a complication for
which time spent transferring the patient to a hospital
could be detrimental. All of the exclusions that apply
to cardiac catheterization laboratories at hospitals
without full-support services also apply to freestanding
laboratories. Other patients who should not be studied
in a freestanding facility include those with cardiac
or comorbid conditions of such severity that the patient's
condition could potentially become unstable during or
after the procedure (Table 2).
2. The Mobile Cardiac Catheterization Laboratory
The mobile cardiac catheterization laboratory may
be located at a hospital with cardiac surgical backup,
at a hospital without cardiac surgery capability, or
even in a freestanding environment. These laboratories
are subject to the same concerns and quality controls
as those of any laboratory in the respective setting.
Mobile laboratories are occasionally used as temporary
facilities before completion of a fixed (permanent)
laboratory. To be eligible for study in the mobile laboratory,
patients must meet the same criteria as those for more
traditional environments.
D. Candidates for Same-Day or Ambulatory Cardiac
Catheterization
Improvements in the safety and ease of performing invasive
cardiac procedures plus the constant pressure to minimize
costs have made it quite uncommon to hospitalize patients
for only an invasive cardiac procedure. Indeed, for
the vast majority of adult patients, a diagnostic procedure
can be safely completed in an ambulatory setting. Patients
should be hospitalized if their clinical condition warrants
it, after which an invasive cardiac procedure may then
become part of their overall management. In some isolated
situations, preprocedure hospitalization is still appropriate.
For example, patients who require continuous anticoagulation
therapy may require hospitalization to switch safely
from warfarin to heparin anticoagulation. Patients with
renal insufficiency benefit from preprocedural hydration
or drugs to help reduce contrast nephropathy. Patients
with brittle diabetes who also require steroids to reduce
the risk of contrast-allergic reactions may require
prehospitalization. Preprocedural admission may also
be appropriate for other situations, and the decision
of the individual practitioner should be respected when
it is in the best interest of the patient.
Noninvasive testing can often identify patients with
high-risk coronary or valvular disease before catheterization
and is helpful for identifying patients who should not
be studied in settings without cardiac surgery capability.
However, diagnostic studies of high-risk patients may
still be initiated in the outpatient setting before
referral to the appropriate settings. If, as suspected
from noninvasive testing, the catheterization study
confirms a high-risk anatomic situation, admission to
the hospital may become necessary after the procedure.
Because of the overall safety of diagnostic procedures,
patients are often discharged within 2 to 6 h of completion
of the study. This applies not only to outpatients,
but also to inpatients for whom a disposition is made
rapidly after completion of the procedure. A general
scheme for the disposition of patients after diagnostic
catheterization is shown in Figure
1. Rarely, a patient will develop a procedure-related
complication that requires hospitalization. More patients
will require admission because of the findings from
the procedure. A patient who develops a large hematoma
may require a more prolonged period of bed rest and
observation to ensure that the puncture site has stabilized.
Patients who are found to have important left main disease
should be considered for admission pending early surgical
therapy or at least until it is clear that the diagnostic
procedure has not caused clinical instability. Finally,
some patients may require observation overnight simply
because they do not have a supervised home setting.
Table 3 lists possible situations
for which early (<2 to 6 h) discharge after diagnostic
catheterization may be unwise. These are not meant as
absolute exclusion criteria prohibiting early discharge,
but the practitioner should consider hospitalization
when treating such patients. Based on the judgment of
the physician, it would be appropriate to observe patients
with 1 or more of these clinical risks for a longer
period of time.
Because of the improving safety of coronary interventions
and newer access techniques, such as the radial approach
as well as the availability of vascular closure devices,
outpatient coronary intervention may become a reality.
This concept is currently being investigated. At this
time it is not approved by the Committee.
Because of the simplicity and safety of diagnostic
catheterization, the vast majority of patients can be
discharged home within 2 to 6 h. This applies to inpatients
as well as outpatients. For example, a patient may be
admitted for evaluation of a prolonged episode of chest
pain, but subsequent testing shows no evidence of MI.
In some patients, it may be appropriate to consider
coronary angiography as the first diagnostic test. If
coronary angiography shows no evidence of coronary disease,
the patient may be discharged 2 to 6 h after the procedure
to complete evaluation as an outpatient. Patients undergoing
radial artery cardiac catheterization may be discharged
as early as 90 min after the procedure.
There are 3 basic steps in determining the appropriateness
of early discharge for patients. First, a patient may
require a prolonged stay if an important complication
has occurred. Second, the procedure may reveal new findings
for which hospitalization is indicated. Finally, appropriate
care of the patient for noncardiac issues may be necessary
for safety.
