Recommendations

ACC - www.acc.org
AHA - www.americanheart.org
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Smith et al. 2005
ACC/AHA/SCAI Practice Guidelines
35
performed with a zero adverse event rate. It demonstrates
that if 10 consecutive cases are performed without a complication,
the upper bound of the 95% CI is 25%. If 50 cases
are performed without an adverse event, the upper bound is
5.8%.
Thus, although it is likely that certain low-volume operators
and institutions perform procedures with acceptable
quality, satisfactory quality is difficult to prove unless a sufficient
number of procedures are compiled for analysis. The
quality-assessment process must take the above issues into
consideration. This means that it is essential that institution
and operator outcomes be tracked over sufficiently long
periods of time to assemble a sufficient number of procedures
to permit a satisfactory analysis.
In addition, mere tabulation of adverse event rates, even
with appropriate risk adjustment, is inadequate to judge
operator or program quality. Such tabulations do not address
numerous other quality issues, in particular, appropriateness.
Thus, the quality-assessment process should also conduct
detailed reviews both of cases that have adverse outcomes
(to determine the cause(s) of the adverse event) and of
uncomplicated cases (to judge case selection appropriateness
and procedure execution quality). These reviews should
be conducted by recognized experienced interventionalists
drawn either from within the institution or externally if a
requisite number of appropriately qualified, unconflicted
individuals are not available.
Role of Low-Volume PCI Programs
There is an ongoing debate as to whether PCI services
should be diffused widely to be available in most healthcare
institutions or whether the service should be regionalized
and concentrated in specialized high-volume centers. Given
the widespread availability of sophisticated interventional/
surgical programs in the United States, it is difficult to
demonstrate a need for additional low-volume programs to
perform elective angioplasty except in underserved areas
that are geographically distant from major centers. At this
writing, outcome data that link activity level to outcomes
indicate that the development of small cardiovascular surgical
programs to support angioplasty is a poor use of
resources that will likely lead to suboptimal results (320). In
general, the proliferation of small angioplasty or small surgical
programs to support such angioplasty programs is not
needed to improve patient access to PCI services and would
appear not to be in the interest of fostering optimal quality;
thus, it should be discouraged. An exception to this principle
should be when geographic considerations become important
determinants of patient access.
These data support the conclusion that not every cardiologist
desiring to perform PCI should perform these procedures,
and not every hospital that would like to have an
interventional program should start one (322). This caveat is
particularly true where high-volume programs and operators
are already nearby.
The Writing Committee, therefore, recommends that elective
PCI be performed by higher-volume operators (75 cases
per year) with advanced technical skills (e.g., subspecialty
certification) at institutions with fully equipped interventional
laboratories and an experienced support staff. This
setting is optimally a high-volume center (more than 400
cases per year) with an onsite cardiovascular surgical program
(332).
It is recommended that primary PCI for STEMI be performed
by higher-volume operators experienced in both
elective PCI and primary PCI for STEMI with ongoing
activity levels of more than 75 elective PCI procedures per
year and, ideally, annual PCI for STEMI activity levels of at
least 11 per year. It is clear that an effective PCI for STEMI
program, irrespective of whether cardiac surgery is available
onsite, requires appropriate physician operator expertise,
appropriate institutional commitment, and the achievement
of the requisite utilization levels. The nursing and technical
catheterization laboratory staff must be experienced in handling
acutely ill patients, must be skilled in all aspects of
interventional equipment, and must participate in a 24-
hours-per-day, 365-days-per-year call schedule. Ideally,
these procedures should be performed in institutions that
perform more than 400 elective PCIs per year and more than
36 primary PCIs for STEMI per year and that achieve riskadjusted
outcomes that are comparable to national benchmark
standards.
The Writing Committee cannot recommend angioplasty by
low-volume operators (fewer than 75 cases per year) working
in low-volume institutions (200 to 400 cases per year)
with or without onsite surgical coverage. As noted earlier,
ongoing investigational experience and clinical data are
mandatory if these recommendations are to be modified.
Any change in this recommendation awaits further data
assessing the safety and outcomes for patients treated in various
settings.
4.3. Role of Onsite Cardiac Surgical Back-Up
Class I
1. Elective PCI should be performed by operators with
acceptable annual volume (at least 75 procedures per
year) at high-volume centers (more than 400 procedures
annually) that provide immediately available
onsite emergency cardiac surgical services. (Level of
Evidence: B)
2. Primary PCI for patients with STEMI should be performed
in facilities with onsite cardiac surgery. (Level
of Evidence: B)
Class III
Elective PCI should not be performed at institutions
that do not provide onsite cardiac surgery. (Level of
Evidence: C)*
*Several centers have reported satisfactory results based on careful
case selection with well-defined arrangements for immediate trans-