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Clasificación Aha:acc Lesiones Coronarias
Clasificación Aha:acc Lesiones Coronarias
Special Report
cal therapy, surgical revascularization signifi- tarily collect data on an additional 2,500 patients.
cantly reduces symptoms and improves the These recent additions to the Registry indicate
quality of life.3 At the same time there has been that the immediate success rate (defined as
an expansion of the subsets of patients in whom >20% change in luminal diameter narrowing
it is recognized that bypass surgery improves without the occurrence of death, myocardial
survival. This improvement in survival has been infarction or bypass operation during hospital-
established for patients with left main coronary ization) increased to 78% compared with 61% in
artery disease (>50% stenosis)4 and certain the initial patient cohort. 13 Despite a recognized
patients with three vessel coronary disease.5-7 change in the case mix to more complex cases,
Additional information from the Coronary Artery the rate of nonfatal myocardial infarction
Surgery Study Registry would also suggest that decreased from 4.9 to 4.3% and emergency
coronary bypass surgery improves survival in coronary artery bypass graft surgery from 5.8 to
3.4%; the mortality rate remained unchanged
patients with three vessel disease and normal (1.2 versus 1.0%). Whereas only 25% of patients
ventricular function if either severe symptoms in the initial Registry had multivessel disease,
exist or an exercise test is positive for ischemia 53% were so categorized in the most recent
or chest pain.8.9 Registry. This subgroup of patients in the new
B. Immediate and Long-Term Results Registry (that is, patients with multivessel cor-
Coronary angioplasty was first introduced by onary artery disease) had an overall success rate
Andreas Gruentzig in September 197710 as an of 73%. However, when the data are analyzed
alternative form of revascularization; it thus for completeness of revascularization, defined
constitutes a relatively new form of therapy. in the conventional manner as no residual lesions
During the early years of its application, Gruent- of >50% narrowing, only one-third of the patients
zig and others used coronary angioplasty pre- qualified.'4 Such data must be viewed in the
dominantly to treat patients with discrete, prox- context that balloon angioplasty is not currently
imal, noncalcified subtotal occlusive lesions in a undertaken when lesions have 50 to 60% luminal
single coronary artery. In subsequent years the diameter narrowing or when chronic total occlu-
technique has been applied successfully to sions are present.
patients with multivessel disease, multiple sub- The long-term benefit of angioplasty has been
total stenoses in the same vessel, accessible examined in the first PTCA Registry group for
complete occlusions of recent vintage, partial which >5 years of follow-up are available.'5
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occlusion of saphenous vein or internal mam- After hospital discharge the annual mortality
mary artery grafts, and recent total thrombotic rate is low, approximately 1% per year, and the
occlusions in acute myocardial infarction, as rate of nonfatal myocardial infarction is also low
well as to isolated high risk patients with con- at 2% per year. Symptomatic improvement in
gestive heart failure and cardiogenic shock. the successful cases was high with 70% of the
By 1980, Gruentzig had performed the pro- patients pain-free at 4 years. Freedom from
cedure on 169 symptomatic patients, 40% of major cardiac events (death, myocardial infarc-
whom had multivessel disease. The follow-up tion, need for bypass surgery) over a 5 year
of these patients now extends to as long as 10 period of follow-up of a large series from one
years and documents persistent long-term ben- major center was reported to be 79%. 16 These
efit with only 5 cardiac deaths; 90 patients data, although they do not address the problem
remain asymptomatic. However, repeat angio- of restenosis and are derived from a population
plasty was required in 27 patients and coronary in which 75% of the patients had single vessel
bypass surgery in 19." disease, do indicate that long-term clinical ben-
NHLBI Registry. Because of the promising efit without increased risk of death or myocar-
early clinical experience, the National Heart, dial infarction can be expected after angio-
Lung, and Blood Institute (NHLBI) established plasty. Follow-up information on patients
a Percutaneous Transluminal Coronary Angio- exclusively with multivessel disease is less com-
plasty (PTCA) Registry in 1979 to help evaluate plete. Cowley et al'7 reported initial success in
the technique. Through 1982, a total of 3,079 92% of patients with multivessel coronary artery
patients were entered into the voluntary Regis- disease, with 48% of the patients asymptomatic
try and numerous analyses from this data bank and 82% symptomatically improved at a mean
have substantiated the effectiveness and safety follow-up time of 24 months. A follow-up study
of angioplasty.'2 As with any new procedure, of 605 patients undergoing angioplasty for mul-
technical advances have resulted in improved tivessel disease at Emory University demon-
success and wider applicability of the proce- strated a 3 year freedom from cardiac event rate
dure. Prompted by these changes, the National of 83%. 18 Preliminary findings in the National
Heart, Lung, and Blood Institute reopened the Heart, Lung, and Blood Institute Registry indi-
Registry in 1985 to evaluate more recent trends cate a freedom from death, myocardial infarc-
in angioplasty. Sixteen centers agreed to volun- tion, or surgery after 1 year of follow-up in 75%
ACCIAHA Task Force Guidelines for PTCA 489
of 402 patients with multivessel disease.'9 In angiographic studies suggest that the rate of
these studies restenosis with subsequent hospi- restenosis is as frequent as 30 to 35%28,29 and
talization for redilation was not considered a may be as high as 45% for lesions at the origin of
cardiac event but viewed as an integral part of the left anterior descending artery. Preliminary
the strategy of angioplasty. studies in patients with multivessel disease sug-
Comparison with bypass surgery. Whereas gest that restenosis may also be more frequent as
angioplasty now is applied successfully to more lesions are dilated.30 Experience indicates
patients with multivessel coronary artery that restenosis can be managed very successfully
disease,'32.2 it must be viewed in comparison by repeat angioplasty3'; however, the procedure
with coronary bypass surgery. The operative exposes the patient to additional morbidity, mor-
mortality rate for patients undergoing elective tality, and cost. Nevertheless, angioplasty is ini-
bypass surgery has steadily fallen and now tially less expensive and inherently less invasive
approximates 2% in most centers.2' Although it than is bypass surgery and is a more attractive
is recognized that >50% of bypass grafts will
occlude after 10 years,22 internal mammary artery alternative to many patients because a rapid
bypass grafts may provide a superior conduit return to normal functional status is possible.
with improved long-term patency. Indeed, recent C. Contraindications to Angioplasty
studies23 suggest that a patency rate of >90% at In general, the contraindications to angio-
10 years can be achieved. The long-term clinical plasty include all of the relative contraindica-
benefit of bypass surgery is well defined, with a tions enumerated for the performance of coro-
survival rate of 82% at 8 years for double vessel nary angiography as outlined in the guidelines of
disease and 79% for triple vessel disease as an earlier ACC/AHA report.2 Before undertak-
reported from the Coronary Artery Surgery ing angioplasty it is imperative that the patient
Study.24 Symptomatic improvement can be clearly understand the procedure, its potential
expected in 70% and asymptomatic status in complications, and the alternatives of medical
50% after 5 years. For patients who have therapy or bypass surgery. Additionally, the
received an internal mammary artery graft to importance of a relative contraindication to angio-
the left anterior descending coronary artery, plasty will vary with the symptomatic state as
with or without associated vein grafts, there is well as the general medical condition of the
evidence of both improved survival and a reduc- individual patient. Certain risks may be appro-
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tion in major cardiac events after 10 years of priate in severely symptomatic individuals who,
follow-up compared with findings in patients for example, are not candidates for bypass sur-
who received vein grafts only.23 gery, whereas these risks would be inadvisable
Inherent differences exist between angioplasty for an asymptomatic or mildly symptomatic
and bypass surgery. When successful, the for- individual. With this caveat the following are
mer is less traumatic, less costly, and requires a enumerated as generally accepted contraindica-
shorter hospital stay than the latter. However, tions to the performance of angioplasty:
bypass surgery is applicable to a wider group of 1. Absolute contraindications:
patients because dilation of longstanding total a) There is no significant obstructing lesion.
occlusions and diffuse disease is often not pos- b) Multivessel disease with severe diffuse
sible with angioplasty. Angioplasty, in certain atherosclerosis is present for which an
instances, leaves patients with incomplete rev- alternative form of revascularization would
ascularization, which understandably is a more be unequivocally more efficacious.
common phenomenon with increasing severity c) There is a significant obstruction (>50%)
of disease. 14,25 There are those26 who advocate a in the left main coronary artery and this
strategy of "intentional" incomplete revascula- main segment is not protected by at least
rization in some patients with multivessel dis- one completely patent bypass graft to the
ease, and they report follow-up data suggesting left anterior descending or left circumflex
that these patients are no more symptomatic artery.
than are individuals who have complete reva- d) There is no formal cardiac surgical pro-
scularization. Other reports2527 on the long- gram within the institution.
term follow-up of patients with multivessel dis- 2. Relative contraindications:
ease indicate that those who have incomplete a) A coagulopathy is present: Conditions
revascularization after angioplasty are more associated with bleeding abnormalities or
symptomatic than are those who have complete hypercoaguable states may be associated,
revascularization. respectively, with unacceptable risks of
Restenosis. Angioplasty outcome is also com- serious bleeding or thrombotic occlusion
plicated by restenosis, the phenomenon of renar- of a recently dilated vessel.
rowing of the dilated arterial segment within 8 b) There is no clinical evidence for sponta-
months of the procedure. Symptomatic resten- neous or inducible myocardial ischemia.
osis occurs in 20 to 25% of patients, whereas c) In multivessel angioplasty, the patient's
490 Special Report Circulation Vol 78, No 2, August 1988
condition is such that coronary occlusion trauma to the coronary artery wall; the net result
resulting from any one dilation could result is usually atheroma fracture and arterial expan-
in cardiogenic shock. This group of sion that produce an increase in the luminal area
patients is characterized, for example, by available for blood transport. At times, balloon
patients who have large areas of myocar- inflation or guide wire or catheter manipulation
dial dysfunction as a result of previous can cause more extensive arterial wall damage
myocardial infarction and who have arter- with medial dissection and the creation of an
ies with high grade lesions whose acute occlusive intimal flap. Thrombus formation also
occlusion would result in cumulative dam- may occur at the dilation site. Either of these two
age equal to approximately 40 to 50% of latter consequences can exacerbate coronary nar-
the total myocardium. rowing and result in progression to abrupt total
d) The anticipated success rate of dilation is coronary artery occlusion. In the absence of a
low (for example, chronic total occlusions well developed collateral circulation, acute cor-
>3 months old or subtotal lesions exceed- onary occlusion usually results in severe myocar-
ing 20 mm in length). dial ischemia and myocardial infarction that, if
e) The lesion under consideration is a border- extensive or in the setting of preexisting impaired
line stenotic lesion (usually <60% sten- left ventricular systolic function, may cause hemo-
osis). Such lesions should not be dilated dynamic collapse and death. The most recent data
because of the demonstrated risk of a reste- in the National Heart, Lung, and Blood Institute
notic lesion at the same site of even greater Registry (derived from very experienced centers)
severity. In some instances, objective evi- indicate that the procedure is still associated with
dence of myocardial ischemia related to a 1% in-hospital mortality rate and an incidence
the lesion can change the designation from rate of nonfatal myocardial infarction of approxi-
a "borderline" to a "significant" lesion mately 4%, although the need for emergency
that would be appropriate for dilation. bypass surgery has decreased to about 3.5%. 13 In
f) Variant or vasospastic angina is present in a recent study,32- investigators reported a death
patients with <60% stenoses. rate of 0.2% for patients undergoing elective angio-
g) The lesion under consideration is in a plasty at two experienced centers.
noninfarct-related artery in patients with If coronary occlusion should occcur, recross-
multivessel disease who are undergoing ing the occluded segment and repeating balloon
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cardiac catheterization during the acute inflation, inserting a perfusion catheter or using
phase of myocardial infarction. thrombolytic or vasodilator agents can, on occa-
In addition to these generally accepted rela- sion, reestablish coronary artery patency and
tive contraindications, there are other condi- relieve ischemia. Prolonged maneuvers to this
tions in which clinicians have considerable res- end are discouraged because emergency surgi-
ervation about the risk/benefit ratio of cal revascularization may be delayed. The use
angioplasty. Over and above a fundamental risk of intraaortic balloon counterpulsation in the
of mortality and morbidity there is the added setting of acute coronary occlusion may reduce
dimension of risk of failure of the procedure as the magnitude of ischemia and augment sys-
a result of early closure as well as a substantial temic perfusion. When needed, surgical reva-
risk of restenosis. These risks are viewed as a scularization should be undertaken immediately
continuum and it is their aggregate weight that because of known time limitations on preserving
should ultimately determine whether a specific ischemic myocardium. The probability of myo-
procedure should or should not be undertaken cardial infarction is high and mortality is
(see section IIIF). increased when coronary artery surgery is under-
D. Risks Associated With Angioplasty taken on an emergency basis; reports33-35 indi-
Because coronary angioplasty requires visual- cate a 25 to 40% incidence rate of nonfatal new
ization of the coronary anatomy as well as sys- Q wave infarctions among patients undergoing
temic arterial and venous access, patients under- emergency surgery after failed angioplasty.
going the procedure are at risk for the same Other infrequent complications unique to cor-
potential complications that are known to be asso- onary angioplasty include intracoronary embo-
ciated with diagnostic cardiac catheterization. lization of atherosclerotic or thrombotic mate-
Included are arterial or venous obstructions, ves- rial, coronary perforation, laceration, or rupture
sel perforations, bleeding, hypersensitivity reac- of a coronary artery with subsequent hemoperi-
tions, and infection. Myocardial infarction, stroke, cardium and tamponade.
and death can also occur as a result of cardiac E. Need for Surgical Backup
catheterization but are infrequent. An experienced cardiovascular surgical team
Specific complications can occur that are should be available within the institution* for
directly related to the coronary angioplasty pro- emergency surgery for all angioplasty proce-
cedure. Balloon inflation results in localized dures. The Subcommittee feels strongly that
ACCIAHA Task Force Guidelines for PTCA 491
there should be no exception to this requirement interprets the diagnostic studies leading to the
and holds the position that all arrangements procedure itself. In this latter circumstance it is
requiring the transportation of patients to off- imperative that the responsible physician arrange
site surgical facilities for such emergency sur- for a consulting opinion from an appropriate
gery fail to meet the necessary standards of care specialist.
exercised by prudent physicians and cannot be Although institutional review can take many
condoned. forms and will vary according to such factors as
A formal surgical consultation for elective the size of institutions and departments, the
angioplasty provides a means for a second opin- number of staff, and the volume of procedures,
ion to the cardiologist, the patient, and the there are some basic requirements for such
family, and represents the ideal approach review to be meaningful. At a minimum, the
because it underscores the reality of potential, opportunity must exist for cardiologists and
serious complications and the need for a team cardiac surgeons knowledgeable about the pro-
approach. However, this is often impractical, cedure to review the overall results of the pro-
may introduce delay in the procedure, and gram on a regular basis. Specific attention should
lengthen the hospital stay. It is appropriate, be directed to success and failure rates and
however, to obtain prior surgical and anesthesi- complications leading to morbidity, including
ology consultations on all patients identified as emergency surgical procedures, and mortality.
being at high risk for abrupt vessel closure as The review should also examine the quality and
well as those patients judged to be high risk accuracy of cinearteriographic studies and the
surgical candidates because of age, markedly appropriateness of indications and it should
impaired ventricular function, or associated med- discuss contraindications.
ical disorders such as chronic pulmonary dis- The surgical profession has long since pro-
ease, cerebrovascular disease and the like. The vided a workable model for addressing these and
exact arrangement for surgical standby will vary similar issues with regularly scheduled mortality
from institution to institution depending on such and morbidity conferences that include appropri-
obvious factors as the number of operating ate committee (for example, tissue) reports and
rooms available for cardiac surgery and the impose attendance requirements that are designed
number of surgeons, perfusionists, nurses, and to assure impartial peer review. Institutions with
other personnel.35 The primary and essential medical or surgical groups, or both, that cannot
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requirement is the capacity to provide rapid adequately meet this obligation should undertake
surgical support when angioplasty fails; other- regional review with cooperating institutions or
wise, optimal patient care becomes seriously abandon their program in angioplasty.
compromised. III. Specific Considerations
On-going experience in large multicenter tri-
als underscores the need for urgent revasculari- A. Successful Angioplasty and Its Determinants
zation by emergency bypass surgery in the A successful angioplasty procedure is defined
setting of both elective and emergency angio- as one in which a .20% change in luminal
plasty. Thus it is reaffirmed that all angioplasty diameter is achieved, with the final diameter
procedures should be undertaken only in insti- stenosis <50% and without the occurrence of
tutions that have formally approved cardiac death, acute myocardial infarction, or the need
surgical programs. for emergency bypass operation. Atheroscle-
F. Need for Institutional Review rotic coronary stenoses are considered signifi-
A rigorous mechanism of valid peer review cant if they have the potential of impairing
must be established and on-going within each coronary blood flow under physiologic circum-
institution performing coronary angioplasty stances. Experimental data indicate that coro-
because 1) angioplasty is an interventional pro- nary flow reserve declines as coronary diameter
cedure associated with known risks of serious is reduced beyond 50%. It is acknowledged that
complications including death; 2) it is a thera- the visual assessment of coronary narrowing on
peutic modality whose efficacy has a recognized cineangiograms is associated with substantial
association with operator skill and experience; interobserver and intraobserver variability.
and 3) in certain instances, the procedure can be Determination of coronary narrowing by caliper
viewed as a remunerative undertaking per- techniques is a readily available methodology
formed by the same physician who initiates and that correlates closely with sophisticated com-
puter quantitative methods. For the purpose of
*"Within the institution" is generally intended to mean within this report, a significant stenosis is defined as
the same hospital. In those instances in which two adjacent one that results in a 50% reduction in coronary
hospitals are physically connected such that emergency trans- diameter as determined by caliper method.
port by stretcher or gurney can be achieved rapidly and effec- After a decade of experience it is now reason-
tively, the transport of patients between the two hospitals for
emergency cardiac surgical services would not be viewed as "off able to expect an overall success rate of .85%
site." for single lesion dilations within any angioplasty
492 Special Report Circulation Vol 78, No 2, August 1988
reasonable to prepare the patient for this possi- ate. Accordingly, the equipment and services
bility before diagnostic cardiac catheterization required to perform repeat angiography and, if
by obtaining informed consent and a complete necessary, repeat angioplasty, need to be avail-
preangioplasty evaluation. Similarly, individu- able 24 hours a day in institutions that under-
als who have had prior angioplasty and are take a program in angioplasty.
undergoing catheterization to evaluate the pos- Patients should be instructed about risk fac-
sibility of restenosis represent a group of patients tor modification before hospital discharge.
whose coronary anatomy is generally known in Depending on the individual case, this advice
advance and whose clinical management is facil- would include hypertension control, diabetes
itated by performing angioplasty immediately management, serum lipid reduction, absti-
after the diagnostic study when indicated. In nence from tobacco, weight control, and tim-
selected patients with acute myocardial infarc- ing of the return to full activity. Patients should
tion in whom adequate reperfusion is not be informed of the importance of contacting
obtained by thrombolytic therapy, angioplasty their physicians if symptoms recur.
may be of benefit. In such patients, when mul- D. Restenosis
tivessel disease is present, only the vessel related Although the initial outcome for coronary
to the area of infarction should be dilated. If angioplasty procedures has improved progres-
angioplasty is to be considered in lieu of throm- sively over the last 10 years (reaching primary
bolytic therapy, it is recommended that the success rates in native coronary arteries as high
procedure be applied to patients who present as 90 to 95% in well chosen patients), the
within 4 hours of the onset of symptoms unless incidence of restenosis over the first 6 to 8
there is strong evidence for ongoing ischemia. months after dilation has remained unchanged
Whatever the clinical circumstances, it is imper- at approximately 30%. The rate of restenosis in
ative that high quality fluoroscopic and video native arteries depends partly on its definition;
replay images or promptly developed cine films in the National Heart, Lung, and Blood Institute
be available before undertaking angioplasty at Registry, restenosis was defined as a loss of 50%
the time of initial diagnostic catheterization. of the gain achieved in luminal diameter at the
C. Postangioplasty Management time of the successful angioplasty, or a 30%
Immediately after coronary angioplasty, atten- increase in narrowing at the site of stenosis.28
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tion is directed to monitoring for evidence of Follow-up of 557 patients undergoing repeat
recurrent ischemia and to assure appropriate coronary angiography indicated that restenosis
hemostasis at the site of catheter insertion. was associated with the recurrence of symp-
Specific protocols for sheath removal, continu- toms in the majority of patients; likewise, rela-
ation of anticoagulation, and antiplatelet ther- tively few patients with single vessel disease
apy will vary from institution to institution. harbor a clinically silent restenosis. The rate of
Ordinarily, heparin anticoagulation used during silent restenosis was 14% in the National Heart,
the procedure is not reversed with protamine for Lung, and Blood Institute Registry, and a 4%
fear of inducing thrombosis at sites of balloon rate was reported in a combined study from the
inflation. When angioplasty is performed percu- Cardiology Branch of the National Heart, Lung,
taneously, the indwelling vascular sheaths usu- and Blood Institute and Georgetown
ally can be removed within 3 to 4 hours after the University.28,37 On the basis of multivariate anal-
last bolus injection of heparin. In certain ysis, independent factors that predispose to
instances, such as the setting of extensive intimal restenosis include angioplasty in the left ante-
disruption, thrombus formation or emboliza- rior descending coronary artery, absence of
tion, a constant infusion of heparin may be intimal dissection immediately after angio-
desirable. Sheaths are then removed after the plasty, residual gradient after dilation >15 mm
termination of the heparin infusion or after Hg, a large residual stenosis after angioplasty,
temporary cessation of therapy. and unstable angina.29 Univariate analysis has
A small proportion of patients in whom angio- pointed to several other risk factors for resten-
plasty was judged angiographically successful osis, including male gender, diabetes mellitus,
will experience symptoms of myocardial isch- patients with chronic total occlusions, throm-
emia during this observation period after the bus, an initial transstenotic gradient >40 mm
procedure. If electrocardiographic (ECG) abnor- Hg, and recent, as opposed to long-standing,
malities suggesting ischemia are detected, there occurrence of angina. In addition, several cen-
is a substantial risk of abrupt vessel closure, ters have reported38 that lesions that involve the
which has been associated with a comparatively origin of a vessel or its branch points are more
high mortality rate (10 to 12%).36 An individual- prone to restenosis. Factors that have not been
ized judgment must be made as to whether correlated with risk of restenosis include age,
additional angioplasty, emergency bypass sur- functional class, history of previous myocardial
gery or continued medical therapy is appropri- infarction, hypertension, history of smoking,
494 Special Report Circulation Vol 78, No 2, August 1988
serum cholesterol, presence of calcification at less common phenomenon than restenosis after
the site of dilation, morphologic features, of the arterial dilation.
lesion, lesion length, inflation pressure, and At present, partial revascularization after cor-
medications on discharge. onary angioplasty is an inherent limitation of the
Patients who develop clinical or angiographic procedure and can be expected to occur fre-
evidence, or both, of restenosis in native coro- quently in patients undergoing multivessel angio-
nary arteries are readily treated with a second plasty. Notwithstanding, the advocates of angio-
dilation procedure. For repeat angioplasty, the plasty in patients with multivessel disease point
primary success rate is higher than for the initial to the successful relief of symptoms and the
procedure (85 versus 63% in the National Heart, elimination of objective signs of ischemia after
Lung, and Blood Institute Registry), a relatively stress tests in a high percentage of such patients
low myocardial infarction rate of 1.5%, and a in whom all lesions cannot be successfully
reduced incidence of complete occlusion with dilated. Moreover, the claim is made that angio-
need for emergent coronary artery bypass graft plasty palliates the disease process and often
surgery (2 versus 3.5%). allows a period of clinical temporizing before
A significantly higher restenosis rate of 50% is surgical revascularization is required. Angio-
noted when coronary angioplasty is performed plasty also allows for a strategy of performing
in the proximal anastomosis or body of a saphe- the dilation procedure on successive days or
nous vein bypass graft. By contrast, dilations weeks. Multiple successive interventions are
performed in the distal graft/artery anastomotic feasible and, although there is some degree of
site exhibit restenosis rates comparable with cumulative risk, angioplasty differs in this regard
those of native vessel sites. from aortocoronary bypass graft surgery, in
E. Incomplete Revascularization which the opportunity for serial repeat thoraco-
As coronary angioplasty is being utilized in tomies is understandably more limited.
ever more complex clinical and pathoanatomic There has not been sufficient accumulation of
situations, concern is now expressed that patients clinical experience, either retrospectively or pro-
are being subjected to "incomplete revasculari- spectively, to judge the relative advantage of
zation" or less than optimal correction of their angioplasty versus aortocoronary bypass graft
pathophysiologic state. In patients with multi- surgery for relief of signs and symptoms of
vessel disease, some operators attempt to dilate myocardial ischemia and infarction in multives-
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all accessible, significant lesions whereas others sel disease. The adequacy of myocardial revas-
approach only the lesion deemed most likely to cularization by angioplasty, particularly in com-
cause myocardial ischemia (the so-called culprit parison with that provided by surgery, will
lesion). The surgical experience is relatively require randomized prospective studies in which
convincing that "complete revascularization," coronary pathoanatomic subsets are closely
that is, graft insertion around all moderate to matched. The National Heart, Lung, and Blood
severe coronary stenoses, leads to a superior Institute has funded two such studies to date:
therapeutic result. Follow-up studies39 of patients one at Emory University that began in July
with surgical revascularization suggest that com- 1987, and the multicenter BARI Trial (Bypass
plete revascularization not only relieves signs Angioplasty Revascularization Investigation) that
and symptoms of myocardial ischemia, but also began in the fall of 1987. Also of importance will
it is more effective than incomplete revasculari- be the long-term follow-up of large numbers of
zation in protecting the patient against future patients treated by these two competing inter-
coronary events. ventions with matched cohorts compared by
During surgery, partial or incomplete revascu- multivariate analysis.
larization usually results from the extent or dis- F. Cumulative Consequences of Failed
tribution of a patient's coronary artery disease Angioplasty
and less often is a reflection of the skills and Inherent to the strategy of coronary angio-
diligence of the surgical team. In patients under- plasty is the "price of failure." This is more
going angioplasty, partial revascularization is than the risk of a serious complication and
likely to occur for several reasons in addition to embraces the consideration that 5 to 15% of
the extent and distribution of coronary disease these procedures will be initially unsuccessful
and the extent of myocardial fibrosis. Quite clearly and that 3 to 6% of patients will require urgent
it also relates to the specific anatomy that deter- or emergent surgery to bypass a coronary artery
mines the accessibility of lesions for angioplasty. occluded during the procedure. Furthermore,
The occurence of restenosis in one or more of the approximately 30% of the patients who have an
dilated lesions also may result in the develop- initially successful procedure will develop resten-
ment of partial revascularization. Although early osis of the dilated segment within 8 months and
graft closure after bypass surgery also converts will require a second angioplasty or bypass
complete to partial revascularization this is a surgery. Thus, there are a number of patients in
ACCIAHA Task Force Guidelines for PTCA 495
whom the risk relative to the cost and morbidity gender, single vessel disease, single lesion, angio-
associated with angioplasty as a primary ther- plasty, subtotal occlusions, absence of calcification,
apy may be considerably higher than that of accessibility of the lesion, and normal ventricular
some patients who are treated from the outset function. Counterbalancing these variables that sup-
with revascularization surgery. port the likelihood of successful angioplasty are the
These consequences of early failure must be preprocedural factors that favor abrupt vessel closure
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considered in clinical decision making and in during or shortly after angioplasty. These are viewed
evaluating the relative merits of bypass surgery as being female gender, length of lesion, eccentric
versus coronary angioplasty in a given patient. lesions, bifurcation/side branch lesions, angulation of
Although there is little specific information on the segment being dilated, other stenoses in the same
the price of failure in patients with multivessel vessel, and the presence of thrombus.40
angioplasty, it is likely that it is higher than for The clinical variables that have been associated
single vessel angioplasty and indeed there will with increased procedural mortality are currently
be categories of patients in whom multivessel identified as age >65 years, female gender, a history
angioplasty is not prudent. of hypertension, diabetes, prior myocardial infarc-
tion, prior bypass surgery, multivessel disease, left
IV. Indications for Angioplasty main coronary disease, a large area of myocardium
Preamble at risk, impairment of left ventricular function, and
The approach to every angioplasty procedure collateral vessels that supply significant areas of
requires a knowledgeable judgment that weighs the myocardium and originate distal to the segment to be
likelihood of a successful procedure* against the dilated.32
likelihood of failure and the risk of complications The factors associated with restenosis are cur-
(abrupt vessel closure, morbidity, mortality, and rently recognized as recent onset of angina (<3
restenosis). In attempting to prioritize indications months), unstable angina, variant angina, diabetes
for angioplasty, the Subcommittee was greatly influ- mellitus, multivessel disease, right ostial lesions,
enced by the specific considerations discussed in lesions located at the origin of the left anterior
section Ill: 1) factors favoring a successful dilation; descending coronary artery, lesions in the proximal
2) factors associated with abrupt vessel closure; 3) anastomoses or body of a vein graft, chronic total
restenosis; 4) incomplete revascularization; and 5) occlusions, presence of thrombus, severity of resid-
the consequences of failure of the procedure. ual lesion (>30%), and a significant residual gradi-
Experience to date suggests that the factors favor- ent (>15 to 20 mm Hg).28,29
ing a successful procedure are age <65 years, male Both clinical judgment and statistical estimates
permit appropriate weighting and integration of
these variables to formulate likelihood estimates
*A successful procedure is defined as one in which a -20% (high, moderate, or low) for any given procedure
change in luminal diameter is achieved with the final diameter
stenosis <50%, without the occurrence of death, acute myocar- according to
dial infarction, or bypass operation during hospitalization. 1. the likelihood of a successful dilation,
496 Special Report Circulation Vol 78, No 2, August 1988
2. the likelihood of abrupt vessel closure with testing, i.e., ischemia induced by low level
subsequent morbidity and mortality, and exercise and manifested by
3. the likelihood of restenosis. a) .1 mm of ischemic ST segment depression
Although operator experience and individual in multiple leads, or
patient characteristics are important factors relating b) reversible thallium perfusion defects in more
to outcome, both procedural success and the devel- than one vascular region, or
opment of abrupt vessel closure are largely deter- c) exercise-induced reduction in the ejection
mined by specific characteristics of the vessels and fraction or wall motion abnormalities on
lesions involved. Recognizing the unique technical radionuclide ventriculographic studies, or
aspects of angioplasty and with the objective of both, or
fostering knowledgeable judgments about risk strat- 2. have been resuscitated from cardiac arrest or
ification, the Subcommittee has summarized three from sustained ventricular tachycardia in the
types of lesion-specific characteristics based on the absence of acute myocardial infarction, or
current state of knowledge in Table 1 (see also 3. must undergo high risk noncardiac surgery,
section Ill-A). such as repair of an aortic aneurysm, iliofem-
Type A lesions have those characteristics that oral bypass, or carotid artery surgery, if angina
allow an anticipated success rate of .85% and have is present or there is objective evidence of
a low risk of abrupt vessel closure. ischemia, or
Type B lesions have those characteristics that 4. have a history of myocardial infarction together
result in a lower than optimal success rate ranging with a history of hypertension and ischemic
from 60 to 85% or have a moderate risk of abrupt ST segment depression on the baseline ECG.
vessel closure, or both. All of these patients should
Type C lesions have those characteristics that * have one or more type A lesions in the same
result in an unacceptably low success rate (<60%) vessel or its branches and
or have a high risk of abrupt closure, or both. * be in the low risk group for morbidity (abrupt
It is recognized that we are dealing with a disci- vessel closure <4%) and mortality (<0.5%).
pline of cardiovascular care that is undergoing con-
siderable growth and development; as new insights Class II (mild or no symptoms, single vessel coronary
are gained, we can anticipate further refinement of
disease)
the guidelines for coronary angioplasty that are set This category applies to patients who have a
forth in this document using the following significant lesion in a major epicardial artery that
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patient and physician agree that angina signif- lesion proposed for dilation. Although significant
icantly interferes with the patient's occupation symptoms may justify a lower tolerance for the risk
or ability to perform his or her usual activities, of abrupt vessel closure or subsequent restenosis,
or one cannot compromise on the risk for significant
3. are intolerant of medical therapy because of mortality or morbidity.
uncontrollable side effects.
All of these patients should II. Multivessel Coronary Artery Disease
* have at least a moderate likelihood of success- A. Asymptomatic or Mildly Symptomatic (functional
ful dilation and class I) Patients With or Without Medical Therapy
* be in the low risk group for morbidity and Class I
mortality. This category applies to patients who have one
Class II (symptomatic, single vessel coronary disease) significant lesion in a major epicardial artery that
This category applies to patients who have a could result in nearly complete revascularization
significant lesion in a major epicardial artery that because the additional lesion(s) subtends a small
subtends at least a moderate-sized area of viable viable or nonviable area of myocardium. Addition-
myocardium and who ally, patients in this category must
1. show evidence of myocardial ischemia while 1. have a large area of viable myocardium at risk,
on medical therapy during laboratory testing and
(including ECG monitoring at rest) and 2. show evidence of severe myocardial ischemia
a) have one or more type B lesions in the while on medical therapy during laboratory
same vessel or its branches, or testing, or
b) are in the moderate risk group for morbid- 3. have been resuscitated from cardiac arrest or
ity (abrupt vessel closure <8%) and mor- from sustained ventricular tachycardia in the
tality (<1%), or absence of acute myocardial infarction, or
2. have disabling symptoms and a small area of 4. be undergoing high risk noncardiac surgery
viable myocardium at risk, and and demonstrate objective evidence of isch-
a) at least a moderate likelihood of successful emia, or
dilation, and 5. have a history of myocardial infarction together
b) are in the low risk group for morbidity and with a history of hypertension and ST segment
mortality, or depression on the baseline ECG.
498 Special Report Circulation Vol 78., No 2, Auguist 1988
while on medical therapy during laboratory impact of procedural delay required to undertake
testing performed before hospital discharge, angioplasty, the influence of thrombus on abrupt
or vessel closure and subsequent restenosis.
3. have recurrent ventricular tachycardia or ven- The use of angioplasty in conjunction with throm-
tricular fibrillation, or both, while on intensive bolytic therapy is of particular interest and is thought
antiarrythmic therapy. by many to hold great promise. A note of caution is
All of these patients should: warranted, however, in light of the findings of three
* have one or more type A lesions and separate large randomized trials43-45 that have
* be in the low risk group for morbidity and recently reported adverse effects when angioplasty
mortality. was performed immediately, rather than later, after
the administration of tissue plasminogen activator.
Class Il The optimal timing and long-term benefit of angio-
This category applies to the dilation of significant plasty in the management of patients with acute
lesions in patients who infarction are questions that must await further data.
1. are similar to patients in class I but who
a) have type B lesions, or Appendix A
b) undergo multivessel angioplasty, or Training and Credentialing
c) are in the moderate risk group for morbid- It is generally acknowledged that specialized skills
ity or mortality, or both, or are required for coronary interventional techniques.
2. are within the very early hours of an evolving Training in these procedures necessitates thorough
myocardial infarction, with or without throm- skills in diagnostic and therapeutic cardiology and
bolytic therapy, or particularly cardiac catheterization and angiogra-
3. are within 12 hours of the onset of cardiogenic phy. Whereas the majority of individuals currently
shock or, in those who have survived cardio- performing angioplasty learned the technique by
genic shock, in the period before discharge, or observing experts and attending "how-to" semi-
4. are asymptomatic and have a significant resid- nars, the complexity of the procedure and the
ual lesion in the infarct-related artery after recognized need for hands-on experience dictate
thrombolytic therapy, or that formal training programs in angioplasty become
5. show objective evidence of myocardial isch- the required means of learning. Entrance require-
emia during laboratory testing performed before ments to such programs should follow the comple-
discharge, or tion of a structured cardiology fellowship training
500 Special Report Circulation Vol 78, No 2, August 1988
program as outlined in the guidelines set forth in the would seem that existing national organizations
Bethesda Conference on Adult Cardiology Training have both the resources and the manpower to meet
(JAm Coll Cardiol 1986;7:1205-1206). this major obligation in a prompt and effective
There is a growing consensus within the cardiol- manner. The hospital industry must likewise alter
ogy community that, for the individual who plans to its current practices regarding this specific form of
perform coronary angioplasty, an additional year of high technology care. Success, failure, death, and
training beyond 3 years of fellowship training that morbidity mandate some form of regionalization
includes extensive experience with angiography is and centralization of resources. To accomplish this
required. A suggested minimum of 125 coronary mission in a responsible fashion, a deregulated
angioplasty procedures, including 75 performed as industry must, in short order, demonstrate that it
the primary operator, has been recommended as the can accomplish this stated mission by its own sense
experience required to develop the appropriate skill of community responsibility, or it should give way
and judgment. Equally important is the demonstra- to state and federal regulation.
tion of continued experience on the completion of a
formal training program. A minimal case load for a Appendix B
single physician is estimated to be about one case per Requisite Facilities for Coronary Angioplasty
week. Continued performance of angioplasty should
be dependent on the demonstration of success and The rate of growth for coronary angioplasty within
complication rates that meet expected standards. the United States over the past decade has clearly
Regular attendance at major angioplasty postgradu- had an impact on the need for well equipped, well
ate courses would provide continuing education in staffed cardiac catheterization laboratories.
newer angioplasty techniques and equipment. The minimal requirements for facilities in any
Alternate routes of training for established angiog- hospital where coronary angioplasty is to be per-
raphers should be developed. Individualized train- formed are
ing programs that provide an extensive, primary 1. A cardiac laboratory that is well equipped with
operator experience can equip such an angiog- a physiologic recording system, a high resolu-
rapher to perform angioplasty expertly. In this tion fluoroscopic and cineangiographic x-ray
setting, the quality and manner of the direct super- unit, full emergency resuscitation equipment
vision are of greater importance than the absolute including circulatory assist devices and a full
number of cases to be performed in this "tutorial" complement of drugs for treatment of myocar-
setting. In general, it is believed that such a training dial ischemia or infarction, or both;
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experience should include involvement in no less 2. A surgical operating suite that is equipped to
than 50 cases. provide general anesthesia and extracorporeal
The physicians with appropriate training and dem- circulation and has a full complement of instru-
onstrated competence in the performance of angio- ments for thoracic and cardiac surgery and a
plasty are those who should receive proper creden- full complement of drugs used for manage-
tialing to perform angioplasty in hospitals. It is ment of the cardiac patient.
recognized that hospitals are currently under intense The optimal resources for a cardiac catheteriza-
pressure to grant privileges to cardiologists who tion and radiographic facility have been carefully
have not had adequate training so as to protect the and exhaustively detailed in "Optimal Resources
hospitals' referral base. This practice should not be For Examination Of The Heart And Lungs: Cardiac
condoned; rather, the responsible leadership of Catheterization And Radiographic Facilities" (Cir-
institutions offering coronary angioplasty as part of culation 1983;68:893A-930A). This report sets guide-
their health care program should insist on the doc- lines for administration, space, equipment, person-
umentation of accredited training and the mainte- nel, and working arrangements for diagnostic
nance of skills of its approved operators by some cardiovascular laboratories. Basically all of the rec-
reasonable standard of practice. ommendations set forth in that document apply to
In the present climate it should be clear that not any laboratory planning to perform angioplasty pro-
every cardiologist desiring to perform angioplasty cedures.
should perform the procedure. Similarly, not every In addition, however, it is recommended that a
institution anxious to offer the procedure as part of laboratory performing coronary angioplasty have
its health care program can be allowed to do so. A available the following:
significant volume of cases per institution and per 1. An ample inventory of balloon dilation cathe-
operator is essential for the maintenance of assured ters ranging from 2.0 to 4.0 mm, a complete
quality and safe care. It is the strong sense of this range of existing guide wires of variable flex-
Subcommittee that these issues should not be ibility and steerability, and two or more cali-
resolved in the marketplace but within the structure brated balloon inflation devices.
of organized medicine. Formal credentialing should 2. A high resolution fluoroscopic system and an
quickly be put into place and the oversight of the optimal TV chain that allows ready visualiza-
operational aspects and maintenance of skills should tion of a 0.014 inch guide wire and where still
fall within the province of organized cardiology. It frames or " Aroad map images" can be dis-
ACCIAHA Task Force Guidelines for PTCA 501
played simultaneously with the real time fluo- 3. CASS Principal Investigators and their associates. Coronary
roscopic image. Artery Surgery Study (CASS). A randomized trial of coro-
nary artery bypass surgery. Quality of life in patients ran-
3. Either biplane fluoroscopic capability or pref- domly assigned to treatment groups. Circulation 1983;
erably an angulating x-ray tube image intensi- 68:951-960
fier arm that allows ready three-dimensional 4. Takaro T, Hultgren HN, Lipton MJ, Detre KM, and partic-
determination of the anatomic position of a ipants in the study group: The VA cooperative randomized
guide wire or balloon catheter. study of surgery for coronary arterial occlusive disease, II.
4. Radiation exposure control systems that would Subgroup with significant left main lesions. Circulation 1976;
54(suppl III):III-107-III-117
include such items as an x-ray beam with 5. The Veterans Administration Coronary Artery Bypass Sur-
automatic collimation, a carbon fiber scattered gery Cooperative Study Group: Eleven-year survival in the
radiation grid, carbon fiber table top, and a veterans administration randomized trial of coronary bypass
correct tube filter. Further reduction of radia- surgery for stable angina. N Engl J Med 1984;311:1333-1339
6. Varnauskas E, The European Coronary Surgery Study Group:
tion exposure to personnel can be achieved by Survival, myocardial infarction, and employment status in a
gap filling during cinematography, using a ref- prospective randomized study of coronary bypass surgery.
erence monitor for path finding and video Circulation 1985;72(suppl V):V-90-V-101
discs for automatic storage and replay. All 7. Killip T, Passamani E, Davis K, and the CASS Principal
personnel should be further protected from Investigators and their Associates: Coronary Artery Surgery
Study (CASS): A randomized trial of coronary bypass sur-
radiation exposure by the use of appropriate gery. Eight year followup and survival in patients with
lead aprons, eyeglasses, thyroid protection, reduced ejection fraction. Circulation 1985;72(suppl V):
and additional shielding of the x-ray tube. V-102-V- 109
5. The specific requisite space, equipment, per- 8. Kaiser GC, Davis KB, Fisher LD, et al: Survival following
coronary artery bypass grafting in patients with severe
sonnel, and administration of a cardiac sur- angina pectoris (CASS). J Thorac Cardiovasc Surg 1985;89:
gery operating suite have been outlined previ- 513-524
ously in detail by the Inter-society Commission 9. Ryan TJ, Weiner DA, McCabe CH, et al: Exercise testing in
for Heart Disease Resources (Circulation the Coronary Artery Surgery Study randomized population.
Circulation 1985 ;72(suppl V):V-31-V-38
1975 ;52:A23-A41). 10. Gruentzig AR, Senning A, Siegenthaler WE: Nonoperative
dilation of coronary-artery stenosis: Percutaneous translu-
Appendix C minal coronary angioplasty. N Engl J Med 1979;301 :61-68
Grading of Angina of Effort by the Canadian 11. Gruentzig AR, King SB, Schlumpf M, Siegenthaler W:
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saphenous vein aortocoronary bypass grafts. Mod Concepts outcome of coronary bypass surgery after failed elective
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36. Stolz RI. Varricchione TR, Kellett MA Jr, Christelis EM,
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Analysis of risk factors from 8.207 procedures. J Am Coll No additional benefit from immediate percutaneous coro-
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