Percutaneous transluminal coronary recanalization: Procedure, results, and acute complications

Percutaneous recanalization: complications

translu.minal Procedure,

coronary results, and acute

Percutaneous transluminal coronary recanalization, a new therapeutic procedure used in acute myocardial infarctlon, offers significant reduction in mortality, as well as more effective limitation of the zone of infarction than has been possible wlth other pharmacologic treatment employed in the past. The risk of coronary anglography during acute myocardial infarction was surprisingly low, as was the risk of hemorrhagic complications following the intracoronary administration of relatively low doses of thrombolytlc substances such’ as streptokinase. Mechanical recanallzatlon was possible In about one fifth of patients and successful In approximately half of all such attempts, but complications occurred in a small percentage of attempts at this step. Coronary artery spasm was excluded as a possible cause of occlusion in almost all cases. Selective lntracoronary infusion of streptoklnase produced the highest degree of myocardial reperfusion, and best results were achieved when therapy was lnltlated shortly after thrombotlc occlusion occurred. Residual stenosis of more than 75% lumlnal dlameter narrowing was present In approximately three fourths of cases after complete thrombolysis, and the majority of patients remained appropriate candidates for coronary bypass surgery or for percutaneous transluminal coronary angloplasty (Griintxlg procedure). Although complete analysls of the efficacy of selective recanaiization was difficult because It was not possible to establish a suitable control group for purposes of comparison, the mortality of less than 1% In the present group of 232 patients within the first 6 hours following myocardlal reperfuslon provldes an encouraging result. (AM HEART J 102: 1176, 1961.)

W. Rutsch,

M.D., M. Schartl,

W. Merx, M.D.,

M.D., D. Mathey,

R. Dorr, M.D., P. Rentrop,

Aachen, Gattingen,

and Hamburg,

M.D., K. Kuck, M.D.,

M.D., and H. Blanke, of Germany

Percutaneous transluminal coronary recanalization (PTCR) during the acute phase of evolving myocardial infarction is capable of protecting myocardial tissue and reducing overall mortality. We report the results obtained in 232 patients treated at four West German university hospitals in the period from 1978 to March, 1981. Special attention in this presentation is given to the procedure used, rate of success, duration of therapy until recanalization was achieved, and angiographic findings after complete thrombolysis, as well as to complications encountered during the procedure. INCLUSION

CRITERIA

Patients were included in the study when onset of persistent angina pectoris resistant to therapy was From the Klinikum Charlottenburg of the Free University of Berlin; University Hospital Eppandorft, Hamburg; Medical Clinic of the University of Aachen; and Medical Clinic of the University of Gettingen. Reprint requests: W. Rutsch, M.D., Freie Universitat tatsklinikum Charlottenburg (FB 3). Spandeuer Damm 19, West Germany.

1178

M.D., Berlin,

Federal Republic

Berlin, Universi130, 1000 Berlin

exactly defined, since this allowed estimation of the duration of coronary artery occlusion (Table I). Although the period between onset of chest pain and the decision to perform the thrombolytic procedure varied somewhat, a 3-hour interval was generally considered as a limit for initiation of therapy. One work group set 8 hours as the limit, whereas another included all patients with angina pectoris and the diagnosis of acute myocardial infarction. Objective criteria of coronary artery occlusion were considered to be demonstration of ST segment elevation that proved resistant to nitroglycerin and/or demonstration of an akinetic segment by two-dimensional echocardiogram. The work groups that chose a 3-hour limit for inclusion usually initiated therapy before serum creatine phosphokinase (CPK) values were known; retrospective analysis showed that initial serum CPK values were normal in all such patients. Normal coagulation studies were not a prerequisite for inclusion in the study, since the total dose of streptokinase had little influence on coagulation parameters. 0002-8703/81/121178

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1981

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Volume 102 Number 6, part 2

Table

PER

I. Criteria for inclusion

Table

Persistentangina pectoris resistant to nitroglycerin Interval of less than 3 hr from onset of angina pectoris until beginning of heart catheterization ST segment elevation or verification of an akinetic segment by two-dimensional echocardiogram Normal CPK values

1179

Ill. Procedure of coronary recanalization

Attempt at mechanical tipped guide wire Intracoronary injection pine Intracoronary infusion

Table Table

in AMI: Procedures/results/complications

IV. Additional

thrombus

perforation

with

of 0.1 mg nitroglycerin of streptokinase,

a soft-

or nifedi-

2000-4000

IU/min

therapy

II. Criteria for exclusion

Age more than 70 yr Reinfarction in identical coronary circulation Resuscitation with cardiac massage Serious noncardiac diseases Incompletely healed gastrointestinal ulcer Cerebrovascular bleeding complications

EXCLUSION

area

Heparin, 10,000 IU, IV Acetylsalicylic acid, 500-1000 mg, IV Infusion of nitroglycerin, 3-6 mg/hr Glucocorticoids, prednisolone, 500-1000

Table

V. Mean duration of thrombolysis related to site of

occlusion Artery

CRITERIA

Patients older than 70 years were excluded from the study (Table II). Patients with a history of infarction in the region served by the occluded vessel and patients with a long history of severe angina pectoris were also excluded because it was assumed that factors other than thrombotic occlusion might play a significant role in these cases. High risk of potentially fatal hemorrhage, in patients who had undergone cardiovascular resuscitation with external heart massage and in patients with gastrointestinal bleeding or cerebrovascular hemorrhage, was also a criterion for exclusion from the study. The procedure was not performed in patients with severe noncardiac disease. All patients were potential candidates for coronary bypass surgery. PTCR PROCEDURE

The Judkins technique was used in the majority of cases. In general, there was no problem in maintaming catheter position in the ostium during streptokinase infusion, which averaged 84 minutes. The arterial catheter was left in place for 24 hours in most cases and removed without significant local hemorrhage. The recanalization procedure began with an attempt at mechanical perforation of the thrombus with a soft-tipped guide wire when the position of the thrombus permitted the maneuver (Table III). Such was the case in 22% of patients, and the attempt was successful in 41% of these. However, this step of the procedure was not without some risk, since perforation of the vessel with extravasation of contrast medium occurred in 2 of 97 patients (4%). The next step involved selective injection of nitroglycerin, 0.1 mg, or nifedipine, 0.1 mg, in order to exclude the possibility of coronary artery spasm.

mg, IV

Duration

Left anterior descending Left circumflex Right coronary

34 min 42 min 35 min

One study group did not follow this step of the procedure in all cases, but vasorelaxant drugs were administered to 92% of all patients in the study. The results of such vasorelaxant therapy were unsatisfactory, even in the 3% of patients in whom a slight degree of recanalization was achieved. Regardless of the results obtained with the two maneuvers described above, selective infusion of streptokinase or urokinase was performed in all cases. Three study groups administered 2000 IU/ min, and the fourth used 4000 IU/min. The thrombolytic agent was delivered in solution by means of volume expanders (dextran [Rheomacrodex, Onkovertin]), electrolyte solutions of varying concentrations, 5% levulose, 5% glucose, or human albumin. Rate of infusion averaged 325 ml/hr. Recanalization occurred 35.5 minutes after initiation of streptokinase therapy, with a mean total dose of 71,000 IU of streptokinase in 192 ml at a dosage rate of 200 IU/min. When hemodynamic considerations allowed, all patients received heparin, 10,000 IU; acetylsalicylic acid, 500 to 1000 mg; corticosteroids (prednisolone, 500 to 1000 mg); and nitroglycerin, 3 to 6 mg/hr (Table IV). P-Adrenergic receptor blockers, catecholamines, slow-channel calcium blockers, sedatives, analgesics, and antiarrhythmic drugs were used as required. FREQUENCY OCCLUSIONS

OF SUBTOTAL STENOSES RESISTANT TO PTCR

Subtotal obstruction was found (? 14.2%, range 5% to 37%) of patients,

AND

in 19.5% despite the

1180

December. 1991 American Heart Journal

Rutsch et al.

Table VI. Time relation duration of lysis

between

age of thrombus Lysis

Thrombus

Less than 2 hr 2-4 hr 4-6 hr More than

Table sis

23 min 31 min 43 min 43 min

6 hr

VII. Residual Before

stenoses

after

complete

thrombolysis

Approximately Between Between Subtotal

thromboly-

Residual

i%

50%

50% and 75% 75% and 90% stenosis

18% 49% 27%

Table VIII. Degree of residual related to age

stenosis after thrombolysis,

Younger than 40 yr From Older

Table

One-vessel Two-vessel Three-vessel

Table PTCR Death Death Total

62% 83% 87%

40 to 60 yr than 60 yr

IX. Degree

and

of CAD

in PTCR

X. Mortality

in

44% 35% 21%

232 patients

after

attempted

prior to completion of PTCR procedure within 6 hr after successful recanalization mortality within 6 hr after PTCR attempted

2.1% 0.9% 3.0%

Table Xl. Incidence of bleeding complications 6 hours after start of streptokinase infusion At At In In

site of arterial other puncture gastrointestinal cerebrovascualr

puncture sites tract system

during

first

4.8% 1.0% 0.3% 0.3%

use of all criteria of acute myocardial infarction, including angina pectoris, ST segment elevation, increased serum CPK levels, and demonstration of an akinetic segment with two-dimensional echocardiography. Selective administration of nitroglycerin or nifedipine and streptokinase did not result in significant dilatation of the stenoses. Attempted recanalization was unsuccessful in 19% (+ 3.3%, range 14% to 22%) of cases with complete vascular occlusion.

FEATURES

The interval between onset of angina pectoris and initiation of streptokinase infusion averaged 211.3 minutes (+- 44.3 minutes, range 151 to 276 minutes) ‘in the patients who underwent successful recanalization procedures. Mean duration of streptokinase infusion was 35.5 minutes ( f 8.4 minutes, range 30 to 50 minutes) but there were differences related to location of the occlusion and age of the thrombus. Although there was a considerable degree of variation, successful recanalization of the left anterior descending artery and of the right coronary artery was achieved after almost identical periods of streptokinase infusion; occlusion of the left circumflex artery required a longer period (Table V). Recanalization was achieved at 23 minutes when the thrombus was less than 2 hours old (Table VI). In comparison, recanalization was achieved at 31 minutes when therapy was initiated 2 to 4 hours after the onset of angina pectoris, and 43 minutes were required when the thrombus was more than 4 hours old. REPERFUSION

patients

disease disease disease

TIME INTERVALS AND OCCLUSION RELATED TO SUCCESSFUL PTCR

ARRHYTHMIAS

Arrhythmias were observed at the same time as successful recaQalization in 25% ( -I- 5%, range 19% to 32%) of cases. Reperfusion arrhythmias were not related to the location of occlusion and were generally benign. A few cases of serious arrhythmias required therapy, but there were no fatalities caused by arrhythmias. Conduction disturbances were observed for periods ranging from a few minutes to 1 hour. RESIDUAL

STENOSES

AFTER

SUCCESSFUL

PTCR

Residual stenosis was present following successful recanalization and was estimated at 50% luminal diameter narrowing in 6% of cases, between 50% and 75% in 18% of cases, and between 75% and 90% in 49% of cases; subtotal stenosis remained in 27% of patients (Table VII). Severity of residual stenosis was probably due to atherosclerotic lesions and demonstrated a relation to patient age (Table VIII). A lesser degree of residual stenosis was found in younger patients, with a mean residual stenosis of 62% diameter narrowing in patients younger than 40 years of age. The 40- to 60-year-old patients had mean residual stenosis averaging 830/o, whereas patients older than 60 years had 87% obstruction after recanalization procedures. One-vessel coronary artery disease (CAD) was present in 44% of patients and two-vessel CAD in another 35% of cases (Table IX).

Volume 102

PTCR

Number 6, part 2

PTCR COMPLICATIONS

AND MORTALITY

Seven of the 232 patients (3%) died within 6 hours after the PTCR procedure was attempted (Table X), and five fatalities (2.1%) occurred before the recanalization procedure was completed. Only two patients (0.9%) died within 6 hours of successful recanalization. Causes of death included cardiogenic shock and other complications of infarction. No patient died as a direct result of the PTCR procedure, nor was cardiac or noncardiac hemorrhage implicated as a cause of death.

in AMI:

Procedures/results/complications

1181

Hemorrhagic complications were rare (Table XI), since the total dose of streptokinase was low. Large hematomas at the sites of arterial puncture were the most common such complications. Bleeding sufficient to produce hemodynamic changes occurred in 3.9% of cases and resulted in a decline of hemoglobin concentrations that required blood transfusion. Intracerebral hemorrhage occurred in one patient who died of cardiogenic shock. Major untoward sequelae were not observed in the remaining cases with serious hemorrhagic complications.

Evaluation of the effectiveness of intracoronary streptokinase infusion in acute myocardial infarction: Postprocedure management and hospital course in 204 patients A multicenter study evaluated the early management and subsequent hospital course of 204 patients with acute myocardial infarction who were receiving intracoronary infusions of streptokinase (STK). The in-hospital mortality in 37 patients with thrombotic occlusion of the infarct-related vessel, in whom recanalization could not be achieved, was 24%. However, the cardiac mortality in 129 patients who were successfully treated by percutaneous transluminal coronary recanalization (PTCR) was only 5.4%. Cardiac deaths (five patients) and nonfatal reinfarctions (20 patients) occurred in the early period in the cardiac care unit (CCU) in 21% of the latter group and, despite anticoagulation measures, could not be consistently prevented. Hemorrhagic complications, necessitating blood transfusion, occurred in 15 (7.4%) of the total 204 patients in the group, usually in the acute CCU stage, and were positively related to decline of Abrinogen serum concentrations below 100 mg/dl and to use of the Judkins technique. The later course of most of the patients on the general ward was uneventful until hospital discharge. Thus there were only two more cardiac deaths, and of 64 successfully treated STK-PTCR patients who left the CCU without clinical indications of reinfarction and agreed to repeat coronary angiography before hospital discharge, the infarct-related vessel was patent in 59 patients and reoccluded in only five (7.8%). (AM HEART J 102:1181, 1981.)

W. Merx, M.D., R. Dorr, M.D., P. Rentrop, M.D., H. Blanke, M.D., K. R. Karsch, M.D., D. G. Mathey, M.D., P. Kremer, M.D., W. Rutsch, M.D., and H. Schmutzler, M.D. Aachen, Giittingen, Hamburg, and Berlin, Federal Republic of Germany Although it has been proved that recanalization can be achieved by selective intracoronary infusion of streptokinase (STK) in the majority of patients with From the Department of Internal Medicine I of the University Hospital, Aachen; Department for Cardiology of the University Hospital of G&tingen; Department for Cardiology of the University Hospital of Hamburg; and Department for Cardiology of the Free University of Berlin. Reprint 27/29,

requests: 5100 Aachen,

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acute myocardial infarction (AMI) caused by complete thrombotic occlusion,‘. Z little is known concerning the potential reduction of mortality and possible late complications. Information is also needed in regard to the necessity and best means of anticoagulant therapy following short-term intervention with percutaneous transluminal coronary recanalization (PTCR). To provide such important knowledge, this presentation evaluates the data on