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To examine the role of antiplatelet therapy in the prevention of arterial restenosis after percutaneous transluminal coronary angioplasty (PTCA), we conducted a randomized, double-blind, placebo-controlled study in 376 patients. The active treatment consisted of an oral aspirin-dipyridamole combination (330 mg-75 mg) given three times daily, beginning 24 hours before PTCA. Eight hours before PTCA, the oral dipyridamole was replaced with intravenous dipyridamole at a dosage of 10 mg per hour for 24 hours, and oral aspirin was continued. Sixteen hours after PTCA, the initial combination was reinstituted. Treatment was continued in patients with a successfully dilated vessel until follow-up angiography four to seven months after PTCA--or earlier, if symptoms dictated. Of 249 patients who underwent follow-up angiography, 37.7 percent of patients receiving the active drug had restenosis in at least one segment, as compared with 38.6 percent of patients taking placebo (P not significant). The number of stenotic segments was virtually the same in the two groups. Among the 376 randomized patients, there were 16 periprocedural Q-wave myocardial infarctions--13 in the placebo group and 3 in the active-drug group (6.9 percent vs. 1.6 percent, P = 0.0113). Although the use of this antiplatelet regimen before and after PTCA did not reduce the six-month rate of restenosis after successful coronary angioplasty, it markedly reduced the incidence of transmural myocardial infarction during or soon after PTCA. Thus, the short-term use of antiplatelet agents in relation to PTCA can be recommended.

Between August 1978 and September 1984, 440 patients were implanted with the Omniscience cardiac valve at three North American medical centers (210 aortic, AVR; 165 mitral, MVR; and 65 double valve replacements). Total follow-up was 1056 patient years; survivors were followed up to 76 months (mean 32), with 99% accountability. One hundred and eighty-six (42%) also underwent prior or concomitant major cardiac surgical procedures. Mean age was 56 +/- 12 years. Preoperatively, 3% were in New York Heart Association (NYHA) Class I, 18% II, 54% III, 26% IV. The 5 1/2 year actuarial survival rate for death from valve-related causes (thromboembolism, valve thrombosis, perivalvular leak) was 97% overall. The 5 1/2 year actuarial survival rate from all death causes was 78%. The complication rates, expressed as %/patient-year (endocarditis 0.7; anticoagulant-related hemorrhage 1.0; perivalvular leak 1.5; pannus/tissue overgrowth 0.6; and transient ischemic episode 1.2) demonstrate that advanced age at implant and additional major cardiac surgical procedures do not affect occurrence. Actuarial freedom from thrombotic complications (thromboembolism with residual deficit and valve thrombosis) at 5 1/2 years was 95% overall. Postoperatively, of 348 patients with known NYHA, 65% were in NYHA I, 28% II, 5% III, and 2% IV.

Digital subtraction and computer enhancement of left ventriculography allow the injection of small amounts of contrast medium into the left ventricle. Image quality measurements of cardiac volumes, and ejection fraction and evaluation of regional wall motion were compared following digital subtraction and cine ventriculography in 30 patients undergoing coronary arteriography for suspected or proven ischemic heart disease. At concentrations of 13% to 19% (iodine contents: 2.0 to 5.0 g) meglumine sodium diatrizoate used for digital subtraction ventriculography, no alterations of ventricular pressures were noted; premature ventricular contraction and cineventriculography in 30 patients undergoing coronary arteriography for suspected wall motion by two independent observers showed complete agreement between digital and cineventriculography in 141 of 150 segments (94%), including 114 normal segments; digital ventriculography led to underestimation of four segments and to overestimation of five. Left ventricular ejection fraction and volumes calculated using both techniques correlated relatively well (ejection fraction: r = 0.86; end systolic volume: r = 0.88; end diastolic volume: r = 0.665). Thus, intraventricular injection of low concentrations of contrast medium provides good digital angiographic images and may eventually replace cine ventriculography for invasive assessment of left ventricular performance. However, ECG gating and shorter exposure times will be required for accurate measurement of ventricular volumes and ejection fractions.

The relation between restenosis and progression of atherosclerosis in other coronary segments after angioplasty was studied in 98 consecutive patients with 110 coronary stenoses successfully treated with angioplasty. At early angiographic restudy (5 +/- 2 months after angioplasty) 37 patients (38%) had restenosis (defined as a stenosis greater than or equal to 50% of the luminal diameter or loss of greater than or equal to 50% of the gain achieved by angioplasty); progression of atherosclerosis was observed in 4 patients with and 7 without restenosis (13 versus 11%, p = NS). Ninety of the 98 patients underwent a late angiographic restudy a mean of 34 +/- 11 months after angioplasty. Late restenosis was found in one patient. Progression of coronary artery disease (defined as a greater than or equal to 20% decrease in the diameter of a vessel initially narrowed by greater than or equal to 50% or a greater than or equal to 30% decrease when the initial stenosis was less than 50%) was examined in relation to restenosis in 85 of the 90 patients. It occurred in 9 of 27 patients with and 22 of 58 patients without restenosis (33 versus 38%, p = NS). Restenosis developed more rapidly than did progression of disease. Diameter stenosis increased from 35 +/- 8 to 73 +/- 11% at the early restudy in lesions with restenosis; in lesions with disease progression it increased from 9 +/- 18 to 20 +/- 28% (p less than 0.001) at the early restudy to 53 +/- 21% (p less than 0.001) at the late restudy.(ABSTRACT TRUNCATED AT 250 WORDS)

Carpentier-Edwards bioprostheses were implanted in 605 patients, 509 of whom had a single valve replacement, and 96 of whom had a multiple valve replacement. There were 54 early deaths (8.9%) and 26 late deaths (4.3%). The five-year actuarial survival was 87% for aortic valve replacement, 83% for mitral valve replacement, and 81% for multiple valve replacement. Of the 525 survivors, all but 3 were followed for a total of 964 patient-years; 354 patients (68%) remained asymptomatic, and 95 patients (18%) were improved. The incidence of thromboembolism, endocarditis, and reoperation due to primary tissue failure of the bioprosthesis were 2.0, 1.3, and 0.1% per patient-year, respectively. The actuarial probability of being free of all valve-related complications was 93% after five years. Satisfactory hemodynamic performance of the bioprosthesis was demonstrated by postoperative studies done in 70 patients. Thus, the Carpentier-Edwards porcine valve provides good clinical improvement, with a low incidence of valve-related complications and tissue failure at five years postoperatively.

The Angell-Shiley porcine xenograft was evaluated in 48 asymptomatic subjects who underwent cardiac catheterization an average of 14 months after operation. Nineteen patients had mitral and 29 had aortic valve replacement. The average mitral valve gradient was 8 +/- 3 mm Hg and the average effective orifice area was 1.8 +/- 0.6 cm2. The average aortic valve gradient was 22 +/- 7 mm Hg and the average effective orifice area was 1.2 +/- 0.3 cm2. During supine leg exercise, the average mitral valve gradient increased to 12 +/- 4 mm Hg (p less than 0.001) and the average aortic valve gradient increased to 27 +/- 8 mm Hg (p less than 0.001) compared to findings at rest. On the basis of data obtained with a regression analysis model, there is a high probability that an Angell-Shiley aortic xenograft with a stent diameter less than 25 mm will have a postoperative effective orifice area of less than 1 cm2, and that an Angell-Shiley mitral xenograft with a stent diameter less than 30 mm will have a postoperative effective orifice area of less than 1.5 cm2. Our data suggest that the Angell-Shiley xenograft has suboptimal hemodynamic performance in stent sizes less than 30 mm in the mitral position and less than 25 mm in the aortic position.

Initial results, complications, restenosis rates and clinical outcomes were compared in 78 patients undergoing multilesion and 128 patients undergoing multivessel percutaneous transluminal coronary angioplasty (PTCA). Multilesion PTCA was defined as a procedure in which a proximal PTCA site had to be crossed to dilate a distal severe narrowing and multivessel PTCA as multiple dilatations without having to cross 1 severe narrowing to dilate another. The clinical and angiographic features of the 2 groups were similar. More sites per patient were attempted among those who underwent multilesion PTCA. Primary success rate per lesion was 86% (236 of 274) among those who underwent multivessel and 73% (155 of 211) among those who underwent multilesion PTCA (p less than 0.001). A success rate of 81% (101 of 124) for proximal lesions among those with multilesion PTCA was not significantly worse than that for those with multivessel PTCA; however, lesions distal to proximal sites had a success rate of only 62% (54 of 87), worse than either those with proximal stenoses or multivessel PTCA (p less than 0.005). Arterial diameter, severity of stenosis or procedural variables did not account for this difference. Complication rates were similar in the 2 groups. Despite a poorer success rate among patients with multilesion PTCA, clinical improvement to functional class 0 or 1 occurred in more than 70% of patients in both groups and was equal in patients with and without successful distal dilatations. Restenosis rates per lesion in patients with multivessel (31%) and multilesion (30%) PTCA were similar.(ABSTRACT TRUNCATED AT 250 WORDS)

To assess the interrelation of clinical and procedural factors responsible for restenosis, 119 patients undergoing coronary arteriography were studied a mean of 5.8 +/- 3 months after successful multiple percutaneous transluminal coronary angioplasty. In all clinical, angiographic and procedural variables, the 119 patients undergoing repeat catheterization were similar to the 87 patients that did not. Overall, restenosis occurred in 74 (34%) of 215 lesions. Sixty-three patients had no restenosis, 44 had at least one restenosis and 12 had restenosis at all angioplasty sites. The statistical distribution of restenoses did not follow a binomial model, suggesting that restenosis is more than a lesion-specific phenomenon. Of all the clinical and procedural variables assessed by multivariate logistic regression analysis, only percent stenosis before angioplasty (p less than 0.01), diabetes mellitus (p less than 0.01) and percent stenosis after angioplasty (p less than 0.05) were predictive of restenosis in the entire group. Patients with no restenosis and patients with restenosis at all sites were not different with respect to procedural variables; however, patients with restenosis at all sites more often (p less than 0.05) had diabetes and recent onset angina. In contrast, patients with no restenosis differed from patients with isolated restenosis with respect to procedural variables: severity of stenosis before and after angioplasty, balloon/artery lumen ratio and maximal inflation pressure. Thus, procedural factors may be more related to isolated restenosis, but patient-related factors such as diabetes and recent onset angina may play a more important role in patients with multiple restenoses.

Two women with typical clinical and angiographic findings of aorto-iliac occlusive disease underwent a successful percutaneous transluminal angioplasty of a severe stenosis of the lower abdominal aorta. One of them in whom control aortograms provide information on the mechanism of balloon angioplasty is reported here.

Intravenous streptokinase already has been demonstrated safe and beneficial in acute myocardial infarction. The adjunction of early angiography seems to be safe, providing the possibility of full revascularization in a larger number of patients with a high rate of primary success. The improvement of global ventricular function, the reduction of mortality, post infarction angina and reocclusion have to be confirmed by longer follow-up.

A reproducible and sensitive radioimmunoassay (RIA) was developed to measure ANF in human plasma. Immunoreactive ANF was extracted from plasma with Sep-Pak cartridges, using 0.2% ammonium acetate (pH 4) with acetonitrile. The sensitivity of the assay was 3.9 pg/ml. The coefficient of variance for inter-assay and intra-assay was 16.8% and 6.8%, respectively. In normal healthy subjects (n = 67), ANF content was 11.9 +/- 1.3 pg/ml (mean +/- SEM). Significantly-higher ANF concentrations were found in proximal coronary sinus blood, being 6 to 37 times greater than in the peripheral circulation. Comparison of the prior extraction method with direct RIA revealed a good correlation (r = 91) in samples containing higher than 100 pg/ml ANF. No correlation was observed with lower values. The elution profiles of reverse-phase HPLC of peripheral and coronary sinus plasma extracts were similar but somewhat complex, with the main immunoreactive peak corresponding to a low-molecular-weight peptide.

This study describes the results of ergonovine testing in 100 consecutive patients who underwent this procedure in a coronary care unit. All patients had recently undergone coronary arteriography. A bolus injection of ergonovine was administered at 5 minute intervals in the following doses (mg): 0.0125, 0.025, 0.05, 0.1, 0.2, 0.3 and 0.4. The criterion for a positive test was the appearance of S-T elevation greater than 1 mm. The test was positive in all 17 patients known to have variant angina and in 18 (40 percent) of 45 patients who had a history of chest pain judged strongly suggestive of variant angina but who had no electrocardiogram recorded during pain. Of 38 patients with a history of chest pain classified as not entirely typical of variant angina, only 1 (2.6 percent) had a positive test. Of the 64 patients with a negative ergonovine test, 47 had chest pain and 25 had nausea but none had more serious complications. Ventricular arrhythmia accompanied S-T elevation in 18 of the 36 patients with a positive test but occurred in only 4 of the 64 with a negative test (p < 0.0005). No patient needed treatment with antiarrhythmic drugs. Four of the 36 patients with a positive test had serious complications: severe transient hypotension (2 patients), recurrent episodes of angina with S-T elevation (1 patient) and a subendocardial infarction (1 patient). Thus, ergonovine testing is useful in patients with a typical clinical history of variant angina but without an electrocardiogram recorded during pain. In this study, a small but definite incidence of serious complications occurred during a positive test.

Clinical data were gathered over five years (650 patient-years) for all 155 aortic valve replacement, 125 mitral valve replacement and 46 double valve replacement patients implanted with the Omniscience cardiac valve prosthesis at three North American medical cent es. Mean age was 56 +/- 12 years, 80% were preoperatively in NYHA class III or IV, and 57% had previous or concomitant cardiac surgery. Data were evaluated for the incidence of thromboembolic complications. During the late postoperative period, transient ischaemic episodes occurred in six patients (0.92% per patient-year). The five-year actuarial thrombus-free rate for serious thromboembolic complications (valve thrombosis or thromboembolism with residual effects) for aortic valve replacement patients is 96% and 95% for mitral valve replacement patients. For patients experiencing any transient or serious thromboembolic complication, 35% had a compromise of coumadin anticoagulation shortly before the thromboembolic event, 60% had a history of atrial fibrillation, and 76% a history of rheumatic heart disease. Statistically, these rates are significantly higher compared with the original valve population. The low incidence of thromboembolic complications over this five-year clinical study demonstrates a commendable degree of safety and performance for the Omniscience valve.

From 1981 to 1987, 189 patients underwent isolated aortic valve replacement with the Carpentier-Edwards bovine pericardial bioprosthesis. There were 9 early deaths (30-day mortality of 4.8%) and 18 late deaths (3.3% pt-yr). After 5 years, the actuarial survival rate was 81.9%. All patients but one were followed for an average of 37 months after operation, and follow-up totaled 551 patient-years. Valve-related complications included 12 thromboembolic episodes (2.2%/pt-yr), 7 endocarditis (1.3%/pt-yr), 2 hemorrhages due to anticoagulation (0.4%/pt-yr), and 3 reoperations (0.5%/pt-yr). After five years, freedom from thromboembolic events was 91%, that from reoperation was 98%, and 87% for all valve-related complications. There was no primary tissue failure of the valve. Before operation, 55% of the patients were in functional Class III or IV, 97% of the survivors were in Class I or II after valve replacement. Hematological evaluation of 77 patients, an average of 18 months postoperatively, showed no clinically significant hemolysis. Postoperative hemodynamic studies in 28 patients showed mean aortic pressure gradients across the prosthesis at rest ranging from 24 mmHg with the smaller (19 mm) to 11 mmHg with the larger (25 mm and more) valves, and effective orifice areas ranging from 1.0 to 1.9 cm2, respectively. Thus, the Carpentier-Edwards pericardial bioprosthesis appears to be a reliable and hemodynamically effective substitute for replacement of the aortic valve.

Exercise, ergonovine and the cold pressor test have been used to provoke variant angina attacks. The sensitivity of these three tests was compared in 34 hospitalized patients with well documented, active variant angina who had recently undergone coronary arteriography. The three tests were usually performed on three consecutive days, and 28 of the 34 had the three tests within 1 week. Angina was provoked by ergonovine in all 34 patients, by exercise in 17 and by cold pressor test in only five (p less than 0.005). ST elevation developed during the ergonovine test in 32 (94%), during exercise in 10 (29%) and during the cold pressor test in only three (9%). With ergonovine, one patient had only ST depression and one had no ECG changes. During the cold pressor test two patients had pseudonormalization of abnormally negative T waves and 29 had no ECG changes. Exercise induced T-wave pseudonormalization in four patients, ST depression in nine others and no ECG changes in 11. ST elevation was more frequent with ergonovine than with either of the other tests (p less than 0.0001). ST elevation or T-wave pseudonormalization occurred more often with exercise than with cold (p less than 0.05), but both occurred less often than with ergonovine (p less than 0.0001). We conclude that the sensitivity of the ergonovine test is very high in patients with active variant angina and that exercise will provoke angina with ST elevation in about 30% of these cases. In contrast, the sensitivity of the cold pressor test is too low to be of much clinical value in the diagnosis of variant angina.

Repeat coronary angiography was performed within 6 months after successful percutaneous transluminal coronary angioplasty (PTCA) in 178 of our first 181 patients (98%). The remaining 3 patients were symptom free, had negative treadmill exercise test results and were considered not to have had restenosis. A second follow-up angiogram was performed in 107 patients (59%), including all patients with persistent or recurrent anginal symptoms, between 7 and 18 months after PTCA. Fifty-one of the 181 patients (28%) had restenosis on 51 of 205 successfully dilated segments (25%). The stenosis was greater than or equal to 70% in 49 of these 51 segments; it was 65% and 55%, respectively, in the 2 remaining patients. Restenosis was documented angiographically at a median time of 4.7 +/- 4 months. However, 47 patients (92%) had restenosis documented within 6 months, 2 between 7 and 12 months and 2 between 13 and 18 months after PTCA. Stepwise logistic regression analysis selected the following factors as independent predictors of restenosis after PTCA: variant angina, multivessel disease, severity of residual stenosis and less reduction in the diameter of the stenosis on the angiogram immediately after PTCA. Of these 4 factors, the degree of residual stenosis immediately after PTCA was by far the most significant. It is concluded that restenosis occurs in approximately 25% of patients, almost always within the first 6 months, after successful PTCA. The degree of residual stenosis after PTCA is the most important predictor of restenosis. Increased experience and improved instrumentation may eventually lead to less residual stenosis and better late results after PTCA.

The respective diagnostic values of M mode and 2D echocardiography and pulsed and continuous wave Doppler were assessed in bioprosthetic valve dysfunction. The results of the ultrasonic investigations were compared with the operative findings and anatomo pathological appearances in 56 cases of dysfunction. Only cases with surgical confirmation were included. Doppler examinations were carried out in 13 cases. Echocardiographic imaging alone cannot resolve all the diagnostic problems posed: specific signs are rare and were only observed in one out of 7 cases of periprosthetic leak, 7 out of 10 cases of valvular stenosis and 20 out of 36 cases (55 per cent) of valve tear. In cases of valve tear, 2D echocardiography was falsely normal in 15 per cent of cases and gave equivocal results in 30 per cent of cases because it was not possible to visualise the three cusps of the bioprostheses. Doppler echocardiography does not have the same limitations and gives an immediate and accurate assessment of valve function. It is particularly useful for the diagnosis of stenosis and valve tear in which the diagnostic specificity and sensitivity attain 100 per cent (exact diagnosis in all 11 cases of valve tear). At present, continuous wave Doppler seems to be the most reliable diagnostic tool for qualitative and quantitative assessment of primary degeneration of valvular prostheses.

The authors report three cases of duplication of the superior vena cava which were demonstrated by radionuclide angiography. Nuclear imaging was performed in order to demonstrate a left-to-right intracardiac shunt. Injection into the left external jugular vein demonstrated the presence of a duplication of the superior vena cava in addition to the presence of a shunt.

Coronary occlusion or myocardial infarction occurred in 50 of 394 (13%) one-vessel-disease patients awaiting percutaneous transluminal coronary angioplasty (PTCA). To identify risk factors for these events, we first matched the 37 patients who demonstrated occlusion on the immediate preangioplasty repeat angiogram with 37 patients who did not. Matching was based on the time interval between angiograms, the date of the procedure, and the site of the lesion. Preangioplasty occlusion patients did differ from controls by age (47 +/- 11 vs 54 +/- 8 years, P less than .01), smoking status (34/37 vs 24/37, P less than .01), and angina class (2.6 +/- 1.0 vs 2.3 +/- 0.7, P less than .10) at the time of the first angiogram. Second, we pooled the data of the 37 preangioplasty occlusion patients with those of the 13 patients with preangioplasty myocardial infarction. The 50 cases with complication (coronary occlusion or myocardial infarction) were younger (47 +/- 12 vs 54 +/- 8 years, P less than .01), more often smokers (42/50 vs 24/37, P less than .05), and more symptomatic (2.7 +/- 0.8 vs 2.3 +/- 0.7, P less than .05) than the 37 controls. This study suggests that young smokers with severe angina are at high risk of preangioplasty occlusion and/or myocardial infarction; prompt management of these patients, when considered for PTCA, seems advisable.

The authors have studied by pulsed and continuous Doppler ultrasonography 108 pericardial prostheses in a good functional state implanted for less than five years to patients without any clinical and echographic signs of heart failure. The pulsed Doppler ultrasonography allowed to exclude the possible dysfunction of the prostheses; continuous Doppler ultrasonography allowed the measurement of the maximal transprosthetic velocities and to deduce the corresponding maximal and middle gradients by means of simplified Bernouilli's equation. Using three types of bioprostheses (Carpentier-Edwards, Ionescu and Mitroflow) the following problems were investigated: Normal ranges of maximal transprosthetic velocity and gradients. At the aortic level the maximal velocity ranges from 1.60 to 2.83 +/- 14 m/s and the maximal gradients from 10 for size 27-29 to 32 +/- 3.3 mmHg for size 19. At the mitral level the maximal velocity ranges from 0.80 to 2 m/s and the mean gradients from 1 for size 33 to 7 mmHg for size 25. The mean half-life of decrease is 100 +/- 28 ms. Thus all aortic bioprostheses appear to be stenosing, which is not the case for the mitral ones, size 31 and 33. Factors governing the maximal transprosthetic velocity and the gradients: these determining factors are the size, the type and the age of the bioprosthesis (r = 0.59 for the correlation between maximal velocity and size, r = 0.53 between size and mean aortic gradient). The accessory factors are the age and the functional condition of the myocardium. All these factors have to be considered and neutralized for allowing a valid comparison of various types of prostheses. Comparison of the three pericardial prostheses studied: in patients without signs of myocardial dysfunction of prosthetic origin and with comparable basal conditions, comparison of maximal velocity and of the gradient points to a significant superiority of the Mitroflow at the aortic level and of the Ionescu and Mitroflow at the mitral level. It should be noted in the end that the great similarity of the results obtained in the present study by Doppler ultrasonography with the previously reported hemodynamic data confirms the important role of the Doppler method in the evaluation of valvular bioprostheses.

From 1980 to 1985, 154 Omniscience valve prostheses were implanted in 132 patients (mitral in 72, aortic in 33, and both in 27), 81 women and 51 men, aged 22 to 72 years. There were 13 early deaths (30 day mortality of 9.8%) and nine late deaths. The actuarial survival rate was 79.1% after 4 years, and survival rates after aortic, mitral, and multiple valve replacement were 71.8%, 80%, and 85.2%, respectively. After a postoperative follow-up period averaging 27 months, 96% of the survivors were in Class I or II. The linearized incidence of thromboembolism, hemorrhagic episodes, and reoperation was 3.8%, 3.4%, and 2.3% per patient-year, respectively. After 4 years, freedom from valve-related mortality, valve-related mortality and reoperation, thromboembolic episodes, and all valve-related complications was 93%, 89%, 88%, and 70%. Moderate hemolysis with increases of reticulocyte count and serum lactic dehydrogenase above normal values was found in 80% of the patients, but only one had hemolytic anemia. In 22 patients, the maximal opening angle of the prosthetic disc averaged 54 +/- 11 degrees. Postoperative hemodynamic evaluation was obtained in five patients with aortic prostheses and in 13 with mitral prostheses. Mean aortic gradient and effective orifice area averaged 17.6 mm Hg and 1.2 cm2 at rest and increased to 18.8 mm Hg and 1.7 cm2 with exercise. With mitral prostheses, these values averaged 6.5 mm Hg and 1.9 cm2 at rest and 15.4 mm Hg and 2.1 cm2 with exercise. Thus excellent clinical improvement is obtained with the Omniscience prosthesis; however, the hemodynamic performance of the valve and opening of the tilting disc are suboptimal, causing the prosthesis to be moderately obstructive to blood flow.