Multicenter registry to evaluate the efficacy of the NIROYAL stent in de novo or restenotic coronary stenosis.

The purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm. Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5+/-10.8% to 2.7+/- 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [i.e., did not experience a major adverse cardiac event (MACE)] and 95.2% had no anginal symptoms. Furthermore, 87.3% of the patients were free of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis pre-procedure were identified as statistically significant (p<0.05) predictive factors for MACE. The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revascularization rates were low.

The MUST Trial: Acute Results and Six-Month Clinical Follow-up.

Coronary stenting is now an established technique which is associated with improved acute and long-term results and prevents restenosis in comparison to balloon angioplasty in selected patients. However, subacute thrombosis and vascular complications associated with conventional anticoagulant therapy (warfarin for one month, with 4Ð5 days of IV heparin) remain of concern. By means of a prospective, multi-center registry, we sought to demonstrate that the use of ticlopidine and aspirin as the sole post-stenting treatment was safe by reducing bleeding complications without increasing the risk of major cardiac events. A total of 260 patients with stable and unstable angina and a short, single de novo lesion were enrolled in this registry. Successful stent deployment without ultrasound guidance was achieved in 259 patients. All patients were treated with aspirin ³ 100 mg daily for 6 months and ticlopidine 250 to 500 mg daily according to body weight for 1 month. The primary endpoint was safety, defined by the occurrence of death, myocardial infarction (MI), coronary bypass surgery (CABG) or repeat angioplasty (PTCA) within 30 days of the procedure, in addition to subacute stent thrombosis and bleeding and vascular complications within 30 days of the intervention. During hospital stay there were no deaths; 8 patients experienced MI, 1 patient underwent urgent CABG and 4 patients had repeat PTCA. Therefore, the clinical success rate was 96.0%. Bleeding complications requiring blood transfusion or vascular repair occurred in 2 patients. Treatment was discontinued in one patient because of mild reversible leucopenia. At 6 months, event-free survival was 90.3%. Major events involved CABG in 4 patients and a second PTCA at the same site in 14 patients. The target vessel revascularization rate at 6 months was 6.2%. This study demonstrates that Palmaz-Schatz stenting of single de novo lesions with length < 15 mm, without ultrasound guidance but with the routine use of high-pressure balloon dilatation, and with ticlopidine and aspirin as the sole treatment post intervention, is feasible and safe both in terms of clinical outcome and hematologic adverse side-effects. This registry demonstrates that six-month event-free survival exceeding 90% can be achieved.

Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group.

OBJECTIVES: This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial. BACKGROUND: The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations. METHODS: To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion. RESULTS: After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up. CONCLUSIONS: These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.

Intracoronary stenting without coumadin: one month results of a French multicenter study.

In order to simplify post-coronary stenting treatment and to obtain a lower rate of complications, especially in bailout situations, seven French institutions treated 246 stented patients with 0.25 g/day of ticlopidine, 0.1 g/day of IV aspirin, and 2 days of heparin followed by low-molecular-weight heparin for 1 month. Fifty percent of patients had a planned stenting procedure, and 50% had an unplanned procedure, including 29 (11.8%) in bailout situations. Subacute occlusion occurred in three (1.2%) patients (one death, two non-Q-wave infarctions). During the 1 month follow-up period, another death was reported (non-stent-related), two elective coronary artery bypass grafts were performed, and three additional patients presented with non-Q-wave myocardial infarctions. Nine (3.7%) patients had a groin complication that required blood transfusion or surgical repair. These results suggest that while waiting for the technological advancements of stents, postprocedural treatment that includes a low dosage of ticlopidine, aspirin, and low-molecular-weight heparin is a very effective alternative to conventional poststenting therapy.

Critical analysis of cineangiographic criteria for diagnosis of arrhythmogenic right ventricular dysplasia.

Biplane 30-degree RAO and 60-degree LAO RV selective cineangiography was performed in 21 patients with significant ventricular arrhythmias (ventricular tachycardia in 14, salvos in three, and complex PVCs in seven) and a high presumption of arrhythmogenic RV dysplasia (ARVD), and in a control group of 10 presumed normal individuals. Comparing the two series revealed the lack of specificity of some angiographic images usually reported as suggestive signs of ARVD, such as slow dye evacuation of RV during the levophase and deep fissuring in the anterior wall with a "pile of plates" image. Inversely, localized morphologic and contraction abnormalities in the RV free wall were more sensitive and specific signs for diagnosis of ARVD; these were localized akinetic or dyskinetic bulges sometimes giving a true image of aneurysm (90%), wide and deep fissuring of the apex or of the inferior wall (33%), and large areas of akinesia. By order of frequency, these abnormalities were found on the apex in 71%, on the inferior wall in 52%, on the anterior wall in 48%, in the subtricuspid area in 38%, and on the pulmonary infundibulum in 33%. These localized lesions can suffice for the diagnosis of RV dysplasia in the absence of associated pathologies, such as ischemic heart disease or congenital defects. Usually a global RV systolic dysfunction is associated in ARVD, as confirmed by greater RV volumes (134 +/- 26 vs 79 +/- 10 ml/m2 for RVEDV, p less than 0.001; 76 +/- 34 vs 32 +/- 6 ml/m2 for RVESV, p less than 0.001), and lower RV ejection fraction (58 +/- 18% vs 47 +/- 8%, p less than 0.001) in the ARVD group compared to controls. Nevertheless, normal RV volumes and ejection fraction can be observed in some localized forms with mono- or bisegmental lesions in which RV systolic dysfunction is absent or moderate, and extensive forms with multiple segmental lesions where RV systolic dysfunction is constant and often severe. Six out of 21 patients in the ARVD group exhibited obvious global or segmental LV dysfunction, indicating the possibility of biventricular forms, as previously reported in other publications.

[pHmetry and manometry of the esophagus in patients with pain of the angina type and a normal angiography]. / pH-métrie et manométrie de l'oesophage chez des sujets avec douleurs de type angineux et une coronarographie normale.

The role of gastroesophageal reflux and esophageal motility abnormalities in patients with angina-type chest pain and normal coronary angiogram is not clear. The aim of this study was: a) to assess the importance of these two disorders in the same patients, b) to study the diagnostic usefulness of provocation tests, c) to determine final outcome in these patients. Seventeen patients with angina-type chest pain and normal coronary angiograms were studied to determine the diagnostic value of esophageal manometry, postprandial esophageal pH monitoring, provocation tests (methylergometrine stimulation, acid perfusion test) and endoscopy. Baseline esophageal motility was abnormal in 10 patients. Esophageal motility disorders were nonspecific in seven patients. Eight patients had reflux. The mean lower esophageal sphincter pressure was decreased in these patients as compared with normals, and endoscopy showed a high Z line, and/or a large opening of the cardia in 7 of them. Neither conventional manometry nor postprandial esophageal pH monitoring allowed to consider the esophagus as responsible for chest pain. The methylergometrine test was positive in 4 patients (simultaneous occurrence of familiar pain and esophageal dysmotility). Baseline manometric studies did not allow to forecast the response to methylergometrine injection. The acid perfusion test was negative (no symptoms were reproduced) in all patients. After esophageal evaluation, 16 patients were followed for a mean of 26 +/- 9 months. No cardiac disorders appeared, but all patients continued to have pain, and 7 were incapable of working.(ABSTRACT TRUNCATED AT 250 WORDS)

Angiographic and surgical aspects of compressive muscular bridges and intramyocardial paths of the anterior interventricular artery (based on 12 cases).

The authors report 12 cases of myocardial bridges over the anterior interventricular artery discovered surgically. In 5 the compressive myocardial bridges were limited; in 7 the intramyocardial course of the anterior ventricular artery was discovered at operation. Comparison of the operative appearances with the angiographic findings affords a basis for anatomico-radiologic correlation. The authors stress the difference in frequency and significance between the compressive myocardial bridge (an indication for surgery) and the intramyocardial anterior interventricular artery discovered by chance during a procedure for coronary revascularization indicated for stenosing atherosclerotic lesions.

[Mid-term outcome of acute right ventricular dysfunction in biventricular myocardial infarction. Hemodynamic and cineangiographic studies]. / Devenir à moyen terme de la dysfonction aiguë du ventricule droit dans les infarctus du myocarde biventriculaires. Etude hémodynamique et cinéangiographique.

This study was designed to evaluate the mid-term outcome of the right ventricular (RV) dysfunction which characterizes infarction of both ventricles in the acute phase. Thirteen patients hospitalized for inaugural posterior or infero-posterior infarction extending to the right ventricle (haemodynamic and cineangiographic diagnosis) were explored in the acute phase and 4 months later by right heart catheterization and selective cineangiography of the right ventricle in a 30 degrees RAO projection. The results were compared with those obtained in a control group. Haemodynamically, the RV filling pressures (p less than 0.001) and the indices of RV dysfunction--i.e. RV end-diastolic pressure/RV systolic pressure ratio (p less than 0.001) and right atrial pressure/pulmonary wedge pressure ratio (p less than 0.02)--were significantly decreased between the acute and chronic phases, but they remained pathological compared with those measured in the control group. Angiographically, the right ventricular dysfunction in the acute phase was reflected in an increase of the RV end-systolic volume (p less than 0.02) and a decrease of the RV ejection fraction (p less than 0.01), whereas diastolic cavitary dilatation was inconstant, with mean values of RV end-diastolic volume close to those found in the control group. The systolic dysfunction persisted, unchanged, during the chronic phase. Segmental kinetics of the inferior wall was much reduced in the acute phase (p less than 0.001), this hypokinesia partially regressing in the chronic phase; but in fact there were wide individual variations, and some patients even recovered an almost normal contractility. Tricuspid valve regurgitation was frequent (6/13 cases) in the acute phase and regressed in 2 out of 3 cases in the chronic phase; its presence introduced a degree of bias in the measurement of RV end-systolic volume and RV ejection fraction, with a tendency to underestimate the severity of diastolic dysfunction. To summarize, right ventricular dysfunction was constant but often modest in the acute phase and remained relatively stable at mid-term, whereas segmental kinetics of the inferior wall improved, sometimes dramatically.

[Measurement of right ventricular volume by cineangiography. Validation of monoplane analysis compared with biplane]. / Mesure des volumes ventriculaires droits par la cinéangiographie. Validation de l'analyse monoplan comparée au biplan.

It is demonstrated that right ventricular volumes can be measured accurately by biplane cineangiography using the Simpson's rule or various area-length methods. In order to validate the single plane approach a biplane (30 degrees RAO-60 degrees LAO) right ventricle (RV) cineangiography was performed in 10 adults investigated for chest pain without coronary artery disease or any other heart disease. RV volumes (EDV: end-diastolic; ESV: end-systolic; SV: stroke volume) and EF (ejection fraction) were measured by biplane and single plane analysis with the same area-length method using the pyramide with triangular base as geometric model (Ferlinz). The results are: RVEDV (ml/m2) biplane (B) 81 +/- 10, monoplane (M) 82 +/- 11; RVESV (ml/m2) B 33 +/- 6, M 35 +/- 8; RVSV (ml/m2) B 48 +/- 8, M 47 +/- 10; RVEF (%) B 59 +/- 6, M 57 +/- 8. Equations of linear regression show the following correlations: RVEDV R = 0.82 p less than 0.01; RVESV R = 0.77 p less than 0.01; RVSV R = 0.92 p less than 0.001; RVEF R = 0.85 p less than 0.01. Authors conclude to a good enough correlation between monoplane and biplane analysis especially for RVSV and RVEF. They underline the great variability of individual values.

Thrombolysis of acute total occlusion of the left main coronary artery and long-term survival.

A young woman was admitted with acute anterior myocardial infarction. Emergency coronary angiography showed a total occlusion of the LMCA. Selective infusion of streptokinase recanalized the left main coronary artery (LMCA), the circumflex artery, and the first diagonal, but not the entire left anterior descending artery (LAD). The right coronary artery was dominant and normal. The left-sided congestive heart failure was severe; treatment improved the heart failure and the patient was discharged on Day 25. She was readmitted for control 28 months later: she was only moderately disabled and coronary angiography showed the same occlusion of the LAD; result on ejection fraction (right anterior oblique view 30 degrees) was not significant, but circumflex artery recanalization probably preserved lateral wall contraction. The presence of a normal dominant right coronary artery seems to be a very important factor in contributing to initial survival.

Dilated cardiomyopathy and the level of alcohol consumption: a planned multicentre case-control study.

The association between clinical or environmental factors and dilated cardiomyopathy (DCM) has been assessed in a planned case-control study. Patients and controls were men aged between 20 and 65 years, matched for age, profession and geographic location. DCM was defined by strict radiologic and angiographic criteria excluding multiple-vessel coronary disease. Controls were recruited from the surgical centres after excluding diseases usually linked with alcohol or tobacco consumption. Univariate and multivariate analyses were used to ensure adequate techniques for matched pairs. The prevalence of diabetes and hypertension and the exposure to toxic substances, drugs and tobacco was identical in both groups. Alcohol consumption before the onset of first symptoms was higher in patients than in controls (101 vs 64 ml day-1, P less than 0.001); the excess of consumption concerns all kinds of alcoholic beverage (wine, beer, etc.). The relative risk (RR), estimated from the odds ratio, increased only among heavy drinkers (greater than or equal to 110 ml day-1; RR: 7.6, P less than 0.001) with an independent contribution of both wine (RR: 4.7, P less than 0.001) and other alcoholic beverages (RR: 4.1, P less than 0.01). In conclusion, alcohol is a strong risk factor for DCM, but the excess of risk is limited to heavy drinkers and is independent of the type of beverage.

[Evaluation of coronary lesions in biventricular inferoposterior infarction]. / Bilan lésionnel coronarien des infarctus inféro-postérieurs biventriculaires.

Fifty-two patients with primary transmural infero-posterior infarcts underwent right heart catheterisation on admission to hospital and coronary angiography between the 7th day and 4th month after onset of symptoms. The patients were divided into two groups A (N = 34) with signs of right ventricular dysfunction on admission indicating biventricular infarction, and B (N = 18) without right ventricular dysfunction classified as isolated LV infarction. No significant differences were observed between the two groups with respect to: global and regional LV function; the incidence of single, double and triple vessel disease; the incidence and location of right coronary artery thrombosis; the incidence and location of lesions of the left coronary tree (LCA, LAD, Cx); the extent of coronary disease (Gensini score); the dominant artery (right coronary/circumflex), the frequency and quality of revascularisation of distal vessels. The only significant differences were the higher incidence of severe lesions (90 p. 100) of the right coronary and circumflex arteries and of stenosis of the first large septal branch of the LAD artery in Group A (p less than 0.05). These results show that the indications for coronary angiography in biventricular inferior infarction are no greater than those in mono LV inferior infarction. This supports experimental data on the physiopathology of RV infarction which demonstrates that except in cases of proximal thrombosis of the right coronary artery, the possibilities of revascularisation from the left coronary tree are limited.

[Severe hypoxemia due to a right-to-left shunt at the atrial level caused by an infarction of the right ventricle]. / Hypoxémie sévère par shunt droite-gauche à l'étage auriculaire lié à un infarctus du ventricule droit.

The authors report the case of a biventricular inferior myocardial infarction complicated in the acute phase by massive tricuspid regurgitation and a right-to-left interatrial shunt through a patent foramen ovale; this resulted in severe hypoxaemia. The diagnosis was made by contrast 2D echocardiography which showed ventriculo-atrial regurgitation and the passage of microbubbles from the right to the left atrium leading to opacification of the left ventricule: right heart catheterisation with oxymetry and selective right ventriculography confirmed the diagnosis. The hypoxaemia became less severe as the haemodynamic conditions improved. This is one possible mechanism of severe hypoxaemia in the acute phase of myocardial infarction and should be excluded routinely in this situation as it can have important prognostic and therapeutid implications.

[Tricuspid insufficiency in biventricular myocardial infarct]. / L'insuffisance tricuspidienne des infarctus du myocarde biventriculaires.

Tricuspid insufficiency (TI) has already been reported as a possible complication of biventricular infarction. However, in the absence of large study groups, this condition is not well known. This paper reports the results of 2 studies: a retrospective study of 91 biventricular infarcts, identified by haemodynamic criteria, and a prospective study of 23 consecutive patients (belonging to the previous group) in whom selective right ventricular cineangiography was performed in the acute phase. The following conclusions were drawn: moderate to severe TI is very common during the first days of infarction (30%/39%); the diagnosis is simple, based on non invasive, very sensitive (89%) and specific (100%) haemodynamic criteria; it is associated with a much more severe clinical and haemodynamic presentation and with a higher mortality in the acute phase (37% vs 6.2% in the global study); the poor prognosis does not persist in the long term; regression is common (2/3 to 3/4 of cases) and angiographic data suggests that it is often related to a transient ischaemic papillary muscle dysfunction. Acute paralysis of the right atrium may also play a major role; the TI remains unchanged only in rare cases and may then be responsible for a chronic right ventricular dysfunction and then raise the question of surgical intervention.

[Infarction of the right ventricle]. / Les infarctus du ventricule droit.

Anatomical studies have confirmed that isolated right ventricular and anterior biventricular infarcts are rare. However, RV extension is found in 36 to 50 per cent of cases of postero-inferior infarcts, which confirms the findings of invasive and non-invasive investigations which detect acute RV dysfunction with the same frequency after this type of infarct. It is difficult to create right ventricular infarction experimentally because of the relative protection against ischaemia of the RV. In man, this condition almost always implies an associated thrombosis of the proximal right coronary artery and significant stenosis of the IVA, which justifies the broad indications for coronary angiography. The two major haemodynamic consequences of right ventricular infarction are due to original pathophysiological mechanisms: the adiastole seems to be due to a limitation of RV dilatation by the pericardium, the reduced output is due to faulty LV filling as a result of RV systolic dysfunction and associated factors such as the absence of efficient and synchronous atrial systole secondary to AVB (60%) or to acute right atrial paralysis. The choice of treatment is based on these pathophysiological data. The diagnosis of infarction of the RV is straightforward, often suggested on clinical examination (RVI syndrome: reduced output in 45% of cases) and the surface E.C.G. (ST-T depression 1 mm in V3R-V4R-V5R). The diagnosis is confirmed by more sophisticated investigations which can evaluate the degree of systolic dysfunction.(ABSTRACT TRUNCATED AT 250 WORDS)

[Prospective study of the diagnostic and prognostic criteria of right ventricular involvement in the acute phase of inferoposterior infarction]. / Etude prospective des critères diagnostiques et pronostiques de l'atteinte ventriculaire droite à la phase aiguë des infarctus inféro-postérieurs.

Right ventricular involvement has been shown to be common in the acute phase of infero-posterior myocardial infarction. The aim of this prospective study was to assess the diagnostic and prognostic value of the different criteria obtained by clinical and paraclinical methods of investigation. Forty patients (35 men, 5 women: mean age 57,1 years) admitted consecutively with this type of transmural infarct without any other cause of acute or chronic volumic or barometric overload of the RV were investigated. In addition to clinical data, the following paraclinical investigations were carried out during the first three days of admission: ECG and vectorcardiogramme (VCG); transaminase levels (SGOT and SGPT), creatinine phosphokinase (CPK), alpha HBDH, serum creatinine, blood gases (pO2), M mode and 2 D echo, right heart catheterisation and cardiac output estimations, selective RV and pulmonary cineangiography centered on the LV in the monoplane 30 degrees LAO projection. Two groups of twenty patients were identified, comparable in age and sex, according to the angiographic extension of akinesia of the RV inferior wall: Group A: extensive akinesia (greater than or equal to 30 p. 100), Group B: very localised or no akinesia (less than 30 p. 100). Analysis of the results showed a number of features characterising patients in Group A: the high incidence of initial shock (45 p. 100 (A)/0 p. 100 (B] and signs of RV failure (85 p. 100/0 p. 100), higher SGOT, SEPT (p less than 0,05) and alpha HBDH (p less than 0,02) but not of CPK; much higher serum creatinine (p less than 0,01) and lower p02 (p less than 0,05); the ECG showed a high incidence (85 p. 100) and specificity (95 p. 100) of ST-T elevation in V3R and V4R, and also 2nd or 3rd degree AV block (60 p. 100/5 p. 100): there were no characteristic VCG changes. Catheterisation showed very significant increases (p less than 0,001) of mean RA, and RV end diastolic pressures, of the RA/mean pulmonary capillary pressure ratio and of Yu's index. There was a moderate increase in PCP (p less than 0,01), a drop in right ventricular systolic work index (RSSWI); adiastole was very common (90 p. 100) and very specific (95 p. 100); angiography showed an increase in RV end diastolic and end systolic volumes (p less than 0,05) and a fall in RV ejection fraction (p less than 0,05) but with a lot of individual variations; there were no significant differences between the two groups as regards the volumes, ejection fractions and p. 100 akinesia of the LV.(ABSTRACT TRUNCATED AT 400 WORDS)

[Exercise tests before and after aortocoronary bypass]. / Les épreuves d'effort avant et après pontage aorto-coronarien.

A stress test was performed before and after by-pass grafts in 83 patients. Post-operatively, the number of painful stress tests fell from 68 to 28. Whatever the initial clinical picture (stable angina, anterior or inferior infarct), the improvements is significantly better when all of the lesions have been by-passed. Furthermores, there was no significant change in the maximal performance, but the appearance of pain occurred at much higher values, reflecting the improvement in coronary perfusion and the displacement of the point of appearance of ischaemia.