IPO-V2: a prospective, multicenter, randomized, comparative clinical investigation of the effects of sulodexide in preventing cardiovascular accidents in the first year after acute myocardial infarction.

OBJECTIVES: This study was conducted to assess the efficacy of sulodexide, a glycosaminoglycan compound with antithrombotic properties, in preventing death and thromboembolic events after acute myocardial infarction. BACKGROUND: Antithrombotic therapy has been found to play an important role in the prevention of cardiovascular events and death after acute myocardial infarction. Glycosaminoglycan-containing compounds, including sulodexide, show profibrinolytic and antithrombotic properties that render them suitable for use in patients after infarction. METHODS: A total of 3,986 patients who had recovered from acute myocardial infarction were randomized to receive either the standard therapy routinely administered at each study center, excluding antiplatelet and anticoagulant drugs (control group, 1,970 patients), or the standard therapy plus sulodexide (treated group, 2,016 patients). Between 7 and 10 days after the episode of acute myocardial infarction, sulodexide was administered as a single daily 600-lipoprotein-lipase-releasing unit (LRU) intramuscular injection for the 1st month, followed by oral capsules of 500 LRU twice daily. Patients were evaluated for > or = 12 months. RESULTS: At the end of the study, 140 deaths (7.1%) were recorded in the control group and 97 (4.8%) in the sulodexide group (32% risk reduction, p = 0.0022, chi-square test). A total of 90 patients (4.6%) in the control group had a further infarction, compared with 66 (3.3%) in the sulodexide group (28% risk reduction, p = 0.035). Furthermore, a reduction in left ventricular thrombus formation (evaluated by echocardiography) was observed in the sulodexide group (n = 12; 0.6%), compared with values in the control group (n = 25; 1.3%) (53% risk reduction, p = 0.027). Sulodexide was well tolerated and devoid of significant adverse events. All significant results were confirmed by "actual treatment" analyses. CONCLUSIONS: The study provides evidence that long-term therapy with sulodexide started early after an episode of acute myocardial infarction is associated with reductions in total mortality, rate of reinfarction and mural thrombus formation.

Enhanced "in vitro" release of platelet alpha-granules after acute myocardial infarction (AMI).

In vivo platelet activity was studied in 58 patients with AMI on admittance to the Coronary Care Unit, in 48 of these patients after 1 week, in 30 after 1 month and in 24 patients after 6 months. Patients were carefully selected and excluded if they had associated diseases known to increase platelet activity. In vivo activation was studied by evaluating the plasma concentration of beta-thromboglobulin (beta-TG) and platelet factor 4 (PF4) in the same blood sample. On admittance (x = 58.5) and on day 7 (x = 52.9) beta-TG values were significantly higher than those obtained in the control group (x = 29). beta-TG values were moderately elevated after 1 month (x = 37.7) and then returned to values similar to those of the control group after 6 months (x = 27.9). The simultaneous assessment of PF4 shows a beta-TG/PF4 ratio indicative for in vitro release (less than or equal to 2.5) in many patients on days 1 and 7. Moreover, the beta-TG/PF4 ratio in patients with AMI tends towards 2 when beta-TG values are high. These results may indicate a greater tendency to an in vitro platelet release in the acute phase of AMI.

Adenosine diphosphate (ADP)-induced alpha-granules release from platelets of native whole blood is reduced by ticlopidine but not by aspirin or dipyridamole.

A brief contact between native whole blood and ADP promotes a dose-dependent release of platelet alpha-granules without a fall in the platelet number. We assessed the "ex vivo" effect of three widely used antiplatelet drugs, aspirin dipyridamole and ticlopidine, on this system. Aspirin (a single 800 mg dose) and dipyridamole (300 mg/die for four days) had no effect, while ticlopidine (500 mg/die for four days) significantly reduced the alpha-granules release for an ADP stimulation of 0.4 (p less than 0.02), 1.2 (p less than 0.01) and 2 microM (p less than 0.01). No drug, however, completely inhibits this early stage of platelet activation. The platelet release of alpha-granules may be related to platelet shape change of the light transmission aggregometer and may be important "in vivo" by enhancing platelet adhesiveness and by liberating the platelet-derived growth factor.

Pregnancy in patients with a porcine valve bioprosthesis.

Seven patients who became pregnant after valve replacement with a Hancock bioprosthesis were followed up during 8 pregnancies. Six had undergone isolated mitral valve replacement, and 1 had mitral and aortic valve replacement. Their age at the time of operation ranged from 14 to 31 years (average 24); delivery occurred 21 to 88 months (average 51.3) after valve replacement. All women were in sinus rhythm at the time of gestation, and administration of oral anticoagulants was avoided in all. No embolic episodes occurred either after operation or during pregnancy, labor, or puerperium. The only major complication during pregnancy was cardiac failure in 1 patient, associated with onset of atrial fibrillation. Four women had vaginal delivery and 3 required cesarean section. All but 1 delivered a normal, healthy baby. One premature infant died soon after birth because of respiratory distress. No maternal or fetal hemorrhagic complications were observed. One patient died 3 months after delivery in severe heart failure caused by diffuse calcification of both mitral and aortic xenografts. Another women underwent successful reoperation soon after the second pregnancy because of calcific stenosis of the mitral porcine valve. It is concluded that (1) bioprosthetic valves can be considered the most suitable devices employed in women of childbearing age because anticoagulants can be avoided, therefore eliminating the risks related to inappropriate administration of oral anticoagulants as well as the hazards associated with the potential teratogenic effect of coumarin drugs; and (2) pregnancy might favor calcification of porcine heterografts, leading to bioprosthetic failure. Until further data are available to support this suspicion, close clinical and echocardiographic follow-up study of these patients is recommended after pregnancy.

Surgical removal of a left atrial myxoma during pregnancy.

Successful removal of a left atrial myxoma in a pregnant woman has not been previously reported. The patient postoperatively had an uncomplicated pregnancy, delivering at term a normal, healthy baby.

Recurrent thrombosis of Omniscience prostheses in the mitral position: a case report.

We report a patient who experienced thrombotic obstruction of an Omniscience prosthesis three years after mitral valve replacement. At reoperation another Omniscience prosthesis was inserted which became thrombosed after eight months. Recurrent thrombosis of the same prosthesis in the same patient is unusual and raises the problem of which device to use when replacing a thrombosed valve. In our patient another mechanical prosthesis was inserted at second reoperation because of her young age and in the hope of reducing the risk of further thrombosis by using a valve with better flow characteristics such as a bileaflet prosthesis.

[Idiopathic orthostatic hypotension (Shy-Drager syndrome). Clinical and hemodynamic studies of a case]. / Ipotensione ortostatica idiopatica (sindrome di Shy-Drager). Osservazioni cliniche ed emodinamiche in un caso.

A case of idiopathic orthostatic hypotension (Shy-Drager syndrome) in a 50-year-old man is reported. The diagnosis was made after other possible causes of orthostatic hypotension had been excluded. The Authors emphasize the need for a correct diagnosis in order to adopt an adequate symptomatic therapy, and to avoid useless and often harmful treatments.

Pregnancy in a patient after mitral valve replacement with a porcine bioprosthesis.

The course of two pregnancies in a woman, who had previously undergone mitral valve replacement with a porcine bioprosthesis, is reported. The present case suggests that porcine heterografts are to be considered as the most suitable cardiac valve substitutes in females of childbearing age, since anticoagulants are not needed, avoiding therefore the risks related to both an incorrect anticoagulation and to the recognized teratogenic effect of coumarin drugs.

[Sampling study on practitioners' attitude to the prevention of infectious endocarditis]. / Indagine campionaria sull'orientamento dei medici di base nella prevenzione dell'endocardite infettiva.

UNLABELLED: BACKGROUNDS AND METHODS: The opinions and the experience of Veneto practitioners about prevention of infective endocarditis were detected through a sample survey among the 386 practitioners of Health and Social Unit Nr 16, 17, and 36 of Veneto Region. The interview was carried out through a questionnaire, sent by mail, asking for: 1) general information on the practitioner's profession; 2) information about the previous experience in diagnosis and care of heart diseases, particularly of infective endocarditis, of atrial septal defect ostium secundum type without pulmonary hypertension, of unstable angina, and moderate mitral stenosis; 4) attitudes in the prevention of infective endocarditis. Of 386 practitioners surveyed, 186 (48.2%) responded. More than 60% of the responders held a diploma of specialization and 7% were cardiologists, half of the responders had worked in public hospitals. The 63.8% of the practitioners had patients over sixty in a percentage of 15-44%. In 1990 only 5.9% of the practitioners observed new cases of infective endocarditis, while half of them stated that some of their patients had suffered from this disease in the past. RESULTS: The assessment of the level of severity for every heart disease is ranged between 0 (the minimum) and 10 (the maximum). The statistical analysis showed that the minimum arithmetic mean (+/- SD) is given for atrial septal defect without pulmonary hypertension with 4.6 +/- 2. Then for moderate mitral stenosis with 7.1 +/- 1.6, unstable angina pectoris with 7.4 +/- 2 and the maximum mean is given for infectious endocarditis with 8 +/- 1.7. ANOVA statistical analysis applied on the four paired series of assessment of severity carried out a high significant difference (F of Snedecor = 328.2; P < 0.001) among assessments, and among practitioners (F = 1.71; P < 0.01). High significant linear correlation (at least P < 0.01) is observed among the severity of the four heart diseases. Vice versa not significant association is showed between severity for every heart diseases and the experience of the interviewed. CONCLUSIONS: Most practitioners would prescribed prophylaxis for infective endocarditis to patients with rheumatic valve disease (91% of the responders), with previous episodes of infective endocarditis (90.4%), with prosthetic valve (67.6%) or with degenerative valve disease (57.3%). On the contrary most practitioners would not prescribe the prevention for infective endocarditis to patients with coronary heart disease (84.9%), with coronary bypass (71.4%), with mitral valve prolapse without insufficiency (60.6%), with dilatative cardiomyopathy (67%) or with obstructive cardiomyopathy (57.8%). A prevailing trend in case of congenital heart disease and mitral valve prolapse with insufficiency was not observed. The 86.6% of practitioners would prescribe the prophylaxis for infective endocarditis in case of dental extraction, but only the 64.4% would prescribe it in case of any potentially haemorrhagic oral or dental procedure. The 61.7% of the responders would not prescribe the prevention for infective endocarditis to patients receiving the prophylaxis for rheumatic fever. The practitioners would use in the following order: amoxicillin (77.3%), erythromycin (76.9%), penicillin V (76.3%) and ampicillin-gentamycin (61.3%). On the contrary, most responders would prescribe neither tetracycline (73%) nor spiramycin (69.8%). There is no prevailing trend to the employ of oral cephalosporins. The 90.3% of the practitioners think that infective endocarditis can be a quite interesting and useful subject for an up-to-date course.