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Biomedical subjects

E Varani

Publications and source records attributed to E Varani.

At least 19 recordsLinked to original sources

Starc II, a multicenter randomized placebo-controlled double-blind clinical trial of trapidil for 1-year clinical events and angiographic restenosis reduction after coronary angioplasty and stenting.

The objective of this study was to investigate the effect of trapidil 200 mg t.i.d. in preventing the occurrence of death, of myocardial infarction and the need for repeat revascularization at 12 months after balloon PTCA with or without stenting. Coronary restenosis after stenting is still a major drawback of percutaneous coronary interventions (PCI) for 30-40% of patients. Trapidil has been shown to prevent restenosis after PTCA. Eligible patients were randomized to placebo or oral trapidil 200 mg t.i.d. at least 48 hr before PCI and continuing 6 months after a successful balloon angioplasty or stent implantation. Aspirin was given to all patients, and ticlopidine 250 mg b.i.d. to those who received a stent for 4 weeks. In a randomized subgroup of 216 patients, quantitative coronary angiography was performed also at 6-month follow-up. Out of the 933 patients enrolled, primary endpoint incidence was 20.3% in trapidil and 18.0% in placebo (P = 0.37). When recurrence or deterioration of angina was added to the combined endpoint, incidence was 27.4% in trapidil and 23.0% in placebo (P = 0.12). Restenosis rate in patients with 6-month angiography was 25.0% in trapidil arm vs. 30.1% in placebo (P = 0.43). Stent restenosis rate was similar in patients randomized to trapidil or placebo (30.2% vs. 23.8%, respectively; P = 0.44), while in patients treated with balloon angioplasty, it was lower in trapidil (17.1%) than in placebo (40.0%; P = 0.03). Oral trapidil 200 mg t.i.d. for 6 months in addition to aspirin did not influence the occurrence of major cardiac events after coronary angioplasty with or without stenting. In a prespecified subgroup of 191 patients treated with balloon angioplasty only, trapidil reduced angiographic restenosis.

Angioplasty, Balloon, Coronary↗

[Cost of diagnostic and therapeutic hemodynamic procedures: comparison with DRG reimbursement].

BACKGROUND: The cumulative costs of diagnostic and interventional procedures in the catheterization laboratory in public hospitals are still largely unknown, notwithstanding the present stress upon the cost-effectiveness issues in medicine. METHODS: From January through April 2000 we have evaluated procedures in the catheterization laboratory of the Ravenna USL. Costs taken into consideration were the following: the mean cost of materials for each type of examination and of medications used for each patient, personnel costs, machinery mortgages' costs, ambulance transportation's costs, and general hospital expenditures. DRGs and reimbursements have been calculated on the basis of clinical indications and modalities of procedures. RESULTS: During the evaluation period 268 patients have been studied. The procedures taken into consideration included: 135 coronary angiographies, 36 right and left catheterizations plus coronary angiography, 87 coronary angiographies plus percutaneous coronary intervention (PCI), 10 PCI. The total cost of diagnostic catheterization was Itl 1,226,000 (Euro 632) whereas that of each PCI (including stent implantation in 80% of cases) associated in 87 cases with coronary angiography was Itl 5,956,000 (Euro 3044). Patients with an acute coronary syndrome or heart failure were mostly studied during their first hospital stay; those with stable disease (stable angina, previous myocardial infarction, valvular heart disease or cardiomyopathy without heart failure) were studied during ordinary hospital admission or in the context of a day-hospital. DRGs and corresponding reimbursements for the different clinical situations were the following: unstable angina DRG 124 valued at Itl 6,180,000; stable angina DRG 125 valued at Itl 3,900,000; acute or recent myocardial infarction with or without complications DRG 121 or 122 valued at ItI 8,290,000 or Itl 5,900,000; heart failure in valvular heart disease or cardiomyopathy DRG 124 valued at Itl 6,180,000; valvular heart disease or cardiomyopathy DRG 125 valued at Itl 3,900,000. The DRG for a PCI is no. 112 valued at Itl 10,235,000. CONCLUSIONS: The costs of diagnostic and interventional hemodynamic procedures were acceptable and proportional to the DRG-related reimbursements. Appropriately indicated procedures and their quick execution during the first hospital stay lead to global economic savings for the health care system and are also clinically advantageous for the individual patient.

Cardiac Catheterization↗

[Presence of patent foramen ovale in different heart diseases: incidence in 211 consecutive patients studied by transesophageal echocardiography].

BACKGROUND: Contrast echocardiography during the decompression phase of the Valsalva manoeuvre in course of transesophageal echo study is the ideal method to identify patent foramen ovale. METHODS: In order to evaluate the incidence of patent foramen ovale in patients with different cardiac diseases we performed contrast injection in 211 consecutive pts submitted to TEE (Transesophageal Echocardiography) in our laboratory between march 1991 and march 1993. RESULTS: Fiftythree of 211 pts (25%) presented a patent foramen ovale. The incidence in the different cardiac diseases was as follows: 0% in rheumatic mitral disease, 23% in aortic valve disease, 17% in mitral and/or aortic valve prosthesis, 29% in congenital heart disease other than interatrial septal defect, 44% in mitral valve prolapse and 92% in atrial septal aneurysm. CONCLUSIONS: This study indicates that patent foramen ovale is a common finding in different cardiac pathologies and frequent in mitral valve prolapse and even more in atrial septal aneurysm. In case of peripheral embolism of likely cardiac origin, the patency of the foramen ovale must be recognized, especially when these two latter cardiac anomalies are identified.

Aged↗

[Management and prognosis of acute myocardial infarct in advanced age: comparison of the cardiac intensive care unit and the cardiology ward].

The aim of this prospective study was to assess the prognostic and most suitable management of AMI in elderly patients (age > or = 75 years). From September 1988 to August 1991, 129 such patients (pts) were evaluated: 35 (27%) were admitted to CCU because of arrhythmias or severe hemodynamic complications; 94 (73%) were addressed, according to bed availability, to CCU (55 pts) or Cardiology Ward (39 pts), where all patients underwent continuous ECG monitoring for at least 72 hours. Age, gender, history of previous angina or myocardial infarction, presence of chest pain or ECG ischemia on admission, site and extent of AMI, delay on admission, CPK-MB peak, recurrent angina, arrhythmias, heart failure, emotional disorders, hospital mortality and length of hospital stay were compared. Our results show that elderly patients who suffered from complicated AMI were at high risk for death and severe in-hospital complications. No significant prognostic differences were observed between the two groups with uncomplicated AMI. Thus hospitalization in the Cardiology Ward seems to be valuable, safe and well tolerated in our population of elderly patients with AMI, and without initial complications.

Age Factors↗

[Thallium and echo- dipyridamole in the early selection of patients at risk after acute myocardial infarction. Which test? What dose?].

UNLABELLED: The optimal iv dose of Dipyridamole (Dip) in echocardiography (echo) or Thallium scintigraphy (Tl) remains undetermined. To select the high-risk patients (pts) subset, we performed echo and Tl with standard dose (SD) and high dose (HD) Dip infusion (0.56 mg/Kg/4'-0.84 mg/Kg/10' respectively) in 40 pts 9 +/- 3 days after admission for acute myocardial infarction (AMI). Of these, 38 pts had coronary artery disease at angiography and 2 had no significant lesions. Worsening in regional wall motion on echo and reversible perfusion defects on Tl were considered abnormal patterns. SD had no side effects; only in one pt was ischemic ventricular dysfunction detected on echo, whereas Tl redistribution was found in 24 pts (12 had multivessel disease and 12 had one coronary stenosis greater than or equal to 70%). HD caused adverse reaction in 24 pts, did not enhance SD-Tl sensitivity, but induced abnormal echo in 18/24 pts with transient defects on SD-Tl. Eleven of the 16 Tl negative pts had occlusive disease, 3 had one vessel disease and 2 showed no evidence of coronary artery disease. IN CONCLUSION: SD is safe but often provokes a submaximal coronary vasodilation. Failure to detect ischemia on echo may be explained by this. SD-Tl is, however, able to identify high-risk pts who may benefit from early myocardial revascularization. HD does not enhance SD-Tl sensitivity, but it is necessary to induce echo abnormalities which are all too often undetectable at SD.

Adult↗

Usefulness of nicorandil in congestive heart failure.

Rest and exercise hemodynamic and hormonal effects of nicorandil, a nicotinamide-nitrate vasodilator, were assessed in 9 patients with New York Heart Association class II or III congestive heart failure (CHF) and left ventricular ejection fraction less than or equal to 40%. Single oral doses of placebo and 40 and 60 mg of nicorandil were given in a double-blind, randomized trial. Hemodynamic measurements were assessed at rest, up to 8 hours after dose and at peak exercise performed on an upright cycloergometer 1 hour after the dose. Forearm blood flow and venous capacitance were measured by plethysmography 45 minutes after dose. Plasma noradrenaline and plasma renin activity were assessed 1 hour and 2 hours after dose, respectively. Data were analyzed by analysis of variance. Peak effects were observed between 30 and 60 minutes after dose. Mean blood pressure decreased from 86 +/- 7 mm Hg after placebo to 78 +/- 7 mm Hg after 40 mg (p less than 0.05) and to 78 +/- 7 mm Hg after 60 mg (p less than 0.05) of nicorandil. Mean pulmonary artery pressure decreased from 24 +/- 11 to 15 +/- 17 mm Hg (p less than 0.05) and to 17 +/- 7 mm Hg (p less than 0.05) and mean pulmonary wedge pressure decreased from 15 +/- 8 to 9 +/- 4 mm Hg (p less than 0.05) and to 10 +/- 5 mm Hg (p less than 0.05). The changes were significant up to 6 to 8 hours after both doses.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

[The clinical evaluation of the severity of chronic heart failure: a comparison between the NYHA functional class and the Goldman scale].

Controversies exist about the functional evaluation of chronic heart failure; aim of this study has been the assessment of the feasibility of the Goldman classification, based on the metabolic cost of various daily physical activities, in a cohort of patients with mild to moderate heart failure, its relation to NYHA class and to the main clinical parameters currently used. We evaluated 114 patients (mean age 61 years) with mild to moderate heart failure due to idiopathic cardiomyopathy (78%), ischemic heart disease (14%) and others (8%). Based on the Goldman classification there were 82 patients (72%) in second and 28 (24%) in third class while 83 (73%) were in NYHA II class and 31 (27%) in NYHA III class. The concordance rate between Goldman second and NYHA II class was 84% and 64% between Goldman third and NYHA III class. The cardiothoracic ratio was statistically different in all 3 Goldman classes while this happened only in NYHA IIM and III versus IIS. Double product and duration of exercise were statistically different in all Goldman classes but only in NYHA II and III class. No relation was observed with ejection fraction on echocardiogram. In the subgroups analysis there was a linear positive relation between duration of exercise versus double product and cardiothoracic ratio versus cardiac volume. We conclude that Goldman class is a feasible method to assess quality of life in chronic heart failure and is more helpful and objective than NYHA class in determining the functional class of the patient.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Peripheral hemodynamic and humoral effects of oral zofenopril calcium (SQ. 26,991) in patients with congestive heart failure.

In 14 patients with congestive heart failure (CHF) of various grade (NYHA class 2-4) the effects of zofenopril calcium (SQ 26,991) on blood pressure and forearm circulation were studied by venous occlusion plethysmography. Changes in plasma renin activity (PRA), aldosterone, Atrial natriuretic factor (ANF) and arginine-vasopressin (AVP) were also measured. Two hours after oral administration of 7.5 mg of zofenopril we observed a decrease in blood pressure, heart rate, and forearm vascular resistance along with an increase in venous distensibility. Zofenopril also decreased ANP levels in a manner directly related to peripheral venodilatation (r = .64; P less than .05) and modified arginine-vasopressin (AVP) proportionally to the fall in blood pressure observed in response to drug administration (%SBP/%AVP: r = .64, P less than .05; %DBP/%AVP: r = .67, P less than .05). Hemodynamic and humoral responses to zofenopril occurred without any significant unwanted adverse reaction, even in patients with greater pressor reduction. We conclude that oral acute zofenopril administration, in patients with congestive heart failure, causes an arterial and venous forearm vasodilatation which is probably involved in the acute changes in plasma levels of ANF and AVP observed after drug administration.

Administration, Oral↗

Felodipine in severe chronic congestive heart failure: acute effects on central hemodynamics and regional blood flow distribution.

In order to assess the effect of felodipine, a new calcium antagonist with vascular selectivity, on regional blood flow distribution at rest in chronic congestive heart failure, ten patients were studied during an acute test. Right heart catheterization allowed the evaluation of hemodynamic parameters; renal blood flow was calculated using paraamino-hippuric acid clearance; hepatic blood flow measurement was based on indocyanine green clearance; and limb blood flow was assessed with venous occlusion plethysmography. Blood samples were collected for the analysis of plasma catecholamines, renin, and aldosterone. All parameters were recorded in duplicate under basal conditions and after felodipine infusion. The infusion of felodipine induced a significant increase in cardiac index, stroke work index, and limb blood flow. Systemic and pulmonary arterial blood pressure, pulmonary wedge pressure, and systemic resistance underwent a significant decrease. The heart rate, pulmonary resistance, renal blood flow, and hepatic blood flow were not changed. In conclusion, felodipine was of benefit in congestive heart failure at rest in an acute test, acting through a marked decrease in vascular resistance and a consequent improvement in cardiac output and limb blood flow. No changes in renal and hepatic blood flow were observed.

Adult↗

[Analysis of the diastolic function of the left ventricle by Doppler echocardiography in athletes engaged in competitive sports activities].

In order to assess left ventricular diastolic function in elite athletes we studied 24 athletes (mean age 21 +/- 5 years) with the echo-Doppler technique. The control group consisted of 14 healthy males (mean age 24 +/- 6 years) and 99 patients (mean age 50 +/- 14 years) with primary or secondary left ventricular hypertrophy. The following variables were calculated: age, systolic and diastolic blood pressure, septal and posterior wall thickness, left ventricular volume and dimensions, myocardial mass index and mass/volume ratio, left ventricular end-systolic and peak systolic stress, RR interval, isovolumic relaxation time (IVRT), early (E) and late (A) peak flow velocity, E/A ratio, time and rate of deceleration of early diastolic flow. Compared with the normal subjects significant differences were observed with regard to systolic blood pressure, left ventricular wall thickness, myocardial mass, mass/volume ratio and peak systolic stress in the athlete group. In spite of a noticeable increase in myocardial mass indexes, all the diastolic function parameters were normal in the athletes. In this group a linear positive correlation between rapid filling indexes, ventricular mass and mass/volume ratio exists. These correlations are not present in the patients group. Moreover a linear negative correlation between RR interval and late diastolic flow velocity was found. In conclusion, the global diastolic ventricular function, evaluated with the echo-Doppler technique, is normal in athletes in spite of an increase in ventricular mass. Th early diastolic flow velocity is in direct proportion with mass increase and may represent one of the physiological mechanisms of the athlete heart adaptations.

Adolescent↗

[Non-invasive diagnosis of acute rejection in heart transplant].

The purpose of this study was to evaluate the sensibility of some clinical and non-invasive parameters in the early diagnosis of cardiac rejection in heart transplant patients. Eighteen patients (15 males and 3 females) aged 13-57 years (mean 44 +/- 14), with orthotopic heart transplant were followed clinically for a mean period of 15 +/- 8.7 months (range 3-27). They were all treated with cyclosporin, associated with azathioprine or prednisone, or both. During the same day of the endomyocardial biopsy, the patients were submitted to a clinical examination, 12 leads ECG and 2-dimensional and Doppler-echocardiography. The following parameters were evaluated: systolic and diastolic blood pressure, heart rate, body weight, summated QRS voltage in the 12 leads ECG, interventricular septum and left ventricular posterior wall end-diastolic thickness, left ventricular myocardial mass and fractional shortening, isovolumic relaxation time. Biopsy specimens were graded according to the Billingham criteria. Totally, 251 biopsies were performed: 130 were negative, 98 positive for mild or moderate rejection, 23 had a resolving rejection pattern; in 61 cases the patients were treated for acute rejection. Compared to negative biopsies, during acute rejection the QRS voltage and the isovolumic relaxation time significantly decreased, while left ventricular wall thickness and body weight increased. To evaluate the effects of the acute immunosuppressive therapy, the same parameters before and after treatment were compared. The QRS voltage, the wall thickness and the isovolumic relaxation time were significantly modified, returning to the pre-rejection values. In conclusion, both clinical and non-invasive information, may be useful to suspect an episode of acute rejection in heart transplant patients and to program myocardial biopsy.

Acute Disease↗

[Clinical characteristics and prognostic factors in chronic heart failure secondary to primary dilated cardiomyopathy and ischemic heart disease].

Natural history and prognostic factors in chronic congestive heart failure were investigated in 141 patients (100 males and 41 females), aged 58 +/- 14.5 years, who were hospitalized between 1981-1985. Heart failure was due to idiopathic dilated cardiomyopathy in 79 patients and ischemic heart disease in 62 patients. The following parameters were examined: sex, age, etiology, NYHA functional class, mean arterial blood pressure, heart rate, presence of 3rd heart sound, atrial fibrillation and left ventricular conduction delay, plasma sodium, echocardiographic shortening fraction, and treatment with vasodilators. Mean follow-up was 31 +/- 19 months. Overall survival was 83% at 1 year, 58% at 3 years and 49% at 5 years. No difference in mortality was evident between the two etiological groups, while the data on the cause of death showed a significant difference: sudden death was prevalent in the patients with ischemic disease (50% vs 24%), intractable heart failure predominated in patients with idiopathic dilated cardiomyopathy (69.7% vs 42.8%) (p less than 0.05). The multivariate analysis with the Cox model resulted in a negative prognostic significance of the male sex (p less than 0.02), III and IV NYHA functional class (p less than 0.04), heart rate at rest greater than 85 b/min (p less than 0.002) and the presence of left ventricular conduction delay on standard ECG (p less than 0.001).

Adolescent↗