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C De Vita

Publications and source records attributed to C De Vita.

At least 19 recordsLinked to original sources

Epidemiologic study of use of resources in patients with unstable angina: the EARISA registry. On behalf on the EARISA Investigators (Epidemiologia dell'Assorbimento di Risorse nell'Ischemia, Scompenso e Angina).

AIM: The EARISA Registry was designed to describe diagnostic and therapeutic resources used in Italian cardiology centers for patients with the epidemiologically most relevant cardiac diseases. This article focuses on patients with unstable angina; characteristics associated with invasive procedures were specifically analyzed. METHODS AND RESULTS: Information was collected over a 2-week period on 1420 patients with unstable angina discharged from 308 cardiology centers. The mean length of stay was 9 +/- 6 days; 51% of patients were admitted to a coronary care unit (mean length of stay, 4 +/- 3 days). Noninvasive procedures included echocardiography (64%), Holter monitoring (25%), exercise stress testing (24%), and echocardiographic stress testing or nuclear imaging (7%). Invasive procedures were coronary angiography (39%) and percutaneous transluminal coronary angioplasty or coronary artery bypass grafting (13%). Unstable angina had a greater impact on invasive procedures than acute myocardial infarction. Variables independently associated with a higher rate of coronary angiographic procedures were younger age, higher technologic level of the hospital, and need for intravenous therapy. CONCLUSION: In Italy, approximately half the patients with unstable angina are admitted to hospitals without catheterization laboratories or cardiac surgery facilities. This fact supports the concept that treatments that can be administered in all types of hospitals are more likely to affect the outcome of patients with unstable angina. Overall, the rates of coronary angiography and revascularization procedures appeared low, and the setting where cardiologists practice, rather than patient characteristics, is the major determinant of the care given to patients with unstable angina.

Aged↗

Prognostic indices in heart transplant candidates after the first hospitalization triggered by the need for intravenous pharmacologic circulatory support.

BACKGROUND: Patients with heart failure refractory to optimal oral pharmacologic therapy have a dismal short term prognosis. Heart transplantation is the only therapy shown to improve survival in these patients. Unfortunately, due to the critical shortage of donor organs, approximately 30% of listed patients with end-stage heart failure die before a suitable donor heart becomes available. The principal aim of this study was to determine whether intravenous pharmacologic circulatory support favorably influences the clinical course of heart transplant candidates or whether mechanical circulatory support should be instituted in this high risk patient population. METHODS: Data from 154 consecutive hospitalizations in 125 patients 49+/-12 years were retrospectively reviewed. The product limit method was used to estimate survival. Multiple logistic regression analysis was used to identify the clinical and hemodynamic variables that independently predict outcome after each admission in which heart transplantation did not occur. RESULTS: One year survival for the study population was 65%. This survival is significantly lower than the 91% 1 year survival in similarly ill patients undergoing heart transplantation. The Cox proportional hazard method identified serum bilirubin, blood urea nitrogen (BUN), serum sodium levels and right atrial pressure as independent prognostic indices. Serum bilirubin, BUN levels and duration of intravenous pharmacologic circulatory support were associated with a poor outcome. A composite index including serum bilirubin and BUN levels predicted outcome with a sensitivity and specificity of 79% and 77%, respectively. The addition of pharmacologic support duration increased the model's sensitivity to 95%, but did not significantly alter specificity that was 74%. Of the 125 patients hospitalized due to the need to initiate intravenous pharmacologic support for the first time (index hospitalization), 69 (55%) were discharged after optimization of medical therapy. Of 21 patients who did not undergo transplantation during the follow-up period, 18 (86%) died within 2 years of the index hospitalization. The duration of intravenous pharmacologic support beyond which prognosis dramatically worsens without heart transplantation is 21 days. CONCLUSION: Heart transplant candidates who require intravenous pharmacologic circulatory support for more than 21 days and do not receive a suitable donor heart within this period of time have a high mortality. Alternative therapies, such as implantation of a mechanical circulatory assist device should be considered in this high risk population.

Adolescent↗

[Acute epiglottitis in children: current criteria for the diagnosis and treatment].

Acute epiglottitis is still a potentially lethal pathology, particularly in early childhood. The present study involves seven cases of acute epiglottitis in children under 4 years of age. The authors describe the diagnostic and therapeutic protocols used in these pediatric patients placing particular emphasis on the use of endoscopy and the need for prompt hospitalization in an intensive care unit to best integrate the diagnostic approach with therapeutic treatment.

Acute Disease↗

Ten-year follow-up of the first megatrial testing thrombolytic therapy in patients with acute myocardial infarction: results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-1 study. The GISSI Investigators.

BACKGROUND: We conducted a 10-year follow-up of the 11 712 patients with acute myocardial infarction randomized in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-1 study, the first large trial assessing thrombolytic therapy. METHODS AND RESULTS: Information on survival at 10 years was obtained for the 93% of all randomized patients through the census offices of their towns of residence. The difference in survival produced by streptokinase and sustained up to 1 year was still significant at 10 years (log-rank test, P=0.02), with the absolute benefit of 19 (95% CI 1 to 37) lives saved per 1000 patients treated. The time dependence of the extent of the benefit was confirmed, as the higher mortality rate reductions found in patients treated earlier were still present at 10 years. In the overall population, most of the benefit was obtained before hospital discharge (RR 0.81, 95% CI 0.72 to 0.90), since no difference in survival between thrombolyzed and control patients discharged alive was found at 10 years (RR 0.98, 95% CI 0.90 to 1.06). However, a slight albeit nonsignificant divergence of the survival curves of patients randomized within the first hour was observed [90 (95% CI 34 to 146) lives saved per 1000 at 10 years versus 72 (95% CI 37 to 107) lives saved at hospital discharge]. CONCLUSIONS: The benefits of a single intravenous infusion of 1.5 million units of streptokinase in prolonging survival of patients with acute myocardial infarction is sustained up to 10 years, with a still-evident trend in favor of the patients admitted earlier.

Age Factors↗

Dipyridamole thallium-201 imaging very early after uncomplicated acute myocardial infarction in patients treated with thrombolytic therapy.

The aim of this study was to assess the safety and prognostic value of dipyridamole 201T1 imaging very early after acute myocardial infarction in patients treated with thrombolytic therapy. Fifty-two consecutive patients with an uncomplicated clinical course underwent quantitative planar dipyridamole 201T1 imaging 2 5 days after acute myocardial infarction. The patients were followed for 14 +/- 7 months after discharge. No major complications occurred during the test. Of the 30 patients with redistribution, five (16.6%) developed in-hospital unstable angina as against none of the 22 patients without redistribution. During follow-up, a total of live late cardiac events were observed: two deaths and two cases of unstable angina in the group with reversible defects and one reinfarction in the group with fixed defects. The 1-year actuarial probability of being free of cardiac events was, respectively, 66 +/- 10% and 94 +/- 5% in the patients with and without redistribution (P < 0.01). In conclusion, in patients treated with thrombolysis, dipyridamole-201T1 imaging very early after uncomplicated acute myocardial infarction is a feasible and safe test. Patients with fixed defects appear to be at low risk and may be candidates for early discharge; the presence of redistribution identifies a subgroup of patients who may benefit from further careful clinical evaluation.

Adult↗

Restrictive criteria for heart transplantation candidacy maximize survival of patients with advanced heart failure.

BACKGROUND: The shortage of organ donors and the amelioration of medical management of advanced heart failure mandate strict selection of heart transplant candidates on the basis of the need and probability of success of transplantation, with the aim of maximizing survival of patients with advanced heart failure, both with and without transplantation. This study analyzes the impact of restricting the criteria for heart transplantation candidacy on the outcome of patients with advanced heart failure referred for transplantation. METHODS: Survival and freedom from major cardiac events (death, resuscitated cardiac arrest, transplantation while supported with inotropes or mechanical devices) were compared between patients listed during 1990 to 1991, when standard criteria were applied (group 1, n = 118), and patients listed during 1993 to 1994, when only patients requiring continuous/recurrent intravenous inotrope therapy in spite of optimized oral medications and outpatients showing actual progression of the disease were admitted to the waiting list (group 2, n = 88). Survival and freedom from cardiac events (defined as above plus listing in urgent status) were also calculated in stable outpatients evaluated in 1993 to 1994, who were potential heart transplant candidates according to standard criteria but were not listed because of restrictive criteria (group 3, n = 52, New York Heart Association functional class > or = III, mean echocardiographic ejection fraction 0.22 +/- 0.05, mean peak oxygen consumption 12.3 +/- 1.5 ml/kg/min, mean follow-up 19 +/- 10 months). RESULTS: Thirty-one percent, 40%, and 50% of group 1 patients versus 58%, 65%, and 77% of group 2 patients underwent transplantation within 3, 6, and 12 months after listing (p < 0.0007). The 1- and 2-year survival rates after listing were 80% and 71% in group 1 versus 85% and 84% in group 2 (p < 0.0001). Freedom from death/urgent transplantation was lower in group 2 than in group 1 (55% and 48% versus 72% and 59% at 6 and 12 months, respectively; p < 0.0001). In patients undergoing transplantation, the postoperative survival rate was similar (87% and 91% at 2 years in group 1 and group 2, respectively). Two years after heart transplantation candidacy was denied, 86% of group 3 patients were alive, and 74% were event-free. CONCLUSIONS: Restricting the admissions to the waiting list to patients with refractory/progressive heart failure improved survival rates after listing by increasing the probability to undergo transplantation in a short time. Selection of most severely ill candidates did not affect postoperative survival. Survival and freedom from cardiac events were good in patients with advanced but stable heart failure, in spite of their severe functional limitation. Thus restrictive criteria for heart transplantation candidacy allows maximal survival benefit from both medical therapy and transplantation.

Adolescent↗

A semiquantitative approach to the evaluation of acute cardiac allograft rejection at endomyocardial biopsy.

BACKGROUND: Histopathologic criteria for grading of acute cardiac allograft rejection are focused on the most severe lesion that is recognized among the myocardial fragments provided by each endomyocardial biopsy specimen. Considering the distribution of rejection lesions among all the fragments improved the accuracy in characterizing the severity of rejection in pathologic studies. This study was undertaken to verify the usefulness of a semiquantitative evaluation of endomyocardial biopsy specimens, consisting of the calculation of the proportion of fragments showing rejection in the clinical setting. METHODS: Of the 2386 biopsy specimens obtained during the first posttransplantation year in 168 consecutive cardiac allograft recipients, 290 biopsy specimens constituted by > or = 3 adequate fragments and showing rejection not followed by treatment (n = 159) or being the first biopsy specimen prompting treatment with augmented immunosuppression for that rejection episode (n = 131) were selected. These biopsy specimens (index biopsy specimens) were grouped according to whether rejection was present in < or = 33%, > 33% to < or = 67%, and > 67% of the fragments. The rejection grade (according to the standardized grading system) and the proportion of fragments positive for rejection were correlated with the occurrence of clinical symptoms and signs of rejection at index biopsy and with the results of the next biopsy. RESULTS: Rejections graded > or = 3A were more frequently symptomatic (36% vs 9% for those graded < 3, p < 0.0001), as were those involving increasing proportions of fragments (< or = 33%: 5 of 124, 4%; > 33 to < or = 67%: 13 of 99, 13%; > 67%: 19 of 67, 28% [p < 0.0001]). Spontaneous resolution after untreated biopsies was more frequent in focal (grade 1A and 2) than in diffuse mild (1B) rejections (68% vs 38% [p < 0.04]), whereas progression to grade 3A or greater was less frequent (4% vs 27% [p < 0.01]). Increasing proportions of positive fragments were associated with lower frequencies of spontaneous resolution (p < 0.05) and higher frequencies of worsening (9%, 22%, 43% [p < 0.009]) or progression to grade 3A or greater (2%, 6%, 28% [p < 0.005]). Complete resolution after treatment was less frequent for increasing proportions of positive fragments at index biopsy (80%, 66%, 49% [p < 0.05]). CONCLUSIONS: Diffuse versus focal rejection pattern and the proportion of positive fragments seem to be clinically relevant in terms of occurrence of symptoms, spontaneous evolution, and response to treatment.

Adolescent↗

Morphological bases for thallium-201 uptake in cardiac imaging and correlates with myocardial blood flow distribution.

To determine the morphological bases of thallium-201 myocardial distribution in chronic cardiac dysfunction and their relation to myocardial blood flow, myocardial slices from ten excised hearts of five chronic ischaemic heart disease patients and five idiopathic dilated cardiomyopathy patients, were imaged on a gamma camera to quantitate the uptake of thallium-201, injected 4 h before surgery, and myocardial blood flow from distribution of technetium-99m-labelled human albumin microspheres injected during surgery. Tracer distribution was correlated with histologically assessed myocardial fibrosis and myocytolysis. Thallium-201 uptake was inversely related to fibrosis (r = -0.73, in ischaemic heart disease, r = -0.65 in idiopathic dilated cardiomyopathy). In ischaemic heart disease, myocardial blood flow was related neither to thallium-201 uptake (r = 0.41) nor to the extent of fibrosis (r = -0.48). In this group, segments with normal or mildly reduced thallium-201 uptake showed significantly lower fibrosis than those with moderate or severe uptake defects (5 +/- 7% and 7 +/- 11% vs 33 +/- 14% and 42 +/- 12%, respectively, P < 0.0001. In a clinical model of chronic ischaemic dysfunction, despite severely depressed myocardial blood flow, extensive areas of myocardium devoid of significant structural impairment are present. Thallium-201 uptake effectively discriminates regions with preserved viability from those with relevant myocardial damage.

Adult↗

["Silent" gastroesophageal reflux and upper airway pathologies in childhood].

In children, gastroesophageal reflux (GER) plays an important role in both acute and chronic upper airway disorders including stridor, chronic cough, recurrent upper respiratory infections, obstructive apnea, laryngospasm, and wheezing. Diagnosis may prove difficult unless there is reason to suspect GER and one is aware of the concept of "silent" GER. This paper presents our experience with chronic and/or recurrent respiratory disorders of uncertain origin and without gastrointestinal symptoms in children. Thirty-two pediatric patients with upper respiratory symptoms were evaluated. Out-patient 24-hour intraesophageal pH was monitored and 56% of the patients underwent pharyngo-laryngeal fibroscopy. The patients were divided into two subgroups: Group A (18 patients < 6 months of age) and Group B (14 patients > 6 months). All the patients tested positive for GER with a mean Reflux Index of 21.5. The most common symptoms in Group A were apnea-cianosis and stridor while they were chronic cough for group B. The present study confirms the association between GER and respiratory disease and between GER respiratory-related symptoms and patient age. Emphasis is placed on the importance of otolaryngological diagnostic procedures and 24-hour pH-gastroesophageal monitoring in evaluating patients with respiratory disorders related to silent GER.

Female↗

Significance of pericardial effusion after heart transplantation.

The aim of this study was to evaluate the clinical significance of pericardial effusion after heart transplantation and to assess its correlation with acute rejection. One hundred fifty transplanted patients were followed up for the first year: serial echocardiographic studies were performed on the same day as were the endomyocardial biopsies; hemodynamic studies and coronary angiographies were performed 1 year after transplant. Ten days after surgery, pericardial effusion was absent in 77 patients, small in 52, moderate in 14, and large in 7, and was significantly related to severe postoperative bleeding (p < 0.001). Patients were classified according to the presence and the course of pericardial effusion in group A (absence or disappearance of previous pericardial effusion within 1 month, 107 patients) and in group B (onset, persistence, or increase in pericardial effusion, 43 patients). One hundred nineteen patients experienced > or = 1 acute rejection episode. The evolution of pericardial effusion was different (p < 0.0001) according to the number of acute rejection episodes and biopsy specimens showing acute rejection, histologic grading and time of the first episode, and histologic grading of the most severe acute rejection episode. Furthermore, there was a significant correlation with the cumulative duration of acute rejection episodes (p < 0.005) and the presence of previous cardiac surgical history (p < 0.007), but no correlation with cardiac transplant vasculopathy or with a positive weight mismatch. This study suggests that pericardial effusion in transplant recipients is associated with a higher incidence and more severe histologic grading of acute rejection episodes; its presence indicates the need for stricter monitoring of acute rejection.

Acute Disease↗

Strategy of diagnostic imaging before and after PTCA.

It is now widely accepted that percutaneous transluminal coronary angioplasty (PTCA) is an effective nonsurgical technique for achieving coronary revascularization. Exercise electrocardiography remains the standard procedure for functional evaluation before, early, and late after angioplasty because of its availability, safety, and limited cost. The drawback of exercise testing is its low specificity and the fact that the attainment of diagnostically useful data requires a level of exercise that substantially increases myocardial oxygen demand. Exercise thallium imaging has been shown to be highly predictive of restenosis and adverse events after angioplasty, but it is possible that myocardial perfusion may not return to normal immediately after successful revascularization. Stress echocardiography has many practical advantages over scanning tests, as result of its lower cost, shorter imaging time, and the absence of radiation exposure. Dipyridamole echocardiography testing (DET) is an exercise-independent method of evaluating patients who have to undergo coronary angioplasty. Before PTCA, DET allows the clinician to localize the site and extent of myocardial ischemia anatomically. Early after a successful procedure, DET identifies a group at high risk for the late recurrence of symptoms. Late after PTCA, DET is more accurate than exercise electrocardiography in detecting restenosis or disease progression. In asymptomatic patients with exercise-induced ST depression, DET has the same good diagnostic accuracy as thallium scintigraphy. For these reasons, as well as because of its noninvasive nature and availability, DET should be considered an attractive option for the evaluation of patients after anatomically successful angioplasty.

Angioplasty, Balloon, Coronary↗

[Short-term survival after heart transplantation: the relationships between preoperative hemodynamics, organ function and postoperative clinical events].

AIM OF THE STUDY: Pulmonary hypertension is known to affect prognosis of cardiac allograft recipients. Aim of this study is to elucidate the mechanisms relating preoperative hemodynamics to early post-transplant mortality. METHODS: Hemodynamic and pre- and postoperative clinical data of 122 heart transplant recipients were reviewed with respect to early mortality (within 1 month or in-hospital). The relationships between hemodynamics and mortality were studied by means of univariate and multivariate analysis of absolute data and at different cut-off values of hemodynamic parameters. RESULTS: The following hemodynamic parameters were significantly different between survivors (n = 107) and non-survivors (n = 15): right atrial pressure (7.7 +/- 4.7 vs. 12.1 +/- 8.6 mm Hg, p < 0.004), pulmonary vascular resistance (2.57 +/- 1.44 vs. 3.72 +/- 1.88 Wood units, p < 0.007), pulmonary vascular resistance index (4.43 +/- 2.53 vs. 6.53 +/- 3.28 Wood units x m2, p < 0.005), and transpulmonary gradient (8.8 +/- 4.8 vs. 12.3 +/- 6.4 mm Hg, p < 0.02). Right atrial pressure and pulmonary vascular resistance index showed an independent value at stepwise multiple logistic regression analysis (p < 0.008 and < 0.03 respectively). When mortality was tested using cut-off values, it was significantly higher with right atrial pressure > or = 12 (7/28 vs 8/94, p < 0.05), pulmonary vascular resistance index > or = 8 (6/13 vs 9/109, p < 0.0005), and transpulmonary gradient > or = 15 (5/13 vs 10/109, p < 0.01). High right atrial pressure, pulmonary vascular resistance index, and transpulmonary gradient were associated with higher preoperative bilirubin (p < 0.03), which was significantly superior in non-survivors (1.44 +/- 1.53 vs. 0.83 +/- 0.61 mg/dl, p < 0.02). Postoperatively, severe right ventricular failure, severe renal failure and infections within 1 month were all strongly associated with an increased mortality (p < 0.00003); they were more common in patients with high preoperative right filling pressure (9% vs. 43%, p < 0.00002) and/or high pulmonary vascular resistance index (14% vs. 38%, p < 0.03), in those with high right atrial pressure (9% vs. 35%, p < 0.0009), and in those with high pulmonary vascular resistance index (17% vs. 58%, p < 0.002) respectively. Mortality after acute rejection within 1 month was significantly higher in patients with high preoperative right atrial pressure (8% vs. 57%, p < 0.006). CONCLUSIONS: Besides pulmonary hypertension, elevated preoperative right filling pressure appears to indicate an increased risk of early death after transplantation; pre- and postoperative end-organ dysfunction and post-transplant complications are more common or more threatening in this setting.

Adult↗

[Atenolol i.v. in the acute phase of AMI: the indications, contraindications and interactions with thrombolytic drugs in the GISSI-2 study. The GISSI-2 Researchers. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico].

BACKGROUND: In the pre-thrombolytic era, several studies showed the effectiveness of beta-blocker administration in the treatment of patients (pts) with acute Myocardial Infarction (MI). Results from the ISIS-1 and GISSI trials suggested that the combined administration of beta-blocker and of thrombolytic drugs in the acute phase of infarction could lead to a better prognosis. The possibility of synergic effects from the associated administration of these drugs was confirmed by small clinical trials. In GISSI-2 study a large number of patients treated with thrombolytic drugs were given i.v. atenolol (10 mg) as recommended therapy, not following a randomized study design. AIM: We reviewed the data of the GISSI-2 study population in order to evaluate: 1) the number of pts treated with i.v. atenolol; 2) the anamnestic and clinical characteristics of treated und untreated pts; 3) the causes of exclusion from the beta-blocker therapy; 4) the causes of scheduled dose withdrawal and the incidence of side effects related to atenolol administration; 5) the interaction between atenolol and streptokinase (SK) and rtPA; 6) the incidence of relevant clinical events and the causes of death during the in-hospital period. RESULTS: Among 12377 evaluated pts, 5616 (45.4%) were given atenolol i.v., 2772 received SK (49.5%) and 2844 (50.5%) rtPA. Mean age was 59.5 +/- 11.3 yrs in atenolol treated pts vs 63.4 +/- 10.9 yrs in untreated pts (p < 0.001); 34.1% of pts aged > 70 yrs vs 48.6% of younger pts (p < 0.00001) and 42.1% of females vs 46.2% of males (p < 0.003) received atenolol. Pts with previous MI received less frequently atenolol than those without MI (17.5% vs 13.5%, p < 0.00001). 88.5% of the treated pts was in Killip class I at entry (untreated 69.5%, p < 0.00001); anterior and lateral site, non-Q type and > or = 5 electrocardiographic leads with ST segment elevation were more frequently found in atenolol treated pts, inferior and unknown site in untreated pts. Among 6761 untreated pts, 32% did not receive atenolol for the occurrence of bradycardia, 15.2% for hypotension, 14.1% for heart failure, 7.2% for bronchospasm or history of asthma, 6.2% for bradycardia and hypotension, 0.3% for death; in 25% of the untreated pts, none of the above-mentioned causes was detectable. 1064 pts (18.9%) did not complete the scheduled dose of atenolol for the occurrence of bradycardia or atrioventricular block > or = II degree (7.3%), hypotension (7%), bradycardia and hypotension (1.8%), heart failure (0.7%), death (0.03%), other causes (1.9%). Transient hypotension was found more frequently in pts treated with SK than in those receiving rtPA (9.3% vs 4.8%, p < 0.0001), but the rate of persistent hypotension was not different in both groups (4.6%). During the hospital phase a higher incidence of advanced atrioventricular block (12.3% vs 4.3%), need of temporary or permanent pacing (5.6% vs 1.9%), sustained ventricular tachycardia (4.5% vs 2.8%), heart failure (12% vs 7.1%), ventricular fibrillation (8% vs 4.9%) and death (11.9% vs 5.1%) were shown in pts that were not given i.v. atenolol. Heart failure was the main cause of death in both groups (untreated 2.3% vs 2.2%); ventricular fibrillation (0.2% vs 0.48%), cardiac rupture (0.5% vs 1.4%), and electromechanical dissociation (0.9% vs 1.9%) were less frequent in treated pts. CONCLUSIONS: The absence of randomized design of atenolol administration limits the value of the differences found in the clinical outcome of the two groups of pts. In spite of that, the low incidence of death and side effects in treated pts, and the high percentage of pts who completed the scheduled dose of atenolol, confirm that the iv. administration of beta-blockers in the acute phase of the myocardial infarction is safe, well tolerated and suitable in almost an half of the patients submitted to thrombolytic therapy with SK or rtPA.(ABSTRACT TRUNCATED AT 400 WORDS)

Aged↗

Acute rejection after heart transplantation: noninvasive echocardiographic evaluation.

OBJECTIVES: The purpose of this study was to assess the reliability of echocardiography in the noninvasive diagnosis of acute rejection in heart transplant recipients. BACKGROUND: Although echocardiographic results seem to correlate well with allograft rejection, published data are limited and contradictory. METHODS: In 130 transplant recipients, 1,400 serial echocardiograms were recorded within 24 h of endomyocardial biopsy. Increased wall thickness, myocardial echogenicity, pericardial effusion, shorter pressure half-time, isovolumetric relaxation time and a decrease in left ventricular ejection fraction were considered markers of rejection. RESULTS: The distribution of echocardiographic markers revealed highly significant differences between bioptically graded moderate, mild and no rejection and between untreated and treated rejection episodes (both chi-square test, p < 0.0001). Specificity was 98.6% for two markers, but sensitivity was good (80%) for only moderate rejection because of the large number of false negatives in untreated patients with mild rejection. In untreated patients, there was a highly significant difference in the number of echocardiographic criteria between a benign and nonbenign outcome (chi-square test, p < 0.0001). In treated patients, the significant difference in the variation in echocardiographic criteria between favorable and unfavorable responses after 1 week was more pronounced after 2 weeks (t test, p < 0.01 vs. < 0.001). Diastolic indexes and pericardial effusion at 2 weeks seemed to be predictive of therapeutic response. CONCLUSIONS: Poor sensitivity to mild rejection indicates that serial echocardiography cannot supplant endomyocardial biopsy in the early diagnosis of acute rejection, but it seems to be a reliable noninvasive means of identifying acute rejection requiring intensified immunosuppressive therapy and of evaluating outcome.

Acute Disease↗

Immunoactivity of pidotimod against episodes of recurrent tonsillitis in childhood.

The therapeutic efficacy of the synthetic immunostimulant pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) was evaluated in a double-blind placebo-controlled study in parallel groups in the management of recurrences in 235 children with recurrent tonsillitis. The ambulant study provided for 15 days of treatment with two oral vials of pidotimod 400 mg or placebo daily, in accordance with a randomisation list, 60 days of treatment with one oral vial of pidotimod 400 mg or placebo daily, and a 90-day follow-up period. The total trial period was 165 days. In addition to evaluating the number of tonsillitis recurrences which occurred during the 75 days of treatment and the 90-day follow-up period, the number of days on which the principal symptoms of the illness were present and on which drugs such as antibiotics or anti-inflammatory agents were used concomitantly, as well as the number of days' absence from school, were analyzed. The findings showed that, taking the treatment phase and the three-month follow-up period together, pidotimod significantly reduces the incidence of inflammatory upper airways episodes. The very low incidence of adverse effects, which was the same as that in the placebo group, confirmed the excellent safety of the product.

Adjuvants, Immunologic↗