We analysed the performance of the electrocardiogram in diagnosing left ventricular hypertrophy in 70 patients with isolated left anterior hemiblock and in 75 patients with right bundle branch block, ...either isolated (44 cases) or associated (31 cases) with left anterior hemiblock. Left ventricular hypertrophy defined as an echocardiographically determined left ventricular mass greater than 261 g in men and 172 g in women or left ventricular mass index greater than 125 g/m2 in men and 112 g/m2 in women was present in 48 subjects (57%) with isolated left anterior hemiblock and 33 subjects (44%) with right bundle branch block. In patients with isolated left anterior hemiblock the best results were obtained using the SV1 or SV2 + (RV6 + SV6) greater than 25 mm with 74% in sensitivity and 67% in specificity; the criterion SIII + (R + S) maximal in a precordial lead greater than or equal to 30 mm showed a sensitivity of 74% but a specificity of 47%. In the whole group of patients with right bundle branch block none of the criteria nor combination of criteria achieved an acceptable performance (sensitivities ranged from 17% to 41% and specificities ranged from 54% to 85%). When these patients were divided according to the presence or absence of concomitant left anterior hemiblock the electrocardiographic indexes mostly showed, in comparison to whole group, higher values in sensitivity and lower values in specificity in right bundle branch block plus left anterior hemiblock and an opposite behaviour in isolated right bundle branch block.
We assessed the reliability of multiple electrocardiographic variables for detecting left ventricular hypertrophy in 100 patients (aged 23 to 92 years, mean age 39 +/- 14) with complete left bundle ...branch block and different underlying cardiac diseases. Left ventricular hypertrophy, defined as an echocardiographically evaluated left ventricular mass greater than 241 g, was present in 66 of the 100 patients. The electrocardiographic parameters with the highest sensitivity were both the Cornell voltage criteria (RaVL + SV3 greater than 28 mm in men and greater than 20 mm in women) and the combination of criteria proposed by Kafka (any of these four indexes: RaVL greater than or equal to 11 mm, QRS axis -40 degrees or less, SV1 + RV5 or RV6 greater than or equal to 40 mm, SV2 greater than or equal to 30 mm and SV3 greater than or equal to 25 mm), with a sensitivity of 77%. Both criteria had a very low specificity (32 and 35%, respectively). The high specificities (greater than or equal to 88%) of several electrocardiographic criteria were accompanied by ineffective low sensitivities (less than 35%). Moreover, the cumulative parameters of Kafka and Cornell voltage criteria achieved a sensitivity of 84 and 89%, respectively, in hypertensive patients and in those with valvar diseases. None of the electrocardiographic indexes tested showed a significant difference in sensitivity when applied in categories of patients with left ventricular hypertrophy and different left ventricular geometry (cavity dilation or concentric hypertrophy). These data indicate that both conventional and recently proposed electrocardiographic criteria for left ventricular hypertrophy in the presence of left bundle branch block poorly recognize an augmented left ventricular mass.
Objective: To design a Health-related Quality of Life (HRQoL) instrument for HIV-infected people in the era of highly active antiretroviral therapy (HAART). Methods: The self-administered ...questionnaire was developed by an Italian network including researchers, physicians, people living with HIV, national institutions and community-based organizations (CBO) through several steps: (1) review of existing HRQoL literature and questionnaires for HIV-infected people; (2) selection of relevant domains measuring HRQoL in HIV-infected people, and identification of new domains related to new aspects of HRQoL concerning HAART-treated individuals; (3) conduction of two pre-test analyses in independent groups of Italian HIV-positive people (n ≡ 100) distributed throughout the conutry. The objectives of the first pre-test were to verify the usefulness of the questionnaire, to construct a form easily understandable by everyone, to define the domains and their significance; the second pre-test aimed at evaluating and reshaping the questionnaire based on a statistical analysis of the outcomes of first pre-test; (4) validation analysis. A large cohort of people with HIV infection was recruited for the last step. Results: The internal consistence reliability (Cronbach's α) was ≥0.70 for all domains. Most domains had Cronbach's coefficient >0.80. All domains demonstrated convergent and discriminant validity. The version of ISSQoL includes two sections: HRQoL Core Evaluation Form (9 domains) and Additional Important Areas for HRQoL (6 domains). The ISSQoL was administered together with two additional forms: a Daily Impact of Symptoms Form and a Demographic Information Form. The Additional Important Areas for HRQoL include social support, interaction with medical staff, treatment impact, body changes, life planning, and motherhood/fatherhood. Conclusion: The data reported in the present paper provide preliminary evidence of the reliability and validity of the ISSQoL questionnaire for the measurement of HRQoL in HIV-infected people. The direct involvement of HIV-positive in all the phases of the project was a key aspect of our work.
To evaluate the quality of life outcomes in antiretroviral-naive patients randomized to zidovudine plus didanosine versus zidovudine plus didanosine plus nevirapine for treatment of advanced HIV ...disease (the Istituto Superiore di Sanità 047 trial).
A 48-week randomized, double-blind trial.
Sixty patients were enrolled and evaluated over 24 weeks. Quality of life was assessed using a modified version of the Medical Outcomes Study-HIV Health Survey. For analysis, we calculated two summary scores reflecting the physical (PHS) and the mental (MHS) components of health.
Although the three-drug combination was superior at inducing immunologic and virologic responses, the two-drug regimen was superior for both PHS and MHS, especially at week 8 where differences were both statistically and clinically significant (5.8 and 9.2 points, respectively, P< 0.02 for both). Quality of life changes paralleled trends in body weight and Karnofsky performance status score.
Although a three-drug antiretroviral therapy regimen was superior in terms of short term virologic/immunologic response, the two-drug regimen was better in terms of quality of life. In general, triple therapy remains the most effective treatment option. However, quality of life assessments can yield results that may be discordant with and complementary to those obtained using conventional endpoints. Comparative trials should collect a comprehensive range of outcome measures, including patient-reported quality of life, in order to provide clinicians and patients with additional information that may influence treatment decisions.
Background
No biological marker has been identified that predicts the development of lipodystrophy (LD). We investigated whether metabolic and body composition parameters could predict the ...development of LD over 2 years in adults initiating antiretroviral therapy (ART).
Methods
We used stored plasma collected at baseline and weeks 12, 24 and 48 from adults initiating combination ART. Adipocytokine, inflammatory cytokine, lipid and glycaemic parameters were measured and related to subsequent lipoatrophy (loss of limb fat mass of at least 2 kg from weeks 24 to 96 by dual‐energy X‐ray absorptiometry) and an increase in visceral adipose tissue (VAT; an increase of at least 18 cm2 from baseline to week 48 by abdominal computed tomography). Risk factors associated with limb fat loss and VAT gain were analysed by logistic regression.
Results
Fifty‐four HIV‐infected, treatment‐naïve adults were included in the study: 53 (98%) of them were men, and they had a median age of 39 years interquartile range (IQR) 34–48 years and a median body mass index of 22.6 kg/m2 (IQR 20–24.8 kg/m2). In multivariate analysis, a higher baseline limb fat percentage, and a 1 mmol/L increase in plasma leptin levels during the first 6 months of ART, independently predicted a peripheral fat loss of ≥2 kg odds ratio (OR) 2.58, 95% confidence interval (CI) 1.04–6.41; OR 3.15, 95% CI 1.34–7.35, respectively). VAT changes showed a borderline association with high baseline tumour necrosis factor‐α levels and hip circumference (OR 1.04, 95% CI 1.00–1.07; OR 1.44, 95% CI 1.07–1.95, respectively).
Conclusions
In ART‐naïve men, higher baseline limb fat and an early increase in leptin concentrations may predict the subsequent development of lipoatrophy. We did not find the same risk factors in the two different groups of patients with peripheral fat loss and central fat gain, suggesting a partially independent pathogenesis.
In order to investigate if genetic factors could be involved in the pathogenesis of hypertrophic obstructive cardiomyopathy, we determined HLA-A, HLA-B, HLA-C, and HLA-DR specificities in 12 Italian ...patients affected with the disease and in healthy family members of one of them. HLA-DR3 was found in 50% of patients as compared to 17.1% of normal control subjects (p = 0.023, relative risk = 4.82). The two relatives also had HLA-DR3 antigen and, in addition, showed equivocal signs of hypertrophy at echocardiographic examination. Thus hypertrophic obstructive cardiomyopathy is associated with genes in the HLA-DR region, and immunogenetic factors could be involved in the pathogenesis of the disease. Furthermore, the minimal target organ abnormalities in "healthy" relatives could represent a subclinical stage of the disease.
Antimitochondrial autoantibodies (AMA) were tested by indirect immunofluorescence in three groups of subjects with different types of myocardial hypertrophy: 35 patients affected with hypertrophic ...cardiomyopathy (HC), 20 patients with cardiac hypertrophy secondary to essential hypertension, and 35 active endurance athletes with exercise-induced left ventricular hypertrophy. Forty-two healthy subjects served as a control group. Left ventricular hypertrophy was considered a left ventricular mass (LVM) echocardiographically calculated (Devereux formula), exceeding 244 gm or a LVM index exceeding 122 gm/m2 (greater than 2 SD from a previously studied normal population). AMA were found in 15 of 35 (43%) patients with HC and in 6 of 20 (30%) patients with hypertensive heart disease (p less than 0.01); in contrast, AMA were not present in the sera of athletes or in the sera of controls. Although the significance of AMA in subjects with pathologic myocardial hypertrophy has not yet been established, their absence in the sera of athletes strengthens the opinion that cellular changes, as a compensatory response of the myocardium to a work overload, have a physiologic fashion in these cases. Moreover, identification of AMA in the sera of athletes with disproportionate severe left ventricular hypertrophy of uncertain origin may be helpful to ensure a single diagnosis.
We performed exercise testing, 24-h ambulatory blood pressure monitoring and echocardiography in 37 selected patients with borderline hypertension (24 men and 13 women, mean age 39.8 years, range ...23-50) in an attempt to detect early cardiovascular changes that could predict future established hypertension. All subjects were clinically reinvestigated after a mean period of 28 +/- 4 months. At entry 24/37 (65%) showed an exaggerated blood pressure response to exercise (systolic pressure > or = 220 mmHg and/or diastolic pressure > or = 105 mmHg) while 13 (35%) had a normal pressure response. Patients with exaggerated pressure response showed significantly higher left ventricular mass index in comparison to those with normal pressure response (98.1 +/- 10.7 vs. 84 +/- 13, respectively; P < 0.05). They also had higher, although not significantly different, average 24-h systolic and diastolic blood pressure levels. At follow up seven subjects (16%) were diagnosed as having established hypertension, while 30 (84%) remained borderline hypertensives. No subject was judged normotensive. All of the seven hypertensive subjects were a proportion (7/24 = 29%) of the group with exaggerated blood pressure response to exercise. Also, they were the eldest of the total group of borderlines (mean age 44 years) and had the highest left ventricular mass index (100.6 +/- 13 g/m2). Borderline hypertensives show a spectrum of cardiovascular changes that could be considered as a part of the hypertensive risk profile. However, there are no specific characteristics that reliably distinguish subjects prone to develop hypertension. Repeated clinical observations and correct measurements of resting blood pressure may have greater relevance in the management of patients with borderline hypertension.
The immunologic and virologic activity of nevirapine in combination with two nucleosides (zidovudine ZDV and didanosine ddI) was evaluated in antiretroviral-naive patients with a CD4 count <200/mm3 ...or clinical AIDS. In all, 68 patients were enrolled in a 48-week double-blind, placebo-controlled trial. A group of 32 patients received ZDV + ddI + nevirapine, and 36 patients received ZDV + ddI. Primary efficacy parameters were the activity on HIV-1 RNA and on peripheral blood CD4+ cells, with differences between groups analyzed by the Wilcoxon's nonparametric two-sample test. Baseline RNA was high in both treatment groups (median values, 5.8 and 5.7 log10). RNA and CD4 responses were significantly higher with the triple combination (median RNA reductions, 2.69 versus 1.05 log10 at 24 weeks and 1.97 versus 1.20 log10 at 48 weeks; median CD4 increases, 81 versus 64 cells/mm3 at 24 weeks and 101 versus 27 cells/mm3 at 48 weeks). This study demonstrates that a triple combination of ZDV + ddI + nevirapine used as first-line regimen in antiretroviral-naive patients can induce sustained virologic and immunologic response in patients with low CD4 count or a previous diagnosis of AIDS.
Ambulatory electrocardiographic monitoring (AEM) was performed in 22 patients (range 13-62 years; mean age 38.2 +/- 12.7) with grades I, II and III of myotonic dystrophy in order to evaluate the ...occurrence of potentially dangerous cardiac arrhythmias and conduction disturbances. All patients had previously undergone echocardiographic examination to determine whether structure and function abnormalities were present. In 6 patients with normal resting electrocardiogram, AEM revealed: first degree A-V block (4 cases), class IVa Lown ventricular arrhythmias (3 cases) and episodes of atrial fibrillation (4 cases). In 2 of 3 cases with abnormal scalar electrocardiogram new abnormalities (first degree A-V block and further prolongation of P-R interval) were demonstrated by AEM. Only 1 patient had mild signs of left ventricular dysfunction at echo. Disorders of cardiac conduction and rhythm are characteristic of myotonic dystrophy and can predispose to severe cardiac events. In this respect AEM is shown to be an early and sensitive tool in identifying patients at risk.
PDF
