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PubMed2005

Intermediate-term outcome following the fontan operation: a survival, functional and risk-factor analysis.

OBJECTIVE: To investigate survival and risk factors influencing intermediate outcome after the Fontan procedure. METHODS: Retrospective analysis of 122 patients operated between April 1991 and September 2002. Poor outcome was defined as late death or poor functional status (intractable supraventricular arrhythmias/NYHA 3-4) necessitating revision surgery. RESULTS: 64(52%) patients had an intermediate bi-directional cavo-pulmonary shunt (BCPS). 91 (76%) patients had a lateral tunnel total cavo-pulmonary connection, 21(17%) patients had an atrio-pulmonary connection and 10 (8%)patients had a Kawashima connection. There were 6 (5%)early deaths. Over a median follow up of 54 months (1-133), 12 (10%)patients have had surgical revision for poor functional status. There were 7 (6%) late deaths, 5 of which occurred after revision surgery. Univariate analysis identified older age at operation (>4 years) (P=0.04), higher postoperative pulmonary artery pressure at 24h (P=0.012), arrhythmia postoperatively (P=0.03) or during follow-up (P=0.01) and the requirement for anticoagulation during follow-up (P=0.03) as significant predictors of poorer outcome. Patients who had an intermediate BCPS (P=0.002) or Norwood Stage 1 (P=0.05) had a better outcome. Multivariate analysis identified an intermediate Glenn shunt and lower postoperative pulmonary artery pressure as significant predictors of better outcome. Actuarial freedom from death or revision is 93% (+/-2), 88% (+/-3), 86% (+/-4) and 69% (+/-7) at 1, 5, 7 and 9 years respectively. Actuarial freedom from death or revision for the lateral tunnel group is 92% (+/-2), 89% (+/-3), 85% (+/-5) and 66% (+/-10) respectively. CONCLUSION: Atrio-pulmonary connection results in a higher incidence of arrhythmias and failure than the lateral tunnel Fontan. Even in patients with a lateral tunnel Fontan there is a continuing hazard phase in the intermediate term. Mid-term outcome appears to be favorably influenced by an intermediate BCPS.

Analysis of Variance↗

PubMed2005

Prognosis in cervical insufficiency at less than 32 weeks of gestation.

OBJECTIVE: To identify prenatal events associated with adverse outcome in babies at less than 32 weeks of gestation in cases of cervical insufficiency and preterm labor (PTL)/premature rupture of the membranes (PROM). STUDY DESIGN: A case-control study was performed using a logistic regression model at 17 tertiary hospitals in Japan. Adverse outcome was defined as neonatal death or abnormal cerebral ultrasound scans (intraventricular hemorrhage [IVH] and periventricular leukomalacia [PVL]) prior to discharge from hospital. RESULTS: Data were analyzed for 307 cases (74 for cervical insufficiency and 233 for PTL/PROM). Neonatal death and IVH/PVL were noted in 25 and 29 cases, respectively. A significant association of cervical insufficiency (odds ratio (OR) 1.32, 95% confidence interval (CI) 1.02-1.68), gestational age at delivery (<26 weeks) (OR 4.64, 95% CI 1.73-12.44), and Apgar score <7 at 5 min (OR 3.3, 95% CI 1.42-7.64) with combined neonatal death or IVH and PVL was found in a logistic regression model that controlled for in utero transportation, gestational age on admission, clinical chorioamnionitis, and histopathologic chorioamnionitis. CONCLUSION: Cervical insufficiency is a significant factor related to the occurrence of adverse outcome.

Case-Control Studies↗

PubMed2004

Determination of vessel size: a putative framework to assess clinical outcome.

BACKGROUND: Unknown is the predictive value of the coronary artery diameter without the administration of vasomotor stimuli. A small reference diameter of the target vessel has been demonstrated to be an adverse prognostic factor in patients undergoing revascularisation. The present study investigated the prognostic value of the proximal non-stenotic left anterior descending coronary artery (LAD) diameter in patients referred for a first diagnostic angiogram without a previous revascularisation. METHODS: A total of 277 patients (mean age 57 year, 61% male) were eligible for analysis. The proximal non-stenotic diameter of the LAD was measured by quantitative coronary angiography without prior nitrate infusion. We defined a small LAD as a diameter < or =2.5 mm. Cardiovascular events were defined as cardiac death, myocardial infarction, and hospitalizations for unstable angina. RESULTS: During a median follow-up of 47 months, 24 major cardiac events occurred. The cumulative survival for patients with a small LAD was significantly lower, than for patients with a large LAD (hazard ratio 2.51; 95% confidence interval 1.11-5.66, p=0.03). In the multivariate analysis, a LAD diameter < or =2.5 mm remained a significant predictor of cardiovascular events after adjustment for age, gender, and the presence of significant coronary artery disease (hazard ratio 2.32; 95% confidence interval 1.01-5.34, p=0.048). CONCLUSION: In patients referred for a first diagnostic angiogram without a previous revascularisation, the diameter of the proximal non-stenotic LAD is an independent predictor of cardiovascular events.

Aged↗

PubMed2003

Validation of Mayo Clinic risk adjustment model for in-hospital complications after percutaneous coronary interventions, using the National Heart, Lung, and Blood Institute dynamic registry.

OBJECTIVES: We sought to validate the recently proposed Mayo Clinic risk score model for complications after percutaneous coronary interventions (PCI), using an independent data set. BACKGROUND: The Mayo Clinic risk score has eight simple clinical and angiographic variables for the prediction of complications defined as either death, Q-wave myocardial infarction, emergent or urgent coronary artery bypass graft surgery, or cerebrovascular accident after PCI. External validation using an independent data set is lacking. METHODS: A total of 3,264 patients undergoing PCI at each of the 17 sites in the National Heart, Lung, and Blood Institute's Dynamic Registry during two enrollment periods (July 1997 to February 1998 and February to June 1999) were studied. Logistic regression was used to model the calculated risk score and major procedural complications. The expected number of complications, with 95% confidence bounds (CBs), was also calculated. RESULTS: There were 96 (2.94%) observed procedural complications, and the Mayo Clinic risk score predicted 93.5 events (2.86%; 95% CB 2.32% to 3.41%; p = NS). The Hosmer-Lemeshow goodness-of-fit p value was 0.28, and the area under the receiver operating curve was 0.76, indicating excellent overall discrimination. There were no statistical differences between observed and predicted procedural complications using the Mayo Clinic risk score among the most selected high- and low-risk subgroups. CONCLUSIONS: Eight variables were combined into a convenient risk scoring system that accurately predicts cardiovascular complications after PCI. The Mayo clinic predictive model for procedural complications yielded excellent results when applied to a multi-center external data set.

Aged↗

PubMed2004

Varicella zoster as a manifestation of immune restoration disease in HIV-infected children.

BACKGROUND: Exacerbation of opportunistic infections in HIV-infected patients shortly after initiation of highly active antiretroviral therapy (HAART) has been named immune restoration disease (IRD). Thus far, IRD has not been reported in children. OBJECTIVE: We describe the clinical and immune characteristics of IRD in HIV-infected children treated with HAART. METHODS: A historical cohort study was conducted in a tertiary HIV center in perinatally HIV-infected children who were started on a first stable HAART between January 1996 and July 2002. The incidence of opportunistic infections, newly AIDS-defining events or death after initiation of HAART, and virologic and immunologic information was evaluated at baseline and every 3 months post-HAART. RESULTS: Sixty-one perinatally HIV-infected children were started and maintained on HAART for >6 months. Seven episodes of IRD occurred. All were cutaneous herpes zoster (HZ). Children who developed HZ had significantly lower baseline CD4+ and CD8+ T-cell numbers compared with children who did not. HZ occurred only in children (7 of 34 subjects) with virological and immunological success to HAART. In children with a previous history of varicella infection, the risk of developing HZ after HAART was higher in those without a protective level of varicella-specific IgG (50%, or 5 of 10 subjects) compared with those with seroprotection (10%, or 2 of 20). CONCLUSION: Herpes zoster is a common manifestation of IRD in HIV-infected children after the initiation of HAART. Risks for developing HZ include no protective varicella-specific antibody despite previous varicella infection, severe immunodeficiency at baseline, and vigorous immunologic and virologic responses to HAART.

Antiretroviral Therapy, Highly Active↗

PubMed2004

Outcome of low-risk patients discharged home after a normal cardiac troponin I.

Patients with symptoms suggestive of, but at low risk for, acute coronary syndrome (ACS), who have a negative electrocardiogram (EKG) and a single normal troponin I at 6-9 h after symptom onset are frequently discharged from our Emergency Department (ED). We sought to determine their rate of adverse cardiac events at 30 days (ACE-30), defined as cardiac death or myocardial infarction (MI), by chart review, telephone interview, or county death records. Of 663 patients, data were available for 588 (89%). Mean age was 48 years; 59% were male. There were 390 patients (66%) who complained of chest pain. Previous coronary artery disease (CAD) was reported in 145 patients (25%). Two patients (0.34%) had ACE-30, both with non-ST elevation MI. There were no cases of cardiac death. None of the patients died in Hennepin County within 30 days. At our institution, low-risk patients with symptoms suggestive of ACS who are discharged home after a normal cTnI drawn 6-9 h after symptom onset have a very low incidence of cardiac events at 30 days.

Angina, Unstable↗

PubMed2005

Plant programmed cell death and the point of no return.

The point of no return during programmed cell death (PCD) is defined as the step beyond which the cell is irreversibly committed to die. Some plant cells can be saved before this point by inducing the formation of functional chloroplasts. A visibly senescent tissue will then become green again and live for months or years. The mechanism of this reversal is only partially known. The point of no return in fungi and animals is often associated with lack of mitochondrial function. In plant cells that do not regreen, there is no evidence for PCD reversal that results in a long life. It is unclear why chloroplast-containing cells, in contrast to those with only mitochondria, have long lives after PCD reversal.

Animals↗

PubMed2006

MELD score as a prognostic model for listing acute liver failure patients for liver transplantation.

OBJECTIVES: The King's College Hospital (KCH) criteria are widely used for listing patients with acute liver failure (ALF) for liver transplantation (LT). Recent reports have suggested that the Model for End-Stage Liver Disease (MELD) score may be useful in assessing prognosis in ALF (nonparacetamol). This study compares prognostic accuracy of the two systems in patients with paracetamol (POD)-induced ALF treated in this unit. METHODS: Seventy-two patients (average age 38 years; F:M ratio 2:1) admitted from 1994 to 2005 with POD-related ALF were studied. Clinical and biochemical parameters were recorded. The effect of applying a MELD score of greater than 30 as listing criteria for LT was calculated and compared with the KCH criteria. Outcomes were defined as LT, death, or full recovery. RESULTS: Thirty-one patients (43%) recovered with medical therapy, 29 (40%) patients died, and 12 (17%) underwent LT. Sixty five percent of patients had a MELD > 30 and therefore could potentially be listed on admission; however, using KCH criteria only 24% patients were listed immediately. Sensitivity and negative predictive value of MELD was higher then KCH; however, we found KCH to have much higher specificity and positive predictive value. CONCLUSION: MELD has higher sensitivity and negative predictive value for POD-induced ALF than the KCH criteria. However, the high false-positive rate associated with MELD limits its clinical utility. The high negative predictive value of MELD score may allow it to be used in conjunction with KCH criteria to avoid unneeded LT in patients who will likely recover spontaneously.

Adult↗

PubMed1997

Potential cost effectiveness of initial myocardial perfusion imaging for assessment of emergency department patients with chest pain.

Previous investigations have confirmed the diagnostic and predictive usefulness of initial single-photon emission computed tomography (SPECT) myocardial perfusion imaging using technetium-99m sestamibi in the evaluation of emergency department patients with chest pain. Patients with a normal SPECT perfusion scan performed during chest pain have an excellent short-term prognosis, and may be candidates for expeditious cardiac evaluation or outpatient management. However, there are limited data regarding the cost effectiveness of this technique. This analysis models the potential cost effectiveness of this procedure. In the current investigation we compared 2 model strategies for management of emergency department patients with typical chest pain and a normal or nondiagnostic electrocardiogram (ECG). In 1 model strategy, (the technetium-99m sestamibi SPECT myocardial perfusion imaging [SCAN] strategy), the decision whether to admit or discharge a patient from the emergency department is based on results of initial technetium-99m sestamibi SPECT myocardial imaging. Patients with normal scans are discharged; others are admitted. In the second model strategy, (the NO SCAN strategy), the decision whether or not to admit a patient is based on a combination of clinical and electrocardiographic variables. Patients with > or = 3 cardiac risk factors or an abnormal ECG are admitted; others are discharged. Adverse cardiac events were prospectively defined as cardiac death, nonfatal myocardial infarction, or the need for acute coronary intervention. Costs were assigned using data derived from 102 patients who underwent SPECT myocardial perfusion imaging and an additional 107 emergency department patients with ongoing chest pain who either underwent or were eligible for initial SPECT myocardial perfusion imaging. Mean (+/- SE) costs were highest among hospital admitted patients who experienced an adverse cardiac event ($21,375 +/- $2,733) and lowest in patients discharged from the emergency department ($715 +/- 71). Mean costs per patient of the SCAN strategy and NO SCAN strategy were $5,019 versus $6,051, respectively. These results were stable in a sensitivity analysis across a range of costs and predictive values. Thus, the SCAN model strategy for initial management of emergency department patients with typical ongoing angina and a normal or nondiagnostic ECG using initial myocardial perfusion imaging with technetium-99m sestamibi appears to be safe, accurate, and potentially cost effective. Validation of these preliminary retrospective observations will require further prospective investigation.

Angina Pectoris↗

PubMed1994

Predictive value of neonatal electroencephalograms before and during extracorporeal membrane oxygenation.

We studied the prognostic significance of electroencephalograms recorded serially at 2- to 4-day intervals during the acute neonatal course of 119 near-term infants with severe respiratory failure treated by venoarterial extracorporeal membrane oxygenation (ECMO). A poor prognosis was defined as early death (n = 27), an abnormally low developmental assessment score (n = 14), or cerebral palsy (n = 14) at 12 to 45 months of age. The only electroencephalographic abnormalities that were significantly related to a poor prognosis were burst suppression (B-S) and electrographic seizure (ES). The 30 infants with two or more recordings of B-S or ES, when compared with the 58 neonates without such electroencephalographic abnormalities, had an odds ratio for a poor prognosis of 6.6 (95% confidence limits, 2.2 to 20.2). The 31 infants with a single ES or B-S recording did not have a significantly increased risk for a poor prognosis. Cardiopulmonary resuscitation immediately before ECMO (n = 8) and the lowest systolic blood pressure before or during ECMO were significantly related to the occurrence of ES or B-S recordings. There was no significant predilection of ES for either cerebral hemisphere. We conclude that in near-term neonates with respiratory failure, serial electroencephalographic recordings are of predictive value, and may facilitate clinical care including the decision to initiate or to continue ECMO.

Acute Disease↗

PubMed2003

Metalloproteinase inhibition reduces lung injury and improves survival after cecal ligation and puncture in rats.

BACKGROUND: Neutrophil activation with concomitant matrix metalloproteinase-2 (MMP-2) and matrix metalloproteinase-9 (MMP-9) release has been implicated in the development of sepsis-induced acute lung injury. We hypothesized that COL-3, a chemically modified tetracycline known to inhibit MMP-2 and MMP-9, would reduce lung injury and improve survival in rats following cecal ligation and puncture (CLP). METHODS: Sprague-Dawley rats were separated into five groups: 1) sham CLP+ carboxymethylcellulose (CMC; vehicle for COL-3, n = 6); 2) sham CLP + COL-3 (n = 6); 3) CLP + CMC (n = 10); 4) CLP + single-dose (SD) COL-3 administered concomitant with CLP (n = 9); and 5) CLP + multiple-dose (MD) COL-3 administered concomitant with CLP and at 24 h after CLP (n = 15). Rats were sacrificed at 168 h (7 days) or immediately after death, with survival defined as hours after CLP. Histological lung assessment was made based on neutrophil infiltration, alveolar wall thickening, and intraalveolar edema fluid. Lung MMP-2 and MMP-9 levels were assessed by immunohistochemistry. MMP-2 and MMP-9 levels were correlated with survival by simple regression analysis. RESULTS: The mortality of rats in the cecal ligation and puncture without treatment group (CLP + CMC) was 70% at 168 h. A single dose of COL-3 in the CLP + COL-3 (SD) group significantly reduced mortality to 54%. Furthermore, with a repeat dose of COL-3 at 24 h after CLP, mortality was significantly reduced to 33%. Pathologic lung changes seen histologically in the CLP + CMC group were significantly reduced by COL-3. A significant reduction in lung tissue levels of MMP-2 and MMP-9 was noted in both groups treated with COL-3. Reduction of MMP-2 and MMP-9 levels correlated with improved survival. CONCLUSION: Inhibition of MMP-2 and MMP-9 by COL-3 in a clinically relevant model of sepsis-induced acute lung injury reduces pulmonary injury and improves survival in a dose-dependent fashion. Our results suggest that prophylactic treatment with COL-3 in high-risk patients may reduce the morbidity and mortality associated with sepsis-induced acute respiratory distress syndrome.

Animals↗

PubMed1982

Cyclophosphamide, methotrexate and 5-fluorouracil combination chemotherapy versus chloroethyl-cyclohexy-nitrosourea in the treatment of metastatic prostatic cancer.

In a prospective, randomized study the effect of cyclophosphamide, methotrexate and 5-fluorouracil combination chemotherapy was compared to the single agent, chloroethyl-cyclohexy-nitrosourea, in the treatment of hormonally refractive metastatic prostatic carcinoma. All patients could be evaluated and were followed for at least 2 years or until death. Responses were defined by the National Prostatic Cancer Project criteria. Of 20 patients who received cyclophosphamide, methotrexate and 5-fluorouracil 3 (15 per cent) had partial (median duration of 2.5 months), 4 (20 per cent) had stable (median duration of 5 months) and 13 had progression of the disease. Of 20 patients who received chloroethyl-cyclohexy-nitrosourea none had a partial response, 6 (30 per cent) had stability (median duration of 6.2 months) and 13 had progression of the disease. The over-all response rate for patients receiving cyclophosphamide, methotrexate and 5-fluorouracil was 35 per cent (stable plus partial regressions) and it was 30 per cent for those receiving chloroethyl-cyclohexy-nitrosourea (stable only). Subjective improvement was noted in all 7 patients who responded to combination chemotherapy and in 3 of the 6 patients who responded to the single agent. After 2 courses resistant patients were crossed over to the opposite regimen and none had an objective, stable or subjective response. Although the duration of response was short (2 to 6 months) patients with partial regressions or stabilized disease survived longer (p less than 0.05) than patients whose disease progressed (52 versus 24 weeks, respectively). The mean interval from diagnosis to chemotherapy (lead time) was 40 months for patients who responded to chemotherapy compared to 19 months for those with progression, which suggested a slower growing pattern of disease in those who did respond. There was no improvement in cohort survival with either treatment regimen. Over-all response rates to cyclophosphamide, methotrexate and 5-fluorouracil were not superior to reported responses to cyclophosphamide alone, and both treatment regimens appeared to be only marginally effective in the treatment of endocrine-resistant, advanced prostatic cancer.

Aged↗

PubMed2001

Individualized risk assessment for adverse pregnancy outcome by uterine artery Doppler at 23 weeks.

OBJECTIVE: To provide individualized risk prediction of severe adverse pregnancy outcome based on uterine artery Doppler screening at 23 weeks. METHODS: Color Doppler assessment of the uterine arteries was carried out in 5121 women attending for routine care at 23 weeks in two inner-city obstetric units. The mean uterine artery pulsatility index (PI) was calculated, and the likelihood ratios in relation to PI were generated for severe adverse outcome. This was defined as fetal death, placental abruption, and delivery before 34 weeks associated with preeclampsia and birth weight less than the 10th centile. RESULTS: The likelihood of severe adverse pregnancy outcome increased quadratically with mean uterine artery PI. This relationship was not affected by maternal age, ethnicity, or parity. At a mean PI of 1.45, the 95th centile for our population, the likelihood ratio for severe adverse pregnancy outcome was 5. Cigarette smoking had an additional contribution to PI in predicting severe adverse outcome, roughly doubling the risk for a given PI. CONCLUSION: The individualized risk of severe adverse pregnancy outcome can be determined by uterine artery Doppler screening at 23 weeks and knowledge of cigarette smoking history. Such individualized risk would allow ultrasound resources and clinical follow-up to be tailored to the pregnant woman for the most appropriate use of antenatal care.

Adult↗

PubMed1997

Middle cerebral artery velocimetry: different clinical relevance depending on umbilical velocimetry.

OBJECTIVE: To evaluate the role of cerebral velocimetry as a predictor of perinatal outcome in high-risk pregnancies. METHODS: Middle cerebral artery pulsatility index was measured in 576 high-risk pregnancies undergoing umbilical velocimetry. The results of both tests were evaluated with respect to the birth of small for gestational age (SGA) infants and adverse perinatal outcome, defined as perinatal death, cesarean delivery for fetal distress, or low Apgar score. RESULTS: Once umbilical velocimetry was taken into account, cerebral velocimetry did not improve the prediction of fetal growth restriction or adverse perinatal outcome. Neither test was able to predict adverse perinatal outcome in normally grown fetuses. As for SGA fetuses with adverse perinatal outcome, the simultaneous assessment of both umbilical and cerebral velocimetry did not improve diagnostic accuracy (kappa index 0.37 versus 0.41 for umbilical velocimetry only). However, within the group of high-risk pregnancies with abnormal umbilical velocimetry, the risk of being SGA and having an adverse perinatal outcome was doubled (relative risk 2.1, 95% confidence interval 1.1, 4.3) if cerebral velocimetry also was abnormal. CONCLUSION: The routine use of cerebral velocimetry in high-risk pregnancies adds little information beyond that obtained from umbilical velocimetry; however, it is useful in predicting SGA infants with adverse perinatal outcome when umbilical velocimetry is abnormal.

Blood Flow Velocity↗

PubMed2002

Prognosis of HIV-1-infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies.

BACKGROUND: Insufficient data are available from single cohort studies to allow estimation of the prognosis of HIV-1 infected, treatment-naive patients who start highly active antiretroviral therapy (HAART). The ART Cohort Collaboration, which includes 13 cohort studies from Europe and North America, was established to fill this knowledge gap. METHODS: We analysed data on 12,574 adult patients starting HAART with a combination of at least three drugs. Data were analysed by intention-to-continue-treatment, ignoring treatment changes and interruptions. We considered progression to a combined endpoint of a new AIDS-defining disease or death, and to death alone. The prognostic model that generalised best was a Weibull model, stratified by baseline CD4 cell count and transmission group. FINDINGS During 24,310 person-years of follow up, 1094 patients developed AIDS or died and 344 patients died. Baseline CD4 cell count was strongly associated with the probability of progression to AIDS or death: compared with patients starting HAART with less than 50 CD4 cells/microL, adjusted hazard ratios were 0.74 (95% CI 0.62-0.89) for 50-99 cells/microL, 0.52 (0.44-0.63) for 100-199 cells/microL, 0.24 (0.20-0.30) for 200-349 cells/microL, and 0.18 (0.14-0.22) for 350 or more CD4 cells/microL. Baseline HIV-1 viral load was associated with a higher probability of progression only if 100,000 copies/microL or above. Other independent predictors of poorer outcome were advanced age, infection through injection-drug use, and a previous diagnosis of AIDS. The probability of progression to AIDS or death at 3 years ranged from 3.4% (2.8-4.1) in patients in the lowest-risk stratum for each prognostic variable, to 50% (43-58) in patients in the highest-risk strata. INTERPRETATION: The CD4 cell count at initiation was the dominant prognostic factor in patients starting HAART. Our findings have important implications for clinical management and should be taken into account in future treatment guidelines.

Adolescent↗

PubMed2003

Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial.

BACKGROUND: Renal transplant recipients are at increased risk of premature cardiovascular disease. Although statins reduce cardiovascular risk in the general population, their efficacy and safety in renal transplant recipients have not been established. We investigated the effects of fluvastatin on cardiac and renal endpoints in this population. METHODS: We did a multicentre, randomised, double-blind, placebo-controlled trial in 2102 renal transplant recipients with total cholesterol 4.0-9.0 mmol/L. We randomly assigned patients fluvastatin (n=1050) or placebo (n=1052) and follow up was for 5-6 years. The primary endpoint was the occurrence of a major adverse cardiac event, defined as cardiac death, non-fatal myocardial infarction (MI), or coronary intervention procedure. Secondary endpoints were individual cardiac events, combined cardiac death or non-fatal MI, cerebrovascular events, non-cardiovascular death, all-cause mortality, and graft loss or doubling of serum creatinine. Analysis was by intention to treat. FINDINGS: After a mean follow-up of 5.1 years, fluvastatin lowered LDL cholesterol concentrations by 32%. Risk reduction with fluvastatin for the primary endpoint (risk ratio 0.83 [95% CI 0.64-1.06], p=0.139) was not significant, although there were fewer cardiac deaths or non-fatal MI (70 vs 104, 0.65 [0.48-0.88] p=0.005) in the fluvastatin group than in the placebo group. Coronary intervention procedures and other secondary endpoints did not differ significantly between groups. INTERPRETATION: Although cardiac deaths and non-fatal MI seemed to be reduced, fluvastatin did not generally reduce rates of coronary intervention procedures or mortality. Overall effects of fluvastatin were similar to those of statins in other populations.

Adult↗

PubMed1999

Therapeutic immunisation with recombinant gp160 in HIV-1 infection: a randomised double-blind placebo-controlled trial. Nordic VAC-04 Study Group.

BACKGROUND: The immune system's ability to scavenge and destroy detrimental HIV-1 products has an important effect on virion production and the course of infection. In earlier trials of therapeutic immunisation with envelope protein recombinant gp160 (rgp160) we observed a transient positive effect on CD4-lymphocyte counts. This randomised placebo-controlled study investigated whether our preliminary findings represented a potential for a more benign clinical course. METHODS: 835 HIV-seropositive patients from 20 centres in Sweden, Norway, and Finland with CD4-cell counts above 200/microL were randomly assigned to receive 160 microg rgp160 or placebo (alum adjuvant alone) every 3 months for 3 years after an induction period, as well as optimum available treatment. Analyses were by intention to treat. FINDINGS: 63 of 416 vaccine-group patients and 61 of 419 placebo-group patients reached a primary clinical endpoint (AIDS-defining event or death); the time to first clinical endpoint did not differ between the groups (p=0.864). Significantly fewer vaccine-group patients than placebo-group patients reached the primary immunological endpoint of a decrease of more than 30% from baseline CD4-cell count (157 vs 189, p=0.03). A higher proportion of the vaccine group had CD4-cell counts higher than baseline at 6 months (167 vs 133, p=0.014). HIV-1-specific T-cell immune reactivity was induced in all vaccine recipients studied. No severe adverse events associated with the vaccine were noted during the study. There were significantly fewer deaths among the vaccine recipients than among the placebo-group patients at 2 years, but not at the end of the study. INTERPRETATION: Therapeutic immunisations with rgp160 have a modest effect on CD4-cell counts, but this treatment alone did not lead to clinical benefit when given in addition to best clinical practice at the time of the trial. Immunisation in conjunction with antiretroviral therapy was also effective, which strongly suggests that a combination with highly active therapy would improve the total effect.

AIDS Vaccines↗

PubMed2003

Prognostic significance of heart rate variability in dilated cardiomyopathy.

BACKGROUND: Identifying high-risk individuals among patients with nonischemic dilated cardiomyopathy (DCM) is a major and unsolved task of clinical cardiology. We aimed to determine prognostic significance of heart rate variability (HRV) for predicting cardiac events in DCM patients with markedly depressed left ventricular function. METHODS: In 69 DCM patients in sinus rhythm, with normal coronary angiography and mean ejection fraction 32 (11%) cardiac events defined as cardiac death or heart transplantation during a mean 20-month follow-up were related to baseline time-domain HRV parameters calculated from 24-h digital Holter monitoring. RESULTS: There were 18 (26%) cardiac events (10 deaths and 8 heart transplantations). In multivariate Cox analysis, standard deviation of normal-to-normal intervals (SDNN) (hazard ratio: 1.35; 95% confidence interval 1.11-1.63; P=0.002) and ejection fraction (hazard ratio: 4.21; confidence interval 1.64-10.78; P=0.003) were significant and independent predictors of cardiac events. One-year event-free survival was significantly lower in patients with SDNN<80 ms compared to those with SDNN>or=80 ms (35% vs. 89%, respectively; P<0.00005). Low SDNN was identifying high-risk patients among those with both depressed and relatively preserved left ventricular function. CONCLUSIONS: Broadly available time-domain HRV analysis adds independent prognostic information improving risk stratification of DCM patients and therefore it should be incorporated in routine clinical evaluation to determine patients' priority for heart transplantation.

Adult↗