Left atrial functions in long term after catheter ablation of premature ventricular complexes.

OBJECTIVE: Premature ventricular complex (PVC) ablation has been shown to improve left ventricle (LV) diastolic function and left atrial (LA) reverse modeling, especially in the short term. In the present study, PVC ablation via radiofrequency catheter (RFCA) was evaluated with respect to its long-term effects on LA size and dynamic functions. PATIENTS AND METHODS: A total of 71 patients (age 43.49±12.8 years, 37 men [52%]) with high-burden (21% mean burden) PVCs who were treated with RFCA were included in this retrospective study. The effects of RFCA on three characteristics - LV systolic functions, LV diastolic dysfunctions and mechanical effects pertaining to the LA - were examined by echocardiography at baseline and at 3 months and 18 months after the procedure. RESULTS: Advancement in LV ejection fraction (LVEF) was seen on long-term follow-up (LVEF baseline 53.01; 3rd month 54.55; 18th month 58.02; p<0.001). LA function gradually improved after RFCA. The LA volume index was significantly decreased after RFCA (baseline 18.15±2.89; 3 months 17.11±2.71; 18 months 16.67±2.61; p<0.001). The LA passive emptying fraction was still increasing over long-term follow-up (baseline 33.33; 3rd month 37.11; 18th month 40.91; p<0.001). CONCLUSIONS: In the present study, in patients with or without apparent cardiomyopathy, RFCA was shown to successfully eliminate PVCs and improve LA functions in the long term.

A novel intermediate coronary artery stenosis severity method: Fluoroscopy-Assisted Measurement of Coronary Volume Ratio (The FLAME FFR Trial).

OBJECTIVE: The fluoroscopy-assisted coronary volume measurement (FLASH) algorithm, based on contrast passage time and vessel size, is a simple and non-invasive method of assessing coronary blood volume. The present study evaluated the diagnostic performance of FLASH flow ratio-derived fractional flow reserve (FFRFLAME) compared to wire-based FFR (FFRWB). PATIENTS AND METHODS: FFRFLAME was defined as the ratio of FLASH at baseline to maximal hyperemia. Forty-eight patients with one intermediate coronary lesion (30-70% by angiographic visual estimation) were enrolled in this cross-sectional study. FFRFLAME and FFRWB measurements were collected in each patient. Intravenous administration of adenosine was used to achieve maximal hyperemia. The Pearson correlation coefficient and receiver operating characteristic analysis were performed to determine the predictive accuracy of FFRFLAME. RESULTS: The average age of the patients was 58 years, and 43% (21 of 48) were female. The predominant vessel assessed was the left anterior descending artery system (87.5%). The mean FFRWB was 0.91 ± 0.05 at baseline and 0.83 ± 0.07 at the hyperaemic level, with 27% (13 of 48) of patients having an FFRWB of ≤0.80. For each patient, the mean FFRFLAME was 0.668 ± 0.17. The mean FFRFLAME was 0.85 ± 0.16 for patients having an FFRWB of ≤0.80. A strong relationship existed between FFRFLAME and FFRWB (Pearson's r = - 0.765 p<0.001). The optimal cutoff value of the functional significance of coronary artery stenosis for FFRFLAME was determined to be > 0.84 (AUC: 0.899, 84% sensitivity and 97% specificity) when the FFRWB cutoff value for significant lesions was ≤ 0.80. CONCLUSIONS: FFRFLAME, applied to coronary angiography without the need for an invasive pressure wire, can be a beneficial index for appropriate lesion selection in coronary artery diseases.

Budesonide administered using chlorofluorocarbon and hydrofluoroalkane pressurized metered-dose inhalers: pharmacokinetics, pharmacodynamics and clinical equivalence.

OBJECTIVE: The traditional chlorofluorocarbon (CFC) propellants used in pressurized metered-dose inhalers (pMDIs) have unacceptable environmental effects and are being replaced by alternatives such as hydrofluoroalkanes (HFAs). However, there is a need to ensure that pMDIs with these novel propellants are as effective and safe as their older counterparts. MATERIALS AND METHODS: Single-dose pharmacokinetic and multiple high-dose Phase I studies in healthy volunteers and randomized, controlled 12-week Phase III clinical trials in children, adolescents and adults with mild-to-moderate asthma have been performed to compare the efficacy and safety of HFA-based budesonide inhaler therapy with the traditional CFC-based pMDI. RESULTS: The pharmacokinetic study in 40 persons showed comparable characteristics of CFC and HFApMDIs, with good dose-proportionality, at doses of 400, 800 and 1,600 microg. The high-dosage (1,600 microg/day) study in 48 subjects showed both inhaler types to be similar in terms of effects on hypothalamic-pituitary-adrenal axis function over 4 weeks. The pediatric clinical study involved 159 children and showed noninferiority of the HFA pMDI in terms of 12-week change in forced expiratory volume in 1 sec, other spirometric parameters and symptomatic measures. The adolescent/adult study in 321 subjects also showed similarity between the two formulations, in terms of 12-week primary endpoint (changes in morning peak expiratory flow rates) and other lung function and symptom measures. Both formulations were well-tolerated, with no safety issues being identified for the novel HFA inhaler in any study. CONCLUSION: Budesonide HFA pMDI is pharmacokinetically and clinically comparable to the traditional CFC-based inhaler, with similar safety profile.

Evaluation of arterial stiffness and cardiac function in patients with vascular erectile dysfunction: acute effects of phosphodiesterase-5 inhibitor tadalafil.

This study aimed to detect endothelial dysfunction in erectile dysfunction (ED) patients free from cardiovascular diseases or atherosclerotic risk factors and to evaluate acute effects of phosphodiesterase-5 inhibitor tadalafil on endothelial dysfunction and cardiac function. Thirty ED patients and 20 healthy male subjects (mean ages: 48.7±11.7 and 48.3±8.7 years, respectively) were enrolled. Endothelium functions were assessed by applanation tonometry. Aortic stiffness and cardiac function were evaluated by transthoracic echocardiography. Pulse pressure was greater in the ED group (P<0.05), whereas aortic strain and aortic distensibility were significantly lower (P<0.001). Treatment with tadalafil reduced pulse pressure (P=0.0179), systolic blood pressure (P=0.001) and diastolic blood pressure (P=0.054) and increased aortic distensibility (P=0.001) and aortic strain (P=0.003) in the ED group. Tadalafil administration also increased large artery and small artery elasticity indices that were reduced in the ED group at baseline (P=0.02 and 0.003, respectively). Systemic vascular disease and compromised left ventricular diastolic function (LVDF) were present in ED patients with no known atherosclerotic risk factors and cardiac diseases. Tadalafil positively affected arterial stiffness and LVDF.

Clinical comparability between the CFC and HFA budesonide pressurised metered-dose inhalers in paediatric patients with asthma: a randomised controlled trial.

OBJECTIVE: To evaluate the efficacy and tolerability of a novel hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) formulation of budesonide (Pulmicort) versus the conventional chlorofluorocarbon (CFC) pMDI formulation in paediatric patients with asthma. METHODS: This was a Phase III, multicentre, 12-week, double-blind, randomised, parallel-group study involving children (6-12 years of age) with mild to moderate asthma. Patients received either budesonide HFA pMDI or budesonide CFC pMDI 200 mug twice daily, with or without a spacer (NebuChamber/Nebunette). Primary efficacy endpoint: mean percentage change in forced expiratory volume in 1 second (FEV(1)) from baseline to week 12. Secondary efficacy endpoints included changes in FEV(1) per cent of predicted normal, forced vital capacity, morning and evening peak expiratory flow rate, asthma symptoms and use of rescue medication. RESULTS: A total of 159 patients received treatment (HFA 77, CFC 82). For mean percentage change in FEV(1) from baseline to week 12, the difference between the treatments (CFC pMDI - HFA pMDI) was -3.1% (95% confidence interval [CI] -8.0% to 1.8%) for the full analysis set and was not affected by spacer use. The upper CI was < 10% (the predefined non-inferiority margin), so non-inferiority was demonstrated. Improvements in the secondary efficacy endpoints with both budesonide formulations were not significantly different. In both groups there were similar numbers of adverse events and no evidence of oral candidiasis at week 12. CONCLUSIONS: Treatment with budesonide HFA pMDI is effective and well tolerated in children with asthma and is clinically comparable to budesonide CFC pMDI.

Clinical correlation with changing radiographic appearance during partial liquid ventilation.

STUDY OBJECTIVES: To evaluate the chest radiographic filling pattern associated with partial liquid ventilation (PLV) with the perfluorochemical perflubron (LiquiVent; Alliance Pharmaceutical Corp; San Diego CA) as a function of dose and timing. DESIGN: Post hoc review of chest radiographs by three independent observers with correlation to clinical variables. SETTING: Phase II randomized, uncontrolled, prospective, multicenter clinical trial. PATIENTS: Sixteen adult patients with diffuse bilateral infiltrates consistent with acute lung injury and a PaO(2)/fraction of inspired oxygen (FIO(2)) ratio < 300 with positive end-expiratory pressure of 13 cm H(2)O and FIO(2) > or = 0.5. INTERVENTIONS: All patients were treated with either a 10-mL/kg or 20-mL/kg loading dose of perflubron followed by maintenance dosing at 3-h intervals to protocol-determined levels. RESULTS: There was a significant relationship between inhomogeneous radiographic filling during the first 48 h of treatment and the use of the lower loading dose of perflubron. Inhomogeneous radiographic filling (in 5 patients) was associated with a lower high-dose/FIO(2) ratio at 24 h compared with the remaining patients. These differences resolved by 48 h. There were no other statistically significant correlations identified. CONCLUSIONS: The radiographic appearance of PLV with perflubron appears to depend on the dose administered. Lower doses can be associated with both inhomogeneous radiographic filling and a transient deterioration in oxygenation during the first 24 to 48 h of treatment.

Modest correlation between serum neopterin levels and Gensini scores in a cohort of patients undergoing coronary angiography.

OBJECTIVE: We initially tried to study the possible correlation between the severity of coronary artery disease (CAD) and serum neopterin levels in stable coronary artery disease patients. Also we tried to investigate the neopterin as an indicator for the extent of CAD using the Gensini score. METHODS: A total of 40 patients with stable angina pectoris who are chosen for coronary angiography were selected for the study. Before the angiography procedure, blood samples were taken for the measurement of serum neopterin levels and the results of the coronary angiography were scored according to the Gensini scoring system. RESULTS: Neopterin levels were correlated with the Gensini scores [p = 0.010, ρ = 0.401] and a correlation between the age of patient population and Gensini score was also observed in the study [p = 0.016, ρ = 0.380]. CONCLUSION: By the guidance of our results, we can confidently state that there is a correlation between serum neopterin levels and the severity and extent of CAD in stable coronary artery disease patients.