Green Synthesis of Silver Nanoparticles: Optimizing Green Tea Leaf Extraction for Enhanced Physicochemical Properties.

In this paper, we present the optimization of green tea leaf (Camellia sinensis L.) extraction, carried out using water and hydroalcoholic solvents, for the subsequent synthesis of silver nanoparticles (AgNPs). The value ranges for independent variables, including pH, time, and temperature, were selected based on single-factor experiments and used for extraction in the order presented by the Box-Behnken design. Three-dimensional response surface graphs were used to visually present the optimization results and determine the optimal extraction conditions: pH = 7, 30 min, 80 °C for water and pH = 5.5, 50 min, and 80 °C for water-ethanol. Our findings indicate that the water-ethanol mixture extracted more polyphenols. We compared the physicochemical properties of AgNPs obtained using both types of extractants via DLS and TEM analysis. We proposed a predicted mechanism for the reduction and stabilization of AgNPs based on the Fourier transform infrared data. The hydroethanolic extract leads to significant nanoparticle aggregation, which can be explained by the nucleation theory and agglomeration of nanoparticles in the presence of excess macromolecular organic substances (flocculation).

Effect of Schwertmannite Surface Modification by Surfactants on Adhesion of Acidophilic Bacteria.

Bacterial cell adhesion onto mineral surfaces is important in a broad spectrum of processes, including bioweathering, bioleaching, and bacterial cell transport in the soil. Despite many research efforts, a detailed explanation is still lacking. This work investigates the role of surface-active compounds, cetyltrimethylammonium bromide (CTAB), sodium dodecyl sulfate (SDS), and pure rhamnolipid (RH), in the process of bacteria attachment on the schwertmannite surface. The surface energy was calculated based on the wettability of the tested systems, and for bacteria it was 54.8 mJ/m2, schwertmannite-SDS 54.4 mJ/m2, schwertmannite-CTAB 55.4 mJ/m2, and schwertmannite-RH 39.7 mJ/m2. The total energy of adhesion estimated based on thermodynamic data was found to be negative, suggesting favorable conditions for adhesion for all examined suspensions. However, including electrostatic interactions allowed for a more precise description of bacterial adhesion under the tested conditions. The theoretical analysis using the extended Derjaguin-Landau-Verwey-Overbeek (DLVO) approach showed a negative value of total adsorption energy only in bacteria-mineral suspensions, where SDS and rhamnolipid were added. The calculated data were in good agreement with experimental results indicating the significance of electrostatic forces in adsorption.

The colloid hematite particle migration through the unsaturated porous bed at the presence of biosurfactants.

Colloidal particles have an ability to sorb heavy metals, metalloids, and organic compounds (e.g. biosurfactants) present in soil and groundwater. The pH and ionic strength changes may promote release of such particles causing potential contaminant transport. Therefore, it is very important to know how a colloid particle-mineral particle and colloid-mineral-biosurfactant system behaves in the natural environment. They can have negative impact on the environment and human health. This study highlighted the influence of biosurfactants produced by Pseudomonas aeruginosa on the transport of colloidal hematite (α-Fe2O3) through porous bed (materials collected from the Szklary and Zloty Stok solid waste heaps from Lower Silesia, Poland). Experiments were conducted using column set in two variants: colloid solution with porous bed and porous bed with adsorbed biosurfactants, in the ionic strengths of 5 × 10-4 and 5 × 10-3 M KCl. The zeta potential of mineral materials and colloidal hematite, before and after adsorption of biosurfactant, was determined. Obtained results showed that reduction in ionic strength facilitates colloidal hematite transport through the porous bed. The mobility of colloidal hematite was higher when the rhamnolipid adsorbed on the surface of mineral grain.

Biosorption of malachite green by eggshells: mechanism identification and process optimization.

In the present work, eggshells were used to remove a dye (malachite green) from wastewater. The study was focused on identification and describing the binding mechanism of the dye by eggshells in a biosorption process optimized by Response Surface Methodology based on the Box-Behnken Design. The mechanism of biosorption was determined by characterization of the biosorbent before and after biosorption using scanning electron microscopy, X-ray diffraction analysis, the Brunauer-Emmett-Teller isotherm method, Fourier transform infrared spectroscopy. The second-order polynomial equation and 3D response surface plots were used to quantitatively determine the relationships between dependent and independent variables. The obtained results suggested the mechanism of wastewater treatment that included physical adsorption, alkaline fading phenomenon and microprecipitation. The results of the present study showed that waste eggshells have the potential to be used as an inexpensive but effective biosorbent useful in wastewater treatment.

Impact of percutaneous coronary intervention on biomarker levels in patients in the subacute phase following myocardial infarction: the Occluded Artery Trial (OAT) biomarker ancillary study.

BACKGROUND: The purpose of the Occluded Artery Trial (OAT) Biomarker substudy was to evaluate the impact of infarct related artery (IRA) revascularization on serial levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and dynamics of other biomarkers related to left ventricular remodeling, fibrosis and angiogenesis. METHODS: Patients were eligible for OAT-Biomarker based on the main OAT criteria. Of 70 patients (age 60.8 ± 8.8, 25% women) enrolled in the substudy, 37 were randomized to percutaneous coronary intervention (PCI) and 33 to optimal medical therapy alone. Baseline serum samples were obtained prior to OAT randomization with follow up samples taken at one year. The primary outcome was percent change of NT-proBNP from baseline to 1 year. The secondary outcomes were respective changes of matrix metalloproteinases (MMP) 2 and 9, tissue inhibitor of matrix metalloproteinase 2 (TIMP-2), Vascular Endothelial Growth Factor (VEGF), and Galectin-3. RESULTS: Paired (baseline and one-year) serum samples were obtained in 62 subjects. Baseline median NT-proBNP level was 944.8 (455.3, 1533) ng/L and decreased by 69% during follow-up (p < 0.0001). Baseline MMP-2 and TIMP-2 levels increased significantly from baseline to follow-up (p = 0.034, and p = 0.027 respectively), while MMP-9 level decreased from baseline (p = 0.038). Levels of VEGF and Galectin-3 remained stable at one year (p = NS for both). No impact of IRA revascularization on any biomarker dynamics were noted. CONCLUSIONS: There were significant changes in measured biomarkers related to LV remodeling, stress, and fibrosis following MI between 0 and 12 month. Establishing infarct vessel patency utilizing stenting 24 hours-28 days post MI did not however influence the biomarkers' release.

Long-term effects of percutaneous coronary intervention of the totally occluded infarct-related artery in the subacute phase after myocardial infarction.

BACKGROUND: Despite observations suggesting a benefit for late opening of totally occluded infarct-related arteries after myocardial infarction, the Occluded Artery Trial (OAT) demonstrated no reduction in the composite of death, reinfarction, and class IV heart failure over a 2.9-year mean follow-up. Follow-up was extended to determine whether late trends would favor either treatment group. METHODS AND RESULTS: OAT randomized 2201 stable patients with infarct-related artery total occlusion >24 hours (calendar days 3-28) after myocardial infarction. Patients with severe inducible ischemia, rest angina, class III-IV heart failure, and 3-vessel/left main disease were excluded. We conducted extended follow-up of enrolled patients for an additional 3 years for the primary end point and angina (6-year median survivor follow-up; longest, 9 years; 12 234 patient-years). Rates of the primary end point (hazard ratio, 1.06; 95% confidence interval, 0.88-1.28), fatal and nonfatal myocardial infarction (hazard ratio, 1.25; 95% confidence interval, 0.89-1.75), death, and class IV heart failure were similar for the percutaneous coronary intervention (PCI) and medical therapy alone groups. No interactions between baseline characteristics and treatment group on outcomes were observed. The vast majority of patients at each follow-up visit did not report angina. There was less angina in the PCI group through early in follow-up; by 3 years, the between group difference was consistently <4 patients per 100 treated and not significantly different, although there was a trend toward less angina in the PCI group at 3 and 5 years. The 7-year rate of PCI of the infarct-related artery during follow-up was 11.1% for the PCI group compared with 14.7% for the medical therapy alone group (hazard ratio, 0.79; 95% confidence interval, 0.61-1.01; P=0.06). CONCLUSIONS: Extended follow-up of the OAT cohort provides robust evidence for no reduction of long-term rates of clinical events after routine PCI in stable patients with a totally occluded infarct-related artery and without severe inducible ischemia in the subacute phase after myocardial infarction.

The Occluded Artery Trial (OAT) Viability Ancillary Study (OAT-NUC): influence of infarct zone viability on left ventricular remodeling after percutaneous coronary intervention versus optimal medical therapy alone.

BACKGROUND: The Occluded Artery Trial (OAT) showed no difference in outcomes between percutaneous coronary intervention (PCI) versus optimal medical therapy (MED) in patients with persistent total occlusion of the infarct-related artery 3 to 28 days post-myocardial infarction. Whether PCI may benefit a subset of patients with preservation of infarct zone (IZ) viability is unknown. METHODS AND RESULTS: The OAT nuclear ancillary study hypothesized that (1) IZ viability influences left ventricular (LV) remodeling and that (2) PCI as compared with MED attenuates adverse remodeling in post-myocardial infarction patients with preserved viability. Enrolled were 124 OAT patients who underwent resting nitroglycerin-enhanced technetium-99m sestamibi single-photon emission computed tomography (SPECT) before OAT randomization, with repeat imaging at 1 year. All images were quantitatively analyzed for infarct size, IZ viability, LV volumes, and function in a core laboratory. At baseline, mean infarct size was 26% ± 18 of the LV, mean IZ viability was 43% ± 8 of peak uptake, and most patients (70%) had at least moderately retained IZ viability. There were no significant differences in 1-year end-diastolic or end-systolic volume change between those with severely reduced versus moderately retained IZ viability, or when compared by treatment assignment PCI versus MED. In multivariable models, increasing baseline viability independently predicted improvement in ejection fraction (P = .005). There was no interaction between IZ viability and treatment assignment for any measure of LV remodeling. CONCLUSIONS: In the contemporary era of MED, PCI of the infarct-related artery compared with MED alone does not impact LV remodeling irrespective of IZ viability.

Evaluation of the functional status questionnaire in heart failure: a sub-study of the second cardiac insufficiency bisoprolol survival study (CIBIS-II).

AIMS: We evaluated a generic quality of life (QoL) Functional Status Questionnaire (FSQ), in patients with chronic heart failure (CHF). The FSQ assesses the 3 main dimensions of QoL: physical functioning, mental health and social role. It also includes 6 single item questions about: work status, frequency of social interactions, satisfaction with sexual relationships, days in bed, days with restricted activity and overall satisfaction with health status. The FSQ was compared to the Minnesota Living with Heart Failure questionnaire (MLwHF). METHODS AND RESULTS: The FSQ was evaluated in a substudy (n = 340) of the second Cardiac Insufficiency Bisoprolol Survival study (CIBIS-II), a placebo-controlled mortality trial. 265 patients (75%) patients completed both questionnaires at 6 months of follow-up. Both questionnaires indicated substantially impaired QoL. The FSQ demonstrated high internal consistency (Cronbach's α > 0.7 for all items except "social activity" = 0.66) and construct and concurrent validity. After 6 months, the only item on either questionnaire to show a difference between the placebo- and bisoprolol-treatment groups was the single item FSQ question about "days in bed" (p = 0.018 in favour of bisoprolol). CONCLUSIONS: The FSQ performed well in this study, provided additional information to the MLwHF questionnaire and allowed interesting comparisons with other chronic medical conditions. The FSQ may be a useful general QoL instrument for studies in CHF.

Renal impairment and heart failure with preserved ejection fraction early post-myocardial infarction.

AIM: To study if impaired renal function is associated with increased risk of peri-infarct heart failure (HF) in patients with preserved ejection fraction (EF). METHODS: Patients with occluded infarct-related arteries (IRAs) between 1 to 28 d after myocardial infarction (MI) were grouped into chronic kidney disease (CKD) stages based on estimated glomerular filtration rate (eGFR). Rates of early post-MI HF were compared among eGFR groups. Logistic regression was used to explore independent predictors of HF. RESULTS: Reduced eGFR was present in 71.1% of 2160 patients, with significant renal impairment (eGFR < 60 mL/min every 1.73 m(2)) in 14.8%. The prevalence of HF was higher with worsening renal function: 15.5%, 17.8% and 29.4% in patients with CKD stages 1, 2 and 3 or 4, respectively (P < 0.0001), despite a small absolute difference in mean EF across eGFR groups: 48.2 ± 10.0, 47.9 ± 11.3 and 46.2 ± 12.1, respectively (P = 0.02). The prevalence of HF was again higher with worsening renal function among patients with preserved EF: 10.1%, 13.6% and 23.6% (P < 0.0001), but this relationship was not significant among patients with depressed EF: 27.1%, 26.2% and 37.9% (P = 0.071). Moreover, eGFR was an independent correlate of HF in patients with preserved EF (P = 0.003) but not in patients with depressed EF (P = 0.181). CONCLUSION: A significant proportion of post-MI patients with occluded IRAs have impaired renal function. Impaired renal function was associated with an increased rate of early post-MI HF, the association being strongest in patients with preserved EF. These findings have implications for management of peri-infarct HF.

Over 10 years with an implantable cardioverter-defibrillator - a long term follow-up of 60 patients.

BACKGROUND: Transvenous implantable cardioverter-defibrillators (ICD) have been implanted in Poland since 1995. As the method spreads it is important to consider its long-term benefits and disadvantages. AIM: To assess survival, efficacy and complication rate in ICD patients, who received the device more than ten years earlier. METHODS: Retrospective analysis of 60 ICD patients implanted between 1995-1999. RESULTS: There were 42 (70%) males, mean age 50.6 ± 16.4 years. In 59 patients ICD was implanted for sudden cardiac death (SCD) secondary prevention. Thirty eight patients (34 M, 63.3%) had coronary artery disease (CAD). The CAD was diagnosed in 89.5% of males and 10.5% of females (p〈 0.0001). Mean follow-up time was 75.4 ± 34.7 months. During this time 22 patients died (37%, 19 M, 3 F). Three deaths were SCD. Mean one-year mortality was 6.7%. Deaths were more frequent among males: 45.2% vs 16.7%, p〈 0.005. In CAD mortality was higher than in non-CAD patients (50% vs 13.6%, p〈 0.005). Appropriate ICD discharges in the ventricular fibrillation (VF) zone occurred in 35 (58%) patients, and in ventricular tachycardia (VT) zone - in 26 (43%) patients. Mean intervention rate per year was 3.7 for VF and 0.6 for VT. Complications occurred in 27 (45%) patients and 5 (8%) of them had no ICD intervention during follow-up. In 5 patients more than one complication was diagnosed. There were inappropriate discharges in 15 (25%) patients, 11 (18%) had electrical storm, and ICD-related infections were noted in 3 (5%) patients. During the perioperative period, lead revisions were done in 4 patients; in 3 with discharges induced by T-wave oversensing and in one with lead dislocation. Four cases of lead failure occurred during follow-up, requiring new lead implantation. In 4 patients, electrical storm (3 patients) and supraventricular tachycardia with ICD discharges (1 patient) were treated with radiofrequency ablation. Only 10 (17%) patients did not demonstrate any ICD interventions or ICD-related complications. CONCLUSIONS: 1. ICD interventions caused by malignant ventricular arrhythmias occurred in 75% patients with the device implanted more than 10 years earlier. 2. Almost a half of the analysed population suffered from complications and side effects related to implanted ICD and they were present in 8% of subjects without ICD intervention. Neither ICD interventions nor device-related adverse events were recorded in 17% of patients.

Use of fly ash agglomerates for removal of arsenic.

The aim of this work is to investigate the application of fly ash adsorbent for removal of arsenite ions from dilute solution (100-1,000 ppm). Experiments were carried out using material from the "Turów" (Poland) brown-coal-burning power plant, which was wetted, then mixed and tumbled in a granulator to form spherical agglomerates. Measurements of arsenic adsorption from aqueous solution were carried out at room temperature and natural pH of fly ash agglomerates, in either a shaken flask or circulating column, to compare two different methods of contacting solution with adsorbent. Adsorption isotherms of arsenic were determined for agglomerated material using the Freundlich equation. Kinetic studies indicated that sorption follows a pseudo-second-order model. Preferable method to carry out the process is continuous circulation of arsenite solution through a column.

Improved survival with bisoprolol in patients with heart failure and renal impairment: an analysis of the cardiac insufficiency bisoprolol study II (CIBIS-II) trial.

AIMS: Information on the effectiveness of beta-blockade in patients with heart failure (HF) and concomitant renal impairment is scarce and beta-blockers are underutilized in these patients. METHODS AND RESULTS: The Cockcroft-Gault formula normalized for body surface-area was used to estimate renal function (eGFR(BSA)) in 2622 patients with HF, left ventricular ejection fraction < or =35%, New York Heart Association class III/IV and serum creatinine <300 micromol/L (3.4 mg/dL) in the second Cardiac Insufficiency Bisoprolol Study II. Patients were divided into four sub-groups according to baseline eGFR(BSA) (<45, 45-60, 60-75 and > or =75 mL/min per 1.73 m(2)). Cox proportional-hazards models adjusted for pre-specified confounders were used to assess the effect of bisoprolol and potential heterogeneity of effect across the eGFR(BSA) sub-groups. Older age, female-sex, diabetes and ischaemic-aetiology were more common in those with reduced eGFR(BSA). The hazard associated with bisoprolol use for all-cause mortality, the composite of all-cause mortality or HF-hospitalization and HF-hospitalization alone was consistently <1.0 across eGFR(BSA) categories with no treatment by renal-function interaction (P = 0.81, P = 0.66, P = 0.71, respectively). The rate of bisoprolol discontinuation was higher in patients with eGFR(BSA) < 45 mL/min per 1.73 m(2). Nevertheless the absolute benefit of bisoprolol was greater for patients with chronic kidney disease compared with those without. CONCLUSION: The beneficial effects of bisoprolol on mortality and hospitalization for worsening heart-failure were not modified by baseline eGFR(BSA). Renal impairment should not prevent the use of bisoprolol in patients with HF.

Impact of stress testing before percutaneous coronary intervention or medical management on outcomes of patients with persistent total occlusion after myocardial infarction: analysis from the occluded artery trial.

BACKGROUND: In the Occluded Artery Trial (OAT), 2,201 stable patients with an occluded infarct-related artery (IRA) were randomized to percutaneous coronary intervention (PCI) or optimal medical treatment alone (MED). There was no difference in the primary end point of death, reinfarction, or congestive heart failure (CHF). We examined the prognostic impact of prerandomization stress testing. METHODS: Stress testing was required by protocol except for patients with single-vessel disease and akinesis/dyskinesis of the infarct zone. The presence of severe inducible ischemia was an exclusion criterion for OAT. We compared outcomes based on performance and results of stress testing. RESULTS: Five hundred ninety-eight (27%) patients (297 PCI, 301 MED) underwent stress testing. Radionuclide imaging or stress echocardiography was performed in 40%. Patients who had stress testing were younger (57 vs 59 years); had higher ejection fractions (49% vs 47%); and had lower rates of death (7.8% vs 13.2%), class IV CHF (2.4% vs 5.5%), and the primary end point (13.9% vs 18.9%) than patients without stress testing (all P < .01). Mild-moderate ischemia was observed in 40% of patients with stress testing and was not related to outcomes. Among patients with inducible ischemia, outcomes were similar for PCI and MED (all P > .10). CONCLUSIONS: In OAT, patients who underwent stress testing had better outcomes than patients who did not, likely related to differences in baseline characteristics. In patients managed with optimal medical therapy or PCI, mild-moderate inducible ischemia was not related to outcomes. The lack of benefit for PCI compared to MED alone was consistent regardless of whether stress testing was performed or inducible ischemia was present.

Coronary bypass surgery with or without surgical ventricular reconstruction.

BACKGROUND: Surgical ventricular reconstruction is a specific procedure designed to reduce left ventricular volume in patients with heart failure caused by coronary artery disease. We conducted a trial to address the question of whether surgical ventricular reconstruction added to coronary-artery bypass grafting (CABG) would decrease the rate of death or hospitalization for cardiac causes, as compared with CABG alone. METHODS: Between September 2002 and January 2006, a total of 1000 patients with an ejection fraction of 35% or less, coronary artery disease that was amenable to CABG, and dominant anterior left ventricular dysfunction that was amenable to surgical ventricular reconstruction were randomly assigned to undergo either CABG alone (499 patients) or CABG with surgical ventricular reconstruction (501 patients). The primary outcome was a composite of death from any cause and hospitalization for cardiac causes. The median follow-up was 48 months. RESULTS: Surgical ventricular reconstruction reduced the end-systolic volume index by 19%, as compared with a reduction of 6% with CABG alone. Cardiac symptoms and exercise tolerance improved from baseline to a similar degree in the two study groups. However, no significant difference was observed in the primary outcome, which occurred in 292 patients (59%) who were assigned to undergo CABG alone and in 289 patients (58%) who were assigned to undergo CABG with surgical ventricular reconstruction (hazard ratio for the combined approach, 0.99; 95% confidence interval, 0.84 to 1.17; P=0.90). CONCLUSIONS: Adding surgical ventricular reconstruction to CABG reduced the left ventricular volume, as compared with CABG alone. However, this anatomical change was not associated with a greater improvement in symptoms or exercise tolerance or with a reduction in the rate of death or hospitalization for cardiac causes. (ClinicalTrials.gov number, NCT00023595.)

Intracoronary KAI-9803 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction.

BACKGROUND: KAI-9803, a delta-protein kinase C inhibitor, has been shown to ameliorate injury associated with ischemia and reperfusion in animal models of acute myocardial infarction (MI). METHODS AND RESULTS: Direct Inhibition of delta-Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction (DELTA MI) was a "first-in-human," dose-escalation study that evaluated the safety, tolerability, and activity of KAI-9803 for patients with acute anterior ST-segment elevation MI undergoing primary percutaneous coronary intervention. Patients who presented within 6 hours of symptom onset and had an occluded left anterior descending infarct artery on angiography were randomized in a 2:1 fashion to receive 1 of 4 doses of KAI-9803 (cohort 1, 0.05 mg; cohort 2, 0.5 mg; cohort 3, 1.25 mg; cohort 4, 5.0 mg) versus blinded concurrent placebo delivered in 2 divided doses via intracoronary injection before and after reestablishment of antegrade epicardial flow with percutaneous coronary intervention. Safety and biomarker end points were assessed. Overall, 154 patients were randomized and treated with study drug (37 in cohort 1, 38 in cohort 2, 38 in cohort 3, 41 in cohort 4). The incidence of serious adverse events was similar between patients treated with KAI-9803 versus placebo. Other safety end points, including changes in QT intervals and standard laboratory values after study drug administration, were similar between treatment groups. Although the study was not powered to demonstrate efficacy with the biomarker end points assessed, signs of drug activity with KAI-9803 were suggested by trends for consistent, nonsignificant reductions in creatine kinase-MB area under the curve and ST-recovery area under the curve values across all dosing cohorts with KAI-9803 compared with concurrent placebo, and similar trends were demonstrated for improvements in (99m)technetium sestamibi infarct size values with active study drug in cohorts 1, 2, and 3. CONCLUSIONS: KAI-9803 had an acceptable safety and tolerability profile when delivered via intracoronary injection during primary percutaneous coronary intervention for ST-segment elevation MI. Signs of potential drug activity were demonstrated with biomarker end points in this small exploratory study, indicating that further testing of KAI-9803 as an adjunctive therapy for ST-segment elevation MI is warranted.

Predictors of outcome and the lack of effect of percutaneous coronary intervention across the risk strata in patients with persistent total occlusion after myocardial infarction: Results from the OAT (Occluded Artery Trial) study.

OBJECTIVES: This study sought to determine predictors of outcome and examine the influence of baseline risk on therapeutic impact of late mechanical opening of a persistently occluded infarct related artery after myocardial infarction in stable patients. BACKGROUND: Previous studies in patients with acute coronary syndromes suggest that the impact of infarct-related artery recanalization on clinical outcome is greatest in patients at highest risk. METHODS: Of 2,201 patients (age 58.6 +/- 11.0 years) with infarct-related artery occlusion on days 3 to 28 after myocardial infarction in the OAT (Occluded Artery Trial) study, 1,101 were assigned to percutaneous coronary intervention (PCI) and 1,100 to medical therapy alone and followed for a mean of 3.2 years. The primary end point was a composite of death, reinfarction, or New York Heart Association functional class IV heart failure. Interaction of treatment effect with tertiles of predicted survival were examined using the Cox survival model. RESULTS: The 5-year rate for the primary end point was 18.9% versus 16.1% for patients assigned to PCI and medical treatment alone, respectively (hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.92 to 1.43, p 0.23). Lack of benefit of PCI was consistent across the risk spectrum for both the primary end point and total mortality, including for the highest tertile (33.9% PCI vs. 27.3% medical treatment alone, HR: 1.27, 99% CI: 0.87 to 1.85 primary end point and 23.5% PCI vs. 21.7% medical treatment alone, HR: 1.16, 99% CI: 0.73 to 1.85 mortality). The independent predictors of the composite outcome were history of heart failure (HR: 2.06, p < 0.001), peripheral vascular disease (HR: 1.93, p 0.001), diabetes (HR: 1.49, p 0.002), rales (HR: 1.88, p < 0.001), decreasing ejection fraction (HR: 1.48 per 10%, p < 0.001), decreasing days from myocardial infarction to randomization (HR: 1.04 per day, p < 0.001), and decreasing glomerular filtration rate (HR: 1.11 per 10 ml/min/1.73 m(2), p < 0.001). CONCLUSIONS: In the OAT study, there was no variation in the effect of PCI on clinical outcomes at different levels of patient risk, including the subset with very high event rates. (Occluded Artery Trial [OAT]; NCT00004562)

Mortality in patients with heart failure treated with cardiac resynchronisation therapy. A long-term multi-centre follow-up study.

BACKGROUND: Benefits of cardiac resynchronisation therapy (CRT) for survival in selected congestive heart failure (CHF) patients have been acknowledged by the 2005 ESC guidelines. AIM: To analyse mortality in CRT pacing only (CRT-P) patients during at least one-year follow-up. METHODS: This was a prospective, multi-site, at least one-year observational study on mortality and mode of death in patients who received CRT-P due to commonly accepted indications. One-year follow-up data (or earlier death) were available for 105 patients (19 females, 86 males) aged 60.6+/-9.8 years (35-78). Baseline NYHA class was 3.2+/-0.4 (3-4). Coronary artery disease (CAD) was the underlying aetiology of CHF in 57 (54%) patients and 48 (46%) patients had CHF due to non-coronary factors. RESULTS: Mean follow-up duration was 730 days (360-1780), median 625. There were 21 (20%) deaths: 5 (24%) sudden cardiac deaths (SCD), 13 (62%) deaths due to heart failure (HFD) and 3 (14%) other deaths. Thirteen (62%) patients died within the first year of observation. All SCD occurred in this period. Mean time to death was 303+/-277 days (19-960) to HFD - 339+/-313 days (19-960) and to SCD - 208+/-127 days (31-343). There were no significant differences between survivors and non-survivors with respect to left ventricular ejection fraction (LVEF) (25+/-10 vs. 20+/-8%), 6-minute walk test (6 min WT) (276+/-166 vs. 285+/-163 m) and LV diastolic diameter (LVEDD) (71+/-9 vs. 78+/-10 mm) (all NS). The SCD and HFD patients had similar age (62.0+/-5.4 vs. 56.6+/-13.2 years), gender (80 vs. 83% males), NYHA class (3.1+/-0.2 vs. 3.5+/-0.3), LVEF (22+/-9 vs. 17+/-5%), LVEDD (86+/-10 vs. 79+/-9 mm), 6 min WT (270+/-142 vs. 292+/-188 m) (NS). In 4 patients from the SCD group CHF was of non-coronary aetiology and only in 1 patient from the HFD group (p=0.003). The values of LVEF, LVEDD and NYHA class in HFD patients who died during the first year after implantation, compared with those who died later, were similar. CONCLUSIONS: Sudden cardiac death probability in the studied CRT-P population was the highest during the first year after implantation. Afterwards, the risk of HFD started to increase. Thus, in all patients eligible for CRT prophylactic defibrillation function should be considered.

Impact of female sex on death and bleeding after fibrinolytic treatment of myocardial infarction in GUSTO V.

BACKGROUND: Women with acute myocardial infarction are more likely than men to experience reinfarction, bleeding, or death. This difference has been hypothesized to be due to older age, treatment delay, and comorbidities in women. Use of diagnostic and therapeutic modalities may also differ. There is controversy regarding whether female sex is an independent risk factor for death and/or bleeding. METHODS: The GUSTO (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes) V Investigators studied standard-dose reteplase vs standard-dose abciximab plus half-dose reteplase in patients with myocardial infarction. RESULTS: Women were older and more often had diabetes mellitus and hypertension. Angiography and percutaneous coronary intervention were less frequent in women. Death (9.8% vs 4.4% at 30 days; odds ratio [OR], 2.00; 95% confidence interval, 1.59-2.53; P < .001) and bleeding (6.4% vs 2.5%; OR, 1.31; 95% confidence interval, 1.18-1.45; P < .01) were more common in women. There was no association between treatment assignment and death in either sex; bleeding was more common in both sexes receiving combination therapy. Female sex was independently associated with mortality. After Killip class greater than 1 (OR, 4.7), female sex (OR, 2.0) was the strongest correlate of death. Female sex was independently associated with bleeding for both treatments. CONCLUSIONS: Female sex is independently associated with death and bleeding complications among fibrinolytic-treated patients with myocardial infarction. There remains a sex differential in the use of angiography and, therefore, percutaneous coronary intervention after fibrinolysis. Further research will determine what mediates excess risk in women.

A strategy of using enoxaparin as adjunctive antithrombin therapy reduces death and recurrent myocardial infarction in patients who achieve early ST-segment resolution after fibrinolytic therapy: the ExTRACT-TIMI 25 ECG study.

AIMS: To determine the relationship between a strategy of enoxaparin (ENOX), early ST-segment resolution (STRes), and clinical outcomes on patients with ST-segment elevation myocardial infarction (STEMI) after fibrinolysis. METHODS AND RESULTS: Baseline and 180 min ECGs were analysed in 3208 of the 20 479 patients in the ExTRACT-TIMI 25 trial, which randomifzed patients with STEMI to ENOX vs. unfractionated heparin (UFH) as adjunctive therapy. STRes was defined as complete (70%), partial (30-70%), or none (<30%). There was no evidence for a difference in STRes between the groups assigned to the ENOX or UFH (median 69.4 vs. 67.2%; P = 0.13). Among patients with complete STRes (n = 1100), ENOX significantly reduced death or non-fatal recurrent MI at 30 days when compared with UFH (4.4 vs. 9.9%; OR(adj) 0.39; P < 0.001), whereas there was no difference in patients with only partial or no STRes [14.2 vs. 12.5%; OR(adj) 1.0; P = 0.98 (n = 368) and 16.2 vs. 15.9%; OR(adj) 1.0; P = 0.97 (n = 830), P for interaction = 0.008]. CONCLUSION: When compared with UFH, a strategy of ENOX significantly reduces death or non-fatal recurrent MI in patients who achieved complete STRes, but not in patients with less STRes. These data suggest that a strategy of ENOX improves outcomes by preventing re-occlusion in patients achieving initial successful reperfusion after fibrinolytic therapy rather than by facilitating initial reperfusion.

Coronary intervention for persistent occlusion after myocardial infarction.

BACKGROUND: It is unclear whether stable, high-risk patients with persistent total occlusion of the infarct-related coronary artery identified after the currently accepted period for myocardial salvage has passed should undergo percutaneous coronary intervention (PCI) in addition to receiving optimal medical therapy to reduce the risk of subsequent events. METHODS: We conducted a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion (an ejection fraction of <50% or proximal occlusion). Of these patients, 1082 were assigned to routine PCI and stenting with optimal medical therapy, and 1084 were assigned to optimal medical therapy alone. The primary end point was a composite of death, myocardial reinfarction, or New York Heart Association (NYHA) class IV heart failure. RESULTS: The 4-year cumulative primary event rate was 17.2% in the PCI group and 15.6% in the medical therapy group (hazard ratio for death, reinfarction, or heart failure in the PCI group as compared with the medical therapy group, 1.16; 95% confidence interval [CI], 0.92 to 1.45; P=0.20). Rates of myocardial reinfarction (fatal and nonfatal) were 7.0% and 5.3% in the two groups, respectively (hazard ratio, 1.36; 95% CI, 0.92 to 2.00; P=0.13). Rates of nonfatal reinfarction were 6.9% and 5.0%, respectively (hazard ratio, 1.44; 95% CI, 0.96 to 2.16; P=0.08); only six reinfarctions (0.6%) were related to assigned PCI procedures. Rates of NYHA class IV heart failure (4.4% vs. 4.5%) and death (9.1% vs. 9.4%) were similar. There was no interaction between treatment effect and any subgroup variable (age, sex, race or ethnic group, infarct-related artery, ejection fraction, diabetes, Killip class, and the time from myocardial infarction to randomization). CONCLUSIONS: PCI did not reduce the occurrence of death, reinfarction, or heart failure, and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction. (ClinicalTrials.gov number, NCT00004562 [ClinicalTrials.gov].).