Clinical predictors of complications in patients with left-sided infective endocarditis: A retrospective study of 206 episodes.

PURPOSE: Early identification of specific patient subgroups at high risk of developing life-threatening infective endocarditis (IE) complications is of paramount importance. Better stratification may allow more intensive treatment of these patients and positively influences clinical outcomes. METHODS: We carried out a retrospective survey of consecutive left-sided IE adult patients, admitted over a 15-year period to two main tertiary care centres in the Czech Republic. RESULTS: Among a group of 196 patients (155 males; median age 64 years), a total of 206 left-sided IE episodes were identified. Perivalvular extension of infection was most frequently seen in prosthetic aortic valve endocarditis (OR 6.706, p<0.0001). Valve prolapse/perforation during IE episodes was significantly associated with mitral valve IE (OR 2.136, p=0.026) and vegetation length (OR 1.055, p=0.009). Septic shock was significantly related to two main risk factors: S. aureus infection (OR 8.459, p=<0.0001) and smoking (OR 8.403, p=0.001). Mitral valve IE with a vegetation length ≥13 mm was the strongest risk factor for this complication (OR 3.24, p=0.001), followed by S. aureus infection (OR 3.59, p=0.002). Finally, septic shock (OR 6.000, p=0.001) represented the most important risk factor of in-hospital mortality. CONCLUSIONS: This study provides the most detailed profile of complication predictors related to left-sided IE in Central Europe. Early individual stratification of IE related occurrence of complications might help to decrease extremely high morbidity and mortality of this disease (Tab. 5, Ref. 37).

The importance of age and statin therapy in the interpretation of Lp-PLA(2) in ACS patients, and relation to CRP.

C-reactive protein (CRP) is a marker of arterial inflammation while lipoprotein-associated phospholipase A(2) (Lp-PLA(2)) is related to plaque instability. The aim of this study was to evaluate the correlation between the risk of unstable plaque presenting as acute coronary syndrome (ACS) and Lp-PLA(2), and to assess the influence of statins on interpretation of Lp-PLA(2). A total of 362 consecutive patients presenting to the emergency department (ED) with acute chest pain suggestive of ACS were evaluated by cardiologists as STEMI, NSTEMI, or unstable angina, and non-ACS. Serum biomarkers measured on admission: troponin I, C-reactive protein (Abbott), and Lp-PLA(2) (DiaDexus). Four groups were defined according to the final diagnosis and history of statin medication: ACS/statin-; ACS/statin+; non-ACS/statin-; non-ACS/statin+. Lp-PLA(2) was highest in ACS/statin- group; statins decreased Lp-PLA(2) both in ACS and non-ACS of about 20 %. Lp-PLA(2) was higher in ACS patients in comparison with non-ACS patients group without respect to statin therapy (p<0.001). Lp-PLA(2) predicted worse outcome (in terms of acute coronary syndrome) effectively in patients up to 62 years; limited prediction was found in older patients. C-reactive protein (CRP) failed to discriminate four groups of patients. Statin therapy and age should be taken into consideration while interpreting Lp-PLA(2) concentrations and lower cut-off values should be used for statin-treated persons.

Repetitive use of levosimendan for treatment of chronic advanced heart failure: clinical evidence, practical considerations, and perspectives: an expert panel consensus.

BACKGROUND: The intravenous inodilator levosimendan was developed for the treatment of patients with acutely decompensated heart failure. In the last decade scientific and clinical interest has arisen for its repetitive or intermittent use in patients with advanced chronic, but not necessarily acutely decompensated, heart failure. Recent studies have suggested long-lasting favourable effects of levosimendan when administered repetitively, in terms of haemodynamic parameters, neurohormonal and inflammatory markers, and clinical outcomes. The existing data, however, requires further exploration to allow for definitive conclusions on the safety and clinical efficacy of repetitive use of levosimendan. METHODS AND RESULTS: A panel of 30 experts from 15 countries convened to review and discuss the existing data, and agreed on the patient groups that can be considered to potentially benefit from intermittent treatment with levosimendan. The panel gave recommendations regarding patient dosing and monitoring, derived from the available evidence and from clinical experience. CONCLUSIONS: The current data suggest that in selected patients and support out-of-hospital care, intermittent/repetitive levosimendan can be used in advanced heart failure to maintain patient stability. Further studies are needed to focus on morbidity and mortality outcomes, dosing intervals, and patient monitoring. Recommendations for the design of further clinical studies are made.

Is severe pulmonary hypertension a contraindication for orthotopic heart transplantation? Not any more.

Pulmonary hypertension (PH) unresponsive to pharmacological intervention is considered a contraindication for orthotopic heart transplantation (OHTX) due to risk of postoperative right-heart failure. In this prospective study, we describe our experience with a treatment strategy of improving severe PH in heart transplant candidates by means of ventricular assist device (VAD) implantation and subsequent OHTX. In 11 heart transplantation candidates with severe PH unresponsive to pharmacological intervention we implanted VAD with the aim of achieving PH to values acceptable for OHTX. In all patients we observed significant drop in pulmonary pressures, PVR and TPG (p < 0.001 for all) 3 months after VAD implantation to values sufficient to allow OHTX. Seven patients underwent transplantation (mean duration of support 216 days) while none of patients suffered right-side heart failure in postoperative period. Two patients died after transplantation and five patients are living in very good condition with a mean duration of 286 days after OHTX. In our opinion, severe PH is not a contraindication for orthotopic heart transplantation any more.

Prospective validation of 'Allergy-Control-SCORE(TM)': a novel symptom-medication score for clinical trials.

BACKGROUND: Combined symptom and medication scores (SMS) are recommended as primary endpoints in clinical trials. Several SMS have been created, but none has been formally validated. OBJECTIVE: To evaluate the validity of the 'Allergy-Control-SCORE© (ACS)', a novel instrument to assess patient's allergy severity by recording symptoms and rescue medication. METHODS: One hundred and twenty-one consenting subjects (age 18-65 year), including 81 patients with allergic rhino-conjunctivitis and/or asthma and 40 healthy controls, participated in the study. They recorded daily nasal, eye, and lung symptoms using a 4-point scale (none, mild, moderate, and severe) and use of anti-symptomatic medication. Pollen counts were monitored during the study period. Symptom and medication scores values were compared to global allergy severity, quality of life, and allergy-related medical consultations. Feasibility was tested through a questionnaire on comprehensibility, easiness of use, and completeness. Retest reliability was assessed by testing consistency, in relation to pollen exposure, and for values recorded during each of 2 consecutive weeks. RESULTS: Convergent reliability analysis indicated a highly significant correlation between ACS© and global allergy severity (P < 0.0001), quality of life (P < 0.0001), and allergy-related medical consultations (P < 0.0001). Scores were highly related to pollen counts. Allergy-Control-SCORE© showed a good retest reliability (r = 0.81; P < 0.0001) and discriminated extremely well between patients with allergy and healthy controls (6.1 ± 4.8 vs 0.2 ± 0.5; t = 10.82; P < 0.0001) with a sensitivity of 97% and a specificity of 87%. Study participants evaluated the feasibility of the SMS as excellent. CONCLUSIONS: Allergy-Control-SCORE© is a valid and reliable instrument to assess allergy severity in clinical trials and observational studies of respiratory allergic diseases.

Sildenafil is more selective pulmonary vasodilator than prostaglandin E1 in patients with pulmonary hypertension due to heart failure.

In some patients, heart failure (HF) is associated with increased pulmonary vascular resistance (PVR). The magnitude and the reversibility of PVR elevation affect the HF management. Sildenafil has been recently recognized as potent PVR-lowering drug in HF. The aim of the study was to compare hemodynamic effects and pulmonary selectivity of sildenafil to prostaglandin E(1) (PGE(1)). Right-heart catheterization was performed in 13 euvolemic advanced HF patients with elevated PVR (6.3+/-2 Wood's units). Hemodynamic parameters were measured at the baseline, during i.v. infusion of PGE1 (alprostadil 200 ng · kg(-1) · min(-1)) and after 40 mg oral dose of sildenafil. Both drugs similarly reduced systemic vascular resistance (SVR), but sildenafil had higher effect on PVR (-28 % vs. -49 %, p = 0.05) and transpulmonary pressure gradient than PGE(1). The PVR/SVR ratio--an index of pulmonary selectivity, did not change after PGE(1) (p = 0.7) but it decreased by -32 % (p = 0.004) after sildenafil. Both drugs similarly reduced pulmonary artery mean and wedge pressures and increased cardiac index (+27 % and +28 %). Sildenafil led more often to transplant-acceptable PVR while causing smaller drop of mean systemic pressure than PGE(1). In conclusion, vasodilatatory effects of sildenafil in patients with heart failure are more pronounced in pulmonary than in systemic circulation.

[Right ventricular dysfunction after left ventricular assist device implantation]. / Dysfunkce pravé komory po implantaci levostranné mechanické srdecní podpory.

OBJECTIVE: The frequency of long-term left ventricular assist device (LVAD) implantation is increasing. Acute right ventricular dysfunction or right ventricular failure after LVAD implantation has important influence on morbidity and mortality. The aim of our study was to assess the management of right ventricular dysfunction after LVAD implantation. METHODS: The study group comprised 21 patients with implanted HeartMate II LVAD since December, 2006 to April, 2009. We evaluated in retrospective fashion baseline parameters of cardiovascular and other organ systems before LVAD implantation, applied pharmacological and mechanical support for the right ventricle, and important clinical outcomes to the end ofJune, 2009. RESULTS: LVAD was implanted in 18 men and 3 women with mean age of 48.7 +/- 11.2 years. The most frequent diagnosis was dilatational cardiomyopathy (9 patients; 42.9%), and the most frequent indication for implantation was bridge-to-transplantation (19 patients; 90.4%). Pharmacological support of the right ventricle after LVAD implantation comprised dobutamine (21 patients; 100%), milrinone (21 patients; 100%), isoproterenol (1 patient; 4.8%), and levosimendan (5 patients; 23.8%). In 2 (9.5%) cases there was a need for repeated application of levosimendan during postoperative course. Inhalational nitric oxide was used in 14 (66.7%) patients. Despite extensive pharmacological support, 3 (14.3%) patients needed right ventricular assist device (RVAD) implantation. Most patients (9; 42.8%) survived to heart transplantation; in one (4.8%) case LVAD was successfuly explanted; 6 (28.6%) patients is living with LVAD; 5 (23.8%) patients died during LVAD support. CONCLUSION: After LVAD implantation there is a need for aggressive pharmacological, and in some cases mechanical, support of the right ventricular function to provide adequate blood flow to LVAD in order to minimize morbidity and mortality.

[Stress cardiomyopathy]. / Stresová kardiomyopatie.

Stress cardiomyopathy is a disease characterized by an acute systolic dysfunction of the left ventricle of the heart which is fully reversible and does not affect basal segments of the left ventricle. It is not accompanied by significant stenoses of the coronary arteries and it is caused by a preceding stressful situation. This article provides an overview of the ethiopathogenesis, diagnostic and therapeutic methods. Finally, we present a case report of our patient who suffers from a rare form of the midventricular type of stress cardiomyopathy.

Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid.

BACKGROUND: The clinical efficacy and safety of a six-grass pollen allergoid has been studied. The advent of more exacting clinical guidelines and a better appreciation of the possible mechanisms of treatment prompted this reappraisal. METHODS: A 2-year double-blind multicentre placebo-controlled phase 3 clinical trial was undertaken in 154 patients suffering symptoms of rhinoconjunctivitis with or without asthma (GINA I or II). Therapy comprised two consecutive preseasonal short-courses of subcutaneous injections using a grass pollen allergoid adsorbed to aluminium hydroxide. RESULTS: A combined symptom and medication score (SMS) was used as the primary end-point for clinical efficacy. SMS from the first year showed a significant difference of 26.6% between the two study groups (P=0.026) and this was improved after the second year when there was a 48.4% difference in SMS between active and placebo treatment in favour of the allergoid (P = 0.018). Highly significant increases in grass pollen allergen-specific IgG1 and IgG4 antibody concentrations were measured in association with active treatment. Allergen tolerance was increased as judged by a conjunctival provocation test and significant improvements in quality of life were documented using a standardized questionnaire. The allergoid was well tolerated. CONCLUSIONS: The grass pollen allergoid was shown to be safe and clinically efficacious in the management of hay fever with or without asthma (GINA I or II).

[Mechanical cardiac support--the first use in Czech Republic]. / Pouzití mechanické srdecní podpory--první zkusenosti v Ceské republice.

BACKGROUND: Implantation of mechanical assist device is widely accepted modality of treatment of patients with refractory heart failure. In the present study we evaluated our first one-year experiences with this method for bridging patients to cardiac transplantation. METHODS AND RESULTS: Between April 2003 and May 2004, the Thoratec VAD (Thoratec, Pleasanton, CA, USA) was implanted in 6 patients ( males; age 28-61 years) as a bridge-to-transplant procedure after having received maximum inotropic support and who were at imminent risk of death. In all patients was performed VAD as biventricular device (BiVAD). During a week after placement was observed recovery of organs function in all patients. Five patients survived to heart transplantation. One patient died 21 days after BiVAD placement due to massive bleeding to the respiratory tract. In post-transplantation period 1 patient died second day from acute graft failure and other patient died 34 days after from intracranial bleeding. Three patients has been discharged from the hospital and they are surviving more than I year. CONCLUSIONS: Analysis of our first experiences with the Thoratec BiVAD implantation as bridging to heart transplantation suggests that it is well suited method with respect to long- term prognosis of this group of patients.

Equivalence of as-required salbutamol propelled by propellants 11 and 12 or HFA 134a in mild to moderate asthmatics. German Study Group.

This randomized, double-blind, parallel-group study compared the efficacy and tolerability of as-required salbutamol 100 microg administered from either a chlorofluorocarbon (CFC) pressurized metered dose inhaler (pMDI; Ventolin) or from a non-CFC hydrofluoroalkane (HFA) 134a pMDI (Ventolin CFC-free) in patients with mild to moderate asthma. All patients (n = 423) continued with their standard asthma therapy, and recorded their daily use of study medication, morning and evening peak expiratory flow (PEF) and symptom scores, throughout the 4-week treatment period. Clinic lung function was measured at 2-week intervals. The median daily use of inhaled study medication remained constant at four actuations per day throughout the study in both treatment groups and statistical analysis indicated that the two formulations were equivalent. Small improvements in both treatment groups were reported in mean morning and evening PEF, clinic forced expiratory volume in 1 sec and clinic PEF and there were no significant differences between the two groups. Both formulations were well tolerated. This study indicates that as-required salbutamol 100 microg administered via a HFA 134a pMDI is as effective and safe as the currently available CFC-propelled formulation.

Self-administered faecal occult blood tests do not increase compliance with screening for colorectal cancer: results of a randomized controlled trial.

In the UK, compliance with conventional faecal occult blood (FOB) tests such as Haemoccult is about 50% in the general population. It has been postulated that characteristics of the performance of conventional tests, in particular the need for dextrous gathering and manipulation of faeces, delay in receiving results, and the recommended dietary restrictions, may all diminish compliance. New FOB tests have been developed, popularly termed 'magic toilet paper' tests, which not only minimize faecal manipulation but are also self-reported. Compliance rates with two self-administered faecal occult blood tests (Early Detector and Coloscreen Self-Test) were compared with Haemoccult in a randomized trial involving 1,842 subjects aged 40-74 years. Use of self-administered FOB tests did not increase compliance significantly, with rates of 52.1% for Early Detector, 50.6% for Coloscreen and 49.1% for Haemoccult. Moreover, dietary restriction did not reduce compliance significantly (restricted 49.3%, unrestricted 51.8%). A wide variation (from 1.3% to 21.4%) in positivity rates was observed which was dependent on which of the three tests was used and whether dietary restrictions were applied. Since the physical aspects of test performance do not appear to determine an individual's decision to be screened, self-administered tests will not overcome the problem of poor compliance with FOB screening.

Effectiveness and cost-benefit of an influenza vaccination program for health care workers.

This study retrospectively reviewed the effectiveness of a vaccination program for hospital workers in a large tertiary care hospital, quantified influenza-induced absenteeism, and examined the factors determining the costs and benefits of this program. Absenteeism among high risk hospital workers was increased by 35% (P=0.001) during the virulent influenza epidemic of 1987-88. Benefits, measured as the value of sick time avoided, compared with costs, including materials, occupational nursing staff time, employee time during vaccination, and time lost due to adverse reactions, revealed a net benefit of $39.23 per vaccinated employee. Sensitivity analyses highlighted vaccine efficacy and absenteeism due to influenza and adverse reactions to vaccination as the most important factors; with time lost due to adverse reactions as much as 0.013 days per vaccinated employee and a vaccine efficacy of 70%, net positive benefits could be achieved if influenza-induced absenteeism is 0.5% or greater of paid employee time during the epidemic season. The results suggested that the net cost-benefit of a hospital employee vaccination program to decrease both employee morbidity and nosocomial influenza among patients, would be increased by active promotion of the vaccination program, especially for employees in high risk areas.

Is there a preference for different ways of performing faecal occult blood tests?

Low compliance with faecal occult blood screening reduces the power of clinical trials, potential benefit, and efficiency. It has been proposed that the faecal manipulation required to perform conventional guaiac based tests may be an important factor in low compliance. The aim of this study was to evaluate whether use of a new method (vehicle) of stool collection for the faecal occult blood guaiac test would be preferred to the established standard. A novel self-interpreted test, Early Detector (ED), requires the subject to apply a guaiac/peroxide spray to a stool sample collected simply by wiping the anus with a specimen pad. To determine whether this method would be preferred to the stool manipulation required by Haemoccult (HO) and to compare test validity, employees at a London company were invited to use both tests. Eight-hundred and fifty-seven subjects were shown both tests. Before use, 48% indicated a preference for the method of Early Detector; 24% chose Haemoccult (p less than 0.001), while 28% indicated no immediate preference. Seven-hundred and one performed both tests. After use, 74% preferred ED; 5% preferred HO (p less than 0.001); 21% had no preference (NP). The preference for the ED test method was consistent by sex categories, age groups and occupational class. Logistics, aesthetics, and immediacy of results were the main reasons indicated for choosing ED. Whether the preference for ED could result in higher compliance remains to be proven. Its high positivity (14%), however, would preclude its use as a sole test to determine the need for endoscopic and/or radiologic investigation in the screened patient.