Clinical Results of Dynamic Cardiomyoplasty

Thirty-five cardiomyoplasty procedures were performed in five patients with dilated and 30 patients with ischemic cardiomyopathies. Russian-made cardiomyostimulators (CMS) were implanted in these patients. Twenty-one patients underwent a one-step procedure using a left thoracotomy for cardiomyoplasty, while in 14 patients, a two-step procedure that included a mid-line sternotomy was carried out. During the average follow-up period of 9 ± 2.1 months, studies were carried out that showed in survivors improved clinical functional status and decreased heart failure symptoms. Evidence of revascularization of the ischemic myocardium from the latissimus dorsi muscle (LDM) wrap was obtained by angiography and radioactive scintigraphy. In five patients, the CMS had to be removed due to complications, and in all these patients, their clinical functional status deteriorated following the cessation of cardiomyostimulation.     

Validation of semi-automatic device UA-704 for self-measurement of blood pressure

OBJECTIVE: To perform a clinical validation for a semi-automatic arm-type device UA-704 (A&D Company, Ltd., Tokyo, Japan) according to the British Hypertension Society protocol. METHODS: Eighty-five study participants (37 men) were included. The mean age was 50.1+/-17.0 years, systolic blood pressure range was 79-212 mmHg and diastolic blood pressure range was 43-118 mmHg. For each participant, three readings of the UA-704 were compared with simultaneous auscultatory measurements by two trained independent observers. The observers used a mercury calibrated sphygmomanometer and a dual stethoscope. The results were graded according to the 1993 British Hypertension Society protocol. RESULTS: The average difference between mercury sphygmomanometer and UA-704 readings was -1.85+/-4.26 mmHg (mean+/-SD) for systolic blood pressure and -1.44+/-3.97 mmHg for diastolic blood pressure. The proportions of values agreeing to within 5, 10 and 15 mmHg were 79.2%, 96.5% and 99.6% for systolic blood pressure and 86.7%, 96.9% and 99.6% for diastolic blood pressure for the observers and device (A/A grade for British Hypertension Society). CONCLUSIONS: For an adult population, the UA-704 device for self-measurement of blood pressure achieved a British Hypertension Society grade A/A and therefore can be recommended for home blood pressure monitoring.     

Validation of the TM-2564G device for in-hospital blood pressure measurement

OBJECTIVE: To perform clinical validation of the TM-2564G device for in-hospital blood pressure measurement according to the British Hypertension Society protocol. METHODS: The tests were carried out on 85 patients aged 19-82 years (41 male patients, mean age 50+/-19 years) with systolic blood pressure 75-219 mmHg and diastolic blood pressure 43-117 mmHg (mean 142+/-33/85+/-20 mmHg). For each patient, three readings of the TM-2564G device were compared with simultaneous auscultatory measurements by two trained independent observers. The observers used a mercury-calibrated sphygmomanometer and dual stethoscope. The results were graded according to the British Hypertension Society protocol 1993. RESULTS: The average difference was -1.85 mmHg for systolic blood pressure and -1.20 mmHg for diastolic blood pressure. The standard deviation of the difference between TM-2564G and the observers' results was 4.85 and 4.16 mmHg for systolic and diastolic blood pressures, respectively. Systolic blood pressure percentage of readings agreeing to within 5 mmHg was 75.7%, 10 mmHg 95.36% and 15 mmHg 99.6%, and for DBP 82.7, 97.6 and 99.8%, respectively. CONCLUSIONS: The TM-2564G device achieved A/A British Hypertension Society grade and can be recommended for in-hospital measurement of blood pressure.     

In‐hospital mortality in SARS‐CoV‐2 stratified by gamma‐glutamyl transferase levels

BackgroundThis study investigates in‐hospital mortality amongst patients with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and its relation to serum levels of gamma‐glutamyl transferase (GGT).MethodsPatients were stratified according to serum levels of gamma‐glutamyl transferase (GGT) (GGT<50 IU/L or GGT≥50 IU/L).ResultsA total of 802 participants were considered, amongst whom 486 had GGT<50 IU/L and a mean age of 48.1 (16.5) years, whilst 316 had GGT≥50 IU/L and a mean age of 53.8 (14.7) years. The chief sources of SARS‐CoV‐2 transmission were contact (366, 45.7%) and community (320, 40%). Most patients with GGT≥50 IU/L had either pneumonia (247, 78.2%) or acute respiratory distress syndrome (ARDS) (85, 26.9%), whilst those with GGT<50 IU/L had hypertension (141, 29%) or diabetes mellitus (DM) (147, 30.2%). Mortality was higher amongst patients with GGT≥50 IU/L (54, 17.1%) than amongst those with GGT<50 IU/L (29, 5.9%). More patients with GGT≥50 required high (83, 27.6%) or low (104, 34.6%) levels of oxygen, whereas most of those with GGT<50 had no requirement of oxygen (306, 71.2%). Multivariable logistic regression analysis indicated that GGT≥50 IU/L (odds ratio [OR]: 2.02, 95% confidence interval [CI]: 1.20–3.45, p=0.009), age (OR: 1.05, 95% CI: 1.03–1.07, p<0.001), hypertension (OR: 2.06, 95% CI: 1.19–3.63, p=0.011), methylprednisolone (OR: 2.96, 95% CI: 1.74–5.01, p<0.001) and fever (OR: 2.03, 95% CI: 1.15–3.68, p=0.016) were significant predictors of all‐cause cumulative mortality. A Cox proportional hazards regression model (B = −0.68, SE =0.24, HR =0.51, p = 0.004) showed that patients with GGT<50 IU/L had a 0.51‐times lower risk of all‐cause cumulative mortality than patients with GGT≥50 IU/L.ConclusionHigher levels of serum GGT were found to be an independent predictor of in‐hospital mortality.     

First Indications of Omsk Haemorrhagic Fever Virus beyond Russia

Omsk haemorrhagic fever virus (OHFV) is the agent leading to Omsk haemorrhagic fever (OHF), a viral disease currently only known in Western Siberia in Russia. The symptoms include fever, headache, nausea, muscle pain, cough and haemorrhages. The transmission cycle of OHFV is complex. Tick bites or contact with infected small mammals are the main source of infection. The Republic of Kazakhstan is adjacent to the endemic areas of OHFV in Russia and febrile diseases with haemorrhages occur throughout the country—often with unclear aetiology. In this study, we examined human cerebrospinal fluid samples of patients with suspected meningitis or meningoencephalitis with unknown origins for the presence of OHFV RNA. Further, reservoir hosts such as rodents and ticks from four Kazakhstan regions were screened for OHFV RNA to clarify if this virus could be the causative agent for many undiagnosed cases of febrile diseases in humans in Kazakhstan. Out of 130 cerebrospinal fluid samples, two patients (1.53%) originating from Almaty city were positive for OHFV RNA. Screening of tick samples revealed positive pools from different areas in the Akmola region. Of the caught rodents, 1.1% out of 621 were positive for OHFV at four trapping areas from the West Kazakhstan region. In this paper, we present a broad investigation of the spread of OHFV in Kazakhstan in human cerebrospinal fluid samples, rodents and ticks. Our study shows for the first time that OHFV can not only be found in the area of Western Siberia in Russia, but can also be detected up to 1.600 km away in the Almaty region in patients and natural foci.     

Determinants of subject visit participation in a prospective cohort study of HTLV infection

Background  

Understanding participation in a prospective study is crucial to maintaining and improving retention rates. In 1990–92, following attempted blood donation at five blood centers, we enrolled 155 HTLV-I, 387 HTLV-II and 799 HTLV seronegative persons in a long-term prospective cohort.     

Are elevated fetal nucleated red blood cell counts an indirect reflection of enhanced erythropoietin activity?

OBJECTIVE: Animal and human studies demonstrated elevated erythropoietin (EPO) levels in response to intrauterine hypoxic events. Other studies documented an association between fetal hypoxia and elevated nucleated red blood cell (NRBC) counts and have speculated that it is the elevation of EPO that results in an increase in NRBC counts. Thus, the purpose of our study was to determine the correlation between EPO levels and NRBC counts in the human fetus. STUDY DESIGN: Data were collected prospectively between April and July of 2003. Term singleton pregnancies were eligible to participate in the study. Umbilical cord blood was collected immediately after birth for determination of fetal EPO levels and NRBC counts. RESULTS: Forty pregnancies formed the study population. The mean gestational age at delivery was 39.5 +/- 1.2 weeks (+/-SD) and the mean birth weight was 3500 +/- 372 g. The median EPO (mU/mL) was 34 (range 13-427). The median NRBC/100 white blood cells was 10 (range 0-150). A simple regression analysis indicated that NRBC counts are significantly and positively correlated with EPO (P=.0004, R(2)=0.287). CONCLUSION: Our results suggest a significant association between EPO and NRBC counts in term singleton fetuses. These results support the hypothesis that fetal NRBC and EPO are interrelated. However, the relatively low R(2) indicates that there are other (yet to be determined) hypoxia-derived mediators that result in an elevation of fetal NRBC counts.     

Effects of the moderate CYP3A4 inhibitor, fluconazole, on the pharmacokinetics of fesoterodine in healthy subjects

AIMS

To assess the effects of fluconazole, a moderate CYP3A4 inhibitor, on the pharmacokinetics (PK) and safety/tolerability of fesoterodine.

METHODS

In this open-label, randomized, two-way crossover study, 28 healthy subjects (18–55 years) received single doses of fesoterodine 8 mg alone or with fluconazole 200 mg. PK endpoints, including the area under the plasma concentration–time curve from 0 to infinity (AUC(0,∞)), maximum plasma concentration (C_max), time to C_max (t_max), and half-life (t_1/2), were assessed for 5-hydroxymethyl tolterodine (5-HMT), the active moiety of fesoterodine.

RESULTS

Concomitant administration of fesoterodine with fluconazole increased AUC(0,∞) and C_max of 5-HMT by approximately 27% and 19%, respectively, with corresponding 90% confidence intervals of (18%, 36%) and (11%, 28%). There was no apparent effect of fluconazole on 5-HMT t_max or t_½. Fesoterodine was generally well tolerated regardless of fluconazole co-administration, with no reports of death, serious adverse events (AEs) or severe AEs. Following co-administration of fesoterodine with fluconazole, 13 subjects (48%) experienced a total of 40 AEs; following administration of fesoterodine alone, six subjects (22%) experienced a total of 19 AEs. The majority of AEs were of mild intensity. There were no clinically significant changes in laboratory or physical examination parameters.

CONCLUSION

Fesoterodine 8 mg single dose was well tolerated when administered alone or with fluconazole. Based on the observed increase in 5-HMT exposures being within the inherent variability of 5-HMT pharmacokinetics, adjustment of fesoterodine dose is not warranted when co-administered with a moderate CYP3A4 inhibitor provided they are not also inhibitors of transporters.