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Background: The assessment of symptoms experienced by patients with heart failure (HF) has important contextual implications for self-care and allows for early recognition of signs of worsening HF. The Heart Failure Somatic Perception Scale (HFSPS) is a measurement tool developed in the U.S. to assess symptoms experienced by patients with HF, but it is expected to be applicable to patients in countries with different cultural backgrounds. Objectives: To evaluate the psychometric properties (validity and reliability) of the HFSPS in Japanese HF patients. Methods: This study assessed the factor structure of the HFSPS using confirmatory factor analysis in 320 HF outpatients in Japan. Criterion-related validity of the HFSPS was evaluated by correlating its factor scores with Patient-Reported Outcomes Measurement Information System (PROMIS) scores using Pearson's correlation coefficient. Internal consistency reliability of the HFSPS was evaluated using the factor score coefficient of determination, Cronbach's alpha, and the model-based internal consistency index. Results: The sample (n=320) was 72% male, mean age 72.9±12.8 years. Confirmatory factor analysis examining the four-factor structure of the HFSPS (dyspnea, chest discomfort, early and subtle, and edema), resulted in resulted in the following fit indices: χ2= (129, N=310), P Conclusion: This study suggests the HFSPS is a reliable and valid tool among Japanese with HF. Using this scale will provide accurate assessment of symptoms experienced by HF patients in research testing educational interventions to improve HF symptom recognition and response.

Background Amlodipine is used for the treatment of hypertension, but reports on its use in early pregnancy are limited. Methods and Results In the present study, we recruited 231 women with chronic hypertension, including those who received amlodipine or other antihypertensives during early pregnancy, and investigated frequencies of morphologic abnormalities in their 231 offspring. Specifically, we evaluated 48 neonates exposed to amlodipine in the first trimester (amlodipine group, Group A), 54 neonates exposed to antihypertensives other than amlodipine (other antihypertensive group, Group O), and 129 neonates not exposed to antihypertensives (no‐antihypertensive group, Group N). The number of morphologic abnormalities of offspring in each group were 2 in Group A (4.2%; 95% CI , 0.51–14.25); 3 in Group O (5.6%; 95% CI , 1.16–15.39) and 6 in Group N (4.7%; 95% CI, 1.73–9.85). The odds ratio of the primary outcome comparing Group A and Group O was 0.74 (95% CI : 0.118–4.621) and Group A and Group N was 0.89 (95% CI : 0.174–4.575). Conclusions The odds of birth defects in Group A in the first trimester were not significantly different from those with or without other antihypertensives.

Supplemental Digital Content is available in the text, Pregnancy and inflammatory bowel disease (IBD) are independent risk factors for venous thromboembolism (VTE). Nevertheless, the optimal VTE prevention strategy for women with IBD in pregnancy and postpartum period has not been established yet. We assessed VTE risks during pregnancy and the postpartum period in women with IBD through systematic review and meta-analysis. Systematic searches were conducted in MEDLINE (Ovid), Embase (Ovid), CENTRAL (Ovid), and Web of Science (Tomson Reuters) from the database inception till May 2017 to identify relevant studies reporting the risk of VTE during pregnancy and/or the postpartum period in women with IBD. Random effect meta-analyses were performed to compare VTE-related outcomes between women with IBD and without IBD. Our protocol was registered: CRD 42017060199 in the PROSPERO International prospective register of systematic reviews. In the analysis of 5 studies reviewed, IBD population (n = 17,636) had a significantly increased risk of VTE during pregnancy (pooled risk ratio (RR) 2.13, 95% confidence interval (CI) 1.66–2.73) and postpartum (RR 2.61, 95% CI 1.84–3.69), comparing to the non-IBD population (n = 11,251,778). According to the location of VTE, the risk of deep vein thrombosis increased significantly by RR of 2.74 (95% CI 1.73–4.36) during pregnancy, whilst risk increase of pulmonary embolism was not statistically significant. In the subgroup analysis, the degree of VTE risk was higher in both periods in the UC group than in the CD group, as compared to that in the non-IBD population (UC group, during pregnancy: RR 2.24, 95% CI 1.6–3.11; postpartum period: RR 2.85, 95% CI 1.79–4.52). Significantly increased risks of VTE during pregnancy were found in the women with IBD, according to the periods and type of IBD, which might support a detailed strategy regarding administration of prophylactic anticoagulants to women with IBD.

We report the first cases of tissue-proven eosinophilic myocarditis after single vaccine administration of conjugate meningococcal C and hepatitis B vaccine, respectively. The nature of histopathologic findings strongly supports hypersensitivity reaction and negates viral etiology, which is typically characterized by a lymphocytic infiltrate. Both episodes resolved with corticosteroid therapy. To enhance discussion of our cases, we performed a systematic review of the literature on postimmunization myocarditis or pericarditis, and identified 37 publications, reporting 269 cases during the search period (1966-2007). Time of onset of cardiac symptoms in all patients ranged from 1 to 30 days postimmunization.

Introduction: Heart failure with preserved ejection fraction (HFpEF) is a significant and increasing public health problem, which has similar outcomes to HF with reduced EF (HFrEF). However, the prognostic factors of HFpEF have not been clarified. Recently, it has been reported that stroke volume (SV) is often reduced in HFpEF patients regardless of preserved EF. This study aimed to determine the importance of SV assessment on clinical outcomes in patients with HFpEF. Methods: We retrospectively reviewed 699 consecutive patients with acutely decompensated heart failure who were admitted in our institution between 2009 and 2011. Among them, both baseline and follow-up data including echocardiography were available in 425 patients. The patients were divided into 3 groups; EF≥50% (HFpEF), 41-49% (borderline), and EF Results: The mean follow-up period was 2.4±1.8 years. There were 176 patients (41%) with HFpEF, 70 (16%) with borderline and 182 (43%) with HFrEF. There were no significant differences among the 3 groups with respect to actuarial survival (67% vs 58% vs 68%, P=0.33), and event-free survival, defined as a composite of death from any cause, HF readmission, myocardial infarction and stroke (44% vs 33% vs 40%, P=0.20) at 3 years. In HFpEF patients, there were 48 patients (28%) with low SV ( Conclusions: Low SV regardless of preserved EF could be a possible marker for high risk patients with HFpEF.

If lithium therapy is required during pregnancy or lactation, serum lithium monitoring may be indicated in the newborns. In the neonatal population, however, blood samples are often obtained with a sampling device containing lithium heparin. Given the infrequent nature of lithium measurement in the neonatal population, a risk of oversight on the use of these lithium-containing devices for lithium measurements exists. Two such neonatal cases are reported, which may have been mismanaged if the measured levels of lithium were not suspected to be spurious. Patient 1 was a 3-day-old infant with a congenital heart disease born at 31 weeks' gestation to a mother on lithium. After a surgical repair, because of a potential need to monitor lithium in the infant's serum during breastfeeding, a remaining sample of apparently serum from a previous blood testing on day 1 of life was measured for lithium as a baseline value. Despite the lack of toxic signs, the result showed a toxic lithium level of 4.19 mmol/L. Lithium levels in follow-up samples were 0.11 mmol/L (day 4) and undetectable (day 6). Patient 2 was a full-term infant exposed to maternal lithium throughout the fetal life and breastfeeding. Serum lithium at day three of life in a hospital was undetectable, but after discharge, the lithium concentrations increased to 1.1 mmol/L on day 18, with no sign of lithium toxicity or renal dysfunction. This raised a possibility of significant exposure through breastfeeding, but later they were found to be spurious due to the use of lithium-containing devices. Separate investigation of effects of sampling devices on lithium levels indicated that levels of >3 mmol/L were possible if a sampling volume of blood was substantially small compared with the capacity of a tube containing lithium heparin [corrected]

Digoxin-drug interactions are relatively common causes of digitalis toxicity. Recently, the clinical importance of the renal tubular secretion of digoxin has been proven by documenting drug interactions at this level. The authors describe a model using cultured renal tubular cell monolayers that can be used to predict drug interactions with the cardiac glycoside. This model accurately documents known clinical digoxin interactions such as those with verapamil and propafenone. The common feature of these interactions is that they involve P-glycoprotein substrates (e.g., digoxin, vincristine, vinblastine) or inhibitors (e.g., quinidine, cyclosporine). In the case of the newly described interaction of digoxin with itraconazole, the model preceded the emergence of clinical cases.

Lithium is a drug of choice for the management of bipolar disorder, a disease frequently affecting women in their childbearing years. Unfortunately, this drug has typically been contraindicated in nursing women. Data in humans are limited with respect to the use of this drug in lactating women, and early reports suggest high excretion into milk. The purpose of this report was to verify the excretion of lithium into human milk and to assess infant safety after breast-feeding. The authors found wide interpatient variability in lithium dose offered to the infant through breast milk (from 0% to 30% of maternal weight-adjusted dose), indicating that therapeutic drug monitoring of lithium in milk and/or in infant's blood, coupled with close monitoring of adverse effects, is a rational approach. Since therapeutic drug monitoring of lithium is routine, physicians caring for these women and infants should be encouraged to individualize their recommendations.

Although many female patients of childbearing age who are receiving cyclosporine have successful pregnancies, these women may be advised not to breast-feed. During recent years, cases of uneventful pregnancies and subsequent successful breast-feeding have been reported in the literature. The infant's blood cyclosporine concentration was usually very low. Based on these findings and the lack of detectable adverse effects, some investigators have suggested that women on cyclosporine may breast-feed, challenging the conventional view that cyclosporine is contraindicated during breast-feeding. Here, we report our experience with cyclosporine use during breast-feeding in five mother-infant pairs. We show a wide range of infant exposures to the drug in milk, noting that one of the infants had therapeutic blood concentrations of cyclosporine despite relatively low concentrations of the drug in milk.

The article by Nichols et al1 has ad d essed an important and complex issue. Because increasing birth order and younger maternal age are likely to be associated with lower levels of expo sure to potentially carcinogenic environ mental pollutants in breastmilk, the au thors postulated that adult breast cancer risk would be lower in breastfed women with higher birth order, and in those breastfed by younger mothers. Their re sults showed that higher birth order is associated with reduced risk of breast

Before marketing a new drug, the manufacturer almost never tests the product in pregnant women to determine its effects on the fetus. Consequently, most drugs are not labeled for use during pregnancy. Typically, descriptions of drugs that appear in the Physicians' Desk Reference and similar sources contain statements such as, “Use in pregnancy is not recommended unless the potential benefits justify the potential risks to the fetus.” Since the risk has been adequately established for only a few drugs, physicians caring for pregnant women have very little information to help them decide whether the potential benefits to the mother outweigh . . .