Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry

Central illustration: cumulative major adverse cardiac events (MACE) and bioresorbable vascular scaffold (BVS) thrombosis rates after 1, 2, 3, 4 and 5 years.

     

Enhanced surveillance of tetanus toxoid,reduced diphtheria toxoid,and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011–2015

BackgroundIn October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine.ObjectivesWe characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011–2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005–2010).MethodsWe searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011–6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005–06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation.ResultsWe found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5–2.8%) and injection site reactions/arm pain (4.5–11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7–1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports.ConclusionsNo new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of Tdap in pregnant women in the third trimester.     

Myocardial perfusion imaging and cardiac events in a cohort of asymptomatic patients with diabetes living in southern France.

AIMS: To assess the association between abnormal stress myocardial perfusion imaging (MPI) and cardiac events (CE) in asymptomatic patients with diabetes and with > or = 1 additional risk factor. Predictors of abnormal stress MPI were also evaluated. METHODS: Four hundred and forty-seven consecutive patients who underwent stress MPI were prospectively followed for 2.1 [0.5-4.1] years for the subsequent occurrence of hard CE (myocardial infarction and sudden or coronary death) and soft CE (unstable angina and ischaemic heart failure requiring hospitalization). Re-vascularization procedures performed as a result of the screening protocol were not included in the analysis. RESULTS: Follow-up was successful in 419 of 447 patients (94%), of whom 71 had abnormal MPI at baseline. Medical therapy was intensified in all subjects and especially in those with abnormal MPI. Twenty-three patients with abnormal MPI underwent a re-vascularization procedure. CEs occurred in 14 patients, including six of 71 patients (8.5%) with abnormal MPI and eight of 348 patients (2.3%) with normal MPI (P < 0.005). Only two patients developed a hard CE and 12 a soft CE. In multivariate analysis, abnormal MPI was the strongest predictor for CEs [odds ratio (OR) (95% CI) = 5.6 (1.7-18.5)]. Low-density lipoprotein cholesterol > or = 3.35 mmol/l [OR (95% CI) = 7.3; 1.5-34.7] and age > median [OR (95% CI) = 6.0 (1.2-28.6)] were additional independent predictors for CE. The independent predictors for abnormal MPI were male gender, plasma triglycerides > or = 1.70 mmol/l, creatinine clearance < 60 ml/min and HbA1c > 8%, with male gender the strongest [OR (95% CI) = 4.0 (1.8-8.8)]. CONCLUSIONS: Asymptomatic patients with diabetes in this study had a very low hard cardiac event rate over an intermediate period. This could be explained by the effects of intervention or by the low event rate in the background population. Randomized studies of cardiac heart disease screening are required in asymptomatic subjects with diabetes to determine the effectiveness of this intervention.     

Differences between urban and rural suicides

As part of a nation-wide psychological autopsy we examined the differences in DSM-III-R mental disorders, recent life events and other characteristics between urban (n=143) and rural (n=85) completed suicides in a random sample of 229 cases from the National Suicide Prevention Project in Finland for the period 1987-1988. Psychoactive substance use disorders (48% vs. 34%), cluster B personality disorders (24% vs. 9%) and psychiatric comorbidity (66% vs. 42%) were found more commonly among urban than rural suicides. Urban suicides were also more often reported to be preceded by a recent separation (25% vs. 8%), whereas rural suicide victims tended to have lacked a close companion of the opposite sex (36% vs. 18%) and to have had physical disorders (56% vs. 40%). Overall, urban and rural suicides may vary with regard to the prevalence of some mental disorders, their comorbidity, and physical disorders, as well as the preceding life situation. This variation may also imply the need for differences in strategies for suicide prevention in each setting.     

西雅图心绞痛调查量表对冠心病患者机体功能及生活质量的评估研究

目的对冠心病患者机体功能状态及生活质量进行评估。方法采用Ｓｐｅｔｕｓ等设计的ＳｅａｔｔｌｅＡｎｇｉｎａＱｕｅｓｔｉｏｎｎａｉｒｅ问卷对１００例冠心病患者躯体活动受限程度、心绞痛稳定状态及发作情况、治疗满意程度和疾病认识程度进行测评研究。结果重复测定显示该量表有良好的重复性，心理疗法配合药物治疗组的评分明显优于单纯药物治疗组（Ｐ＜０．０５）。结论该量表用于我国冠心病患者有较满意的信度，同时也证实了心理疗法在冠心病治疗中的重要地位。     

Life satisfaction in patients with chest pain subsequently diagnosed as coronary heart disease – connection through depressive symptoms?

The aim of this study was to investigate factors associated with life dissatisfaction in symptomatic patients (n = 144) with chest pain subsequently diagnosed as coronary heart disease (CHD) by coronary angiography. Life dissatisfaction was assessed with a four-item life satisfaction scale (LS), depression with the 21-item Beck Depression Inventory (BDI) and other psychiatric symptoms with the symptom check list (SCL). DSM-III-R Axis I and Axis II psychiatric diagnoses were performed by means of the Structured Clinical Interview. All assessments took place one day before angiography. Twenty-four per cent of CHD patients were dissatisfied with their lives. Life dissatisfaction was associated with being unmarried. Dissatisfied patients had Axis I mental disorders and Axis II personality disorders more frequently than others. Psychiatric and depressive symptoms according to the SCL and BDI, respectively, were also higher among dissatisfied patients. In multiple logistic regression analyses, mental disorders were related to life dissatisfaction when age, sex, employment status, New York Heart Association class, duration of chest pain symptoms and work load were controlled in the model. Married subjects had a lower probability of being dissatisfied with their lives than other subjects (Odds Ratio, OR: 0.23). When BDI scores were included in the model, the only factor independently associated with life dissatisfaction was the severity of depressive symptoms (OR: 1.81). To conclude, life dissatisfaction is not primarily determined by the severity of CHD but by the existence of depressive symptoms.     

Adverse events in phase one studies: a study in 430 healthy volunteers

Summary All the clinical, laboratory and electrocardiographic adverse events detected during 24 Phase I studies in the same unit over a 5 y period are reported here. 430 healthy male volunteers were involved, corresponding to 5488 days of follow-up.The overall incidence of adverse events was 13.5%, with a significant difference between active drug (15.3%) and placebo (7.4%) treatments. There were 69 distinct types of adverse events. Headache was the most frequent symptom (2%). There were severe adverse events in 20 cases (0.36%), with an incidence of 20/430 per subject (4.6%). There were no deaths or life-threatening events.Although the main objective of Phase I studies is to determine the maximum dose tolerated, cause-effect relationships with adverse events are hard to establish, because of the frequency of adverse events with placebo, and because of the limited number of subjects included such studies.