Sex Differences in Outcomes After Percutaneous Coronary Intervention or Coronary Artery Bypass Graft for Left Main Disease: From the DELTA Registries

Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug-Eluting Stents for Left Main Coronary Artery Disease) and DELTA-2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men (P<0.05). At a median follow-up of 29 months (interquartile range 12-49), a significant interaction between sex and revascularization strategy was observed for the primary end point (pint=0.012) and all-cause death (pint=0.037). Among women, compared with percutaneous coronary intervention, coronary artery bypass grafting was associated with lower risk of the primary end point (event rate 9.5% versus 15.3%; adjusted hazard ratio [AHR], 0.53; 95% CI, 0.35-0.79, P<0.001) and all-cause death (event rate 5.6% versus 11.7% AHR, 0.50; 95% CI, 0.30-0.82) and no significant differences were observed in men. Conclusions In women undergoing coronary revascularization for unprotected left main coronary artery disease, coronary artery bypass grafting was associated with lower risk of death, myocardial infarction, or cerebrovascular accidents whereas no significant differences between coronary artery bypass grafting and percutaneous coronary intervention were observed in men. Further dedicated studies are needed to determine the optimal revascularization strategy in women with unprotected left main coronary artery disease. Keywords: cardiovascular disease in women; coronary revascularization; unprotected left main coronary artery disease

Depressive Symptoms during Pregnancy. Prevalence and Correlates with Affective Temperaments and Psychosocial Factors

Pregnancy is a unique experience in women's life, requiring a great ability of adaptation and self-reorganization; vulnerable women may be at increased risk of developing depressive symptoms. This study aimed to examine the incidence of depressive symptomatology during pregnancy and to evaluate the role of affective temperament traits and psychosocial risk factors in predicting them. We recruited 193 pregnant women, collected data regarding sociodemographic, family and personal clinical variables, social support and stressful life events and administered the Mood Disorder Questionnaire (MDQ), the Patient Health Questionnaire-9 (PHQ-9), and the Temperament Evaluation of Memphis, Pisa, Paris and San Diego-Autoquestionnaire (TEMPS-A). In our sample, prevalence of depressive symptomatology was 41.45% and prevalence of depression was 9.85% (6.75% mild and 3.10% moderate depression). We have chosen a cutoff &gt;4 on PHQ-9 to identify mild depressive symptoms which may predict subsequent depression. Statistically significant differences between the two groups were found in the following factors: gestational age, occupation, partner, medical conditions, psychiatric disorders, family psychiatric history, stressful life events, and TEMPS-A mean scores. In our sample mean scores on all affective temperaments but the hyperthymic, were significantly lower in the control group. Only depressive and hyperthymic temperaments were found to be, respectively, risk and protective factors for depressive symptomatology. The current study confirms the high prevalence and complex aetiology of depressive symptomatology during pregnancy and suggests that affective temperament assessment seems to be a useful adjunctive instrument to predict depressive symptomatology during pregnancy and postpartum

Efficacy and Safety of an Octreotide Implant in the Treatment of Patients With Acromegaly

Context: Acromegaly is caused by excessive GH secretion and IGF-I overproduction. The goals of treatment are to reduce GH and IGF-I values to normal and relieve the associated symptoms. Objective: The purpose of this article was to demonstrate that an octreotide implant (84 mg) is safe and efficacious in patients with acromegaly who were responsive to prior monthly octreotide long-acting release (LAR) injections. Design: This was a phase 3, open-label study. Before treatment, subjects received a stable monthly dose of octreotide LAR injections (10−40 mg) for ≥3 months. Randomization was in a 3:1 ratio to either a 6-month octreotide implant or monthly octreotide LAR injections. Setting: This was a multicenter, international study conducted in private or institutional practices. Subjects: Enrollment included 163 subjects (aged ≥18 years) with acromegaly. Main Outcome Measure: The efficacy, safety, and tolerability of the octreotide implant during 24 weeks of treatment was evaluated. Results: After 24 weeks, the success rate of the implant for maintenance of IGF-I and GH levels was 86% (95% confidence interval, 80.3%) compared with a rate of 84% (95% confidence interval, 73.8%) for octreotide LAR. Serum octreotide concentrations after implant insertion increased within 8 days and peaked between days 14 and 28. The overall safety of the octreotide implant and octreotide LAR were similar. Diarrhea and headache were more frequent with the implant, whereas cholecystitis and hypertension were more frequent with octreotide LAR. Conclusions: In this pivotal phase 3 study, the octreotide implant maintained reduced blood levels of GH and IGF-I with continuous octreotide release over 6 months, which was well tolerated

Efficacy and Safety of an Octreotide Implant in the Treatment of Patients With Acromegaly

Context: Acromegaly is caused by excessive GH secretion and IGF-I overproduction. The goals of treatment are to reduce GH and IGF-I values to normal and relieve the associated symptoms. Objective: The purpose of this article was to demonstrate that an octreotide implant (84 mg) is safe and efficacious in patients with acromegaly who were responsive to prior monthly octreotide long-acting release (LAR) injections. Design: This was a phase 3, open-label study. Before treatment, subjects received a stable monthly dose of octreotide LAR injections (10−40 mg) for ≥3 months. Randomization was in a 3:1 ratio to either a 6-month octreotide implant or monthly octreotide LAR injections. Setting: This was a multicenter, international study conducted in private or institutional practices. Subjects: Enrollment included 163 subjects (aged ≥18 years) with acromegaly. Main Outcome Measure: The efficacy, safety, and tolerability of the octreotide implant during 24 weeks of treatment was evaluated. Results: After 24 weeks, the success rate of the implant for maintenance of IGF-I and GH levels was 86% (95% confidence interval, 80.3%) compared with a rate of 84% (95% confidence interval, 73.8%) for octreotide LAR. Serum octreotide concentrations after implant insertion increased within 8 days and peaked between days 14 and 28. The overall safety of the octreotide implant and octreotide LAR were similar. Diarrhea and headache were more frequent with the implant, whereas cholecystitis and hypertension were more frequent with octreotide LAR. Conclusions: In this pivotal phase 3 study, the octreotide implant maintained reduced blood levels of GH and IGF-I with continuous octreotide release over 6 months, which was well tolerated

Multicenter prospective longitudinal study in 34 patients with Dravet syndrome: Neuropsychological development in the first six years of life

The objective of this study was to identify developmental trajectories of developmental/behavioral phenotypes and possibly their relationship to epilepsy and genotype by analyzing developmental and behavioral features collected prospectively and longitudinally in a cohort of patients with Dravet syndrome (DS).Thirty-four patients from seven Italian tertiary pediatric neurology centers were enrolled in the study. All patients were examined for the SCN1A gene mutation and prospectively assessed from the first years of life with repeated full clinical observations including neurological and developmental examinations. Subjects were found to follow three neurodevelopmental trajectories. In the first group (16 patients), an initial and usually mild decline was observed between the second and the third year of life, specifically concerning visuomotor abilities, later progressing towards global involvement of all abilities. The second group (12 patients) showed an earlier onset of global developmental impairment, progressing towards a generally worse outcome. The third group of only two patients ended up with a normal neurodevelopmental quotient, but with behavioral and linguistic problems. The remaining four patients were not classifiable due to a lack of critical assessments just before developmental decline.The neurodevelopmental trajectories described in this study suggest a differential contribution of neurobiological and genetic factors. The profile of the first group, which included the largest fraction of patients, suggests that in the initial phase of the disease, visuomotor defects might play a major role in determining developmental decline.Early diagnosis of milder cases with initial visuomotor impairment may therefore provide new tools for a more accurate habilitation strategy. (c) 2020 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved

Sex Differences in Outcomes After Percutaneous Coronary Intervention or Coronary Artery Bypass Graft for Left Main Disease: From the DELTA Registries

Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug‐Eluting Stents for Left Main Coronary Artery Disease) and DELTA‐2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men (P<0.05). At a median follow‐up of 29 months (interquartile range 12–49), a significant interaction between sex and revascularization strategy was observed for the primary end point (pint=0.012) and all‐cause death (pint=0.037). Among women, compared with percutaneous coronary intervention, coronary artery bypass grafting was associated with lower risk of the primary end point (event rate 9.5% versus 15.3%; adjusted hazard ratio [AHR], 0.53; 95% CI, 0.35–0.79, P<0.001) and all‐cause death (event rate 5.6% versus 11.7% AHR, 0.50; 95% CI, 0.30–0.82) and no significant differences were observed in men. Conclusions In women undergoing coronary revascularization for unprotected left main coronary artery disease, coronary artery bypass grafting was associated with lower risk of death, myocardial infarction, or cerebrovascular accidents whereas no significant differences between coronary artery bypass grafting and percutaneous coronary intervention were observed in men. Further dedicated studies are needed to determine the optimal revascularization strategy in women with unprotected left main coronary artery disease

Pregnancy-related psychopathology: A comparison between pre-COVID-19 and COVID-19-related social restriction periods

BACKGROUNDThe coronavirus disease 2019 (COVID-19) pandemic impacted in a still undefined way pregnant women's mental health. There are reports of mood and affect changes in the general population and the suggestion that similar changes occur also in the pregnant population. The greater vulnerability of women during the COVID-19 restriction period may translate into a greater risk for mental disorders in the gestational period. We hypothesised that pregnant women in the pre-pandemic period would have less psychopathology and more psychological support than pregnant women during the pandemic restriction period. AIMTo compare pregnant women for anxiety, prenatal depression, psychopathology, and social support before and after the awareness of the pandemic. METHODSWe administered to women willing to participate in their 2(nd)-3(rd) trimesters of pregnancy the Edinburgh Postnatal Depression Scale (EPDS), the State-Trait Anxiety Inventory Form Y (STAI-Y), and the Symptom CheckList-90-Revised (SCL-90R); we further collected sociodemographic variables and explored women's social support. The comparison was cross-sectional. The first sample was termed nonCOVID-19 because data were gathered before the COVID-19 outbreak (January 2020-February 2020) was declared, and the second sample termed COVID-19 because participants were already subjected to the COVID-19-related restrictive measures (January 2021-February 2021). Since normal distribution was not met (Shapiro-Wilk test applied), we applied nonparametric Mann-Whitney's U-test to compare psychometric tests. Ethical standards were met. RESULTSThe nonCOVID-19 group reported higher support from partners only, while the COVID-19 group reported multiple support (chi(2) = 9.7181; P = 0.021); the nonCOVID-19 group scored higher than the COVID-19 group only on state anxiety among psychometric scales [STAI-Y1, nonCOVID-19 median = 39 (95%CI: 39.19-51.10) vs COVID-19 median= 32 (95%CI: 30.83-38.90); Mann-Whitney's U=117.5, P = 0.00596]. Other measures did not differ meaningfully between the two groups. Scores on the EPDS, the state and trait subscales of the STAI-Y, and most SCL-90R subscales inter-correlated with one another. The anxiety component of the EPDS, EPDS-3A, correlated poorly with other measures, while it was the Global Symptom Index of the SCL-90-R that correlated most strongly with most measures. Our results are at odds with most literature and do not confirm increased depression and anxiety rates in pregnant women during the pandemic. CONCLUSIONThe ability of pregnant women to deal with novel generalised threats involves mobilization of inner resources. Increasing sources of social support may have produced anxiolysis in the COVID-19 sample

Depressive Symptoms in Expecting Fathers: Is Paternal Perinatal Depression a Valid Concept? A Systematic Review of Evidence

Background: Since the identification of Couvade syndrome in the late 1950s, little attention has been dedicated to the issue of depression in expecting fathers. Objective: To quantify the extent of depression in expecting fathers and find out if they match their pregnant partners' depression. Methods: We conducted a PubMed and ClinicalTrials.gov search using paternal depression and all its variants as terms. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement to include eligible studies. Results: We identified a grand total of 1443 articles, of which 204 were eligible. The total number of fathers/expecting fathers involved was 849,913. Longitudinal studies represented more than half of the included studies; more than three-quarters of the studies used the Edinburgh Postnatal Depression Scale (EPDS). The average occurrence of paternal depression was around 5%, which confers the entity some clinical dignity. Depression tends to occur more in expecting women and new mothers than in expecting partners or new fathers, while the co-occurrence in the same couple is quite low. Limitations: The methodological heterogeneity of the included studies prevents us from meta-analyzing the obtained data. The validity of the instruments used is another issue. Conclusions: Paternal depression is distinct from maternal depression and occurs at lower rates (about half). The very existence of a paternal depression clinical entity is beyond any doubt. Future research should address methodological heterogeneity