Adverse perinatal outcome and placental abnormalities in pregnancies with major fetal congenital heart defects: A retrospective case‐control study

Objective The placental development has been shown to be compromised in pregnancies affected by fetal congenital heart defects (CHD). This study aimed to investigate the frequency of complications related to utero‐placental insufficiency in pregnancies with and without major CHD. Method This retrospective case‐control study was conducted at a Fetal Echocardiography Center in Milan. The following outcomes were compared between the two groups: preeclampsia (PE), small for gestational age (SGA), placental disorders and preterm birth (PTB). The logistic regression analysis was adjusted for maternal age, parity, co‐morbidities and mode of conception. Results The CHD group (n = 480) showed significantly increased incidence of PE (2.9% vs 0.9%; aOR, 6.50; 95% CI, 1.39‐30.41; P = .017) as compared to the control group (n = 456). Placental disorders occurred more frequently in the CHD than in controls, but the increased risk showed only a borderline significance (4.5% vs 3.3%; aOR, 2.56; 95% CI, 0.99‐1.02; P = .046). There was a significantly higher risk of SGA in CHD than in controls (8.7% vs 3.9%; aOR, 3.37; 95% CI, 1.51‐7.51; P = .003). PTB occurred in 65/477 (13.6%) cases and in 39/447 (8.7%) controls (P = .022) (aOR, 2.17; 95% CI, 1.24‐3.81; P = .007). Conclusion Major CHD are significantly associated with the risk of PE, SGA and PTB

Neuropsychological and psychological functioning aspects in myotonic dystrophy type 1 patients in Italy

Introduction: Myotonic Dystrophy Type 1 (DM1) is an autosomal dominant genetic illness, characterized by a progressive loss of strength. Important deficits in cognitive functioning and a significant prevalence of psychiatric disorders have been previously reported. Methods: A neuropsychological and psychological assessment was carried out in 31 DM1 patients (61% males) in order to measure the cognitive functioning and explore their personality profiles. The MMSE Mini-Mental State Examination, Frontal Assessment Battery (FAB), ENB-2 Battery assessing memory (short term, long term and working memory), integration capacities, visual-spatial ability, attention (selective, divided, shifting/switching) executive functions, praxis, discrimination and logic capabilities and psychopathology Symptom Check List 90-R (SCL-90-R) were administered. The neuropsychological and psychological evaluation of DM1 patients was carried out taking into consideration the clinical parameters (CTG repeat, age at onset, disease duration, Muscular Impairment Rate Scale (MIRS), Medical Research Council Scale (MRC) and the Epworth Sleepiness Scales (EPS)). Results: Regarding psychopathology 19.4% of patients scored a moderate or high level of symptoms intensity index (GSI), 12.9% reported a high number of symptoms (PST) and 16.1% reported a high intensity level of the perceived symptoms (PSDI). Fatigue and daytime sleepiness resulted as being associated with higher levels of psychoticism (PSY). Only 1 patient reported a severe impairment in the spatial and temporal orientation, memory, language, praxis, attention and calculation. Longer disease duration was also associated with cognitive impairment evaluated through ENB-2 (p < 0.05). Discussions and Conclusions: There are indications of the utility of neuropsychological and psychological screening and support for these patients and their families due to the link between disease duration and cognitive performances. A proposal of a clinical protocol, with an illustration of a clinical case report of a family is presented

Phenotypes of adults with congenital heart disease around the globe: a cluster analysis

Objective To derive cluster analysis-based groupings for adults with congenital heart disease (ACHD) when it comes to perceived health, psychological functioning, health behaviours and quality of life (QoL). Methods This study was part of a larger worldwide multicentre study called APPROACH-IS; a cross sectional study which recruited 4028 patients (2013–2015) from 15 participating countries. A hierarchical cluster analysis was performed using Ward's method in order to group patients with similar psychological characteristics, which were defined by taking into consideration the scores of the following tests: Sense Of Coherence, Health Behavior Scale (physical exercise score), Hospital Anxiety Depression Scale, Illness Perception Questionnaire, Satisfaction with Life Scale and the Visual Analogue Scale scores of the EQ-5D perceived health scale and a linear analogue scale (0–100) measuring QoL. Results 3768 patients with complete data were divided into 3 clusters. The first and second clusters represented 89.6% of patients in the analysis who reported a good health perception, QoL, psychological functioning and the greatest amount of exercise. Patients in the third cluster reported substantially lower scores in all PROs. This cluster was characterised by a significantly higher proportion of females, a higher average age the lowest education level, more complex forms of congenital heart disease and more medical comorbidities. Conclusions This study suggests that certain demographic and clinical characteristics may be linked to less favourable health perception, quality of life, psychological functioning, and health behaviours in ACHD. This information may be used to improve psychosocial screening and the timely provision of psychosocial care

Analysing Researchers&rsquo; Engagement in Research Hospitals: A Pilot Study in IRCCS&mdash;Italian Research Hospitals

Despite universities in the UK, USA and Australia having developed tools and strategies to enhance academic engagement, there is a paucity of information from universities and research hospitals where conceptual and theoretical research still appears more heterogeneous. In Italy, there is a growing recognition that more needs to be done to define strategies to improve research engagement. Italian research hospitals are represented by the Scientific Institute for Research, Hospitalization and Healthcare (named IRCCS from the Italian acronym of these organisations), representing the best of Italian research and the National Health Service System. This article provided a pilot description of research engagement in a representative Italian IRCCS hospital for the first time. A pilot study was developed, and a brief questionnaire was validated to explore research engagement. The identified clusters of researchers&rsquo; engagement were provided to describe an initial theory-grounded framework. Based on the perspective of research administrators and the Ministry of Health during round tables, the developed questionnaire identified two clusters of researchers&rsquo; engagement and measured &ldquo;Project-oriented&rdquo; and &ldquo;Organisation-oriented&rdquo; engagement. Among the responders, IRCCS senior researchers tended to have higher project-oriented engagement, while young researchers had slightly higher organisation-oriented engagement. The contribution of this article is a hypothesised two-level theory-grounded framework to study and improve research engagement activities and strategies in a research hospital, with the potential for an overlap with other European research institutions

Conization in Early Stage Cervical Cancer: Pattern of recurrence in a 10-year single-institution experience

OBJECTIVE: The main objective of this study was to analyze the pattern of recurrence after conization and pelvic lymphadenectomy in early-stage cervical cancer (CC). METHODS: We retrospectively identified 60 patients with early-stage CC who referred to the European Institute of Oncology (IEO; Milan, Italy) for fertility-sparing surgery. All of them underwent conization and pelvic lymphadenectomy (one received neoadjuvant chemotherapy followed by simple trachelectomy because of the size of the tumor). RESULTS: In total, 54 patients were considered for final analysis; only 23 patients were entirely treated at IEO. Relapse occurred in 7 (13%) of 54 patients, and in 6 cases (86%) it was local. One patient experienced a pelvic lymph node recurrence (in a woman who conceived 4 months after conservative surgery). However, this was an atypical case for site and timing of recurrence with the consistent doubt that the nodal involvement was already present before conization. Thus, analyzing only IEO population, the recurrence rate was lower (9%), becoming 4% excluding the atypical case with nodal involvement. CONCLUSIONS: In our series, the relapse was mainly local (on the cervix). However, the pattern of recurrence and recurrence rates after conization and pelvic lymphadenectomy for early-stage CC are still unclear. Further studies, comparing conization with radical trachelectomy, are necessary to confirm that the adoption of this procedure in clinical practice is safe. Our data highlight that the management of such as a particular condition in dedicated and highly specialized centers is mandatory.OBJECTIVE: The main objective of this study was to analyze the pattern of recurrence after conization and pelvic lymphadenectomy in early-stage cervical cancer (CC). METHODS: We retrospectively identified 60 patients with early-stage CC who referred to the European Institute of Oncology (IEO; Milan, Italy) for fertility-sparing surgery. All of them underwent conization and pelvic lymphadenectomy (one received neoadjuvant chemotherapy followed by simple trachelectomy because of the size of the tumor). RESULTS: In total, 54 patients were considered for final analysis; only 23 patients were entirely treated at IEO. Relapse occurred in 7 (13%) of 54 patients, and in 6 cases (86%) it was local. One patient experienced a pelvic lymph node recurrence (in a woman who conceived 4 months after conservative surgery). However, this was an atypical case for site and timing of recurrence with the consistent doubt that the nodal involvement was already present before conization. Thus, analyzing only IEO population, the recurrence rate was lower (9%), becoming 4% excluding the atypical case with nodal involvement. CONCLUSIONS: In our series, the relapse was mainly local (on the cervix). However, the pattern of recurrence and recurrence rates after conization and pelvic lymphadenectomy for early-stage CC are still unclear. Further studies, comparing conization with radical trachelectomy, are necessary to confirm that the adoption of this procedure in clinical practice is safe. Our data highlight that the management of such as a particular condition in dedicated and highly specialized centers is mandatory

Revisiting and Implementing the Weber and Ventilatory Functional Classifications in Heart Failure by Cardiopulmonary Imaging Phenotyping

BackgroundIn heart failure, the exercise gas exchange Weber (A to D) and ventilatory classifications (VC-1 to VC-4) historically define disease severity and prognosis. However, their applications in the modern heart failure population of any left ventricular ejection fraction combined with hemodynamics are undefined. We aimed at revisiting and implementing these classifications by cardiopulmonary exercise testing imaging.Methods and Results269 patients with heart failure with reduced (n=105), mid-range (n=88) and preserved (n=76) ejection fraction underwent cardiopulmonary exercise testing imaging, primarily assessing the cardiac output (CO), mitral regurgitation, and mean pulmonary arterial pressure (mPAP)/CO slope. Within both classes, a progressively lower exercise CO, higher mPAP/CO slopes, and mitral regurgitation (P&lt;0.01 all) were observed. After adjustment for age and sex, Cox proportional hazard regression analyses showed that Weber (hazard ratio [HR], 2.9; 95% CI, 1.8-4.7; P&lt;0.001) and ventilatory classes (HR, 1.4; 95% CI, 1.1-2.0; P=0.017) were independently associated with outcome. The best stratification was observed when combining Weber (A/B or C/D) with severe ventilation inefficiency (VC-4) (HR, 2.7; 95% CI, 1.6-4.8; P&lt;0.001). At multivariable analysis the best hemodynamic determinants of peak oxygen consumption and ventilation to carbon dioxide production slope were CO (beta-coefficient, 0.72 +/- 0.16; P&lt;0.001) and mPAP/CO slope (beta-coefficient, 0.72 +/- 0.16; P&lt;0.001), respectively.ConclusionsIn the contemporary heart failure population, the Weber and ventilatory classifications maintain their prognostic ability, especially when combined. Exercise CO and mPAP/CO slope are the best predictors of peak oxygen consumption and ventilation to carbon dioxide production slope classifications representing the main targets of interventions to impact functional class and, likely, event rate

Ultrasonographic diagnosis and longitudinal follow-up of recurrences after conservative surgery for borderline ovarian tumors

Background Borderline ovarian tumors are generally diagnosed in young women. Because of the young age of patients at first diagnosis and at recurrence, and given the good prognosis of borderline ovarian tumors, a conservative surgical approach in those women who wish to preserve their fertility is advised. In this scenario, transvaginal ultrasound examination plays a key role in the detection of borderline ovarian tumor recurrence, and in assessment of amount of normal functioning parenchyma remaining. To date, no data are available about the natural history of borderline ovarian tumor recurrence. Objective The aim of the study was to determine growth rate of recurrent ovarian cysts by a scheduled follow-up by ultrasound examination, in women previously treated with fertility-sparing surgery due to borderline ovarian tumors. Study Design In this prospective observational study, we collected data from 34 patients previously treated with fertility-sparing surgery due to borderline ovarian tumors, who had a suspicious recurrent lesion. The patients underwent transvaginal ultrasonographic examination every 3 months, until the clinical setting recommended proceeding with surgery. According to cyst size at study entry, they were categorized into 3 groups: ≤10 mm, 10-20 mm, and >20 mm. Summary statistics for cyst size, growth rate, and the probability of remaining within the same dimension category at first ultrasound during the follow-up were also obtained. For each cyst the growth rate was calculated as the slope of the linear interpolation between 2 consecutive measurements. Results Follow-up timing (P 20 mm. The final histology of all recurrent lesions confirmed the same histotype of primary borderline ovarian tumors. Conclusion This article represents the first observational study that describes the trend in the growth rate of borderline ovarian tumor recurrence in relation to their size detected at the first ultrasound examination. The findings of this study seem to confirm, in selected patients, that a thorough ultrasonographic follow-up of borderline ovarian tumor recurrence has proven to be safe and feasible. The final goal of such management is to maximize the impact on fertility potential of these young women without worsening their prognosis

HPV Tests Comparison in the Detection and Follow-Up after Surgical Treatment of CIN2+ Lesions

Background: HPV tests differ for technology, targets, and information on genotyping of high risk (HR) HPV. In this study, we evaluated the performance of 6 HPV DNA tests and one mRNA test in the detection of cervical intraepithelial lesions (CIN) and as a test-of-cure in the follow-up after surgical conservative treatment. Methods: One hundred seventy-two women referred to the European Institute of Oncology, Milan, for surgical treatment of pre-neoplastic cervical lesions, were enrolled in this study (IEO S544) from January 2011 to June 2015. For all women, a cervical sample was taken before treatment (baseline) and at the first follow-up visit (range 3 to 9 months): on these samples Qiagen Hybrid Capture 2 (HC2), Roche Linear Array HPV Test (Linear Array), Roche Cobas 4800 HPV test (Cobas), Abbott RealTime High Risk HPV test (RT), BD Onclarity HPV assay (Onclarity), Seegene Anyplex II HPV HR Detection (Anyplex), and Hologic Aptima HPV Assay (Aptima) histology and cytology were performed at baseline, and the same tests and cytology were performed at follow-up. Results: At baseline 158/172 (92%), histologies were CIN2+, and 150/172 (87%) women were recruited at follow-up. Assuming HC2 as a comparator, the concordance of HPV tests ranges from 91% to 95% at baseline and from 76% to 100% at follow-up (PABAK ranging from 0.81 to 0.90 at baseline and PABAK ranging from 0.53 to 1 at follow-up). All HPV showed a very good sensitivity in CIN2+ detection at baseline, more than 92%, and a very good specificity at follow-up, more than 89%. Conclusions: HPV tests showed a good concordance with HC2 and a very good and comparable sensitivity in CIN2+ detection. Hence, an HPV test represents a valid option as test-of-cure in order to monitor patients treated for CIN2+ lesions during follow-up

Comparison of the Digene HC2 Assay and the Roche AMPLICOR Human Papillomavirus (HPV) Test for Detection of High-Risk HPV Genotypes in Cervical Samples

Many different methods with different sensitivity and specificity have been proposed to detect the presence of high-risk human papillomavirus (HR HPV) in cervical samples. The HC2 is one of the most widely used. Recently, a new standardized PCR-based method, the AMPLICOR HPV test, has been introduced. Both assays recognize the same 13 HR HPV genotypes. The performances of these two commercially available assays were compared in 167 consecutive women (for a total of 168 samples) who presented at the Colposcopy Clinic either for a follow-up or for a diagnostic visit. Concordant results were found in 140/168 cervical samples (overall agreement, 83%; Cohen's kappa = 0.63). Twenty-eight samples gave discordant results: 20 were positive with the AMPLICOR HPV test and negative with the HC2 assay, and 8 were negative with the AMPLICOR HPV test and positive with the HC2 assay. The genotyping showed that no HR HPV was detected in the 8 HC2 assay-positive AMPLICOR HPV test-negative samples, while in 8/20 AMPLICOR HPV test-positive HC2 assay-negative samples, an HR HPV genotype was found. The AMPLICOR HPV test scored positive in a significantly higher percentage of subjects with normal Pap smears. All 7 cervical intraepithelial neoplasia grade 3 patients scored positive with the AMPLICOR HPV test, while 2 of them scored negative with HC2. Both tests had positive results in the only patient with squamous cell carcinoma. In conclusion, this study shows that the HC2 assay and the AMPLICOR HPV test give comparable results, with both being suitable for routine use. The differences noted in some cases may suggest a different optimal clinical use