Le morti in utero: risultati di un progetto pilota di sorveglianza della mortalità perinatale in Italia (SPItOSS).

OBJECTIVES: to describe the results of a pilot population-based perinatal mortality surveillance system, with regards to stillbirths; to study maternal, obstetric, and foetal characteristics, evaluating risk factors and understanding causes. DESIGN: a cross-sectional study was conducted on incident cases of stillbirths collected by the surveillance system from July 2017 to June 2019 in three Italian Regions (Lombardy, Tuscany, and Sicily). SETTING AND PARTICIPANTS: data on stillbirths, resulting from the in-hospital multidisciplinary audits, organised using the Significant Event Audit methodology, were analysed. According to the World Health Organization (WHO) definitions, the project identified stillbirths as foetuses born dead >=28 weeks of gestation. The WHO International Classification of Diseases-Perinatal Mortality was used to categorise the causes of foetal death. MAIN OUTCOMES MEASURES: maternal characteristics, obstetric and foetal findings were investigated. Unadjusted relative risks and 95% confidence intervals were computed with respect to the background population. Finally, causes of death and contributing maternal conditions have been considered. RESULTS: the maternity and neonatal units of the three participating Regions notified 520 stillbirths, of which 435 cases underwent to the multidisciplinary audit (83.7%); 40.0% of cases occurred in the gestational age range between 36 and 39 weeks. The risk of stillbirth was significantly increased in mothers with foreign citizenship (RR: 1.39; 95%CI: 1.13-1.71), multiple pregnancies (RR: 1.59; 95%CI 1.05-2.42), and pregnancies conceived with assisted reproductive technologies (RR: 2.15; 95%CI 1.45-3.19). The rate of congenital malformations was 6.0%. A diagnosis of foetal growth restriction was reported in 10.3% of cases, although the percentage of dead foetuses weighting <10° centile was at least twice in almost all gestational age periods. Post-mortem and placental histological examinations were carried out in more than 70% and more than 90% of cases, respectively. CONCLUSIONS: the implementation of a population-based surveillance system with high participation rate of maternity units and the use of universally accepted definitions could improve the identification of stillbirth avoidable risk factors and potentially modifiable predisposing maternal conditions, highlighting issues of perinatal assistance in need of improvement.

Coronary computed tomography angiography in acute chest pain: A sustainable model with remote support.

PURPOSE: To propose a sustainable model of coronary computed tomography angiography (CCTA) use in acute coronary syndrome (ACS) in emergency department (ED) using a partially based teleradiology reporting model. We also analyzed impact of the protocol on short- and long-term patient's outcome. METHODS: During a 12-month period, 104 consecutive patients admitted to the ED for acute chest pain (ACP) with low-to-intermediate risk of ACS were selected and underwent CCTA. Medical reporting was based on a model combining on-site physician and a remote radiologist supported by a web client-based teleradiology system, covering a 24/7 service. CCTA findings were correlated with the incidence of major adverse cardiovascular events (MACEs) over a 5-year follow-up. RESULTS: CCTA ruled-out CAD in 76 patients (73.1%). Moderate (7.7%) to severe (19.2%) CAD was identified in 28 patients who were directly referred to functional tests or invasive angiography. The mean discharge time was 10.8 ± 5.8 h; patients with absent to mild disease were safely and quickly discharged. Remote reporting using a teleradiology platform was performed in 82/104 cases (78.9%), with slight impact on patient's discharge time (10.4 ± 5.6 vs. 12.1 ± 6.1 h, p: 0.24). MACEs at 6-month and at 5-year follow-up were 0.96% (n = 1/104) and 15.5% (n = 14/90). CONCLUSION: CCTA assessment of patients with ACP enables to quickly rule-out ACS, avoiding waste of time and resources, to identify patients with obstructive CAD which should be referred to subsequent tests and to stratify the risk of MACEs at short and long time. A partial teleradiology based 24/7 CCTA service is feasible and sustainable, even in small ED.

OPHTHALMIA NEONATORUM in Italy: it is time for change.

Ophthalmia neonatorum (ON) refers to any conjunctivitis occurring in the first 28 days of life. In the past Neisseria gonorrhoeae was the most common cause of ON. It decreased with the introduction of prophylaxis at birth with the instillation of silver nitrate 2% (the Credè's method of prophylaxis). Today, the term ON is used to define any other bacterial infection, in particular due to Chlamydia Trachomatis. Currently, the WHO reccomends topical ocular prophylaxis for prevention of gonococcal and chlamydial conjunctivitis for all neonates. On the contrary, several European countries no longer require universal prophylaxis, opting for screening and treatment of pregnant women at high risk of infection. And what about Italy? Have a look on Italian history of prophylaxis, starting by the first decree issued in 1940, signed by Benito Mussolini. In the following decades the law has undergone many changes. At the moment, legislation is unclear, therefore careful consideration is required in order to draft the correct appoach.

Neonatal Air Medical Transportation Practices in Italy: A Nationwide Survey.

The present article shows the current neonatal air transport organization and activity in Italy. The results were obtained on the basis of a recent 2019 survey (year of activity 2018) performed by the Neonatal Transport Study Group of the Italian Society of Neonatology. The total number of newborn transports during the year 2018 was 6,464. The air-suitable transports were 512 of 5,852 (8.74%), and among them, 101 of 512 (19.72%) were performed by helicopter and 34 by airplane. Besides the availability of air transport, the interfacility distance, weather and traffic conditions, and rural mountainous roads were the main factors in determining the vehicle choice. Neonatal air transport in Italy is not homogeneously distributed and needs organizational corrections. The high density of neonatal emergency transport services on the national territory indicates the need to overcome the limits imposed by regional administrative borders, thus expanding the geographic area of competence.

Acute Rheumatic Fever: Where Do We Stand? An Epidemiological Study in Northern Italy.

Acute rheumatic fever (ARF) is a non-septic complication of group A ß-hemolytic streptococcal (GAS) throat infection. Since 1944, ARF diagnosis relies on the Jones criteria, which were periodically revised. The 2015 revision of Jones criteria underlines the importance of knowing the epidemiological status of its own region with updated data. This study aims to describe ARF features in a retrospective cohort retrieved over a 10-year timespan (2009-2018) and to report the annual incidence of ARF among children in the Province of Monza-Brianza, Lombardy, Italy during the same period. This is a multicentric cross-sectional/retrospective study; 70 patients (39 boys) were diagnosed with ARF. The median age at diagnosis was 8.5 years (range, 4-14.2 years). Overall, carditis represented the most reported major Jones criteria followed by arthritis and chorea (40, 27, and 20 cases, respectively). In order to calculate the annual incidence of ARF, only children resident in the Province of Monza-Brianza were included in this part of the analysis. Therefore, 47 patients aged between 5 and 14 years were identified. The median incidence during the study time was 5.7/100,000 (range, 2.8-8.3/100,000). In the Province of Monza-Brianza, we found an incidence rate of ARF among children aged 5-14 years constantly above the threshold of low-risk area as defined in the 2015 revision of Jones criteria. Therefore, the diagnosis of ARF should be based on the moderate-high-risk set of Jones criteria. However, given the burden of secondary prophylaxis, expert opinion is advisable when the diagnosis of ARF is uncertain.

Opioids for newborn infants receiving mechanical ventilation.

BACKGROUND: Mechanical ventilation is a potentially painful and discomforting intervention that is widely used in neonatal intensive care. Newborn infants demonstrate increased sensitivity to pain, which may affect clinical and neurodevelopmental outcomes. The use of drugs that reduce pain might be important in improving survival and neurodevelopmental outcomes. OBJECTIVES: To determine the benefits and harms of opioid analgesics for neonates (term or preterm) receiving mechanical ventilation compared to placebo or no drug, other opioids, or other analgesics or sedatives. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 9), in the Cochrane Library; MEDLINE via PubMed (1966 to 29 September 2020); Embase (1980 to 29 September 2020); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 29 September 2020). We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing opioids to placebo or no drug, to other opioids, or to other analgesics or sedatives in newborn infants on mechanical ventilation. We excluded cross-over trials. We included term (≥ 37 weeks' gestational age) and preterm (< 37 weeks' gestational age) newborn infants on mechanical ventilation. We included any duration of drug treatment and any dosage given continuously or as bolus; we excluded studies that gave opioids to ventilated infants for procedures. DATA COLLECTION AND ANALYSIS: For each of the included trials, we independently extracted data (e.g. number of participants, birth weight, gestational age, types of opioids) using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included 23 studies (enrolling 2023 infants) published between 1992 and 2019. Fifteen studies (1632 infants) compared the use of morphine or fentanyl versus placebo or no intervention. Four studies included both term and preterm infants, and one study only term infants; all other studies included only preterm infants, with five studies including only very preterm infants. We are uncertain whether opioids have an effect on the Premature Infant Pain Profile (PIPP) Scale in the first 12 hours after infusion (MD -5.74, 95% confidence interval (CI) -6.88 to -4.59; 50 participants, 2 studies) and between 12 and 48 hours after infusion (MD -0.98, 95% CI -1.35 to -0.61; 963 participants, 3 studies) because of limitations in study design, high heterogeneity (inconsistency), and imprecision of estimates (very low-certainty evidence - GRADE). The use of morphine or fentanyl probably has little or no effect in reducing duration of mechanical ventilation (MD 0.23 days, 95% CI -0.38 to 0.83; 1259 participants, 7 studies; moderate-certainty evidence because of unclear risk of bias in most studies) and neonatal mortality (RR 1.12, 95% CI 0.80 to 1.55; 1189 participants, 5 studies; moderate-certainty evidence because of imprecision of estimates). We are uncertain whether opioids have an effect on neurodevelopmental outcomes at 18 to 24 months (RR 2.00, 95% CI 0.39 to 10.29; 78 participants, 1 study; very low-certainty evidence because of serious imprecision of the estimates and indirectness). Limited data were available for the other comparisons (i.e. two studies (54 infants) on morphine versus midazolam, three (222 infants) on morphine versus fentanyl, and one each on morphine versus diamorphine (88 infants), morphine versus remifentanil (20 infants), fentanyl versus sufentanil (20 infants), and fentanyl versus remifentanil (24 infants)). For these comparisons, no meta-analysis was conducted because outcomes were reported by one study. AUTHORS' CONCLUSIONS: We are uncertain whether opioids have an effect on pain and neurodevelopmental outcomes at 18 to 24 months; the use of morphine or fentanyl probably has little or no effect in reducing the duration of mechanical ventilation and neonatal mortality. Data on the other comparisons planned in this review (opioids versus analgesics; opioids versus other opioids) are extremely limited and do not allow any conclusions. In the absence of firm evidence to support a routine policy, opioids should be used selectively - based on clinical judgement and evaluation of pain indicators - although pain measurement in newborns has limitations.

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes.

BACKGROUND: The NeoChord echo-guided transapical beating heart repair is a promising early-stage minimally invasive surgical procedure for degenerative mitral valve (MV) regurgitation (DMR) correction. The technique has been improved since its inception following procedure standardization, patient selection optimization, and learning curve stabilization. We hereby present the mid-term clinical results through three years of our large single center experience. METHODS: All consecutive patients with severe symptomatic DMR due to prolapse or flail of one or both mitral leaflets that underwent the NeoChord procedure between November 2013 and June 2019 were included. Patients were categorized according to MV anatomy; Type A isolated central posterior leaflet prolapse and/or flail, Type B posterior multi-segment prolapse and/or flail, Type C anterior and/or bi-leaflet prolapse or flail, Type D paracommissural prolapse and/or flail and/or significant leaflet and/or annular calcifications. Patients underwent clinical and echocardiographic follow-up at one, three, six, twelve months and yearly thereafter. Clinical outcomes and the composite primary endpoint (patient success) were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria. Mitral regurgitation (MR) severity was graded as absent, mild, moderate and severe according to American Society of Echocardiography (ASE) and European Society of Cardiology (ESC) guidelines. RESULTS: Two hundred and three patients were included; median follow-up was 24 months [interquartile range (IQR), 9-36]. Median age was 64 years (IQR, 54-74 years), median Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) was 0.60% (IQR, 0.32-1.44%). There were 106 Type A patients (52.2%), 68 Type B (33.5%), 16 Type C (7.9%), and 13 Type D (6.4%). Kaplan-Meier estimate of survival was 99.0%±0.7% at one and two years and 94.0%±2.9% at three years. At one-year follow-up patient success was 91.2%±2.0% and 111 patients (74%) presented a residual MR mild or less (1+). At three-year follow-up patient success was 81.2%±3.8% and 32 patients (64%) had a residual MR mild or less (1+). Patient success was significantly different according to anatomical type (P=0.001). Echocardiographic analysis showed a significant acute left ventricle and left atrial reverse remodeling that was maintained up to three years. CONCLUSIONS: The NeoChord echo-guided transapical beating heart repair procedure demonstrated good clinical outcomes and echocardiographic results up to three-year follow-up.

Managerial features and outcome in neonatal intensive care units: results from a cluster analysis.

BACKGROUND: Healthcare organisations differ in performance even if they are located in the same country or region. Suitable managerial practices and organisational processes can lead to better health outcomes. As a result, hospitals are constantly looking for managerial arrangements that can improve outcomes and keep costs down. This study aims to identify different managerial models in neonatal intensive care units (NICUs) and their impact on a large number of outcomes. METHODS: The research was conducted in Italy, within the SONAR project. SONAR's aim was to identify the characteristics of NICUs, monitor outcomes and promote best practices. This study includes 51 of the 63 NICUs that took part in the SONAR project. Questionnaires on the activities and managerial features were administered to doctors and nurses working in NICUs. A total of 643 questionnaires were analysed from doctors and a total of 1601 from nurses. A cluster analysis was performed to identify managerial models of NICUs. RESULTS: Three managerial models emerged from cluster analysis: traditional, collaborative and individualistic. In the "traditional" model the doctor is above the nurse in the hierarchy, and the nurse therefore has exclusively operational autonomy. The "collaborative" model has as key elements professional specialisation and functional coordination. The "individualistic" model considers only individual professional skills and does not concern the organisational conditions necessary to generate organisational effectiveness. The results also showed that there is an association between managerial model and neonatal outcomes. The collaborative model shows best results in almost all outcomes considered, and the traditional model has the worst. The individualistic model is in the middle, although its values are very close to those of traditional model. CONCLUSIONS: Health management needs to assess NICU strategically in order to develop models to improve outcomes. This study provides insights for management useful for designing managerial characteristics of NICUs in order to achieve better results. NICUs characterised by a collaborative model in fact show better neonatal outcomes.

Neuroprem: the Neuro-developmental outcome of very low birth weight infants in an Italian region.

INTRODUCTION: The survival of preterm babies has increased worldwide, but the risk of neuro-developmental disabilities remains high, which is of concern to both the public and professionals. The early identification of children at risk of neuro-developmental disabilities may increase access to intervention, potentially influencing the outcome. AIMS: Neuroprem is an area-based prospective cohort study on the neuro-developmental outcome of very low birth weight (VLBW) infants that aims to define severe functional disability at 2 years of age. METHODS: Surviving VLBW infants from an Italian network of 7 neonatal intensive care units (NICUs) were assessed for 24 months through the Griffiths Mental Developmental Scales (GMDS-R) or the Bayley Scales of Infant and Toddler Development (BSDI III) and neuro-functional evaluation according to the International Classification of Disability and Health (ICF-CY). The primary outcome measure was severe functional disability at 2 years of age, defined as cerebral palsy, a BSDI III cognitive composite score < 2 standard deviation (SD) or a GMDS-R global quotients score < 2 SD, bilateral blindness or deafness. RESULTS: Among 211 surviving VLBW infants, 153 completed follow-up at 24 months (72.5%). Thirteen patients (8.5%) developed a severe functional disability, of whom 7 presented with cerebral palsy (overall rate of 4.5%). Patients with cerebral palsy were all classified with ICF-CY scores of 3 or 4. BSDI III composite scores and GMDS-R subscales were significantly correlated with ICF-CY scores (p < 0.01). CONCLUSION: Neuroprem represents an Italian network of NICUs aiming to work together to ensure preterm neuro-developmental assessment. This study updates information on VLBW outcomes in an Italian region, showing a rate of cerebral palsy and major developmental disabilities in line with or even lower than those of similar international studies. Therefore, Neuroprem provides encouraging data on VLBW neurological outcomes and supports the implementation of a preterm follow-up programme from a national network perspective.

Mechanisms of recurrent regurgitation after transapical off-pump mitral valve repair with neochord implantation†.

OBJECTIVES: The aim of this study was to describe possible mechanisms of recurrent mitral regurgitation (MR) in patients who have been treated with the NeoChord procedure. METHODS: Patients presenting with recurrent severe or moderate MR were categorized as Not Expected Surgical-Like Result (NESLR)-Redo and NESLR-MR2 [NESLR reintervention or moderate MR (2+), respectively]. NESLR patients were stratified by onset (intraoperative, perioperative 24 h-30 days, or early 30 days to follow-up), by MR jet direction (central or eccentric) and by jet orientation (anterior or posterior). Specific mechanisms of NESLR were analysed. RESULTS: Fifty-two patients were identified with 13 (25%) categorized as NESLR-Redo, and 39 (75%) as NESLR-MR2. NESLR-Redo patient stratification included: intraoperative = 2 patients (1.2%), both eccentric anteriorly directed jets; perioperative = 7 patients (4.2%), all eccentric with 3 anteriorly and 4 posteriorly directed jets; and early = 4 patients (2.4%), 1 central, 3 eccentric, 2 posteriorly and 1 anteriorly directed jets. NESLR-MR2 patient stratification included: perioperative = 2 patients (5.1%), both eccentric, 1 anteriorly and 1 posteriorly directed jets; and early = 37 patients (94.9%), 4 central, 33 eccentric, 22 anteriorly and 11 posteriorly directed jets. Possible mechanisms of recurrent MR were identified as: patient selection (17.3%), technical issues (28.8%), progression of baseline disease (15.4%), left ventricle reverse remodelling (1.9%), excessive over-tensioning (35.8%) and PML curling (30.8%). CONCLUSIONS: The mechanisms of recurrent MR after the NeoChord procedure can be determined. Understanding recurrent MR mechanisms has led to improvements in procedural standardization and ad hoc prevention strategies that have been widely adopted since our initial clinical experience.

A machine learning approach to estimating preterm infants survival: development of the Preterm Infants Survival Assessment (PISA) predictor.

Estimation of mortality risk of very preterm neonates is carried out in clinical and research settings. We aimed at elaborating a prediction tool using machine learning methods. We developed models on a cohort of 23747 neonates <30 weeks gestational age, or <1501 g birth weight, enrolled in the Italian Neonatal Network in 2008-2014 (development set), using 12 easily collected perinatal variables. We used a cohort from 2015-2016 (N = 5810) as a test set. Among several machine learning methods we chose artificial Neural Networks (NN). The resulting predictor was compared with logistic regression models. In the test cohort, NN had a slightly better discrimination than logistic regression (P < 0.002). The differences were greater in subgroups of neonates (at various gestational age or birth weight intervals, singletons). Using a cutoff of death probability of 0.5, logistic regression misclassified 67/5810 neonates (1.2 percent) more than NN. In conclusion our study - the largest published so far - shows that even in this very simplified scenario, using only limited information available up to 5 minutes after birth, a NN approach had a small but significant advantage over current approaches. The software implementing the predictor is made freely available to the community.

Ventricular Arrhythmias in Young Competitive Athletes: Prevalence, Determinants, and Underlying Substrate.

BACKGROUND: Whether ventricular arrhythmias (VAs) represent a feature of the adaptive changes of the athlete's heart remains elusive. We aimed to assess the prevalence, determinants, and underlying substrates of VAs in young competitive athletes. METHOD AND RESULTS: We studied 288 competitive athletes (age range, 16-35 years; median age, 21 years) and 144 sedentary individuals matched for age and sex who underwent 12-lead 24-hour ambulatory electrocardiographic monitoring. VAs were evaluated in terms of number, complexity (ie, couplet, triplet, or nonsustained ventricular tachycardia), exercise inducibility, and morphologic features. Twenty-eight athletes (10%) and 13 sedentary individuals (11%) showed >10 isolated premature ventricular beats (PVBs) or ≥1 complex VA (P=0.81). Athletes with >10 isolated PVBs or ≥1 complex VA were older (median age, 26 versus 20 years; P=0.008) but did not differ with regard to type of sport, hours of training, and years of activity compared with the remaining athletes. All athletes with >10 isolated PVBs or ≥1 complex VA had a normal echocardiographic examination; 17 of them showing >500 isolated PVBs, exercise-induced PVBs, and/or complex VA underwent additional cardiac magnetic resonance, which demonstrated nonischemic left ventricular late gadolinium enhancement in 3 athletes with right bundle branch block PVBs morphologic features. CONCLUSIONS: The prevalence of >10 isolated PVBs or ≥1 complex VA at 24-hour ambulatory electrocardiographic monitoring did not differ between young competitive athletes and sedentary individuals and was unrelated to type, intensity, and years of sports practice. An underlying myocardial substrate was uncommon and distinctively associated with right bundle branch block VA morphologic features.

Functional gastrointestinal disorders in newborns: nutritional perspectives.

Functional gastrointestinal disorders (FGIDs) definition in children has changed over the years trying to facilitate clinicians, because the diagnostic process is complicated by the interpretation variability of symptoms described by children or by their caregivers for newborns and toddlers. This review refers to the Rome IV classification system, drafted in 2016. FGIDs pathophysiology is multifactorial and still poor understood, with limitations for the therapeutic process, which results often in unnecessary and alternative treatments trying to reduce the relevant caregiver distress, but with increased costs for families and for the National Health Service. This study reports the most recent evidence-based treatments for FGIDs in newborns: though in most cases the first action is an educational and behavioral intervention, reassuring caregivers about the transient and self-limiting natural history of FGIDs, there is now more evidence to recommend probiotics in some infant FGIDs.

Prognostic impact of leaflet-to-annulus index in patients treated with transapical off-pump echo-guided mitral valve repair with NeoChord implantation.

BACKGROUND: The transapical echo-guided NeoChord repair is a procedure to correct mitral regurgitation (MR) without the need for concomitant annuloplasty for degenerative mitral valve (MV) disease. Lacking strict criteria to define normal annular dimensions for patients undergoing MV repair, we consequently missed having precise selection criteria to identify patients who can benefit from a ringless procedure with respect to who would need a combined annular and leaflet repair. The aim of this study is to identify whether a new preoperative echocardiographic index may predict postoperative outcomes after NeoChord repair. METHODS: All consecutive patients with posterior leaflet disease who underwent NeoChord repair between November 2013 and January 2016 presenting complete postoperative echocardiographic assessment up to 1year were included. Leaflet-to-Annulus Index (LAI) was defined as the ratio between the sum of anterior leaflet length (AML) and posterior leaflet length (PML) over antero-posterior length (AP; AML+PML/AP). Measurements were performed with 2D transesophageal echocardiography. RESULTS: Sixty-six patients were enrolled. At 1year MR was absent in (24) 38% of patients, mild in (28) 44%, moderate in (10) 16% and severe in (1) 2%. Logistic regression analysis identified LAI as positive prognostic predictor of MR≤mild for values >1.35 at 3months, 1.30 at 6months and 1.25 at 1year. At 30days LAI was not associated with the grade of residual MR. CONCLUSIONS: LAI is a positive postoperative predictor of MR≤mild at 1-year follow-up and can be used to identify patients who could benefit from a ringless NeoChord repair procedure for the absence of a leaflet-to-annulus mismatch.

Learning curve analysis of transapical NeoChord mitral valve repair.

OBJECTIVES: Transapical off-pump mitral valve intervention with neochordae implantation is a novel, minimally invasive procedure for treatment of degenerative mitral valve regurgitation. The aim of this study was to apply control charts (CUSUM curves) to monitor the performance of NeoChord repair during the initial phase of its adoption. METHODS: The first 112 consecutive patients who underwent NeoChord repair at our institution between November 2013 and March 2016 were included in the analysis. Mitral Valve Academic Research Consortium criteria for 1-year patient success was utilized to determine failed procedures. Control charts had predetermined acceptable and unacceptable failure rates of 5% and 15%, respectively. RESULTS: The actual incidence of 1-year-patient failure was 11% (12 of 112 cases), with a cluster of failures within the first 20 cases. The CUSUM analysis demonstrated an initial learning curve; however, the upper boundary (alarm line) was never crossed. The reassurance line was first crossed after 40 procedures and performance remained stable after 49 procedures. CONCLUSIONS: NeoChord repair is a safe procedure, and the results are maintained through the 1-year follow-up. A relative high number of implants were required to overcome the learning curve at our institution due to the concurrent development of patient selection criteria and the technical refinement of the procedure. Future studies are needed to assess the evolution of the learning curve after the wide adoption of the procedure across European and North American centres.

Acute intraoperative echocardiographic changes after transapical off-pump mitral valve repair with NeoChord implantation.

OBJECTIVES: Our aim is to investigate the acute intraoperative effects of the NeoChord repair procedure on mitral valve (MV) annular geometry and LV function and the impact of these changes on MR at 1-year follow-up. BACKGROUND: Recently transapical off-pump mitral valve repair with NeoChord implantation has been demonstrated to be safe and effective in patients with degenerative mitral regurgitation (DMR). METHODS: We retrospectively analyzed baseline and early postoperative 3-dimensional transesophageal echocardiography of 66 patients who underwent NeoChord repair for isolated posterior leaflet MV disease using semiautomatic off-line analysis software. RESULTS: We observed a significant acute reduction of indexed LV end diastolic volume (Δ% = 14, p < .001), LV ejection fraction (Δ = 5.7%, p = .002), indexed left atrial volume (Δ = 14.7%, p = .045), and pulmonary artery pressure (Δ = 2.1%, p = .026). Among MV geometric parameters, we observed a significant reduction of MV antero-posterior diameter (Δ = 7%, p < .001), sphericity index (Δ = 8%, p < .001), annulus circumference (Δ = 0.9%, p = .021), and annulus area (Δ = 2.7%, p = .018). At 1-year, 53 patients (85.5%) presented MR ≤ mild, while 9 patients (14.5%) had MR ≥ moderate. Reduction of AP diameter (OR = 0.14, CI -3.83; 0.08, p < .001), annulus circumference (OR = 0.27, CI -2.98; 0.37, p = .005), MV area (OR = 0.39, CI -2.46; 0.61, p = .04), aorto-mitral angle (OR = 0.38, CI -2.49; 0.54, p = .002) and iEDV (OR = 0.44, CI -2.44; 0.81, p = .001) were independent protective factors against recurrence of MR greater than mild at 1-year follow-up. CONCLUSIONS: Transapical NeoChord repair produces important acute intraoperative changes in MV anatomy in DMR patients. The acute changes observed were associated with procedure durability at 1-year FU.

Antenatal Corticosteroid Prophylaxis in Singleton and Multiple Pregnancies.

BACKGROUND: The effects of antenatal corticosteroids (ANS) in multiple pregnancies are disputed. In this article, we examined whether estimated effects differ in singletons and multiples and in small for gestational age (SGA) preterm infants. METHODS: We studied 17 073 singletons (81% treated with ANS) and 8274 multiples (86% treated) born at 24-33 weeks from the Italian Neonatal Network (2005-2013). We used Poisson regression models with robust variance to estimate adjusted risk ratios (RR) of in-hospital death, severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), and the composite outcome of severe IVH and death. RESULTS: Mortality was lower among ANS-treated vs. ANS-untreated infants, both in singletons (RR 0.63, 95% confidence interval (CI) 0.58, 0.68) and in multiples (RR 0.85, 95% CI 0.73, 0.98). IVH and the composite outcome of IVH and death, but not PVL, also occurred less frequently among ANS-treated infants. For these outcomes, the effect of ANS was stronger in singletons than in multiples (+35%, +32%, and +22% for death, IVH, and the composite outcome, respectively). Also among SGA infants, singletons, and multiples, ANS-treated infants had lower risk of death, IVH and of composite outcome than untreated ones. CONCLUSIONS: In this large cohort of preterm infants, both multiples and singletons treated with ANS had a lower risk of mortality, of severe IVH, and of composite outcome of IVH and death, both in the overall sample and in SGA infants. Although ANS effect was weaker in multiples, our results support current recommendations to administer ANS prophylaxis in multiple pregnancies at risk of preterm delivery.

Patient-Specific Ventricular Access Site Selection for the NeoChord Mitral Valve Repair Procedure.

Selecting the ventricular access site on the basis of mitral valve anatomy improves the outcomes for a subgroup of patients undergoing the transapical echocardiographically guided NeoChord (NeoChord, Inc, St. Louis Park, MN) repair procedure to correct mitral regurgitation and who have a leaflet-to-annulus index lower than the recommended efficacy threshold of 1.25.

Breastfeeding promotion: evidence and problems.

Although breastfeeding is associated with many health benefits in children and mothers, and World Health Organization (WHO) recommends exclusive breastfeeding until 6 months of age and continued breastfeeding until 2 years of age, overall breastfeeding rates remain low. Italian rates of exclusive breastfeeding do not differ from international data. The aim of this review is to evaluate evidence of breastfeeding promotion interventions and the remaining problems to achieve them. We found that breastfeeding support is a complex system of interventions, including individual, structural and environmental factors. Many systematic reviews report evidence that breastfeeding support offered to women increases duration and exclusivity of breastfeeding, both in full term healthy newborns and in preterm infants. Political and economic efforts should be made to ensure breastfeeding support to all women in the different settings, assuming it as a collective target.