A randomized trial of hyperimmune globulin to prevent congenital cytomegalovirus

BACKGROUND: Congenital infection with human cytomegalovirus (CMV) is a major cause of morbidity and mortality. In an uncontrolled study published in 2005, administration of CMV-specific hyperimmune globulin to pregnant women with primary CMV infection significantly reduced the rate of intrauterine transmission, from 40% to 16%. METHODS: We evaluated the efficacy of hyperimmune globulin in a phase 2, randomized, placebo-controlled, double-blind study. A total of 124 pregnant women with primary CMV infection at 5 to 26 weeks of gestation were randomly assigned within 6 weeks after the presumed onset of infection to receive hyperimmune globulin or placebo every 4 weeks until 36 weeks of gestation or until detection of CMV in amniotic fluid. The primary end point was congenital infection diagnosed at birth or by means of amniocentesis. RESULTS: A total of 123 women could be evaluated in the efficacy analysis (1 woman in the placebo group withdrew). The rate of congenital infection was 30% (18 fetuses or infants of 61 women) in the hyperimmune globulin group and 44% (27 fetuses or infants of 62 women) in the placebo group (a difference of 14 percentage points; 95% confidence interval, -3 to 31; P = 0.13). There was no significant difference between the two groups or, within each group, between the women who transmitted the virus and those who did not, with respect to levels of virus-specific antibodies, T-cell-mediated immune response, or viral DNA in the blood. The clinical outcome of congenital infection at birth was similar in the two groups. The number of obstetrical adverse events was higher in the hyperimmune globulin group than in the placebo group (13% vs. 2%). CONCLUSIONS: In this study involving 123 women who could be evaluated, treatment with hyperimmune globulin did not significantly modify the course of primary CMV infection during pregnancy. Copyright \ua9 2014 Massachusetts Medical Society

How future surgery will benefit from SARS-COV-2-related measures: a SPIGC survey conveying the perspective of Italian surgeons

COVID-19 negatively affected surgical activity, but the potential benefits resulting from adopted measures remain unclear. The aim of this study was to evaluate the change in surgical activity and potential benefit from COVID-19 measures in perspective of Italian surgeons on behalf of SPIGC. A nationwide online survey on surgical practice before, during, and after COVID-19 pandemic was conducted in March-April 2022 (NCT:05323851). Effects of COVID-19 hospital-related measures on surgical patients' management and personal professional development across surgical specialties were explored. Data on demographics, pre-operative/peri-operative/post-operative management, and professional development were collected. Outcomes were matched with the corresponding volume. Four hundred and seventy-three respondents were included in final analysis across 14 surgical specialties. Since SARS-CoV-2 pandemic, application of telematic consultations (4.1% vs. 21.6%; p < 0.0001) and diagnostic evaluations (16.4% vs. 42.2%; p < 0.0001) increased. Elective surgical activities significantly reduced and surgeons opted more frequently for conservative management with a possible indication for elective (26.3% vs. 35.7%; p < 0.0001) or urgent (20.4% vs. 38.5%; p < 0.0001) surgery. All new COVID-related measures are perceived to be maintained in the future. Surgeons' personal education online increased from 12.6% (pre-COVID) to 86.6% (post-COVID; p < 0.0001). Online educational activities are considered a beneficial effect from COVID pandemic (56.4%). COVID-19 had a great impact on surgical specialties, with significant reduction of operation volume. However, some forced changes turned out to be benefits. Isolation measures pushed the use of telemedicine and telemetric devices for outpatient practice and favored communication for educational purposes and surgeon-patient/family communication. From the Italian surgeons' perspective, COVID-related measures will continue to influence future surgical clinical practice

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Citomegalovirus

Il Citomegalovirus umano (CMV) è uno degli otto virus, appartenenti alla famiglia Herpesviridae, che infetta la specie umana. L’infezione da CMV è endemica ed ubiquitaria e non risente di variazioni stagionali. Nel corso dell’esistenza dal 40 all’80% degli individui nei Paesi industrializzati e la quasi totalità degli individui nei Paesi in via di sviluppo, va incontro ad infezione da CMV che di norma evolve senza sintomi morbosi e si traduce in una infezione latente (1,2). Si ritiene che gli esseri umani siano l’unico reservoir per il CMV umano; la trasmissione avviene per contatto interumano diretto e più raramente indiretto. Le fonti di infezione includono: secrezioni oro-faringee, urina, secrezioni cervicali e vaginali, sperma, latte materno, lacrime, feci, sangue, ect. Nella popolazione adulta, in particolare nelle donne in età feconda, oltre alla via sessuale, il contatto molto stretto e quotidiano con i bambini gioca un ruolo importante per la diffusione dell’infezione (3). CMV è causa di patologie fetali anche gravi se trasmesso in utero, infatti risulta essere la principale causa di infezione congenita nei paesi sviluppati con un’incidenza compresa tra lo 0.3 e il 2% di tutti i nati vivi (4,5). Dei neonati infettati congenitamente solo il 10-15% circa viene alla luce con sintomatologia evidente, in questi pazienti la mortalità perinatale è del 10% ed importanti sequele neurologiche - prevalentemente difetti dello sviluppo psicomotorio e sordità - si osservano in circa il 70-80% di quanti sopravvivono (6). L’ 85-90%, invece, pur essendo infetto, non presenta alla nascita alcuna sintomatologia. Di questi, però, un 8-15% presenterà segni tardivi (6,7). CMV è la più importante causa non genetica di sordità nell’infanzia: più del 50% dei nati con infezione sintomatica e circa il 10% degli asintomatici alla nascita svilupperà sordità neurosensoriale variabile tra forme lievi e profonde, con deterioramento progressivo in circa il 50% dei casi (8). La trasmissione materno-fetale è legata principalmente all’infezione materna primaria che presenta un rischio di trasmissione variabile tra il 24 e il 75% (valore medio 40%) (4,7), percentuali più basse sono osservate nel primo trimestre (~36%) e più alte nel terzo trimestre (~78%) (9). Casi di trasmissione materno-fetale conseguenti ad infezioni non primarie sono stati riportati nello 1-2.2% dei casi, quindi un rischio di trasmissione molto più basso rispetto a quello delle infezioni primarie (7). L’infezione congenita viene acquisita per via transplacentare, cioè dal sangue materno (dai leucociti materni) il virus infetta la placenta, si replica in essa fino ad arrivare a contatto con il circolo fetale. Lo stato sierologico materno è pertanto un fattore fortemente e maggiormente condizionante la possibilità di infezione congenita da CMV. E’ stato stimato che nell’Italia del nord approssimativamente il 30% della popolazione adulta risulta sieronegativa per CMV (10) e di conseguenza circa il 30% delle donne in età feconda sono a rischio di contrarre un’infezione primaria durante la gravidanza. L’entità dei danni feto-neonatali, in particolare le severe compromissioni cerebrali, appaiono correlabili prevalentemente all’epoca gestazionale in cui si verifica la trasmissione verticale: un rischio di prognosi feto-neonatale più grave è principalmente correlabile ad una infezione materna primaria contratta nei primi due trimestri di gravidanza (11). La maggior parte delle infezioni da CMV nelle donne gravide sono asintomatiche anche durante la fase acuta; raramente possono comparire sintomi non specifici e molto modesti, quali febbricola persistente, mialgia, adenomegalia. Le analisi di laboratorio possono evidenziare qualche volta la presenza di linfocitosi atipica e modesto rialzo delle transaminasi. Poiché della maggior parte delle donne lo stato sierologico pregravidico è ignoto e comunque esso non modifica di norma il decorso clinico dell’infezione, solitamente privo ..

Fetal cerebral periventricular halo at midgestation: an ultrasound finding suggestive of fetal cytomegalovirus infection.

OBJECTIVE: The objective of the study was to identify a cerebral ultrasound finding indicative of fetal cytomegalovirus (CMV) infection at midgestation. STUDY DESIGN: All fetuses of 218 patients with primary CMV infection underwent prospective transvaginal neurosonographic examination at 20-22 weeks' gestation. RESULTS: Transvaginal sonography identified a periventricular echogenic halo with well-defined borders in 6 infected fetuses at a mean gestational age of 20.5 weeks. Transabdominal axial views of the fetal head were normal in all cases. All patients opted for termination of pregnancy. Autopsy in 2 fetuses showed changes compatible with subacute white matter injury resembling telencephalic leukomalacia. CONCLUSION: A fetal cerebral periventricular halo disclosed by transvaginal sonography at midgestation in pregnant patients with recent CMV infection is suggestive of fetal infection and may be associated with white matter lesions