Suture-Mediated Patent Foramen Ovale Closure Using the NobleStitch EL: Results from a Hospital-Based HTA.

(1) Background: Patent foramen ovale (PFO) is a congenital abnormality present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. We applied the hospital-based HTA model (AdHopHTA) to conduct a multidimensional assessment of NobleStitch EL, an innovative suture-mediated PFO closure device. We compared it to Amplatzer PFO Occluder (APO) to provide evidence to inform technologies' governance in hospital settings. (2) Methods: For each AdHopHTA dimension we: systematically retrieved available evidence from the literature applying the PRISMA guidelines and then analyzed original clinical and cost data of a NobleStitch EL device at San Raffaele research hospital in Milan (Italy). The economic dimension was analyzed through activity-based costing and a cost analysis. We conducted semi-structured interviews with selected healthcare professionals to explore the organizational, legal, social, and ethical impact. (3) Results: A single study was included for the NobleStitch EL, with 10 for APO. Both literature data and original data showed comparable safety. Efficacy data analysis found that the PFO closure was at 89% for NobleStitch EL vs. 89-97% for APO. APO has a better impact on the budget and minor process costs. Consulted experts reported that the organizational impact of NobleStitch EL in the short and the long run as null, albeit a better impact under the social and the ethical aspects. (4) Conclusion: We suggest that there is inadequate evidence to conclude the relative efficacy of NobleStitch EL as compared to APO. Nevertheless, this report shows a good safety profile and higher costs for NobleStitch EL, with no organizational or legal impact. Further studies in selected population are recommended.

Optical coherence tomography quantifying photo aging: skin microvasculature depth, epidermal thickness and UV exposure.

INTRODUCTION: Photo aging predominantly occurs in the face, neck and hands due to UVA and UVB irradiation. It is associated with skin cancer and histological studies indicate thinning of the epidermis and elastosis occurs. Dynamic Optical coherence tomography (D-OCT) is a non-invasive imaging tool able to visualize the epidermis and upper dermis and its blood vessels as well as to evaluate epidermal thickness (ET) and blood flow. OBJECTIVE: To investigate ET and blood vessel depth using D-OCT in human subjects correlated to UV exposure. METHODS: We evaluated data from 249 healthy adults, that had D-OCT-scans conducted at four different regions (forehead, neck, arm and hand) and correlated ET and blood vessel depth with occupational UV exposure (total standard erythema dose, Total SED), season and demographic data. RESULTS: Regional differences in ET and blood vessel depth were found (p values < 0.001). Multiple linear regressions showed a seasonal effect on both ET (- 0.113 to - 0.288 µm/day, p values < 0.001) and blood vessel depth (0.168-0.347 µm/day, p values < 0.001-0.007) during August-December. Significant age-related decrease of ET was seen in forehead, arm and hand (0.207-0.328 µm/year, p values = 0.002-0.18) and blood vessel depth in forehead (0.064-0.553 µm/year, p values = 0.01-0.61). Males had thicker epidermis (3.92-10.93 µm, p values = 0.002-0.15). CONCLUSION: Changing seasons are a major predictor of both ET and blood vessel depth, showing strongest effect in non-exposed areas, suggesting a systemic effect, possibly due to seasonal vitamin D fluctuation. Sex, age and occupational UV exposure affect ET. This study demonstrated the feasibility of D-OCT to evaluate epidermal thickness and blood vessel depth.

Efficacy and safety of Impella 5.0 in cardiogenic shock: an updated systematic review.

Aim: The impact on safety and efficacy outcomes of Impella 5.0 in cardiogenic shock (CS) has not been systematically assessed. Materials & methods: We conducted a systematic review of the literature (PROSPERO protocol: CRD42020164680) to critically appraise available evidence on Impella 5.0 comparative safety, efficacy and effectiveness. Results: Of 244 retrieved citations, 17 original articles met the a priori defined inclusion criteria. All included studies had a retrospective study design and, overall, reported on, respectively, 52 and 67 different safety and efficacy/effectiveness outcomes. Thirty-day survival rates ranged from 40 to 94%, myocardial recovery from 18 to 93%. Conclusion: Impella 5.0 provides a full cardiac support, it is associated with a lower rate of vascular complications, it represents a valuable bridge-to-decision and allows for resolution of intercurrent clinical conditions. As available data suggest Impella 5.0 good performance in CS of various etiologies, more solid evidence will come from much-needed large-scale all-comer registries and prospective multicenter randomized trials.

Cardiogenic shock (CS) is a life-threatening condition in which the heart cannot pump enough blood to meet the body's needs. Despite advances in biomedical research and technology, CS is still associated with high mortality. Some devices (Intra-aortic balloon pump (IABP), Impella, Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO), placed through vascular accesses, can support the heart in the failing phase. The aim of this systematic review of the scientific literature is to evaluate safety, efficacy and effectiveness of Impella 5.0 in CS.

Immediate adverse events following COVID-19 immunization. A cross-sectional study of 314,664 Italian subjects.

BACKGROUND AND AIM: The urgency of having rapidly safe and efficient COVID-19 vaccines called for the need to shorten trial phases, reduce sample sizes, and speed-up the approval process by the regulatory Agencies. In light of this, monitoring adverse effects (AEFI) (both immediate and at medium-long term) become of great importance. Aim of this cross-sectional study was to explore the associations between several factors and risk of immediate AEFI. METHODS: Data come from the electronic dataset developed ad hoc to record demographic data, anamnesis and data related to immunization, set-up in the mass vaccination site in Novegro (Milan). Novegro mass vaccination site was one of the mass vaccinations sites with the highest flow in Lombardy Region, with a maximum capacity of 5,000 vaccinations/day. The center opened in April 2021 and closed the 1st of August 2021. A multivariable logistic regression model was used. Odds ratios adjusted (aOR) for age and sex are presented. Statistical significance was set at p<0.05. Analyses were conducting using STATA. RESULTS: Among the total of 314,671 subjects vaccinated, 0.5% developed an immediate AEFI, on average 17.0 ± 0.43 minutes after the administration. The three most frequent AEFI recorded were vagal response (30%), anxiety reaction (24%) and dizziness (21%). AEFI were more frequently observed among women [aOR= 2.24 (95%CI= 2.00 - 2.50)], and those with at least one previous disease [aOR= 1.47 (95%CI= 1.22-1.76)]. CONCLUSIONS: In conclusion, AEFI were less likely to occur for increasing age and after the second dose. Results from this large, complete and representative sample population regarding enrich the interesting scientific debate on potential adverse events following COVID-19 immunization.

Epidemiological assessment of the first COVID-19 epidemic wave in Lombardy. A systematic review.

BACKGROUND AND AIM: After the first cases of COVID-19 detected in Wuhan (China), the virus rapidly spread in the world, so much so that on February 20 the first autochthonous case was officially identified in Italy. However, this person had no apparent history of travel abroad or contact with people tested positive for the virus. For this reason, the aim of this literature review was to reconstruct the epidemiological dynamics of the first wave of SARS-CoV-2 infection in the Lombardy Region. METHODS: To this end, a systematic review was carried out on PubMed/MEDLINE and EMBASE, and on grey literature. All article assessing incidence, mortality and hospitalizations by Lombardy province and municipality, and the impact of the main containment and organizational measures were considered eligible. In addition, data on general mortality and mortality due to COVID-19, hospital admission, and serological and environmental were also retrieved. RESULTS: From the included studies, it emerged that Lombardy was the first European region in which the virus began to circulate as early as January 2020 (and probably even earlier). Despite the high number of cases and deaths recorded, the reproduction number observed in Lombardy Region was, at the beginning of March 2020, the same (or lower) than in other regions. CONCLUSIONS: In conclusion, data of the first epidemic wave in Lombardy, compared to other Italian and foreign regions, highlight the extreme criticality of having had the first autochthonous case (and the first substantial outbreaks) when knowledge was still scarce and individual prevention measures were not widespread.

Transition to retirement impact on health and lifestyle habits: analysis from a nationwide Italian cohort.

BACKGROUND: Retirement is a life-course transition likely to affect, through different mechanisms, behavioural risk factors' patterns and, ultimately, health outcomes. We assessed the impact of transitioning to retirement on lifestyle habits and perceived health status in a nationwide cohort of Italian adults. METHODS: We analysed data from a large cohort of Italian adults aged 55-70, derived from linking six waves of the Participation, Labour, Unemployment Survey (PLUS), a national survey representative of the Italian workforce population, conducted between 2010 and 2018. We estimated relative-risk ratios (RRR) of transition to retirement and their corresponding 95% confidence intervals (CIs) for selected behavioural risk factors and health outcomes using multivariable logistic regression models. We used propensity score matching (PSM) to account for potential confounders. RESULTS: We included 5169 subjects in the study population, of which 1653 retired between 2010 and 2018 (exposed, 32%). Transition to retirement was associated with a 36% increased probability of practising sports (RRR 1.36, 95% CI 1.12-1.64). No statistically significant changes were reported for smoking habit (current smoker RRR: 1.18, 95% CI 0.94-1.46) and BMI (overweight/obese RRR: 0.96, 95% CI 0.81-1.15). Overall, retiring was associated with improved self-rated health status (RRR 1.26, 95% CI 1.02-1.58). CONCLUSION: Individual data-linkage of multiple waves of the PLUS can offer great insight to inform healthy ageing policies in Italy and Europe. Transition to retirement has an independent effect on perceived health status, physical activity and selected behavioural risk factors. It should be identified as a target moment for preventive interventions, with particular reference to primary prevention so as to promote health and wellbeing in older ages.

The runaway science: a bibliometric analysis of the COVID-19 scientific literature.

BACKGROUND AND AIM OF THE WORK: To reflect on content, trends and quality of scientific publishing on COVID-19. In particular, to report on the systematic screening, quantitative assessment and critical appraisal of the first 10,000 scientific papers published on COVID-19 and to compare how scientific outputs matched identified research priorities and public health needs. METHODS: A comprehensive research strategy was developed to systematically retrieve on a daily basis all studies published on COVID-19. From included studies we extracted: bibliometric parameters, country of studies' implementation and study design. We assigned papers to 25 a priori defined COVID-19-related topics and we described scientific outputs in relation to countries' academic publishing ranking, as well as COVID-19 burden. RESULTS: 10,000 scientific articles were published on COVID-19 between 20th January and 7th May 2020,  accounting for 2.3% of total scientific production over the study period. One third (33%) focused on COVID-19 clinical management, with little adherence to identified research priorities.   Over sixty per cent of papers were opinion pieces not reporting original data. Papers were published on 1881 different journals but with half of scientific production included in 8% of journals. The US accounted for one fourth of total scientific production, followed by China (22.2%) and Italy (9%). CONCLUSIONS: Never before in the history of academic publishing such a great volume of research focused on a single topic, this being likely to introduce major changes in the way science is produced and communicated, at the risk of  bringing it far from its ultimate aim: informing clinical and public health practice and decision making.

Does the use of personal electronic health records increase vaccine uptake? A systematic review.

BACKGROUND: Although Personal Electronic Health Records (PEHR) have been identified as innovative tools enabling the provision of patient-centered care and prevention, evidence on the impact of their use is scant. With PEHRs being more and more marketed as easily implementable and cost-effective instruments to provide people with direct control on their health, the question on whether their use might be associated with the priority to improve vaccine coverage arises. METHODS: We conducted a systematic review following the PRISMA guidelines to retrieve, quantitatively pool and critically appraise the effectiveness of PEHR access on vaccine uptake. Analysis on PEHR effectiveness were carried out for the following comparison strata: i) PEHR access vs no intervention (standard care, no access to PEHR), ii) PEHR access only vs access to PEHR with additional features (e.g. health education materials, active reminders). RESULTS: Of 3114 identified citations, 8 studies were included, the majority published in the US and before 2015; 62% were randomized trials, the rest having an observational study design. Evidence suggests a moderate positive impact of PEHR access in increasing vaccine uptake, with data available for influenza and pneumococcal vaccines, diabetic patients and childhood immunization. Pooled data report the addition of digital communication features, i.e. the delivery of educational messages, reminders and availability of scheduling features might increase vaccine uptake, as compared to PEHR access alone. However, evidence is not conclusive. CONCLUSION: While immunization programs are struggling to achieve optimal coverage targets, it seems the potential of PEHRSs supporting informed adherence to vaccines recommendations is neither fully exploited nor explored. Which factors mediate the association between PEHRs access and vaccine uptake? Which PEHRs' design and functional components can maximize their impact? On which target populations? Which PEHR models works better for high-risk populations? Our findings can only partially answer those questions and further experimental research is needed.

The campaign "This Is Public Health" in Italy, set up by a team of Public Health Schools in Northern Italy.

Despite the great effort to raise awareness among health promotion, nowadays Public Health policies are not often recognized as important tools. For this reason, the Health in All Policies (HiAP) approach is instrumental in tackling this information gap. In 2018, the US Association of Schools and Programs of Public Health (ASPPH) launched an international campaign called "This is Public Health" (TIPH), whose aim was "to brand public health and raise awareness of how it affects individuals, communities and populations". The Association of Schools of Public Health in the European Region (ASPHER), in coordination with ASPPH, decided to create a European campaign to support and to reproduce the American one, by opening a challenge among the European Public Health Schools. The Schools and Programs of PH of Vita-Salute "San Raffaele" University, Milan, University of Parma, University of Pavia and Politecnico of Milan won this bid. In this "briefing on" we present a report on the Italian project for raising awareness of Public Health among general population and health care personell.

[The IRCCS San Raffaele Hospital organizational model to assess the clinical documentation completeness and the appropriateness of hospitalization: the SVAD experience and the results of the three-year period 2018-2020.] / Modello di organizzazione dei controlli interni di completezza della documentazione clinica e di appropriatezza dei ricoveri all'IRCCS Ospedale San Raffaele: il Servizio Valutazione Appropriatezza della Documentazione clinica (SVAD) e i risultati del triennio 2018-2020.

According to the progressive increase in the number of medical records checked by the Agenzia di Tutela della Salute (ATS) of the Metropolitan City of Milan, the San Raffaele Hospital established a Unit supporting healthcare personnel in clinical documentation management. Therefore, in 2003 the Servizio Valutazione Appropriatezza della Documentazione clinica (SVAD), consisting of a nursing staff highly qualified in checking the appropriateness of clinical pathways, completeness and correctness of the clinical documentation and appropriate coding in the hospital discharge cards, was set up in the Health Directorate. Since 2018, the Service has seen an increase in resources, a re-organization and integration with the Operating Units. The aim of the article is to describe the introduction of a new organizational model and the results obtained, with reference to the quality self-control carried out for the ATS. In order to conduct a descriptive analysis of the trend, the sample data, required by the ATS in the three-year period 2018-2020, stratified by outcome and consequent percentage of reduction on the reimbursement of hospitalization, were considered. We observe an overall percentage increase in medical records without any reduction from 2018 to 2020, going from 84% to 94% (+ 10%); at the same time, there is a constant trend of medical records with complete curtailment between 2018 and 2019, while there is a reduction between 2019 and 2020, going from 4% to 2% (-2%). The positive results demonstrate the essential role of SVAD and consolidate an alternative career for nursing staff.