Surveillance of adverse events following immunisation in Australia annual report, 2021.

Abstract: Annual seasonal influenza epidemics cause substantial disease and economic burden worldwide. During the coronavirus disease 2019 (COVID-19) pandemic in 2020 and 2021, influenza activity significantly declined. However, influenza resurged in Australia following the relaxation of non-pharmaceutical interventions, with increased influenza virus circulation in early 2022 coinciding with the SARS-CoV-2 Omicron BA.2 variant wave. Together with other respiratory virus diseases, these disease impacts on the Australian population and healthcare system have re-emphasised the importance of influenza vaccination and control. We aim to provide an overview of the current seasonal influenza vaccination program in Australia and summarise evidence and considerations underpinning potential future immunisation strategies. Influenza causes disproportionately higher morbidity and mortality in young children and older adults. Other populations at elevated risk from influenza include Aboriginal and Torres Strait Islander peoples, pregnant women, and people with certain underlying medical conditions. All Australians aged ≥ 6 months are recommended to receive influenza vaccine every year. The National Immunisation Program (NIP) provides free vaccine for eligible at-risk populations. While approximately 70% of older adults had received influenza vaccine in 2022, coverage in other age groups remains suboptimal. There are several key unmet needs and challenges, but also potential strategies for enhancing the influenza vaccination program in Australia. Improved monitoring and evaluation, including the use of relevant linked datasets for such purposes, is imperative to better understand variations in coverage and vaccination impact in specific populations. Adoption of evidence-based strategies, such as culturally appropriate resources that consider the characteristics of diverse Australian populations, may also help to achieve higher vaccine coverage rates. Additionally, greater vaccine uptake across the population could be facilitated by expanding the NIP-eligible population where cost-effective, and adopting the use of more effective and different types of vaccines when available.

German Registry for Cardiac Operations and Interventions in Congenital Heart Disease: Annual Report 2022.

BACKGROUND: The German Registry for Cardiac Operations and Interventions in Patients with Congenital Heart Disease is a voluntary registry initiated by the German Society for Thoracic and Cardiovascular Surgery and the German Society for Pediatric Cardiology and Congenital Heart Defects. Since 2012, the registry collects data for the assessment of treatment and outcomes of surgical and interventional procedures in patients with congenital heart disease (CHD) of all age groups. METHODS: This real-world, prospective all-comers registry collects clinical and procedural characteristics, adverse events (AEs), mortality, and medium-term outcomes (up to 90 days) of patients undergoing surgical and interventional. A unique pseudonymous personal identifier (PID) allows longitudinal data acquisition in case of further invasive treatment in any participating German heart center. Prior to evaluation, all data sets are monitored for data completeness and integrity. Evaluation includes risk stratification of interventional and surgical procedures and classification of AEs. Each year's data are summarized in annual reports containing detailed information on the entire cohort, all subgroups, and 15 index procedures. In addition, each participating center receives an institutional benchmark report for comparison with the national results. This paper presents a comprehensive summary of the annual report 2021. RESULTS: In 2021, a total of 5,439 patients were included by 22 participating centers. In total, 3,721 surgical, 3,413 interventional, and 34 hybrid procedures were performed during 6,122 hospital stays. 2,220 cases (36.3%) could be allocated to the 15 index procedures. The mean unadjusted in-hospital mortality ranged from 0.4% among interventional and 2% among surgical cases up to 6.2 % in cases with multiple procedures. In-hospital mortality among index procedures accounted for 2.3% in total cavopulmonary connection, 20.3% in Norwood procedures, and 0.4% following interventional closure of patent ductus arteriosus. For the remaining seven surgical and five interventional index procedures, no in-hospital deaths were recorded. The 10-year longitudinal evaluation of 1,795 patients after tetralogy of Fallot repair revealed repeat interventional or surgical procedures in 21% of the patients. Over the same period, 31.1% of 2,037 patients, following initial treatment of native coarctation, required at least one additional hospital admission, 39.4% after initial interventional, and 21.3% after initial surgical therapy. CONCLUSION: The annual report 2021 of the German Registry for Cardiac Operations and Interventions in CHD shows continuously good results in accordance with previous data of the registry. Compared to international registries on CHD, it can be ascertained that in Germany invasive treatment of CHD is offered on a high medical level with excellent quality. The proven fact that patients with various malformations like tetralogy of Fallot and coarctation of the aorta require repeat procedures during follow-up confirms the urgent requirement for longitudinal assessment of all patients presenting with complex lesions.

Australian Rotavirus Surveillance Program Annual Report, 2022.

Abstract: This report from the Australian Rotavirus Surveillance Program describes the circulating rotavirus genotypes identified in children and adults during the period 1 January to 31 December 2022. After two years of a lower number of stool samples received as a result of the coronavirus disease 2019 (COVID-19) pandemic, this reporting period saw the highest number of samples received since the 2017 surveillance period, with samples received from all states and territories. During this period, 1,379 faecal specimens had been referred for rotavirus G- and P- genotype analysis, of which 1,276 were confirmed as rotavirus positive. In total, 1,119/1,276 were identified as wildtype rotavirus, 155/1,276 identified as the Rotarix vaccine strain and 2/1,276 that could not be confirmed as vaccine or wildtype due to sequencing failure. Whilst G12P[8] was the dominant genotype nationally among wildtype samples (28.2%; 315/1,119), multiple genotypes were identified at similar frequencies including G9P[4] (22.3%; 249/1,119) and G2P[4] (20.3%; 227/1,119). Geographical differences in genotype distribution were observed, largely driven by outbreaks reported in some jurisdictions. Outbreaks and increased reports of rotavirus disease were reported in the Northern Territory, Queensland, and New South Wales. A small number of unusual genotypes, potentially zoonotic in nature, were identified, including: G8P[14]; G10[14]; caninelike G3P[3]; G6P[9]; and G11P[25]. Ongoing rotavirus surveillance is crucial to identify changes in genotypic patterns and to provide diagnostic laboratories with quality assurance by reporting incidences of wildtype, vaccine-like, or false positive rotavirus results.

Twelfth Interagency Registry for Mechanically Assisted Circulatory Support Report: Readmissions After Left Ventricular Assist Device.

The twelfth annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 26 688 continuous-flow left ventricular assist device (LVAD) patients over the past decade (2011-2020). In 2020, we observed the largest drop in yearly LVAD implant volumes since the registry's inception, which reflects the effects of the COVID-19 pandemic on cardiac surgical volumes in the United States. The 2018 heart transplant allocation policy change in the United States continues to affect LVAD implantation volumes and device strategy, with 78.1% of patients now receiving LVAD implants as destination therapy. Despite an older and sicker patient cohort, survival in the recent era (2016-2020) at 1 and 2 years continues to improve at 82.8% and 74.1%. Patient adverse event profile has also improved in the recent era, with significant reductions in stroke, gastrointestinal bleeding, infection, and device malfunction/pump thrombosis. Finally, we review the burden of readmissions after LVAD implant and highlight an opportunity to improve patient outcomes by reducing this frequent and vexing problem.

Annual Report for 2018 by the Japanese Association for Coronary Artery Surgery (JACAS).

PURPOSE: The principal of this analysis was to understand global feature of the number and type of grafts and number of diseased vessels of those undergoing coronary artery bypass grafting (CABG) and their short-term clinical results. METHODS AND RESULTS: This report presents annual report on the collective data of CABG in the year 2018 (1 January-31 December). Data were collected based on the series of questionnaire which has been performed by The Japanese Association for Coronary Artery Surgery (JACAS), capturing the corresponding data from the Japan Adult Cardiovascular Surgery Database (JCVSD). We also analyzed descriptive clinical results of those undergoing surgeries for acute myocardial infarction and ischemic mitral regurgitation. CONCLUSION: This is the first article summarizing the results from annually performed questionnaires by JACAS based on JCVSD, on the trend of CABG procedures and clinical results in Japan as a scientific manuscript.

A EPS e a humanização no enfrentamento à covid-19 "produzindo redes e territórios vivos": Planejamento, Monitoramento e Avaliação ­ PMA / EPS and humanization in the fight against covid-19 "producing networks and living territories": Planning, Monitoring and Evaluation - PMA

A organização do Coletivo da Educação Profissional em Saúde - EPS/Humanização no contexto da pandemia. Trata dos caminhos e pistas metodológicas para a estruturação do Planejamento, Monitoramento e Avaliação. Apresenta as memórias e instrumentos como dispositivo de PMA.

The organization of the Collective of Professional Education in Health - EPS / Humanization in the context of the pandemic. It deals with the methodological paths and clues for structuring Planning, Monitoring and Evaluation. It presents memories and instruments as a PMA device.

The 2020 annual report of DataDerm: The database of the American Academy of Dermatology.

The American Academy of Dermatology launched DataDerm in 2016 as the clinical data registry platform of the American Academy of Dermatology. DataDerm is approved by the Centers for Medicare & Medicaid Services as a Qualified Clinical Data Registry for the Merit-Based Incentive Payment System. The ultimate purpose of DataDerm is to provide dermatologists with a registry and database that will serve as a vehicle to advance the specialty in the domains of science, discovery, education, quality assessment, quality improvement, advocacy, and practice management. DataDerm is currently the largest clinical registry and database of patients receiving dermatologic care in the world. As of December 31, 2019, DataDerm contained data from 10,618,879 unique patients and 32,309,389 unique patient visits. Depending on the reporting period, 800 to 900 practices (representing 2400-2600 clinicians) actively participate in DataDerm by submitting data. This article provides the first of a planned series of annual updates of the status of DataDerm. The purpose of this article is to present the rationale for the creation, maintenance, history, and current status of DataDerm, as well as the future plans for DataDerm.

Cardiology on the cutting edge: updates from the European Society of Cardiology (ESC) Congress 2020.

The 2020 annual Congress of the European Society of Cardiology (ESC) was the first ever to be held virtually. Under the spotlight of 'the cutting edge of cardiology', exciting and ground-breaking cardiovascular (CV) science was presented both in basic and clinical research. This commentary summarizes essential updates from ESC 2020-The Digital Experience. Despite the challenges that coronavirus disease 2019 (COVID-19) has posed on the conduct of clinical trials, the ESC Congress launched the results of major studies bringing innovation to the field of general cardiology, cardiac surgery, heart failure, interventional cardiology, and atrial fibrillation. In addition to three new ESC guidelines updates, the first ESC Guidelines on Sports Cardiology and Exercise in Patients with Cardiovascular Disease were presented. As former ESC president, Professor Casadei undoubtedly pointed out the ESC Congress 2020 was a great success. During the ESC 2020 Congress, BMC Cardiovascular Disorders updated to seven journal sections including Arrhythmias and Electrophysiology, CV Surgery, Coronary Artery Disease, Epidemiology and Digital health, Hypertension and Vascular biology, Primary prevention and CV Risk, and Structural Diseases, Heart Failure, and Congenital Disorders. To conclude, an important take-home message for all CV health care professionals engaged in the COVID-19 pandemic is that we must foresee and be prepared to tackle the dramatic, long-term CV complications of COVID-19 patients.

Multiplexed Plasma Immune Mediator Signatures Can Differentiate Sepsis From NonInfective SIRS: American Surgical Association 2020 Annual Meeting Paper.

OBJECTIVES: Sepsis and sterile both release "danger signals' that induce the systemic inflammatory response syndrome (SIRS). So differentiating infection from SIRS can be challenging. Precision diagnostic assays could limit unnecessary antibiotic use, improving outcomes. METHODS: After surveying human leukocyte cytokine production responses to sterile damage-associated molecular patterns (DAMPs), bacterial pathogen-associated molecular patterns, and bacteria we created a multiplex assay for 31 cytokines. We then studied plasma from patients with bacteremia, septic shock, "severe sepsis," or trauma (ISS ≥15 with circulating DAMPs) as well as controls. Infections were adjudicated based on post-hospitalization review. Plasma was studied in infection and injury using univariate and multivariate means to determine how such multiplex assays could best distinguish infective from noninfective SIRS. RESULTS: Infected patients had high plasma interleukin (IL)-6, IL-1α, and triggering receptor expressed on myeloid cells-1 (TREM-1) compared to controls [false discovery rates (FDR) <0.01, <0.01, <0.0001]. Conversely, injury suppressed many mediators including MDC (FDR <0.0001), TREM-1 (FDR <0.001), IP-10 (FDR <0.01), MCP-3 (FDR <0.05), FLT3L (FDR <0.05), Tweak, (FDR <0.05), GRO-α (FDR <0.05), and ENA-78 (FDR <0.05). In univariate studies, analyte overlap between clinical groups prevented clinical relevance. Multivariate models discriminated injury and infection much better, with the 2-group random-forest model classifying 11/11 injury and 28/29 infection patients correctly in out-of-bag validation. CONCLUSIONS: Circulating cytokines in traumatic SIRS differ markedly from those in health or sepsis. Variability limits the accuracy of single-mediator assays but machine learning based on multiplexed plasma assays revealed distinct patterns in sepsis- and injury-related SIRS. Defining biomarker release patterns that distinguish specific SIRS populations might allow decreased antibiotic use in those clinical situations. Large prospective studies are needed to validate and operationalize this approach.

Patient safety reports analysis: post COVID-19.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham discusses the recently published Cumberlege report on medicines and medical devices safety.

Reports to the Membership.

The following are edited/abbreviated versions of the annual reports of the APA Secretary, Treasurer, CEO and Medical Director, Speaker, and Speaker-Elect and the chairpersons of the APA Committee on Bylaws, Membership Committee, Committee of Tellers, and Elections Committee. The full reports were presented at the APA Virtual Spring Highlights Meeting, April 25-26, 2020.

Australian National Enterovirus Reference Laboratory annual report, 2015.

Australia conducts surveillance for cases of acute flaccid paralysis (AFP) in children less than 15 years as recommended by the World Health Organization (WHO) as the main method to monitor its polio-free status. Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System and faecal specimens are referred for virological investigation to the National Enterovirus Reference Laboratory. In 2015, no cases of poliomyelitis were reported from clinical surveillance and Australia reported 1.2 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive surveillance system. Two non-polio enteroviruses, enterovirus A71 and coxsackievirus B3, were identified from clinical specimens collected from AFP cases. Australia complements the clinical surveillance program with enterovirus and environmental surveillance for poliovirus. Two Sabin-like polioviruses were isolated from sewage collected in Melbourne in 2015, which would have been imported from a country that uses the oral polio vaccine. The global eradication of wild poliovirus type 2 was certified in 2015 and Sabin poliovirus type 2 will be withdrawn from oral polio vaccine in April 2016. Laboratory containment of all remaining wild and vaccine strains of poliovirus type 2 will occur in 2016 and the National Enterovirus Reference Laboratory was designated as a polio essential facility. Globally, in 2015, 74 cases of polio were reported, only in the two remaining countries endemic for wild poliovirus: Afghanistan and Pakistan. This is the lowest number reported since the global polio eradication program was initiated.

Australian National Enterovirus Reference Laboratory annual report, 2016.

Australia monitors its polio-free status by conducting surveillance for cases of acute flaccid paralysis (AFP) in children less than 15 years of age, as recommended by the World Health Organization (WHO). Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System and faecal specimens are referred for virological investigation to the National Enterovirus Reference Laboratory. In 2016, no cases of poliomyelitis were reported from clinical surveillance and Australia reported 1.38 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive surveillance system. Several non-polio enteroviruses, coxsackievirus A6, enterovirus A71, enterovirus A74 and enterovirus D68, were identified from clinical specimens collected from AFP cases. The global withdrawal of Sabin poliovirus type 2 from oral polio vaccine occurred in April 2016. This event represents the start of the polio endgame with an increased focus on the laboratory containment of all remaining wild and vaccine strains of poliovirus type 2. The National Enterovirus Reference Laboratory was designated as a polio essential facility as part of this process. In 2016, 37 cases of wild polio were reported with three countries remaining endemic: Afghanistan, Nigeria and Pakistan. Nigeria was declared polio-free in 2015, after 12 months without detection of wild poliovirus, but was reinstated as an endemic country after the reporting of four cases in August 2016. This is a salient reminder of the need to maintain sensitive surveillance for poliovirus until global eradication is certified.

Australian National Enterovirus Reference Laboratory annual report, 2017.

Australia monitors its polio-free status by conducting surveillance for cases of acute flaccid paralysis (AFP) in children less than 15 years of age, as recommended by the World Health Organization (WHO). Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System and faecal specimens are referred for virological investigation to the National Enterovirus Reference Laboratory. In 2017, no cases of poliomyelitis were reported from clinical surveillance and Australia reported 1.33 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive surveillance system. Three non-polio enteroviruses, coxsackievirus B1, echovirus 11 and enterovirus A71, were identified from clinical specimens collected from AFP cases. Australia established enterovirus and environmental surveillance systems to complement the clinical system focussed on children and an ambiguous vaccine-derived poliovirus type 2 was isolated from sewage in Melbourne. In 2017, 22 cases of wild polio were reported with three countries remaining endemic: Afghanistan, Nigeria and Pakistan.

Australian National Enterovirus Reference Laboratory annual report, 2018.

Australia monitors its polio-free status by conducting surveillance for cases of AFP in children less than 15 years of age, as recommended by the WHO. Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System and faecal specimens are referred for virological investigation to the National Enterovirus Reference Laboratory. In 2018, no cases of poliomyelitis were reported from clinical surveillance and Australia reported 1.24 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive surveillance system. Several non-polio enteroviruses, coxsackievirus A4, coxsackievirus B1, echovirus 9, echovirus 30, enterovirus D68 and enterovirus A71, were identified from clinical specimens collected from AFP cases. Australia also performs enterovirus and environmental surveillance to complement the clinical system focussed on children. In 2018, 33 cases of wild polio were reported with three countries remaining endemic: Afghanistan, Nigeria and Pakistan.

Patient safety reports and crisis events round up.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent patient reports and crisis events.