Safety of Transcatheter Aortic Valve Replacement in Patients with Aortic Aneurysm: A Propensity-Matched Analysis

Introduction There is a paucity of data regarding the outcomes of transcatheter aortic valve replacement (TAVR) among patients with thoracic or abdominal aortic aneurysms (AA). Using the Nationwide Inpatient Sample (NIS) database, we explored the safety of TAVR among patients with a diagnosis of AA. Methods We queried the National Inpatient Sample database (2012–2017) for hospitalized patients undergoing TAVR, using ICD-9 and ICD-10 codes for endovascular TAVR. Reports show that \u3e 95% of endovascular TAVR in the US is via transfemoral access, so our population are mostly patients undergoing transfemoral TAVR. Using propensity score matching, we compared the trends and outcomes of TAVR procedures among patients with versus without AA. Results From a total sample of 29,517 individuals who had TAVR procedures between January 2012 and December 2017, 910 had a diagnosis of AA. In 774 matched-pair analysis, all-cause in-hospital mortality was similar in patients with and without AA OR 0.63 [(95% CI 0.28–1.43), p = 0.20]. The median length of stay was higher in patients with AA: 4 days (IQR 2.0–7.0) versus 3 days (IQR 2.0–6.0) p = 0.01. Risk of AKI [OR 1.01 (0.73–1.39), p = 0.87], heart block requiring pacemaker placement [OR 1.17 (0.81–1.69), p = 0.40], aortic dissection [OR 2.38 (0.41–13.75), p = 0.25], acute limb ischemia [OR 0.46 (0.18–1.16), p = 0.09], vascular complications [OR 0.80 (0.34–1.89), p = 0.53], post-op bleeding [OR 1.12 (0.81–1.57), p = 0.42], blood transfusion [OR 1.20 (0.84–1.70), p = 0.26], and stroke [OR 0.58 (0.24–1.39), p = 0.25] were similar in those with and without AA. Conclusions Data from a large nationwide database demonstrated that patients with AA undergoing TAVR are associated with similar in-hospital outcomes compared with patients without AA. Key Summary Points Patients with a diagnosis aortic aneurysm (thoracic or abdominal) undergoing transcatheter aortic valve replacement (TAVR) have same risk of periprocedural complications as those without a diagnosis of aortic aneurysms (AA). Patients with a diagnosis of aortic aneurysm had a longer length of hospital stay. Further studies are needed to determine how specific features of aortic aneurysm such as size, shape, thrombus burden, or calcifications affect the safety of TAVR

Evaluation of different packaging types for adoption in safe handling and transportation of fresh tomato fruits in Nigeria

ABSTRACTThis work evaluated plastic, wooden and carton crates and compared the best of them to traditional basket for possible adoption in safe handling and transportation of fresh tomato fruits in Nigeria. This was achieved through laboratory experiments and analysis involving static tests, simulating storage conditions (at average temperature and humidity of 28.920C and 62.08% respectively) and dynamic tests, simulating handling and transportation conditions involving dropping from different heights and vibration at different amplitudes and frequency. Based on experimental results and economic considerations, carton crate was adjudged the best and a new modified design of it was developed. The performance of the designed crate and the traditional basket presently in use in Nigeria was compared. Results of comparative predictive analysis between the carton and the traditional basket revealed that losses that can be incurred using traditional basket while on transit is about 6.25-7.08%; which can be reduced to an average of 5.71% when carton crates are used. In case of accident, the traditional method can incur an average loss of 51.59%, which can be reduced to an average of 37.88% when carton crates are used. In case of delay in travel (2-3weeks), the traditional method may lose an average of 23.81-88.10%, but this can be reduced to 14-67% when carton crates are used

Impact of primary kidney disease on the effects of empagliflozin in patients with chronic kidney disease: secondary analyses of the EMPA-KIDNEY trial

Background: The EMPA KIDNEY trial showed that empagliflozin reduced the risk of the primary composite outcome of kidney disease progression or cardiovascular death in patients with chronic kidney disease mainly through slowing progression. We aimed to assess how effects of empagliflozin might differ by primary kidney disease across its broad population. Methods: EMPA-KIDNEY, a randomised, controlled, phase 3 trial, was conducted at 241 centres in eight countries (Canada, China, Germany, Italy, Japan, Malaysia, the UK, and the USA). Patients were eligible if their estimated glomerular filtration rate (eGFR) was 20 to less than 45 mL/min per 1·73 m2, or 45 to less than 90 mL/min per 1·73 m2 with a urinary albumin-to-creatinine ratio (uACR) of 200 mg/g or higher at screening. They were randomly assigned (1:1) to 10 mg oral empagliflozin once daily or matching placebo. Effects on kidney disease progression (defined as a sustained ≥40% eGFR decline from randomisation, end-stage kidney disease, a sustained eGFR below 10 mL/min per 1·73 m2, or death from kidney failure) were assessed using prespecified Cox models, and eGFR slope analyses used shared parameter models. Subgroup comparisons were performed by including relevant interaction terms in models. EMPA-KIDNEY is registered with ClinicalTrials.gov, NCT03594110. Findings: Between May 15, 2019, and April 16, 2021, 6609 participants were randomly assigned and followed up for a median of 2·0 years (IQR 1·5–2·4). Prespecified subgroupings by primary kidney disease included 2057 (31·1%) participants with diabetic kidney disease, 1669 (25·3%) with glomerular disease, 1445 (21·9%) with hypertensive or renovascular disease, and 1438 (21·8%) with other or unknown causes. Kidney disease progression occurred in 384 (11·6%) of 3304 patients in the empagliflozin group and 504 (15·2%) of 3305 patients in the placebo group (hazard ratio 0·71 [95% CI 0·62–0·81]), with no evidence that the relative effect size varied significantly by primary kidney disease (pheterogeneity=0·62). The between-group difference in chronic eGFR slopes (ie, from 2 months to final follow-up) was 1·37 mL/min per 1·73 m2 per year (95% CI 1·16–1·59), representing a 50% (42–58) reduction in the rate of chronic eGFR decline. This relative effect of empagliflozin on chronic eGFR slope was similar in analyses by different primary kidney diseases, including in explorations by type of glomerular disease and diabetes (p values for heterogeneity all >0·1). Interpretation: In a broad range of patients with chronic kidney disease at risk of progression, including a wide range of non-diabetic causes of chronic kidney disease, empagliflozin reduced risk of kidney disease progression. Relative effect sizes were broadly similar irrespective of the cause of primary kidney disease, suggesting that SGLT2 inhibitors should be part of a standard of care to minimise risk of kidney failure in chronic kidney disease. Funding: Boehringer Ingelheim, Eli Lilly, and UK Medical Research Council

The evolving SARS-CoV-2 epidemic in Africa: Insights from rapidly expanding genomic surveillance

INTRODUCTION Investment in Africa over the past year with regard to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) sequencing has led to a massive increase in the number of sequences, which, to date, exceeds 100,000 sequences generated to track the pandemic on the continent. These sequences have profoundly affected how public health officials in Africa have navigated the COVID-19 pandemic. RATIONALE We demonstrate how the first 100,000 SARS-CoV-2 sequences from Africa have helped monitor the epidemic on the continent, how genomic surveillance expanded over the course of the pandemic, and how we adapted our sequencing methods to deal with an evolving virus. Finally, we also examine how viral lineages have spread across the continent in a phylogeographic framework to gain insights into the underlying temporal and spatial transmission dynamics for several variants of concern (VOCs). RESULTS Our results indicate that the number of countries in Africa that can sequence the virus within their own borders is growing and that this is coupled with a shorter turnaround time from the time of sampling to sequence submission. Ongoing evolution necessitated the continual updating of primer sets, and, as a result, eight primer sets were designed in tandem with viral evolution and used to ensure effective sequencing of the virus. The pandemic unfolded through multiple waves of infection that were each driven by distinct genetic lineages, with B.1-like ancestral strains associated with the first pandemic wave of infections in 2020. Successive waves on the continent were fueled by different VOCs, with Alpha and Beta cocirculating in distinct spatial patterns during the second wave and Delta and Omicron affecting the whole continent during the third and fourth waves, respectively. Phylogeographic reconstruction points toward distinct differences in viral importation and exportation patterns associated with the Alpha, Beta, Delta, and Omicron variants and subvariants, when considering both Africa versus the rest of the world and viral dissemination within the continent. Our epidemiological and phylogenetic inferences therefore underscore the heterogeneous nature of the pandemic on the continent and highlight key insights and challenges, for instance, recognizing the limitations of low testing proportions. We also highlight the early warning capacity that genomic surveillance in Africa has had for the rest of the world with the detection of new lineages and variants, the most recent being the characterization of various Omicron subvariants. CONCLUSION Sustained investment for diagnostics and genomic surveillance in Africa is needed as the virus continues to evolve. This is important not only to help combat SARS-CoV-2 on the continent but also because it can be used as a platform to help address the many emerging and reemerging infectious disease threats in Africa. In particular, capacity building for local sequencing within countries or within the continent should be prioritized because this is generally associated with shorter turnaround times, providing the most benefit to local public health authorities tasked with pandemic response and mitigation and allowing for the fastest reaction to localized outbreaks. These investments are crucial for pandemic preparedness and response and will serve the health of the continent well into the 21st century

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

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

Biodegradability and kinetic studies on biomethane production from okra (Abelmoschus esculentus) waste

Emerging from the energy crisis of 2008 in South Africa, climate change concerns and the global desire to reduce high ozone-depleting emissions, renewable energy sources like biogas are gaining wide acceptance in most localities for heating and electricity. The paucity of feedstock varieties is a major challenge plaguing the sustainability of this sector. Biomethane potential, biodegradability and degradation kinetics of organic substrates are essential for assessing the suitability of feedstocks for methane generation and the overall performance of the anaerobic digestion process in biogas plants. Waste from the vegetable okra (Abelmoschus esculentus) is a novel substrate; its biodegradability and degradation dynamics in biomethane production are largely unstudied, and were therefore the aims of this research. The substrate was digested for 25 days at the mesophilic condition and the biomethane potential data were recorded. Measured data of methane yield and the elemental composition of the substrate were used to fit five models (modified Gompertz, Stannard, transference function, logistic and first-order models) to predict degradation parameters and determine biodegradability of the substrate, respectively. Low lag phase (0.143 d), positive kinetic constant (0.2994/d) and the model fitness indicator (&lt;10) showed that transference and first-order kinetic models predicted the methane yield better than did other growth functions. The experimental methane yield was 270.98 mL/gVS, theoretical methane yields were 444.48 mL/gVS and 342.06 mL/gVS and model simulation ranged from 267.5 mL/gVS to 270.89 mL/gVS. With a prediction difference of 0.03–1.28%, all growth functions acceptably predicted the kinetics of A. esculentus waste. The findings of this study offer information on this novel substrate important for its use in large-scale biogas production. Significance: Growing interest in biogas technology as an alternative energy source for both South African rural dwellers and industries, has mounted enormous pressure on known feedstocks, and instigated the search for novel substrates. Our study shows that okra waste is a viable feedstock for biogas production. The suitability of the first-order kinetic model over other models in predicting okra waste degradation was highlighted