Effects on Right Ventricular Function One Year after COVID-19-Related Pulmonary Embolism.

The aim of this study was to investigate the presence of subclinical cardiac dysfunction in recovered coronavirus disease 2019 (COVID-19) patients, who were stratified according to a previous diagnosis of pulmonary embolism (PE) as a complication of COVID-19 pneumonia. Out of 68 patients with SARS-CoV-2 pneumonia followed up for one year, 44 patients (mean age 58.4 ± 13.3, 70% males) without known cardiopulmonary disease were divided in two groups (PE+ and PE-, each comprising 22 patients) and underwent clinical and transthoracic echocardiographic examination, including right-ventricle global longitudinal strain (RV-GLS), and RV free wall longitudinal strain (RV-FWLS). While no significant differences were found in the left- or right-heart chambers' dimensions between the two study groups, the PE+ patients showed a significant reduction in RV-GLS (-16.4 ± 2.9 vs. -21.6 ± 4.3%, p < 0.001) and RV-FWLS (-18.9 ± 4 vs. -24.6 ± 5.12%, p < 0.001) values compared to the PE- patients. According to the ROC-curve analysis, RV-FWLS < 21% was the best cut-off with which to predict PE diagnosis in patients after SARS-CoV-2 pneumonia (sensitivity 74%, specificity 89%, area under the curve = 0.819, p < 0.001). According to the multivariate logistic regression model, RV-FWLS < 21% was independently associated with PE (HR 34.96, 95% CI:3.24-377.09, p = 0.003) and obesity (HR 10.34, 95% CI:1.05-101.68, p = 0.045). In conclusion, in recovered COVID-19 patients with a history of PE+, there is a persistence of subclinical RV dysfunction one year after the acute phase of the disease, detectable by a significant impairment in RV-GLS and RV-FWLS. A reduction in RV-FWLS of lower than 21% is independently associated with COVID-related PE.

Oral Immunization with Escherichia coli Nissle 1917 Expressing SARS-CoV-2 Spike Protein Induces Mucosal and Systemic Antibody Responses in Mice.

As of October 2022, the COVID-19 pandemic continues to pose a major public health conundrum, with increased rates of symptomatic infections in vaccinated individuals. An ideal vaccine candidate for the prevention of outbreaks should be rapidly scalable, easy to administer, and able to elicit a potent mucosal immunity. Towards this aim, we proposed an engineered Escherichia coli (E. coli) Nissle 1917 (EcN) strain with SARS-CoV-2 spike protein (SP)-coding plasmid, which was able to expose SP on its cellular surface by a hybridization with the adhesin involved in diffuse adherence 1 (AIDA1). In this study, we presented the effectiveness of a 16-week intragastrically administered, engineered EcN in producing specific systemic and mucosal immunoglobulins against SARS-CoV-2 SP in mice. We observed a time-dependent increase in anti-SARS-CoV-2 SP IgG antibodies in the sera at week 4, with a titre that more than doubled by week 12 and a stable circulating titre by week 16 (+309% and +325% vs. control; both p < 0.001). A parallel rise in mucosal IgA antibody titre in stools, measured via intestinal and bronchoalveolar lavage fluids of the treated mice, reached a plateau by week 12 and until the end of the immunization protocol (+300, +47, and +150%, at week 16; all p < 0.001 vs. controls). If confirmed in animal models of infection, our data indicated that the engineered EcN may be a potential candidate as an oral vaccine against COVID-19. It is safe, inexpensive, and, most importantly, able to stimulate the production of both systemic and mucosal anti-SARS-CoV-2 spike-protein antibodies.

[GISE (Italian Society of Interventional Cardiology) Position paper: Short-term hospitalization for percutaneous coronary intervention; a helpful tool to manage post-COVID-19 backlogs]. / Position paper GISE (Società Italiana di Cardiologia Interventistica): Ricovero breve per la PCI in elezione, uno strumento per la "ripartenza".

Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs. Low-risk patients undergoing elective percutaneous coronary intervention (PCI) can be candidate for short-term hospitalization, with consequent reduction of waiting lists. Several single-center and multicenter observational studies, multiple randomized trials and some meta-analyses have addressed this topic.In this position paper, we present a proposal for short hospitalization for elective PCI procedures in selected patients who present complications only exceptionally and exclusively immediately after the procedure, if the inclusion and exclusion criteria are met. Each Center can choose between admission in day surgery or one day surgery, extending hospital length of stay only for patients who present complications or who are candidate for urgent surgery. Short-term hospitalization considerably reduces costs even if, with the current model, it generally results in a parallel reduction in reimbursement. Hence, we present an actual model, already tested successfully in an Italian hospital, that warrants sustainability. This approach can then be tailored to single Centers.

Impact of COVID-19 pandemic on timing and early clinical outcomes of transcatheter aortic valve implantation.

BACKGROUND: We sought to investigate the applicability and outcomes of a novel system to manage patients requiring transcatheter aortic valve implantation (TAVI) at a tertiary level hospital during the coronavirus disease-2019 (COVID-19) pandemic. METHODS: To analyse the impact of hospitalisation pathways during the pandemic on clinical outcomes of TAVI patients, the study population was divided into two groups (pre-pandemic and pandemic groups) and all perioperative/follow-up data were compared. The primary endpoint was all-cause mortality at 30 days; secondary endpoints included procedural success and short-term complications. RESULTS: A total of 315 patients received TAVI during the study period. Pandemic group (n = 77) showed a more complex baseline clinical profile (NYHA class III-IV, 70.1% vs. 56.3%; p = 0.03). The overall time to procedure was significantly longer during pandemic (56.9 ± 68.3 vs.37.7 ± 25.4; p = 0.004) while intensive care unit stay was shorter (2.2 ± 1.4 vs. 3.7 ± 3.9, p < 0.05). Hospitalisation length was similar in both groups as well as all-cause mortality rate and the incidence of major periprocedural complications. No case of infection by COVID-19 was reported among patients during the hospital stay. CONCLUSIONS: Comparative analysis of early clinical outcomes showed that COVID-19 pandemic did not affect the safety and effectiveness of TAVI as similar rates of procedural complications and all-cause mortality were reported than before February 2020. Despite the increased time lag between diagnosis and procedure and a more complex clinical profile of patients at baseline, the revised pathway of hospitalisation allowed to resume inpatient procedures while not affecting patients' and healthcare workers' safety.

AI-Based Chest CT Analysis for Rapid COVID-19 Diagnosis and Prognosis: A Practical Tool to Flag High-Risk Patients and Lower Healthcare Costs.

Early diagnosis of COVID-19 is required to provide the best treatment to our patients, to prevent the epidemic from spreading in the community, and to reduce costs associated with the aggravation of the disease. We developed a decision tree model to evaluate the impact of using an artificial intelligence-based chest computed tomography (CT) analysis software (icolung, icometrix) to analyze CT scans for the detection and prognosis of COVID-19 cases. The model compared routine practice where patients receiving a chest CT scan were not screened for COVID-19, with a scenario where icolung was introduced to enable COVID-19 diagnosis. The primary outcome was to evaluate the impact of icolung on the transmission of COVID-19 infection, and the secondary outcome was the in-hospital length of stay. Using EUR 20000 as a willingness-to-pay threshold, icolung is cost-effective in reducing the risk of transmission, with a low prevalence of COVID-19 infections. Concerning the hospitalization cost, icolung is cost-effective at a higher value of COVID-19 prevalence and risk of hospitalization. This model provides a framework for the evaluation of AI-based tools for the early detection of COVID-19 cases. It allows for making decisions regarding their implementation in routine practice, considering both costs and effects.

Municipal Pathways in Response to COVID-19: A Strategic Management Perspective on Local Public Administration Resilience.

This paper aims to understand the different resilience pathways local governments may take during moments of crisis, specifically focusing on the COVID-19 pandemic. Through survey responses from local administrations in Wallonia, Belgium, we consider how varied contexts led to different strategic resilience pathways. These pathways range from static (i.e., no strategy) to innovative change. Our findings highlight that digital technology solutions may play a role in supporting resilience across the different pathways. Therefore, we adapt strategic public management literature to suggest propositions for future research to test the specific role that digital technologies play in supporting resilience within local administrations.

Assessment of Non-Invasive Measurements of Oxygen Saturation and Heart Rate with an Apple Smartwatch: Comparison with a Standard Pulse Oximeter.

The most commonly used method to assess peripheral oxygen saturation (SpO2) in clinical practice is pulse oximetry. The smartwatch Apple Watch 6 was developed with a new sensor and an app that allows taking on-demand readings of blood oxygen and background readings, day and night. The present study aimed to assess the feasibility and agreement of the Apple Watch 6 compared with a standard SpO2 monitoring system to assess normal and pathological oxygen saturation. We recruited study participants with lung disease or cardiovascular disease and healthy subjects. A total of 265 subjects were screened for enrolment in this study. We observed a strong positive correlation between the smartwatch and the standard commercial device in the evaluation of SpO2 measurements (r = 0.89, p < 0.0001) and HR measurements (r = 0.98, p < 0.0001). A very good concordance was found between SpO2 (bias, -0.2289; SD, 1.66; lower limit, -3.49; and upper limit, 3.04) and HR (bias, -0.1052; SD, 2.93; lower limit, -5.84; and upper limit, 5.63) measured by the smartwatch in comparison with the standard commercial device using Bland-Altman analysis. We observed similar agreements and concordance even in the different subgroups. In conclusion, our study demonstrates that the wearable device used in the present study could be used to assess SpO2 in patients with cardiovascular or lung diseases and in healthy subjects.

Prehospital ECG in patients with acute myocardial infarction during the COVID-19 pandemic

Aims Primary percutaneous coronary intervention (PCI) represents the preferred revascularization strategy among patients with acute ST-segment elevation myocardial infarction (STEMI). A decline in the rates of primary PCI has been observed globally during the outbreak of coronavirus disease-19 (COVID-19). Fear of exposure to in-hospital infection has been hypothesized as the main mechanism of this phenomenon, also contributing to a delayed presentation of patients with STEMI. However, a formal assessment of initial electrocardiograms (ECGs) among STEMI patients during the COVID-19 pandemic is still lacking. We therefore compared pre-hospital ECGs of STEMI patients hospitalized in Italy after the first reported case of COVID-19 on 21 February 2020 with data from the same period in 2019 to identifying potential changes between the two periods. Methods and results Prehospital ECGs were obtained from the STEMI care network in the Campania region. Deidentified ECGs were analysed by two expert reviewers who were blinded to date of recording. Pathological Q-waves were defined as a Q-wave with a duration ≥40 ms and/or depth ≥25% of the R-wave in the same lead or the presence of a Q-wave equivalent. These criteria have been shown to be associated with final infarct size at cardiac magnetic resonance. For all conventional STEMI, the timing of STEMI onset was estimated with the Anderson-Wilkins (AW) acuteness score, ranging from 1 (least acute) to 4 (most acute). From 21 February 2020 to 16 April 2020, a total of 3239 pre-hospital ECGs were recorded by the emergency medical system and 167 (5.15%) were classified as STEMI. During the same period in 2019, 3505 pre-hospital ECGs were recorded, and 196 (5.59%) were classified as STEMI. There was no difference between the two study periods in terms of age, gender, type, and location of STEMI (Table 1). Pathological Q-waves were present in 54.5% of ECGs recorded during the COVID-19 period compared with 22.1% of ECGs recorded in the same period in 2019 (risk difference 32.3, 95% confidence intervals [CI]: 21.2–43.5 percentage points). There was also an increase in the mean number of Q-waves during the COVID-19 compared with the control period (1.4 vs. 0.9;P < 0.001). These findings remained similar when QS- and qR complexes were analysed separately. Consistently, the AW score was significantly lower during the COVID-19 period (2.4 vs. 2.8;P < 0.001). Conclusions Prehospital ECGs of STEMI patients during the COVID-19 pandemic presented more frequently with signs of late ischemia compared with the equivalent period in 2019. Approximately, one out of two patients had already pathological Q-waves in the initial ECG. The AW acuteness score is superior to patient history (historical timing) in predicting myocardial salvage and mortality after reperfusion in STEMI patients, thus explaining the higher mortality rate and the increased risk of infarct-related complications observed during the COVID-19 pandemic.

Not everything is as it seems: Digital technology affordance, pandemic control, and the mediating role of sociomaterial arrangements.

An overly favorable narrative has developed around the role played by digital technologies in containing Covid-19, which oversimplifies the complexity of technology adoption. This narrative takes sociomaterial arrangements for granted and conceptualizes technology affordance - the problem-solving capability of a technology - as a standard built-in feature that automatically activates during technology deployment, leading to undiversified and predetermined collective benefits. This paper demonstrates that not everything is as it seems; implementing a technology is a necessary but insufficient condition for triggering its potential problem-solving capability. The potential affordance and effects of a technology are mediated by the sociomaterial arrangements that users assemble to connect their goals to the materiality of technological artifacts and socio-organizational context in which technology deployment takes place. To substantiate this argument and illustrate the mediating role of sociomaterial arrangements, we build on sociomateriality and technology affordance theory, and we present the results of a systematic review of Covid-19 literature in which 2187 documents are examined. The review combines text data mining, co-occurrence pattern recognition, and inductive coding, and it focuses on four digital technologies that public authorities have deployed as virus containment measures: infrared temperature-sensing devices; ICT-based surveillance and contact-tracing systems; bioinformatic tools and applications for laboratory testing; and electronic mass communications media. Reporting on our findings, we add nuances to the academic debate on sociomateriality, technology affordance, and the governance of technology in public health crises. In addition, we provide public authorities with practical recommendations on how to strengthen their approach to digital technology deployment for pandemic control.

[Impact of COVID-19 pandemic on structural heart interventions in Italy]. / Impatto della pandemia da COVID-19 sulla cardiologia interventistica strutturale in Italia.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has led to deferral of many non-urgent procedures in most healthcare systems worldwide. With this study we aimed to quantify the impact of COVID-19 on interventional treatment of structural heart disease (SHD) in Italy. METHODS: Numbers of transfemoral transcatheter aortic valve replacement (TAVR), percutaneous mitral valve repair (PMVR), left atrial appendage occlusion (LAAO), patent foramen ovale (PFO) closures performed over a 4-week period during the national lockdown in Italian centers performing over 60 structural heart interventions (SHI)/year were compared with the same 4-week period in 2019. Incidence rate reductions (IRR) were estimated by zero-inflated negative binomial regression. RESULTS: According to our nationwide analysis, SHIs were reduced by 79% as compared to the same period in 2019 (IRR 0.21, 95% confidence interval [CI] 0.15-0.29). This reduction was more substantial for PFO closure (IRR 0.03, 95% CI 0.01-0.07), LAAO (IRR 0.11, 95% CI 0.05-0.25) and PMVR (IRR 0.12, 95% CI 0.04-0.36) as compared to TAVR (IRR 0.31, 95% CI 0.22-0.47). CONCLUSIONS: The COVID-19 pandemic caused a 79% drop in SHI volumes in Italy. PFO closure, LAAO and PMVR decreased more significantly as compared to TAVR. Further studies are needed to evaluate the impact of this reduction on outcomes of patients with SHD.

A cross-sectional study evaluating hospitalization rates for chronic limb-threatening ischemia during the COVID-19 outbreak in Campania, Italy.

The expansion of coronavirus disease 2019 (COVID-19) prompted measures of disease containment by the Italian government with a national lockdown on March 9, 2020. The purpose of this study is to evaluate the rate of hospitalization and mode of in-hospital treatment of patients with chronic limb-threatening ischemia (CLTI) before and during lockdown in the Campania region of Italy. The study population includes all patients with CLTI hospitalized in Campania over a 10-week period: 5 weeks before and 5 weeks during lockdown (n = 453). Patients were treated medically and/or underwent urgent revascularization and/or major amputation of the lower extremities. Mean age was 69.2 ± 10.6 years and 27.6% of the patients were women. During hospitalization, 21.9% of patients were treated medically, 78.1% underwent revascularization, and 17.4% required amputations. In the weeks during the lockdown, a reduced rate of hospitalization for CLTI was observed compared with the weeks before lockdown (25 vs 74/100,000 inhabitants/year; incidence rate ratio: 0.34, 95% CI 0.32-0.37). This effect persisted to the end of the study period. An increased amputation rate in the weeks during lockdown was observed (29.3% vs 13.4%; p < 0.001). This study reports a reduced rate of CLTI-related hospitalization and an increased in-hospital amputation rate during lockdown in Campania. Ensuring appropriate treatment for patients with CLTI should be prioritized, even during disease containment measures due to the COVID-19 pandemic or other similar conditions.

Coronary artery disease in patients hospitalised with Coronavirus disease 2019 (COVID-19) infection.

OBJECTIVE: Among patients with Coronavirus disease 2019 (COVID-19), coronary artery disease (CAD) has been identified as a high-risk condition. We aimed to assess the clinical outcomes and mortality among patients with COVID-19 according to CAD status. METHODS: We retrospectively analysed data from patients with COVID-19 admitted to the Cremona Hospital (Lombardy region, Italy) between February and March 2020. The primary outcome was all-cause mortality. CAD was defined as a history of prior myocardial infarction (MI), prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG) or CAD that was being medically treated. RESULTS: Of 1252 consecutive patients with COVID-19, 124 (9.9%) had concomitant CAD. Patients with CAD were older and had a higher prevalence of comorbidities compared with those without CAD. Although patients with CAD had a higher risk of all-cause mortality than patients without CAD (HR 3.01, 95% CI 2.27 to 3.99), this difference was no longer significant in the adjusted model (HR 1.14, 95% CI 0.79 to 1.63). Results were consistent among patients with prior MI (adjusted HR (aHR) 0.87, 95% CI 0.54 to 1.41), prior PCI (aHR 1.10, 95% CI 0.75 to 1.62), prior CABG (aHR 0.91, 95% CI 0.45 to 1.82), or CAD medically treated (aHR 0.84, 95% CI 0.29 to 2.44). Multivariable analysis showed that age (aHR per 5 year increase 1.62, 95% CI 1.53 to 1.72) and female sex (aHR 0.63, 95% CI 0.49 to 0.82) were the only two independent correlates of mortality. CONCLUSION: Patients with COVID-19 and CAD have an exceedingly higher risk of mortality, which is mainly attributable to the burden of comorbidities rather than to a direct effect of CAD per se.

Italian Society of Interventional Cardiology (GISE) position paper for Cath lab-specific preparedness recommendations for healthcare providers in case of suspected, probable or confirmed cases of COVID-19.

COVID-19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID-19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019-nCoV infection accessing in cath-lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).

Catheterization laboratory activity before and during COVID-19 spread: A comparative analysis in Piedmont, Italy, by the Italian Society of Interventional Cardiology (GISE).

BACKGROUND: COronaVIrus Disease 19 (COVID-19) led to the reorganization of Cardiology Units in terms of working spaces and healthcare personnel. In this scenario, both outpatient visits and elective interventional cardiology procedures were suspended and/or postponed. We aimed to report the impact of COVID-19 on interventional coronary and structural procedures in Piedmont, Italy. METHODS: The number of coronary angiographies (CAG), percutaneous coronary interventions (PCI), primary PCI (pPCI), transcatheter aortic valve replacements (TAVR) and Mitraclip performed in Piedmont between March 1st and April 20th, 2020 (CoV-time) were collected from each catheterization laboratory and compared to the number of procedures performed the year before in the same months (NoCoV-time). RESULTS: Procedural data from 18 catheterization laboratories were collected. Both coronary (5498 versus 2888: difference: -47.5%; mean 305.4 VS 160.4; p = 0.002) and structural (84 versus 17: difference: -79.8%; mean 4.7 Vs 0.9; p < 0.001) procedures decreased during CoV-time compared to NoCoV-time. In particular, coronary angiographies (1782 versus 3460), PCI (1074 versus 1983), p PCI (271 versus 410), TAVR (11 versus 72) and Mitraclip (6 versus 12) showed a reduction of 48.5%, 45.7%, 33.7%, 84.7% and 50.0%, respectively (all p for comparison <0.05). CONCLUSIONS: Compared to the same time-period in 2019, both coronary and structural interventional procedures during COVID-19 epidemic suffered a dramatic decrease in Piedmont, Italy. Organizational change and structured clinical pathways should be created, together with awareness campaigns.

Epidemiology, prognosis, and clinical manifestation of cardiovascular disease in COVID-19.

INTRODUCTION: At the end of 2019, a novel coronavirus was identified as the cause of a pneumonia cluster in Wuhan, China. Since then, the contagion has rapidly spread all over the world resulting in a global pandemic. Since frequent cardiovascular (CV) system involvement has soon been detected in patients occurring coronavirus disease 2019 (COVID-19), we would provide a simple review available to cardiologists who are going to be involved in the management of COVID-19 patients from several levels: from diagnosis to prevention and management of CV complications. AREAS COVERED: We investigate the role of CV diseases in COVID-19: from the incidence of CV comorbidities to their negative impact on prognosis. We also search Literature in order to identify the main CV manifestations in patients occurring virus infection and their management by cardiologists. EXPERT OPINION: Specific treatments for CV involvement associated with COVID-19 are still debated. Results from ongoing trials are needed to further clarify issues about the therapeutic approach, which is constantly changing according to the continuous flow of published evidence. Finally, it seems necessary to sensitize all population to raise awareness on CV diseases in the COVID era, to hinder the underestimation of both new-onset acute CV diseases and the consequences of chronic mistreated CV diseases.

Impact of diabetes mellitus on clinical outcomes in patients affected by Covid-19.

A possible association could exist between type 2 diabetes mellitus (T2DM) and Coronavirus-19 (Covid-19) infection. Indeed, patients with T2DM show high prevalence, severity of disease and mortality during Covid-19 infection. However, the rates of severe disease are significantly higher in patients with diabetes compared with non-diabetes (34.6% vs. 14.2%; p < 0.001). Similarly, T2DM patients have higher rates of need for Intensive Care Unit (ICU, 37.0% vs. 26.7%; p = 0.028). Thus, about the pneumonia of Covid-19, we might speculate that the complicated alveolar-capillary network of lungs could be targeted by T2DM micro-vascular damage. Therefore, T2DM patients frequently report respiratory symptoms and are at increased risk of several pulmonary diseases. In addition, pro-inflammatory pathways as that involving interleukin 6 (IL-6), could be a severity predictor of lung diseases. Therefore, it looks intuitive to speculate that this condition could explain the growing trend of cases, hospitalization and mortality for patients with T2DM during Covid-19 infection. To date, an ongoing experimental therapy with monoclonal antibody against the IL-6 receptor in Italy seems to have beneficial effects on severe lung disease and prognosis in patients with Covid-19 infection. Therefore, should patients with T2DM be treated with more attention to glycemic control and monoclonal antibody against the IL-6 receptor during the Covid-19 infection?