This paper presents the Mechanical Ventilator Milano (MVM), a novel intensive therapy mechanical ventilator designed for rapid, large-scale, low-cost production for the COVID-19 pandemic. Free of moving mechanical parts and requiring only a source of compressed oxygen and medical air to operate, the MVM is designed to support the long-term invasive ventilation often required for COVID-19 patients and operates in pressure-regulated ventilation modes, which minimize the risk of furthering lung trauma. The MVM was extensively tested against ISO standards in the laboratory using a breathing simulator, with good agreement between input and measured breathing parameters and performing correctly in response to fault conditions and stability tests. The MVM has obtained Emergency Use Authorization by U.S. Food and Drug Administration (FDA) for use in healthcare settings during the COVID-19 pandemic and Health Canada Medical Device Authorization for Importation or Sale, under Interim Order for Use in Relation to COVID-19. Following these certifications, mass production is ongoing and distribution is under way in several countries. The MVM was designed, tested, prepared for certification, and mass produced in the space of a few months by a unique collaboration of respiratory healthcare professionals and experimental physicists, working with industrial partners, and is an excellent ventilator candidate for this pandemic anywhere in the world.

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Background COVID19 has been related to elevated CVB and biventricular dysfunction during hospitalization. However, it is unknown whether patients with biomarker elevation exhibit long-lasting abnormalities in cardiac function. Purpose To determine, using advanced echocardiography, the prevalence and type of cardiovascular sequelae after COVID19 infection with marked elevation of cardiovascular biomarkers (CVB), and their prognostic implications. Methods All patients admitted from March 1st to May 25th, 2020 to a tertiary referral hospital were included. Patients with cardiovascular disease antecedent, death during admission, or the first 30 days after discharge were excluded. Patients with hs-TnI >45 ng/L, NT-proBNP >300 pg/ml, and D-dimer >8000 ng/ml were separated based on each CVB elevation and matched with COVID controls (three biomarkers within the normal range) based on intensive care requirements and age. Results From a total of 2025 hospitalized COVID19 patients, 80 patients with significantly elevated CVB and 29 controls were finally included. No differences in baseline characteristics were observed among groups, but elevated CVB patients were sicker. Follow-up echocardiograms showed no differences among groups regarding LVEF or RV diameters, but TAPSE was lower if hs-TnI or D-dimer were elevated. Hs-TnI patients also had lower global myocardial work and global longitudinal strain. The presence of an abnormal echocardiogram was more frequent in the elevated CVB group compared to controls (23.8 vs 10.3%, P=0.123) but mainly associated with mild abnormalities in deformation parameters. Management did not change in any case and no major cardiovascular events except deep vein thrombosis occurred after a median follow-up of 7 months (Figure 1). Conclusions Minimal abnormalities in cardiac structure and function are observed in COVID19 survivors without previous cardiovascular diseases who presented a significant CVB rise at admission, with no impact on patient management or short-term prognosis. These results do not support a routine screening program after discharge in this population. FUNDunding Acknowledgement Type of funding sources: None. Figure 1

Background Left ventricle (LV) dysfunction after chronic right ventricle (RV) pacing, also known as pacemaker induced cardiomyopathy (PICM) is a relatively common finding, ranging from 15–20% of patients. It has been associated to a high burden RV pacing, age, male gender and intrinsic and paced QRS duration. However, clinical relevance of LV dysfunction in this population has not been studied. Purpose The aim of the study was to identify predictors of heart failure (HF) hospitalization and cardiovascular (CV) mortality in patients with RV pacing. Methods Retrospective and unicentric study. We studied 2418 patients undergoing single or dual-chamber pacemaker implantation between 2012–2018. Patients were included if they had an echocardiogram prior to implantation and a repeated echocardiogram >3 months after implantation. Baseline LV ejection fraction (LVEF) had to be >50%. PICM was defined as ≥10% decrease in LVEF, resulting in LVEF <50%. Alternative causes of LV dysfunction were excluded. Primary endpoint was heart failure hospitalization. Secondary endpoint was cardiovascular mortality. Competing-risk regression analysis was performed to identify predictors of HFH and CV mortality. Results Of 2418 patients, 495 meeting study criteria and 105 (21.2%) met PICM criteria. Follow-up period was 56.1±28.5months. There were no differences in basal LVEF (60.1±0.5% in non-PICM patients vs 59.5±0.5 in PICM patients, p=0.51). Mean LVEF at follow-up was 37.7±0.9 vs 56.7±0.3, p<0.001. After logistic multivariable analysis, factors associated with PICM were alcohol consumption (OR 3.0, 95% CI 1.1–8.0,p=0.032), right bundle branch block (RBBB) (OR 1.9, 95% CI 1.06–3.51,p=0.031), higher RV pacing burden (OR 1.0, 95% CI 1.0–1.1,p=0.008) and higher basal LV end-diastolic diameter (OR 1.1, 95% CI 1.0–1.1,p=0.016). HFH occurred in 144 patients (29.1%). Factors associated with HFH after multivariable analysis were any decrease in LVEF (LVEF>55% as reference: LVEF 46–55% (HR 2.1, 95% CI 1.3–3.3,p=0.002); LVEF 36–45% (HR=1.5, 95% CI 0.7–3.0; p=0.306), LVEF≤35% (HR 2.44, 95% CI 1.11–5.37,p=0.027), age (HR 1.0, 95% CI 1.0–1.1,p=0.037), alcohol consumption (HR 3.4, 95% CI 1.9–6.1,p<0.001), presence of atrial fibrillation (HR 1.7, 95% CI 1.06–2.70,p=0.027) and paced QRS duration (HR 1.0, 95% CI 1.0–1.02,p=0.031). CV mortality occurred in 54 patients (10.9%). Factors associated with CV mortality after multivariable analysis were a decrease in LVEF (LVEF 46–55% (HR 1.6, 95% CI 0.8–3.2,p=0.217); LVEF 36–45% (HR=1.6, 95% CI 0.6–4.2,p=0.33); LVEF≤35% (HR 4.6, 95% CI 2.0–10.7,p<0.001), RBBB (HR 2.1, 95% CI 1.1–3.9,p=0.026) and lower haemoglobin (HR 0.8, 95% CI 0.7–0.99,p=0.033). Conclusion In patients with RV pacing, factors associated with PICM were alcohol consumption, RBBB, RV pacing burden and basal LV end-diastolic diameter. HF hospitalization and CV mortality are common (29.1% and 10.9%). Any decrease in LVEF is associated with an increase in CV events. Funding Acknowledgement Type of funding sources: None.