In the Emergency Department (ED), the decision to hospitalize or discharge COVID-19 patients is challenging. We assessed the utility of lung ultrasound (LUS), alone or in association with a clinical ...rule/score. This was a multicenter observational prospective study involving six EDs (NCT046291831). From October 2020 to January 2021, COVID-19 outpatients discharged from the ED based on clinical judgment were subjected to LUS and followed-up at 30 days. The primary clinical outcome was a composite of hospitalization or death. Within 393 COVID-19 patients, 35 (8.9%) reached the primary outcome. For outcome prognostication, LUS had a C-index of 0.76 (95%CI 0.68−0.84) and showed good performance and calibration. LUS-based classification provided significant differences in Kaplan−Meier curves, with a positive LUS leading to a hazard ratio of 4.33 (95%CI 1.95−9.61) for the primary outcome. The sensitivity and specificity of LUS for primary outcome occurrence were 74.3% (95%CI 59.8−88.8) and 74% (95%CI 69.5−78.6), respectively. The integration of LUS with a clinical score further increased sensitivity. In patients with a negative LUS, the primary outcome occurred in nine (3.3%) patients (p < 0.001 vs. unselected). The efficiency for rule-out was 69.7%. In unvaccinated ED patients with COVID-19, LUS improves prognostic stratification over clinical judgment alone and may support standardized disposition decisions.
Accurate diagnostic testing to identify severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is critical. Although highly specific, SARS-CoV-2 reverse transcriptase–polymerase chain ...reaction (RT-PCR) has been shown in clinical practice to be affected by a noninsignificant proportion of false-negative results. This study seeks to explore whether the integration of lung ultrasonography with clinical evaluation is associated with increased sensitivity for the diagnosis of coronavirus disease 2019 pneumonia, and therefore may facilitate the identification of false-negative SARS-CoV-2 RT-PCR results.
This prospective cohort study enrolled consecutive adult patients with symptoms potentially related to SARS-CoV-2 infection who were admitted to the emergency department (ED) of an Italian academic hospital. Immediately after the initial assessment, a lung ultrasonographic evaluation was performed and the likelihood of SARS-CoV-2 infection, based on both clinical and lung ultrasonographic findings (“integrated” assessment), was recorded. RT-PCR SARS-CoV-2 detection was subsequently performed.
We enrolled 228 patients; 107 (46.9%) had SARS-CoV-2 infection. Sensitivity and negative predictive value of the clinical–lung ultrasonographic integrated assessment were higher than first RT-PCR result (94.4% 95% confidence interval {CI} 88.2% to 97.9% versus 80.4% 95% CI 71.6% to 87.4% and 95% 95% CI 89.5% to 98.2% versus 85.2% 95% CI 78.3% to 90.6%, respectively). Among the 142 patients who initially had negative RT-PCR results, 21 tested positive at a subsequent molecular test performed within 72 hours. All these false-negative cases were correctly identified by the integrated assessment.
This study suggests that, in patients presenting to the ED with symptoms commonly associated with SARS-CoV-2 infection, the integration of lung ultrasonography with clinical evaluation has high sensitivity and specificity for coronavirus disease 2019 pneumonia and it may help to identify false-negative results occurring with RT-PCR.
ABSTRACT
Objectives
Physicians’ gestalt is central in the diagnostic pipeline of suspected COVID‐19, due to the absence of a single tool allowing conclusive rule in or rule out. The aim of this study ...was to estimate the diagnostic test characteristics of physician's gestalt for COVID‐19 in the emergency department (ED), based on clinical findings or on a combination of clinical findings and bedside imaging results.
Methods
From April 1 to April 30, 2020, patients with suspected COVID‐19 were prospectively enrolled in two EDs. Physicians prospectively dichotomized patients in COVID‐19 likely or unlikely twice: after medical evaluation of clinical features (clinical gestalt CG) and after evaluation of clinical features and results of lung ultrasound or chest x‐ray (clinical and bedside imaging–integrated gestalt CBIIG). The final diagnosis was adjudicated after independent review of 30‐day follow‐up data.
Results
Among 838 ED enrolled patients, 193 (23%) were finally diagnosed with COVID‐19. The area under the curve (AUC), sensitivity, and specificity of CG and CBIIG for COVID‐19 were 80.8% and 91.6% (p < 0.01), 82.9% and 91.4% (p = 0.01), and 78.6% and 91.8% (p < 0.01), respectively. CBIIG had similar AUC and sensitivity to reverse transcription–polymerase chain reaction (RT‐PCR) for SARS‐CoV‐2 on the first nasopharyngeal swab per se (93.5%, p = 0.24; and 87%, p = 0.17, respectively). CBIIG plus RT‐PCR had a sensitivity of 98.4% for COVID‐19 (p < 0.01 vs. RT‐PCR alone) compared to 95.9% for CG plus RT‐PCR (p = 0.05).
Conclusions
In suspected COVID‐19, CG and CBIIG have fair diagnostic accuracy, in line with physicians’ gestalt for other acute conditions. Negative RT‐PCR plus low probability based on CBIIG can rule out COVID‐19 with a relatively low number of false‐negative cases.
For COVID-19 patients evaluated in the Emergency Department (ED), decision on hospital admission vs. home discharge is challenging. The 4C mortality score (4CMS) is a prognostication tool integrating ...key demographic/clinical/biochemical data validated for COVID-19 inpatients. We sought to derive and validate a dichotomic rule based on 4CMS identifying patients with mild outcomes, suitable for safe ED discharge.
Derivation was performed in a prospective cohort of ED patients with suspected COVID-19 from two centers (April 2020). Validation was pursued in a prospective multicenter cohort of ED patients with confirmed COVID-19 from 6 centers (October 2020 to January 2021). Chest X-ray (CXR) images were independently scored. The primary composite outcome was all-cause 30-day mortality or hospital admission. Secondary outcomes were ED re-visit, oxygen therapy and ventilation.
In a derivation cohort of 838 ED patients with suspected COVID-19, 4CMS≤8 was associated with low outpatient mortality (0.4%) and was thus selected as a feasible discharge rule. In a validation cohort of 521 COVID-19 outpatients, the mean age was 51±17 years; 97 (18.6%) patients had ≥1 CXR infiltrate. The 4CMS had an AUC of 0.82 for the primary outcome and 0.93 for mortality, outperforming other scores (CURB-65, qCSI, qSOFA, NEWS) and CXR. In 474 (91%) patients with 4CMS≤8, the mortality rate was 0.2% and the hospital admission rate was 6.8%, versus 12.8% and 36.2% for 4CMS≥9 (P<0.001). CXR did not provide additional discrimination.
COVID-19 outpatients with 4CMS≤8 have mild outcomes and can be safely discharged from the ED. NCT0462918.
Abstract Background In the last years, new techniques, drugs and devices have been introduced in the current practice of primary angioplasty (PPCI) and validated by pivotal studies The objective of ...our study was to evaluate if these studies have led to significant changes on the current practice of primary PCI in our center. Methods From March 2003 to December 2013 1980 patients with ST-segment elevation myocardial infarction underwent PPCI within 12-hours of onset of symptoms. We considered 2 periods of our activity: from 2003 to 2009 (P1) with 1078 patients and from 2010 to 2013 (P2) with 902 patients, and compared them in terms of pharmacological and arterial access strategies and of devices utilization. Results In P2 there was a significant increase of radial access (34.1% vs. 1.5, p < 0.001), as well as of the use of bivalirudin (22.7% vs. 0.5%, p < 0.001) and of new antiplatelet drugs (prasugrel or ticagrelor) (18.3% vs. 0%, p < 0.001) whereas the use of GP IIb–IIIa and of intraaortic balloon pump significantly decreased (from 82.3% to 52%, p < 0.001 and from 17% to 7.5%, p < 0.001 respectively). In the P2 there was a significant increase of the procedural efficacy (97.2% vs. 95.1%, p = 0.01) that persisted after the logistic regression adjustment (OR 2.09, CI 95%, 1.04–4.21). Conclusions Our study shows that in the last years, in a high-PCI center, after the publication of pivotal randomized trial and nationwide registries, there were significant changes in the PPCI current practice that could have had an impact on procedural efficacy.
The MGuard (MG) is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which has the purpose of ensuring reduced distal embolization of thrombotic material, thus ...lowering the risk of no-reflow/slow-flow phenomena. Only few data are available that evaluated the usefulness of the MG stent in patients with ST-elevation myocardial infarction (STEMI) with a high thrombotic burden.
We prospectively collected data of patients presenting with STEMI and high thrombotic burden (thrombus burden grade 4 or 5 according to the TIMI score) who underwent primary percutaneous coronary intervention (PCI) with MG stent implantation in our center. Lesions involving a bifurcation or very calcified and tortuous vessels were not included. Final TIMI 3 flow, normal myocardial blush grade (MBG), and complete ST-segment resolution were defined as short-term endpoints, whereas major adverse cardiovascular events were evaluated during follow-up.
From August 2008 to June 2013, the MG stent was implanted in 104 (9.3%) of 1108 patients who underwent primary PCI. Cardiogenic shock on admission was present in 4 patients (3.8%). Final TIMI 3 flow was achieved in 97.1% of patients, MBG 3 in 56.7%, and regression of ST-segment elevation ≥70% within 90 min was recorded in 64.4% of patients. In-hospital mortality was 2.9% (n=3), and at a mean follow-up of 455±430 days overall major adverse cardiovascular events were 11 (10.6%). Cardiac death occurred in 5 patients (4.9%) and stent thrombosis in 2 (1.9%).
In selected patients with STEMI undergoing primary PCI, the use of the mesh-covered MG stent in vessels with high thrombotic burden despite thrombus aspiration was effective and safe both immediately and at mid-term follow-up.
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