Abstract 13819: Case Report of a Mitral Stenosis in a Young Growing Teenager After Rheumatic Mitral Regurgitation Valve Repair

Circulation, Volume 146, Issue Suppl_1, Page A13819-A13819, November 8, 2022. Background:Mitral stenosis (MS) is a well- defined slowly progressive complication after mitral valve repair for non-rheumatic mitral regurgitation (MR) in adults. The pubertal growth spurt has potential hemodynamic implications for a mitral valve prosthesis matched prior to surgery for a projected indexed effective orifice area (EOA) using the lower pre-surgical body surface area (BSA) that preceded the growth spurt. The peak height velocity usually occurs at Tanner stage 3 in females and 4 in males. To our knowledge, there are no reports highlighting a rapid increase in Trans-Mitral pressure gradient (TMPG) and decline in mitral valve area (MVA) after rheumatic MR valve repair in an early pubescent child. Case presentation: A 14-year-old female presented with orthopnea, abdominal distension and bilateral lower limb edema. She was cachectic with a BMI (Body Mass Index) in the first percentile, a high-pitched holosystolic murmur most prominent at the cardiac apex, bilateral basal crackles, tender hepatomegaly, pitting pedal edema and jugular venous distension. Her Tanner’s stage was 2. Anti-streptolysin O (ASO) titer was elevated. The transthoracic echocardiography (TTE) revealed loss of the mitral valve central coaptation with leaflet restriction and MR. There was an annular dilatation of the Tricuspid valve and Tricuspid regurgitation (TR). She had AHA/ACC stage D mitral and tricuspid regurgitation. Tricuspid annuloplasty and mitral valve repair for rheumatic MR were respectively performed utilizing Carpentier Edward numbers 30 and 34, appropriate for her pre-surgical BSA. Following the surgery, the murmur of MR resolved and her MVA was 4cm2. In the first year after surgery, she attained Tanner’s stage 3, a peak growth velocity of 8.4 cm during that year and her BMI rapidly increased to the 10th percentile. However, towards the end of the year she developed progressive increase in TMPG and a decline in the mitral valve area to 1.2 cm2.Conclusion:Growth spurts during puberty can potentially affect MR repair as the Mitral valve prosthesis based on a preoperative BSA is outgrown. There is a need for research for planning, prognostication and development of an optimal, individualized and adaptable approach to MR intervention in early pubescence.

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Ottobre 2022

Abstract 13860: Heart Failure With Preserved Ejection Fraction Induced by Amyloid Light Chain Amyloidosis: A Case Report

Circulation, Volume 146, Issue Suppl_1, Page A13860-A13860, November 8, 2022. Introduction:Cardiac amyloidosis is a clinical disorder defined as an extracellular deposition of protein in the heart. Typically, signs and symptoms of heart failure develop in the advanced disease. High index of suspicion is required for the diagnosis of this disorder.Results:A 62 years old male came to the cardiology clinic due to lower extremity edema, fatigue, dyspnea on exertion. He had a 3 month history of progressive lower leg edema. On physical examination he had a positive S4; lung sounds were diminished and there was dullness to percussion over the lower two thirds; and bilateral lower extremity edema. Hospital admission was decided for management of decompensated heart failure. On admission, the surface ECG showed normal sinus rhythm with low QRS voltage in the limb leads, a RBBB and LPFB. Initial laboratory reported elevated NT-proBNP: 13,816 pg/mL. Chest x-ray demonstrated right interstitial infiltration and bilateral pleural effusion. The echocardiogram revealed severe concentric hypertrophy of the left ventricle, an apical sparing left ventricle longitudinal strain, and an ejection fraction of 68%. A cardiac MRI showed concentric biventricular hypertrophy associated with extensive diffuse late gadolinium enhancement, suggestive of cardiac amyloidosis. Screening resulted in a Perugini score of 1 on Tc-PYP scintigraphy, elevated Kappa and Lambda light chains on serum, and kidney biopsy positive for amyloidosis. Hematology-oncology consultation was done and a daratumumab-CyBorD protocol was started.Conclusions:This case elucidated a stepwise diagnostic approach of cardiac amyloidosis in a patient presenting with signs and symptoms of heart failure. Amyloid AL cardiac amyloidosis and its repercussions are severe because it not only compromises by being infiltrative but also by its toxic capacity. A high index of suspicion and a multidisciplinary approach is needed in order to improve quality of life and prolong survival.

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Ottobre 2022

Abstract 12354: Novel Coronavirus Disease 2019 Infection in a Cohort of Patients With Phenotypic Hypertrophic Cardiomyopathy: An Extended Report

Circulation, Volume 146, Issue Suppl_1, Page A12354-A12354, November 8, 2022. Background:Patients with preexisting heart disease suffer more severe outcomes after COVID-19. Hypertrophic cardiomyopathy (HCM) is a common inherited cardiac conditions. We previously reported incidence and outcomes of COVID-19 in HCM in early days of the pandemic. We report results from an expanded and extended HCM cohort.Methods:343 patients with HCM [age 59±17 years, 55% men, 19% NYHA class >1, 63% obstructive, 14% septal reduction therapy, 24% positive family history, 42% selectively genotyped (43% positive for pathogenic mutations), 22% implantable cardioverter-defibrillator (ICD) implants, 27% paroxysmal or permanent atrial fibrillation (AF), 4% AF ablation] were evaluated for COVID-19 from December 2019 to May 2022.Results.Overall, 54 (16%) patients were diagnosed with COVID-19 [56% men, age 55±17 years, 60% obstructive HCM, 5.5% dilated phase HCM, 28% positive family history, 15% genotype positive, 28% with ICD, 17% NYHA class >1, 31% AF]. There were 289 patients without COVID-19 [55% men, age 58±17 years, 63% obstructive HCM, 3% dilated phase HCM, 23% positive family history, 17% genotype positive, 21% with ICD, 19% NYHA class >1, 27% AF]. Patients with COVID-19 were slightly younger (55±17 vs 58±17 years, p 0.046) and more often had dilated phase HCM (5.5% vs 3%) and more often had ICD (28% vs 21%). Eleven (20%) patients with COVID-19 were hospitalized and 1 (2%) died of the disease. Compared to those with mild disease, hospitalized patients with COVID-19 were more often men (82% vs 49%, p 0.04), older (age 59±15 vs. 54±18 years), with obstructive phenotype (73% vs 56%) and with NYHA class >1 symptoms (27% vs 12%). In the studied patient cohort 70% had at least one dose of COVID-19 vaccine. Prior to the infection 63% of patients had no vaccination against SARS-CoV2. Among hospitalized patients 9 (82%) had no vaccination and 2 (18%) were vaccinated and had mild disease.Conclusions.Although Covid-19 infection rate (16%) in studied cohort was slightly lower than in general US population (~25%), hospitalization rate was higher (20% vs 9%) with similar death rates (1-2%). Older man with symptomatic obstructive HCM phenotype noted to have higher risk for hospitalization. Patients with vaccination against SARS-Cov2 tended to require less hospitalization.

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Ottobre 2022

Abstract 13631: Cardiovascular Risk Profile Among Reproductive Aged Women in the United States: The Behavioral Risk Factor Surveillance System (2015-2020)

Circulation, Volume 146, Issue Suppl_1, Page A13631-A13631, November 8, 2022. Introduction:Suboptimal cardiovascular health (CVH) is associated with adverse pregnancy outcomes and long-term CV risk. Studies examining contemporary trends in CV risk factors (RF) and suboptimal CVH among US women of reproductive age are limited.Methods:We used the 2015 – 2020 Behavioral Risk Factor Surveillance System, a nationally representative survey of US adults, to conduct this serial cross-sectional study. We restricted our sample to nonpregnant reproductive-aged women (18-44 years) without CVD (n=336,102). We calculated the prevalence of each CV RF (current smoking, hypertension, diabetes, hypercholesterolemia, physical inactivity, poor diet, and overweight/obesity) and suboptimal CVH (≥2 RF) for each year and examined trends between 2015 and 2020Results:Between 2015 and 2020, diabetes prevalence remained relatively stable (2.9% to 3.0%; p=0.09) while overweight/obesity prevalence increased (53.1% to 58.4%; p

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Ottobre 2022

Abstract 13836: Factors Associated With a Complicated Hospital Course in Patients With Spontaneous Coronary Artery Dissection: A Report of the iSCAD Registry

Circulation, Volume 146, Issue Suppl_1, Page A13836-A13836, November 8, 2022. Introduction:Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome in younger patients. Though associated with lower short and long-term mortality, there is still a need to identify the subset of patients who are at a higher risk of adverse events or a more complex hospital course.Methods:Using data from the iSCAD Registry, a multicenter registry of patients with SCAD, univariate and multivariable logistic regression models were created to assess the association between factors related to the index admission and a complicated hospital course. A complicated hospital course was defined as the occurrence of either a recurrent myocardial infarction (MI), cerebrovascular accident (CVA), a new arrhythmia, heart failure requiring diuretics, ≥ 2 angiograms performed, or a hospital admission of more than 5 days. The multivariable logistic regression model was developed using a backward selection approach with exit criteria set at p >0.2. Patients presenting with cardiac arrest were excluded.Results:Of the 414 patients included, 159 patients (38.4%) had a complicated hospital course: 76 patients had a prolonged admission, 27 had a recurrent MI, 1 had a CVA, 39 had an arrhythmia, 13 had heart failure requiring diuretics and 72 had ≥ 2 angiograms in the index admission. The final model showed that patients who had structural complications related to MI, fibromuscular dysplasia (FMD), or a history of cardiomyopathy were more likely to experience a complicated hospital course(Table).Finally, patients on anticoagulation were at a higher risk of having the composite outcome but this may be secondary to the indication for anticoagulation.Conclusions:The presence of structural complications related to MI, a diagnosis of FMD, or a history of cardiomyopathy were associated with an increased risk of a complicated hospital course related to SCAD. Identification of risk factors for a complex inpatient stay may help to tailor the acute care of SCAD patients.

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Ottobre 2022

Abstract 325: Evaluation Of The 2015 Cardiopulmonary Resuscitation Guidelines For Patients With Nonshockable Out-of-hospital Cardiac Arrest; Results From The All-japan Utstein Registry 2022

Circulation, Volume 146, Issue Suppl_1, Page A325-A325, November 8, 2022. Background:In nonshockable cardiac arrest (CA) patients, the 2020 cardiopulmonary resuscitation (CPR) guidelines have stressed that high-quality CPR improves survival from CA, as with the 2015 CPR guidelines. However, it is unknown whether the 2015 guidelines contributed to the favorable neurological outcomes in adult CA patients. The present study aimed to clarify the effects of the 2015 guidelines on adult CA patients using the data of the All-Japan Utstein Registry, a prospective, nationwide, population-based registry of out-of-hospital CA (OHCA).Methods:From the data of this registry, between 2011 and 2020, we included adult witnessed OHCA patients due to cardiac etiology who had non-shockable rhythm as an initial rhythm. We excluded patients who received prehospital care in 2011, 2015, 2016, and 2020 because it was difficult to distinguish prehospital care based on either 2010 CPR guidelines, 2015, or 2020. We also excluded patients who received bystander CPR by citizens because we cannot assess the quality of bystander CPR. Study patients were divided into two groups based on the different CPR guidelines; the era of the 2010 guidelines (2010G) and the era of the 2015 guidelines (2015G). The endpoint was the favorable neurological outcome at 30 days after OHCA. Potential confounding factors based on biological plausibility and previous studies were included in the multivariable logistic regression analysis. These variables included the age, sex (male, female), advanced airway or not, the administration of adrenaline or not, the administration of saline or not, and time interval from call EMS to the scene.Results:Of the 1,259,960 patients registered in the All-Japan Utstein Registry, the data of 54,219 patients were included in this analysis. The 2015G was significantly higher in the 30-day favorable neurological outcome than the 2010G (2010G vs. 2015G = 1.5% vs. 1.8%: p=0.008). In the multivariate analysis, the adjusted odds ratio for 30-day favorable neurological outcome in OHCA patients in the 2015G compared to in the 2010G was 1.37 (95%CI 1.19-1.58, p

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Ottobre 2022

Abstract 12458: Limb and Cardiovascular Events at 6 Months Among CLTI Patients Receiving Routine Care at BEST-CLI Sites: An Interim Report From the BEST-Registry

Circulation, Volume 146, Issue Suppl_1, Page A12458-A12458, November 8, 2022. Introduction:Chronic limb-threatening ischemia (CLTI) affects 1-2 million Americans yet remains understudied. Existing CLTI trials focus on endovascular procedures and surgeries, maintain strict inclusion criteria, and may not fully capture the breadth of the CLTI population. We aimed to build a robust understanding of current treatments, outcomes, quality of life, and healthcare utilization among a diverse cohort of CLTI patients from across the United States.Methods:Designed as a companion to the BEST-CLI randomized trial, the BEST-Registry will prospectively enroll >1,000 CLTI patients at 40 U.S. BEST-CLI sites and follow their clinical courses for 12 months. Though initially, only patients ineligible for BEST-CLI were to be enrolled, BEST-Registry enrollment did not begin until after BEST-CLI enrollment ended. Baseline data including demographics, medications, and available hemodynamic data are collected as well as wound care regimens, interventions, and quality of life (VASCUQOL-6, EQ-5D, and SF-12). The primary adjudicated endpoint is major adverse limb events (MALE) defined as above-ankle amputation or major revascularization. Secondary endpoints include mortality, hospitalizations, MALE-free survival, and quality of life.Results:We will present 6-month adjudicated outcomes of 534 participants. The median age is 70.0 years [IQR 62.0, 77.0] and 35% are female (Table). Documented rates of hypertension (89%), diabetes (67%) and hyperlipidemia (78%) are high at baseline. Only 46.6% of patients had hemoglobin A1c and 38.8% LDL-c lab values available within a year. However, control of these two lab values was relatively good (Table).Conclusions:Patients with CLTI enrolled in the BEST-Registry are diverse, have complex disease, many comorbidities, and receive a variety of treatments. Registry data at 6 and 12 months will provide important context for the BEST-CLI trial results and characterize contemporary management and outcomes in CLTI.

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Ottobre 2022

Abstract 14923: A Special Type Aortic Left Ventricular Tunnel With Bicuspid Aortic Valve: A Case Report

Circulation, Volume 146, Issue Suppl_1, Page A14923-A14923, November 8, 2022. Introduction:Aortic-left ventricular tunnel (ALVT) is an extremely rare congenital cardiac lesion that is an abnormal passage connecting the ascending aorta to the left ventricle. ALVT can be diagnosed by the use of real-time two-dimensional and continuous-wave Doppler echocardiography.Case presentation:A two-year and seven-month-old boy with recently diagnosed influenza presented to the hospital because of severe tachypnea and fatigue after running. Physical examination revealed a grade 3/6 systolic and diastolic murmur at the second and third left intercostal space. Transthoracic echocardiography (GE E95 with a 5-MHz scanning head) demonstrated that the aortic valve was a bicuspid aortic valve (BAV) with mild-moderate insufficiency during diastole, the peak systolic velocity (PSV) and gradient of aortic valve were 1.9m/s and 14mmHg, respectively; The aortic sinotubular junction (ASJ) was stenotic, the PSV and gradient of ASJ were 2.7m/s and 29mmHg, respectively; A tubular-like structure originated in the outlet septum beneath the right coronary cusp and terminated in the ascending aorta superior to the right coronary aortic sinus (Fig. A, B), CDFI and continuous-wave Doppler showed unobstructed to-and-fro (systolic and diastolic) flow in the tunnel with a high-velocity color signal that aliased during systole (Fig. C-E). Clinical considerations for congenital heart disease: ALVT combines BAV with aortic insufficiency and supravalvar aortic stenosis. The patient was referred for possible surgical correction.Discussion:In this patient, the type of ALVT does not belong to any one of Hovaguimian’s classifications. Two-dimensional echocardiography can display the tunnel-like structure of ALVT in real-time, and CDFI can identify that two-stage bidirectional shunted blood flow, systolic ventricular ejection occurs through both the tunnel and the semilunar valve, and the diastolic flow reverses from the aorta to ventricle via ALVT.

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Ottobre 2022

Abstract 11108: Implementation of High-Sensitivity Cardiac Troponin Assays in the United States: A Report From the NCDR Chest Pain – MI Registry

Circulation, Volume 146, Issue Suppl_1, Page A11108-A11108, November 8, 2022. Introduction:High-sensitivity cardiac troponin (hs-cTn) assays were first approved for use in the U.S. in 2017. They are the guideline preferred biomarker to evaluate patients with acute chest pain. Few data exist regarding implementation of hs-cTn assays in the U.S.Hypothesis:We hypothesize that use of hs-cTn assays has increased over time and that patients assessed with hs-cTn have a shorter length of stay (LOS) and similar use of cardiac testing.Methods:We examined trends in implementation of hs-cTn assays among participating hospitals in the NCDR Chest Pain MI Registry from 1/1/2019 through 9/30/2021. Excluding STEMI patients, associations between hs-cTn use, in-hospital diagnostic imaging, and patient outcomes were assessed using logistic or negative binomial regression models.Results:Among 550 participating hospitals with 251,000 patients in the registry, implementation of hs-cTn assays increased from 3.3% in Q1, 2019 to 32.6% in Q3, 2021 (Ptrend

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Ottobre 2022

Abstract 14370: Significant Heterogeneity in Antiplatelet Regimen for Spontaneous Coronary Artery Dissection: A Report of the ISCAD Registry

Circulation, Volume 146, Issue Suppl_1, Page A14370-A14370, November 8, 2022. Introduction:Dual antiplatelet therapy (DAPT) is standard for patients (pts.) with acute coronary syndrome due to atherosclerosis. Evidence to support DAPT vs single antiplatelet therapy (SAPT) for spontaneous coronary artery dissection (SCAD) is limited.Hypothesis:Prescription of DAPT vs SAPT varies among specialized centers for SCAD.Methods:Analysis of 505 pts. with complete patient questionnaire, case report form, and angiography review enrolled in the iSCAD Registry from 9 sites with >20 pts. enrolled. Data are presented for 442 pts. with complete medication data who received DAPT or SAPT during index hospitalization (HOSP) and continued at discharge (DC).Results:Patient age 49.6+10.2 years, 83% were female. Presentation of SCAD: NSTEMI (55.9%), STEMI (26.9%), unstable angina (13.8%), cardiac arrest (4.3%), cardiogenic shock (0.2%). Most common SCAD location was the LAD (60.9%); 20.8% had multivessel SCAD. Management was: medical therapy (75.2%), PCI (22.5%), CABG (1.4%), or PCI + CABG (0.92%). During HOSP 70.1% (317/452) were treated with DAPT vs 29.9% SAPT (135/452). At DC, 74.7% were prescribed DAPT (339/442) vs 25.3% SAPT (112/452). In multivariable analyses, only PCI as SCAD treatment was associated with DAPT during HOSP (OR 3.57, 95% CI 1.90-6.70) or DC (OR 4.9, 95% CI 2.28-10.53). There was significant heterogeneity of antiplatelet regimen across sites ranging from 34.0%-87% DAPT during HOSP (p

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Ottobre 2022

Abstract 15645: Posterior Mediastinal Hematoma as a Rare Complication of Anti-Coagulation Use – A Case Report and Literature Review

Circulation, Volume 146, Issue Suppl_1, Page A15645-A15645, November 8, 2022. Introduction:Posterior mediastinal hematoma (PMH) is a rare complication of anti-coagulation (AC) use. We present a complex case of a patient with a sub-massive pulmonary embolism (PE) whose care was complicated by PMH causing airway obstruction following thrombectomy.Case:A 60-year-old male with a history of prostate cancer in remission presented after a syncopal event. On admission, he was afebrile, mildly tachycardic (100bpm), normotensive (135/91), with no oxygen requirement. Laboratory data showed high sensitivity troponin 244 ng/L and BNP 82 pg/ml. CTPA revealed a saddle PE with right heart strain (PESI score 100). He was initiated on anticoagulation and underwent successful mechanical thrombectomy using a Penumbra aspiration catheter. He had acute respiratory failure later that evening, necessitating intubation. Repeat CTPA showed increased clot burden and new onset PMH (Figure 1). Of note, his AC was continued due to clot burden. A repeat thrombectomy was performed using the FlowTriever System Device (Inari Medical, Irvine, CA). Despite this intervention, he continued to struggle with extubation, and a new stridor was noted. Bronchoscopy revealed external compression of proximal trachea correlating with the PMH location. He was deemed too high risk for evacuation of the PMH. Therefore, he underwent tracheostomy to bypass the area of compression. This subsequently allowed for successful extubation.Discussion:While thrombectomy can cause iatrogenic bleeding, no bleeding was seen on the post-procedure angiogram in our patient. Thus, these findings are attributed to PMH. PMH has been reported 6 times in literature (table 1), one associated with PE. Management options include hematoma evacuation or holding AC and performing serial follow up imaging. Our patient did not undergo evacuation of hematoma, and a tracheostomy was used instead to bypass the obstruction. This highlights the need to individualize management of these complex patients.

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Ottobre 2022

Abstract 246: Defibrillation For Pulseless Ventricular Arrhythmias During Pediatric In-hospital Cardiac Arrest: A Report From The AHA Get With The Guidelines®-Resuscitation Registry

Circulation, Volume 146, Issue Suppl_1, Page A246-A246, November 8, 2022. Introduction:Approximately 15,200 children suffer an in-hospital cardiac arrest (IHCA) annually, and 10-20% will have ventricular fibrillation or pulseless ventricular tachycardia (VF/pVT). Timely defibrillation is critical for shockable rhythms, however current data are lacking on outcomes when > 1 shock is required for termination of VF/pVT.Methods:From the AHA Get With The Guidelines®-Resuscitation registry, we identified children < 18 years of age who had IHCA from initial VF/pVT and received > 1 shock from 2000-2020. Patients were analyzed according to total number of shocks received: 2 shocks, 3 shocks, or >4 shocks. Multivariable logistic regression models were used to test the association between number of shocks and return of spontaneous circulation (ROSC), survival to hospital discharge, and survival to hospital discharge with favorable neurologic outcome.Results:436 patients met inclusion criteria and received > 1 shock for VF/pVT. Median age was 8 years [IQR, 0.9,15.0]. Patients that required >4 shocks were older patients (11 years [1.0-15.0; p=0.013]). A higher percentage of patients receiving >4 shocks had renal insufficiency (14% vs. 7% for 2 shocks vs. 6% for 3 shocks, p = 0.041). Patients receiving >4 shocks vs. 2 shocks were less likely to achieve ROSC (OR 0.40 [0.23,0.68]; p=0.0009). There was no statistically significant difference in survival to hospital discharge for patients receiving 2 shocks (42%), 3 shocks (39%), or >4 shocks (32%) or survival to hospital discharge with favorable neurologic outcome.Conclusion:There was no significant association between the number of shocks and survival to hospital discharge or survival to hospital discharge with favorable neurologic outcome. ROSC was significantly less in patients with >4 shocks for VF/pVT compared to 2 shocks. Further research is needed to characterize energy dosing when > 1 shock is needed for VF/pVT.

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Ottobre 2022

Accuracy of a self-report prescription opioid use diary for patients discharge from the emergency department with acute pain: a multicentre prospective cohort study

Objectives
Self-reported approaches that assess opioid usage can be subject to social desirability and recall biases that may underestimate actual pill consumption. Our objective was to determine the accuracy of patient self-reported opioid consumption using a 14-day daily paper or electronic diary.

Design
Prospective cohort study.

Setting
Multicentre study conducted in four Québec (Canada) emergency departments (ED): three university-affiliated centres, two of them Level I trauma centres and one urban community hospital.

Participants
ED patients aged ≥18 years with acute pain (≤2 weeks) who were discharged with an opioid prescription. Patients completed a 14-day daily diary (paper or electronic) assessing the quantity of opioids consumed. On diary completion, a random sample from the main cohort was selected for a follow-up visit to the hospital or a virtual video visit where they had to show and count the remaining pills. Patients were blinded to the main objective of the follow-up visit.

Outcomes
Quantity of opioid pills consumed during the 2-week follow-up period self-reported in the 14-day diary (paper or electronic) and calculated from remaining pills counted during the follow-up visit. Intraclass correlation coefficient (ICC) and Bland-Altman plots were used to assess accuracy.

Results
A total of 166 participants completed the 14-day diary as well as the in-person or virtual visit; 49.4% were women and median age was 47 years (IQR=21). The self-reported consumed quantity of opioid in the 14-day diary and the one calculated from counting remaining opioid pills during the follow-up visit were very similar (ICC=0.992; 95% CI: 0.989 to 0.994). The mean difference between both measures from Bland-Altman analysis was almost zero (0.048 pills; 95% CI: –3.77 to 3.87).

Conclusion
Self-reported prescription opioid use in a 14-day diary is an accurate assessment of the quantity of opioids consumed in ED discharged patients.

Trial registration number
NCT03953534.

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Ottobre 2022