TABLE 4 Percentage Belonging to the Eight Neck/Shoulder and Stomach Clusters and the Percentage Reporting Long Symptom Duration

Background:Adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) are rare autoinflammatory disorders associated with an activated IL-1 pathway, characterized by spiking fever, rash, arthritis, lymphadenopathy, hepatosplenomegaly and serositis. There is a growing understanding that SJIA and AOSD are one disease with different ages of onset, i.e. Still’s disease. The anaSTILLs study (anakinra inStill´sdisease) was designed to further evaluate efficacy and safety of anakinra in patients with Still´s disease across all age groups.Objectives:The primary objective was to demonstrate efficacy of anakinra versus placebo as assessed by ACR30 response with absence of fever at Week 2. Secondary objectives included: early onset of efficacy, sustained efficacy, time to study drug discontinuation, safety, pharmacokinetics, clinical signs and biomarkers.Methods:‘anaSTILLs’ was a randomized, double-blind, placebo-controlled, 12-week study including patients with active and newly diagnosed (6 months) Still´s disease according to adapted ILAR criteria if <16, or Yamaguchi criteria, if ≥16 years of age at disease onset. Patients were randomized to anakinra 2 mg/kg (max 100 mg/day), 4 mg/kg (max 200 mg/day) or placebo.Results:12 patients were randomized and received study drug: 6 anakinra (2 mg/kg n=2, 4 mg/kg n=4) and 6 placebo, the study was terminated early due to slow recruitment. 1 patient on placebo had lymphoma, not Still’s disease, and was excluded; thus in total 11 patients were analyzed for efficacy, 8 were children [median (range) age=4.0 (1-11) years] and 3 were adults [median (range) age=32.0 (25-51) years]. 55% were male and the mean symptom duration was 74.2 days. All patients on anakinra but none on placebo achieved ACR30 response with absence of fever at Week 2 (p-value=0.0022). The efficacy of anakinra was further demonstrated by superiority to placebo in ACR50/70/90 responses with absence of fever at Week 2. All placebo patients discontinued the study within 6 weeks, 2 due to progressive disease, 2 due to lack of efficacy and 1 due to withdrawal by patient. There was a numerically higher proportion with early onset of efficacy (Week 1) in the anakinra group compared to placebo. The ACR30/50/70/90 responses in the anakinra group were sustained throughout the study period. Patients in the anakinra group had a prompt and persistent decrease in CRP and ferritin levels at Week 1, which was not observed in the placebo group. There were no unexpected safety findings. All anakinra patients developed anti-drug antibodies (ADAs) at some timepoint during the study. ADAs were persistent throughout the treatment period, except in one patient. Titers were low to moderate. One placebo patient had low ADA titers at one occasion. No neutralizing antibodies were observed and the ADAs did not appear to impact clinical efficacy or safety.Conclusion:Anakinra is superior to placebo in the treatment of Still’s disease. ADAs occur frequently but do not appear to adversely impact efficacy or safety. These results confirm the benefits of anakinra treatment in patients with active, newly diagnosed Still´s disease across ages.Disclosure of Interests:Laura Schanberg Grant/research support from: Sobi, BMS, Consultant of: Aurinia, UCB, Sanofi, Peter Nigrovic Grant/research support from: Novartis, BMS, Pfizer, Consultant of: Novartis, BMS, Pfizer, Sobi, Miach Orthopedics, Simcere, XBiotech, Quench Bio, Ashley Cooper: None declared, Winn Chatham Grant/research support from: Sobi, Consultant of: Sobi, Shoghik Akoghlanian: None declared, Namrata Singh: None declared, Egla Rabinovich Grant/research support from: AbbVie, UCB Pharma, Janssen Research & Development, Akaluck Thatayatikom: None declared, Alysha Taxter: None declared, Jonathan Hausmann Consultant of: Novartis, Milan Zdravkovic Shareholder of: Sobi, Employee of: Sobi, Sven Ohlman Shareholder of: Sobi, Employee of: Former employee of Sobi, Henrik Andersson Employee of: Sobi, Susanna Cederholm Shareholder of: Sobi, Employee of: Sobi, Margareta Wikén Shareholder of: Sobi, Employee of: Former employee of Sobi, Rayfel Schneider Grant/research support from: Roche, Novartis, Sobi, Pfizer, Consultant of: Sobi, Novartis, Novimmune, Fabrizio De Benedetti Grant/research support from: AbbVie, Pfizer, Novartis, Novimmune, Sobi, Sanofi, Roche, Speakers bureau: AbbVie, Novartis, Roche, Sobi

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Factors related to large bone defects of bipolar lesions and a high number of instability episodes with anterior glenohumeral instability

Journal of Orthopaedic Surgery and Research ◽

10.1186/s13018-021-02395-5 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Noboru Matsumura ◽

Kazuya Kaneda ◽

Satoshi Oki ◽

Hiroo Kimura ◽

Taku Suzuki ◽

...

Keyword(s):

Humeral Head ◽

Glenohumeral Joint ◽

Three Dimensional ◽

Clinical Results ◽

Bone Defects ◽

Symptom Duration ◽

Glenohumeral Instability ◽

Explanatory Variables ◽

Large Bone ◽

Large Bone Defects

Abstract Background Significant bone defects are associated with poor clinical results after surgical stabilization in cases of glenohumeral instability. Although multiple factors are thought to adversely affect enlargement of bipolar bone loss and increased shoulder instability, these factors have not been sufficiently evaluated. The purpose of this study was to identify the factors related to greater bone defects and a higher number of instability episodes in patients with glenohumeral instability. Methods A total of 120 consecutive patients with symptomatic unilateral instability of the glenohumeral joint were retrospectively reviewed. Three-dimensional surface-rendered/registered models of bilateral glenoids and proximal humeri from computed tomography data were matched by software, and the volumes of bone defects identified in the glenoid and humeral head were assessed. After relationships between objective variables and explanatory variables were evaluated using bivariate analyses, factors related to large bone defects in the glenoid and humeral head and a high number of total instability episodes and self-irreducible dislocations greater than the respective 75th percentiles were evaluated using logistic regression analyses with significant variables on bivariate analyses. Results Larger humeral head defects (P < .001) and a higher number of total instability episodes (P = .032) were found to be factors related to large glenoid defects. On the other hand, male sex (P = .014), larger glenoid defects (P = .015), and larger number of self-irreducible dislocations (P = .027) were related to large humeral head bone defects. An increased number of total instability episodes was related to longer symptom duration (P = .001) and larger glenoid defects (P = .002), and an increased number of self-irreducible dislocations was related to larger humeral head defects (P = .007). Conclusions Whereas this study showed that bipolar lesions affect the amount of bone defects reciprocally, factors related to greater bone defects differed between the glenoid and the humeral head. Glenoid defects were related to the number of total instability episodes, whereas humeral head defects were related to the number of self-irreducible dislocations.

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AB1346-HPR REAL-WORLD EFFECTIVENESS AND PERCEIVED USEFULNESS OF SYMPTOM CHECKERS IN RHEUMATOLOGY: INTERIM REPORT FROM THE PROSPECTIVE MULTICENTER BETTER STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1604 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1961.1-1961

Author(s):

J. Knitza ◽

J. Mohn ◽

C. Bergmann ◽

E. Kampylafka ◽

M. Hagen ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Real World ◽

Search Engines ◽

Correct Diagnosis ◽

Perceived Usefulness ◽

Symptom Duration ◽

Research Support ◽

Link Type ◽

The Mean ◽

Research Grant

Background:Symptom checkers (SC) promise to reduce diagnostic delay, misdiagnosis and effectively guide patients through healthcare systems. They are increasingly used, however little evidence exists about their real-life effectiveness.Objectives:The aim of this study was to evaluate the diagnostic accuracy, usage time, usability and perceived usefulness of two promising SC, ADA (www.ada.com) and Rheport (www.rheport.de). Furthermore, symptom duration and previous symptom checking was recorded.Methods:Cross-sectional interim clinical data from the first of three recruiting centers from the prospective, real-world, multicenter bETTeR-study (DKRS DRKS00017642) was used. Patients newly presenting to a secondary rheumatology outpatient clinic between September and December 2019 completed the ADA and Rheport SC. The time and answers were recorded and compared to the patient’s actual diagnosis. ADA provides up to 5 disease suggestions, Rheport calculates a risk score for rheumatic musculoskeletal diseases (RMDs) (≥1=RMD). For both SC the sensitivity, specificity was calculated regarding RMDs. Furthermore, patients completed a survey evaluating the SC usability using the system usability scale (SUS), perceived usefulness, previous symptom checking and symptom duration.Results:Of the 129 consecutive patients approached, 97 agreed to participate. 38% (37/97) of the presenting patients presented with an RMD (Figure 1). Mean symptom duration was 146 weeks and a mean number of 10 physician contacts occurred previously, to evaluate current symptoms. 56% (54/96) had previously checked their symptoms on the internet using search engines, spending a mean of 6 hours. Rheport showed a sensitivity of 49% (18/37) and specificity of 58% (35/60) concerning RMDs. ADA’s top 1 and top 5 disease suggestions concerning RMD showed a sensitivity of 43% (16/37) and 54% (20/37) and a specificity of 58% (35/60) and 52% (31/60), respectively. ADA listed the correct diagnosis of the patients with RMDs first or within the first 5 disease suggestions in 19% (7/37) and 30% (11/37), respectively. The average perceived usefulness for checking symptoms using ADA, internet search engines and Rheport was 3.0, 3.5 and 3.1 on a visual analog scale from 1-5 (5=very useful). 61% (59/96) and 64% (61/96) would recommend using ADA and Rheport, respectively. The mean SUS score of ADA and Rheport was 72/100 and 73/100. The mean usage time for ADA and Rheport was 8 and 9 minutes, respectively.Conclusion:This is the first prospective, real-world, multicenter study evaluating the diagnostic accuracy and other features of two currently used SC in rheumatology. These interim results suggest that diagnostic accuracy is limited, however SC are well accepted among patients and in some cases, correct diagnosis can be provided out of the pocket within few minutes, saving valuable time.Figure:Acknowledgments:This study was supported by an unrestricted research grant from Novartis.Disclosure of Interests:Johannes Knitza Grant/research support from: Research Grant: Novartis, Jacob Mohn: None declared, Christina Bergmann: None declared, Eleni Kampylafka Speakers bureau: Novartis, BMS, Janssen, Melanie Hagen: None declared, Daniela Bohr: None declared, Elizabeth Araujo Speakers bureau: Novartis, Lilly, Abbott, Matthias Englbrecht Grant/research support from: Roche Pharma, Chugai Pharma Europe, Consultant of: AbbVie, Roche Pharma, RheumaDatenRhePort GbR, Speakers bureau: AbbVie, Celgene, Chugai Pharma Europe, Lilly, Mundipharma, Novartis, Pfizer, Roche Pharma, UCB, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, Timo Meinderink: None declared, Wolfgang Vorbrüggen: None declared, Cay-Benedict von der Decken: None declared, Stefan Kleinert Shareholder of: Morphosys, Grant/research support from: Novartis, Consultant of: Novartis, Speakers bureau: Abbvie, Novartis, Celgene, Roche, Chugai, Janssen, Andreas Ramming Grant/research support from: Pfizer, Novartis, Consultant of: Boehringer Ingelheim, Novartis, Gilead, Pfizer, Speakers bureau: Boehringer Ingelheim, Roche, Janssen, Jörg Distler Grant/research support from: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Paid instructor for: Boehringer Ingelheim, Speakers bureau: Boehringer Ingelheim, Peter Bartz-Bazzanella: None declared, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB

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POS1120 PRESENCE OF TOPHI IS ASSOCIATED WITH A RAPID DECLINE IN THE RENAL FUNCTION IN PATIENTS WITH GOUT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.50 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 839.1-839

Author(s):

Y. J. Oh ◽

K. W. Moon

Keyword(s):

Renal Function ◽

Renal Dysfunction ◽

Clinical Characteristics ◽

Multivariate Logistic Regression Analysis ◽

Joint Involvement ◽

Rapid Decline ◽

Symptom Duration ◽

Tophaceous Gout ◽

Duration Of Symptoms ◽

Increased Risk

Background:Gout is the most common inflammatory arthritis resulting from a chronic deposition of MSU crystals in the joints and other soft tissues. After the process of repeated tissue damage and repair due to gout, tophi could be formed around the affected joints. Intra-articular tophi may sometimes result in bone destruction, joint deformities, and dysfunction which can adversely affect the patient’s quality of life. Furthermore, early-onset tophaceous gout patients are more likely to develop renal dysfunction, however, few studies have investigated if the presence of tophi is related with the progression of renal dysfunction in gout patients.Objectives:We aimed to compare clinical characteristics of patients with and without tophi at the time of the diagnosis of gout and investigate the effect of tophi on the renal function in gout patients.Methods:Data of 257 patients who were first diagnosed with gout at the Kangwon National University Hospital from January 2012 to December 2018 were retrospectively studied. Patients were divided into 2 groups according to the presence of tophi at the diagnosis. We compared clinical characteristics and the progression of renal dysfunction between the two groups.Results:Of all patients, 66 (25.5%) initially presented with tophi. Patients with tophi were older, had a longer duration of symptoms, and had a higher prevalence of multiple joint involvement than those without tophi. The decline in the eGFR was more prominent in patients with tophi than in those without (-4.8±14.5 ml/min/1.73m2vs. -0.7±11.9 ml/min/1.73m2, respectively; P=0.039). In multivariate logistic regression analysis, a prolonged symptom duration (odds ratio [OR], 1.010; 95% confidence interval [CI], 1.004–1.017; P=0.001) and multiple joint involvement (OR, 3.027; 95% CI, 1.831–5.004; P<0.001) were significantly associated with increased risk of formation of tophi. The presence of tophi was significantly associated with a rapid decline in the eGFR (β=-0.141; P=0.035).Conclusion:A prolonged symptom duration and multiple joint involvement were independent risk factors for tophi as the presenting symptom in gout patients. The presence of tophi was associated with a declining renal function. Therefore, an early diagnosis and active treatment are important in tophaceous gout.References:[1]Bardin T, Richette P. Definition of hyperuricemia and gouty conditions. Curr Opin Rheumatol 2014;26:186-91.[2]Liu F, Du GL, Song N, Ma YT, Li XM, Gao XM, et al. Hyperuricemia and its association with adiposity and dyslipidemia in Northwest China: results from cardiovascular risk survey in Xinjiang (CRS 2008-2012). Lipids Health Dis 2020;19:58.[3]Dalbeth N, Merriman TR, Stamp LK. Gout. Lancet 2016;388:2039-52.[4]Ruoff G, Edwards NL. Overview of Serum Uric Acid Treatment Targets in Gout: Why Less Than 6 mg/dL? Postgrad Med 2016;128:706-15.[5]Bieber A, Schlesinger N, Fawaz A, Mader R. Chronic tophaceous gout as the first manifestation of gout in two cases and a review of the literature. Semin Arthritis Rheum 2018;47:843-8.Disclosure of Interests:None declared.

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Failed Surgery for Patellar Tendinopathy in Athletes: Midterm Results of Further Surgical Management

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967121994550 ◽

2021 ◽

Vol 9 (3) ◽

pp. 232596712199455

Author(s):

Nicola Maffulli ◽

Francesco Oliva ◽

Gayle D. Maffulli ◽

Filippo Migliorini

Keyword(s):

Surgical Management ◽

Revision Surgery ◽

Case Series ◽

Sports Participation ◽

Patellar Tendinopathy ◽

Symptom Duration ◽

Level Of Evidence ◽

Training Time ◽

The Mean

Background: Tendon injuries are commonly seen in sports medicine practice. Many elite players involved in high-impact activities develop patellar tendinopathy (PT) symptoms. Of them, a small percentage will develop refractory PT and need to undergo surgery. In some of these patients, surgery does not resolve these symptoms. Purpose: To report the clinical results in a cohort of athletes who underwent further surgery after failure of primary surgery for PT. Study Design: Case series; Level of evidence, 4. Methods: A total of 22 athletes who had undergone revision surgery for failed surgical management of PT were enrolled in the present study. Symptom severity was assessed through the Victorian Institute of Sport Assessment Scale for Patellar Tendinopathy (VISA-P) upon admission and at the final follow-up. Time to return to training, time to return to competition, and complications were also recorded. Results: The mean age of the athletes was 25.4 years, and the mean symptom duration from the index intervention was 15.3 months. At a mean follow-up of 30.0 ± 4.9 months, the VISA-P score improved 27.8 points ( P < .0001). The patients returned to training within a mean of 9.2 months. Fifteen patients (68.2%) returned to competition within a mean of 11.6 months. Of these 15 patients, a further 2 had decreased their performance, and 2 more had abandoned sports participation by the final follow-up. The overall rate of complications was 18.2%. One patient (4.5%) had a further revision procedure. Conclusion: Revision surgery was feasible and effective in patients in whom PT symptoms persisted after previous surgery for PT, achieving a statistically significant and clinically relevant improvement of the VISA-P score as well as an acceptable rate of return to sport at a follow-up of 30 months.

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1501. Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED): Updates from Year 2 of multi-site trial

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1682 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S752-S753

Author(s):

Stephanie A Richard ◽

Timothy Burgess ◽

Limone Collins ◽

Rhonda Colombo ◽

...

Keyword(s):

Influenza Vaccine ◽

Clinic Visit ◽

Vaccine Effectiveness ◽

Symptom Duration ◽

Blood Draw ◽

Duration Of Symptoms ◽

Nasal Swabs ◽

Second Year ◽

Military Facilities ◽

Pragmatic Assessment

Abstract Background Despite nearly universal influenza vaccination for active duty military personnel, breakthrough influenza infections occur. We are reporting on the second year of the Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED), comparing three FDA-licensed influenza vaccine types (egg-based, cell -based, and recombinant) to assess differences in immunogenicity and effectiveness. Methods Participants in the second year of PAIVED were enrolled from Oct 2019 through Jan 2020 at 9 military facilities. Participants received weekly inquiries about influenza-like-illnesses (ILI) experienced in the past week, and if the participant reported having a cough or sore throat and a) muscle/body aches or fatigue and/or b) being feverish or having chills, they were scheduled for a clinic visit. During this visit, a blood sample and a nasal swab were collected, as well as information about symptom duration and severity. A second (convalescent) visit was conducted approximately 4 weeks later, which involved collecting additional information about the duration of symptoms and illness burden, as well as a second blood draw. Due to the COVID-19 pandemic, acute and convalescent visits were disrupted at most sites in March and April due to COVID-19 precautions. Results PAIVED year 2 enrolled 5,892 participants who completed demographic forms (Table 1). Among those who reported any ILIs, most reported one ILI (1,345), while 264 reported two ILIs, and 42 reported three ILIs. Nasal swabs were processed from 273 ILIs at four sites (Fig 1), and 14 cases of influenza were identified thus far. The median duration of ILIs was ten days, with a median of three days of limited activity, and two days with fever. Nine individuals were hospitalized. Table 1. Demographic characteristics of individuals enrolled in PAIVED 2019/20 Figure 1. Lab results as of 5/15 (N=273 samples) Conclusion Over 25% of participants reported an ILI, and 5% of the nasal swabs that have been tested thus far have been positive for influenza. While most samples have not yet been analyzed, we have identified some breakthrough cases of influenza among vaccinated participants. Planned analyses include comparative vaccine effectiveness in order to inform future vaccine purchasing decisions. Disclaimer Disclosures All Authors: No reported disclosures

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No Additive Clinical or Physiological Effects of Short-term Anti-inflammatory Treatment to Physical Rehabilitation in the Early Phase of Human Achilles Tendinopathy: A Randomized Controlled Trial

The American Journal of Sports Medicine ◽

10.1177/0363546521991903 ◽

2021 ◽

pp. 036354652199190

Author(s):

Nikolaj M. Malmgaard-Clausen ◽

Oscar H. Jørgensen ◽

Rikke Høffner ◽

Peter E.B. Andersen ◽

Rene B. Svensson ◽

...

Keyword(s):

Early Phase ◽

Controlled Trial ◽

Rehabilitation Program ◽

Achilles Tendinopathy ◽

Physical Rehabilitation ◽

Symptom Duration ◽

Short Term ◽

Nsaid Treatment ◽

T2 Mri

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used in the treatment of Achilles tendinopathy, but whether they have any additive clinical effect on physical rehabilitation in the early phase of tendinopathy remains unknown. Purpose/Hypothesis: To investigate whether an initial short-term NSAID treatment added to a physical rehabilitation program in the early phase of Achilles tendinopathy would have an additive effect. We hypothesized that the combination of NSAID and rehabilitation would be superior to rehabilitation alone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 69 patients with early phase Achilles tendinopathy (lasting <3 months) were randomly assigned to either a naproxen group (7 days of treatment; 500 mg twice daily; n = 34) or a placebo group (7 days of placebo treatment; n = 35). Both groups received an identical 12-week physical rehabilitation program. The clinical outcome of the study was evaluated using the Victorian Institute of Sports Assessment–Achilles (VISA-A) questionnaire and a numerical rating scale (NRS), and the physiological outcome was evaluated using ultrasonography, magnetic resonance imaging (MRI), and ultra-short time to echo T2* mapping MRI (UTE T2* MRI). Follow-up was performed at 1 week, 3 months, and 1 year. Time effects are presented as mean difference ± SEM. Results: No significant differences were found between the 2 treatment groups for any of the outcome measures at any time point ( P > .05). For the VISA-A score, a significant time effect was observed between baseline and 3-month follow-up (14.9 ± 2.3; P < .0001), and at 1-year follow-up, additional improvements were observed (6.1 ± 2.3; P < .01). Furthermore, the change in VISA-A score between baseline and 3-month follow-up was greater in patients with very short symptom duration (<1 month) at baseline compared with patients who had longer symptom duration (>2 months) (interaction between groups, 11.7 ± 4.2; P < .01). Despite clinical improvements, total weekly physical activity remained lower compared with preinjury levels at 3 months (–2.7 ± 0.5 h/wk; P < .0001) and 1 year (–3.0 ± 0.5 h/wk; P < .0001). At baseline, ultrasonography showed increased thickness (0.12 ± 0.03 cm; P < .0001) and vascularity (0.3 ± 0.1 cm2; P < .005) on the tendinopathic side compared with the contralateral side, but no changes over time were observed for ultrasonography, MRI, or UTE T2* MRI results. Conclusion: Clinical symptoms in early tendinopathy improved with physical rehabilitation, but this improvement was not augmented with the addition of NSAID treatment. Furthermore, this clinical recovery occurred in the absence of any measurable structural alterations. Finally, clinical improvements after a physical rehabilitation program were greater in patients with very short symptom duration compared with patients who had longer symptom duration. Registration: NCT03401177 (ClinicalTrials.gov identifier) and BFH-2016-019 (Danish Data Protection Agency)

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A single high-sensitivity cardiac troponin T compared to the HEART score for a rapid rule-out of acute myocardial infarction at a prehospital emergency clinic

European Heart Journal ◽

10.1093/ehjci/ehaa946.1680 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

T.R Johannessen ◽

D Atar ◽

O.M Vallersnes ◽

A.C.K Larstorp ◽

I Mdala ◽

...

Keyword(s):

Primary Care ◽

Cardiac Troponin ◽

Troponin T ◽

High Sensitivity ◽

Low Risk ◽

Symptom Duration ◽

Funding Source ◽

Emergency Setting ◽

Heart Score ◽

Rule Out

Abstract Background Patients presenting with acute chest pain outside of hospitals represent a diagnostic challenge. Purpose We aimed to validate whether a single high-sensitivity cardiac troponin T (hs-cTnT) safely can rule out acute myocardial infarction (AMI) in a primary care emergency setting. In addition, we aimed to investigate if the hs-HEART (History, Electrocardiogram (ECG), Age, Risk factors, and hs-Troponin) score would add valuable diagnostic information. Methods This is a secondary analysis from a prospective diagnostic study, including 1711 patients with acute non-specific chest pain presenting to a primary care emergency clinic from November 2016 to October 2018. The European Society of Cardiology (ESC) 0/1-hour algorithm triages patients towards direct rule-out if the 0-hour hs-cTnT is below 5 ng/L, combined with a normal ECG and a 3-hour symptom duration. The hs-HEART score (0–10 points) was calculated retrospectively, and a score ≤3 points was considered low-risk. In addition, a modified hs-HEART score, with more comparable hs-cTnT cut-off values, was applied. The primary endpoint was AMI during the index episode; the secondary the 90-day incidence of AMI (including index) and all-cause death. Results Among 1711 patients, 61 (3.6%) had an AMI, and 525 (30.7%) were assigned towards direct rule-out. With no AMIs in this group, the rule-out safety was high (negative predictive value (NPV) and sensitivity 100%). The hs-HEART score triaged more patients (n=966) as low-risk, but missed six AMIs (NPV 99.4% and sensitivity 90.2%). The modified hs-HEART score (n=707, AMI=3) increased the low-risk sensitivity to 95.1%. The 90-day incidence of AMI and all-cause death in the direct rule-out, low-risk hs-HEART, and modified hs-HEART group, were 0.0%, 0.7%, and 0.4%, respectively. Conclusions The ESC direct rule-out approach, with a single hs-cTnT below 5 ng/L, combined with a normal ECG, and a 3-hour symptom duration, is superior to the two hs-HEART scores in ruling out AMI in a primary care emergency setting. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): The Norwegian Research Fund for General Practice

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