Jasper Boeddinghaus1, Thomas Nestelberger2, Luca Koechlin3, Desiree Wussler4, Pedro Lopez-Ayala5, Joan Elias Walter4, Valentina Troester5, Paul David Ratmann5, Funda Seidel5, Tobias Zimmermann4, Patrick Badertscher6, Karin Wildi7, Maria Rubini Giménez8, Eliska Potlukova4, Ivo Strebel5, Michael Freese5, Òscar Miró9, F Javier Martin-Sanchez10, Damian Kawecki11, Dagmar I Keller12, Danielle M Gualandro13, Michael Christ14, Raphael Twerenbold5, Christian Mueller15. 1. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: https://twitter.com/J_Boeddinghaus. 2. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: https://twitter.com/thomas_nest. 3. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Switzerland. 4. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Division of Internal Medicine, University Hospital Basel, University of Basel, Basel, Switzerland. 5. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy. 6. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina. 7. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Critical Care Research Group, the Prince Charles Hospital, Brisbane and the University of Queensland, Brisbane, Queensland, Australia. 8. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Leipzig Heart Center, Leipzig, Germany. 9. GREAT Network, Rome, Italy; Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain. 10. GREAT Network, Rome, Italy; Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain. 11. GREAT Network, Rome, Italy; Second Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Katowice, Katowice, Poland. 12. Emergency Department, University Hospital Zurich, Zurich, Switzerland. 13. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy; Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo Brazil. 14. GREAT Network, Rome, Italy; Emergency Department, Kantonsspital Luzern, Luzern, Switzerland. 15. Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: christian.mueller@usb.ch.
Abstract
BACKGROUND: Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms. OBJECTIVES: This study aimed to assess the clinical performance of a point-of-care (POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI). METHODS: This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue-specific 0/1-h algorithm. RESULTS: MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval [CI]: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication. CONCLUSIONS: The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).
BACKGROUND: Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms. OBJECTIVES: This study aimed to assess the clinical performance of a point-of-care (POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI). METHODS: This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue-specific 0/1-h algorithm. RESULTS: MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval [CI]: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication. CONCLUSIONS: The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).
Authors: Tania Coscia; Thomas Nestelberger; Jasper Boeddinghaus; Pedro Lopez-Ayala; Luca Koechlin; Òscar Miró; Dagmar I Keller; Ivo Strebel; Ana Yufera Sanchez; Bernhard Okamura; Desiree Wussler; Samyut Shrestha; Katharina Hausknecht; F Javier Martín-Sánchez; Michael Christ; Damian Kawecki; Raphael Twerenbold; Karin Wildi; Maria Rubini Gimenez; Christian Mueller Journal: JAMA Cardiol Date: 2022-04-01 Impact factor: 30.154
Authors: Tonje R Johannessen; Sigrun Halvorsen; Dan Atar; John Munkhaugen; Anne Kathrine Nore; Torbjørn Wisløff; Odd Martin Vallersnes Journal: BMC Health Serv Res Date: 2022-10-21 Impact factor: 2.908
Authors: Jason P Stopyra; Anna C Snavely; Nicklaus P Ashburn; James O'Neill; Brennan E Paradee; Brian Hehl; Jordan Vorrie; Matthew Wells; R Darrell Nelson; Nella W Hendley; Chadwick D Miller; Simon A Mahler Journal: Prehosp Emerg Care Date: 2022-02-17 Impact factor: 2.686
Authors: Tonje R Johannessen; Dan Atar; Odd Martin Vallersnes; Anne Cecilie K Larstorp; Ibrahimu Mdala; Sigrun Halvorsen Journal: BMJ Open Date: 2021-02-24 Impact factor: 2.692
Authors: Evangelos Giannitsis; Stefan Blankenberg; Robert H Christenson; Norbert Frey; Stephan von Haehling; Christian W Hamm; Kenji Inoue; Hugo A Katus; Chien-Chang Lee; James McCord; Martin Möckel; Jack Tan Wei Chieh; Marco Tubaro; Kai C Wollert; Kurt Huber Journal: Clin Res Cardiol Date: 2021-02-26 Impact factor: 5.460