A Novel N-Terminal Pro-B-Type Natriuretic Peptide Assay in the Early Diagnosis of Acute Heart Failure - Belkin, M.; Wussler, D.; Lopez-Ayala, P.; Nowak, A.; Gualandro, D. M.; Sailova, D.; Popescu, C.; Strebel, I.; Niggemann, M.; Reinhardt, J.; Hure, G.; Kozhuharov, N.; et al. (JACC Adv, 2025)
BACKGROUND: The performance of the novel NT-pro-B-type natriuretic peptide (NT-proBNP)-Access assay in the early diagnosis of acute heart failure (AHF) is unknown. OBJECTIVES: The objective of the study was to assess the diagnostic accuracy of NT-proBNP-Access in patients presenting with acute dyspnea and compare it to the established NT-proBNP-Elecsys assay. METHODS: In a prospective multicenter diagnostic study enrolling patients presenting with acute dyspnea to the emergency department, NT-proBNP-Access was measured in a blinded fashion and compared to NT-proBNP-Elecsys concentrations. The primary endpoint was diagnostic accuracy quantified by area under the receiver operating characteristics curve (AUC). Secondary endpoints were the performance of the guideline-recommended clinical decision values (rule-out: <300 pg/mL, rule-in: age-adjusted >450/900/1,800 pg/mL) for AHF. RESULTS: Among 1,400 patients (53% AHF), the NT-proBNP-Access assay yielded significantly higher NT-proBNP concentrations vs the NT-proBNP-Elecsys assay (median 2,087 pg/mL vs 1,568 pg/mL [P < 0.001]). The NT-proBNP-Access assay had very high diagnostic accuracy (AUC: 0.914; 95% CI: 0.898-0.93), which was slightly lower than the NT-proBNP-Elecsys assay (AUC: 0.922; 95% CI: 0.908-0.937; P = 0.006). Using guideline-recommended clinical decision values, the NT-proBNP-Access assay ruled out fewer patients compared to NT-proBNP-Elecsys (18.7% vs 26.3%) with similar sensitivity (98.9% vs 98.5%). Conversely, more patients were ruled in (58.1% vs 52.1%), with lower specificity (77.6% vs 84.8%; P < 0.001). Diagnostic concordance was high (85.3%), with major mismatch (no AHF vs AHF) uncommon (0.6%), but minor mismatch (gray zone vs rule in/rule out and vice versa) common (14.1%). CONCLUSIONS: The NT-proBNP-Access assay had a very high diagnostic accuracy for AHF. Levels were approximately 25% higher with NT-proBNP-Access vs NT-proBNP-Elecsys, resulting in minor diagnostic discordance in 1 of 7 patients using guideline-recommended decision values.
Keywords: journalArticle; Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Idorsia,; Basel. Dr Mahfoud has been supported by Deutsche Forschungsgemeinschaft (SFB; Beckman Diagnostics and Siemens Healthineers. Dr Breidthardt reported research; Coulter, BRAHMS, Roche, and Singulex. Dr Wussler reported research grants from; Dr Kozhuharov reported research grants received from the Swiss National Science; Foundation (grant numbers P400PM-194477 and P5R5PM_210856), the European Society; Foundation, the Innosuisse, Abbott, Astra Zeneca, Beckman Coulter, Boehringer; Freiwillige Akademische Gesellschaft Basel, and the L. & Th. La Roche Foundation; German Heart Foundation (K22/13) as well as speakers honoraria from PHC outside; Gualandro reports receiving advisory fees from Roche, outside the submitted work; Heart Foundation (FF20079, FF21103, and FF24149) and speaker honoraria from; Heart Foundation (Grant Reference FF22112), the University Hospital Basel and the; Ingelheim, BRAHMS, Ortho Clinical, Quidel, Novartis, Roche, Siemens, Singulex,; Medical. Dr Hammerer-Lercher reports speaker honoraria from Abbott Diagnostics,; NT-proBNP; NT-proBNP-Access assay; Novartis, Novo Nordisk, Osler, Roche, SpinChip, and Sanofi, all paid to the; Quidel and Roche, paid to the institution and outside the submitted work. Dr; Roche. Dr Mueller reported research grants from the University Hospital Basel,; Solutions, Astra-Zeneca, Inari, Medtronic, Merck, Novartis, Philips and ReCor; SpinChip, and Sphingotec, as well as speaker/consulting honoraria from Abbott,; TRR219, Project-ID 322900939), and Deutsche Herzstiftung. Saarland University has; acute heart failure; and; collection, management, analysis, and interpretation of the data; emergency department; grants from the Swiss National Science Foundation, the Swiss Heart Foundation,; grants from the Swiss National Science Foundation, the University Hospital Basel,; institution. The sponsors had no role in the design and conduct of the study; of Cardiology, the Gottfried und Julia Bangerter-Rhyner Foundation, the; preparation, review, or approval of the manuscript. All other authors have; received scientific support from Ablative Solutions, Medtronic and ReCor Medical; reported that they have no relationships relevant to the contents of this paper; the Department of Internal Medicine, University Hospital Basel, Abbott, and; the Swiss National Science Foundation (Grant Reference P500PM_225285), the Swiss; the University of Basel, the Swiss National Science Foundation, the Swiss Heart; the University of Basel, the University Hospital Basel, Abbott, Alere, Beckman; the submitted work. Dr Lopez-Ayala has received research grants from the Swiss; to disclose; until May 2024, he has received speaker honoraria/consulting fees from Ablative