Usefulness of a Novel Electrocardiographic Score to Estimate the Pre-Test Probability of Acute Pulmonary Embolism

•Our experience suggests that electrocardiogram (ECG) has a role in the estimation of the pretest probability of acute pulmonary embolism (acPE).•Therefore we devised a novel ECG score (nECGs) for this purpose.•The nECGs alone or together with a negative D-dimer test could better rule out acPE than a previously published ECG score and the best clinical prediction rules.•The nECGs could better indicate the false positivity of D-dimer test than the previously published ECG score and the prediction rules. According to our experience the 12-lead electrocardiogram (ECG) may be used to estimate the pretest probability of acute pulmonary embolism (acPE). To this end, we devised a novel ECG score (nECGs) composed of 5 known ECG criteria, best characterizing the key pathogenetic steps of acPE. A retrospective derivation cohort including 136 patients with acPE and a prospective validation cohort including 149 consecutive patients were used to devise and validate the nECGs. The latter cohort consisted of 76 patients with acPE and 73 controls presenting with characteristic symptoms of acPE, in whom the work-up ruled out acPE. We compared the diagnostic value of our nECGs with those of another ECG score (Daniel-ECG-score) and of the best prediction rules (3 Wells score and 2 Geneva score variants). The sensitivity (98.7%), negative predictive value (98%), test accuracy (84.4%) and the negative likelihood ratio (LR) (0.019) of the nECGs were superior to those of all other investigated methods. There was no between-groups difference in the positive LR. The specificity (69%) of the nECGs was inferior to those of the Daniel-ECG-score and Wells scores and did not differ or was superior to those of the Geneva score variants. The positive predictive value (77.3%) of the nECGs was superior to those of the 2 Geneva scores and did not differ from those of the other methods. In conclusion, the nECGs due to its superior sensitivity, negative predictive value, test accuracy, and negative LR estimated the pretest probability of acPE better than the Daniel-ECG-score and the prediction rules. According to our experience the 12-lead electrocardiogram (ECG) may be used to estimate the pretest probability of acute pulmonary embolism (acPE). To this end, we devised a novel ECG score (nECGs) composed of 5 known ECG criteria, best characterizing the key pathogenetic steps of acPE. A retrospective derivation cohort including 136 patients with acPE and a prospective validation cohort including 149 consecutive patients were used to devise and validate the nECGs. The latter cohort consisted of 76 patients with acPE and 73 controls presenting with characteristic symptoms of acPE, in whom the work-up ruled out acPE. We compared the diagnostic value of our nECGs with those of another ECG score (Daniel-ECG-score) and of the best prediction rules (3 Wells score and 2 Geneva score variants). The sensitivity (98.7%), negative predictive value (98%), test accuracy (84.4%) and the negative likelihood ratio (LR) (0.019) of the nECGs were superior to those of all other investigated methods. There was no between-groups difference in the positive LR. The specificity (69%) of the nECGs was inferior to those of the Daniel-ECG-score and Wells scores and did not differ or was superior to those of the Geneva score variants. The positive predictive value (77.3%) of the nECGs was superior to those of the 2 Geneva scores and did not differ from those of the other methods. In conclusion, the nECGs due to its superior sensitivity, negative predictive value, test accuracy, and negative LR estimated the pretest probability of acPE better than the Daniel-ECG-score and the prediction rules. Our clinical experience, in contrast to the current ESC acute pulmonary embolism (acPE) guideline,1Konstantinides SV Meyer G Becattini C Bueno H Geersing GJ Harjola VP Huisman MV Humbert M Jennings CS Jiménez D Kucher N Lang IM Lankeit M Lorusso R Mazzolai L Meneveau N Ní Áinle F Prandoni P Pruszczyk P Righini M Torbicki A Van Belle E Zamorano JL 2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Resopiratory Society (ERS).Eur Heart J. 2020; 41: 543-603Crossref PubMed Scopus (811) Google Scholar suggests, that the 12-lead electrocardiogram (ECG) can be applied to estimate the pretest probability of acPE, which can be assessed by empiric clinical judgment, that can use the ECG, but lacks standardization, or by standardized prediction rules, such as the Wells and Geneva scores, that do not include the ECG.1Konstantinides SV Meyer G Becattini C Bueno H Geersing GJ Harjola VP Huisman MV Humbert M Jennings CS Jiménez D Kucher N Lang IM Lankeit M Lorusso R Mazzolai L Meneveau N Ní Áinle F Prandoni P Pruszczyk P Righini M Torbicki A Van Belle E Zamorano JL 2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Resopiratory Society (ERS).Eur Heart J. 2020; 41: 543-603Crossref PubMed Scopus (811) Google Scholar Most studies evaluated the application of the prediction rules together with the D-dimer test, there are only limited, indecisive data on their stand-alone diagnostic value in the diagnosis of acPE.2Wells PS Anderson DR Rodger M Ginsberg JS Kearon C Gent M Turpie AGG Bormanis J Weitz J Chamberlain M Bowie D Barnes D Hirsh J Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer.Thromb Haemost. 2000; 83: 416-420Crossref PubMed Scopus (1246) Google Scholar, 3Gibson NS Sohne M Kruip MJHA Tick LW Gerdes VE Bossuyt PM Wells PS Buller HR on behalf of the Christopher study investigatorsFurther validation and simplification of the Wells clinical decision rule in pulmonary embolism.Thromb Haemost. 2008; 99: 229-234Crossref PubMed Scopus (168) Google Scholar, 4Hendriksen JMT Geersing G-J Lucassen WAM Erkens PMG Stoffers HEJH van Weert HCPM Büller HR Hoes AW Moons KGM Diagnostic prediction models for suspected pulmonary embolism: systematic review and independent external validation in primary care.BMJ. 2015; 351: 44438https://doi.org/10.1136/bmj.h4438Crossref Scopus (48) Google Scholar An optimal sensitivity ELISA D-dimer test in randomized studies could rule out acPE or deep venous thrombosis irrespective of clinical probability5Perrier A Desmarais S Miron M-J de Moerloose P Lepage R Slosman D Didier D Unger P-F Paternaude J-V Bounameaux H Non-invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-195Abstract Full Text Full Text PDF PubMed Scopus (760) Google Scholar, 6Kruip MJHA Slob MJ Schijen JHEM van der Heul C Büller HR Use of a clinical decision rule in combination with D-dimer concentration in diagnostic workup of patients with suspected pulmonary embolism.Arch Intern Med. 2002; 162: 1631-1635Crossref PubMed Scopus (169) Google Scholar, 7Righini M Aujesky D Roy P-M Cornuz J de Moerloose P Bounameaux H Perrier A Clinical usefulness of D-dimer depending on clinical probability and cutoff value in outpatients with suspected pulmonary embolism.Arch Intern Med. 2004; 164: 2483-2487Crossref PubMed Scopus (84) Google Scholar and the specificity and positive predictive value of the prediction rules are suboptimal,4Hendriksen JMT Geersing G-J Lucassen WAM Erkens PMG Stoffers HEJH van Weert HCPM Büller HR Hoes AW Moons KGM Diagnostic prediction models for suspected pulmonary embolism: systematic review and independent external validation in primary care.BMJ. 2015; 351: 44438https://doi.org/10.1136/bmj.h4438Crossref Scopus (48) Google Scholar not strongly supporting the use of the prediction rules. Our aim was to devise an ECG score with a better diagnostic value than the best prediction rules in the determination of pretest acPE probability. To this end, we devised an ECG score from 5 known ECG criteria, which best reflect the key pathogenetic steps of acPE. We conducted a retrospective study to devise the novel ECG score (nECGs) in a group of patients (derivation cohort) and then tested the established nECGs prospectively in a different set of patients (validation cohort) at the 3rd Department of Medicine, Semmelweis University and the Department of Cardiology, Saint Imre University Teaching Hospital. In the retrospective study we collected 12-lead ECGs from 136 patients with verified acPE (derivation cohort) between 2012 and 2017 after applying the same inclusion and exclusion criteria as in the prospective study. In the prospective study, which was conducted for 1 year and was finished recently, we enrolled 149 consecutive patients (validation cohort) admitted with characteristic symptoms of acPE, such as chest pain, dyspnea, collapse or loss of consciousness, hemoptysis, in whom a 12-lead ECG with complementary right-sided chest leads was recorded within 7 days from the onset of symptoms. Among the 149 patients 76 were verified to have acPE and 73 were control patients having cardiopulmonary disease associated with symptoms characteristic to acPE, in whom acPE was ruled out. 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The of acPE was to The electrocardiogram in acute pulmonary PubMed Scopus Google Scholar as and on The nECGs established a diagnosis in of patients with of patients with and of with The superior diagnostic accuracy of the nECGs to the pretest probability of acPE on its superior sensitivity, negative predictive value, test accuracy and negative likelihood ratio to those of all other investigated the specificity of the nECGs was inferior to those of the Wells scores and the Wells PS Anderson DR Rodger M Ginsberg JS Kearon C Gent M Turpie AGG Bormanis J Weitz J Chamberlain M Bowie D Barnes D Hirsh J Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer.Thromb Haemost. 2000; 83: 416-420Crossref PubMed Scopus (1246) Google Scholar that the of verified acPE in patients with negative D-dimer test with the pretest probability of acPE by the Wells the used SimpliRED D-dimer test of sensitivity of an ELISA D-dimer test of optimal sensitivity to R D-dimer for the exclusion of acute venous thrombosis and pulmonary Intern Med. 2004; PubMed Scopus Google Scholar ELISA D-dimer with optimal sensitivity were used alone to rule out acPE, the venous thromboembolism was to as as after a pulmonary in patients left a M H of acute pulmonary PubMed Scopus Google Scholar the false negative with the ELISA D-dimer could rule out acPE or deep venous thrombosis in randomized studies irrespective of the clinical A Desmarais S Miron M-J de Moerloose P Lepage R Slosman D Didier D Unger P-F Paternaude J-V Bounameaux H Non-invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-195Abstract Full Text Full Text PDF PubMed Scopus (760) Google Scholar, 6Kruip MJHA Slob MJ Schijen JHEM van der Heul C Büller HR Use of a clinical decision rule in combination with D-dimer concentration in diagnostic workup of patients with suspected pulmonary embolism.Arch Intern Med. 2002; 162: 1631-1635Crossref PubMed Scopus (169) Google Scholar, 7Righini M Aujesky D Roy P-M Cornuz J de Moerloose P Bounameaux H Perrier A Clinical usefulness of D-dimer depending on clinical probability and cutoff value in outpatients with suspected pulmonary embolism.Arch Intern Med. 2004; 164: 2483-2487Crossref PubMed Scopus (84) Google Scholar the in the and acPE guideline,1Konstantinides SV Meyer G Becattini C Bueno H Geersing GJ Harjola VP Huisman MV Humbert M Jennings CS Jiménez D Kucher N Lang IM Lankeit M Lorusso R Mazzolai L Meneveau N Ní Áinle F Prandoni P Pruszczyk P Righini M Torbicki A Van Belle E Zamorano JL 2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Resopiratory Society (ERS).Eur Heart J. 2020; 41: 543-603Crossref PubMed Scopus (811) Google M H of acute pulmonary PubMed Scopus Google E C G M Bounameaux H Perrier A Righini M Clinical prediction rules for pulmonary embolism: a systematic review and Haemost. Google Scholar the sensitivity ELISA D-dimer test in may be to rule out acPE irrespective of the pretest probability of acPE. The nECGs to the diagnosis of a negative D-dimer test, due to its sensitivity and negative predictive value and negative likelihood than prediction rule or pretest probability. to its negative likelihood ratio value the nECGs can rule out as or better acPE than a R D-dimer for the exclusion of acute venous thrombosis and pulmonary Intern Med. 2004; PubMed Scopus Google Scholar the nECGs diagnosis the false positivity of the D-dimer test with a probability and better than the prediction rules a pretest acPE probability. ECG were in patients with acPE, which are to and all have a sensitivity and N N M M in ECG associated with and clinical in pulmonary Heart J. PubMed Scopus Google The electrocardiogram in acute pulmonary PubMed Scopus Google P R E R R E M J P L and of patients with acute pulmonary J. PubMed Scopus Google Scholar the combination of ECG criteria to be a better as in the of an ECG score of 5 ECG criteria prediction compared with ECG A A H M P MJ in a an 2020; PubMed Scopus Google Scholar The M of from pulmonary embolism with 12-lead Full Text Full Text PDF PubMed Scopus Google Scholar the only ECG score devised for the diagnosis of acPE, did not The diagnostic value of our nECGs in the estimation of acPE pretest probability can be due to the ECG criteria, which best reflect the pathogenetic of acPE. The same the of the its criteria reflect different pathogenetic steps of right-sided the of the due to and Our study has studies are to the diagnostic value of our as we enrolled of patients in our study. The of acPE than control patients the of all patients in the study, after the inclusion and exclusion criteria, an and an of our study. The for this that this study and control patients negative D-dimer test at the their was not at the or were for the study. The of the nECGs for application in patients with left bundle and and the of patients with in our study are In conclusion, on our ECG a role in the rule out diagnostic work-up of acPE. to its sensitivity, negative predictive value, and negative likelihood ratio value the nECGs can be used alone or together with a negative D-dimer test to rule out acPE than the or pretest acPE probability by the prediction rules. The nECGs can indicate the false positivity of the D-dimer test than the Daniel-ECG-score and the pretest probability by the prediction rules. The diagnosis by the nECGs may the likelihood of acPE the D-dimer test positive and there a pretest probability of acPE by the prediction rules. to its positive predictive value, the diagnosis established by the nECGs in patients with a positive D-dimer test the of a chest the application of a prediction the diagnostic value of the clinical prediction rules in the estimation of pretest probability of acPE, we that the nECGs superior to in this We to right-sided chest leads in all patients admitted with acute cardiopulmonary in to the or exclusion of the application of the nECGs for the estimation of the pretest probability of acPE.