Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
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Sgarbossa et al 1996 USA | 131 patients with acute MI (documented by serum enzyme changes) and LBBB on their baseline ECG who were enrolled in the GUSTO-1 trial. The control group consisted of 131 patients randomly selected from the Duke Databank for Cardiovascular Disease, who had complete LBBB and stable, angiographically documented coronary artery disease. These patients did not have acute chest pain at the time of ECG. ECG's interpreted by one of four investigators. A random sample of 10% of ECG's was interpreted by all four investigators and kappa values reported. Only criteria for which the interobserver agreement was at least 0.7 were considered for inclusion in the clinical prediction rule. Once a model for the prediction rule had been derived, it was tested for validation in an independent population of 45 patients with LBBB, acute chest pain and a high likelihood of coronary artery disease (taken from the GUSTO-1 registry and GUSTO-2A study). 22 of these had a diagnosis myocardial infarction and 23 had unstable angina. | Diagnostic cohort | ST elevation >=1mm, concordant with QRS complex, for diagnosis of MI (multivariate analysis) | Odds ratio 25.2 (95% CI 11.6-54.7) | Control group did not have chest pain. The trial may have been more appropriately designed if it had included patients with undifferentiated chest pain and derived a clinical decision rule according to whether they tested positive or negative for MI. Significantly more patients in the control group had a previous MI (59% vs. 26%, p<0.001). Validation group was small (45 patients). |
ST depression >=1mm in lead V1, V2 or V3 (multivariate analysis) | Odds ratio 6.0 (1.9-19.3) | ||||
ST elevation >=5mm and discordant with QRS complex | Odds ratio 4.3 (1.8-10.6) | ||||
Predictive value of the clinical decision rule (Sgarbossa criteria, see Comments) on prospective validation (score >=3) | Sensitivity 30%, specificity 96%, LR+ 9.0, LR- 0.7, PPV 88%, NPV 61%. For every 100 patients with LBBB treated according to the Sgarbossa criteria, two would be thrombolysed despite not having an MI. 31 who were having MI's would not receive thrombolysis. 18 would be appropriately thrombolysed. | ||||
Gunnarsson et al 2001 Sweden | 158 patients with left bundle branch block, chest pain <6 hours and clinical suspicion of MI. ECG's reviewed by the three authors. Where there were disagreements, the majority verdict was taken. If all three authors disagreed, the patient was excluded from analysis. Kappa 0.57-0.70. Diagnosis of MI was made according to CK-MB or CK-B in combination with total CK. | Prospective diagnostic cohort | Total score >=3 using Sgarbossa criteria for diagnosis of MI | Sensitivity 17.1% (95% CI 8.6-25.6%), specificity 94% (88.9%-99.1%), LR+ 2.85, LR- 0.88, post-test probability 72%. For every 100 patients with LBBB treated according to these criteria, three would be inappropriately thrombolysed, 40 with MI would not be thrombolysed and 23 with MI would be thrombolysed. | Outdated diagnosis of myocardial infarction. No mention of how many patients were excluded because of failure to reach an agreement about the ECG. |
Score >=3 on Sgarbossa criteria and survival at 30 days and 1 year | No significant difference in survival (p=0.97) | ||||
Gula et al 2003 Canada | 414 ECG's with LBBB from a cohort of patients with AMI (who had been recruited another trial) compared with 85 controls with LBBB who had been attending hospital out-patient clinics. ECG's were interpreted by the three authors, with disagreements settled by consensus. Diagnosis of MI was made by the primary or "most responsible" diagnosis on the hospital record. | Retrospective diagnostic cohort | Interobserver agreement (kappa values) | LBBB 0.608; >5mm discordant ST elevation 0.368; ST depression V1, V2 or V3 0.523; Concordant ST elevation 0.393. | Lack of objective criteria for diagnosis of MI. Small control group (85 patients). Clinical utility of the scoring system proposed by Sgarbossa not assessed. |
Concordant ST elevation for diagnosis of MI | Sensitivity 6.3%, specificity 98.8%, LR+ 5.3, LR- 1.0 | ||||
ST depression V1-V3 for diagnosis of MI | Sensitivity 3.1%, specificity 100% | ||||
Discordant ST elevation (measured 80ms after J point) for diagnosis of MI | Sensitivity 37.5%, specificity 62.4%, LR+ 1.0, LR- 1.0 | ||||
Any abnormality from the Sgarbossa criteria for diagnosis of MI | Sensitivity 44.5%, specificity 61.2%, LR+1.2, LR- 0.9 | ||||
Kontos et al 2001 United States | 182 patients presenting to the Emergency Department with suspected myocardial ischaemia and LBBB on initial ECG. All ECGs were reviewed by two blinded cardiologists, with disagreements resolved by a third cardiologist. MI diagnosed according to CK-MB levels, although 11 patients were discharged prior to CK-MB estimation, following myocardial perfusion imaging. | Prospective diagnostic cohort | Concordant ST elevation for diagnosis of MI | Sensitivity 8% (95% CI 2-26%), specificity 100% (98-100%), PPV 100%, NPV 88%. Note only two patients had this ECG feature (both had MI). | Not all patients had the 'gold standard' test for diagnosis of MI (CK-MB). The 'gold standard' test for diagnosis of MI is now outdated. Relatively small numbers had the outcome in question (24 had MI); very small numbers had each Sgarbossa criteria. |
ST depression V1-V3 for diagnosis of MI | Sensitivity 17% (7-36%), specificity 100% (98-100%), PPV 100%, NPV 89%. Note only 4 patients had this ECG feature (all had MI). | ||||
Discordant ST elevation >=5mm for diagnosis of MI | Sensitivity 21% (9-41%), specificity 93% (88-96%), PPV 31%, NPV 89%. Note 16 patients had this ECG feature (5 had MI). | ||||
Any Sgarbossa criteria for diagnosis of MI | Sensitivity 46% (28-65%), specificity 93% (88-96%), PPV 50%, NPV 92%. (22 had any criteria, 11 of whom had MI). | ||||
Initial CK-MB or any ECG crtieria for diagnosis of MI | Sensitivity 63% (42-79%), specificity 99% (95-100%), PPV 88%, NPV 94% | ||||
Li et al 2000 United States | 190 patients identified on the ECG database of an urban teaching hospital as having a diagnosis of LBBB and who were intially admitted with suspected cardiac ischaemia. Medical records were reviewed. All patients had cardiac enzyme estimation (CK-MB). Each ECG was reviewed by two physicians and evaluated for the Sgarbossa criteria. | Retrospective diagnostic cohort | Interobserver variability | 91% or higher for each of the three criteria | Retrospective. Relatively small numbers - only 25 patients had the outcome in question. Now outdated criteria for diagnosis of MI (CK-MB), which may have underestimated the incidence. Clinical utility of the scoring system proposed by Sgarbossa not assessed. |
Concordant ST elevation for diagnosis of MI | Sensitivity 16%, specificity 100%, LR+ 16, LR- 0.8. Given a pre-test probability of 13% (study prevalence), a positive finding shifts the post-test probability of MI to 71%. | ||||
Disocrdant ST elevation >=5mm for diagnosis of MI | Sensitivity 8%, specificity 95%, LR+ 1 (95% CI 0.3-4), LR- 1 (95% CI 0.8-1). Hence the post-test probability remains 13% following a positive or negative test. | ||||
ST depression V1-V3 for diagnosis of MI | Sensitivity 0% (95% CI 0-14%), specificity 98%, LR+ 0 (0-8), LR- 1 (0.8-1) | ||||
Any of the Sgarbossa criteria for diagnosis of MI | Sensitivity 20%, specificity 93%, LR+ 3, LR- 0.9. Post-test probability following a positive test 57%. | ||||
Edhouse et al 1999 United Kingdom | 48 patients who presented to a teaching hospital with chest pain suspicious of myocardial ischaemia within 12 hours who had LBBB. ECG's were reviewed blindly, apparently by four independent observers | Retrospective diagnostic cohort | No Sgarbossa criteria on initial ECG and a diagnosis of MI | 27% had MI | Retrospective. No report of how disagreements in ECG interpretation were resolved. Relatively small numbers. |
No Sgarbossa criteria on serial ECG's and a diagnosis of MI | 17.2% had MI | ||||
Any Sgarbossa criteria for diagnosis of MI | Sensitivity 79% (95% CI 63-95%), specificity 100%, PPV 100%, NPV 79% | ||||
Interobserver agreement | Kappa scores 0.65, 0.69, 0.74, 0.77, 0.81 and 0.87 between observers, indicating good agreement. | ||||
Sokolove et al 2000 United States | ECG's from 224 patients with LBBB were independently interpreted by four cardiologists and four emergency physicians using the Sgarbossa clinical prediction rule. 100 ECG's were obtained from patients enrolled to the GUSTO-1 trial, who had MI confirmed by enzyme changes. 124 controls were selected from patients in the Duke Databank for Cardiovascular Disease who had stable, angiographically documented coronary artery disease and LBBB. | Retrospective cohort | Interobserver agreement | Excellent agreement both within groups (kappas 0.81, 0.84) and between cardiologists and emergency physicians (kappa 0.81) | Although the study does help to answer the three-part question, it was primarily designed to investigate interobserver agreement. |
Diagnosis of MI by cardiologists | Median sensitivity 73%, median specificity 98% | ||||
Diagnosis of MI by emergency physicians | Median sensitivity 67%, median specificity 99% | ||||
Shlipak et al 1999 United States | 103 presentations in 83 patients presenting with either chest pain, pulmonary oedema or post-cardiac arrest who had complete LBBB and cardiac enzyme estimation. ECG's evaluated as positive or negative according to the Sgarbossa clinical decision rule. All ECG's evaluated by the most senior electrocardiographer at the institution (intraobserver variability kappa 0.80). MI diagnosed according to characteristic presentation and either troponin or CK-MB elevation). | Prospective diagnostic cohort | Concordant ST elevation for diagnosis of MI | Sensitivity 7% (95% CI 1-21%), specificity 100% (95-100%), PPV 100%, NPV 71% | Not all patients had definitive troponin testing for the diagnosis of MI (some diagnosed using the now outdated CK-MB). Probabilities of survival were derived using data from other studies. Thus the statistics reported are inference not evidence and make considerable assumptions. |
ST depression V1-V3 for diagnosis of MI | Sensitivity 3% (0-17%), specificity 100% (95-100%), PPV 100%, NPV 71% | ||||
Discordant ST elevation >=5mm for diagnosis of MI | Sensitivity 19% (7-37%), specificity 82% (71-90%), PPV 32%, NPV 70%, LR+ 1.1, LR- 0.99 | ||||
Overall Sgarbossa algorithm for diagnosis of MI | Sensitivity 10% (2-26%), specificity 82% (71-90%), PPV 100%, NPV 72%, LR+ undefined, LR- 0.9. Taking the mid-range of the 95% CI for specificity (98%), LR+ can be estimated at 5.0. Given pre-test probability of 30%, this gives a post-test probability of 68%. For every 100 patients treated using these criteria, no patients would be inappropriately thrombolysed, three would be appropriately thrombolysed and 27 would be ineligible for thrombolysis despite having an MI. | ||||
Probability of stroke-free survival (derived by utilising data from other studies) | Thrombolysis for all: 92.6%; Thrombolysis for none 91.6%; Apply ECG algorithm to decide 91.6% |