Corrigendum for health-related quality of life and hospitalizations in chronic thromboembolic pulmonary hypertension versus idiopathic pulmonary arterial hypertension: And analysis from the Pulmonary Hypertension Association Registry.

[This corrects the article DOI: 10.1177/20458940211053196.].

The 6-min walk test (6MW) as an efficacy endpoint in pulmonary arterial hypertension clinical trials: demonstration of a ceiling effect.

BACKGROUND: PAH trials traditionally use 6MW as the primary endpoint. Concerns regarding a "ceiling effect" masking efficacy have led to exclusion of patients with milder disease from most trials (BL 6MW>450 m). STRIDE I evaluated the selective endothelin A receptor antagonist, sitaxsentan (SITAX), in a 12-week randomized, double-blind, trial (178 patients) employing placebo (PBO), 100 mg or 300 mg SITAX orally once daily in PAH and included patients with NYHA class II, congenital heart disease and a BL 6MW>450 m, groups often excluded from previous trials. METHODS: We analyzed 6MW effects For All Pts (intention-to treat) and those meeting Traditional enrollment criteria, defined as patients with NYHA class III or IV and 6MW< or =450 m at BL with idiopathic PAH or PAH related to connective tissue disease. The 100 mg and 300 mg SITAX arms are pooled based on similar treatment effects on 6MW. CONCLUSION: Existence of a "ceiling effect" is supported by these data. The magnitude of the treatment effect and statistical power when using 6MW as the endpoint. Comparisons between PAH trials that do not adjust for the effects of differing enrollment criteria require caution.

Value of posterior and right ventricular leads in comparison to the standard 12-lead electrocardiogram in evaluation of ST-segment elevation in suspected acute myocardial infarction.

In this multicenter prospective trial, we studied posterior (V7 to V9) and right ventricular (V4R to V6R) leads to assess their accuracy compared with standard 12-lead electrocardiograms (ECGs) for the diagnosis of acute myocardial infarction (AMI). Patients aged >34 years with suspected AMI received posterior and right ventricular leads immediately after the initial 12-lead ECG. ST elevation of 0.1 mV in 2 leads was blindly determined and inter-rater reliability estimated. AMI was diagnosed by World Health Organization criteria. The diagnostic value of nonstandard leads was determined when 12-lead ST elevation was absent and present and multivariate stepwise regression analysis was also performed. Of 533 study patients, 64.7% (345 of 533) had AMI and 24.8% received thrombolytic therapy. Posterior and right ventricular leads increased sensitivity for AMI by 8.4% (p = 0.03) but decreased specificity by 7.0% (p = 0.06). The likelihood ratios of a positive test for 12, 12 + posterior, and 12 + right ventricular ECGs were 6.4, 5.6, and 4.5, respectively. Increased AMI rates (positive predictive values) were found when ST elevation was present on 6 nonstandard leads (69.1%), on 12 leads only (88.4%), and on both 6 and 12 leads (96.8%; p <0.001). Treatment rates with thrombolytic therapy increased in parallel with this electrocardiographic gradient. Logistic regression analysis showed that 4 leads were independently predictive of AMI (p <0.001): leads I, II, V3, V5R; V9 approached statistical significance (p = 0.055). The standard ECG is not optimal for detecting ST-segment elevation in AMI, but its accuracy is only modestly improved by the addition of posterior and right ventricular leads.

Use of the emergency department observation unit in the treatment of acute asthma.

Because asthmatics have the highest utilization rate (11%) kin our emergency department (ED) observation unit (OU), we conducted a study correlating predictors of the need for OU therapy to initial disposition (ID) and final disposition (FD) using chart audit of treated asthmatics. Twenty-four clinical variables. (historical, physiological, laboratory, therapy response) were examined utilizing chi-square and Student's t tests. Forty-six asthmatics were treated during a four-month period in 1980. The ID breakdown was as follows: 1) home, 17; 2) OU, 23; and 3) admit, 6. Twenty-seven (59%) of the patients received treatment in the OU at some point in their attack (initial or rebound); 18 (39%) were definitively treated in the ED, and nine (20%) were admitted. The mean OU stay was 19 hours at a cost that was 34% of that incurred for a hospital admission. The FD differed from the ID in 14 of 46 (30%): 1) home, 12; 2) holding, observation, and short-term therapy, 18; and 3) admit, 16. Clinical variables correlating significantly with definitive therapy based on ID and FD were historical; symptoms greater than 24 hours, prior OU admissions, and prior hospitalizations. We conclude that the OU is appropriate, safe, and less expensive than admission; is not used for procrastination in decision making and decreases the hospitalization rate. Historical data correlated significantly with both ID and FD, while clinical variables were of little predictive value.

The evaluation of gross hematuria in anticoagulated patients: efficacy of i.v. urography and cystoscopy.

To determine the efficacy of investigating gross hematuria in anticoagulated patients, records were reviewed of 24 patients who had gross hematuria while being treated with warfarin for various thromboembolic disorders. All had IV urography, and half had cystoscopy. Sources of bleeding were found in seven (29%) of 24 patients by IV urography and in five (42%) of 12 patients by cystoscopy. Abnormalities considered responsible for bleeding included renal stones (four), transitional cell carcinoma (one), calcified renal mass (one), lymphoma (one), bladder tumors (two), hemorrhagic cystitis (two), and a bleeding prostate tumor (one). Additionally, an enlarged prostate was the only abnormal finding in five patients. If an enlarged prostate is considered a source of bleeding, the workup that included both IV urography and cystoscopy identified a cause of bleeding in 17 (71%) of 24 patients. The results suggest that IV urography and cystography are warranted in patients who take anticoagulants and who have gross hematuria.

High incidence of renal artery stenosis in patients with coronary artery disease.

The incidence of renal artery stenosis (RAS) in patients with coronary artery disease (CAD) has not been well documented. Over a 9-month period, 196 patients who underwent coronary angiography because of clinically suspected CAD had routine nonselective renal cine or digital subtraction angiography. There were 68 females and 128 males with a mean age of 63 years (range 35-85). Angiographically significant CAD was present in 152 patients (78%). Of the total patient cohort, 29 patients (15%) had mild RAS (< 50%), and 36 patients (18%) had significant RAS (> or = 50%). In patients with normal coronary arteries, only three patients (7%) had RAS. Thirty-three patients (92%) with severe RAS also had CAD. Of these 33 patients, 45% had hypertension, 30% had hyperlipidemia, 24% had diabetes mellitus, 24% had renal insufficiency (creatinine > or = 1.5), and 51% were smokers. In addition, it was noted that 20 of these patients (61%) had two or more of the above-listed clinical parameters. However, univariate analysis using the chi-square test revealed that only CAD (22% P < 0.03) and renal insufficiency (29% P < 0.15) were reliable clinical predictors of RAS. In conclusion, RAS is a frequent finding in patients with CAD, particularly when renal insufficiency is also present.

Value of serial myoglobin levels in the early diagnosis of patients admitted for acute myocardial infarction.

STUDY OBJECTIVE: The potential for missing the diagnosis of acute myocardial infarction (AMI) and the need for appropriate use of ICU beds make early and accurate diagnostic tests to assist in this diagnosis valuable. We studied the use of serial myoglobin determinations for patients evaluated in the emergency department and admitted for possible AMI. DESIGN: Over a 3.5-month period, all patients presenting to the ED and admitted for suspected cardiac symptoms had serial cardiac enzymes obtained prospectively at admission and 2, 3, 4, and 6 hours after the onset of symptoms. SETTING: Large urban community hospital. PARTICIPANTS: One hundred thirty-three consecutive patients admitted to treat or rule out AMI. RESULTS: Twenty-one of 22 patients with an initially normal myoglobin that doubled within 1 to 2 hours after presentation were positive for AMI (specificity, 95%). Sensitivity of myoglobin at 2 hours after the onset of symptoms was 37% and rose to 86% at 6 hours, with 95% specificity. The negative predictive value if myoglobin was normal at 6 hours and had not doubled within 2 hours was 97% (positive predictive value, 88%). CONCLUSION: A repeat myoglobin level that doubled within 1 to 2 hours after the initial value, even if still within the normal range, was highly specific for AMI. Serial myoglobin levels may be useful in earlier identification of AMI to help prevent inappropriate discharge from the ED and for appropriate placement in ICU beds.

ST segment elevation and the prediction of hospital life-threatening complications: the role of right ventricular and posterior leads.

UNLABELLED: Accurate prognosis in suspected acute myocardial infarction (AMI) is essential for appropriate use of thrombolytic therapy and primary angioplasty. However, previous models may be limited because the 12-lead electrocardiogram (ECG) does not examine the right ventricular (RV) and posterior myocardium. We evaluated ST segment elevation (STSE) in posterior (V7-V9) and RV (V4R-V6R) leads to determine their predictive value for hospital life-threatening complications (HLTCs). METHOD AND RESULTS: This prospective trial of seven Midwestern hospital emergency departments (EDs) had inclusion criteria of age 35 years, chest pain suggestive of ischemia, and coronary care unit (CCU) admission. ECG leads were test positive if STSE was > 0.1 mV. Patients were positive for HLTCs if ED or inpatient hospital course included: ventricular fibrillation or tachycardia, second- or third-degree block, shock, arrest, or death. Univariate and multivariate analyses were performed to test each lead's association with HLTCs. Of 533 patients, 64.7% (345/533) had AMI and 15.8% (85/533) had HLTCs. The sensitivity of 18 leads for HLTCS was increased by 5.8%, but specificity decreased by 8.2%. ECG subgroups by STSE were associated with the following HLTC rates: inferior/+RV (32.4%); anterior (29.5%), lateral (23.1%), inferior RV (17.9%), and posterior (16.2%). V1 (odds = 3.2) and V6R (odds = 3.1) were statistically significant independent predictors. CONCLUSION: Posterior and RV leads did not increase the ECG's overall prognostic value, but in the presence of inferior STSE, were associated with low and high complication rates, respectively. Right and left precordial leads were the best predictors of HTLCs.