Effect of maternal weight on postterm delivery.

OBJECTIVE: Examine the effect of prepregnancy weight and maternal gestational weight gain on postterm delivery rates. STUDY DESIGN: This was a retrospective cohort study of term, singleton births (N=375 003). We performed multivariable analyses of the association between postterm pregnancy and both prepregnancy body mass index (BMI) and maternal weight gain. RESULT: Prolonged or postterm delivery (41 or 42 weeks) was increasingly common with increasing prepregnancy weight (P<0.001) and increasing maternal weight gain (P<0.001). Underweight women were 10% less likely to deliver postterm than normal weight women who gain within the recommendations (adjusted odds ratio 0.90 (95% confidence interval 0.83, 0.97)). Overweight women who gain within or above recommendations were also at increased risk of a 41-week delivery. Finally, obese women were at increased risk of a 41-week delivery with increasing risk with increasing weight (below, within and above recommendations adjusted odds ratios 1.19, 1.21, and 1.27, respectively). CONCLUSION: Elevated prepregnancy weight and maternal weight gain both increase the risk of a postterm delivery. Although most women do not receive preconceptional care, restricting weight gain to the within the recommended range can reduce the risk of postterm pregnancy in normal, overweight and obese women.

The art and science of chart review.

BACKGROUND: Explicit chart review was an integral part of an ongoing national cooperative project, "Using Achievable Benchmarks of Care to Improve Quality of Care for Outpatients with Depression," conducted by a large managed care organization (MCO) and an academic medical center. Many investigators overlook the complexities involved in obtaining high-quality data. Given a scarcity of advice in the quality improvement (QI) literature on how to conduct chart review, the process of chart review was examined and specific techniques for improving data quality were proposed. METHODS: The abstraction tool was developed and tested in a prepilot phase; perhaps the greatest problem detected was abstractor assumption and interpretation. The need for a clear distinction between symptoms of depression or anxiety and physician diagnosis of major depression or anxiety disorder also became apparent. In designing the variables for the chart review module, four key aspects were considered: classification, format, definition, and presentation. For example, issues in format include use of free-text versus numeric variables, categoric variables, and medication variables (which can be especially challenging for abstraction projects). Quantitative measures of reliability and validity were used to improve and maintain the quality of chart review data. Measuring reliability and validity offers assistance with development of the chart review tool, continuous maintenance of data quality throughout the production phase of chart review, and final documentation of data quality. For projects that require ongoing abstraction of large numbers of clinical records, data quality may be monitored with control charts and the principles of statistical process control. RESULTS: The chart review module, which contained 140 variables, was built using MedQuest software, a suite of tools designed for customized data collection. The overall interrater reliability increased from 80% in the prepilot phase to greater than 96% in the final phase (which included three abstractors and 465 unique charts). The mean time per chart was calculated for each abstractor, and the maximum value was 13.7 +/- 13 minutes. CONCLUSIONS: In general, chart review is more difficult than it appears on the surface. It is also project specific, making a "cookbook" approach difficult. Many factors, such as imprecisely worded research questions, vague specification of variables, poorly designed abstraction tools, inappropriate interpretation by abstractors, and poor or missing recording of data in the chart, may compromise data quality.

Optimal reporting of health care process measures: inferential statistics as help or hindrance?

In this paper we discuss the appropriate application of inferential statistics to practice profiles and other measures of care. To accomplish our objectives, we first describe the relative merits of measuring three well-recognized domains of medical quality: structure, process, and outcome. Next, we discuss inferential statistics as used in quality improvement. We then describe several common circumstances that arise in the measurement of medical care, giving attention to the application of inferential statistics to each situation. We end with a brief discussion of statistical techniques commonly used in the measurement of quality and challenges that arise with their use.

Importance of time to reperfusion for 30-day and late survival and recovery of left ventricular function after primary angioplasty for acute myocardial infarction.

OBJECTIVES: The purpose of this study was to evaluate the importance of time to reperfusion for outcomes after primary angioplasty for acute myocardial infarction. BACKGROUND: Survival benefit of thrombolytic therapy for acute myocardial infarction is strongly dependent on time to treatment. Recent observations suggest that time to treatment may be less important for survival with primary angioplasty. METHODS: Consecutive patients (n=1,352) with acute myocardial infarction treated with primary angioplasty were followed for up to 13 years. Paired acute and follow-up ejection fraction data were obtained at cardiac catheterization in 606 patients. RESULTS: Reperfusion was achieved within 2 h in 164 patients (12%). Thirty-day mortality was lowest with early reperfusion (4.3% at <2 h vs. 9.2% at > or = 2 h, p=0.04) and was relatively independent of time to reperfusion after 2 h (9.0% at 2 to 4 h, 9.3% at 4 to 6 h, 9.5% at >6 h). Thirty-day-plus late cardiac mortality was also lowest with early reperfusion (9.1% at <2 h vs. 16.3% at > or = 2 h, p=0.02) and relatively independent at time to reperfusion after 2 h (16.4% at 2 to 4 h, 16.9% at 4 to 6 h, 15.6% at >6 h). Improvement in left ventricular ejection fraction was greatest in the early reperfusion group and relatively modest after 2 h (6.9% at <2 h vs. 3.1% at > or =2 h, p=0.007). CONCLUSIONS: Time to reperfusion, up to 2 h, is important for survival and recovery of left ventricular function. After 2 h, recovery of left ventricular function is modest and survival is relatively independent of time to reperfusion. These data suggest that factors other than myocardial salvage may be responsible for survival benefit in patients treated with primary angioplasty after 2 h.

A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention.

This report details a prospectively randomized clinical trial comparing mechanical clamp compression to hand applied pressure for attaining vascular hemostasis after coronary intervention. Effectiveness was determined by comparing the incidence of femoral vascular complications resulting from each of the 2 techniques. Eligible participants included 778 consecutive patients scheduled for percutaneous coronary intervention over an 8-month period. An unselected cohort of the eligible patients (n = 592), determined by the availability of cross-trained clinicians, underwent follow-up serial physical examinations by blinded observers for the duration of their hospital stay. A second, similarly determined cohort (n = 390), underwent color-duplex ultrasonography within 24 hours of sheath removal. Baseline demographic and clinical characteristics, sheath removal parameters, and subsequent outcomes were collected prospectively. The primary end point was a composite of ultrasound-defined femoral vascular complications: femoral artery thrombosis, echogenic hematoma, pseudoaneurysm, or arteriovenous fistulae formation. Complications diagnosed by physical examination constituted the second fundamental end point and included: persistent oozing, ecchymosis, hematoma, bruit, and pulsatile mass. Compared to manual compression, mechanical clamp hemostasis reduced the primary adverse end point by 63% (p = 0.041). Physical examination detected ecchymosis, oozing, and hematomas at equally high frequencies in the two cohorts. Although 65% of the patients in both treatment groups encountered at least one of these cosmetic complications, the diagnoses made by physical examination did not correlate with ultrasound-defined pathology. Multivariable stepwise logistic regression analysis identified a relationship of advanced age and lower body weight to vascular complications. Utilization of a mechanical clamp rather than conventional hand pressure to attain vascular hemostasis significantly reduces ultrasound-defined femoral vascular pathology. Discrepancies between physical examination and ultrasound diagnoses challenge the utility of clinical assessment alone and establish ultrasound as the diagnostic modality of choice.

Assessment of coronary reperfusion after thrombolysis with a model combining myoglobin, creatine kinase-MB, and clinical variables. TAMI-7 Study Group. Thrombolysis and Angioplasty in Myocardial Infarction-7.

BACKGROUND: Several biochemical markers have been investigated for the noninvasive assessment of reperfusion after myocardial infarction. Because myoglobin is released very soon after myocardial injury and clears rapidly after reperfusion, it may prove to be an excellent marker of occlusion and reperfusion. METHODS AND RESULTS: We examined the relation between various myoglobin measures and Thrombolysis In Myocardial Infarction (TIMI) flow grade in 96 patients enrolled in a study of front-loaded thrombolysis who underwent 90-minute angiography. We also combined myoglobin measures with models that include clinical and creatine kinase-MB variables. The myoglobin level measured within 10 minutes of acute angiography showed the best overall performance and was used for later analyses. Of the clinical variables examined, only time from symptom onset to thrombolysis and chest pain grade at angiography discriminated among TIMI flow grades. Combining the 90-minute myoglobin level and these clinical variables showed a significant difference (P<.0001) between both TIMI 3 versus TIMI 0 through 2 and TIMI 2 or 3 versus TIMI 0 or 1 flow. When the 90-minute myoglobin level was added to an established predictive model containing clinical variables and creatine kinase-MB measures, its contribution remained significant (P=.044). The area under the receiver operator characteristic curve for this combined model was .88. CONCLUSIONS: A single myoglobin measurement obtained 90 minutes after the start of thrombolysis, combined with select clinical variables and creatine kinase-MB levels, enhances the noninvasive prediction of reperfusion after myocardial infarction.

Comparison of inpatient charges between academic and nonacademic services in a children's hospital.

OBJECTIVE: To compare inpatient hospital charges generated within a children's hospital by academic and nonacademic pediatric services for common medical diagnoses. METHODS: Hospital admissions to a free-standing children's hospital between 9/1/90 and 8/30/94 were selected for patients who were hospitalized 1 to 14 days, with one of six selected diagnoses, and with discharge attending of record either a private pediatrician or an academic subspecialist. Discharge diagnoses, based on ICD-9 codes, included asthma (n = 1983), bronchiolitis (n = 692), gastroenteritis (n = 733), rule out sepsis (n = 1065), urinary tract infection (n = 516), and viral meningitis (n = 288). Charges associated with patient records were dichotomized as above or below the median charge for each diagnostic category. Each category was analyzed separately using a logistic regression model where the dichotomous-dependent variable was charges above the median charge for each diagnosis. Independent variables included physician type, payor status, patient residence, ICD-9 code as primary or secondary diagnosis, patient age, and presence of complicating conditions. RESULTS: By univariate comparison, academic physicians cared for a higher percentage of underinsured patients, and their care was more expensive. Complicated claims were associated with higher charges than uncomplicated claims for all diagnostic categories. Academic and nonacademic physicians were equally likely to generate above-median charges for five of the six diagnostic categories when controlling for confounding factors. A linear regression model in which charge was the dependent variable generated similar results. CONCLUSIONS: Within the same pediatric health care facility, no consistent difference was found between charges incurred on academic vs private inpatient services.

Cytomegalovirus pericarditis: a case series and review of the literature.

Cytomegalovirus (CMV) commonly infects both normal and immunocompromised hosts. Although it usually produces an asymptomatic infection to mild illness, CMV has the potential to significantly injure many different organs. Reports of CMV causing pericardial disease, however, are limited and documentation of infection by growth of the virus from tissue or fluid is rare. As part of a prospective trial of subxiphoid pericardial biopsy in 57 adult patients with large pericardial effusions, three culture-proven cases and one serologically confirmed case of CMV pericardial disease were discovered. Subsequently, CMV was grown from the pericardium of an infant with congenital heart disease. A review of the documented cases of CMV pericarditis is provided along with a discussion of the pathogenesis and significance of this perhaps not so uncommon disease.

Intravenous Fluosol in the treatment of acute myocardial infarction. Results of the Thrombolysis and Angioplasty in Myocardial Infarction 9 Trial. TAMI 9 Research Group.

BACKGROUND: This study was performed to determine the safety and potential efficacy of an intravenous perfluorochemical emulsion (Fluosol) as an adjunct reperfusion therapy aimed at preventing reperfusion injury for patients with acute myocardial infarction. METHODS AND RESULTS: Patients (430) were randomized in a prospective open-labeled study, 213 to receive Fluosol and 217 to receive no Fluosol, along with 100 mg of tissue-type plasminogen activator given over 3 hours. Major end points included global ejection fraction, regional wall motion analysis, infarct size as measured by tomographic thallium imaging, and a composite clinical outcome measure. Baseline patient and angiographic characteristics were similar in the two groups. No significant difference in global ejection fraction (52% without Fluosol, 51% with Fluosol) or regional wall motion (-2.4 SD/chord with Fluosol, -2.2 SD/chord without Fluosol) was demonstrated in patients receiving Fluosol versus those not receiving Fluosol, nor was there a significant difference in thallium infarct size. Although Fluosol-treated patients with anterior infarction had an insignificantly lower mean infarct size (18.7% of the left ventricle) compared with patients with anterior infarction not treated with Fluosol (21.2% of left ventricle), this trend was not evident in the median infarct size values (22% versus 17%), left ventricular ejection fraction values (46% without Fluosol, 47% with Fluosol), or regional wall motion (-2.5 SD/chord in both groups). Rates of death and stroke were no different in the two groups; however, patients who received Fluosol experienced less recurrent ischemia. Patients receiving intravenous Fluosol had more transient congestive heart failure and pulmonary edema, perhaps because of necessary fluid administration. There was no difference in hemorrhagic complications between the two study groups. CONCLUSIONS: When given with a thrombolytic agent, Fluosol was not associated with improvement in ventricular systolic function, reduction in thallium infarct size, or overall clinical outcome. Fluosol was, however, associated with a reduction in ischemic complications and with an increase in pulmonary edema and congestive heart failure.

A prospective trial of subxiphoid pericardiotomy in the diagnosis and treatment of large pericardial effusion. A follow-up report.

OBJECTIVE: This study was designed to determine the cause of large pericardial effusions and evaluate the efficacy of subxiphoid pericardiotomy. SUMMARY BACKGROUND DATA: Despite great advances in the techniques used to diagnose pericardial effusions, much controversy remains concerning their cause and the optimal treatment of these effusions. METHODS: In a prospective consecutive case series, 57 patients underwent a thorough preoperative evaluation followed by a subxiphoid pericardiotomy. All tissue and fluid was exhaustively evaluated. Postoperatively, all patients were followed for a least 1 year. RESULTS: Surgery was performed under local anesthesia in 77% of patients, and the complications of surgery were minimal. Pericardial tissue and fluid established or aided in establishing a diagnosis in 81% of patients. Infection and malignancy were the leading causes; the condition in only 4 patients remained undiagnosed. Follow-up revealed recurrent effusion in nine (16%) patients, but only five (9%) required further surgery. The mortality rate at 30 days was 12%, and at 1 year, it was 37%. Fourteen of the 21 deaths occurred in patients with malignancies. CONCLUSIONS: These data show that the cause of most large pericardial effusions can be determined by a thorough evaluation accompanied by subxiphoid pericardiotomy. In addition, subxiphoid pericardial biopsy and window creation is safe and effective in the treatment of these effusions.

Noninvasive detection of reperfusion after thrombolysis based on serum creatine kinase MB changes and clinical variables. TAMI 7 Study Group. Thrombolysis and Angioplasty in Myocardial Infarction.

Coronary artery patency after thrombolytic therapy has important prognostic implications for survival after acute myocardial infarction. The ability to noninvasively identify patients early after thrombolysis may therefore allow other strategies, such as adjunctive therapy or rescue angioplasty, to be used to restore patency of the infarct-related artery. This study examined the use of a rapid creatine kinase (CK)-MB assay in conjunction with selected clinical variables for noninvasive detection of reperfusion after thrombolysis. Patients were enrolled in a study evaluating accelerated plasminogen activator dose regimens with patency assessments by first angiographic injection during acute angiography at a median and interquartile range (25th and 75th percentiles) 142 (96,195) minutes after starting thrombolytic therapy. Serum CK-MB samples measured by a rapid dual monoclonal antibody assay were obtained in 207 patients before (baseline) and 30 minutes, 90 minutes, and 3 hours after starting thrombolytic therapy. In 109 patients a CK-MB sample was obtained within 10 minutes of acute angiography (angio sample). At acute angiography the infarct-related artery was patent (Thrombolysis in Myocardial Infarction trial grade 2 to 3 flow) in 71%. Baseline CK-MB values were similar in patients with and without later reperfusion at acute angiography: 3 (0,8) ng/ml and 0 (0,4) ng/ml, respectively. At acute angiography, patients with successful reperfusion had higher CK-MB values [46 (20,138) ng/ml] compared with patients with persistent occlusion of the infarct-related artery [8 (3,63) ng/ml; p = 0.002).(ABSTRACT TRUNCATED AT 250 WORDS)

Mycoplasmal pericarditis: evidence of invasive disease.

Although the pathogenic mycoplasmas usually infect the respiratory and urogenital tracts, these organisms also can cause disease in remote sites. Such infections are difficult to diagnose because of both the fastidious nature of the mycoplasmas and the failure to consider their presence. Pericarditis is an uncommonly diagnosed and rarely confirmed example of invasive mycoplasmal infection. As part of a prospective study of large pericardial effusions, we discovered two cases with Mycoplasma pneumoniae infection. Subsequently, two cases of pericarditis due to Mycoplasma hominis and one due to Ureaplasma urealyticum were diagnosed. For all five patients, cultures of pericardial tissue and/or fluid were positive. In addition, four of the five patients either were immunocompromised or had undergone cardiac surgery previously. Appropriate antibiotic therapy was uniformly effective. We report here our experience with mycoplasmal pericarditis, provide evidence of an invasive pathogenesis for this syndrome, and suggest that pericardial disease caused by these organisms may not be an uncommon finding when sought in an aggressive manner.

Etiology of large pericardial effusions.

PURPOSE: To determine the effectiveness of the preoperative evaluation and overall diagnostic efficacy of subxiphoid pericardial biopsy with fluid drainage in patients with new, large pericardial effusions. DESIGN: A prospective interventional case series of consecutive patients admitted with new, large pericardial effusions. PATIENTS AND METHODS: Fifty-seven of 75 consecutive patients admitted to a university tertiary-care center and a university-affiliated Veterans Administration Medical Center with new, large pericardial effusions were studied over a 20-month period. Each patient was assessed by a comprehensive preoperative evaluation followed by subxiphoid pericardiotomy. The patients' tissue and fluid samples were studied pathologically and cultured for aerobic and anaerobic bacteria, fungi, mycobacteria, mycoplasmas, and viruses. RESULTS: A diagnosis was made in 53 (93%) patients. The principle diagnoses consisted of malignancy in 13 (23%) patients; viral infection in 8 (14%) patients; radiation-induced inflammation in 8 (14%) patients; collagen-vascular disease in 7 (12%) patients; and uremia in 7 (12%) patients. No diagnosis was made in four (7%) patients. A variety of unexpected organisms were cultured from either pericardial fluid or tissue: cytomegalovirus (three), Mycoplasma pneumoniae (two), herpes simplex virus (one), Mycobacterium avium-intracellulare (one), and Mycobacterium chelonei (one). The pericardial fluid yielded a diagnosis in 15 (26%) patients, 11 of whom had malignant effusions. The examination of pericardial tissue was useful in the diagnosis of 13 (23%) patients, 8 of whom had an infectious agent cultured. Of the 57 patients undergoing surgery, the combined diagnostic yield from both fluid and tissue was 19 patients (33%). CONCLUSIONS: A systematic preoperative evaluation in conjunction with fluid and tissue analysis following subxiphoid pericardiotomy yields a diagnosis in the majority of patients with large pericardial effusions. This approach may also result in the culturing of "unusual" infectious organisms from pericardial tissue and fluid.

Lack of impact of early catheterization and fibrin specificity on bleeding complications after thrombolytic therapy. The TAMI Study Group.

OBJECTIVES: The aim of this study was to assess the hemorrhagic risk associated with fibrin-specific thrombolytic therapy and invasive procedures with acute myocardial infarction. BACKGROUND: Successful coronary artery reperfusion has important prognostic implications. Because immediate coronary angiography is the only method proved to differentiate early fibrinolytic success from failure, its use may be important for selected patients. METHODS: Five hundred seventy-five patients were evaluated with six combined thrombolytic and catheterization strategies. Patients were randomized to intravenous urokinase alone, recombinant tissue-type plasminogen activator (rt-PA) alone, or both; simultaneously they were randomized to an immediate versus a deferred catheterization strategy. Hemorrhagic events were assessed. The correlation of hemorrhage with clinical and hemostatic variables was evaluated. Prespecified transfusion criteria were employed. RESULTS: No difference in baseline characteristics or in hemorrhagic complications was noted among the three thrombolytic regimens. Although mild (< 250 ml) bleeding was more common in the group with immediate catheterization, no clinically significant difference among catheterization groups was seen in moderate to life-threatening hemorrhagic events. Most bleeding occurred at vascular access sites, yet severe and life-threatening hemorrhage occurred in < 1% of patients. Baseline and nadir fibrinogen levels, change in baseline fibrinogen levels and peak fibrin and fibrinogen degradation products did not correlate with bleeding risk. A clinical predisposition for bleeding was observed in women as well as older (> or = 65 years) and lighter (< or = 70 kg) patients. With prespecified transfusion criteria, only a minimal increase in blood product usage was noted with immediate catheterization. CONCLUSIONS: Immediate cardiac catheterization can be accomplished without a clinically significant difference in bleeding risk. Fibrin specificity offers no clear advantage in reducing hemorrhagic risk. Bleeding risk correlates best with baseline patient characteristics. Finally, the amount of blood transfused can be reduced with lower transfusion criteria.

Diagnosis and management (by subxiphoid pericardiotomy) of large pericardial effusions causing cardiac tamponade.

To determine the clinical features, course and outcome of patients with cardiac tamponade, 57 consecutive patients with new, large pericardial effusions were prospectively studied. Twenty-five patients (44%) developed cardiac tamponade with venous hypertension and a pulsus paradoxus greater than 10 mm Hg. Electrocardiography, radiographic studies and echocardiography did not differentiate patients with and without tamponade. All 57 patients underwent thorough diagnostic evaluation followed by subxiphoid pericardial biopsy and drainage. A diagnosis was obtained in 53 patients (93%). Collagen vascular disease was significantly more frequent in the 25 patients with than in the 32 without cardiac tamponade (24 vs 3%; p less than 0.05). The frequency of malignant and uremic effusions was equal in both groups, whereas radiation-induced effusions seldom produced tamponade. At 1-year follow-up, 3 patients (12%) with tamponade had recurrent effusions, and 1 needed reoperation. This was not significantly different from the 32 patients without tamponade. Twelve-month mortality was also similar in both groups (36 vs 44%). This prospective series disclosed several unexpected findings: (1) Cardiac tamponade occurred in almost 50% of patients with new large pericardial effusions; (2) both malignancy and collagen vascular disease occurred with equal frequency as etiologies, whereas radiation-induced tamponade was unusual; (3) thorough clinical evaluation resulted in few idiopathic etiologies; and (4) subxiphoid pericardiotomy was effective for both diagnosis and therapy of tamponade.

Subxiphoid pericardiotomy in the diagnosis and management of large pericardial effusions associated with malignancy.

To determine the safety, diagnostic value, and clinical outcome of patients with malignancy undergoing subxiphoid pericardiotomy for large pericardial effusions, we prospectively studied 25 consecutive patients with malignancy and new, large pericardial effusions diagnosed by echocardiography. Twenty-two of the 25 operations were done under local anesthesia, and no patient died at surgery. Pericardial fluid cytology revealed malignant cells in 11 patients (44 percent), while tumor was seen in only five (45 percent) of these 11 patients on pathologic examination. The remaining 14 patients showed no evidence of pericardial invasion with tumor. Evidence of intrathoracic disease by CT or MRI scanning, tamponade, a sanguineous pericardial fluid character, and an elevated serum and pericardial fluid lactate dehydrogenase level all were suggestive of malignant invasion of the pericardium. All 25 patients were followed at least 12 months postoperatively. Effusions recurred in three patients (12 percent), and one patient required reoperation. Overall mortality was 72 percent with a 91 percent (10 of 11) mortality for those with malignant effusions and a 57 percent (8 of 14) mortality for those with nonmalignant effusions. Diagnostically, subxiphoid pericardiotomy has little advantage over examination of pericardial fluid alone in this group of patients. Therapeutically, however, it is a low morbidity procedure which is safe and effective in treating patients with malignancy and large pericardial effusions.

Accelerated plasminogen activator dose regimens for coronary thrombolysis. The TAMI-7 Study Group.

To determine the clinical profile and efficacy of accelerated recombinant tissue-type plasminogen activator (rt-PA) dose regimens, five different strategies of thrombolytic therapy in a total of 232 patients were systematically evaluated in the setting of acute myocardial infarction. The fifth strategy involved a combination of accelerated rt-PA and intravenous urokinase (regimen E). A weight-adjusted dose of 1.25 mg/kg body weight of tissue plasminogen activator over 90 min (regimen C) yielded the highest coronary patency rate (83%) at acute angiography. The associated in-hospital reocclusion rate for this regimen was low (4%). An exaggerated (60-min) dosage regimen yielded an inferior coronary patency rate (63%). Combination therapy (regimen E) was associated with a 72% patency rate and 3% reocclusion rate. Marginal improvement in global ejection fraction and regional wall function was demonstrated with all strategies by predischarge catheterization. Bleeding complications were most common at the periaccess site and were not different from those in previous experiences reported with conventional 3-h dosing regimens. Measurements of baseline, 30-min and 3-h levels of tissue plasminogen activator, fibrinogen and fibrin(ogen) degradation products were obtained. At 3 h, fibrinogen levels of less than 1 g/liter were demonstrated with combination therapy (regimen E) as well as with regimen C. Major clinical outcomes including death, reocclusion and reinfarction also showed a tendency to be less common with regimen C. Therefore, although accelerated dose regimens of rt-PA do not reliably yield acute coronary patency rates greater than 85%, an acute coronary patency rate of approximately 85% can be approached.(ABSTRACT TRUNCATED AT 250 WORDS)

Usefulness of a pericardial friction rub after thrombolytic therapy during acute myocardial infarction in predicting amount of myocardial damage. The TAMI Study Group.

To evaluate the clinical incidence and outcomes of patients with pericarditis after thrombolytic therapy, 810 patients were prospectively studied during acute myocardial infarction (AMI). Pericarditis was defined as the presence of a pericardial friction rub during the hospital course. Only 5% of patients developed a rub during AMI, a low percent compared with that in the prethrombolytic era. A pericardial friction rub more often occurred in the setting of an anterior wall AMI. Patients with, compared to those without, a pericardial friction rub had lower ejection fractions (45 vs 51%, p = 0.002); worse regional left ventricular function (-3.2 vs 2.7, standard deviation per chord); higher in-hospital mortality (15 vs 6%, p = 0.056); a higher frequency of power failure (83 vs 57%); a higher frequency of anterior wall location of the AMI (53% of cases, p = 0.002); and a higher frequency of 3-vessel disease. Therefore, although the frequency of a pericardial friction rub was low (5%) compared with that in the prethrombolytic era, its occurrence denotes more extensive myocardial damage with a worse clinical outcome. Perhaps with successful reperfusion of the infarct-related vessel, transmural myocardial necrosis is prevented and with it the development of pericarditis. Cardiac tamponade did not occur clinically in any patient who developed a pericardial friction rub.

Results of high dose intravenous urokinase for acute myocardial infarction.

To determine the outcome of patients after treatment with high-dose intravenous urokinase (3 million U) 102 patients were prospectively evaluated in the setting of acute myocardial infarction. The first 61 patients received intravenous urokinase as a continuous infusion and the last 41 patients were treated with an initial 1.5 million U intravenous bolus. Sixty-two percent of all patients had patent infarct-related arteries by the time of immediate angiography (median time 2.2 hours), which was performed in all patients. There was no significant difference in patency rates between patients treated with or without an initial intravenous bolus. Twenty-eight (28%) patients developed clinical evidence of recurrent ischemia (death, reocclusion, emergency angioplasty, urgent bypass surgery) during hospitalization, whereas only 7 (7%) developed angiographically documented reocclusion. Of 28 patients who failed to achieve successful reperfusion at the time of immediate catheterization, rescue angioplasty was technically successful in establishing reperfusion in all but 1 patient. No significant improvement in median global left ventricular function was seen between immediate (48%) and follow-up catheterization (48%). Significant bleeding complications were unusual except in 1 patient who experienced an intracranial hemorrhage. Eight (8%) patients died during hospitalization. Therefore, the use of high-dose intravenous urokinase in patients with acute myocardial infarction is associated with a 62% patency rate, a low incidence of reocclusion and bleeding complications and a high technical success rate with rescue angioplasty at the time of immediate catheterization.(ABSTRACT TRUNCATED AT 250 WORDS)