How safely and for how long can warfarin therapy be withheld in prosthetic heart valve patients hospitalized with a major hemorrhage?

STUDY OBJECTIVES: To identify the risk of thromboembolism after withholding or reversing the effect of warfarin therapy following a major hemorrhage. DESIGN: Retrospective medical record review. SETTING: Tertiary-care hospital. PATIENTS: Twenty-eight patients with prosthetic heart valves receiving warfarin were hospitalized for major hemorrhage from 1990 to 1997. The mean +/- SD age was 61 +/- 11 years (15 men and 13 women). Twenty patients had St. Jude valves, 4 patients had Carpentier-Edwards bioprosthetic valves, 2 patients had Starr Edwards valves, and 2 patients had Bjork-Shiley valves. Valves were in the mitral position in 12 patients, the aortic position in 12 patients, and both mitral and aortic positions in 4 patients. The average interval from valve surgery to index bleeding was 7 years. Twenty-five patients had GI or retroperitoneal hemorrhage, 2 patients had an intracranial hemorrhage, and 1 patient had a subdural hematoma. INTERVENTIONS: Vitamin K was administered to five patients and fresh frozen plasma was given to seven patients to reverse anticoagulation. The mean duration of anticoagulation withholding was 15 +/- 4 days. MEASUREMENTS AND RESULTS: None of the patients had thromboembolic complications. There were four in-hospital deaths. Twenty-two of the 24 hospital survivors resumed warfarin therapy at hospital discharge. At 6-month follow-up, 10 of 19 patients remaining on warfarin therapy had recurrent GI bleeding. CONCLUSIONS: Thromboembolic risk is low in prosthetic heart valve patients hospitalized with major hemorrhage when their warfarin therapy is reversed or withheld. Recurrent bleeding within 6 months of the resumption of anticoagulation is common, and aggressive treatment of the bleeding source and the risk-benefit ratio of continued anticoagulation need to be considered.

Evaluation of guidelines for the use of telemetry in the non-intensive-care setting.

To determine if the American College of Cardiology (ACC) cardiac monitoring guidelines accurately stratify patients according to their risks for developing clinically significant arrhythmias in non-intensive-care settings, we conducted a prospective cohort study of 2,240 consecutive patients admitted to a non-intensive-care telemetry unit over 7 months. Sixty-one percent of patients were assigned to ACC class I (telemetry indicated in most patients), 38% to class II (telemetry indicated in some), and 1% to class III (telemetry not indicated). Arrhythmias were detected in 13.5% of the class I patients, 40.7% of the class II patients, and 12% of the class III patients (p <.001). Telemetry detected an arrhythmia resulting in transfer to an intensive care unit in 0.4% of the class I patients, 1.6% of the class II patients, and none of the class III patients (p =.006). Telemetry led to a change in management for 3.4% of the class I patients, 12.7% of the class II patients, and 4% of the class III patients (p <.001). When patients with chest pain as the reason for admission were moved from class I to class II and patients with arrhythmias as the reason for admission were moved from class II to class I, more arrhythmias and more clinically significant arrhythmias occurred in class I patients and the trends from class I to class III were more consistent with the purpose of the guidelines. These findings indicate that when the ACC guidelines are reexamined, consideration should be given to changing them so they are more useful in non-intensive-care settings.

Quality of history taking in patients with aortic dissection.

STUDY OBJECTIVES: Aortic dissection generally is an acute catastrophe. Rapid diagnosis is critical. We hypothesized that the quality of history taking contributes to the accuracy of diagnosis in patients with dissection. DESIGN: Retrospective chart review of 83 patients, whose diagnosis of aortic dissection was confirmed by autopsy, surgery, CT scan, echocardiogram, or angiogram. The quality of the initial history was reviewed using predetermined criteria. The physicians' initial clinical impressions were recorded. RESULTS: The examining physician correctly suspected aortic dissection after the initial clinical evaluation in 54 of 83 patients (65%). Only 33 of 78 patients with symptoms (42%) were asked about the quality, location, and onset of their pain, the three descriptors identified a priori as important. In 19 patients (24%), only zero or one descriptor was recorded. When all three questions were asked, dissection was suspected in 30 of 33 patients (91%); when zero, one, or two questions were asked, dissection was suspected in 22 of 45 patients (49%). CONCLUSION: Despite important advances in diagnostic imaging, accurate diagnosis of aortic dissection requires an accurate history. In our series, the quality of initial history was associated with the accuracy of the initial clinical impression in patients with aortic dissection.

Torsades de Pointes associated with intravenous haloperidol in critically ill patients.

In this retrospective case-control study, 8 of 223 consecutive patients (3.6%) treated with intravenous haloperidol developed torsades de pointes, and were compared with 41 patients randomly selected as controls. The likelihood of torsades de pointes associated with intravenous haloperidol is significantly greater in patients receiving > or = 35 mg over 24 hours or in those with a QTc interval of >500 ms, or both.

Role of telemetry monitoring in the non-intensive care unit.

To determine the outcomes of patients admitted to a non-intensive care telemetry unit and to assess the role of telemetry for guiding patient management decisions, data from 2,240 patients admitted to a telemetry unit were collected prospectively during 7 months. Physicians recorded the outcomes (intensive care unit transfer and mortality) and assessed whether telemetry assisted in guiding patient management. Indications for admission to the telemetry unit included chest pain syndromes (55%), arrhythmias (14%), heart failure (12%), and syncope (10%). Telemetry led to direct modifications in management in 156 patients (7%; 95% confidence interval [CI] 5.9% to 8%). Telemetry was perceived as useful but did not alter management for 127 patients (5.7%; 95% CI 4.7% to 6.6%). Two hundred forty-one patients were transferred to an intensive care unit from the telemetry unit (10.8%; 95% CI 9.5% to 12%). Nineteen patients (0.8% of all admissions; 95% CI 0.5% to 1.2%) were transferred because of an arrhythmia identified by telemetry. Routine transfer after cardiac revascularization or surgery accounted for 134 transfers; clinical deterioration accounted for 88 transfers. There were 20 deaths in the unit (0.9%; 95% CI 0.5% to 1.3%): 4 of the 20 deaths occurred while patients were being monitored. The role of telemetry in guiding patient management may be overestimated by physicians, since it detected significant arrhythmias that led to change in medications or urgent interventions in a small fraction of patients.

Pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I): reduction in atherosclerosis progression and clinical events. PLAC I investigation.

OBJECTIVES: This study was designed to evaluate the effect of pravastatin on progression of coronary atherosclerosis and ischemic events in patients with coronary artery disease and mild to moderate hyperlipidemia. BACKGROUND: Few clinical trial data support the use of lipid-lowering therapy in patients with coronary artery disease and mild to moderate elevations in cholesterol levels. METHODS: Four hundred eight patients (mean age 57 years) with coronary artery disease and low density lipoprotein (LDL) cholesterol > or = 130 mg/dl (3.36 mmol/liter) but < 190 mg/dl ([4.91 mmol/liter]) despite diet were randomized in a 3-year study to receive pravastatin or placebo. Atherosclerosis progression was evaluated by quantitative coronary arteriography. RESULTS: Baseline mean LDL cholesterol was 164 mg/dl (4.24 mmol/liter). Pravastatin decreased total and LDL cholesterol and triglyceride levels by 19%, 28% and 8%, respectively, and increased high density lipoprotein cholesterol by 7% (p < or = 0.001 vs. placebo for all lipid variables). Progression of atherosclerosis was reduced by 40% for minimal vessel diameter (p = 0.04), particularly in lesions < 50% stenosis at baseline. There was a consistent although not statistically significant effect on mean diameter and percent diameter stenosis. There were also fewer new lesions in those assigned pravastatin (p < or = 0.03). Myocardial infarction was reduced during active treatment (8 in the pravastatin group, 17 in the placebo group; log-rank test, p < or = 0.05; 60% risk reduction), with the benefit beginning to emerge after 1 year. CONCLUSIONS: In patients with coronary artery disease and mild to moderate cholesterol elevations, pravastatin reduces progression of coronary atherosclerosis and myocardial infarction. The time course of event reduction increases the potential for a relatively rapid decrease in the clinical manifestations of coronary artery disease with lipid lowering.

Transesophageal echocardiography in evaluation of atrial masses.

Clinical and transthoracic echocardiographic findings in 92 patients who had atrial mass lesions identified by transesophageal echocardiography were retrospectively analyzed. Transthoracic echocardiography failed to diagnose or misdiagnosed 16 patients with small (< 3 cm) atrial thrombi, patients with thrombi localized to the appendage, or patients with technically difficult studies. The 3 patients with atrial myxoma who were not detected or were misdiagnosed by transthoracic echocardiography had small tumors (< 3 cm) or origin from the free wall of the atrium away from the atrial septum. Transthoracic study also failed to diagnose or misdiagnosed normal anatomic variants in 17 of 32 patients. In conclusion, transesophageal echocardiography is superior to the transthoracic study in evaluating the etiology and significance of atrial mass lesions.

Outcomes of patients hospitalized to a telemetry unit.

To describe the clinical course of patients admitted to a nonintensive care telemetry unit and to determine whether telemetry identifies patients at risk for transfer to the intensive care unit (ICU), 467 patients hospitalized for cardiac monitoring in a nonintensive care telemetry unit were followed until death or discharge. The American College of Cardiology guidelines for telemetry use were applied: 65% of patients were class I (monitoring definitely indicated); 33% class II (probably indicated); and 2% class III (not indicated). In 5 patients (1%), telemetry contributed to the decision for a transfer to the ICU. In 462 patients, telemetry added no significant information. Thirty-eight patients (8.1%) were transferred to an ICU: 22 because of cardiac deterioration and 16 because of noncardiac clinical deterioration. Eighteen percent of patients in class I (95% confidence interval [CI], 14.1 to 22.8), 12% in class II (95% CI, 6.7 to 17), and none in class III (95% CI, 0 to 26) were transferred to the ICU (p = 0.03). Nine patients died (1.9%), 4 with terminal illness. Three patients died while on telemetry: 1 had metastatic lung cancer and 2 died suddenly of cardiac causes during initial evaluation on the ward. Telemetry identified the terminal rhythm in the 3 patients. Patients admitted to a non-ICU monitored ward with ischemic syndromes, heart failure, and arrhythmia rarely deteriorated. Patients who did deteriorate were recognized clinically without appreciable contribution from the monitoring process. It remains unproven that heart rhythm monitoring in general practice units improves patient care.

Efficacy and safety of pravastatin in the long-term treatment of elderly patients with hypercholesterolemia.

PURPOSE: Elevated cholesterol levels are a major risk factor for coronary heart disease, which remains a significant problem in patients beyond age 65 years. Because drug therapy for the control of hypercholesterolemia in elderly patients is frequently considered to be indicated, we investigated the efficacy and safety of pravastatin in the treatment of elderly subjects with primary hypercholesterolemia. PATIENTS AND METHODS: In this 96-week, multicenter, double-blind, placebo-controlled study, 142 subjects (95 women, 47 men) 64 to 90 years of age with elevated cholesterol levels despite dietary intervention were randomized to receive pravastatin 20 mg at bedtime or matching placebo (2:1). Dosage could be doubled after 8 weeks, a bile acid-binding resin could be added after 16 weeks, and nicotinic acid or probucol could be added after 32 weeks, as needed, to adequately lower the low-density lipoprotein cholesterol (LDL-C) levels. RESULTS: Significant reductions in the levels of LDL-C (-30.9%), total cholesterol (Total-C; -21.9%), and triglycerides (TG; -16.7%) and significant increases in the levels of high-density lipoprotein cholesterol (HDL-C; 11.3%) were noted in the group receiving pravastatin treatment at 16 weeks (P < or = 0.001 compared with baseline, P < or = 0.01 compared with placebo). The cholesterol-lowering effects of pravastatin were sustained throughout the 96 weeks of the trial. Pravastatin was well tolerated, with an overall incidence of adverse events nearly identical to that of placebo. CONCLUSIONS: In this study, pravastatin was well tolerated and effective in lowering LDL-C, Total-C, and TG and in raising HDL-C during long-term treatment of elderly patients with primary hypercholesterolemia.

Consortium Research on Indicators of System Performance (CRISP).

Since the CRISP project is in its early stages, reports of performance indicator data are not yet available. It will be late in 1994 before we have sufficient experience with our measures to encourage their use for both internal quality improvement and external evaluation. Some of our participating systems are quite far along in the development of individual indicators and have some experience with their fluctuations over time, but we are just beginning the process of studying cross-system comparisons. Use of measures in comparing the performance of integrated delivery systems is still an unproved technology, no matter how successful the measures may have been in other contexts. We believe that our approach to measuring system performance fits very well with the current direction of health care reform. We hope that the project will allow integrated systems of care to take a lead role in defining and testing measures of performance.

Design and recruitment in the United States of a multicenter quantitative angiographic trial of pravastatin to limit atherosclerosis in the coronary arteries (PLAC I).

The present study was designed to test the effect of pravastatin, a new, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, on the progression of coronary artery disease in patients with moderate hypercholesterolemia. Angiographic entry criteria included the presence of > or = 1 stenosis > or = 50% in a major epicardial coronary artery, and certification of film quality through the core angiography laboratory. Patients qualified for randomization if after diet stabilization their low density lipoprotein cholesterol concentrations were > or = 130 and < 190 mg/dl, and triglycerides were < or = 350 mg/dl. Pravastatin (40 mg) or placebo is administered once daily at bedtime. Arteriography will be repeated at the end of 3 years of treatment. The primary end point of the study is the change in absolute mean coronary artery diameter. During a 30-month recruitment period, 44,145 patients were screened, and 408 were randomized. The most frequent reason for excluding patients during the screening and dietary lead-in periods was a low serum cholesterol level. A large proportion of patients with documented coronary artery disease have cholesterol concentrations that are considered to be normal or only modestly increased. Adherence to strict standards of quality control for digital analysis of angiograms ensures that baseline angiograms can be interpreted at the end of 3-year follow-up.

Clinical activities and satisfaction of general internists, cardiologists, and ophthalmologists.

To define factors that affect the levels of practice satisfaction of different specialities, an observer recorded the activities of 15 physicians in practice (nine general internists, three cardiologists, and three ophthalmologists) as they examined 304 clinic patients. General internists reported less satisfaction with their clinics than did the other physicians and attributed their satisfaction primarily to successful social interaction in 54% of visits, while cardiologists most often derived satisfaction from intellectual stimulation (50%) and ophthalmologists from medical success (81%). The general internists whom the authors observed are less satisfied with clinical encounters than are cardiologists and ophthalmologists and derive satisfaction mostly from social interaction, not biomedical aspects of care.

Transesophageal echocardiographic features of normal and dysfunctioning bioprosthetic valves.

Transesophageal and transthoracic echocardiography and color flow Doppler were performed in patients with 42 normal and 20 dysfunctioning bioprosthetic mitral and aortic valves. Transesophageal echocardiography was superior to the transthoracic approach in delineating bioprosthetic valve cusps and the presence of valve thickening due to valve degeneration. In 27 clinically normal bioprosthetic mitral valves, regurgitation was demonstrated in three patients by the transthoracic approach and in seven by transesophageal study. Both transesophageal and transthoracic color flow Doppler demonstrated mitral regurgitation in 17 clinically regurgitant valves. The severity of mitral regurgitation was accurately assessed by the transesophageal study in all 13 patients who underwent angiography, whereas the transthoracic imaging underestimated valvular regurgitation in 7 of the 13 cases (54%). Bioprosthetic aortic valves were normal on clinical examination in 15 patients and were regurgitant in three others. Both transthoracic and transesophageal color flow Doppler were of equal value in observing and quantifying aortic regurgitation. In five clinically normal and regurgitant mitral and aortic valves, transesophageal color flow Doppler revealed eccentric regurgitant jets suggestive of paravalvular leak. This feature was not evident by the transthoracic approach. In conclusion, transesophageal echocardiography and color flow Doppler are superior to transthoracic imaging in estimating bioprosthetic mitral, but not aortic regurgitation, in differentiating valvular from paravalvular regurgitation, and in demonstrating thickened valves due to cusp degeneration.

Non-Q wave myocardial infarction.

Non-Q wave myocardial infarction is a distinct and changing clinical entity characterized by lower initial mortality and a higher rate of reinfarction compared to Q wave infarction. Clinical and pathologic data suggest that the syndrome results from transient or incomplete coronary occlusion resulting in an infarct which is smaller than when Q waves are present. High-risk patients can be identified during hospitalization, allowing for aggressive therapy aimed at revascularization. Relatively few clinical trials have examined initial therapy or secondary prevention in this group of patients. These studies are reviewed and management guidelines suggested.

Cholesterol embolization: clinical findings and implications.

The clinical characteristics of 13 patients with cholesterol embolization are described. Embolization occurred spontaneously in 2 patients and after a vascular procedure in 11. Acute but vague symptoms were reported by 11 of the 13 patients; skin findings of purple toes or livedo reticularis and renal dysfunction were present in 12 patients, 5 of whom required dialysis. Blood pressure elevation occurred in all 13 patients, eosinophilia in 9 of 10 and elevated sediment rate in 5 of 6. Death occurred within 6 months in three patients. Two distinct patterns were observed: mild (five patients) and severe (eight patients). Compared with the severe pattern, patients with mild cholesterol embolization had early symptoms less frequently (two of five versus eight of eight), less severe renal insufficiency (serum creatinine 1.7 versus 7.4 mg/100 ml), less of an increase in blood pressure (22 versus 34 mm Hg) and later development of skin lesions (14 versus 6 weeks). Baseline blood pressure and development of eosinophilia were comparable in both groups. The presentation of cholesterol embolization is often subtle and may go unrecognized, particularly in its mild form. As vascular interventions increase in elderly atherosclerotic and hypertensive patients, so too will the incidence of this disorder.