Chemotherapy may be overused at the end of life.
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Biomedical subjects
Publications and source records attributed to S Gottlieb.
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The popularity of screening mammography has led to increased detection of mammographic lesions that require pathologic diagnosis. Stereotaxic needle biopsy techniques to sample such lesions can be used to either identify those lesions that require excision from those that can be followed, or to confirm a mammographic impression of malignancy prior to excision. Stereotaxic core biopsy (SCBX) and stereotaxic fine needle aspiration (SFNA) have rarely been directly compared. For this review we undertook a uniform re-analysis of the data that was presented in the published studies of SFNA and/or SCBX. The main endpoint was the negative predictive value (NPV) that measures the frequency that a benign diagnosis is truly benign. There was variability in NPV (likely due to sampling methods) and specific aspects of sampling techniques are discussed. The NPV was compared to indicators of selection of lesions to biopsy (frequency of invasive cancer in the study population), mammographic characteristics (masses or microcalcifications), and the reported nondiagnostic rates. The general conclusion is that SFNA and SCBX are equivalent in accuracy, with considerable variability that reflects the types of lesions that are selected for biopsy and the thoroughness of sampling. For SFNA studies, nondiagnostic rates were inversely related to NPV, and therefore have clinical implications. This was not shown for SCBX studies, and probably reflects an inability to correctly identify non-representative tissue biopsies. The main advantage for including cytologic methods with stereotaxic breast biopsy is immediate sample assessment, and this advantage can also be applied to core needle procedures.
BACKGROUND: This study addresses the impact of availability of on-site catheterization laboratories on the 1-year survival of patients with post-acute myocardial infarction ischemia (P-AMI-I), a high-risk subgroup of AMI patients. METHODS: A prospective 5 month national survey was conducted in 1996 in all operating intensive care units (ICCUs) in Israel (N=26) and included 2377 patients. Four hundred and three (17%) had P-AMI-I, 317 of them were admitted to 18 ICCUs with on-site catheterization laboratories (CATH+) and 86 patients to 8 ICCUs without such facilities (CATH-). A retrospective analysis was performed comparing the in-hospital course and 7 day, 1 month and 1 year mortality data of CATH+ vs. CATH- patients. RESULTS: Patient characteristics in both groups were similar with regard to age, gender AMI location, risk factors, hemodynamic parameters on admission and rate of thrombolytic therapy. Of patients in CATH+, 79% were catheterized before hospital discharge vs. 42% in CATH- (P<0.0001), 45 vs. 15% had PTCA (P<0.0001) and 19 vs. 9% had CABG (P<0.05). At 30 days, patients in CATH+ still had significantly more revascularization procedures (71 vs. 48%, P<0.001). Patients hospitalized in ICCUs with CATH+ and CATH- facilities had similar cardiac mortality rates at 7 days (2.0 vs. 2.3%), 30 days (5.7 vs. 4.7%) and at 1 year (7.6 vs. 7.0%). CONCLUSIONS: Despite a more invasive strategy used during the index hospitalization of patients with P-AMI-I hospitalized in CATH+ ICCUs, their survival was similar to CATH- patients at 7 days, 30 days and at 1 year follow-up.
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BACKGROUND: Acute myocardial infarction (AMI) associated with significant left ventricular dysfunction (LVD) indicates a poor prognosis. Previous studies suggested that revascularization improves survival of patients with AMI complicated by cardiogenic shock. However, other studies that suggested that revascularization improves survival of stable patients with significant LVD did not specifically address patients who had recently had an AMI. OBJECTIVES: Our purpose was to determine whether patients with thrombolysis-treated AMI associated with significant LVD are likely to incur a survival advantage from catheterization and coronary revascularization performed within 30 days after AMI. METHODS: The study population was drawn from the Argatroban in Acute Myocardial Infarction-2 (ARGAMI-2) trial, which included 1200 patients with AMI, all of whom received thrombolytic therapy. Our analysis included 737 patients for whom LV function was estimated by echocardiography. Two hundred two patients had significant LVD; of them, 117 (58%) underwent cardiac catheterization and 85 were treated noninvasively. Among 535 patients without significant LVD, 291 (54%) underwent cardiac catheterization and 244 were treated noninvasively. RESULTS: Compared with a noninvasive approach, an invasive approach resulted in reduced 30-day and 6-month mortality rates in patients with significant LVD: 4.3% versus 10.6%, adjusted odds ratio (OR) 0.26, 95% confidence interval (CI) 0.04 to 1.18, and 6.1% versus 15.5%, OR 0.27, 95% CI 0.06 to 0.98, respectively. A similar comparison in patients without significant LVD resulted in comparable 30-day and 6-month mortality rates for both patient groups: invasively versus noninvasively treated, 0.7% versus 0.8%, OR 1.04, 95% CI 0.04 to 12.7, and 1.4% versus 1.7%, adjusted OR 1.60, 95% CI 0.20 to 9.87. CONCLUSIONS: The current study suggests that AMI patients with significant LVD may benefit from cardiac catheterization and revascularization performed early after AMI, whereas in patients without significant LVD the outcome of those treated invasively or conservatively was similar.
BACKGROUND: Patients with recurrent acute myocardial infarction (AMI) are at increased risk for morbidity and mortality. We compared the outcome of patients with recurrent AMI hospitalized in coronary care units in the prereperfusion and reperfusion eras. METHODS: The study population comprised 2 large-scale cohorts with recurrent AMI: (1) 1415 (24%) of 5839 consecutive patients with AMI hospitalized in 1981 to 1983 (Secondary Prevention Reinfarction Israeli Nifedipine Trial [SPRINT] Registry) and (2) 1093 (25%) of 4317 patients with AMI from three national surveys performed in 1992 to 1996. RESULTS: Patients in the 1990s had significantly lower rates of heart failure and cardiogenic shock. The 7-day mortality declined from 18% in 1981-1983 to 10% in 1992-1996 (adjusted odds ratio [OR] 0.57 [0.44-0.75]), the 30-day mortality rate from 26% to 16% (OR 0.56 [0.44-0.71]), and the 1-year mortality rate from 39% to 26% (adjusted hazard ratio [HR] 0.64 [0.54-0.75]), respectively. In the 1992-1996 cohort, the adjusted risk of 7-day, 30-day, and 1-year mortality for patients with recurrent AMI treated with thrombolysis in comparison to patients without thrombolysis was OR 1.69 (1.07-2.65), 1.52 (1.03-2.23), and HR 1.18 (0.90-1.55), respectively. The mortality rate among patients treated with early percutaneous transluminal coronary angioplasty/coronary artery bypass grafting was 3% versus 12% at 7 days (OR 0.36 [0.16-0.73]), 7% versus 18% at 30 days (OR 0.45 [0.25-0.77]), and 16% versus 29% at 1 year (HR 0.64 [0.46-0.96]), in comparison to patients without revascularization. CONCLUSION: The prognosis of patients with recurrent AMI improved significantly during the reperfusion era. Although thrombolysis may have a limited therapeutic effect among patients with recurrent AMI, an interventional approach seems more appropriate when indicated. A randomized trial of thrombolysis versus early revascularization is needed in patients with recurrent AMI.
BACKGROUND: International placebo-controlled survival trials (Metoprolol Controlled-Release Randomised Intervention Trial in Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS-II], and Carvedilol Prospective Randomized Cumulative Survival trial [COPERNICUS]) evaluating the effects of b-blockade in patients with heart failure have all demonstrated highly significant positive effects on total mortality as well as total mortality plus all-cause hospitalization. Also, the analysis of the US Carvedilol Program indicated an effect on these end points. Although none of these trials are large enough to provide definitive results in any particular subgroup, it is natural for physicians to examine the consistency of results across various subgroups or risk groups. Our purpose was to examine both predefined and post hoc subgroups in the MERIT-HF trial to provide guidance as to whether any subgroup is at increased risk, despite an overall strongly positive effect, and to discuss the difficulties and limitations in conducting such subgroup analyses. METHODS: The study was conducted at 313 clinical sites in 16 randomization regions across 14 countries, with a total of 3991 patients. Total mortality (first primary end point) and total mortality plus all-cause hospitalization (second primary end point) were analyzed on a time to first event. The first secondary end point was total mortality plus hospitalization for heart failure. RESULTS: Overall, MERIT-HF demonstrated a hazard ratio of 0.66 for total mortality and 0.81 for mortality plus all-cause hospitalization. The hazard ratio of the first secondary end point of mortality plus hospitalization for heart failure was 0.69. The results were remarkably consistent for both primary outcomes and the first secondary outcome across all predefined subgroups as well as for nearly all post hoc subgroups. The results of the post hoc US subgroup showed a mortality hazard ratio of 1.05. However, the US results regarding both the second primary combined outcome of total mortality plus all-cause hospitalization and of the first secondary combined outcome of total mortality plus heart failure hospitalization were in concordance with the overall results of MERIT-HF. Tests of country by treatment interaction (14 countries) revealed a nonsignificant P value of.22 for total mortality. The mortality hazard ratio for US patients in New York Heart Association (NYHA) class III/IV was 0.80, and it was 2.24 for patients in NYHA class II, which is not consistent with causality by biologic gradient. We have not been able to identify any confounding factor in baseline characteristics, baseline treatment, or treatment during follow-up that could account for any treatment by country interaction. Thus we attribute the US subgroup mortality hazard ratio to be due to chance. CONCLUSIONS: Just as we must be extremely cautious in overinterpreting positive effects in subgroups, even those that are predefined, we must also be cautious in focusing on subgroups with an apparent neutral or negative trend. We should examine subgroups to obtain a general sense of consistency, which is clearly the case in MERIT-HF. We should expect some variation of the treatment effect around the overall estimate as we examine a large number of subgroups because of small sample size in subgroups and chance. Thus the best estimate of the treatment effect on total mortality for any subgroup is the estimate of the hazard ratio for the overall trial.
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