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Lee Goldman

Publications and source records attributed to Lee Goldman.

At least 19 recordsLinked to original sources

Cost-effectiveness of dual-chamber pacing compared with ventricular pacing for sinus node dysfunction.

BACKGROUND: Compared with single-chamber ventricular pacing, dual-chamber pacing can reduce adverse events and, as a result, improve quality of life in patients paced for sick sinus syndrome. It is not clear, however, how these benefits compare with the increased cost of dual-chamber pacemakers. METHODS AND RESULTS: We used 4-year data from a 2010-patient, randomized trial to estimate the incremental cost-effectiveness of dual-chamber pacing compared with ventricular pacing and then projected these findings over the patients' lifetimes by using a Markov model that was calibrated to the first 5 years of in-trial data. To assess the stability of the findings, we performed 1000 bootstrap analyses and multiple sensitivity analyses. During the first 4 years of the trial, dual-chamber pacemakers increased quality-adjusted life expectancy by 0.013 year per subject at an incremental cost-effectiveness ratio of 53,000 dollars per quality-adjusted year of life gained. Over a lifetime, dual-chamber pacing was projected to increase quality-adjusted life expectancy by 0.14 year with an incremental cost-effectiveness ratio of approximately 6800 dollars per quality-adjusted year of life gained. In bootstrap analyses, dual-chamber pacing was cost-effective in 91.9% of simulations at a threshold of 50,000 dollars per quality-adjusted year of life and in 93.2% of simulations at a threshold of 100,000 dollars. Its cost-effectiveness ratio was also below this threshold in numerous sensitivity analyses that varied key estimates. CONCLUSIONS: For patients with sick sinus syndrome requiring pacing, dual-chamber pacing increases quality-adjusted life expectancy at a cost that is generally considered acceptable.

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Value of immediate postoperative electrocardiogram to update risk stratification after major noncardiac surgery.

Current consensus guidelines recommend postoperative electrocardiographic surveillance only in patients at relatively high risk of postoperative major cardiac complications, but the usefulness of electrocardiograms after major noncardiac surgery is unknown. We prospectively studied 3,570 patients who underwent major noncardiac procedures and had electrocardiograms performed in the recovery room. Rates of major cardiac complications (acute myocardial infarction, pulmonary edema, ventricular fibrillation or primary cardiac arrest, and complete heart block) were higher in patients who had new postoperative electrocardiographic abnormalities consistent with ischemia (ST-T elevation or depression or T-wave abnormalities compatible with ischemia) compared with those without ischemia (6.7% vs 1.9%, p <0.001). Multivariate analysis, after adjusting for pre- and intraoperative clinical data, indicated that the presence of ischemia on the immediate postoperative electrocardiogram was an independent predictor of major cardiac complications (odds ratio 2.2, 95% confidence interval 1.2 to 3.9, p <0.01). When patients were stratified by a preoperative Revised Cardiac Risk Index, ischemia on the immediate postoperative electrocardiogram identified patients with a higher risk of major cardiac complications in low- and high-risk subsets (odds ratio 4.9, 95% confidence interval 1.6 to 15 in lower risk patients; odds ratio 2.0, 95% confidence interval 1.0 to 3.7 in higher risk patients). We conclude that the immediate postoperative electrocardiogram is a valuable tool to adjust risk stratification, even in patients who have lower risks when undergoing noncardiac surgery.

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The relation of autopsy rate to physicians' beliefs and recommendations regarding autopsy.

PURPOSE: Multiple factors have affected the decline in autopsy rates. Our goal was to determine the relation of physicians' recommendations regarding autopsy, as well as patient and surrogate decision-maker characteristics, to autopsy performance. METHODS: We assessed measures related to autopsy performance using data from two teaching institutions in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. We included patients who had died within 6 months of their index hospitalization and for whom information was available on autopsy performance, physicians' response to questions about autopsy, and interviews with surrogate decision makers about autopsy performance. We assessed the association between autopsy performance and the strength of a physician's recommendation for autopsy, adjusting for patient, surrogate, and physician characteristics. RESULTS: Of the 680 patients who died, 59% (n = 402) met our inclusion criteria. Based on physician and surrogate responses, the expected autopsy rate was 42% while the actual autopsy rate was 23%. The autopsy rate was higher when the physician's recommendation for autopsy was strong or very strong at the time of death compared with when autopsy was not recommended strongly or not at all (P <0.001). The strength of the physician's postmortem recommendation was independently associated with autopsy performance after adjusting for patient, surrogate, and physician characteristics (P <0.001). CONCLUSION: Autopsies are less likely to be performed when not recommended strongly or not at all. Training physicians (or others) how to recommend autopsies may increase autopsy rates.

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High incidence of pacemaker syndrome in patients with sinus node dysfunction treated with ventricular-based pacing in the Mode Selection Trial (MOST).

OBJECTIVES: We evaluated the incidence, predictors, and treatment of pacemaker syndrome in patients with sinus node dysfunction treated with ventricular-based (VVIR) pacing in the Mode Selection Trial (MOST). BACKGROUND: Pacemaker syndrome, or intolerance to VVIR pacing, consists of cardiovascular signs and symptoms induced by VVIR pacing. METHODS: The definition of pacemaker syndrome required that a patient with single-chamber VVIR pacing develop either congestive signs and symptoms associated with retrograde conduction during VVIR pacing or a >or=20 mm Hg reduction of systolic blood pressure during VVIR pacing, associated with reproducible symptoms of weakness, lightheadedness, or syncope. RESULTS: Of 996 patients randomized to VVIR pacing, 182 (18.3%) met criteria for pacemaker syndrome in follow-up. Pacemaker syndrome occurred early in most patients (13.8% at 6 months, 16.0% at 1 year, increasing to 19.7% at 4 years). Baseline univariate predictors of pacemaker syndrome included a lower sinus rate and higher programmed pacemaker rate. Previous heart failure, ejection fraction, and drop in systolic blood pressure with VVIR pacing at implantation did not predict the development of pacemaker syndrome. Post-implantation predictors of pacemaker syndrome were a higher percentage of paced beats, higher programmed low rate, and slower underlying spontaneous sinus rate. Quality of life decreased at the time of diagnosis of pacemaker syndrome and improved with reprogramming to atrial-based pacing. CONCLUSIONS: Severe pacemaker syndrome developed in nearly 20% of VVIR-paced patients and improved with reprogramming to the dual-chamber pacing mode. Because prediction of pacemaker syndrome is difficult, the only way to prevent pacemaker syndrome is to implant atrial-based pacemakers in all patients.

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Predictors of stroke in patients paced for sick sinus syndrome.

OBJECTIVES: This study was an analysis of factors associated with stroke in a population of patients paced for sinus node dysfunction in a large prospective clinical trial (Mode Selection Trial [MOST]). BACKGROUND: The effects of dual-chamber versus single-chamber ventricular pacing on subsequent stroke in patients with sinus node dysfunction are not known. METHODS: A total of 2,010 patients with sinus node dysfunction were randomized to ventricular or dual-chamber pacing and followed for a median of 33.1 months. RESULTS: The median participant age was 74 years. During 5,664 patient-years of follow-up, 90 strokes (11 hemorrhagic) occurred. By life-table analysis, the rate of stroke was 2.2% (95% confidence interval [CI] 1.6 to 2.9) at one year and 5.8% (95% CI 4.5 to 7.1) at four years. The incidence of stroke was not significantly different in dual-chamber (4%) as compared with ventricular-paced patients (4.9%) (hazard ratio [HR] 0.82, 95% CI 0.54 to 1.25, p = 0.36). Multivariable analysis demonstrated that significant predictors of stroke included prior stroke or transient ischemic attack, Caucasian race, hypertension, prior systemic embolism, and New York Heart Association functional class III or IV (p < 0.05); pacing mode remained non-significant after adjustment for these factors (p = 0.37). Clinically reported atrial fibrillation after implantation was a risk factor for stroke in this cohort after adjustment for other predictors of stroke (p = 0.042, HR 1.68 [95% CI 1.02 to 2.76]). CONCLUSIONS: Clinical characteristics, but not mode of pacing, were associated with subsequent stroke in patients paced for sinus node dysfunction.

Age Factors↗

Patient quality of life during the 12 months following joint replacement surgery.

OBJECTIVE: To determine whether preoperative characteristics influence quality of life outcomes 1, 6, and 12 months after joint replacement surgery. METHODS: Patients (n = 222) with osteoarthritis undergoing primary joint replacement surgery at a university hospital between November 1990 and March 1993 were prospectively studied. Bodily pain and physical function were assessed preoperatively and at the 3 postoperative time points using the Medical Outcomes Study 36 Item Short Form Health Survey. RESULTS: Bodily pain and physical function improved after joint replacement. At 1 month after surgery, despite improvements in bodily pain, physical function deteriorated. Preoperative bodily pain and physical function, demographic characteristics, and social support were significant correlates of improvement in bodily pain and physical function. CONCLUSIONS: Patients experienced dramatic improvements in bodily pain and physical function after joint replacement. However, decline in physical function at 1 month implies significant need for prolonged informal or formal patient assistance with basic physical function after surgery. Greater preoperative social support was associated with improved bodily pain and physical function outcomes.

Activities of Daily Living↗

Triage of patients with acute chest pain and possible cardiac ischemia: the elusive search for diagnostic perfection.

Few diagnostic decisions in medicine have been more heavily researched than the approach to the patient with acute chest pain. Despite the advances in both diagnosing and treating patients presenting with this symptom, cases of missed myocardial infarctions still cause substantial morbidity and mortality. This article examines a case in which a patient was sent home from the emergency department after presenting with chest pain and was subsequently found to have a myocardial infarction. In the context of the case, the article discusses clinical decision making about the diagnosis and triage of patients presenting with acute chest pain or with symptoms consistent with possible cardiac ischemia. A standardized approach to addressing the management of these patients is essential, given the adverse consequences of missing a life-threatening condition.

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Changes in rates of autopsy-detected diagnostic errors over time: a systematic review.

CONTEXT: Substantial discrepanies exist between clinical diagnoses and findings at autopsy. Autopsy may be used as a tool for quality management to analyze diagnostic discrepanies. OBJECTIVE: To determine the rate at which autopsies detect important, clinically missed diagnoses, and the extent to which this rate has changed over time. DATA SOURCES: A systematic literature search for English-language articles available on MEDLINE from 1966 to April 2002, using the search terms autopsy, postmortem changes, post-mortem, postmortem, necropsy, and posthumous, identified 45 studies reporting 53 distinct autopsy series meeting prospectively defined criteria. Reference lists were reviewed to identify additional studies, and the final bibliography was distributed to experts in the field to identify missing or unpublished studies. STUDY SELECTION: Included studies reported clinically missed diagnoses involving a primary cause of death (major errors), with the most serious being those likely to have affected patient outcome (class I errors). DATA EXTRACTION: Logistic regression was performed using data from 53 distinct autopsy series over a 40-year period and adjusting for the effects of changes in autopsy rates, country, case mix (general autopsies; adult medical; adult intensive care; adult or pediatric surgery; general pediatrics or pediatric inpatients; neonatal or pediatric intensive care; and other autopsy), and important methodological features of the primary studies. DATA SYNTHESIS: Of 53 autopsy series identified, 42 reported major errors and 37 reported class I errors. Twenty-six autopsy series reported both major and class I error rates. The median error rate was 23.5% (range, 4.1%-49.8%) for major errors and 9.0% (range, 0%-20.7%) for class I errors. Analyses of diagnostic error rates adjusting for the effects of case mix, country, and autopsy rate yielded relative decreases per decade of 19.4% (95% confidence interval [CI], 1.8%-33.8%) for major errors and 33.4% (95% [CI], 8.4%-51.6%) for class I errors. Despite these decreases, we estimated that a contemporary US institution (based on autopsy rates ranging from 100% [the extrapolated extreme at which clinical selection is eliminated] to 5% [roughly the national average]), could observe a major error rate from 8.4% to 24.4% and a class I error rate from 4.1% to 6.7%. CONCLUSION: The possibility that a given autopsy will reveal important unsuspected diagnoses has decreased over time, but remains sufficiently high that encouraging ongoing use of the autopsy appears warranted.

Autopsy↗

Death in patients with permanent pacemakers for sick sinus syndrome.

BACKGROUND: Although more than one million patients in the United States have permanent pacemakers, little is known about their cause of death. We evaluated the cause of death in 404 patients who died in the Mode Selection Trial (MOST). METHODS: In MOST, patients received a dual-chamber pacemaker randomly programmed to either dual-chamber or ventricular pacing. The circumstances surrounding each death were reviewed by a clinical events committee, which used prospectively defined criteria to adjudicate the cause of death. RESULTS: A total of 2010 patients with a median age of 74 years were included. After a median follow-up of 33 months, 404 (20%) patients died, including 198 (49%) of noncardiac causes and 143 (35.4%) of cardiac causes. In 63 patients, the cause of death was unknown. Independent predictors of death through the use of a multivariable analysis were (1) demographic factors including age, male sex, and weight; (2) clinical factors including prior myocardial infarction, cardiomyopathy, New York Heart Association class III/IV, and the Charlson Comorbidity Index; and (3) scores from two measures of functional status, the Karnofsky Score and the Mini-Mental State Examination. Independent predictors of cardiovascular death were similar. CONCLUSIONS: Patients treated with permanent pacemakers for sinus node dysfunction are elderly and have a substantial mortality rate, with more than half the classifiable deaths being noncardiac. Baseline demographic variables and scores from quality-of-life measures can identify patients with the highest risk of death.

Age Distribution↗

Association between cardiac and noncardiac complications in patients undergoing noncardiac surgery: outcomes and effects on length of stay.

PURPOSE: To determine the relation between cardiac and noncardiac complications and their effects on length of stay in patients undergoing noncardiac surgery. METHODS: We collected detailed information from the history, physical examination, and preoperative tests of 3970 patients aged > or =50 years who were undergoing major noncardiac procedures. Serial electrocardiograms and cardiac enzyme measurements were performed perioperatively, and cardiac and noncardiac complications were recorded prospectively. Multivariate logistic regression analysis was used to determine the association between cardiac and noncardiac complications, and linear regression was used to assess their effects on length of stay. RESULTS: Cardiac complications occurred in 84 patients (2%), and noncardiac complications developed in 510 patients (13%). Both types of complications occurred in 40 patients (1%). The most common cardiac complications were pulmonary edema (n = 42) and myocardial infarction (n = 41). The most common noncardiac complications were wound infection (n = 291), confusion (n = 87), respiratory failure requiring intubation (n = 62), deep venous thrombosis (n = 48), and bacterial pneumonia (n = 46). Patients with cardiac complications were more likely to suffer a noncardiac complication than were those without cardiac complications, even after adjustment for preoperative clinical factors (odds ratio = 6.4; 95% confidence interval [CI]: 3.9 to 10.6). Mean length of stay was markedly increased in patients who experienced cardiac (11 days; 95% CI: 9 to 12 days) or noncardiac (11 days; 95% CI: 10 to 12 days) complications, or both (15 days; 95% CI: 12 to 18 days), as compared with patients without complications (4 days; 95% CI: 3 to 4 days), even after adjustment for procedure type and clinical factors. CONCLUSION: Cardiac and noncardiac complications were strongly linked in patients undergoing noncardiac surgery. Patients who experienced one type of complication were at increased risk of developing the other type of complication as well as prolonged perioperative length of stay.

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Preoperative risk evaluation and perioperative management of patients with coronary artery disease.

We have reviewed the methods of evaluating a patient's cardiac risk preoperatively using a careful history, physical examination, and EKG. Based on this information, various risk indices, guidelines, and algorithms can further assist the physician in deciding which patients can undergo surgery without further testing and which patients might benefit from further cardiac evaluation or medical therapy prior to surgery. The physician must keep in mind that a test should not be ordered if it is unlikely to alter the patient's management, and it is rarely necessary to perform a revascularization procedure with the sole purpose of getting a patient through surgery. Ongoing research is likely to lead to improvement in perioperative medical therapy.

Coronary Artery Disease↗

Predictors and clinical impact of atrial fibrillation after pacemaker implantation in elderly patients treated with dual chamber versus ventricular pacing.

The Pacemaker Selection in the Elderly (PASE) trial was a prospective, multicenter, single blind, randomized comparison of single chamber, rate adaptive, ventricular pacing (VVIR) with dual chamber, rate adaptive pacing (DDDR) in 407 patients aged > or =65 years(mean 76 +/- 7 years, 60% male)with standard bradycardia indications for dual chamber pacemaker implantation. The incidence, predictors, and clinical consequences of atrial fibrillation (AF) developing after pacemaker implantation in the PASE trial were studied prospectively. During a median follow-up of 18 months, AF developed in 73 (18%) patients. Kaplan-Meier estimated cumulative incidences of AF in patients with sinus node dysfunction (n=176) at 18 months were 28% in the VVIR and 16% in the DDDR groups (P=0.08). After adjustment for other clinical variables using a Cox multivariate regression model, randomization to VVIR compared with DDDR pacing mode among patients with sinus node dysfunction was independently associated with a 2.6-fold increased relative risk (RR) of developing AF after pacemaker implantation (P=0.01). Other independent clinical risk factors for development of postimplant AF included a preimplant history of hypertension (P=0.02) or supraventricular tachyarrhythmias(P<0.04). Patients who developed AF had similar health related quality of life scores and cardiovascular functional status after 18 months of pacing as patients who remained free of AF. The RR of death, stroke, or heart failure hospitalization was not increased in patients who developed AF. Thus, in the elderly patients with sinus node dysfunction requiring permanent pacing, DDDR pacing mode protected against the development of AF. However, development of AF after pacemaker implantation in this population was not associated with a significant impact on quality-of-life, functional status, or other clinical endpoints during 18 months of follow-up.

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