Utility of routine left ventricular ejection fraction measurement before anthracycline-based chemotherapy in patients with diffuse large B-cell lymphoma.

PURPOSE: Despite the lack of evidence, routine left ventricular ejection fraction (LVEF) measurement in diffuse large B-cell lymphoma (DLBCL) before anthracycline-based chemotherapy (ABC) is recommended by practice guidelines and required in DLBCL trials in the United States. METHODS: We determined the frequency of the following in 197 consecutive patients with newly diagnosed DLBCL treated at our institution: one, LVEF measurement before ABC; two, finding of asymptomatic LV dysfunction (ALVD); and three, modification in treatment strategy as a result of LVEF measurement. RESULTS: The median age was 71 years, and 54% of patients were men. LVEF was measured in 128 patients (65%) pretreatment, including in 15 with prior congestive heart failure (CHF). The reasons for not measuring LVEF were: clinically low risk for ALVD (n = 32), medical frailty (n = 15), palliative care (n = 3), ABC not standard therapy (n = 12), and prior CHF (n = 7). Among patients without prior CHF who had LVEF assessed (n = 113), ALVD was detected in four (4%), with LVEF ranging from 41% to 48%. Four patients were not treated despite normal LVEF because of comorbidities and anticipated toxicities. In contrast, all four patients with ALVD received ABC. No patient had a modification in treatment strategy as a result of LVEF measurement. After a median follow-up of 60 months, among those who remained alive, CHF developed in 15% versus 6% of patients receiving ABC who did and did not have LVEF measured, respectively (P = .246). CONCLUSION: Our findings challenge the utility of routine LVEF measurement in patients with DLBCL before ABC. Potential cost savings to our health care system could be substantial.

Physical capability outcomes after total disc replacement with ProDisc-L.

BACKGROUND: Lumbar disc arthroplasty (total disc replacement [TDR]) outcomes have been evaluated using subjective, patient-reported measures of pain, health, and functional impairment. As a condition of TDR coverage, our institution's health plan required that objective physical performance data be collected. Thus our study was designed to explore (1) the feasibility of using preoperative and 1-year postoperative performance on functional capacity tasks as an outcome metric for TDR with ProDisc-L (PD-L) (Synthes Spine, West Chester, Pennsylvania), (2) the magnitude and significance of changes in preoperative and postoperative performance, and (3) whether changes noted in performance are reflected in the subjective measures. METHODS: Seven adapted WorkWell tasks (physical capability assessment tool [PCAT]) (WorkWell Systems, Duluth, Minnesota) were performed preoperatively and 1 year postoperatively by 18 patients who received either single-level or 2-level PD-L implants. Demographic and medical data were reviewed. RESULTS: The PCAT was implemented easily, and the tasks took approximately 30 minutes to complete. Percent improvement and preoperative and postoperative physical capability outcomes for each PCAT task are as follows: squat, 79% (10.7 ± 7.1 repetitions vs 19.2 ± 2.0 repetitions, P < .001); forward bend, 121% (110.2 ± 68.8 seconds vs 243.6 ± 77.2 seconds, P < .001); kneel, 92% (283.2 ± 173.2 seconds vs 544.7 ± 109.3 seconds, P < .001); floor-to-waist lift, 128% (16.1 ± 9.9 lb vs 36.7 ± 20.3 lb, P < .001); horizontal carry, 119% (19.7 ± 8.6 lb vs 43.2 ± 18.3 lb, P < .001); push, 32% (67.7 ± 19.2 lb vs 89.4 ± 24.4 lb, P < .001); and pull, 40% (57.6 ± 17.1 lb vs 80.9 ± 26.4 lb, P < .001). Visual analog scale scores for pain (5.1 ± 1.7 vs 1.4 ± 1.6, P < .001), Oswestry Disability Index scores (49.0% ± 13.2% vs 15.2% ± 14.3%, P < .001), and amount of narcotic use (26.1 ± 43.8 mg of morphine equivalent vs 1.9 ± 7.3 mg of morphine equivalent, P = .031) also improved. In single-level cases, comparison of L4-5 versus L5-S1 showed significant differences only with the forward bend task (P = .002). CONCLUSIONS/CLINICAL RELEVANCE: The physical capability outcome may be a feasible outcome metric. PD-L implantation may result in substantial improvements in physical performance. Similar benefits shown in a larger series over a longer timeframe could have important implications for the long-term health, productivity, and cost of health care for this patient population.

Prevention of vertebral body-splitting fractures after multilevel ProDisc-L implantation.

BACKGROUND: Prior studies of multilevel ProDisc-L (PD-L) implants (Synthes Spine, Inc., West Chester, Pennsylvania) using the standard US technique have used conventional radiography postoperatively. We found vertebral body-splitting fractures (VB-SFs) in interposed vertebral bodies after 5 sequential multilevel PD-L device implantations using the standard US technique. These were identified with postoperative computed tomography (CT) but were not visible on plain radiographs. In an additional patient, we found that a stress-relieving, pilot holes-only technique did not prevent VB-SFs. The 5 patients operated on with the standard technique composed the background series against which we compared the incidence of VB-SFs in patients operated on with a modification of the standard US technique-a combination of stress-relieving pilot holes, removal of cortex in the chisel path, and a fenestrated chisel (PH/CR/FC)-intended to reduce the incidence of VB-SFs in multilevel PD-L constructs. METHODS: Patients receiving multilevel PD-L implants at 2 sites-1 in the United States and the other in Germany-were operated on with the PH/CR/FC technique and their postoperative CT scans evaluated for the presence of VB-SFs. The frequency of VB-SFs in these patients was compared with that of the 5 patients from the background series who were operated on by the standard US technique. The groups' mean sex, age, body mass index, and vertebral body height, as well as average spinal T score, were also compared. RESULTS: No fractures were found in 13 interposed vertebral bodies in 11 patients operated on with the PH/CR/FC technique, as compared with 4 VB-SFs and 1 anterior keel cut-to-anterior keel cut fracture in 5 interposed vertebral bodies in 5 patients operated on with the US technique (P ≤ .001). Although the sample sizes were small, this difference in fracture rate was not associated with sex, age, body mass index, or average spinal T score. At up to 13 months of follow-up of patients in the background series, we found that VB-SFs tend not to bridge with bone, instead forming sclerotic margins. CONCLUSIONS: The PH/CR/FC technique studied reduced the incidence of VB-SF in multilevel PD-L implants. Because previously published multilevel studies did not use postoperative CT scans and because VB-SFs are not visible on conventional radiography, the incidence of VB-SFs in multilevel PD-L applications may be higher than previously reported. Our findings may contribute to prevention of complications in total disc replacement.

Closing the heart failure management gap in the community: managing hypotension and impact on outcomes.

BACKGROUND: Perception of risk in using recommended therapy in heart failure (HF) patients with hypotension adds to the problems of undertreatment in management. We aimed to determine the feasibility and outcomes of therapy in hypotensive HF patients. METHODS AND RESULTS: Data were collected from HF clinic patients between 1999 and 2003. Exclusion criteria were: left ventricular ejection fraction (LVEF) >45%; myocardial infarction or revascularization within 3 months of referral; and consult-only visits. Criteria were met by 500 patients. Median follow-up was 6.8 years, with end points of total mortality and combined death and hospitalizations. Blood pressure measurements were done by the nursing staff after the patient was seated for at least 5minutes. Two measures were taken per each patient encounter and the average of 2 systolic values is recorded for group categorization. Group 1 (hypotension, n=112) subjects were younger (65+/-14 vs. 69+/-12; P=.003) and had lower mean LVEF (22+/-10% vs. 25+/-9%; P=.012) than group 2 (no hypotension, n=338). Drug utilization was similar at 3 months, 1 year, and long-term. Systolic blood pressure (SBP) increased in group 1, but decreased in group 2. Mortality was similar at years 1 and 5 (12.8% vs. 9.9%, P=NS; 45.5% vs. 41.4%, P=.507); however, combined death and hospitalizations were negatively and independently affected by failure to receive therapy. CONCLUSIONS: When treated successfully with recommended therapy, SBP improved and patients with hypotension at baseline enjoyed significant benefits in outcomes. More effort is needed on mechanisms to implement guidelines to improve HF management.

Pilot Results of the Early Detection by Ultrasound of Carotid Artery Intima-Media Thickness Evaluation (EDUCATE) study.

BACKGROUND: Limitations of current models for risk stratification are known. Noninvasive imaging is being advocated as an adjunct to improve risk prediction; however, studies documenting outcomes are rare. Therefore, we aimed to evaluate the negative and positive predictive values of carotid atherosclerosis for future cardiovascular events. METHODS: The Early Detection by Ultrasound of Carotid Artery intima media Thickness Evaluation (EDUCATE) study prospectively enrolled 253 consecutive young to middle-aged adults undergoing elective coronary angiography. Bilateral carotid ultrasound and lipid profiles were performed. Carotid atherosclerosis was defined as intima media thickness >/=1.0 mm in the main body, or focal plaque within the body, bulb, or proximal branch. Future events included major (death, myocardial infarction, stroke) and minor (revascularization and new onset heart failure). RESULTS: Of the enrolled patients 236 completed all tests; mean age was 51 +/- 8 years; 58% women. Sensitivity, specificity, and negative predictive values for carotid atherosclerosis in predicting severe coronary artery disease were 72%, 49% and 79%, with an odds ratio (OR) of 2.2 (95% confidence interval [CI] 1.2-4.0). Of patients suffering major events, 90% had carotid atherosclerosis. Only 1 of 95 without carotid atherosclerosis experienced a major event. Kaplan-Meier analysis revealed differences in event-free survival in favor of subjects without carotid atherosclerosis for major (P = .051) and any event (P = .015). Cox analysis revealed a hazard ratio (HR) of 2.7 (95% CI 1.2-6.2; P = .020) for predicting future events. The relationship remained significant after adjusting for traditional risk factors (HR 2.5, 95% CI 1.1-5.9; P = .034). CONCLUSIONS: Carotid atherosclerosis is associated with severe coronary artery disease and future events. Negative carotid ultrasound is associated with excellent prognosis.

Carotid ultrasound for risk clarification in young to middle-aged adults undergoing elective coronary angiography.

BACKGROUND: An important aspect of risk prediction is the apparent difference between calculated risk and true risk. Current risk predictor models are not sensitive enough to identify many subjects at risk for future events or to prevent overuse of expensive tests. The aim of this study was to determine the usefulness of carotid ultrasound for risk stratification in subjects undergoing elective coronary angiography. METHODS: A total of 253 individuals (men < or =55 years of age and women < or =65 years of age) who were scheduled for elective coronary angiography underwent carotid ultrasonography. Noncoronary atherosclerosis was defined based on a maximal intima-media thickness of > or =1.0 mm or the presence of focal plaque. RESULTS: Of the subjects, 236 completed all of the tests. The mean age was 51 +/- 8 years, and 58% were women and 42% men. Severe angiographic disease (> or =50%) was present in 72 subjects. Carotid atherosclerosis was present in 141 subjects. Use of the Framingham risk score classified 172 subjects as low risk. Carotid atherosclerosis was diagnosed in 57% of the low-risk group compared with 70% of the high-risk group (P = .122). Carotid atherosclerosis was associated with severe coronary angiographic disease (OR = 2.2, CI = 1.2 to 4.0). CONCLUSION: Noncoronary atherosclerosis was associated with severe coronary disease as determined by angiography. Carotid atherosclerosis had a high negative predictive value in subjects with negative stress test results or risk-stratified as low risk. Noninvasive imaging by carotid ultrasonography for noncoronary atherosclerosis may be a good adjunct to clinical risk stratification for premature coronary heart disease.

Metabolic syndrome and coronary heart disease equivalent conditions in predicting cardiovascular events in young to middle-aged adults.

There are questions concerning the validity of the metabolic syndrome as a diagnostic entity and whether the syndrome predicts coronary heart disease (CHD) better than global risk stratification. The use of the metabolic syndrome as a potential adjunct to improve global risk stratification has received less attention. The authors evaluated the relationship between the metabolic syndrome and cardiovascular disease compared with coronary heart disease equivalent. Two hundred thirty-six subjects undergoing elective coronary angiography had bilateral carotid ultrasound studies and global risk scores calculated. Mean total, low-density lipoprotein, and high-density lipoprotein cholesterol and triglyceride values were normal. The metabolic syndrome was associated with carotid atherosclerosis (odds ratio, 2.3; confidence interval, 1.2-4.2), coronary disease (odds ratio, 2.9; confidence interval, 1.6-5.4), and future cardiovascular events. Rates for future events and coronary and carotid atherosclerosis were similar for subjects with the metabolic syndrome compared with coronary heart disease equivalent. Combined, the two conditions identified 70% of subjects who developed events. The metabolic syndrome is associated with cardiovascular disease and provides additive information to clinical risk stratification.

Improving outcomes in heart failure in the community: long-term survival benefit of a disease-management program.

OBJECTIVES: The purpose of our current study was to determine whether our disease-management model was associated with long-term survival benefits. A secondary objective was to determine whether program involvement was associated with medication maintenance and reduced hospitalization over time compared to usual care management of heart failure. DESIGN: A retrospective chart review was conducted in patients who had been hospitalized for congestive heart failure between April 1999 and March 31, 2000, and had been discharged from the hospital for follow-up in the Heart Failure Clinic vs usual care. SETTING: An integrated health-care center serving a tristate area. PATIENTS: Patients (n = 101) were followed up for 4 years after their index hospitalization for congestive heart failure. MEASUREMENTS AND RESULTS: The patients followed up in the Heart Failure Clinic comprised group 1 (n = 38), and the patients receiving usual care made up group 2 (n = 63). The mean (+/- SD) age of the patients in group 1 was 68 +/- 16 years compared to 76 +/- 11 years for the patients in group 2 (p = 0.002). The patients in group 1 were more likely to have renal failure (p = 0.035), a lower left ventricular ejection fraction (p = 0.005), and hypotension at baseline (p = 0.002). At year 2, more patients in group 1 were maintained by therapy with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) [p = 0.036]. The survival rate over 4 years was better for group 1. Univariate Cox proportional hazard ratios revealed that age, not receiving ACEIs or ARBs, and renal disease or cancer at baseline were associated with mortality. When controlling for these variables in a multivariate Cox proportional hazards ratio model, survival differences between groups remained significant (p = 0.021). Subjects in group 2 were 2.4 times more likely to die over the 4-year period than those in group 1. CONCLUSIONS: Our study demonstrated that, after controlling for baseline variables, patients participating in a heart failure clinic enjoyed improved survival.