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Endoscopy has an important role in the pre- and post-treatment staging of esophageal cancer. Complete pathologic response following neoadjuvant chemoradiation therapy occurs in approximately 25% of patients. However, the ability to accurately detect this preoperatively with currently available endoscopic modalities is limited such that the default pathway is for fit patients to proceed with surgical resection. This article discusses the available endoscopic modalities (primarily Esophagogastroduodenoscopy [EGD] with mucosal biopsies and endoscopic ultrasonography with or without fine needle aspiration) used for post-treatment staging of esophageal cancer. We present data regarding the benefits and limitations of endoscopic methods in assessing for residual disease. Unfortunately, endoscopic modalities are not accurate enough to identify complete pathological responsers who may avoid surgical resection.

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The primary goal of visual data exploration tools is to enable the discovery of new insights. To justify and reproduce insights, the discovery process needs to be documented and communicated. A common approach to documenting and presenting findings is to capture visualizations as images or videos. Images, however, are insufficient for telling the story of a visual discovery, as they lack full provenance information and context. Videos are difficult to produce and edit, particularly due to the non-linear nature of the exploratory process. Most importantly, however, neither approach provides the opportunity to return to any point in the exploration in order to review the state of the visualization in detail or to conduct additional analyses. In this paper we present CLUE (Capture, Label, Understand, Explain), a model that tightly integrates data exploration and presentation of discoveries. Based on provenance data captured during the exploration process, users can extract key steps, add annotations, and author "Vistories", visual stories based on the history of the exploration. These Vistories can be shared for others to view, but also to retrace and extend the original analysis. We discuss how the CLUE approach can be integrated into visualization tools and provide a prototype implementation. Finally, we demonstrate the general applicability of the model in two usage scenarios: a Gapminder-inspired visualization to explore public health data and an example from molecular biology that illustrates how Vistories could be used in scientific journals. (see Figure 1 for visual abstract).

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Many transplant centers use endoscopically directed brachytherapy to provide locoregional control in patients with otherwise incurable cholangiocarcinoma (CCA) who are awaiting liver transplantation (LT). The use of endoscopic retrograde cholangiopancreatography (ERCP)-directed photodynamic therapy (PDT) as an alternative to brachytherapy for providing locoregional control in this patient population has not been studied. The aim of this study was to report on our initial experience using ERCP-directed PDT to provide local control in patients with unresectable CCA who were awaiting LT. Patients with unresectable CCA who underwent protocol-driven neoadjuvant chemoradiation and ERCP-directed PDT with the intent of undergoing LT were reviewed. Four patients with confirmed or suspected CCA met the inclusion criteria for protocol LT. All four patients (100%) successfully underwent ERCP-directed PDT. All patients had chemoradiation dose delays, and two patients had recurrent cholangitis despite PDT. None of these patients had progressive locoregional disease or distant metastasis following PDT. All four patients (100%) underwent LT. Intention-to-treat disease-free survival was 75% at mean follow-up of 28.1 months. In summary, ERCP-directed PDT is a reasonably well tolerated and safe procedure that may have benefit by maintaining locoregional tumor control in patients with CCA who are awaiting LT.

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OBJECTIVE: To examine the trends in incidence and long-term case fatality of childhood stroke in New Jersey using a statewide administrative database for the years 1994-2007. METHODS: We assessed demographic and clinical information for children with stroke using the Myocardial Infarction Data Acquisition System (MIDAS) database. We ascertained deaths by matching MIDAS records to New Jersey Death Registration Files at 30 days, 1 year, and 5 years from the index stroke. RESULTS: During the 14-year study period, 715 children were hospitalized for a first time with stroke. Age-adjusted incidence of stroke demonstrated a significant quadratic trend in which the rates decreased from 1994 to a nadir at 1999-2001 and increased thereafter (overall p for trend = 0.06 with quadratic term p = 0.02). Better treatment of sickle cell disease with transfusion therapy after year 1998 (p = 0.007) and improved diagnostic accuracy of MRI (p = 0.009) may partially explain these trends. Thirty-day, 1-year, and 5-year case fatality rates were 12.3%, 15.7%, and 17.5%, respectively. At all time periods, adjusted survival from hemorrhagic stroke was significantly lower than that from ischemic stroke (p = 0.0005). CONCLUSIONS: After an initial decrease, the incidence of pediatric stroke is rising. Children with hemorrhagic stroke had a 2 times higher risk of death than those with ischemic stroke. Whereas approximately 70% of all deaths occurred within the first month of hospitalization, an additional 5.2% of the initial study cohort died over the next 5 years.

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Most reports of the decrease in age-adjusted coronary heart disease (CHD) are based on databases with upper age cut-offs that exclude approximately half of the events. We report changes in rates of acute myocardial infarction (AMI) and of out-of-hospital coronary death between 1986 and 1996 among New Jersey residents > or =15 years old. Data on patients discharged with the diagnosis of AMI from nonfederal acute care hospitals in the state (n = 270,091) and all records in the New Jersey death registration files with CHD (n = 172,175) listed as the cause of death from 1986 to 1996 (total study n = 442,266) were analyzed. The rate of hospitalized AMI cases in the state remained essentially unchanged during these 11 years, whereas in-hospital and 30-day case fatality among all age groups and both sexes declined. Age-adjusted CHD rates showed a decrease in fatal events, a smaller decrease in total events, and a slight increase in nonfatal events. The proportion of fatal CHD events occurring out-of-hospital decreased especially among men. The median age at occurrence of events increased by 1 year. Despite a decrease in CHD mortality, the rate of nonfatal events increased, especially among persons > or =75 years old. Thus, the decrease in age-adjusted CHD mortality is not all due to treatment and true prevention of CHD, but the disease simply occurs at an older age.

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The Systolic Hypertension in the Elderly Program (SHEP) staff contacted 447,921 screenees, of whom 11,919 (2.7%) were originally eligible and 4,736 (1.1%) maintained eligibility and were randomized. The total number of participants enrolled at the 16 clinical centers ranged from 133 to 559. The low yield of screenees to randomizations resulted from the study design, not from low levels of agreement to participate, and required the employment of a variety of recruitment strategies in a prudent overall plan. SHEP was one of the first clinical trials to use mass mailing as a primary strategy of recruitment. The study used mailing lists from seven generic sources. More than 3.4 million letters of invitation were mailed; they yielded an overall response rate of 4.3%. Motor vehicle and voter registration lists provided the greatest numbers of names. Mailings to members of health maintenance organizations (HMOs) and registrants of the Health Care Finance Administration (HCFA) provided the greatest response rates. Considerable variability in response rates existed among clinical centers using generically similar mailing lists. Generally, the number of hours spent on recruitment showed a positive, but not statistically significant, association with randomization yields. The recruitment yield was statistically significantly higher in clinics with experienced recruitment coordinators than in clinics with inexperienced ones (p = 0.0008). From these findings we conclude that mass mailing is an important strategy in an overall recruitment program, that the involvement of experienced recruitment staff is important, and that although the total time spent by staff on recruitment may also improve results, it matters less than the staff's level of recruiting experience.

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We determined the angiotensin-converting enzyme (ACE) insertion/deletion genotype in 209 hypertensive individuals and in 100 matched normotensive controls. A significant association was detected between hypertension and the deletion/deletion (D/D) genotype of the ACE gene when the relation was adjusted for age, sex, and body mass index.

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The Studies of Left Ventricular Dysfunction (SOLVD) assessed the effect of enalapril in patients with systolic left ventricular dysfunction (LVD). We performed retrospective analyses of the association between calcium channel blocker (CCB) use and fatal and nonfatal myocardial infarction (MI) in these patients. MI occurred in 11.5% of 845 patients receiving CCBs versus 7.5% of 2551 patients not receiving CCBs in the enalapril group and in 14.4% of 874 patients receiving CCBs versus 9.3% of 2527 patients not receiving CCBs in the placebo group. By multivariate Cox regression analysis, adjusting for comorbidity, cause and severity of LVD, heart failure, and concomitant drug use, CCB use was an independent predictor of MI (relative risk [RR] 1.37, confidence interval [CI] 1.14 to 1.63). The increase in MI risk was greater among patients with a higher heart rate (RR 1.46, CI 1.14 to 1.86) and lower blood pressure (RR 1.45, CI 1.14 to 1.86). The adjusted risk ratio for all-cause mortality associated with CCB use was 1.14 (CI 1.00 to 1.28; p = 0.0454). In this analysis of patients with LVD, CCB use was associated with significantly increased risk of fatal or nonfatal MI.

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OBJECTIVE: To compare the effectiveness of different approaches to participant enrollment in a behavior modification trial. DESIGN: Concurrent, prospective evaluation performed in context of recruitment for a randomized, controlled trial. SETTING: Four study centers located in Baltimore, Maryland, Memphis, Tennessee New Brunswick, New Jersey, and Winston-Salem, North Carolina. PARTICIPANTS: Men and women aged 60 to 80 years who were being treated with a prescription medication for control of hypertension. MAIN OUTCOME MEASURES: Visit counts and percent yields were assessed at each stage of the screening and randomization process. Logistic regression was used to contrast the randomization yields for different recruitment strategies and to explore the impact of sociodemographic characteristics and geographic location on recruitment yields. RESULTS: The overall randomization yields from a prescreen contact and a first screening visit to enrollment in the trial were 11% and 31%, respectively. Randomization yields varied significantly by participant age, education, and marital status. CONCLUSIONS: Our results demonstrate the feasibility of recruitment for trials of nonpharmacologic interventions in older people and suggest that mass mailing and mass media advertising campaigns provide an effective means of enrolling in such studies participants with a broad range of personal characteristics.

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PURPOSE: To compare the effects of a multimodal nonpharmacologic intervention to digoxin and to placebo in patients with congestive heart failure receiving background therapy with angiotensin-converting enzyme inhibitors. DESIGN: Randomized, parallel assignment to three treatment groups of 20 patients with congestive heart failure (New York Heart Association Class II and III). INTERVENTION: Nonpharmacologic treatment program included the following: (1) graduated exercise training, three to five times per week; (2) structured cognitive therapy and stress management; and (3) dietary intervention aimed at salt reduction and weight reduction in the overweight. Digoxin was titrated to achieve a blood level between 0.8 and 2.0 ng/ml. Placebo and digoxin were administered in a randomized, double-blind fashion. RESULTS: Echocardiographic ejection fraction improved (p < 0.05) in the digitalis group (change = +4.4 +/- 6.5) compared with both placebo (change = -3.2 +/- 3.9) and nonpharmacologic therapy (change = -3.2 +/- 3.9). The nonpharmacologic treatment program was well tolerated by all patients and resulted in significant improvement (p < 0.05) in exercise tolerance (digoxin = +51 +/- 50 s, placebo = +91 +/- 76, nonpharmacologic therapy = +182 +/- 139), as well as Beck Depression Inventory score (digoxin = +1.2 +/- 4.4, placebo = +2.0 +/- 4.2, nonpharmacologic therapy = -5.0 +/- 4.2), Hamilton Scale scores of anxiety (digoxin = +3.0 +/- 6.8, placebo = +6.0 +/- 2.6, nondrug therapy = -5.2 +/- 5.4), and depression (digoxin = +1.0 +/- 4.9, placebo = +5.0 +/- 5.0, nonpharmacologic therapy = -6.6 +/- 10.1). In addition, weight loss was significantly greater with nonpharmacologic therapy (digoxin = +0.32 +/- 1.76 kg; placebo = -1.35 +/- 1.44 kg; nonpharmacologic therapy = -4.37 +/- 4.50 kg) compared with both digoxin and placebo. CONCLUSIONS: Nonpharmacologic therapy improved functional capacity, body weight, and mood state in patients with congestive heart failure. In contrast, digoxin improved ejection fraction without corresponding changes in exercise tolerance or quality of life.

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BACKGROUND: We wished to evaluate whether differences in the rate of invasive cardiac procedures between men and women with acute myocardial infarction are associated with different short- and long-term mortality. METHODS AND RESULTS: The database (Myocardial Infarction Data Acquisition System, MIDAS) included all discharges for the years 1986 and 1987 with the diagnosis of acute myocardial infarction in New Jersey, based on the New Jersey hospital discharge data system (MIDS/UB-82). Accuracy of the data was evaluated by auditing 726 randomly selected charts. The variables examined included age, sex, race, comorbidity (anemia, chronic liver disease, cancer, chronic obstructive pulmonary disease, diabetes, hypertension, prior myocardial infarction), complications (left ventricular dysfunction, arrhythmias, conduction defects), insurance status, performance of cardiac catheterization, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft surgery, and survival up to 3 years. Women were older, had longer hospital stay, and were more likely than men to have anemia, diabetes, hypertension, left ventricular dysfunction, and Medicare or Medicaid insurance coverage. They were less likely than men to be admitted to a hospital equipped to perform invasive procedures or to have chronic obstructive pulmonary disease, chronic liver disease, prior myocardial infarction, or arrhythmias. After adjustment for these differences, women were less likely than men to have cardiac catheterization. Cardiac catheterization was associated with lower mortality. Women up to age 70 had higher 3-year death rates than men after adjustment for age, race, comorbidity, complications, and insurance type. This difference between men and women was somewhat diminished after the performance of cardiac catheterization and revascularization was taken into account. Unadjusted mortality was high in this study group. CONCLUSIONS: Women with acute myocardial infarction are less likely to have invasive cardiac procedures and have higher 3-year adjusted death rate up to age 70 than men.

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In an ancillary study of the Systolic Hypertension in the Elderly Program (SHEP), the effects of diuretics on ventricular ectopic activity were investigated in 186 patients with isolated systolic hypertension. Ventricular premature complexes (VPCs) were examined as the number of VPCs/24 hours, presence of > or = 1 VPC, presence of > or = 10 VPCs/24 hours, and presence of VPC pairs or ventricular tachycardia. Significant changes in VPCs were not observed either in the 92 patients randomized to chlorthalidone stepped-care (12.5 and 25 mg/day) or in the 94 placebo-treated patients (p > 0.1 for all VPC definitions and both groups). Serum potassium decreased from 4.4 +/- 0.5 to 4.1 +/- 0.5 mEq/liter (p = 0.002) in the chlorthalidone group and did not change (4.4 +/- 0.5 to 4.5 +/- 0.4 mEq/liter) in the placebo group. Potassium was prescribed routinely for confirmed hypokalemia < 3.5 mEq/liter. A relation between serum potassium and VPC or change in serum potassium and change in VPC was not observed in the chlorthalidone group. In summary, in patients with isolated systolic hypertension, chlorthalidone in doses that are effective in decreasing stroke and cardiovascular event rates (12.5 or 25 mg/day), did not increase VPCs.

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In a crossover study, 12 patients with mild to moderate hypertension were given placebo, captopril (12.5 to 50 mg three times a day), and nadolol (20 to 160 mg once a day) to control the resting diastolic blood pressure to a nearly identical degree (p less than 0.0001) (106.1 +/- 4 placebo, 89.6 +/- 8 captopril, 89.8 +/- 7 nadolol). Both drugs lowered (p less than 0.0004) systolic and diastolic blood pressure at rest and during exercise. However, systolic blood pressure lowering during exercise was more pronounced (p less than 0.05) with nadolol than with captopril (difference of 6 mmHg, 16 mmHg, and 21 mmHg at 5.0, 7.0, and 9.0 metabolic equivalents (METS) respectively). Heart rate was lower (p less than 0.05) at rest and during exercise with nadolol as compared with placebo and with captopril. These data imply different mechanisms of action of the two drugs at rest and during exercise and may help in selection of drug therapy in special patient subsets.

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The duration of action of three beta blockers (atenolol in nine patients, nadolol in 18 patients, and pindolol in 11 patients) administered once a day was studied in three cohorts of patients with angina on effort. Compared with single-blind run-in placebo, all three beta blockers decreased angina frequency (p less than 0.01), exercise tolerance (p less than 0.01), heart rate recorded by ambulatory ECG, and submaximal heart rate when a treadmill exercise stress test was performed 3 hours after administration of the daily dose (p less than 0.0001). Twenty-four hours after the dose, the percentage of the maximal heart rate-attenuating effect was highest for nadolol (pharmacokinetic half-life, 15.5 hours), followed by atenolol and then by pindolol (half-life, 5.5 hours). A linear relationship between the logarithm of plasma concentration of beta blocker and the heart rate at submaximal exercise (r = 0.72 and p = 0.0001 for nadolol; r = 0.50 and p = 0.0001 for pindolol) was observed. The data suggest that in the treatment of angina on effort, beta blockers should be prescribed according to their pharmacokinetic properties to achieve adequate suppression of the heart rate during exercise.

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Cibenzoline, a new class I antiarrhythmic drug, was administered to 24 patients with frequent (greater than 30/h) premature ventricular complexes. Three patients discontinued the medication because of epigastric distress before repeat ambulatory electrocardiography. Of the remaining 21 patients, 13 responded to 130 mg twice daily by more than 75% suppression of premature ventricular complex frequency and 6 additional patients responded to 160 mg twice daily during an open-label titration phase. Events of ventricular tachycardia (greater than or equal to 3 beats) were totally suppressed in 9 of 10 patients and markedly diminished in the 1 remaining patient. During a double-blind placebo-controlled crossover phase in 16 patients (21 patients minus 2 nonresponders and 3 who developed side effects), cibenzoline suppressed the number of premature ventricular complexes per 24 hours (4,075 +/- 868 to 1,758 +/- 1,089, p = 0.02), the number of events of ventricular tachycardia (31 +/- 30 to 2 +/- 0, p = 0.01) and the number of premature ventricular complex pairs (61 +/- 28 to 25 +/- 21, p = 0.01). Cibenzoline plasma concentration was 59 to 421 ng/ml in responders and higher (387, 758 and 852 ng/ml, respectively) in the three subjects with side effects (right bundle branch block in one, hypotension in one, gastrointestinal upset and central nervous system complaints in one). Cibenzoline plasma concentration correlated with PR interval (r = 0.55, p = 0.0106) and corrected QT interval (r = 0.58, p = 0.0054). Further clinical investigation of this new antiarrhythmic agent is needed.

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Twenty-four hour ambulatory electrocardiography was performed on 28 patients with aortic stenosis without significant coronary artery disease or aortic regurgitation. Compared to a control group of subjects with normal hearts proven by noninvasive and invasive testing, patients with aortic stenosis had higher (p = 0.0001) frequency of premature ventricular contractions (PVC) (3144 +/- 1425 versus 17 +/- 46) per 24 hours and higher (p = 0.001) prevalence of PVC presence (27 of 28 patients versus 39 of 101 normal), and complexity (19 of 28 patients versus 4 of 101 normal). Weak correlations of complexity with left ventricular end-diastolic pressure (r = 0.30) and ejection fraction (r = -0.25) were noted. No correlation of ventricular ectopic activity with peak systolic gradient, aortic valve area, or peak left ventricular systolic pressure was noted. Repeat 24-hour ambulatory electrocardiography performed on 13 patients three months after successful aortic valve replacement did not show significant effect of aortic valve replacement on PVC frequency or complexity.

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In order to study the effect of age, blood pressure and gender on premature ventricular contractions (PVCs), 24-hour ambulatory electrocardiography was performed on 338 apparently normal subjects (Group I; 209 men, 129 women, age 17 to 69, mean 48.5 +/- 11.7) and on 100 subjects with normal hearts proven by extensive invasive and noninvasive testing (Group II; 51 men, 49 women, age 16 to 68, mean 48.8 +/- 10.2). Apparently normal subjects (Group I) had a higher prevalence of PVCs (61.8% vs. 39.0%, p less than 0.001) and of complexity (16.3% vs. 4.0%, p less than 0.003) than subjects with normal hearts (Group II). The distribution of subjects according to PVC frequency was bimodal in Group I and unimodal in Group II. PVC prevalence increased with age in both the apparently normal group (p less than 0.001), and in the group with normal hearts (p less than 0.025). On the contrary, apparently normal (Group I) men had almost twice the PVC prevalence (74.6% vs. 41.1%, p less than 0.001) and complexity (20.1% vs. 10.1%, p less than 0.25) than apparently normal women, while gender had no effect on PVC prevalence in subjects with normal hearts (Group II). Systolic blood pressure was also associated with PVC prevalence (p less than 0.001) and complexity (p less than 0.02) in apparently normal subjects (Group I) but not in subjects with normal hearts (Group II). These data indicate: that apparently normal subjects have higher prevalence of PVCs and of PVC complexity than subjects with normal hearts, probably because of undetected cardiac disease; that the increase in PVC prevalence with age is not necessarily due to cardiac disease; and that PVC complexity in apparently normal subjects should raise the suspicion of cardiac disease especially in men, in subjects with hypertension and in the older age group.

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To delineate the effects of true aging, undetected heart disease and deconditioning on heart rate, we performed 24-hour ambulatory electrocardiography and maximal exercise stress test on 101 subjects with normal hearts. The maximal heart rate recorded was 180 beats/min; the minimum was 35 beats/min. A distinct diurnal pattern was observed. With increasing age, a decrease of the maximal heart rate achieved during exercise stress test (r = 0.27, p = 0.05) or spontaneously recorded during the day (r = 0.41, p = 0.0005) or night (r = 0.24, p = 0.03) was observed. The resting and average heart rates were not affected by age. Older subjects had lower exercise tolerance (r = 0.41, p = 0.0001). Low exercise tolerance was associated with higher increments of heart rate for submaximal exercise levels (r = 0.0001) and lower maximal heart rates (r = 0.43, p - 0.008). These changes of heart rate with age are not due to undetected cardiac disease, because the subjects included in the study were meticulously screened by noninvasive and invasive means.

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