Patient assessment of lower urinary tract symptoms using the international prostate symptom score following low-dose-rate prostate brachytherapy.

PURPOSE: To correlate changes in urinary patient-reported outcomes including the International Prostate Symptom Score (IPSS), acute urinary retention and urethral stricture with urethral dose in those treated with low dose rate (LDR) prostate brachytherapy. MATERIALS AND METHODS: Patients treated with prostate LDR between 2012 and 2019 (n=117) completed IPSS urinary symptom assessments prior to treatment and at each follow-up. CT simulation was obtained with urinary catheter 1-month post-implant for dosimetric analysis. 113 patients with pre- and ≥1 post-LDR IPSS score available were analyzed. Urethral dosimetric parameters including U75, U100, U125, U150 and U200 were abstracted from post-implant dosimetry and assessed for association with urinary toxicity using bivariate logistic regression and Spearman correlation. Outcomes included clinically significant change (CSC, defined as 4 or more points or 25% rise above baseline) in IPSS score at 6 and 12 months, acute urinary retention (AUR), and urethral stricture (US). RESULTS: 89 (79%) patients were treated with LDR monotherapy (145 Gy) and 24 (21%) with LDR boost (110 Gy) with external beam radiation therapy. Twenty (18%) had baseline IPSS ≥15. Median IPSS scores were: baseline 6 (3-12; n=113), 1-month 17 (10-25; n=110), 6 months 12 (7-18; n=77), 1 year 8 (5-14; n=52). CSC-6 was observed in 59 (77%), CSC-12 in 26 (50%), AUR in 12 (11%), and US in 4 (4%). No association was identified between urethral dose parameters and CSC-6, CSC-12, AUR, or US. No correlation between urethral dose and IPSS at 6- and 12-months was identified. The IPSS ≥15 group exhibited lower rates of CSC-12 (13% v. 57%, p=0.05) but not CSC-6 (55% v. 80%, p=0.12). CONCLUSIONS: We did not find a relationship between urethral dose and IPSS elevation, AUR or US. We did identify a significantly lower change in IPSS at 12 months for those with baseline IPSS ≥15 compared to those with low baseline scores.

Fenofibrate-associated changes in renal function and relationship to clinical outcomes among individuals with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) experience.

AIMS/HYPOTHESIS: Fenofibrate has been noted to cause an elevation in serum creatinine in some individuals. Participants in the Action to Control Cardiovascular Risk in Diabetes Lipid Study were studied to better characterise who is at risk of an increase in creatinine level and to determine whether those with creatinine elevation have a differential risk of adverse renal or cardiovascular outcomes. METHODS: A fenofibrate-associated creatinine increase (FACI) was defined as an increase in serum creatinine of at least 20% from baseline to month 4 in participants assigned to fenofibrate. Baseline patient characteristics, and baseline and 4-month drug, clinical, laboratory characteristics and study outcomes were examined by FACI status. RESULTS: Of the sample, 48% of those randomised to receive fenofibrate had at least a 20% increase in serum creatinine within 4 months. In multivariable analysis, participants who were older, male, used an ACE inhibitor at baseline, used a thiazolidinedione (TZD) at 4 months post-randomisation, had baseline CVD, and had lower baseline serum creatinine and LDL-cholesterol levels were all more likely to meet the criteria for FACI. Participants in the FACI group were also more likely to have a decrease in their serum triacylglycerol level from baseline to 4 months. No differences in study outcomes were seen by FACI criteria. CONCLUSIONS/INTERPRETATION: Several characteristics predict a rapid rise in serum creatinine upon starting fenofibrate. Participants who met the criteria for FACI also had a greater change in triacylglycerol levels. In the setting of careful renal function surveillance and reduction of fenofibrate dose as indicated, no increase in renal disease or cardiovascular outcome was seen in those individuals demonstrating FACI. TRIAL REGISTRATION: ClincalTrials.gov: NCT00000620. FUNDING: The ACCORD Trial was supported by grants (N01-HC-95178, N01-HC-95179, N01-HC-95180, N01-HC-95181, N01-HC-95182, N01-HC-95183, N01-HC-95184, IAA-Y1-HC-9035 and IAA-Y1-HC-1010) from the National Heart, Lung, and Blood Institute; by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Eye Institute; by the Centers for Disease Control and Prevention; by General Clinical Research Centers and by the Clinical and Translational Science Awards. Abbott Laboratories, Amylin Pharmaceutical, AstraZeneca Pharmaceuticals LP, Bayer HealthCare LLC, Closer Healthcare, GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Merck, Novartis Pharmaceuticals, Novo Nordisk, Omron Healthcare, sanofi-aventis US and Takeda Pharmaceuticals provided study medications, equipment or supplies.

Renal duplex sonography: main renal artery versus hilar analysis.

OBJECTIVE: The purpose of this study was to compare the accuracy of main renal artery Doppler scanning interrogation and hilar analysis to diagnose hemodynamically significant renal artery disease. METHODS: From January 1998 to August 1999, 41 patients had renal duplex sonography with both main renal artery interrogation and hilar analysis followed by angiography. They form the basis of this review. The sample consisted of 24 men and 17 women, with a mean age of 68.9 +/- 10.2 years, who provided 80 kidneys for comparative analysis. Significant renal artery disease revealed through angiography was defined as >/= 60% diameter-reducing stenosis or occlusion. Peak systolic velocity (PSV) (in meters per second) and the presence of poststenotic turbulence (PST) were determined from main renal artery interrogation. Acceleration time (AT) (in milliseconds) was measured by means of hilar analysis. Significant renal artery stenosis was defined by a PSV of 2.0 m/s or more and a PST or an AT more than 100 ms. Sensitivity analyses of both PSV and AT were examined, and 95% CIs were computed. Receiver operating characteristic curves were used to estimate optimal values for PSV and AT. RESULTS: Angiography revealed hemodynamically significant fibromuscular dysplasia in 5 kidneys (4 patients), atherosclerotic stenosis >/= 60% in 48 kidneys (30 patients), and renal artery occlusion in 4 kidneys (4 patients). Kidneys with significant renal artery stenosis had a higher PSV (2.54 +/- 0.11 vs 1.28 +/- 0.08, P <.001) and AT (82.43 +/- 7.2 vs 30.0 +/- 2.8, P <.001) compared with those without stenosis. Compared with angiography, a PSV of 2.0 m/s or more and PST demonstrated a sensitivity of 91%, specificity of 96%, and overall accuracy of 92% for detection of significant renal artery stenosis. Two of five studies with false-negative results reflected diseased polar vessels. By contrast, AT of more than 100 ms had a sensitivity of 32%, specificity of 100%, and overall accuracy of 54%. Receiver operating characteristic curve analysis revealed a PSV of more than 1.8 m/s and an AT of 58 ms or greater as optimal values. With an AT of 58 ms or more, the sensitivity was 58%, and specificity was 96%, with an overall accuracy of 70%. There were no apparent associations between PSV or AT and type or location of renal artery lesion, serum creatinine level, or end-diastolic ratio. CONCLUSION: Main renal artery interrogation is an accurate screening test to detect significant stenosis or occlusion of the main renal artery. Hilar analysis alone does not provide sufficient sensitivity to be used as a sole screening study. Neither method detects the presence of renovascular disease associated with polar vessels.

Management of ischemic nephropathy: dialysis-free survival after surgical repair.

PURPOSE: This retrospective review describes the surgical management of consecutive patients with severe hypertension and ischemic nephropathy due to atherosclerotic renovascular disease. METHODS: From January 1987 through December 1998, a total of 590 patients underwent operative renal artery repair at our center. A subgroup of 232 hypertensive patients (97 women, 135 men; mean age, 66 +/- 8 years) with atherosclerotic renovascular disease and preoperative serum creatinine levels of 1.8 mg/dL or more forms the basis of this report. Change in renal function was determined from glomerular filtration rates estimated from preoperative and postoperative serum creatinine. The influence of selected preoperative parameters and renal function response on time to dialysis and dialysis-free survival was determined by a proportional hazards regression model. RESULTS: In all, 83 patients underwent unilateral renal artery repair and 149 patients underwent bilateral repair, including repair to a solitary kidney in 17 cases. A total of 332 renal arteries were reconstructed, and 32 nephrectomies were performed in these patients. After surgery, there were 17 deaths (7.3%) in the hospital or within 30 days of surgery. Advanced patient age (P =.001; hazard ratio, 1.1; 95% CI [1.1, 1.2]) and congestive heart failure (P =.04; hazard ratio, 2.9 CI [1.0, 8.6]) demonstrated significant and independent associations with perioperative mortality. With a change of 20% or more in EGFR being considered significant, 58% of patients had improved renal function, including 27 patients removed from dialysis dependence; function was unchanged in 35% and worsened in 7%. Follow-up death from all causes or progression to dialysis dependence demonstrated a significant and independent association with early renal function response. Both patients whose function was unchanged (P =.005; hazard ratio, 6.0; CI [2.2, 16.6]) and patients whose function was worsened (P =.03; hazard ratio, 2.2; CI [1.1, 4. 5]) remained at increased risk of death or dialysis dependence. For patients with unchanged renal function after operation, risk of death or dialysis demonstrated a significant interaction with preoperative renal function. In addition to severe preoperative renal dysfunction, diabetes mellitus demonstrated a significant and independent association with follow-up death or dialysis. CONCLUSION: Surgical correction of atherosclerotic renovascular disease can retrieve excretory renal function in selected hypertensive patients with ischemic nephropathy. Patients with improved renal function had a significant and independent increase in dialysis-free survival in comparison with patients whose function was unchanged and patients whose function was worsened after operation. These results add further evidence in support of a prospective, randomized trial designed to define the value of renal artery intervention in patients with ischemic nephropathy.

Long-term exercise and its effect on balance in older, osteoarthritic adults: results from the Fitness, Arthritis, and Seniors Trial (FAST).

OBJECTIVES: To examine the effects of 18-month aerobic walking and strength training programs on static postural stability among older adults with knee osteoarthritis. DESIGN: Randomized, single-blind, clinical trial of therapeutic exercise. SETTING: Both center-based (university) and home-based. PARTICIPANTS: A cohort of 103 older adults (age = 60 years) with knee osteoarthritis who were participants in a large (n = 439) clinical trial and who were randomly assigned to undergo biomechanical testing. INTERVENTION: An 18-month center- (3 months) and home-based (15 months) therapeutic exercise program. The subjects were randomized to one of three treatment arms: (1) aerobic walking; (2) health education control; or (3) weight training. MEASUREMENTS: Force platform static balance measures of average length (Rm) of the center of pressure (COP), average velocity (Vel) of the COP, elliptical area (Ae) of the COP, and balance time (T). Measures were made under four conditions: eyes open, double- and single-leg stances and eyes closed, double- and single-leg stances. RESULTS: In the eyes closed, double-leg stance condition, both the aerobic and weight training groups demonstrated significantly better sway measures relative to the health education group. The aerobic group also demonstrated better balance in the eyes open, single-leg stance condition. CONCLUSIONS: Our results suggest that long-term weight training and aerobic walking programs significantly improve postural sway in older, osteoarthritic adults, thereby decreasing the likelihood of larger postural sway disturbances relative to a control group.

Surgery after failed percutaneous renal artery angioplasty.

PURPOSE: This retrospective review describes the surgical management of 51 patients after failed percutaneous renal artery angioplasty (F-PTRA). METHODS: From January 1987 through June 1998, 51 consecutive patients underwent surgical repair of either atherosclerotic (32 patients) or fibromuscular dysplastic (FMD; 19 patients) renovascular vascular disease after F-PTRA. These patients form the basis of this report. Surgical repair was performed for hypertension (29 patients with atherosclerosis: mean blood pressure, 205 +/- 34/110 +/- 23 mm Hg; 18 patients with FMD: mean blood pressure, 194 +/- 24/118 +/- 18 mm Hg) or ischemic nephropathy (20 patients with atherosclerosis: mean serum creatinine level, 2.0 +/- 0.8 mg/dL; three patients with FMD: mean serum creatinine level, 2.0 +/- 1.1 mg/dL). Emergency operation was required in four patients for acute renal artery thrombosis (one patient with atherosclerosis, one patient with FMD), renal artery rupture (one patient with atherosclerosis), or infected pseudoaneurysm (one patient with atherosclerosis). Operative management, blood pressure and renal function response to operation, and dialysis-free survival rate were examined and compared with 487 patients (441 patients with atherosclerosis, 46 patients with FMD) treated by operation alone. RESULTS: Among the patients with atherosclerotic renovascular disease, there were three postoperative deaths (9.4%) after repair for F-PTRA. Secondary operative repair was associated with emergent repair or nephrectomy in 16% of cases, while more extensive renal artery exposure and more complex operative management was required in 50% of patients with atherosclerosis and 65% of patients with FMD repaired electively. Among the 28 operative survivors with hypertension and atherosclerotic renovascular disease, blood pressure benefit after F-PTRA was significantly lower when compared with patients with atherosclerosis who underwent treatment with operation only (57% vs 89%; P <.001). However, blood pressure benefit in the 19 patients with FMD did not differ (89% vs 96%). Among the 28 patients with atherosclerosis, preoperative estimated glomerular filtration rate (EGFR) as compared with postoperative EGFR was significantly increased (47.4 +/- 4.2 mL/min/1.73m(2) vs 56. 6 +/- 5.1 mL/min/1.73m(2); P =.002). However, EGFR prior to PTRA was not significantly different from postoperative EGFR (51.6 +/- 3.4 mL/min/1.73m(2) vs 56.6 +/- 4.9 mL/min/1.73m(2); P =.121). As compared with patients with atherosclerosis who underwent treatment with operation alone, there was no difference in the dialysis-free survival rate. CONCLUSION: Operative repair after F-PTRA was altered in 59% of the patients with atherosclerosis and in 68% of patients with FMD. Blood pressure benefit for patients with FMD was unchanged after F-PTRA. However, the blood pressure benefit was significantly decreased among patients with atherosclerosis. Decreased EGFR after F-PTRA was recovered with operative renal artery repair. However, postoperative EGFR as compared with EGFR prior to PTRA was unchanged. Blood pressure and renal function response after F-PTRA for atherosclerotic renovascular disease warrants further study.

1996 Remington lecture: modeling multivariate longitudinal data that are incomplete.

PURPOSE: We describe the impact that missing data may have on model selection for longitudinal multivariate data. METHODS: Maximum likelihood was used to fit several models to ultrasonographic measurements from the Asymptomatic Carotid Artery Progression Study (ACAPS). Graphical techniques were used to examine evidence concerning the underlying missing data mechanisms associated with each model. RESULTS: Using statistical methodology that addressed missing data substantially increased the statistical efficiency of our analysis of ultrasonographic data. Only complex models that included segment-specific parameterizations for longitudinal correlations appeared to allow missing data to be assumed to occur at random. CONCLUSION: Ignoring the nature of missing data in conducting statistical analyses can have serious consequences when missingness is not rare. It may be necessary to fit models of high dimension with maximum likelihood techniques to address missing data appropriately, however these approaches may improve statistical efficiency.

Chronic renal artery occlusion: nephrectomy versus revascularization.

PURPOSE: The surgical management of chronic atherosclerotic renal artery occlusion (RA-OCC) was studied. METHODS: From January 1987 through December 1996, 397 consecutive patients were treated for atherosclerotic renal artery disease. Ninety-five hypertensive patients (mean blood pressure, 204 +/- 31/106 +/- 20 mm Hg; mean medications, 3.0 +/- 1.1 drugs) were treated for 100 RA-OCCs. Eighty-four (88%) patients had renal dysfunction, defined by serum creatinine levels >/=1.3 mg/dL (mean serum creatinine level, 2.8 +/- 2.0 mg/dL). Demographic characteristics, operative morbidity and mortality, blood pressure/renal function response, and postoperative decline in renal function were examined and compared with that of 302 patients treated for renal artery stenosis (RAS). RESULTS: After operation, there were 5 perioperative deaths (5.2%), 2 (2.8%) after revascularization and 3 (12%) after nephrectomy (P =.11), compared with 12 (4.0%) perioperative deaths in the RAS group (P =.59). After controlling for important covariates, estimated survival and blood pressure benefits did not differ between RA-OCC patients treated by nephrectomy or revascularization (P =.13; 87% vs 92%, P =.54). Excretory renal function was considered improved in 49% of 79 RA-OCC patients with renal dysfunction, including 9 patients removed from dialysis-dependence. Among patients treated for unilateral disease, revascularization for RA-OCC was associated with significant improvement in renal function (P <.01); however, nephrectomy alone did not increase renal function significantly. Improved renal function after operation was associated with a significant and independent increase in survival (P <.01) and dialysis-free survival (P <.01) among patients treated for RA-OCC. In addition, blood pressure benefit, renal function response, and estimated survival did not differ significantly after reconstruction for RA-OCC or RAS. CONCLUSION: Among hypertensive patients treated for RA-OCC, equivalent beneficial blood pressure response was observed after both revascularization and nephrectomy. In patients who underwent bilateral renal artery revascularization, the change in excretory renal function attributable to repair of RA-OCC cannot be defined. In patients treated for unilateral disease, however, improvement in function was observed only after revascularization. Moreover, improved renal function demonstrated a significant and independent association with improved survival. This experience supports renal revascularization in preference to nephrectomy for RA-OCC in select hypertensive patients when a normal distal artery is demonstrated at operation.

Isradipine in prediabetic hypertensive subjects.

OBJECTIVE: Investigators from the Multicenter Isradipine Diuretic Atherosclerosis Study (MIDAS) previously reported that the isradipine group had a higher incidence of cardiovascular disease (CVD) events than the diuretic group. The ultimate objective of the analyses presented here was to assess how indices of glycemia (specifically, serum glucose, serum insulin, and HbA1c) might have influenced the effects of the two agents on blood pressure control and CVD events. RESEARCH DESIGN AND METHODS: Inclusion criteria included men and women > or = 40 years of age with ultrasonographically confirmed carotid atherosclerosis and a diastolic blood pressure of > 90 mmHg. Although insulin-dependent diabetic patients were excluded, the three glycemia indices had wide enough ranges to include patients who may be classified as prediabetic. A total of 883 patients were randomized either to the dihydropyridine calcium antagonist (CA) isradipine (2.5-5 mg twice a day) or to the diuretic hydrochlorothiazide (12.5-25 mg twice a day) and followed in double-blind fashion for 3 years. RESULTS: Both treatment groups had achieved comparable control of diastolic blood pressure, and there were no statistically significant differences in any of the glycemia indices, either at baseline or during follow-up. However, the excess isradipine events were noted to be clustered among those patients with elevated baseline levels of HbA1c who also experienced greater blood pressure reductions during follow-up. CONCLUSIONS: The increased cardiovascular risk associated with dihydropyridine CAs in prediabetic patients may be an explanation for the overall CA debate.

Ten-year trends in cigarette smoking among young adults, 1986-1996: the CARDIA study. Coronary Artery Risk Development In Young Adults.

PURPOSE: To calculate ten-year smoking trends in a longitudinal cohort of young adults, and to characterize trends by race, sex, education, and birth cohort. METHODS: Data on cigarette smoking have been collected for ten years (1986-1996) from 5115 black and white men and women, aged 18-30 years, participating in the Coronary Artery Risk Development In Young Adults (CARDIA) study. Regression analysis adjusting for intra-person correlation over time and weighting for factors affecting follow-up was used to estimate change in smoking rates. RESULTS: Overall, smoking rates declined in white women (-0.50%/year, p < 0.001) and white men (-0.24%/year, p = 0.03). Rates remained stable in black women and increased in black men (0.37%/year, p = 0.01). Declining rates were generally observed in white women of all educational levels and birth cohorts and in several subgroups of white men. Increasing rates among black men could be attributed primarily to increasing rates in the youngest birth cohort. Among black men and women, prevalence of smoking in 1986 was considerably lower in the youngest birth cohort compared to the oldest; however, the increasing rates of change in smoking rates observed among the youngest birth cohorts (and decreasing rates in the oldest) lessened the disparity in prevalence rates across birth cohorts by 1996. Smoking initiation rates were highest among black men; cessation rates were highest among white women. CONCLUSIONS: These findings confirm that declines in smoking prevalence are not occurring across all groups, and reveal populations in special need of targeted interventions, particularly young black men.

Renal artery repair: consequence of operative failures.

OBJECTIVE: This report examines the blood pressure and renal function response in 20 consecutive patients after secondary renal revascularization following failed operative repair. SUMMARY BACKGROUND DATA: Most reports describing operative failure of renal artery (RA) repair emphasize the technical aspects of redo RA reconstruction and the immediate blood-pressure response to secondary operation. This report examines the eventual renal function and estimated survival after secondary intervention. METHODS: Primary methods of RA reconstruction, primary blood pressure and renal function responses, and causes of failed RA repair were defined for 20 patients requiring reoperation for recurrent hypertension or renal insufficiency. These parameters were compared with secondary procedures and eventual blood pressure and renal function response. The eventual outcome for these 20 patients was compared with 514 patients managed by primary renal revascularization during the same period. RESULTS: Failure of primary RA repair correlated with complex fibromuscular dysplasia requiring branch ex vivo reconstruction (p = 0.020). RA thrombosis frequently required nephrectomy (83%), whereas RA stenosis was successfully reconstructed (91 %; p = 0.001). Primary and secondary blood-pressure responses were equivalent (94% vs. 95% cured or improved); however, primary and eventual renal function responses differed significantly (p = 0.015), with seven patients dialysis-dependent on follow-up. Eventual dialysis dependence was associated with preoperative azotemia (p = 0.022), bilateral failure of primary RA repair (p = 0.007), and an increased risk of follow-up death (p = 0.002). Considering all 534 patients, failed RA repair demonstrated a significant and independent association with eventual dialysis dependence and decreased dialysis-free survival. CONCLUSIONS: Contemporary rates of reoperation after surgical RA repair are low. In properly selected patients, beneficial blood-pressure response is reliably observed after both primary and secondary operative procedures. However, secondary procedures are associated with a significant and independent risk of eventual dialysis dependence.

Renal artery repair in African-Americans.

PURPOSE: This retrospective review examines the results of atherosclerotic renal artery (RA) repair in consecutive hypertensive African-Americans treated at our center and compares these results with Caucasians treated during the same period. METHODS: From Jan. 1987 through Sep. 1996, a total of 485 patients underwent operative RA repair. Of these, 28 African-Americans and 370 Caucasians were managed for atherosclerotic renovascular disease. These cohorts were compared on the basis of preoperative blood pressure and renal function, extent of renal disease, extrarenal atherosclerosis, response to operation, and estimated survival. RESULTS: The African-American cohort included nine men and 19 women (mean age, 62 years) with hypertension (mean blood pressure, 204 +/- 31/109 +/- 20 mm Hg) for an average of 10.2 +/- 7.5 years. Ischemic nephropathy (serum creatinine level, > 1.3 mg/dl) was present in 82% (n = 23) of the African-American group. RA reconstructions were unilateral in nine patients and bilateral in 19 patients (including repair to two solitary kidneys), for a total of 45 RA reconstructions (30 RA bypass procedures; eight transrenal/transaortic RA endarterectomy procedures; two RA reimplantations; five nephrectomies). Nine patients underwent combined aortic procedures (four abdominal aortic aneurysm; five occlusive disease). There was one perioperative death in the African-American group as a result of sepsis and multiple organ failure. Among surgical survivors, 20 African-American patients (74%) had a beneficial hypertension response (7% cured, 67% improved). Mean estimated glomerular filtration rate improved significantly from 34 to 42 ml/min/1.73 m2 (p < 0.001). In the 23 patients with ischemic nephropathy, 13 (57%) demonstrated greater than 20% decrease in serum creatinine level. In comparison with the 370 Caucasians (191 men, 179 women), the African-American cohort had significantly more preoperative heart disease (congestive heart failure or left ventricular hypertrophy; 68% vs 46%; p = 0.03) and tended toward more severe renal dysfunction (mean serum creatinine level, 2.5 vs 2.1 mg/dl; p = 0.25). However, African-Americans demonstrated a beneficial blood pressure and renal function response after operation, similar to Caucasians. CONCLUSIONS: Our results indicate that the majority of selected African-Americans have a favorable blood pressure and renal function response to operative renal artery repair. This beneficial clinical response appears equivalent to the response observed in Caucasian patients and supports the search for RA disease in hypertensive African-Americans.

Bilateral monocular diplopia associated with lid position during near work.

PURPOSE: To describe a common pattern of topographic changes and clinical signs of six patients presenting with a complaint of monocular diplopia after reading and to investigate the cause of this topographic disturbance. PATIENT POPULATION: Subject group of six patients with monocular diplopia complaints after reading and 20 patients without such complaints. Examinations performed before and after a reading period of 30 min: videokeratoscopic examination, red reflex examination, position of the lids in primary gaze and in reading position. DATA ANALYSIS: inspection of keratoscopic rings, qualitative analysis of topography maps, comparison of SAI and SRI of control and subject groups before and after reading, comparison of lid position of control and subject group. RESULTS: Half of the subject group and none of the control group developed subtle ring distortions of keratoscopic rings. SAI and SRI values increased significantly in the subject group compared with the control group (p = 0.02 and p < 0.001, respectively) corresponding to the development of a focal distortion in the entrance pupil of the videokeratoscopic image. Each subject developed a horizontal band on red reflex located at the superior, middle, or inferior aspect of the pupil after near work. Two controls developed faint bands in the red reflex outside the entrance pupil. The interpalpebral fissure in down gaze was narrower in the subject group compared with the control group (p = 0.001). CONCLUSIONS: Some individuals may develop monocular diplopia after reading. We hypothesize that during near work these corneal topographic alterations occur primarily related to the position of the lids and tear film interaction with the corneal surface.

Is renal revascularization in diabetic patients worthwhile?

PURPOSE: This retrospective review describes surgical management of atherosclerotic renovascular disease (RVD) in hypertensive adults with diabetes mellitus. METHODS: From July 1987 through July 1995, 54 consecutive hypertensive diabetics (mean 213/103 mm Hg; mean medications three drugs) requiring either insulin (16 patients) or oral hypoglycemic therapy (38 patients) had operative repair of atherosclerotic RVD. Renal dysfunction (serum creatinine [SCr] > or = 1.3 mg/dl) was present in 82% of patients (mean SCr 2.4 mg/dl). Associations between blood pressure and renal function response to operation and preoperative parameters were examined. Clinical characteristics, response to operation, and dialysis-free survival were compared with those of 291 nondiabetic patients. RESULTS: Four (7.4%) operative deaths occurred. Among 50 survivors blood pressure response was considered cured or improved in 72% and unchanged in 28%. Of 42 patients with renal dysfunction 40% had improved function including three patients removed from dialysis. No preoperative parameter examined demonstrated a significant association with blood pressure or renal function response. During follow-up 10 additional patient deaths occurred, and eight patients progressed to dialysis dependence. Time to death or dialysis was associated with preoperative estimates of glomerular filtration (p = 0.03) and the change in estimates of glomerular filtration after operation (p = 0.01). Compared with 291 nondiabetics, the diabetic group had no statistical difference in improved function response (40% vs 51%, p = 0.21); however, diabetics had a significantly lower rate of beneficial blood pressure response (72% vs 89%, p = 0.01) and an increased risk of dialysis or death during follow-up (p = 0.02). By multivariate analysis independent predictors of time to death or dialysis included the presence of diabetes mellitus, patient age, history of congestive heart failure, and increased serum creatinine. CONCLUSIONS: Most of the selected diabetic patients had a beneficial blood pressure response after undergoing operative repair of atherosclerotic RVD, albeit at a lower rate compared with nondiabetics. In diabetics poor renal function before and after operation was associated with progression to dialysis and death. Improved renal function after operation was associated with improved survival; however, function response to renal revascularization was difficult to predict.

Combined aortic and renal artery surgery. A contemporary experience.

PURPOSE: This retrospective study examines results with simultaneous aortic and renal artery repair in 133 consecutive hypertensive patients. These results are compared with consecutive patient groups undergoing aortic reconstruction alone (269 patients) or renal artery reconstruction alone (182 patients). METHODS: From January 1987 through July 1995, 61 women and 72 men (mean age, 62.5 years) underwent combined repair of renal artery and aortic disease (abdominal aortic aneurysm [AAA]: 47 patients; occlusive disease: 86 patients; both: 12 patients). All patients were hypertensive (mean blood pressure: 194/103 mmHg; mean medications: 2.4). Evidenced by serum creatinine levels > or = 2.0 mg/dL, 46 patients (35%) had significant renal dysfunction (mean serum creatinine level: 3.78 mg/dL; range 2.0-10.6 mg/dL, including 7 dialysis-dependent patients). Aortic replacements (29% tube grafts; 71% bifurcated grafts) were combined with unilateral renal artery repair in 47% of patients; 53% had bilateral repair. Preoperative clinical features and perioperative mortality were compared with those groups having isolated aortic and renal repairs. RESULTS: There were seven perioperative deaths (5.3%) after combined repair, which differed significantly from isolated aortic repair (mortality: 0.74%; p = 0.005), but did not reach statistical significance when compared with the isolated renal artery group (mortality: 1.65%; p = 0.145). Risk analysis did not reveal a significant association between preoperative clinical features and mortality in either the combined repair group or the groups undergoing renal repair alone or aortic repair alone. Among survivors in the combined group, a favorable hypertension response was observed in 63%. This differed significantly from the group receiving renal repair alone (90% cured/improved; p < 0.001). Based on a 20% decrease in serum creatinine levels, excretory renal function was improved in 33% of patients with combined repair, including four of the seven patients removed from hemodialysis. There were eight late deaths in the combined group. CONCLUSIONS: Our experience suggest that contemporary perioperative mortality for combined aortic and renal repair has improved compared with earlier reports; however, perioperative mortality for simultaneous reconstruction remains greater than repair of aortic disease alone. Moreover, a lower rate of favorable hypertension response was observed after combined correction compared with renal artery repair alone. These differences suggest that aortic and renal artery repair should only be combined for clinical indications rather than for prophylactic repair of clinically silent disease.

Reliability of longitudinal ultrasonographic measurements of carotid intimal-medial thicknesses. Asymptomatic Carotid Artery Progression Study Research Group.

BACKGROUND AND PURPOSE: Serial ultrasonic B-mode measurements of intimal-medial thickness (IMT) of the carotid artery are commonly used as surrogates for describing atherosclerosis progression. This report describes the longitudinal reliability of IMT measurement during a multicenter clinical trial, quantifies the error attributable to differences among readers, and discusses how studies can be efficiently designed. METHODS: Serial B-mode measurements of carotid IMT from the 3-year Asymptomatic Carotid Artery Progression Study (ACAPS; formerly Asymptomatic Carotid Artery Plaque Study) were used to estimate the contributions to longitudinal measurement error of systematic reader effects, nonvisualization, and nonsystematic error and to describe the distribution of "true" progression rates that underlie the observed data. Variance components were estimated from random-effects models fitted to outcome measures formed by averaging IMTs from different sets of carotid artery walls. These were used to contrast the relative efficiency of study designs. RESULTS: Of the total variance of measured IMT, 11% was attributable to systematic differences among readers. Nonvisualization contributed less than 7%. Thus, the predominant source of error was unaccounted for (ie, random error or "noise," which in our analyses included any drift, nonlinearity, and sonographer differences). For studies with measurement protocols similar to ACAPS, follow-up times of 2 years or more are desirable for describing the mean progression rates of cohorts, and of 6 years or more for categorizing progression within individuals. In 3-year studies, sample sizes as low as 237 provide 90% statistical power for detecting risk factors that have correlations with IMT progression of .50 or greater. CONCLUSIONS: The ACAPS measurement protocol provided highly reliable serial IMT data. Moderate-sized multicenter studies using B-mode outcomes are feasible.

Racial differences in the incidence of end-stage renal disease.

OBJECTIVE: To examine trends in the incidence of treated end-stage renal disease (ESRD) and variations between blacks and whites. DESIGN: Retrospective record reviews of all new patients > or = 15 years starting chronic dialysis during 1980-1988 at the Piedmont Dialysis Center, Forsyth County, North Carolina. RESULTS: The cumulative nine-year incidence rate for hypertensive ESRD was 570 per million, and for diabetic ESRD 497 per million. Among men, hypertensive ESRD accounted for the largest proportion of cases (39.2% and 28.4%, blacks and whites respectively), while diabetic ESRD contributed 33.9% of black female cases and 24.4% of white female cases. Compared to whites, blacks were at significantly increased risk, with an adjusted risk odds ratio (OR) of 4.4 (95% confidence interval (CI) 3.5-6.0) for all causes combined, 6.0 (CI 3.9-9.0) for hypertensive renal disease, 6.0 (CI 3.8-9.3) for renal disease due to insulin-dependent diabetes mellitus, and 12.2 (CI 6.9-21.7) due to non-insulin dependent diabetes mellitus (NIDDM). The greatest risk among blacks was seen in the 55-64 year age group, with ORs of 9.1 for all causes combined and 30.6 for hypertensive renal disease. The OR for renal disease due to NIDDM for black versus white women was 20.0 (CI 9.5-41.7). Compared to 1980, 1981, 1982 and 1983, increased incidence rates were seen in each year after 1984. CONCLUSION: These findings show even greater excess risk of ESRD among blacks than previously reported. The majority of the excess risk is seen for ESRD due to hypertension and diabetes, especially NIDDM. The reasons for the increased risk among blacks, and for the increasing incidence rates of ESRD are not known.

Renal artery fibromuscular dysplasia: results of current surgical therapy.

PURPOSE: This retrospective review describes current surgical management of renal artery (RA) fibromuscular dysplasia (FMD) to define contemporary clinical characteristics and surgical results in patients over the age of 21 years. METHODS: From January 1987 through March 1994, 40 consecutive adults with hypertension had operative RA repair of FMD at our center and form the basis of this report. From histologic and angiographic appearance, FMD was classified with regard to specific type, noting the presence of RA dissections, RA macroaneurysms and branch RA involvement. Associations between blood pressure response to operation and patient age, duration of hypertension, presence of extrarenal atherosclerosis, presence of branch renal artery disease, and primary or secondary procedure were examined. Clinical characteristics and blood pressure response in these contemporary patients were compared with the results reported from an earlier surgical series. RESULTS: Unilateral RA repair was performed in 34 patients, and bilateral procedures were required in six patients. Branch renal artery repair was performed in 28 instances, including ex vivo RA repair in 11 patients. There were no perioperative or follow-up deaths; however, three RA grafts (7%) failed within 30 days of operation. Initial blood pressure response was considered cured in 33%, improved in 57%, and failed in 10%. Analysis demonstrated that patients older than 45 years of age had a significantly decreased rate of hypertension cure compared with younger patients; among patients younger than 45 years of age, duration of hypertension was inversely related to cure. Compared with earlier surgical series, our current group of patients was significantly older, with more frequent branch renal artery involvement and extrarenal atherosclerosis, and demonstrated decreased rate of hypertension cure. CONCLUSION: A beneficial blood pressure response is currently observed in most selected patients after surgical correction of RA-FMD. Compared with earlier series, however, the present day patient differs in many respects, including a significantly decreased chance for hypertension cure after surgical repair.

Association of coronary disease with segment-specific intimal-medial thickening of the extracranial carotid artery.

BACKGROUND: Several investigators have evaluated relations between risk factors and intimal-medial thickness (IMT) of the extracranial carotid arteries and between IMT and clinical cardiovascular disease. Different indexes of IMT have been used as referents. We compared the strength of association of various IMT measurements with coronary artery disease as measured at coronary angiography. METHODS AND RESULTS: We quantified the mean of the IMT for 12 sites of the extracranial carotid arteries (common carotid, bifurcation, internal carotid, near and far walls, and left and right sides [mean aggregate]) as well as for various combinations of sites (eg, segment-specific means, far walls only, maximum of any site) in 270 patients with or free of coronary artery disease. Models including age and all the indexes of IMT identified the mean aggregate as the only variable independently associated with the status of coronary atherosclerosis for the group as a whole. Next most strongly correlated was the mean common plus bifurcation. When classification algorithms were tested for ability to correctly classify case patients and control subjects, the mean bifurcation, mean common plus bifurcation, and mean aggregate were most strongly related to case-control status; however, the predictive power of the mean common was also strong. CONCLUSIONS: These data support use of the mean aggregate extracranial carotid IMT for correlation with the status of coronary atherosclerosis; however, the data also support use of the mean common plus bifurcation, since there is little increase in predictive power of the mean aggregate over this index. Use of the common carotid alone is also justifiable and may be preferable for certain analyses.