Metabolic profile and cardiovascular risk factors among Latin American HIV-infected patients receiving HAART.

OBJECTIVE: Determine the prevalence of metabolic abnormalities (MA) and estimate the 10-year risk for cardiovascular disease (CVD) among Latin American HIV-infected patients receiving highly active anti-retroviral therapy (HAART). METHODS: A cohort study to evaluate MA and treatment practices to reduce CVD has been conducted in seven Latin American countries. Adult HIV-infected patients with at least one month of HAART were enrolled. Baseline data are presented in this analysis. RESULTS: A total of 4,010 patients were enrolled. Mean age (SD) was 41.9 (10) years; median duration of HAART was 35 (IQR: 10-51) months, 44% received protease inhibitors. The prevalence of dyslipidemia and metabolic syndrome was 80.2% and 20.2%, respectively. The overall 10-year risk of CVD, as measured by the Framingham risk score (FRF), was 10.4 (24.7). Longer exposure to HAART was documented in patients with dyslipidemia, metabolic syndrome and type 2 diabetes mellitus. The FRF score increased with duration of HAART. Male patients had more dyslipidemia, high blood pressure, smoking habit and higher 10-year CVD than females. CONCLUSIONS: Traditional risk factors for CVD are prevalent in this setting leading to intermediate 10-year risk of CVD. Modification of these risk factors through education and intervention programs are needed to reduce CVD.

Determinants of discontinuation of initial highly active antiretroviral therapy regimens in a US HIV-infected patient cohort.

OBJECTIVES: Optimization of initial highly active antiretroviral therapy (HAART) for complete viral suppression and better tolerability is paramount for the prognosis of HIV-infected patients. Observational studies provide a better means than clinical trials of studying the determinants of discontinuation in actual practice. METHODS: A longitudinal cohort of US HIV-positive patients who initiated HAART for the first time from 1996 to 2003 were included in the analysis. Stratified Cox proportional hazards models, considering time-updated viral load and CD4 count data, were developed for analyzing time to first discontinuation. RESULTS: A total of 3414 antiretroviral-naive HAART patients were identified. In a median follow-up period of 211 days (mean 324 days), 628 patients (18.4%) reportedly discontinued the HAART regimen because of drug toxicity, 456 (13.4%) because of non-compliance, and 257 (7.5%) because of treatment failure. In addition to the recorded reasons for discontinuation, black ethnicity [relative risk (RR) 1.28, 95% confidence interval (CI) 1.13-1.45], current smoking (RR 1.33, CI 1.18-1.50), high pill burden (RR 1.44, CI 1.22-1.70), and recent viral control (RR 0.63, CI 0.56-0.70) were all predictive of discontinuation. Only high pill burden (>15 pills/day), which is considered to be a surrogate for treatment regimen complexity, and the most recent poor viral control (HIV RNA) were found to be consistently associated with a higher likelihood of discontinuation. CONCLUSIONS: Risk factors other than physician- or patient-reported reasons play a role in discontinuation of initial HAART regimens. Identification of these risk factors and simplification of treatment regimens in those at high risk for discontinuation appear to be necessary in order to maximize the effectiveness of HAART regimens.

Protease inhibitor exposure and increased risk of cardiovascular disease in HIV-infected patients.

OBJECTIVES: To study the relationship between exposure to protease inhibitor (PI) therapy and increased risk of cardiovascular events in HIV-infected patients. METHODS: We estimated the risk of cardiovascular disease (CVD) events with PI exposure in a cohort of HIV-infected patients using a time-dependent Cox proportional hazards model adjusting for the major CVD risk factors. Only the first CVD event for each subject was counted. RESULTS: Of a total of 7542 patients, 77% were exposed to PIs. CVD event rates were 9.8/1000 and 6.5/1000 person-years of follow-up (PYFU) in the PI-exposed and nonexposed groups, respectively (P=0.0008). PI exposure >/=60 days was associated with an increased risk of CVD event [adjusted hazards ratio (HR(adj)) 1.71; 95% confidence interval (CI) 1.08-2.74; P=0.03]. Results from a subgroup of patients aged between 35 and 65 years were similar (HR(adj) 1.90; 95% CI 1.13-3.20; P=0.02). Other significant risk factors included smoking status, age, hypertension, diabetes mellitus and pre-existing CVD. CONCLUSIONS: Patients exposed to PI therapy had an increased risk of CVD events. Clinicians should evaluate the risk of CVD when making treatment decisions for HIV-infected patients.

Which stress test is superior for perioperative cardiac risk stratification in patients undergoing major vascular surgery?

OBJECTIVE: to compare the additional prognostic value of Dobutamine Stress Echocardiography (DSE), Dipyridamole Stress Echocardiography (DiSE) and Perfusion Scintigraphy (DTS) on clinical risk factors in patients undergoing major vascular surgery. DESIGN: retrospective analysis. MATERIALS: 2204 consecutive patients who underwent DSE (n=1093), DiSE (n=394), or DTS (n=717) testing before major vascular surgery were studied. METHODS: primary endpoint was a composite of cardiac death and non-fatal myocardial infarction (MI). Logistic regression analysis was performed to evaluate the relation between cardiac risk factors, stress test results and the incidence of the composite endpoint. RESULTS: there were 138 patients (6.3%) with cardiac death or MI. Patients with 0, 1-2, and 3 or more risk factors experienced respectively 3.0, 5.7 and 17.4% cardiac events. We found no statistically significant difference in the predictive value of a positive test result for DiSE and DSE (Odds ratio (OR) of 37.1 [95% CI, 8.1-170.1] vs 9.6 [95% CI, 4.9-18.4]; p=0.12), whereas a positive test result for DTS had significantly lower prognostic value (OR=1.95 [95% CI, 1.2-3.2]). CONCLUSION: a result of stress echocardiography effectively stratified patients into low- and high-risk groups for cardiac complications, irrespective of clinical risk profile. In contrast, the prognostic value of DTS results was more likely to be dependent on patients' clinical risk profile.

Distribution of blood pressure and hypertension in Canada and the United States.

BACKGROUND: Two North American population based surveys, the Third National Health and Nutrition Examination Survey (NHANES III) and the Canadian Heart Health Surveys (CHHS) have similar time frames and methods that allow comparisons between these countries in terms of the distribution of systolic (SBP) and diastolic (DBP) blood pressure and the levels of hypertension awareness, treatment, and control. METHODS: Cross-sectional population surveys using similar methods conducted home interviews and clinic visits (CHHS), and medical examinations (NHANES III). The CHHS included the ten Canadian provinces (1986-1992) and NHANES III, a representative sample of the United States population (1988-1994). Blood pressure measurements were available for 23,111 Canadians (age 18-74 years), and restricted to the 15,326 US participants in the same age range (age 18-74 years) with both systolic and diastolic mean values. Standardized techniques were used for BP measurements. Mean of all available measurements was used from four measurements for the CHHS and six measurements for NHANES III. A mean SBP/DBP of 140/90 mm Hg or treated with medication defined hypertension. All measures were weighted to represent population values. RESULTS: Both surveys showed similar trends in mean BP by age, with slightly higher levels in the CHHS. Hypertension prevalence using the same definitions and the same age range (18-74 years) was NHANES III: 20.1%, CHHS: 21.1%. Although the prevalence of isolated systolic hypertension (ISH) was similar in both studies, around 8% to 9%, the CHHS had higher ISH prevalence than NHANES III in the younger age groups and lower prevalence in the older age groups. Elevated SBP dominated the prevalence figures after the 1950s in both studies. Compared to NHANES III, the CHHS showed a lower proportion (43% v 50%) of individuals with optimal BP (< 120/80 mm Hg) and a very low proportion of hypertensives under control (13% v 25%). About half of diabetic participants were hypertensive (using 140/90 mm Hg) in both countries with a very low level of control in Canada (9%) v the US (36%) for ages 18 to 74 years. CONCLUSIONS: The results of these two surveys highlight the importance of SBP, in the later decades of life, an overall low control of hypertension in both countries, and a better overall awareness, treatment, and control of hypertension in the US than in Canada for that period. Dissemination of hypertension guidelines and a more aggressive focus on SBP are urgently needed in Canada, with special attention to diabetics.

The challenge of controlling systolic blood pressure: data from the National Health and Nutrition Examination Survey (NHANES III), 1988--1994.

Clinicians tend to focus on diastolic blood pressure (DBP), rather than systolic blood pressure (SBP), to identify and treat hypertension. The authors used data from the National Health and Nutrition Examination Survey (NHANES III, 1988--1994) Mobile Examination Center to examine the distributions of SBP and DBP in treated and untreated individuals with hypertension. We identified the percentage of the hypertensive population with SBP controlled to less than 140 mm Hg and the percentage with DBP controlled to less than 90 mm Hg, stratified by treatment status, gender, race, and ethnicity. Individuals were classified as having hypertension if they had SBP of more than 140 mm Hg or DBP of more than 90 mm Hg, or if they were taking medication for hypertension. A weighted analysis was performed to project the results to the entire U.S. population from 1988--1994; these totals were further estimated for the year 2000 by extrapolation. For men, women, whites, African Americans, and Hispanics, SBP control rates were uniformly poorer than DBP control rates. The difference persisted when subgroups were categorized according to treatment status. The disparity in SBP and DBP control rates was especially great for women: only 50% of treated white women with hypertension had SBP control, but 92% had DBP control. The prevalence of isolated systolic hypertension was greater than 50% among all individuals with hypertension in the 55--60-year age group and increased with age thereafter. A greater emphasis on SBP is needed to improve population blood pressure control. (c)2001 Le Jacq Communications, Inc.

A health perception score predicts cardiac events in patients with heart failure: results from the IMPRESS trial.

BACKGROUND: New York Heart Association (NYHA) class and treadmill exercise test variables are widely used for estimating prognosis and measuring the outcomes of treatment in patients with heart failure, but they do not take patients' perceptions into account. METHODS AND RESULTS: Five hundred forty-five patients enrolled in a multicenter 24-week comparison of the effects of omapatrilat and lisinopril on functional capacity in patients with heart failure reported a visual analog scale (VAS) score of their overall health perception at week 12 of the study. A total of 27 first events, defined as death or worsening heart failure (hospitalization, emergency room visit, or study discontinuation), occurred in the subsequent 12 weeks. The mean (+/-SD) health perception scores were 0.43 +/- 0.31 and 0.68 +/- 0.20 in patients with and without events, respectively (P =.0006). The risk ratio (RR) for an event associated with a decile change in the health perception score was 0.74 (95% confidence interval [CI], 0.61-0.88; P =.001). The RR was unaltered by adjustment for demographic variables, treadmill time, and NYHA functional class. Although the week 12 NYHA functional class was predictive of events (RR = 2.1; 95% CI, 1.2-4.6; P =.04), treadmill time was not (RR = 0.87; 95% CI, 0.73-1.03; P = 0.11). CONCLUSIONS: A patient-reported measure of perceived health predicts events in patients with heart failure.

Predominance of isolated systolic hypertension among middle-aged and elderly US hypertensives: analysis based on National Health and Nutrition Examination Survey (NHANES) III.

The purpose of the present study was to examine patterns of systolic and diastolic hypertension by age in the nationally representative National Health and Nutrition Examination Survey (NHANES) III and to determine when treatment and control efforts should be recommended. Percentage distribution of 3 blood pressure subtypes (isolated systolic hypertension, combined systolic/diastolic hypertension, and isolated diastolic hypertension) was categorized for uncontrolled hypertension (untreated and inadequately treated) in 2 age groups (ages <50 and >/=50 years). Overall, isolated systolic hypertension was the most frequent subtype of uncontrolled hypertension (65%). Most subjects with hypertension (74%) were >/=50 years of age, and of this untreated older group, nearly all (94%) were accurately staged by systolic blood pressure alone, in contrast to subjects in the untreated younger group, who were best staged by diastolic blood pressure. Furthermore, most subjects (80%) in the older untreated and the inadequately treated groups had isolated systolic hypertension and required a greater reduction in systolic blood pressure than in the younger groups (-13.3 and -16.5 mm Hg versus -6.8 and -6.1 mm Hg, respectively; P:=0.0001) to attain a systolic blood pressure treatment goal of <140 mm Hg. Contrary to previous perceptions, isolated systolic hypertension was the majority subtype of uncontrolled hypertension in subjects of ages 50 to 59 years, comprised 87% frequency for subjects in the sixth decade of life, and required greater reduction in systolic blood pressure in these subjects to reach treatment goal compared with subjects in the younger group. Better awareness of this middle-aged and older high-risk group and more aggressive antihypertensive therapy are necessary to address this treatment gap.

The response of adult human saphenous vein endothelial cells to combined pressurized pulsatile flow and cyclic strain, in vitro.

Adult human saphenous vein endothelial cells (HVEC) were cultured in a compliant tubular device and evaluated by Northern hybridization for the effects of combined pressurized pulsatile flow and cyclic strain on the expression of mRNAs for endothelin-1 (ET-1), endothelial cell nitric oxide synthase (ecNOS), tissue plasminogen activator (tPA), and plasminogen activator inhibitor type 1 (PAI-1). The hemodynamic environment was designed to mimic shear stress conditions at the distal anastomosis of a saphenous vein graft, a common site of intimal proliferation. Steady-state mRNA levels in experimental tubes were expressed relative to that in controls. No changes were observed in ET-1 mRNA after 1 and 24 hr, but a 50% decrease in experimental cultures was observed after 48 hr in the vascular simulating device. Similar results were obtained for ecNOS mRNA, although a subgroup (4 of 11) showed a significant decrease (>50%) by 24 hr. For tPA mRNA, no change was observed after 1 hr, but a significant decrease (>60%) was measured after 24 hr and no message was detectable after 48 hr. Steady-state levels for PAI-1 mRNA remained unchanged through 48 hr of treatment. These results show that pressure, pulsatile flow, and cyclic strain, when applied in concert, differentially alter vasoactive and fibrinolytic functions in HVEC. Moreover, the dramatic decrease in steady-state levels of tPA mRNA is consistent with a shift toward an increased thrombotic state.

The cardiovascular event reduction tool (CERT)--a simplified cardiac risk prediction model developed from the West of Scotland Coronary Prevention Study (WOSCOPS).

The clinical decision to treat hypercholesterolemia is premised on an awareness of patient risk, and cardiac risk prediction models offer a practical means of determining such risk. However, these models are based on observational cohorts where estimates of the treatment benefit are largely inferred. The West of Scotland Coronary Prevention Study (WOSCOPS) provides an opportunity to develop a risk-benefit prediction model from the actual observed primary event reduction seen in the trial. Five-year Cox model risk estimates were derived from all WOSCOPS subjects (n = 6,595 men, aged 45 to 64 years old at baseline) using factors previously shown to be predictive of definite fatal coronary heart disease or nonfatal myocardial infarction. Model risk factors included age, diastolic blood pressure, total cholesterol/ high-density lipoprotein ratio (TC/HDL), current smoking, diabetes, family history of fatal coronary heart disease, nitrate use or angina, and treatment (placebo/ 40-mg pravastatin). All risk factors were expressed as categorical variables to facilitate risk assessment. Risk estimates were incorporated into a simple, hand-held slide rule or risk tool. Risk estimates were identified for 5-year age bands (45 to 65 years), 4 categories of TC/HDL ratio (<5.5, 5.5 to <6.5, 6.5 to <7.5, > or = 7.5), 2 levels of diastolic blood pressure (<90, > or = 90 mm Hg), from 0 to 3 additional risk factors (current smoking, diabetes, family history of premature fatal coronary heart disease, nitrate use or angina), and pravastatin treatment. Five-year risk estimates ranged from 2% in very low-risk subjects to 61% in the very high-risk subjects. Risk reduction due to pravastatin treatment averaged 31%. Thus, the Cardiovascular Event Reduction Tool (CERT) is a risk prediction model derived from the WOSCOPS trial. Its use will help physicians identify patients who will benefit from cholesterol reduction.

Long-term prognostic value of preoperative dipyridamole thallium imaging and clinical indexes in patients with diabetes mellitus undergoing peripheral vascular surgery.

The objective of this study is to assess the prognostic impact of preoperative dipyridamole thallium imaging and clinical variables on the long-term outcome of diabetic patients undergoing peripheral vascular surgery. Complete follow-up was obtained in 101 consecutive patients with diabetes mellitus undergoing routine dipyridamole thallium scintigraphy before vascular surgery (mean 4.2 +/- 3.2 years, range 1 month to 11 years). Low risk was defined by diabetes alone with a normal resting electrocardiogram. High risk was defined as a history of angina, myocardial infarction, congestive heart failure, or resting electrocardiogram abnormalities. There were 71 deaths in 98 patients discharged alive from the hospital (median survival 4.4 years). Age, the presence of resting electrocardiogram abnormalities, and an abnormal thallium scan were independent predictors of late death. After adjusting for age >70 years and thallium abnormalities, high-risk patients had a death rate 4.8 times (95% confidence interval 1.7 to 13.4, p <0.002) greater than low-risk patients. The presence of >2 reversible thallium defects was useful in further risk stratification of both low- and high-risk patients. Low-risk patients with >2 reversible defects had a median survival of 4.0 years compared with 9.4 years in those with < or =2 reversible defects (p <0.001). Similarly, high-risk patients with < or =2 reversible defects had an intermediate median survival rate of 4.7 years compared with 1.8 years in the group with >2 reversible defects (p <0.001). Therefore, advanced age and the presence of resting electrocardiographic or thallium abnormalities identifies a subset of diabetic patients with a poor long-term outcome after vascular surgery. Combined clinical and thallium variables may identify a population in whom intensive medical or surgical interventions may be warranted to reduce both perioperative and late cardiac events.

Neural network assessment of perioperative cardiac risk in vascular surgery patients.

Neural networks were developed to predict perioperative cardiac complications with data from 567 vascular surgery patients. Neural network scores were based on cardiac risk factors and dipyridamole thallium results. These scores were converted into likelihood ratios that predicted cardiac risk. The prognostic accuracy of the neural networks was similar to that of logistic regression models (ROC areas 76.0% vs 75.8%), but their calibration was better. Logistic regression overestimated event rates in a group of high-risk patients (predicted event rate, 64%; observed rate 30%; n=50, p<0.001). On a validation set of 514 patients, the neural networks still had ROC similar areas to those of logistic regression (68.3% vs 67.5%), but logistic regression again overestimated event rates for a group of high-risk patients. The calibration difference was reflected in the Hosmer-Lemeshow chi-square statistic (18.6 for the neural networks, 45.0 for logistic regression). The neural networks successfully estimated perioperative cardiac risk with better calibration than comparable logistic regression models.

Thoracoabdominal aneurysm repair: perspectives over a decade with the clamp-and-sew technique.

OBJECTIVES: Experience over a decade with thoracoabdominal aortic aneurysm (TAA) repair using a clamp-sew technique was reviewed to compare overall results with alternative operative methods. SUMMARY BACKGROUND DATA: Controversy continues as to the optimal technique for TAA repair, with frequent contemporary emphasis on bypass-distal perfusion methods. Proponents of this technique claim improved results compared to those of historic control subjects in the parameters of operative mortality, postoperative renal failure, and lower extremity neurologic deficit. METHODS: Over the interval from 1987 to 1996, 160 TAA repairs (type I, 32%; type II, 15%; type III, 34%; and type IV, 19%) were performed in 157 patients with a mean age of 70 years and a male-to-female ratio of 1/1. Clinical features included ruptured TAA (10%), urgent operation (22.5%), and aortic dissection (18%). Operative management used a clamp-sew technique with regional hypothermia for spinal cord (epidural cooling, since 1993) and renal protection. Variables associated with the endpoints of operative mortality or major morbidity, particularly spinal cord injury, were assessed with Fisher exact test and logistic regression; late survival was estimated with the Kaplan-Meier method. RESULTS: In-hospital mortality was 9% and was associated with operation for rupture (p < 0.005) or other acute presentation (p < 0.001). After multivariate analysis, the postoperative complication renal failure (relative risk, 6.5 [95% confidence interval, 1.8-23.6, p = 0.004]) and significant spinal cord injury (relative risk, 16.5 [95% confidence interval, 3.2-83.2, p = 0.001]) were associated independently with operative mortality. Paraparesis-paraplegia occurred in 7%, an incidence significantly (p < 0.001) less than that (18.7%) predicted for this cohort from published models. Variables associated (univariate analysis) with this complication included TAA rupture (p < 0.0001), other acute presentation or dissection (p < 0.001), prolonged (>6 hours) operation (p < 0.04), and excessive (>3 L) transfusions (p < 0.02). Operation for acute presentation or dissection (relative risk, 7.9 [95% confidence interval, 1.7-37.7, p = 0.009]) and prolonged surgery [relative risk, 7.5 [95% confidence interval, 1.5-35.3, p = 0.01]) retained independent association with paraplegia-paraparesis after multivariate analysis. Dialysis was needed in 2.5%. Late survival at 1 and 5 years was 86 +/- 2.9% and 62 +/- 5.8%, respectively. CONCLUSIONS: These data compare favorably with those from contemporary reports using other operative strategies and do not support routine adoption of bypass-distal perfusion as the preferred technique for TAA repair.

Clinical experience with epidural cooling for spinal cord protection during thoracic and thoracoabdominal aneurysm repair.

PURPOSE: This report summarizes our experience with epidural cooling (EC) to achieve regional spinal cord hypothermia and thereby decrease the risk of spinal cord ischemic injury during the course of descending thoracic aneurysm (TA) and thoracoabdominal aneurysm (TAA) repair. METHODS: During the interval July 1993 to Dec. 1995, 70 patients underwent TA (n = 9, 13%) or TAA (n = 61) (type I, 24 [34%], type II, 11 [15%], type III, 26 [37%]) repair using the EC technique. The latter was accomplished by continuous infusion of normal saline (4 degrees C) into a T11-12 epidural catheter; an intrathecal catheter was placed at the L3-4 level for monitoring of cerebrospinal fluid temperature (CSFT) and pressure (CSFP). All operations (one exception, atriofemoral bypass) were performed with the clamp-and-sew technique, and 50% of patients had preservation of intercostal vessels at proximal or distal anastomoses (30%) or by separate inclusion button (20%). Neurologic outcome was compared with a published predictive model for the incidence of neurologic deficits after TAA repair and with a matched (Type IV excluded) consecutive, control group (n = 55) who underwent TAA repair in the period 1990 to 1993 before use of EC. RESULTS: EC was successful in all patients, with a 1442 +/- 718 ml mean (range, 200 to 3500 ml) volume of infusate; CSFT was reduced to a mean of 24 degrees +/- 3 degrees C during aortic cross-clamping with maintenance of core temperature of 34 degrees +/- 0.8 +/- C. Mean CSFP increased from baseline values of 13 +/- 8 mm Hg to 31 +/- 6 mm Hg during cross-clamp. Seven patients (10%) died within 60 days of surgery, but all survived long enough for evaluation of neurologic deficits. The EC group and control group were well-matched with respect to mean age, incidence of acute presentations/aortic dissection/aneurysm rupture, TAA type distribution, and aortic cross-clamp times. Two lower extremity neurologic deficits (2.9%) were observed in the EC patients and 13 (23%) in the control group (p < 0.0001). Observed and predicted deficits in the EC patients were 2.9% and 20.0% (p = 0.001), and for the control group 23% and 17.8% (p = 0.48). In considering EC and control patients (n = 115), variables associated with postoperative neurologic deficit were prolonged (> 60 min) visceral aortic cross-clamp time (relative risk, 4.4; 95% CI, 1.2 to 16.5; p = 0.02) and lack of epidural cooling (relative risk, 9.8; 95% CI, 2 to 48; p = 0.005). CONCLUSION: EC is a safe and effective technique to increase the ischemic tolerance of the spinal cord during TA or TAA repair. When used in conjunction with a clamp-and-sew technique and a strategy of selective intercostal reanastomosis, EC has significantly reduced the incidence of neurologic deficits after TAA repair.

Magnetic resonance angiography in the management of lower extremity arterial occlusive disease: a prospective study.

PURPOSE: We conducted a prospective study to clarify the clinical utility of magnetic resonance angiography (MRA) in the treatment of patients with lower extremity arterial occlusive disease. METHODS: During the interval of September 1993 through March 1995, 79 patients (43% claudicants, 57% limb-threatening ischemia) were studied with both MRA and contrast arteriography (ANGIO) and underwent intervention with either balloon angioplasty (9%), surgical inflow (28%), or outflow (63%) procedures. MRA and ANGIO were interpreted by separate blinded vascular radiologists, and arterial segments from the pelvis to the foot were graded as normal or with increasing degrees of mild (25% to 50%), moderate (51% to 75%), or severe (75% to 99%) stenosis or occlusion. Treatment plans were formulated by the attending surgeon and were based initially on hemodynamic, clinical, and MRA data and thereafter with ANGIO. Additional study surgeons formulated independent and specific treatment plans based on MRA or ANGIO alone. Indexes of agreement (beyond chance) for arterial segments depicted by MRA and ANGIO were assessed (kappa value), and treatment plans formulated were compared (chi-square). RESULTS: Precise agreement (%) and the percent of major discrepancies (segment classified as normal/mild stenosis on one study and severe stenosis/occlusion on the other) between MRA and ANGIO for respective arterial segments was as follows: common and external iliacs (n = 256) 77/3.5; superficial femoral and above-knee popliteal (n = 255) 73/6.7; below-knee popliteal (n = 131) 84/3.8; infrapopliteal runoff vessels (n = 864) 74/12.4; pedal vessels (n = 111) 69/19.8 Kappa values indicated moderate agreement (between MRA and ANGIO) beyond chance for all arterial segments. Treatment plans formulated by the attending surgeon, the MRA surgeon, and the ANGIO surgeon agreed in more than 85% of cases. Inability of MRA to assess the significance of inflow disease and inadequate detail of tibial/pedal vessels were the principal deficiencies of MRA in those cases where it was considered an inadequate examination. CONCLUSION: These findings suggest MRA and ANGIO are nearly equivalent examinations in the demonstration of infrainguinal vascular anatomy. MRA is an adequate preoperative imaging study (and may replace ANGIO), particularly in those circumstances when the risk of ANGIO is increased or when clinical and hemodynamic evaluation predict the likelihood of straightforward aortofemoral or femoral-popliteal reconstruction.

Renal failure after thoracoabdominal aortic surgery.

PURPOSE: Renal failure remains a common and morbid complication after complex aortic surgery. This study was performed to identify perioperative factors that contribute to postoperative renal failure. METHODS: The perioperative outcomes of 183 patients who underwent thoracoabdominal aortic surgery with supraceliac clamping were reviewed. During the interval from Jan. 1987 to Nov. 1996, thoracoabdominal aneurysm repair was performed in 154 patients (type I, 49 patients [27%]; type II, 21 patients [11.5%]; type III, 55 patients [30%]; type IV, 29 patients [16%]), suprarenal abdominal aortic aneurysm repair in 17 patients (9%), and visceral/renal revascularization procedures in 12 patients (6.5%). Intraoperative management included thoracoabdominal aortic exposure and clamp-and-sew technique with renal artery cold perfusion whenever the renal arteries were accessible (79% of cases). RESULTS: Relevant clinical features included preoperative hypertension (85%), diabetes mellitus (8%), single functioning kidney (10%), recent intravenous contrast injection (34%), renal insufficiency (creatinine level greater than 1.5 mg/dl; 24%), and emergent operation (19%). Acute renal failure, defined as both a doubling of serum creatinine level and an absolute value greater than 3.0 mg/dl, occurred in 21 patients (11.5%), of whom five required hemodialysis (2.7%). Variables associated with this complication included a preoperative creatinine level greater than 1.5 mg/dl (p = 0.004) and a total cross-clamp time greater than 100 minutes (p = 0.035). The operative mortality risk (within 30 days; 8%) was significantly increased with renal failure (odds ratio, 9.2; 95% confidence interval, 2.6 to 33; p < 0.005). CONCLUSIONS: Renal failure, although uncommon in contemporary practice, greatly increases the risk of early death after thoracoabdominal aortic surgery. The overall incidence of renal failure and dialysis requirement in the present series compare favorably with those reported using other operative techniques, specifically partial left heart bypass and distal aortic perfusion. These data suggest that patients who have preoperative renal insufficiency are prone to postoperative renal failure. Furthermore, regional hypothermic perfusion and minimal clamp times are important elements in the prevention of renal failure after thoracoabdominal aortic surgery.

Coagulation changes during thoracoabdominal aneurysm repair.

PURPOSE: The cause of coagulopathic hemorrhage during thoracoabdominal aneurysm (TAA) repair has not been well defined in human studies. We investigated changes in the coagulation system associated with supraceliac versus infrarenal cross-clamping to address this critical issue. METHODS: Blood levels of fibrinogen, the prothrombin fragment F1.2, D-dimer, and factors II, V, VII, VIII, IX, X, XI, and XII were analyzed in 19 patients with TAAs and four patients with abdominal aortic aneurysms (AAAs) at: (A) induction; (B) 30 minutes into supraceliac (TAA) or infrarenal (AAA) clamping; (C) 30 minutes after release of supraceliac or infrarenal clamps; and (D) immediately after surgery. Preoperative and intraoperative variables, including but not limited to aneurysm type, pathologic findings, comorbid conditions, clamp times, volume and timing of blood products, and clinical outcome, were prospectively recorded. Significance was determined by analysis of variance, Student's t test, and univariate linear regression. RESULTS: Levels of fibrinogen and factors II, V, VIII, VIII, IX, X, XI, and XII decreased (p < 0.05) at time B versus time A and returned to near baseline by time D. D-dimer and F1.2 increased starting at time B and reached significance (p < 0.05) by time D. Data points were compared for the TAA and AAA groups. Although AAA groups demonstrated a trend to factor activity reduction and increased fibrinolysis, the effect was much less pronounced than in TAA and did not approach significance. No correlation of coagulation change with clamping time was present; however, visceral clamping times were all less than 65 minutes (mean, 44 minutes). Blood and factor replacement was initiated after time B. Univariate regression analysis of factor level versus total blood replacement demonstrated a significant (p < 0.04) correlation between the reduction in the levels of factors II, V, VII, VIII, X, and XII, and the increase in the level of D-dimer at time B and subsequent total blood replacement. CONCLUSIONS: Thoracoabdominal aneurysm repair is associated with a reduction in clotting factor activity and an increase in fibrinolytic function, which occurs after placement of the supraceliac clamp. Explanations include visceral ischemia or a greater and longer ischemic tissue burden as the likely cause of coagulation alterations. Total blood replacement during TAA procedures was correlated to the degree of factor reduction and fibrinolysis at the time of visceral cross-clamping. An aggressive approach to early blood component replacement and to coagulation monitoring could lessen blood loss during TAA repair and avoid potentially disastrous bleeding complications.

Characteristics of vascular wall cells subjected to dynamic cyclic strain and fluid shear conditions in vitro.

We recently developed an in vitro silicone rubber tubular apparatus, the vascular simulating device (VSD), which simulates pressure, flow, and strain characteristics of peripheral arteries (Benbrahim et al., 1994, J. Vasc. Surg. 20, 184-194). In this report, we tested the ability of silicone rubber surfaces to support the growth and differentiation of endothelial cells (EC) and smooth muscle cells (SMC) and studied the effects of arterial levels of pressure, flow, and strain on these properties. Human umbilical and saphenous vein EC and bovine aortic EC and SMC were cultured on coated and uncoated silicone rubber in flat and tubular configurations (6 mm inner diameter) and on tissue culture plastic (TCP). Attachment, growth, and differentiation were compared on these surfaces. In addition, the effects of arterial pressure, flow, and strain conditions on adhesion and subsequent growth and differentiation were studied in the tubular configuration. Attachment and growth of vascular wall cells on fibronectin-coated silicone rubber was similar to that obtained on TCP. Application of arterial levels of pressure, flow, and strain did not alter adhesion of the cells to the tubes. Subsequent passage of these cells demonstrated that attachment, growth, and differentiation (uptake of LDL and expression of factor VIII-related antigen by EC and expression of muscle-specific actin by SMC) were similar in cells derived from experimental and control tubes which were not subjected to arterial conditions. Finally, mRNA expression of specific "housekeeping" genes was similar in cells isolated from experimental and control tubes. We conclude that the VSD supports the culture of viable and differentiated EC and SMC. These experiments demonstrate that it is possible to evaluate the effects of arterial strain and fluid shear on vascular wall cells in vitro, in a configuration similar to the blood vessel wall.

Renal artery reconstruction for the preservation of renal function.

PURPOSE: We reviewed a 13-year experience with an emphasis on long-term survival and renal function response when renal artery reconstruction (RAR) was performed primarily for the preservation or restoration of renal function in patients who had atherosclerotic renovascular disease. METHODS: From January 1, 1980, to June 30, 1993, 139 patients underwent RAR for renal function salvage and were retrospectively reviewed. Inclusion criteria were either preoperative serum creatinine level > 2.0 mg/dl (67% of patients) or RAR to the entire functioning renal mass irrespective of baseline renal function. Patient survival was calculated by life-table methods. Cox regression analysis was used to determine relative risk (RR) estimates for the late outcomes of continued deterioration of renal function and late survival after RAR. A logistic regression model was used to evaluate variables associated with perioperative complications. RESULTS: Clinical characteristics of the cohort were notable for advanced cardiac (history of congestive heart failure, 27%; angina, 22%; previous myocardial infarction, 19%) and renal disease (serum creatinine level < 2.0 mg/dl, 33%; 2.0 mg/dl to 3.0 mg/dl, 40%, > 3.0 mg/dl, 27%). Cardiac disease was the principle cause of early (6 of 11 operative deaths) and late death. Operative management consisted of aortorenal bypass in 47%, extraanatomic bypass in 45%, and endarterectomy in 8%; 45% of patients required combined aortic and RAR. The operative mortality rate was 8%; significant perioperative renal dysfunction occurred in 10%. Major operative morbidity was associated with increasing azotemia (RR = 2.1; p = 0.001; 95% confidence interval [CI], 1.3 to 4.7 for each 1.0 mg/dl increase in baseline creatinine level). Of those patients who had a baseline creatinine level > or = 2.0 mg/dl, 54% had > or = 20% reduction in creatinine level after RAR. Late follow-up data were available for 87% of operative survivors at a mean duration of 4 years (range, 6 weeks to 12.6 years). Actuarial survival at 5 years was 52% +/- 5%. Continued deterioration in renal function occurred in 24% of patients who survived operation, and eventual dialysis was required in 15%. Deterioration of renal function after RAR was associated with increasing levels of preoperative creatinine (RR = 1.6; 95% CI, 1.2 to 1.8; p = 0.001 for each 1.0 mg/dl increment in baseline creatinine level), and inversely related to early postoperative improvement in creatinine level (RR = 0.41; 95% CI, 0.2 to 0.9; p = 0.04). CONCLUSIONS: Intervention before major deterioration in renal function and an aggressive posture toward the frequently associated coronary artery disease are necessary to improve long-term results when RAR is performed for renal function salvage.