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PubMed2005

The safety of intra-abdominal surgery in patients with cirrhosis: model for end-stage liver disease score is superior to Child-Turcotte-Pugh classification in predicting outcome.

HYPOTHESIS: We hypothesized that the model for end-stage liver disease (MELD) score may be a better and less subjective method than the Child-Turcotte-Pugh score for stratifying patients with cirrhosis before abdominal surgery. DESIGN: Retrospective medical record review. SETTING: Tertiary care institution. PATIENTS: Fifty-three adult patients with histologically proven cirrhosis undergoing abdominal surgery at Saint Louis University Hospital, St Louis, Mo, between 1991 and 2001. Those undergoing hepatic surgery (such as resection or transplantation) or closed abdominal surgery (such as hernia repair) were excluded. MAIN OUTCOME MEASURE: A poor outcome after surgery was defined as death or liver transplantation within 90 days of the operative procedure or a hospital stay of longer than 21 days. Demographic, clinical, and laboratory features predictive of poor outcome were assessed by multivariate analysis. RESULTS: A total of 13 patients (25%) had poor outcomes including 9 deaths (17%). Model for end-stage liver disease score and plasma hemoglobin levels lower than 10 g/dL were found to be independent predictors of poor outcomes. A MELD score of 14 or greater was a better clinical predictor of poor outcome than Child-Turcotte-Pugh class C. CONCLUSIONS: A MELD score of 14 or greater should be considered as a replacement for Child-Turcotte-Pugh class C as a predictor of being very high risk for abdominal surgery. Patients with cirrhosis with hemoglobin levels lower than 10 g/dL should receive corrective blood transfusions before abdominal surgery.

Adult↗
PubMed1995

Hospital mortality of major hepatectomy for hepatocellular carcinoma associated with cirrhosis.

OBJECTIVE: To define the safety of major hepatectomy for hepatocellular carcinoma (HCC) associated with cirrhosis and the selection criteria for surgery in terms of hospital mortality. DESIGN: Major hepatectomy for HCC in the presence of cirrhosis is considered to be contraindicated by many surgeons because the reported mortality rate is high (26% to 50%). Previous workers recommended that only selected patients with Child's A status or indocyanine green (ICG) retention at 15 minutes of less than 10% undergo major hepatectomy. A survey was made, therefore, of our patients with HCC and cirrhosis undergoing major hepatectomy between 1989 and 1994. SETTING: A tertiary referral center. PATIENTS: The preoperative, intraoperative, and postoperative data of 54 patients with cirrhosis who had major hepatectomy were compared with those of 25 patients with underlying chronic active hepatitis and 22 patients with normal livers undergoing major hepatectomy for HCC. The data had been prospectively collected. INTERVENTION: Major hepatectomy, defined as resection of two or more liver segments by Goldsmith and Woodburn nomenclature, was performed on all the patients. MAIN OUTCOME MEASURE: Hospital mortality, which was defined as death within the same hospital admission for the hepatectomy. RESULTS: Preoperative liver function in patients with cirrhosis was worse than in those with normal livers. The intraoperative blood loss was also higher (P = .01), but for patients with cirrhosis, chronic active hepatitis, and normal livers, the hospital mortality rates (13%, 16%, and 14%, respectively) were similar. The hospital mortality rate for patients with cirrhosis in the last 2 years of the study was only 5%. Patients with cirrhosis could tolerate up to 10 L of blood loss and survive the major hepatectomy. By discriminant analysis, an ICG retention of 14% at 15 minutes was the cutoff level that could maximally separate the patients with cirrhosis with and without mortality. CONCLUSION: Major hepatectomy for HCC in the presence of cirrhosis is associated with a mortality rate that is not different from the rate for patients with normal livers. An ICG retention of 14% at 15 minutes would serve as a better selection criterion than the 10% previously used.

Adult↗
PubMed1996

Pyogenic liver abscess. An audit of experience over the past decade.

OBJECTIVES: To audit our experience in managing patients with pyogenic liver abscesses since 1984 and to identify any risk factor associated with hospital mortality. DESIGN: Retrospective review. SETTING: A tertiary referral center. PATIENTS: Eighty-three patients with pyogenic liver abscesses were studied to determine demographic characteristics; clinical features, laboratory, imaging, and microbiologic findings; methods of treatment; and final outcome. The median follow-up period was 9.8 months. INTERVENTION: All patients were treated with intravenous antibiotic drugs. Fifty-three patients were to image-guided percutaneous aspiration of the abscess. A percutaneous drainage catheter was inserted after aspiration in 27 patients. Laparotomy was performed in 27 patients; seven of them underwent an elective operation. MAIN OUTCOME MEASURE: Hospital mortality, defined as death within the same hospital admission for management of liver abscess. RESULTS: Biliary tract disease was the most frequently identifiable cause. The right lobe abscess was more frequently cryptogenic, while the left lobe abscess was more frequently related to intrahepatic stones (P < .001). The overall hospital mortality rate was 18% (15/83). On univariate analysis, female gender, rupture on presentation, emergency laparotomy, management without aspiration or catheter drainage, presence of malignancy, hyperglycemia, hyperbilirubinemia, elevated prothrombin time, and elevated activated partial thromboplastin time were significantly associated with hospital mortality. On multivariate logistic regression analysis, presence of malignancy, hyperbilirubinemia, and elevated activated partial thromboplastin time were found to be independent risk factors. CONCLUSIONS: Pyogenic liver abscess is still a disease with significant mortality. Early diagnosis and prompt treatment are necessary to further improve our results of management.

Adult↗
PubMed1996

Transient systolic hypotension. A serious problem in the management of head injury.

OBJECTIVE: To determine the frequency and clinical impact of transient systolic hypotension (systolic blood pressure < 100 mm Hg) in patients with severe anatomic head injury. DESIGN: Retrospective case-control study. SETTING: Urban level 1 trauma center. PATIENTS: Consecutive trauma patients admitted to the intensive care unit (ICU) with severe anatomic head injury, defined as Head and Neck Abbreviated Injury Scale Score of 4 or higher. One thousand thirteen trauma patients were admitted to the ICU during the study period, 157 of whom met inclusion criteria. MAIN OUTCOME MEASURES: Acute mortality, defined as death during initial ICU admission, and functional status of ICU survivors, assessed as level of function sufficient for discharge to home. RESULTS: One hundred fifty-seven patients with severe head injury had a total of 831 episodes of systolic hypotension. Fifty-five percent of the patients suffered at least one event. Patients were grouped by total number of low systolic blood pressure events and by average number of events per ICU day. The total number of hypotensive events was associated with increased mortality rates and decreased rate of discharge to home. Average daily frequency of events was associated with increased mortality rates. After stratification by admission Glasgow Coma Scale score, the effects were most dramatic in patients with an initial Glasgow Coma Scale score higher than 8. CONCLUSIONS: Transient hypotension is common in the ICU and is associated with increased acute mortality and decreased functional status in patients with head injury. The impact of this secondary insult is greatest in patients with less severe primary injury. Strict avoidance of hypotension through enhanced monitoring and active treatment appears to be important, especially in patients with higher presenting Glasgow Coma Scale scores.

Brain Injuries↗
PubMed2000

Arterial hypertension and renal allograft survival.

CONTEXT: Several observational studies have investigated the significance of hypertension in renal allograft failure; however, these studies have been complicated by the lack of adjustment for baseline renal function, leaving the role of elevated blood pressure in allograft failure unclear. OBJECTIVE: To examine the relationship between blood pressure adjusted for renal function and survival after cadaveric allograft transplantation. DESIGN: Nonconcurrent historical cohort study conducted from 1985 through 1997. SETTING: University teaching hospital. PARTICIPANTS: A total of 277 patients aged 18 years or older who underwent cadaveric renal transplantation without another simultaneous organ transplantation and whose allograft was functioning for a minimum of 1 year. Follow-up continued through 1997 (mean follow-up, 5.7 years). MAIN OUTCOME MEASURE: Time to allograft failure (defined as death, return to dialysis, or retransplantation) by systolic, diastolic, and mean arterial blood pressure measurements at 1 year after transplantation. RESULTS: Multivariate Cox proportional hazards modeling demonstrated that nonwhite ethnicity, history of acute rejection, and nondiabetic kidney disease were significant predictors of failure (P = .01 for all). In addition, the calculated creatinine clearance at 1 year had an adjusted rate ratio (RR) for allograft failure per 10 mL/min (0.17 mL/s) of 0.74 (95% confidence interval [CI], 0.62-0.88). The RR per 10-mm Hg increase in blood pressure measured at 1 year after transplantation, after adjustment for creatinine clearance, was 1.15 (95% CI, 1.02-1.30) for systolic pressure, 1.27 (95% CI, 1.01-1.60) for diastolic pressure, and 1.30 (95% CI, 1.05-1.61) for mean arterial pressure. Supplemental analyses that did not include death as a failure event or reduce the minimum allograft survival time for study subjects to 6 months yielded results consistent with the primary analysis. There was no evidence of modification of the blood pressure-allograft failure relationship by ethnicity or diabetes mellitus. CONCLUSIONS: Systolic, diastolic, and mean arterial blood pressures at 1 year posttransplantation strongly predict allograft survival adjusted for baseline renal function. More aggressive control of blood pressure may prolong cadaveric allograft survival.

Adult↗
PubMed2001

Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes.

CONTEXT: Hip fracture is a common clinical problem that leads to considerable mortality and disability. A need exists for a practical means to monitor and improve outcomes, including function, for patients with hip fracture. OBJECTIVES: To identify and compare the importance of significant prefracture predictors of functional status and mortality at 6 months for patients hospitalized with hip fracture and to compare risk-adjusted outcomes for hospitals providing initial care. DESIGN: Prospective study with data obtained from medical records and through structured interviews with patients and proxies. SETTING AND PARTICIPANTS: A total of 571 adults aged 50 years or older with hip fracture who were admitted to 4 New York, NY, metropolitan hospitals between August 1997 and August 1998. MAIN OUTCOME MEASURES: In-hospital and 6-month mortality; locomotion at 6 months; and adverse outcomes at 6 months, defined as death or needing assistance to ambulate, compared by hospital, adjusting for patient risk factors. RESULTS: The in-hospital mortality rate was 1.6%. At 6 months, the mortality rate was 13.5%, and another 12.8% needed total assistance to ambulate. Laboratory values were strong predictors of mortality but were not significantly associated with locomotion. Age and prefracture residence at a nursing home were significant predictors of locomotion (P =.02 for both) but were not significantly associated with mortality. Adjustment for baseline characteristics either substantially augmented or diminished interhospital differences in outcomes. Two hospitals had 1 outcome (functional status or mortality) that was significantly worse than the overall mean while the other outcome was nonsignificantly better than average. CONCLUSIONS: Mortality and functional status ideally should be considered both together and individually to distinguish effects limited to one or the other outcome. Hospital performance for these 2 measures may differ substantially after adjustment, probably because different processes of care are important to each outcome.

Activities of Daily Living↗
PubMed2002

Effect of homocysteine-lowering therapy with folic acid, vitamin B12, and vitamin B6 on clinical outcome after percutaneous coronary intervention: the Swiss Heart study: a randomized controlled trial.

CONTEXT: Plasma homocysteine level has been recognized as an important cardiovascular risk factor that predicts adverse cardiac events in patients with established coronary atherosclerosis and influences restenosis rate after percutaneous coronary intervention. OBJECTIVE: To evaluate the effect of homocysteine-lowering therapy on clinical outcome after percutaneous coronary intervention. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind placebo-controlled trial involving 553 patients referred to the University Hospital in Bern, Switzerland, from May 1998 to April 1999 and enrolled after successful angioplasty of at least 1 significant coronary stenosis (> or = 50%). INTERVENTION: Participants were randomly assigned to receive a combination of folic acid (1 mg/d), vitamin B12 (cyanocobalamin, 400 micro g/d), and vitamin B6 (pyridoxine hydrochloride, 10 mg/d) (n = 272) or placebo (n = 281) for 6 months. MAIN OUTCOME MEASURE: Composite end point of major adverse events defined as death, nonfatal myocardial infarction, and need for repeat revascularization, evaluated at 6 months and 1 year. RESULTS: After a mean (SD) follow-up of 11 (3) months, the composite end point was significantly lower at 1 year in patients treated with homocysteine-lowering therapy (15.4% vs 22.8%; relative risk [RR], 0.68; 95% confidence interval [CI], 0.48-0.96; P =.03), primarily due to a reduced rate of target lesion revascularization (9.9% vs 16.0%; RR, 0.62; 95% CI, 0.40-0.97; P =.03). A nonsignificant trend was seen toward fewer deaths (1.5% vs 2.8%; RR, 0.54; 95% CI, 0.16-1.70; P =.27) and nonfatal myocardial infarctions (2.6% vs 4.3%; RR, 0.60; 95% CI, 0.24-1.51; P =.27) with homocysteine-lowering therapy. These findings remained unchanged after adjustment for potential confounders. CONCLUSION: Homocysteine-lowering therapy with folic acid, vitamin B12, and vitamin B6 significantly decreases the incidence of major adverse events after percutaneous coronary intervention.

Angioplasty, Balloon, Coronary↗
PubMed2004

Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure: a randomized controlled trial.

CONTEXT: Nearly 1 million hospitalizations for chronic heart failure occur yearly in the United States, with most related to worsening systemic congestion. Diuretic use, the mainstay therapy for congestion, is associated with electrolyte abnormalities and worsening renal function. In contrast to diuretics, the vasopressin antagonist tolvaptan may increase net volume loss in heart failure without adversely affecting electrolytes and renal function. OBJECTIVE: To evaluate the short- and intermediate-term effects of tolvaptan in patients hospitalized with heart failure. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, phase 2 trial conducted at 45 centers in the United States and Argentina and enrolling 319 patients with left ventricular ejection fraction of less than 40% and hospitalized for heart failure with persistent signs and symptoms of systemic congestion despite standard therapy. INTERVENTION: After admission, patients were randomized to receive 30, 60, or 90 mg/d of oral tolvaptan or placebo in addition to standard therapy, including diuretics. The study drug was continued for up to 60 days. MAIN OUTCOME MEASURES: In-hospital outcome was change in body weight at 24 hours after randomization; outpatient outcome was worsening heart failure (defined as death, hospitalization, or unscheduled visits for heart failure) at 60 days after randomization. RESULTS: Median (interquartile range) body weight at 24 hours after randomization decreased by -1.80 (-3.85 to -0.50), -2.10 (-3.10 to -0.85), -2.05 (-2.80 to -0.60), and -0.60 (-1.60 to 0.00) kg in the groups receiving tolvaptan 30, 60, and 90 mg/d, and placebo, respectively (P< or =.008 for all tolvaptan groups vs placebo). The decrease in body weight with tolvaptan was not associated with changes in heart rate or blood pressure, nor did it result in hypokalemia or worsening renal function. There were no differences in worsening heart failure at 60 days between the tolvaptan and placebo groups (P =.88 for trend). In post hoc analysis, 60-day mortality was lower in tolvaptan-treated patients with renal dysfunction or severe systemic congestion. CONCLUSION: Tolvaptan administered in addition to standard therapy may hold promise for management of systemic congestion in patients hospitalized for heart failure.

Ambulatory Care↗
PubMed2000

The prognostic value of cyclin D1, p53, and MDM2 protein expression in uveal melanoma.

Malignant uveal melanoma is the commonest primary intraocular tumour in adults. It metastasizes frequently and 50% of patients die within 10 years of diagnosis. The expression of cyclin D1, p53, and MDM2 in uveal melanoma and their relationship to metastasis-free 5-year survival was determined, in order to investigate whether these proteins help to distinguish those patients with a favourable prognosis from those with a poorer one. Ninety-six eyes enucleated for uveal melanomas were immunohistochemically analysed for the protein expression of cyclin D1 and related cell-cycle markers, p53 and MDM2. The evaluation of the specimens was undertaken by two independent pathologists without knowledge of the outcome. Statistical analysis of clinical, morphological, and immunohistological features was performed. A 'favourable outcome' was defined as survival of at least 5 years after diagnosis, without metastases (n=57). An 'unfavourable outcome' was defined as death from metastases within the first 5 years after diagnosis of uveal melanoma (n=39). Cyclin D1 positivity (>15% positive tumour cells) as well as p53 positivity (>15% positive tumour cells) was associated with an unfavourable outcome (for cyclin D1: odds ratio=4. 2, 95% confidence interval 1.5-11.8, p=0.006; for p53: odds ratio=3. 2, 95% confidence interval 1.1-9.3, p=0.03). In addition, cyclin D1 positivity was associated with the presence of extraocular extension of the tumour (p=0.01), with the mixed or epithelioid cell type (p=0. 02), and with the tumour cell MIB-1 positivity (p=0.0001). MDM2 immunoreactivity of the tumour cells showed a potential correlation with clinical outcome (odds ratio=2.1, 95% confidence interval 0.8-5. 8, p=0.13). Multiple logistic regression models showed that cyclin D1 positivity is an independent prognostic factor after control for other prognostic markers. The expression of cyclin D1 in uveal melanoma is associated with a more aggressive course and histologically unfavourable disease. This could serve as a further independent prognostic factor in uveal melanoma.

Adolescent↗
PubMed1998

Correlation of residual stenosis immediately after coronary angioplasty with long-term prognosis.

This study evaluated the correlation of residual stenosis after percutaneous transluminal coronary angioplasty with the long-term prognosis. Among consecutive 1,230 patients who underwent coronary angioplasty in the National Cardiovascular Center in Osaka, Japan, 894 patients had de novo lesions. Of these, the 70 patients with acute myocardial infarctions and 105 with unstable angina who had emergency coronary angioplasties were excluded from the study. Among the remaining 719 patients, successful dilatation of the main target vessel was achieved in 592 patients, who then comprised the study group. They were divided into three groups according to their residual stenosis (RS) immediately after coronary angioplasty: group A, RS < 15% (n=208); group B, 15% < or = RS < or = 35% (n=286), and group C, 35% < RS < 50% (n=98). The duration of follow-up was 1,668, 1,660, and 1,680 days in group A, B, and C, respectively. The groups A, B, and C were not significantly different in terms of age, history of myocardial infarction, left ventricular ejection fraction, number of diseased vessels and target vessels, and risk factors such as hypertension, hyperlipidemia, and diabetes mellitus. Primary end point of follow-up was defined as death from any cause and the second end point was occurrence of cardiac events. Kaplan-Meier survival analysis showed significant differences among the three groups. Moreover, survival curves seem to be dependent on the degree of post-procedural residual stenosis. Multivariate analysis using a Cox proportional hazard regression model showed that age, ejection fraction, and residual stenosis were independent determinants of event-free, cardiac, and total survival. Residual stenosis immediately after coronary angioplasty is an independent contributor to long-term clinical prognosis in patients treated with successful balloon coronary angioplasty.

Analysis of Variance↗
PubMed1999

One-year outcome in multivessel coronary disease patients undergoing coronary stenting.

The purpose of this study was to assess 1-year clinical outcome of patients with multivessel coronary artery disease (CAD) who underwent coronary stenting and were prospectively enrolled in the Registro Impianto Stent Endocoronarico (RISE). Of 939 consecutive patients included in the registry, 377 patients with angiographic evidence of multivessel CAD had a 1-year clinical follow-up. All patients underwent PTCA and single or multiple stenting in at least one vessel. Angiographic optimization was usually performed by using high-pressure balloon dilation. After the procedure, continuation of aspirin (at least 250 mg/day) was recommended, whereas the use of anticoagulation or ticlopidine was determined by the physician in charge of the patient in the various centers. Major adverse cardiac events were defined as death, Q-wave or non-Q-wave myocardial infarction and target vessel revascularization. Mean age of patients (311 men, 66 women) was 60 +/- 10 years. Globally, there were 596 stents implanted (72% Palmaz-Schatz stents) in 434 vessels. In about 75% of the procedures, an inflation pressure > 12 atm was used. Angiographic success rate was 98.5%. After stenting, 77% of patients received antiplatelet treatment with ticlopidine and aspirin. During hospitalization, there were 34 major adverse cardiac events in 24 patients. At 1-year follow-up, 309 patients were alive and event-free; cumulative incidence of death, myocardial infarction, and repeat revascularization were 2.9%, 4.7%, and 10.8%, respectively. By Cox regression analysis, multiple stents implantation (HR 1.72, 95% CI 1-2.97), left anterior descending artery revascularization (HR 1.86, 95% CI 1.01-3.42), use of inflation pressure > 12 atm (HR 0.93, 95% CI 0.89-0.97), ticlopidine therapy (HR 0.41, 95% CI 0.23-0.74), and stent length (HR 1.03, 95% CI 1.01-1.05) were associated with 1-year major cardiac events. In patients with multivessel CAD undergoing stent implantation in at least one vessel, 1-year follow-up is favorable and the need for repeat revascularization procedures, based on clinical data, is lower than previously reported for conventional PTCA. Cathet. Cardiovasc. Intervent. 48:343-349, 1999.

Aged↗
PubMed2000

Primary stenting in nonselected patients with acute myocardial infarction: the Multilink Duet in Acute Myocardial Infarction (MIAMI) trial.

Most randomized trials comparing primary stenting with primary coronary angioplasty (PTCA) excluded patients at high risk from enrollment, thus arising the important question about the generalizability of the randomized trial results to all patients with AMI. The aim of this study was to assess the feasibility and effectiveness of a primary infarct-related artery (IRA) stenting strategy using a second-generation tubular stent in nonselected patients with acute myocardial infarction (AMI). All patients with AMI were considered eligible for primary IRA stenting. No restriction was made based on age or clinical status on presentation, or coronary anatomy, except in cases of a reference IRA diameter < 2.5 mm. The primary endpoint of the study was clinical target vessel failure defined as death, reinfarction, or repeat TVR due to restenosis or reocclusion of the IRA. Between June 1998 and March 1999, 201 consecutive patients with AMI underwent mechanical recanalization of the IRA. The mean age was 64 +/- 12, and 16% of patients were aged 75 years or over. The incidence of shock was 9%. Primary IRA stenting was performed in 89% of the patients. Patients who underwent PTCA alone had a smaller IRA diameter as compared to patients with a stented IRA (2.48 +/- 0.46 mm vs. 3.15 +/- 0.37 mm; P < 0.001). There were no stent deployment failures. The 6-month primary endpoint rate was 15% (2 deaths, 27 repeat TVR, 0 reinfarctions), while the 6-month angiographic restenosis rate was 22%. Primary IRA stenting in nonselected patients with AMI is highly feasible and associated with favorable clinical and angiographic outcomes. Cathet. Cardiovasc. Intervent. 51:273-279, 2000.

Adult↗
PubMed1995

Randomized controlled multicentre study of the prevention of complications by octreotide in patients undergoing surgery for chronic pancreatitis.

A randomized double-blind placebo-controlled multicentre trial was carried out in 247 patients undergoing major elective surgery for chronic pancreatitis to clarify whether the perioperative application of octreotide prevents postoperative complications. Eleven complications were defined, including death, anastomotic leakage, pancreatic fistula, abscess, fluid collection, shock, sepsis, bleeding, pulmonary insufficiency, renal insufficiency and postoperative pancreatitis. A total of 124 patients underwent pancreatic head resection, 55 left resection, 61 pancreaticojejunostomy and seven had other procedures. The overall mortality rate was 1.2 per cent (octreotide group 1.6 per cent, placebo group 0.8 per cent [corrected] (P not significant)). The postoperative complication rate in the octreotide group was 16.4 per cent (20 of 122 patients) and in the placebo group 29.6 per cent (37 of 125) (P < 0.007). The perioperative application of octreotide substantially reduces the risk of postoperative complications in patients undergoing major pancreatic surgery for chronic pancreatitis.

Adult↗
PubMed2003

Correlates of failure following treatment with Sr-90 beta irradiation for in-stent restenosis.

We sought to determine the correlates of failure following intracoronary radiation therapy (IRT) with Sr-90 using the Novoste Beta-Cath system for the treatment of in-stent restenosis (ISR) in a broad range of patients. IRT has been shown to be more efficacious compared to placebo for the treatment of ISR in large randomized trials. However, even in patients treated with IRT, major adverse cardiac events occur in approximately 20% of cases on follow-up. This trial sought to elucidate the correlates of failure following successful IRT for ISR. To determine the correlates of IRT failure, we retrospectively compared the demographics, lesion characteristics, and clinical outcomes of 102 consecutive patients with ISR treated with Sr-90 from September 1998 to July 2001. IRT failure was defined as death, myocardial infarction (MI), or target vessel revascularization (TVR) due to repeat ISR on follow-up. A comparison of the clinical and angiographic profile of IRT failures (n = 16) vs. IRT successes (n = 86) revealed that a history of smoking (75% vs. 40%; P = 0.012), current use of calcium channel blockers (84% vs. 45%; P = 0.013), ostial location of target lesion (44% vs. 16%; P = 0.020), and mean posttreatment minimal luminal diameter (MLD; 1.64 +/- 0.19 vs. 2.21 +/- 0.29 mm; P < 0.001), respectively, were correlated with failure using univariate analysis. After multivariate regression analysis, the correlates of failure that remained significant were treatment of an ostial lesion (OR = 31.2; 95% CI = 2.6-382.7; P = 0.007) and final posttreatment MLD (P < 0.001). Ostial location of target lesion and smaller posttreatment MLD are correlated with subsequent death, MI, and TVR following therapy with Sr-90 for ISR.

Aged↗
PubMed2006

Functional and clinical outcomes of nitinol stenting with and without abciximab for complex superficial femoral artery disease: a randomized trial.

OBJECTIVE: To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease. BACKGROUND: Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions. METHODS: We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months. RESULTS: Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect. CONCLUSION: (Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect.

Abciximab↗
PubMed1996

Prediction of in-hospital cardiac events using dipyridamole-thallium scintigraphy performed very early after acute myocardial infarction.

BACKGROUND AND HYPOTHESIS: Ischemic complications occur frequently during hospitalization after acute myocardial infarction. Dipyridamole-thallium scintigraphy performed early after admission can detect residual ischemia, may have additional prognostic value and be useful in the management of these patients. METHODS: Dipyridamole infusion and 201thallium imaging were performed on the third day of infarction in 114 consecutive patients. Coronary angiography was performed before hospital discharge in 90% of patients and exercise testing was performed at the time of discharge in patients without contraindications. RESULTS: Side effects occurred in 28 patients, but they were mild and transient or rapidly reversed with intravenous aminophylline. During hospitalization, three patients died and four had a nonfatal reinfarction. Patients with these major cardiac events had previously shown a higher prevalence of reversible perfusion defects during testing (71 vs. 31%, p < 0.05). In addition, 19 patients had early recurrent ischemia requiring early in-hospital revascularization. Overall, cardiac events defined as death, reinfarction, or early myocardial revascularization occurred in 22 patients. Of the patients with these events, 68% had thallium redistribution on initial myocardial scanning compared with 25% of patients without events (p = 0.0001). Patients with cardiac events also showed a higher number of myocardial segments with reversible perfusion defects (1.8 +/- 2.2 vs. 0.6 +/- 1.3, p = 0.001). Logistic regression analysis revealed that among all the other clinical, scintigraphic, and angiographic variables, the presence of thallium redistribution on the dipyridamole-thallium scan was the only independent predictor of cardiac events, increasing the risk by sixfold. Furthermore, during a 1-year follow-up, 14 other patients had ischemic events. Of these, 64% had previously shown thallium redistribution during early dipyridamole testing compared with 19% of patients without cardiac events (p < 0.001). CONCLUSIONS: Intravenous dipyridamole-thallium-scintigraphy performed very early after myocardial infarction is safe and useful to predict in-hospital ischemic events.

Aged↗
PubMedDate not supplied

Elevated serum urate concentration independently predicts poor outcome following stroke in patients with diabetes.

BACKGROUND: Type 2 diabetes is a risk factor for stroke and confers increased risk of poor outcome and further vascular events following stroke. Hyperuricaemia occurs commonly in patients with type 2 diabetes, but its significance as a predictor of outcome following stroke is uncertain. We sought to investigate the prognostic significance of elevated serum urate concentration in diabetic subjects following stroke. METHODS: We studied a cohort of type 2 diabetes patients presenting to our unit with computed tomography-confirmed acute stroke. Fasting blood samples were drawn within 24 h of admission for urate concentration and standard battery of biochemistry and hematological tests. Information on age, stroke type, prior hypertension, smoking status, resolution time of symptoms and National Institutes of Health Stroke Score was collated. The main outcome event was time to myocardial infarction, recurrent stroke or vascular death, as defined in the CAPRIE trial. Stepwise proportional hazards regression was used to estimate the effect of the above variables on event-free survival following stroke. RESULTS: One hundred and forty patients were studied. Median follow-up duration was 974 days (IQR 163 to 1830 days). Sixty-four patients suffered an outcome event. Urate levels of greater than 0.42 mmol/L (p < 0.001) and an increasing NIHSS score (p < 0.001) independently predicted increased likelihood of suffering an event. CONCLUSION: Elevated urate concentration is significantly and independently associated with increased risk of future vascular events in diabetic stroke patients. Further studies to elucidate the mechanism of this observation are required.

Aged↗
PubMed2005

Methotrexate (MTX) plus ursodeoxycholic acid (UDCA) in the treatment of primary biliary cirrhosis.

This placebo-controlled, randomized, multicenter trial compared the effects of MTX plus UDCA to UDCA alone on the course of primary biliary cirrhosis (PBC). Two hundred and sixty five AMA positive patients without ascites, variceal bleeding, or encephalopathy; a serum bilirubin less than 3 mg/dL; serum albumin 3 g/dL or greater, who had taken UDCA 15 mg/kg daily for at least 6 months, were stratified by Ludwig's histological staging and then randomized to MTX 15 mg/m2 body surface area (maximum dose 20 mg) once a week while continuing on UDCA. The median time from randomization to closure of the study was 7.6 years (range: 4.6-8.8 years). Treatment failure was defined as death without liver transplantation; transplantation; variceal bleeding; development of ascites, encephalopathy, or varices; a doubling of serum bilirubin to 2.5 mg/dL or greater; a fall in serum albumin to 2.5 g/dL or less; histological progression by at least two stages or to cirrhosis. Patients were continued on treatment despite failure of treatment, unless transplantation ensued, drug toxicity necessitated withdrawal, or the patient developed a cancer. There were no significant differences in these parameters nor to the time of development of treatment failures observed for patients taking UDCA plus MTX, or UDCA plus placebo. The trial was conducted with a stopping rule, and was stopped early by the National Institutes of Health at the advice of our Data Safety Monitoring Board for reasons of futility. In conclusion, methotrexate when added to UDCA for a median period of 7.6 years had no effect on the course of PBC treated with UDCA alone.

Adult↗