Association of Race and Ethnicity with Vascular Access Type Selection and Outcomes.

BACKGROUND: Black patients with end-stage renal disease (ESRD) represent 30.5% of the prevalent ESRD population in the United States, despite only accounting for 18% of the total population. Black patients are less likely to have pre-ESRD care compared with their white counterparts and are 3-4 times more likely to progress from chronic kidney disease to ESRD than whites, suggesting that black patients are particularly vulnerable to disparities in outcomes related to hemodialysis and ESRD. The objective of this study is to examine the association of race with outcomes of hemodialysis access and selection of arteriovenous fistula (AVF) versus arteriovenous graft (AVG). METHODS: Patients with chronic kidney disease who initiated dialysis through a tunneled hemodialysis catheter (THC) were identified in the Optum's De-identified Clinformatics® Data Mart (OptumInsight, Eden Prairie, MN) claims database (2011-2017). The odds of AVF versus AVG creation and the odds of repeat vascular access creation were analyzed using logistic regression. Time from initial AVF/AVG to THC removal and time to repeat AVF/AVG were analyzed using Cox proportional hazards. RESULTS: About 7,584 vascular access patients met the inclusion criteria: 5,852 (77%) AVF and 1,732 (23%) AVG. Median follow-up was 583 days overall (range, 1-2,543), 589 days among AVF patients (range, 1-2,543), and 260 days among AVG patients (range, 1-2,529). Between races, there was no clinically significant variation in characteristics or comorbidities, with the exception of a much lower rate of obesity among Asians. Black patients had 36% lower odds of AVF index versus AVG index (P < 0.001). Patients 70 years or older and patients with diabetes had lower odds of AVF index, whereas men and obese patients had greater odds of receiving AVF. Overall, graft patients were 73% more likely to have a shorter time to THC removal than fistula patients, but Hispanic graft patients were 25% more likely to have a shorter time to THC removal than whites. Patients with diabetes, patients with cardiac arrhythmia, and obesity were more likely to have a longer time to THC removal. About 1,589 (21%) patients underwent a repeat vascular access creation during the follow-up period: 19% of whites (n = 802), 26% of blacks (n = 483), 19% of Hispanics (n = 250), and 19% of Asians (n = 54) (P < 0.001). Multivariate analysis demonstrated that black patients had 58% greater odds of requiring a second access than white patients (P < 0.001). Graft patients, patients 70 years or older, and men had lower odds of repeat access. Black patients were 45% more likely to have a shorter time until second access creation. Graft patients, patients aged 70 years or older, and men were more likely to have a longer time until second access. Patients with obesity were more likely to have a shorter time until second access. CONCLUSIONS: This study's findings suggest that after initial vascular access, compared with whites, blacks have no difference in time to index access success, but their access fails earlier and more frequently, independent of access type, age, and comorbidities. Given blacks constitute 30.5% of the hemodialysis population in the United States, it is imperative that future research investigate the root causes of these disparities.

Survival and Reintervention Risk by Patient Age and Preoperative Abdominal Aortic Aneurysm Diameter after Endovascular Aneurysm Repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) has become the standard of care for abdominal aortic aneurysm (AAA), but questions remain regarding the benefit in high-risk and elderly patients. The purpose of this study was to examine the effect of age, preoperative AAA diameter, and their interaction on survival and reintervention rates after EVAR. METHODS: Our integrated health system's AAA endograft registry was used to identify patients who underwent elective EVAR between 2010 and 2014. Of interest was the effect of patient age at the time of surgery (≤80 vs. >80 years old), preoperative AAA diameter (≤5.5 cm vs. >5.5 cm), and their interaction. Primary endpoints were all-cause mortality and reintervention. Between-within mixed-effects Cox models with propensity score weights were fit. RESULTS: Of 1,967 patients undergoing EVAR, unadjusted rates for survival at 4 years after EVAR was 76.1%, and reintervention-free rate was 86.0%. For mortality, there was insufficient evidence for an interaction between age and AAA size (P = 0.309). Patient age >80 years was associated with 2.53-fold higher mortality risk (hazard ratios [HR] = 2.53; 95% confidence intervals [CI], 1.73-3.70; P < 0.001), whereas AAA > 5.5 cm was associated with 1.75-fold higher mortality risk (HR = 1.75; 95% CI, 1.26-2.45; P = 0.001). For reintervention risk, there were no significant interactions or main effects for age or AAA diameter. CONCLUSIONS: Age and AAA diameter are independent predictors of reduced survival after EVAR, but the effect is not amplified when both are present. Age >80 years or AAA size >5.5 cm did not increase the risk of reintervention. No specific AAA size, patient age, or combination thereof was identified that would contraindicate AAA repair.

Anesthetic type and risk of myocardial infarction after carotid endarterectomy in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).

OBJECTIVE: Carotid endarterectomy (CEA) is usually performed under general anesthesia (GA), although some advocate regional anesthesia (RA) to reduce hemodynamic instability and allow neurologic monitoring and selective shunting. RA does not reduce risk of periprocedural stroke or death, although some series show a reduction in myocardial infarction (MI). We investigated the association of anesthesia type and periprocedural MI among patients receiving GA or RA for CEA and patients undergoing carotid artery stenting (CAS) in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). METHODS: Between 2000 and 2008, 1151 patients underwent CEA (anesthetic type available for 1149 patients), and 1123 patients underwent CAS ≤30 days of randomization in CREST. CEA patients were categorized by anesthetic type (GA vs RA). CREST defined protocol MI as chest pain or electrocardiogram change plus biomarker evidence of MI, and total MI was defined as protocol MI plus biomarker-positive (+)-only MI. The incidence of protocol MI and total MI in patients undergoing CEA under GA and RA were compared with those undergoing CAS. Other study end points were similarly compared. Differences in baseline characteristics and periprocedural events were evaluated among the three groups. Logistic regression, adjusting for age and symptomatic status, was used to assess group differences. RESULTS: The three groups had similar demographic risk factors, except for prevalence of symptomatic carotid stenosis, which was lowest in the CEA-RA group (P = .03). Of the 111 patients in the CEA-RA group, no protocol MIs occurred and only two biomarker+-only MIs, for an overall incidence of 1.8%, similar to the 1.7% overall incidence in patients undergoing CAS. In contrast, the combined incidence of protocol and biomarker+-only MIs in the 1038 patients in the CEA-GA group was significantly higher at 3.4% (P = .04), twice the risk of protocol MI and biomarker+-only MI compared with those undergoing CAS (odds ratio [OR], 2.01; 95% confidence interval [CI], 1.14-3.54). Direct comparison of the MI incidence between CEA-RA and CEA-GA showed no statistical difference. Patients undergoing CEA-GA had lower odds of a periprocedural stroke (OR, 0.48; 95% CI, 0.28-0.79) and stroke or death (OR, 0.46; 95% CI, 0.27-0.76) compared with those undergoing CAS but were not significantly different from those undergoing CEA-RA. CONCLUSIONS: Patients in CREST undergoing CEA-RA had a similar risk of periprocedural MI as those undergoing CAS, whereas the risk for CEA-GA was twice that compared with patients undergoing CAS. Nevertheless, because periprocedural MI is one of the few variables favoring CAS over CEA and has been associated with decreased long-term survival, RA should be seriously considered for patients undergoing CEA.

Right-Side Colon Ischemia: Clinical Features, Large Visceral Artery Occlusion, and Long-Term Follow-Up.

CONTEXT: Large visceral artery occlusion (LVAO) could underlie right-side colon ischemia (RSCI) but is little known. OBJECTIVE: To assess patients with RSCI through long-term follow-up, including features and management of LVAO. MAIN OUTCOME MEASURES: Mesenteric ischemia and mortality. DESIGN: Retrospective observational study in an integrated health care system. RESULTS: Of 49 patients (30 women [61.2%]; mean [standard deviation] age, 69.4 [11.9] years), 19 (38.8%) underwent surgery­that is, 5 (83.3%) of 6 who developed RSCI in hospital following surgical procedures and 14 (32.6%) of 43 who had RSCI before hospitalization (p value = 0.03); overall, 5 (10.2%) died. Among 44 survivors with a median (range) follow-up of 5.19 (0.03-14.26) years, 5 (11.4%), including 3 (20.0%) of 15 operated cases, had symptomatic LVAO and underwent angioplasty and stent placement: 2 for abdominal angina that preceded RSCI, 1 for acute mesenteric ischemia 1 week after resection of RSCI, 1 for RSCI 6 weeks after resection of left-side ischemia, and 1 for abdominal angina that began 3 years after spontaneous recovery from RSCI. None had further mesenteric ischemia until death from nonintestinal disease or the end of follow-up (1.6 to 10.2 years later). Kaplan-Meier survival estimates for all 44 survivors at 1, 3, 5, and 10 years were 88.6%, 72.3%, 57.6%, and 25.9%, respectively. Thirty-one patients (70.4%) died during follow-up, 19 (61.3%) of a known cause; the 39 patients not treated for LVAO lacked mesenteric ischemia. CONCLUSION: Patients with RSCI may have symptomatic LVAO; therefore, we advise they undergo careful query for symptoms of abdominal angina and routine visceral artery imaging.

Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial.

BACKGROUND AND PURPOSE: Post-hoc, we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), increasing experience and improved patient selection with carotid stenting, and to a lesser extent, carotid endarterectomy would contribute to lower periprocedural event rates. METHODS: Three study periods with approximately the same number of patients were defined to span recruitment. Composite and individual rates of periprocedural stroke, myocardial infarction, and death rate were calculated separately by treatment assignment (carotid stenting/carotid endarterectomy). Temporal changes in unadjusted event rates, and rates after adjustment for temporal changes in patient characteristics, were assessed. RESULTS: For patients randomized to carotid stenting, there was no significant temporal change in the unadjusted composite rates that declined from 6.2% in the first period, to 4.9% in the second, and 4.6% in the third (P=0.28). Adjustment for patient characteristics attenuated the rates to 6.0%, 5.9%, and 5.6% (P=0.85). For carotid endarterectomy-randomized patients, both the composite and the combined stroke and death outcome decreased between periods 1 and 2 and then increased in period 3. CONCLUSIONS: The hypothesized temporal reduction of stroke+death events for carotid stenting-treated patients was not observed. Further adjustment for changes in patient characteristics between periods, including the addition of asymptomatic patients and a >50% decrease in proportion of octogenarians enrolled, resulted in practically identical rates. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic shunt versus portacaval shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis.

IMPORTANCE: Bleeding esophageal varices has been studied extensively, but bleeding gastric varices (BGV) has received much less investigation. However, BGV has been reported in ≤ 30% of patients with acute variceal bleeding. In our studies of 1,836 bleeding cirrhotics, 12.7% were bleeding from gastric varices. BGV mortality rate of 45-55% has been reported. The BGV literature has mainly involved retrospective case reports, often with short-term follow-up. OBJECTIVE: We sought to describe the results of a prospective, randomized, controlled trial (RCT) in unselected, consecutive patients with BGV comparing endoscopic therapy (ET) with portacaval shunt (PCS; n = 518), and later comparing emergency transjugular intrahepatic portosystemic shunt (TIPS) with emergency portacaval shunt (EPCS; n = 70). DESIGN, SETTING, AND PARTICIPANTS: Initially, our RCT involved 518 patients with BGV comparing ET with direct PCS regarding control of bleeding, mortality rate, and disability. When entry of patients ended, the RCT was expanded to compare emergency TIPS with EPCS (n = 70). This RCT of BGV was separate from our other RCTs of bleeding esophageal varices. INTERVENTIONS: Initially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS). MAIN OUTCOME MEASURES: Outcomes were survival, control of bleeding, portal-systemic encephalopathy (PSE), quality of life, and direct costs of care. In the RCT of ET versus PCS, 28 and 30%, respectively, were in Child class C. In the expanded RCT of TIPS versus EPCS, 40 and 41%, respectively, were in Child class C. Permanent control of BGV was achieved in 97-100% of patients treated by emergency or elective PCS, compared with 27-29% by ET. TIPS was even less effective, achieving long-term control of BGV in only 6%. Survival rates after PCS were greater at all time intervals and in all Child classes (P < .001). Repeated episodes of PSE occurred in 50% of TIPS patients, 16-17% treated by ET, and 8-11% treated by PCS. Shunt stenosis or occlusion occurred in 67% of TIPS patients, in contrast with 0-2% of PCS patients. CONCLUSION: These results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.

A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Registries have been proven useful to assess clinical outcomes, but data entry and personnel expenses are challenging. We developed a registry to track patients undergoing endovascular aortic aneurysm repair (EVAR) in an integrated health care system, leveraging an electronic medical record (EMR) to evaluate clinical practices, device performance, surgical complications, and medium-term outcomes. This study describes the registry design, data collection, outcomes validation, and ongoing surveillance, highlighting the unique integration with the EMR. METHODS: EVARs in six geographic regions of Kaiser Permanente were entered in the registry. Cases were imported using a screening algorithm of inpatient codes applied to the EMR. Standard note templates containing data fields were used for surgeons to enter preoperative, postoperative, and operative data as part of normal workflows in the operating room and clinics. Clinical content experts reviewed cases and entered any missing data of operative details. Patient comorbidities, aneurysm characteristics, implant details, and surgical outcomes were captured. Patients entered in the registry are followed up for life, and all relevant events are captured. RESULTS: Between January 2010 and June 2013, 2112 procedures were entered in the registry. Surgeon compliance with data entry ranges from 60% to 90% by region but has steadily increased over time. Mean aneurysm size was 5.9 cm (standard deviation, 1.3). Most patients were male (84%), were hypertensive (69%), or had a smoking history (79%). The overall reintervention rate was 10.8%: conversion to open repair (0.9%), EVAR revision (2.6%), other surgical intervention (7.3%). Of the reinterventions, 27% were for endoleaks (I, 34.3%; II, 56.9%; III, 8.8%; IV and V, 0.0%), 10.5% were due to graft malfunction, 3.4% were due to infection, and 2.3% were due to rupture. CONCLUSIONS: Leveraging an EMR provides a robust platform for monitoring short-term and midterm outcomes after abdominal aortic aneurysm repair. Use of standardized templates in the EMR allows data entry as part of normal workflow, improving compliance, accuracy, and data capture using limited but expert personnel. Assessment of patient demographics, device performance, practice variation, and postoperative outcomes benefits clinical decision-making by providing complete and adjudicated event reporting. The findings from this large, community-based EVAR registry augment other studies limited to perioperative and short-term outcomes or small patient cohorts.

Incidence, outcomes, and effect on quality of life of cranial nerve injury in the Carotid Revascularization Endarterectomy versus Stenting Trial.

OBJECTIVE: Cranial nerve injury (CNI) is the most common neurologic complication of carotid endarterectomy (CEA) and can cause significant chronic disability. Data from prior randomized trials are limited and provide no health-related quality of life (HRQOL) outcomes specific to CNI. Incidence of CNIs and their outcomes for patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) were examined to identify factors predictive of CNI and their impact on HRQOL. METHODS: Incidence of CNIs, baseline and procedural characteristics, outcomes, and HRQOL scores were evaluated in the 1151 patients randomized to CEA and undergoing surgery ≤30 days. Patients with CNI were identified and classified using case report forms, adverse event data, and clinical notes. Baseline and procedural characteristics were compared using descriptive statistics. Clinical outcomes at 1 and 12 months were analyzed. All data were adjudicated by two neurologists and a vascular surgeon. HRQOL was evaluated using the Medical Outcomes Short-Form 36 (SF-36) Health Survey to assess general health and Likert scales for disease-specific outcomes at 2 weeks, 4 weeks, and 12 months after CEA. The effect of CNI on SF-36 subscales was evaluated using random effects growth curve models, and Likert scale data were compared by ordinal logistic regression. RESULTS: CNI was identified in 53 patients (4.6%). Cranial nerves injured were VII (30.2%), XII (24.5%), and IX/X (41.5%), and 3.8% had Horner syndrome. CNI occurred in 52 of 1040 patients (5.0%) receiving general anesthesia and in one of 111 patients (0.9%) operated on under local anesthesia (P = .05). No other predictive baseline or procedural factors were identified. Deficits resolved in 18 patients (34%) at 1 month and in 42 of 52 patients (80.8%) by 1 year. One patient died before the 1-year follow-up visit. The HRQOL evaluation showed no statistical difference between groups with and without CNI at any interval. By Likert scale analysis, the group with CNI showed a significant difference in the difficulty eating/swallowing parameter at 2 and 4 weeks (P < .001) but not at 1 year. CONCLUSIONS: In CREST, CNI occurred in 4.6% of patients undergoing CEA, with 34% resolution at 30 days and 80.8% at 1 year. The incidence of CNI was significantly higher in patients undergoing general anesthesia. CNI had a small and transient effect on HRQOL, negatively affecting only difficulty eating/swallowing at 2 and 4 weeks but not at 1 year. On the basis of these findings, we conclude that CNI is not a trivial consequence of CEA but rarely results in significant long-term disability.

Management of spontaneous isolated visceral artery dissection.

BACKGROUND: Spontaneous isolated dissection of the celiac artery (CA) or the superior mesenteric artery (SMA) is rare but increasingly recognized because of widespread use of advanced abdominal imaging technology. Indications for specific therapeutic options and long-term outcomes are not well defined. This study analyzed clinical features, management strategies, and outcomes for patients with spontaneous visceral artery dissections. METHODS: Medical records of all patients diagnosed with CA or SMA dissections at 2 institutions (Scripps Green Hospital and San Diego Kaiser Medical Center) between January 2005 and January 2014 were retrospectively reviewed. Patient demographics included age, symptoms, associated comorbidities, and type of intervention. Anatomic features including length of dissection and entry point were measured. Efficacy of the various treatments was compared on the basis of symptom resolution and clinical course. RESULTS: Over an 8-year period, 23 patients with a diagnosis of visceral artery dissection were identified. Eighteen (78%) patients were men. Most patients (78%) were symptomatic on initial presentation with abdominal or back pain. Treatment included observation in 4, anticoagulation in 13, and endovascular stenting in 6 patients. The mean follow-up was 23.8 months. No patient required bowel resection. Twenty of twenty-three patients reported resolution of symptoms at follow-up. CONCLUSIONS: In this series, all patients with isolated visceral artery dissection had favorable outcomes, with no significant morbidity or mortality. Conservative management with anticoagulation is recommended as the first-line therapy. When conservative management fails, endovascular therapy is the treatment of choice.

Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease.

OBJECTIVE: This study explored the safety and efficacy of recombinant type I pancreatic elastase (PRT-201) topically applied once to the external surface of an arteriovenous fistula. METHODS: This was a randomized, double-blind, placebo-controlled trial. Adults with kidney disease undergoing creation of a radiocephalic fistula (RCF) or brachiocephalic fistula were randomized to treatment with placebo (n = 51), PRT-201 at 10 µg (n = 51), or PRT-201 at 30 µg (n = 49). The primary efficacy measure was unassisted primary patency (PP) over 1 year. Secondary efficacy measures were secondary patency (SP), unassisted maturation by ultrasound interrogation, use for hemodialysis, and hemodynamically significant lumen stenosis. RESULTS: Median PP was 224 days for placebo and >365 days for the PRT-201 groups. At 1 year, 45%, 54%, and 53% of placebo, 10-µg, and 30-µg patients retained PP. The risk of PP loss was nonsignificantly reduced for 10 µg (hazard ratio [HR], 0.69; P = .19) and 30 µg (HR, 0.67; P = .17) vs placebo. In the subset (44% of patients) with a RCF, the median PP was 125 days for placebo and >365 days for the PRT-201 groups. At 1 year, 31%, 50%, and 63% of placebo, 10-µg, and 30-µg RCFs retained PP. The risk of RCF PP loss was nonsignificantly reduced by 10 µg (HR, 0.59; P = .18) and significantly reduced by 30 µg (HR, 0.37; P = .02) vs placebo. At 1 year, 77%, 81%, and 83% of placebo, 10-µg, and 30-µg patients retained SP. The risk of SP loss was nonsignificantly reduced for 10 µg (HR, 0.79; P = .61) and 30 µg (HR, 0.76; P = .55) vs placebo. In the subset with RCFs, 65%, 82%, and 90% of placebo, 10-µg, and 30-µg patients retained SP at 1 year. The risk of RCF SP loss was nonsignificantly reduced for 10 µg (HR, 0.45; P = .19) and 30 µg (HR, 0.27; P = .08) vs placebo. At month 3, 67%, 87% (P = .03), and 92% (P < .01) of the placebo, 10-µg, and 30-µg group fistulas had unassisted maturation by ultrasound interrogation. At month 3 in the subset with an RCF, 47%, 74% (P = .17), and 93% (P < .01) of placebo, 10-µg, and 30-µg group fistulas had unassisted maturation by ultrasound interrogation. Adverse event reports were not meaningfully different between groups. CONCLUSIONS: PRT-201 appeared safe. The primary efficacy end point was not met. However, both PRT-201 doses were associated with improved unassisted maturation. The 30-µg dose was associated with increased PP in the subset with RCF.

Leveraging the electronic medical record to implement an abdominal aortic aneurysm screening program.

OBJECTIVE: Screening for abdominal aortic aneurysms (AAAs) reduces aneurysm-related mortality and has been recommended by the U.S. Preventive Services Task Force and American Heart Association since 2005. Medicare has covered a one-time screening ultrasound for new male enrollees with a familial or smoking history since 2007. Nevertheless, in the U.S., screening has remained underutilized. Review of patients with ruptured AAA in our system in 2007 showed the majority were undiagnosed, yet met U.S. Preventive Services Task Force and American Heart Association screening guidelines. To reduce the number of preventable AAA ruptures and deaths in our patients, we implemented an AAA screening program using our electronic medical record (EMR). This study describes the design, implementation, and early results of that screening program. METHODS: Between March 2012 and June 2013, men aged 65 to 75 years with any history of smoking were targeted for screening. Medical records were reviewed electronically to exclude patients with abdominal imaging studies within 10 years that would have diagnosed an AAA. Best practice alerts (BPA) were created in the EMR so when an appropriate patient is seen, office staff and providers are prompted to order an aortic ultrasound. AAA was defined as aortic diameter ≥3.0 cm or greater, and ultrasound reports contained a standard template providing guidance for patient management when an aneurysm was identified. Newly identified AAAs were triaged for vascular surgery consultation or follow-up with their primary physician. The number of eligible patients, unscreened patients, and AAAs identified were tabulated by our Regional Outpatient Safety Net Program. RESULTS: In a population of 3.6 million, 55,610 patients initially met screening criteria, and 26,837 (48.26%) were excluded from the BPA because of prior abdominal imaging studies. After 15 months, there were 68,164 patients who met screening criteria, 54,356 (79.74%) of whom had undergone an abdominal imaging study. Thus, 27,519 patients underwent an imaging study after the BPA was activated. During the study period, 731 new AAAs were diagnosed, 165 over 4.0 cm in diameter. Screening rates have increased at all medical centers where the BPA was activated, and the percentage of unscreened patients has been reduced from 51.74% to 20.26% system-wide. CONCLUSIONS: In an integrated health care system using an EMR, AAA screening can be implemented with a dramatic reduction in unscreened patients. Further analysis is required to assess the impact of the screening program on AAA rupture rate and cost-effectiveness in our system.

Randomized controlled trial of emergency transjugular intrahepatic portosystemic shunt versus emergency portacaval shunt treatment of acute bleeding esophageal varices in cirrhosis.

BACKGROUND: Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic shunt (TIPS) when bleeding is not controlled. Surgical portosystemic shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency portacaval shunt (EPCS) in patients with cirrhosis and acute BEV. STUDY DESIGN: A total of 154 unselected, consecutive cirrhotic patients ("all comers") with acute BEV were randomized to TIPS (n = 78) or EPCS (n = 76), and the two treatments were compared with regard to effect on survival, control of bleeding, portal-systemic encephalopathy (PSE), and disability. Diagnostic workup was completed within 6 h and TIPS or EPCS was initiated within 24 h. Regular follow-up was accomplished in 100 % of patients and lasted for 5 to 10 years in 85 % and 3 to 4.5 years in the remainder. This report focuses on control of bleeding and survival. RESULTS: The clinical characteristics of the two groups were similar, and the distribution of Child classes A, B, and C was almost identical. TIPS was successful in controlling BEV for 30 days in 80 % of patients but achieved long-term control of BEV in only 22 %. In contrast, EPCS controlled BEV immediately in all patients and permanently in 97 % (p < 0.001). TIPS patients required almost twice as many units of blood transfusion as EPCS patients. Survival rate at all time intervals and in all Child classes was significantly greater following EPCS than after TIPS (p < 0.001). Median survival was over 10 years following EPCS, compared to 1.99 years following TIPS. Stenosis or occlusion of TIPS was demonstrated in 84 % of patients who survived 21 days, 63 % of whom underwent TIPS revision, which failed in 80 %. In contrast, EPCS remained permanently patent in 97 % of patients. Recurrent PSE was threefold more frequent following TIPS than after EPCS (61 versus 21 %). CONCLUSIONS: EPCS was uniformly effective in the treatment of BEV, while TIPS was disappointing. EPCS accomplished long-term survival while TIPS resulted in a survival rate that was less than one fifth that of EPCS. The results of this RCT in unselected, consecutive patients justify the use of EPCS as a first-line emergency treatment of BEV in cirrhosis (clinicaltrials.gov #NCT00734227).

Influence of vascular access type on sex and ethnicity-related mortality in hemodialysis-dependent patients.

OBJECTIVES: To determine whether sex- and ethnicity-based mortality differences in patients dependent on hemodialysis (hemodialysis patients) are because of prevalence of vascular access type. METHODS: Southern California Permanente Medical Group Renal Database, which contained 5821 chronic hemodialysis patients between 2000 and 2008, was studied. RESULTS: Mean age of the patients was 62 years, and 59% were male. Of the population, 33% were white; 32%, Hispanic; 23%, African American; 9%, Asian/Pacific Islander; and 3%, other race or ethnicity. Predominant access type over the course of the study was arteriovenous fistula (AVF) in 73%, arteriovenous graft (AVG) in 12%, and tunneled catheter in 14%. There was a higher percentage of AVF in whites (71%) than in African Americans (63%). Risk of death was independently increased by age (hazard ratio [HR], 1.04; 95% confidence interval [CI], 1.04-1.05), male sex (HR, 1.33; 95% CI, 1.22-1.45), diabetes (HR, 1.22; 95% CI, 1.12-1.33), use of an AVG (HR, 1.51; 95% CI, 1.34-1.71) or a tunneled catheter (HR, 6.45; 95% CI, 5.78-7.20). Compared with whites, African-American race decreased the risk of death (HR, 0.63; 95% CI, 0.56-0.70), as did Asian/Pacific Islander (HR, 0.58; 95% CI, 0.49-0.69), Hispanic (HR, 0.58; 95% CI, 0.51-0.65), and other race (HR, 0.67; 95% CI, 0.52-0.86). CONCLUSION: Age, sex, race or ethnicity, access type, and diabetes are independent risk factors for mortality in hemodialysis patients. After controlling for potential confounders, when compared with whites, minorities all demonstrate significantly decreased risk of mortality. African Americans had reduced mortality risk despite a lower prevalence of arteriovenous fistula compared with whites. Male sex increased mortality. Differences in mortality between sexes and ethnicities in this population cannot be accounted for by differences in type of dialysis access.

Disability index in a randomized controlled trial of emergency sclerotherapy versus portacaval shunt for bleeding varices in cirrhosis.

BACKGROUND: Disability has not been studied after emergency treatment of bleeding esophageal varices (BEV). We created a disability index (DI) in a randomized controlled trial comparing emergency endoscopic therapy (EST) versus emergency portacaval shunt (EPCS). METHODS: There were 211 unselected, consecutive patients with cirrhosis and acute BEV who were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic work-up and treatment were performed within 8 hours. Ninety-six percent underwent more than 10 years follow-up evaluation. Disability was measured by assessing 9 factors to create a DI. RESULTS: Ten-year survival was 8% after EST versus 51% after EPCS (P < .001). EPCS had a significantly better DI. The EST and EPCS values were as follows: liver function improvement: not applicable and ++; worsening liver function, ++ and not applicable; portal-systemic encephalopathy (PSE) incidence, 36 and 15; PSE episodes, 179 and 94; packed red blood cell units, 1,005 and 320; hospital readmissions, 387 and 292; and number of readmission days, 9.6 and 4.7. All of the P values were less than .001. CONCLUSIONS: EPCS resulted in a markedly better DI than EST, a significantly higher survival rate, better control of bleeding, and a lower incidence of PSE. EPCS is an effective first-line emergency treatment of BEV.

Child-Turcotte score versus MELD for prognosis in a randomized controlled trial of emergency treatment of bleeding esophageal varices in cirrhosis.

BACKGROUND AND AIMS: Bleeding esophageal varices is responsible for much of the high mortality rate in cirrhosis. An important objective of management of bleeding varices is to develop reliable tools for predicting survival, controlling bleeding and encephalopathy, and improve quality of life. This study compared two widely used prognostic tools, the model for end-stage liver disease (MELD) and the Child-Turcotte (C-T) score, in a randomized controlled trial of emergency treatment of bleeding varices. METHODS: We randomized 211 unselected consecutive patients with cirrhosis and bleeding varices to endoscopic sclerotherapy (n = 106) or emergency portacaval shunt (n = 105). Diagnosis and treatment were accomplished within 20 hours. Follow-up was 100% for 10 y. We compared the prognostic powers of MELD and C-T upon entry, and then monthly for the first year and every 3 months thereafter. Statistical analysis included computation of receiver operating curves, the area under the curve, and the proportion of variability. RESULTS: In baseline determinations of MELD versus C-T, there were no significant differences in predicting survival, recurrent encephalopathy, and rebleeding. The Child-Turcotte score was a stronger predictor than MELD of hospital readmissions and readmission days. In serial determinations over years, the prognostic power of both MELD and C-T was substantial, but C-T was significantly more effective in predicting survival and time to recurrent encephalopathy. CONCLUSIONS: In this first long-term comparison of MELD versus C-T in cirrhosis with bleeding varices, C-T was consistently as effective as MELD in predicting survival, encephalopathy, rebleeding, hospital readmissions, and readmission days. In some measures, C-T was a more effective prognostic tool than MELD.

Alcoholic versus nonalcoholic cirrhosis in a randomized controlled trial of emergency therapy of bleeding varices.

BACKGROUND: It has been proposed that portal-systemic shunts be avoided in alcoholic cirrhotics because survival rate is allegedly lower in alcoholics than in nonalcoholics. We examined this issue in a randomized controlled trial. METHODS: Two hundred eleven unselected, consecutive patients with cirrhosis and bleeding esophageal varices were randomized to endoscopic sclerotherapy (EST) (n = 106) or emergency portacaval shunt (EPCS) (105). Treatment was initiated within 8 h. EST failure was treated by rescue portacaval shunt (PCS). Ten-year follow-up was 96%. RESULTS: Results strongly favored EPCS over EST (P < 0.001). Among EPCS patients, 83% were alcoholic and 17% nonalcoholic. Outcomes were (1) permanent control of bleeding 100% versus 100%; (2) 5-y survival 71% versus 78%; (3) encephalopathy 14% versus 19%; (4) yearly charges $38,300 versus $43,000. CONCLUSIONS: EPCS results were similar in alcoholic and nonalcoholic cirrhotics. EPCS is an effective first line emergency treatment in all forms of cirrhosis, including alcoholic.

A randomized controlled trial of emergency treatment of bleeding esophageal varices in cirrhosis for hepatocellular carcinoma.

BACKGROUND: Ninety percent of patients with hepatocellular carcinoma (HCC) have cirrhosis. Bleeding esophageal varices (BEV) is a frequent complication of cirrhosis. Detection of HCC in cirrhotic patients with BEV has not been studied. METHODS: Two hundred eleven unselected patients with cirrhosis and BEV were randomized to endoscopic sclerotherapy (n = 106) or emergency portacaval shunt (n = 105). Diagnostic workup and treatment were initiated within 8 hours. Ninety-six percent had >10 years of follow-up. HCC screening involved serum α-fetoprotein (AFP) every 3 months, ultrasonography every 6 months, and selective computed tomography (CT). RESULTS: HCC occurred in 15 patients, all incurable, a mean of 2.94 years after entry. They died a mean 1.33 years after discovery. Serial AFP and ultrasound examinations were unrevealing over a mean of 2.3 years. The mean model of end-stage liver disease score was 12.7 at entry and 17.4 at HCC diagnosis. CONCLUSIONS: Long-term screening by AFP and ultrasound plus selective CT failed to detect HCC at a curable stage. The detection of HCC in cirrhotic patients with BEV remains a serious, unsolved problem. The use of CT for routine screening warrants consideration despite increased costs.

Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4.

BACKGROUND: Emergency treatment of bleeding esophageal varices (BEV) in cirrhotic patients is of prime importance because of the high mortality rate surrounding the episode of acute bleeding. Nevertheless, there is a paucity of randomized controlled trials of emergency surgical therapy and no reports of the costs of any of the widely used forms of emergency treatment. The important issue of direct costs of care was examined in a randomized controlled trial that compared endoscopic sclerotherapy (EST) to emergency portacaval shunt (EPCS). METHODS: Two hundred eleven unselected consecutive patients with ultimately biopsy-proven cirrhosis and endoscopically proven acute BEV were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic workup was completed, and EST or EPCS was initiated within 8 h. Criteria for failure of EST or EPCS were clearly defined, and crossover rescue treatment was applied, when primary therapy failed. Ninety-six percent of patients underwent more than 10 years follow-up, or until death. Complete charges for all aspects of care were obtained continuously for more than 10 years. RESULTS: Direct charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy. Charges per patient, per year of treatment, and per year in each child's risk class were significantly lower in patients randomized to EPCS. Charges in patients who failed endoscopic sclerotherapy and underwent a rescue portacaval shunt were significantly higher than the charges in both the unshunted sclerotherapy patients and the patients randomized to EPCS. This result was particularly noteworthy given the widespread practice of using surgical portacaval shunt as rescue treatment only when all other forms of therapy have failed. CONCLUSIONS: In this randomized controlled trial of emergency treatment of acute BEV, EPCS was significantly superior to EST with regard to direct costs of care as reflected in charges for care as well as in survival rate, control of bleeding, and incidence of portal-systemic encephalopathy. These results provide support for the use of EPCS as a first line of emergency treatment of BEV in cirrhosis.