Tassos C. Kyriakides

Outcomes Following Endovascular vs Open Repair of Abdominal Aortic Aneurysm: A Randomized Trial

CONTEXT Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. OBJECTIVE To compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. DESIGN, SETTING, AND PATIENTS A randomized, multicenter clinical trial of 881 veterans (aged > or = 49 years) from 42 Veterans Affairs Medical Centers with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report describes the period between October 15, 2002, and October 15, 2008. INTERVENTION Elective endovascular (n = 444) or open (n = 437) repair of AAA. MAIN OUTCOME MEASURES Procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. RESULTS Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs 3.0%; P = .004), but there was no significant difference in mortality at 2 years (7.0% vs 9.8%, P = .13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechanical ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. CONCLUSIONS In this report of short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00094575.

Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm

BACKGROUND Whether elective endovascular repair of abdominal aortic aneurysm reduces long-term morbidity and mortality, as compared with traditional open repair, remains uncertain. METHODS We randomly assigned 881 patients with asymptomatic abdominal aortic aneurysms who were candidates for both procedures to either endovascular repair (444) or open repair (437) and followed them for up to 9 years (mean, 5.2). Patients were selected from 42 Veterans Affairs medical centers and were 49 years of age or older at the time of registration. RESULTS More than 95% of the patients underwent the assigned repair. For the primary outcome of all-cause mortality, 146 deaths occurred in each group (hazard ratio with endovascular repair versus open repair, 0.97; 95% confidence interval [CI], 0.77 to 1.22; P=0.81). The previously reported reduction in perioperative mortality with endovascular repair was sustained at 2 years (hazard ratio, 0.63; 95% CI, 0.40 to 0.98; P=0.04) and at 3 years (hazard ratio, 0.72; 95% CI, 0.51 to 1.00; P=0.05) but not thereafter. There were 10 aneurysm-related deaths in the endovascular-repair group (2.3%) versus 16 in the open-repair group (3.7%) (P=0.22). Six aneurysm ruptures were confirmed in the endovascular-repair group versus none in the open-repair group (P=0.03). A significant interaction was observed between age and type of treatment (P=0.006); survival was increased among patients under 70 years of age in the endovascular-repair group but tended to be better among those 70 years of age or older in the open-repair group. CONCLUSIONS Endovascular repair and open repair resulted in similar long-term survival. The perioperative survival advantage with endovascular repair was sustained for several years, but rupture after repair remained a concern. Endovascular repair led to increased long-term survival among younger patients but not among older patients, for whom a greater benefit from the endovascular approach had been expected. (Funded by the Department of Veterans Affairs Office of Research and Development; OVER ClinicalTrials.gov number, NCT00094575.).

HIV-1 transmission in injection paraphernalia: heating drug solutions may inactivate HIV-1.

In response to recent concerns about risk of HIV-1 transmission from drug injection paraphernalia such as cookers, ethnographic methods were used to develop a descriptive typology of the paraphernalia and practices used to prepare and inject illegal drugs. Observational data were then applied in laboratory studies in which a quantitative HIV-1 microculture assay was used to measure the recovery of infectious HIV-1 in cookers. HIV-1 survival inside cookers was a function of the temperature achieved during preparation of drug solutions; HIV-1 was inactivated once temperature exceeded, on average, 65 degrees C. Although different types of cookers, volumes, and heat sources affected survival times, heating cookers 15 seconds or longer reduced viable HIV-1 below detectable levels.

Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial

OBJECTIVE This study was conducted to determine the costs and comparative cost-effectiveness of two methods of abdominal aortic aneurysm (AAA) repair in the Open Versus Endovascular Repair (OVER) Veterans Affairs (VA) Cooperative Study, a multicenter randomized trial of 881 patients. METHODS The primary outcomes of this analysis were mean total health care cost per life-year and per quality-adjusted life-year (QALY) from randomization to 2 years after. QALYs were calculated from EuroQol (EQ)-5D questionnaires collected at baseline and annually. Health care utilization data were obtained directly from patients and from national VA and Medicare data sources. VA costs were obtained from national VA sources using methods previously developed by the VA Health Economics Resource Center. Costs for non-VA care were determined from Medicare claims data or billing data from the patients health care providers. RESULTS After 2 years of follow-up, mean life-years were 1.78 in the endovascular repair group and 1.74 in the open repair group (difference, 0.04; 95% confidence interval [CI], -0.03 to 0.09; P = .29). Mean QALYs were 1.462 in the endovascular group and 1.461 in the open group (difference adjusting for baseline EQ-5D score, 0.006; 95% CI, -0.038 to 0.052; P = .78). Mean graft costs were higher in the endovascular group (

Quality of Life of Patients With Advanced HIV/AIDS: Measuring the Impact of Both AIDS-Defining Events and Non-AIDS Serious Adverse Events

14,052 vs

Predictors and outcomes of endoleaks in the Veterans Affairs Open Versus Endovascular Repair (OVER) Trial of Abdominal Aortic Aneurysms

1363; P < .001), but length of stay was shorter (5.0 vs 10.5 days; P < .001), resulting in a lower mean cost of the hospital admission for the AAA procedure in the endovascular repair group of

Elevated Muscle-Specific miRNAs in Serum of Myotonic Dystrophy Patients Relate to Muscle Disease Progress

37,068 vs

Connection domain mutations in treatment-experienced patients in the OPTIMA trial.

42,970 (difference, -

The Prevalence of Peyronie's Disease in the United States: A Population-Based Study

5901; 95% CI, -

Results of Antiretroviral Treatment Interruption and Intensification in Advanced Multi-Drug Resistant HIV Infection from the OPTIMA Trial

12,135 to -