The Viborg vascular (VIVA) screening trial of 65-74 year old men in the central region of Denmark: study protocol

<p>Abstract</p> <p>Background</p> <p>Screening for abdominal aortic aneurysm (AAA) of men aged 65-74 years reduces the AAA-related mortality and is generally considered cost effective. Despite of this only a few national health care services have implemented permanent programs.</p> <p>Around 10% of men in this group have peripheral arterial disease (PAD) defined by an ankle brachial systolic blood pressure index (ABI) below 0.9 resulting in an increased mortality-rate of 25-30%. In addition well-documented health benefits may be achieved through primary prophylaxis by initiating systematic cholesterol-lowering, smoking cessation, low-dose acetylsalicylic acid (aspirins), exercise, a healthy diet and blood-pressure control altogether reducing the increased risks for cardiovascular disease by at least 20-25%.</p> <p>The benefits of combining screening for AAA and PAD seem evident; yet they remain to be established. The objective of this study is to assess the efficacy and the cost-effectiveness of a combined screening program for AAA, PAD and hypertension.</p> <p>Methods</p> <p>The Viborg Vascular (VIVA) screening trial is a randomized, clinically controlled study designed to evaluate the benefits of vascular screening and modern vascular prophylaxis in a population of 50,000 men aged 65-74 years. Enrolment started October 2008 and is expected to stop in October 2010. The primary outcome is all-cause mortality. The secondary outcomes are cardiovascular mortality, AAA-related mortality, hospital services related to cardiovascular conditions, prevalence of AAA, PAD and potentially undiagnosed hypertension, health-related quality of life and cost effectiveness. Data analysis by intention to treat.</p> <p>Results</p> <p>Major follow-up will be performed at 3, 5 and 10 years and final study result after 15 years.</p> <p>Trial registration</p> <p>ClinicalTrials.gov NCT00662480</p

Value of routine flexible sigmoidoscopy and potential predictive factors for colonic ischemia after open ruptured abdominal aortic aneurysm repair

Background and Objectives: colonic ischemia (CI) after ruptured abdominal aortic aneurysm (rAAA) repair is associated with increased morbidity and mortality. CI may be detected by using flexible sigmoidoscopy, but routine use of flexible sigmoidoscopy after rAAA is not clearly proven. The objective of this study was to evaluate the efficacy of routine flexible sigmoidoscopy in detecting CI after rAAA repair, and to identify potential hemodynamic, biochemical, and clinical variables that can predict the development of CI in the patients who underwent rAAA surgery. Materials and Methods: we retrospectively included all rAAA cases treated in Viborg hospital from 1 April 2014 until 31 August 2017, recorded the findings on flexible sigmoidoscopy, and the incidence of CI. We collected specific hemodynamic, biochemical, and clinical variables, measured pre- and perioperatively, and the first three postoperative days. The association between CI and possible predictors was analyzed in a logistic regression model. Results: a total of 80 patients underwent open rAAA repair during the study period. Flexible sigmoidoscopy was performed in 58 of 80 patients (73.5%) who survived at least 24 h after open rAAA surgery. Perioperative variables lowest arterial pH (p = 0.02) and types of operations-aortobifemoral bypass vs. straight graft (p = 0.04) showed statistically significant differences between CI groups. The analysis of the postoperative variables showed statistically significant difference in highest lactate on postoperative day 1 (p = 0.01), and lowest hemoglobin on postoperative day 2 (p = 0.04) comparing CI groups. Logistic regression model revealed that postoperative hemoglobin and lactate turned out to be independent risk factors for the development of CI (respectively OR = 0.44 (95% CI = 0.29-0.67) and OR = 1.91 (95% CI = 1.2-3.05)). Conclusions: flexible sigmoidoscopy can identify patients being at higher risk of mortality after open rAAA repair. The postoperative lactate and hemoglobin were found to be independent risk factors for the development of CI after open rAAA repair. Further larger studies are warranted to demonstrate these findings