Novel Oral Anticoagulants in Peripheral Artery Disease: Current Evidence.

BACKGROUND: Peripheral artery disease is a common manifestation of systemic atherosclerosis which strongly correlates to cardiovascular morbidity and mortality. In addition, the progression of peripheral artery disease leads to an increased risk of limb loss. In order to reduce these events, the benchmark of treatment and research over the last years has been the antiplatelet therapy which aims at inhibition of platelet aggregation. Over the last years, new studies combining antiplatelet agents in different therapeutic schemes have been proven efficacious. Unfortunately, patients remain still at high risk of CV events. Novel Oral Anticoagulants have been introduced as alternatives to warfarin, in the prevention and treatment of venous thromboembolism. The rationale of using medication which acts on platelet activation and the coagulation pathway of thrombosis has led investigators to examine the role of Noac's in preventing CV events in patients with peripheral artery disease, stable or unstable. METHODS: The aim of this study is to review the current evidence with respect to recently published studies concerning the use of Novel anticoagulants in peripheral artery disease. RESULTS: The Compass trial has shown that a combination of rivaroxaban with traditional therapy may produce promising results in reducing amputation rates, stroke, cardiac events, and mortality, however, there are still safety issues with bleeding requiring acute care. The ePAD study has provided us with insight concerning safety and efficacy after peripheral angioplasty or stenting and actually the need for further research. The Voyager Pad study, following the steps of Compass, is studying the effect and safety of the addition of rivaroxaban to traditional therapy in the highest risk population aka patients undergoing peripheral revascularization. The evidence concerning patients with concomitant atrial fibrillation appears to be insufficient, however, recent guidelines propose the use of novel oral anticoagulants. CONCLUSION: For the time being, novel oral anticoagulants in combination with aspirin may provide an alternative treatment in PAD, however, it is deemed necessary to identify patient subgroups who will benefit the most.

Lack of evidence for use of heparin-bonded grafts in access surgery: a meta-analysis.

The aim of this study was to evaluate the efficacy of heparin-bonded vascular grafts to offer improved outcomes compared with standard prosthetic grafts in access surgery. A systematic review and meta-analysis was performed and eight studies (seven observational studies and one randomized controlled trial) were included. The pooled 6-month and 1-year primary patency was not significantly different between heparin-bonded arteriovenous (AV) grafts and standard prosthetic AV grafts in seven studies reporting on 1,209 access procedures. The assisted primary patency and secondary patency at 1-year was not significantly different either. Heparin-bonded AV grafts offer no distinct advantage over standard prosthetic AV grafts and their preferential use in access surgery cannot be recommended based on the available evidence.

The Necessity for Routine Pre-operative Ultrasound Mapping Before Arteriovenous Fistula Creation: A Meta-analysis.

OBJECTIVE/BACKGROUND: Existing guidelines suggest routine use of pre-operative color Doppler ultrasound (DUS) vessel mapping before the creation of arteriovenous fistulae (AVF); however, there is controversy about its benefit over traditional clinical examination or selective ultrasound use. METHODS: This was a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing routine DUS mapping before the creation of AVF with patients for whom the decision for AVF placement was based on clinical examination and selective ultrasound use. A search of MEDLINE/PubMed, SCOPUS, and the Cochrane Library was carried out in June 2014. The analyzed outcome measures were the immediate failure rate and the early/midterm adequacy of the fistula for hemodialysis. Additionally, assessment of the methodological quality of the included studies was carried out. RESULTS: Five studies (574 patients) were analyzed. A random effects model was used to pool the data. The pooled odds ratio (OR) for the immediate failure rate was 0.32 (95% confidence interval [CI] 0.17-0.60; p < .01), which was significantly in favor of the DUS mapping group. The pooled OR for the early/midterm adequacy for hemodialysis was 0.66 (95% CI 0.42-1.03; p = .06), with a trend in favor of the DUS mapping group; however, subgroup analysis revealed that routine DUS mapping was more beneficial than selective DUS (p < .05). CONCLUSION: The available evidence, based mainly on moderate quality RCTs, suggests that the pre-operative clinical examination should always be supplemented with routine DUS mapping before AVF creation. This policy avoids negative surgical explorations and significantly reduces the immediate AVF failure rate.

Computational estimation of the influence of the main body-to-iliac limb length ratio on the displacement forces acting on an aortic endograft. Theoretical application to Bolton Treovance® Abdominal Stent-Graft.

AIM: The influence of the relative iliac limb length of an endograft (EG) on the displacements forces (DF) predisposing to adverse effects are under-appreciated in the literature. Therefore, we conducted a computational study to estimate the magnitude of the DF acting over an entire reconstructed EG and its counterparts for a range of main body-to-iliac limb length (L1/L2) ratios. METHODS: A customary bifurcated 3D model was computationally created and meshed using the commercially available ANSYS ICEM (Ansys Inc., Canonsburg, PA, USA) software. Accordingly, Fluid Structure Interaction was used to estimate the DF. The total length of the EG was kept constant, while the L1/L2 ratio ranged from 0.3 to 1.5. RESULTS: The increase in L1/L2 slightly affected the DF on the EG (ranging from 3.8 to 4.1 N) and its bifurcation (4.0 to 4.6 N). However, the forces exerted at the iliac sites were strongly affected by the L1/L2 values (ranging from 0.9 to 2.2 N), showing a parabolic pattern with a minimum for 0.6 ratio. CONCLUSION: It is suggested that the hemodynamic effect of the relative limb lengths should not be considered negligible. A high main body-to-iliac limb length ratio seems to favor hemodynamically a low bifurcation but it attenuates the main body-iliac limbs modular stability. Further clinical studies should investigate the relevant value of these findings. The Bolton Treovance(®) device is presented as a representative, improved stent-graft design that takes into account these hemodynamic parameters in order to achieve a promising, improved clinical performance.

The hemodynamic impact of misalignment of fenestrated endografts: a computational study.

OBJECTIVE: The hemodynamic consequences of misaligned stent-grafts (SG) in fenestrated endografts (EG) have not been adequately studied. Our aim was to study the hemodynamic effects of positional variations of SG, investigating the potential influence on the total displacement forces acting on the EG and the shear stress values at the stented segments. METHODS: This was a computational study. An idealized EG model with two renal fenestrations was computationally reconstructed and centrally extended up to the suprarenal level to treat a suprarenal aneurysm. The misalignment of SG was represented by a variable take-off angle between the SG and the EG centerline axis, corresponding to angles of 90°, 176°, 142°, 38°, and 4°, respectively. Accordingly, the maximum EG displacement forces and the shear stress within the stented segments were calculated, using commercially available software. RESULTS: The variable positions of the SG caused no effect on the maximum displacement force acting on the EG, being quite steady and equal to 5.55 N. On the contrary, the values of maximum shear stress acting on the stented segments were influenced by their orientation. The narrow transition zone between the distal end of the mating stent and the target artery showed higher stresses than any other segment. The right-angle take off SG position (90°) was associated with the lowest stresses (12.5 Pa), whereas the highest values were detected at 38° and 142° (16.5 and 16.1 Pa, respectively). The vessel segments distal to the SG exhibited constantly lower stress values (1.9-2.2 Pa) than any other segment. CONCLUSION: We detected differences in the values of shear stress exerted on the stented arteries, depending on different positions that SG can adapt after the deployment of fenestrated EG. The pathophysiologic implication of our findings and their potential association with clinical events deserve further investigation and clinical validation.