Commentary

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Optical Coherence Tomography after Carotid Stenting: Rate of Stent Malapposition, Plaque Prolapse and Fibrous Cap Rupture According to Stent Design

ObjectivesThis study aims to evaluate the rate of stent malapposition, plaque prolapse and fibrous cap rupture detected by optical coherence tomography (OCT) imaging according to carotid stent design.DesignIt was a prospective single-centre study.Materials and methodsForty consecutive patients undergoing protected carotid artery stenting (CAS) and high-definition OCT image acquisition were enrolled in the study. OCT frames were analysed off-line, in a dedicated core laboratory by two independent physicians. Cross-sectional OCT images within the stented segment of the internal carotid artery were evaluated at 1-mm intervals for the presence of strut malapposition, plaque prolapse and fibrous cap rupture according to stent design.ResultsClosed-cell design stents (CC) were used in 17 patients (42.5%), open-cell design stents (OC) in 13 (32.5%) and hybrid design stents (Hyb) in 10 (25%). No procedural or post-procedural neurological complications occurred (stroke/death 0% at 30 days). On OCT analysis the frequencies of malapposed struts were higher with CC compared to OC and Hyb (34.5% vs 15% and 16.3%, respectively; p < 0.01). Plaque prolapse was more frequent with OC vs CC (68.6% vs 23.3%; p < 0.01) and vs Hyb stents (30.8%; p < 0.01). Significant differences were also noted in the rates of fibrous cap rupture between CC and OC (24.2% vs 43.8%; p < 0.01), and between CC and Hyb (24.2% vs 39.6%; p < 0.01), but not between OC and Hyb stents (p = 0.4).ConclusionIntravascular OCT after CAS revealed that micro-defects after stent deployment are frequent and are related to the design of implanted stents. Stent malapposition is more frequent with CC stents, while plaque prolapse is more common with OC stents.It remains, however, unknown whether these figures now detected with OCT are of any clinical and prognostic significance

Surveillance imaging modality does not affect detection rate of asymptomatic secondary interventions following EVAR.

OBJECTIVES: Literature reports that surveillance imaging following endovascular aortic aneurysm repair (EVAR) gives rise to asymptomatic secondary interventions (SI) in 1.4-9% of cases. This retrospective study aimed to evaluate whether the modality of surveillance imaging influences the detection rate of asymptomatic SI. MATERIALS AND METHODS: Two EVAR surveillance protocols were compared at the same vascular centre. Protocol I, performed from January 2003 to December 2006, consisted of colour duplex ultrasound scan (CDU) plus CT angiography (CTA) 1 month after procedure and every 6 months thereafter. Protocol II, performed from January 2007 to June 2010, consisted of CDU plus CTA 1 month after operation and CDU plus plain abdominal films (XR) every 6 months thereafter. In the second protocol, CTA was carried out only during follow-up in specific conditions. The term 'asymptomatic SI' was used when the necessity for SI was detected by imaging alone on an elective basis, prior to development of any symptoms. RESULTS: Enrolment included 376 and 341 consecutive patients with a mean follow-up of 1148 days (range 1-3204 days) and 942 days (range1-1512 days) in Protocols I and II, respectively (p < 0.001). Freedom rates from aneurysmal rupture, freedom from SI and detection rate for asymptomatic SI at 3 years were 98.3% and 98.7% (p = 0.456), 82% and 83.5%(p = 0.876) and 8.8% (n = 33/376) and 8.5%(n = 25/341) (p = 0.49) in Protocols I and II, respectively. Estimated comparison of the costs, radiation exposure and contrast used at 3 years in Protocol I versus Protocol II showed that Protocol II allowed for a three-, four- and six fold reduction in overall costs, radiation exposure and contrast used, respectively (p < 0.0001). CONCLUSIONS: The detection rate of asymptomatic SI following EVAR is not affected by the type of surveillance imaging. A surveillance schedule based primarily on CDU and XR appears to be justified

Does Free Cell Area Influence the Outcome in Carotid Artery Stenting?

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Editor's Choice - Carotid Stenosis Treatment : Variation in International Practice Patterns

Objectives: The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR). Methods: Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country. Results: Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7). Conclusions: Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world. (C) 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.Peer reviewe

Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis

Background: Single-cohort studies suggest that second-generation stents (SGS; “mesh stents”) may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p &lt; 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p &lt; 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p &lt; 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p &lt; 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p &lt; 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a “mesh stent” class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials

Treatment of peripheral arterial disease in diabetes: a consensus of the Italian Societies of Diabetes (SID, AMD), Radiology (SIRM) and Vascular Endovascular Surgery (SICVE).

AbstractDiabetic foot (DF) is a chronic and highly disabling complication of diabetes. The prevalence of peripheral arterial disease (PAD) is high in diabetic patients and, associated or not with peripheral neuropathy (PN), can be found in 50% of cases of DF. It is worth pointing out that the number of major amputations in diabetic patients is still very high. Many PAD diabetic patients are not revascularised due to lack of technical expertise or, even worse, negative beliefs because of poor experience. This despite the progress obtained in the techniques of distal revascularisation that nowadays allow to reopen distal arteries of the leg and foot. Italy has one of the lowest prevalence rates of major amputations in Europe, and has a long tradition in the field of limb salvage by means of an aggressive approach in debridement, antibiotic therapy and distal revascularisation. Therefore, we believe it is appropriate to produce a consensus document concerning the treatment of PAD and limb salvage in diabetic patients, based on the Italian experience in this field, to share with the scientific community

Chapter VI: Follow-up after Revascularisation

AbstractStructured follow-up after revascularisation for chronic critical limb ischaemia (CLI) aims at sustained treatment success and continued best patient care. Thereby, efforts need to address three fundamental domains: (A) best medical therapy, both to protect the arterial reconstruction locally and to reduce atherosclerotic burden systemically; (B) surveillance of the arterial reconstruction; and (C) timely initiation of repeat interventions. As most CLI patients are elderly and frail, sustained resolution of CLI and preserved ambulatory capacity may decide over independent living and overall prognosis. Despite this importance, previous guidelines have largely ignored follow-up after CLI; arguably because of a striking lack of evidence and because of a widespread assumption that, in the context of CLI, efficacy of initial revascularisation will determine prognosis during the short remaining life expectancy. This chapter of the current CLI guidelines aims to challenge this disposition and to recommend evidentially best clinical practice by critically appraising available evidence in all of the above domains, including antiplatelet and antithrombotic therapy, clinical surveillance, use of duplex ultrasound, and indications for and preferred type of repeat interventions for failing and failed reconstructions. However, as corresponding studies are rarely performed among CLI patients specifically, evidence has to be consulted that derives from expanded patient populations. Therefore, most recommendations are based on extrapolations or subgroup analyses, which leads to an almost systematic degradation of their strength. Endovascular reconstruction and surgical bypass are considered separately, as are specific contexts such as diabetes or renal failure; and critical issues are highlighted throughout to inform future studies

The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

<p>Abstract</p> <p>Background</p> <p>A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN^®" for the treatment of neuropathic pain.</p> <p>Methods</p> <p>Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN^®or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale.</p> <p>Results</p> <p>There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN^®led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN^®reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN^®group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed.</p> <p>Conclusions</p> <p>This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN^®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief.</p> <p>Trial registration</p> <p><b>ISRCTN registered: </b>ISRCTN13226601</p