European and US guidelines on acute DVT management.

Acute deep venous thrombosis (DVT) is a common health problem, affecting millions of patients in Europe and the United States annually. Europe and US national clinical practice guidelines are formulated by evaluation of the available scientific evidence, with expert opinion to create pragmatic guidance for the optimal patient management, representing the best available knowledge at the time of publication, and providing the best evidence-based recommendations for vascular patient care and venous pathologies. We here focus on the novel recommendations proposed by European and US guidelines for acute DVT, denoting main differences between the two panels. This review gives vascular surgeons the opportunity to identify the key points of the two largest Vascular Committees guidelines, in order to use them and offer their best individualized treatment approach to the specific patient's anatomy, lesion, and history.

Quantifying Carotid Stenosis: History, Current Applications, Limitations, and Potential: How Imaging Is Changing the Scenario.

Carotid artery stenosis is a major cause of morbidity and mortality. The journey to understanding carotid disease has developed over time and radiology has a pivotal role in diagnosis, risk stratification and therapeutic management. This paper reviews the history of diagnostic imaging in carotid disease, its evolution towards its current applications in the clinical and research fields, and the potential of new technologies to aid clinicians in identifying the disease and tailoring medical and surgical treatment.

Carotid Plaque-RADS: A Novel Stroke Risk Classification System.

BACKGROUND: Carotid artery atherosclerosis is highly prevalent in the general population and is a well-established risk factor for acute ischemic stroke. Although the morphological characteristics of vulnerable plaques are well recognized, there is a lack of consensus in reporting and interpreting carotid plaque features. OBJECTIVES: The aim of this paper is to establish a consistent and comprehensive approach for imaging and reporting carotid plaque by introducing the Plaque-RADS (Reporting and Data System) score. METHODS: A panel of experts recognized the necessity to develop a classification system for carotid plaque and its defining characteristics. Using a multimodality analysis approach, the Plaque-RADS categories were established through consensus, drawing on existing published reports. RESULTS: The authors present a universal classification that is applicable to both researchers and clinicians. The Plaque-RADS score offers a morphological assessment in addition to the prevailing quantitative parameter of "stenosis." The Plaque-RADS score spans from grade 1 (indicating complete absence of plaque) to grade 4 (representing complicated plaque). Accompanying visual examples are included to facilitate a clear understanding of the Plaque-RADS categories. CONCLUSIONS: Plaque-RADS is a standardized and reliable system of reporting carotid plaque composition and morphology via different imaging modalities, such as ultrasound, computed tomography, and magnetic resonance imaging. This scoring system has the potential to help in the precise identification of patients who may benefit from exclusive medical intervention and those who require alternative treatments, thereby enhancing patient care. A standardized lexicon and structured reporting promise to enhance communication between radiologists, referring clinicians, and scientists.

An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Current Clinical Knowledge on GORE EXCLUDER Conformable Abdominal Aortic Aneurysm Repair Endoprosthesis: A Case Series and Literature Review.

The GORE EXCLUDER Conformable abdominal aortic aneurysm (AAA) Endoprosthesis (CEXC), is currently the newest stent-graft system for treating patients with AAA. CEXC is approved for patients with proximal aortic neck angles ≤90° with a ≥15 mm aortic neck length or proximal aortic neck angles ≤60° with ≥10 mm aortic neck length. The present study describes a clinical series of 5 males with AAA, one of whom had a ruptured infrarenal AAA and a 90° proximal aortic neck angle. All patients were treated with 100% technical success using the CEXC device. Dosimetric data were recorded regarding the total kerma-area product and total fluoroscopy time. During the 30-day follow-up, no device migration or failure was detected, whereas type Ib and II endoleaks were observed in two patients. The type Ib endoleak required re-intervention with limb extension placement, and the type II endoleak was treated with lumbar artery embolization. This clinical series showed that CEXC has no technical defects or AAA-related mortality. We also reviewed the current knowledge on CEXC's clinical outcomes, showing promising technical and clinical results in some studies, even outside the instructions for use. CEXC expands the vascular surgeons' armamentarium against hostile neck anatomy, as it is the only repositionable endovascular aneurysm repair device available. Multicenter, long-term outcome studies should confirm the promising preliminary results of our case series and the literature review.

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

BMI-Based organ doses in endovascular aneurysm repair interventions utilising Monte Carlo simulation.

In this study, the effect of body-mass-index (BMI) on organ doses (ODs) during infrarenal endovascular-aneurysm-repair (EVAR) procedures was evaluated. Patient- and intra-operative data from fifty-nine EVAR procedures were inserted into VirtualDose-IR software to calculate ODs. For overweight, obesity class-I and obesity class-II, ODs were up to 147%, 412% and 775% higher than those for normal weight-patients, respectively. A large variation was observed in ODs published in literature mainly due to the differences in the software and the technical parameters used for the calculations.

FACTORS INFLUENCING FLUOROSCOPY TIME IN ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSMS: A RETROSPECTIVE STUDY.

Patients who undergo endovascular aortic aneurysm repair (EVAR) may require prolonged radiation exposure affected by several factors. The objectives of this study were to document fluoroscopy time (FT) during EVAR and identify possible factors that influence it. A retrospective analysis of a 180 patients' database with abdominal infrarenal aortic aneurysms submitted to EVAR during a 7-y period was performed. The FT is evaluated regarding risk factors and comorbidities, graft type and patient-related, clinical and technical parameters. FT's median (interquartile range) was 1011 (698-1500) s. Excluder and C3 Excluder were associated with significantly lower FT values when compared with other grafts. Hypertension, dyslipidemia, age ≥ 70 y, maximum aneurysm diameter ≥ 6 cm and procedure duration ≥2 h resulted in higher FT values. A significantly lower FT was found for the operations performed in the 7th y of the study's period compared with the previous 6 y, mainly because of the use of Excluder or C3 Excluder grafts. However, these grafts did not show any significant difference in FT values during the 7 y. A significant correlation between FT with age and procedure duration was found. Nevertheless, procedure duration is a poor FT predictor in linear and logistic regressions, although is significantly correlated with FT. Dyslipidemia, procedure duration and graft type are independent predictors of FT larger than the median, whereas only the procedure duration is a predictor for FT larger than the 75th percentile value. The identified factors regarding radiation protection issues should be considered when contemplating abdominal aortic aneurysm repair, however, without compromising the procedure's efficacy. Further work is necessary to identify more potential anatomical, clinical and technical factors affecting procedures' complexity and FT and patient radiation dose during EVAR interventions.

Vascular handlebar syndrome with blunt injury of common femoral artery.

Vascular handlebar syndrome with blunt injury of the common femoral artery is a rare vascular trauma mechanism, with high possibility of being missed or delayed. We present two cases of vascular handlebar syndrome treated in our hospital and a systematic review of the literature using MEDLINE and SCOPUS databases. Literature review identified 20 similar cases. The median age of patients was 18 years, and in vast majority males in gender. In most cases, the common femoral artery injury was an intimal flap and lumen occlusion with intramural thrombosis followed by transection and intimal injury without occlusion or thrombosis. The median time between injury and diagnosis/treatment was half an hour. Clinical presentation ranged from asymptomatic to acute limb ischemia. The grade of acute ischemia was mostly Rutherford class I (n=14), while acute IIa (n=4), chronic ischemia (n=3), and no ischemia (n=1) were also noticed. The correct diagnosis was revealed by clinical examination only (n=1), or by the combination of clinical and imaging techniques including computed tomography angiography (n=7) and duplex ultrasonography (n=4) or both (n=10). Management of the handlebar trauma syndrome injuries was surgical in most cases. Outcome was favorable in all patients. Vascular handlebar syndrome is extremely rare and high suspicion is required for early diagnosis and definitive treatment, as the early management is effective and crucial for averting the devastating consequences. An individualized approach to the vascular trauma patient is to be applied with considerations taken to the age of the patient, the mechanism of the injury, the anatomy of the lesion, and symptomatology of the case.

Risk of recurrent thromboembolic events according to treatment duration in patients with superficial vein thrombosis treated with intermediate dose of tinzaparin.

OBJECTIVES: To evaluate the risk of symptomatic venous thromboembolism (VTE) recurrence at 3 months in relation to treatment duration, according to baseline risk factor profiles, in patients with superficial vein thrombosis (SVT) treated with intermediate dose of tinzaparin. METHODS: We performed a pooled analysis on individual data from two prospective studies designed to assess the efficacy and safety of tinzaparin in intermediate dose (131 IU/kg) in patients with SVT. Treatment duration was at the treating physician's discretion. All patients were followed up for at least 3 months. RESULTS: A total of 956 patients (65% female, mean age 58.7 ± 13.7 years) were included. The median treatment duration was 30 days (range, 3-200 days). History of deep vein thrombosis (DVT), location of SVT above the knee, and palpable induration were the only independent factors associated with prolonged treatment duration. During follow-up, 95.9% of patients were event free. Outcomes-related adverse events occurred in 39 (4.1%) patients and their median duration of treatment was 33 days (range, 7-200 days). Recurrent VTE events occurred in 33 patients, including 22 cases of SVT recurrence, 8 cases of DVT, and 1 case of pulmonary embolism. The median time to the event was 29 (6-113) days. Recurrent thromboembolic events were not related to treatment duration as occurred in 17 patients (51.5%) treated up to 30 days and in 16 patients (48.8%) received prolong treatment (p = .46). Length of thrombus at the index event was significantly associated with higher risk for VTE recurrence. CONCLUSIONS: Intermediate dose of tinzaparin for 30 days is an effective and safe treatment for SVT. The risk of recurrent VTE events may be higher in patients with greater amount of thrombus at index event.

Why do guidelines recommend screening for abdominal aortic aneurysms, but not for asymptomatic carotid stenosis? A plea for a randomized controlled trial.

BACKGROUND: Current guidelines do not recommend screening for asymptomatic carotid artery stenosis (AsxCS). The rationale behind this recommendation is that detection of AsxCS may lead to an unnecessary carotid intervention. In contrast, screening for abdominal aortic aneurysms is strongly recommended. METHODS: A critical analysis of the literature was performed to evaluate the implications of detecting AsxCS. RESULTS: Patients with AsxCS are at high risk for future stroke, myocardial infarction and vascular death. Population-wide screening for AsxCS should not be recommended. Additionally, screening of high-risk individuals for AsxCS with the purpose of identifying candidates for a carotid intervention is inappropriate. Instead, selective screening for AsxCS should be considered and should be viewed as an opportunity to identify individuals at high risk for atherosclerotic cardiovascular disease and future cardiovascular events for the timely initiation of intensive medical therapy and risk factor modification. CONCLUSIONS: Although mass screening should not be recommended, there are several arguments suggesting that selective screening for AsxCS should be considered. The rationale supporting such selective screening is to optimize risk factor control and to initiate intensive medical therapy for prevention of future cardiovascular events, rather than to identify candidates for an intervention.