Vein Lesions Research Articles

Immediate postprocedure anticoagulation with factor Xa inhibitors of venous stents for nonthrombotic venous lesions does not increase stent patency

BackgroundMany clinicians will prescribe anticoagulation therapy for patients after iliac vein stenting to prevent early or late stent thrombosis. At present, it is unknown whether therapeutic anticoagulation has any effect on stent patency. Thus, we assessed the role of short-term anticoagulation on iliac vein stent patency in patients with nonthrombotic iliac vein lesions (NIVLs). MethodsWe performed a retrospective medical record review of all iliac vein stents placed for NIVLs at the Center for Vascular Medicine from January 2018 to December 2019. We compared the stent patency in the two groups. The anticoagulation (AC) group had received rivaroxaban or apixaban postoperatively for a minimum of 90 days and were compared with a group that had received no postoperative anticoagulation (NAC). Stent patency was assessed using transabdominal ultrasound at 3, 6, 12, 18, 24, and 30 months. At the discretion of the treating physician, the patients who demonstrated thrombus layering on surveillance ultrasound scanning continued rivaroxaban or apixaban until thrombus resolution was observed. The demographics and stent location, diameter, and length were assessed. Stent patency was analyzed using life table analyses. Differences in stent patency were analyzed using GraphPad Prism, version 8, statistical software (GraphPad Software Inc, La Jolla, Calif) and the log-rank (Mantel-Cox) test. ResultsThe number of patients and stents in each group were as follows: AC group, 299 patients and 308 stents; and NAC group, 77 patients and 90 stents. The average age was 52.24 ± 13.44 years and 55.63 ± 14.49 years in the AC and NAC groups, respectively (P ≤ .065). Women constituted 76% of the patients in the AC group and 72% in the NAC group. The average stent diameter and length for the AC group was 20 ± 2 mm and 77 ± 13 mm and for the NAC group was 19 ± 2 mm and 82 ± 9 mm, respectively. The stents had been placed in the right common iliac vein, bilaterally, or left common iliac vein territory in 15%, 3%, and 82% in the AC group and 18%, 2%, and 80% in the NAC group, respectively. The cumulative stent patency at 30 months was 98.7% and 94.6% for the NAC and AC groups, respectively (P ≤ .83). All the stents placed were Wallstents (Boston Scientific, Marlborough, Mass). A total of eight insertion site thromboses occurred that did not affect stent patency: five in the AC group (1.6%) and three in the NAC group (4.5%; P = .15). In addition, 19 patients demonstrated evidence of thrombus layering, with 6 receiving extended anticoagulation. ConclusionsOur data indicate that perioperative stent thrombosis in patients with NIVLs is uncommon. Thus, anticoagulation for perioperative stent thrombosis prophylaxis is not necessary. Anticoagulation should only be used for patients with insertion site thromboses and should be considered if thrombus layering is observed on surveillance scanning.

The diagnostic role of IVUS in pelvic venous disease

The two main mechanisms for pelvic venous disease (PeVD) are reflux of ovarian vein and obstruction of left common iliac or left renal vein. Some patients have a combination of the two. Adequate assessment of the location and degree of stenosis and delineation of venous anatomy are the key elements in the success of interventions to treat chronic obstructions causing PeVD. While venography is more accessible and less expensive to perform than intravascular ultrasound (IVUS), an increasing number of studies have demonstrated that IVUS is significantly more sensitive than venography in identifying stenotic lesions and real-time anatomical alterations of the affected venous segments. In this paper, we discuss the derived information and the clinical applications of IVUS during such interventions. The definitive diagnosis of PeVD can be achieved with venography combined with IVUS to evaluate for obstructive lesions in the iliac veins and compression of the left renal vein. Venography has poor sensitivity and specificity in the detection of venous stenosis. However, IVUS can detect fine intraluminal trabeculae and outside compression that can be missed with standard multiplanar venography. The IVUS can confidently confirm the persistent venous stenosis regardless of the hemodynamical alterations of venous pressure, as well. Moreover, it is possible to precisely measure the diameter of ovarian vein with IVUS. This may be helpful to decide about the diameter of the coils or the plugs needed to avoid migration. In conclusion, IVUS enables us to accurately evaluate the underlying cause of PeVD and apply a patient"s tailored treatment on table.

Iliofemoral venous stenting in patients with central neuromuscular disorders

BackgroundLeg swelling in patients with various central neuromuscular disorders is a common clinical scenario and can lead to significant morbidity. The aim of the present study was to evaluate a subset of patients with central neuromuscular disorders who had undergone iliofemoral venous stenting at a specialty venous clinic at a tertiary care hospital. MethodsFrom January 2000 to December 2020, the medical records of all patients with a known central neuromuscular disorder who had undergone iliofemoral venous stenting for chronic iliofemoral venous obstruction were retrospectively analyzed. ResultsA total of 42 patients (45 limbs) with central neuromuscular disorders had undergone iliofemoral stenting after failure of a trial of conservative therapy. The central neuromuscular disorders included Parkinson disease (n = 20 limbs), multiple sclerosis (n = 15 limbs), and other neuromuscular conditions (n = 10 limbs). The mean age of the sample was 59 ± 14 years. The ratio of post-thrombotic to nonthrombotic iliac vein lesions was 3:1. Most of the patients had had CEAP (clinical, etiologic, anatomic, pathophysiologic) class ≥C4 (64.4%); 25 limbs had a history of venous thromboembolism (56%). A trend was seen toward improvement in all clinical parameters measured (venous clinical severity score, visual analog scale for pain score, and edema grade) after stenting. An ulcer healing rate of ≤90% was noted after stenting. Of the 45 limbs, 24 had required some form of reintervention (53%) after initial stent placement. ConclusionsVenous intervention in the form of endovenous stenting was associated with improvement in the clinical parameters for patients with central neuromuscular disorders. However, these patients should be counseled regarding the relatively higher rate of reinterventions that might be required to correct residual or recurrent symptoms.

Venous Stent Patency is Independent of Total Stented Length in Nonthrombotic Iliac Vein and Post-thrombotic Venous Stenoses

Venous stenting has become the preferred treatment of symptomatic iliofemoral venous obstruction due to nonthrombotic iliac vein lesions (NIVLs) and post-thrombotic venous stenoses (PTs). A paucity of data is available regarding the effect of stent length on patency rates after intervention. We evaluated the association between stent length and patency in patients treated for iliofemoral venous outflow obstruction.

Left Retroaortic Renal Vein and Superior Mesenteric Artery Vascular Lesion Risk

To highlight the importance of preoperative assessment of imaging studies to rule out vascular abnormalities involving high bleeding risk in para-aortic lymphadenectomy for gynecological cancer.

Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction

PurposeTo assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction.Materials and MethodsTwenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included the Venous Clinical Severity Score Pain Assessment and Chronic Venous Quality-of-Life Questionnaire assessments (hypothesis tested). Secondary observations included primary patency, target vessel and lesion revascularization (TVR/TLR), and assessment of stent integrity through 36 months.ResultsFreedom from major adverse events through 30 days was 93.5%, statistically higher than a pre-specified performance goal of 89% (p = 0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p < 0.0001). Mean quality-of-life measures were statistically improved compared to baseline values at 12 months (p < 0.0001). Primary patency at 36 months was 84% (Kaplan–Meier analysis) while freedom from TVR/TLR was 88.1%. There was no stent embolization/migration, and no core laboratory assessed stent fractures reported through 36 months. Six deaths were reported; none adjudicated as device or procedure related.ConclusionThe Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the pre-specified primary outcome measures through 12 months. At 3 years, primary patency was 84%, reintervention rates were low, standardized quality-of-life and pain measures improved from baseline, and there was no stent migration or fractures.Level of EvidenceLevel 2—prospective, multicenter, controlled clinical study without a concurrent control or randomization. Pre-specified endpoints were hypothesis-tested to performance goals derived from peer-reviewed clinical literature.Registration clinicaltrials.govUnique Identifier NCT02655887.

Partial In-Stent Thrombosis After Iliac Vein Stenting in Non-Thrombotic Vein Lesions

Iliac vein stenting is a safe and efficacious procedure for the correction of iliac vein stenosis. One of its known major complications is complete iliac vein stent thrombosis. However, we have noticed in our practice that a number of patients developed only early partial in-stent (<60%) thrombosis, within the first 30 days. In order to try to learn more about these lesions, we reviewed the data for possible causes of these lesions. From September 2012 to August 2018, we obtained 3518 iliac vein venograms using intravascular ultrasound (IVUS) for patients with venous insufficiency who failed to respond to conservative therapy. Patients were followed up with transcutaneous duplex ultrasound (DUS) every 3 months for the first year and every 6 - 12 months thereafter. Patients were prescribed clopidogrel for 3 months or were told to continue their pre-existing anticoagulants. There were 2234 women and 1284 men who received an iliac vein stent. The mean age was 65.7 ±14 years. Mean follow-up for this cohort was 17 months. Of 74 patients developed a full thrombosis, 38 developed a partial venous thrombosis and 3406 developed no thrombosis. When comparing those who developed a partial thrombus versus those who developed no thrombus/full thrombus, overall age, laterality, CEAP, gender, and whether the patient received clopidogrel prior to the procedure and after the procedure were not found to be statistically significant factors. However, patients with an ASA score of 2 or 3,were found to be at a higher risk of developing a partial thrombus(P=0.0223) compared to those who had an ASA score of 1 or 4. CEAP Scores and ASA class breakdown can be seen in Table 1 and Table 2, respectively. Of the 38 partial venous thrombosis that developed,18 completely resolved within the first 3 months after the procedure and 20 remained chronic past 3 months after the procedure. Patients with partial venous thrombosis were asymptomatic upon clinical presentation, and none developed post thrombotic syndrome (PTS) or pulmonary embolism (PE). Male gender was associated with partial thrombus resolution(P=0.0036) CONCLUSIONS: Patients with ASA scores of 2 or 3, seemed to be at a higher risk of developing a partial thrombus when compared to patients with ASA score of 1 or 4. Male gender was associated with partial thrombus resolution. All other factors appear to not be statistically significant in impacting the development of a partial thrombus. This has been the first attempt to look at this new clinical entity.

Effect of Interventional Therapy on Iliac Venous Compression Syndrome Evaluated and Diagnosed by Artificial Intelligence Algorithm-Based Ultrasound Images.

In order to explore the efficacy of using artificial intelligence (AI) algorithm-based ultrasound images to diagnose iliac vein compression syndrome (IVCS) and assist clinicians in the diagnosis of diseases, the characteristics of vein imaging in patients with IVCS were summarized. After ultrasound image acquisition, the image data were preprocessed to construct a deep learning model to realize the position detection of venous compression and the recognition of benign and malignant lesions. In addition, a dataset was built for model evaluation. The data came from patients with thrombotic chronic venous disease (CVD) and deep vein thrombosis (DVT) in hospital. The image feature group of IVCS extracted by cavity convolution was the artificial intelligence algorithm imaging group, and the ultrasound images were directly taken as the control group without processing. Digital subtraction angiography (DSA) was performed to check the patient's veins one week in advance. Then, the patients were rolled into the AI algorithm imaging group and control group, and the correlation between May–Thurner syndrome (MTS) and AI algorithm imaging was analyzed based on DSA and ultrasound results. Satisfaction of intestinal venous stenosis (or occlusion) or formation of collateral circulation was used as a diagnostic index for MTS. Ultrasound showed that the AI algorithm imaging group had a higher percentage of good treatment effects than that of the control group. The call-up rate of the DMRF-convolutional neural network (CNN), precision, and accuracy were all superior to those of the control group. In addition, the degree of venous swelling of patients in the artificial intelligence algorithm imaging group was weak, the degree of pain relief was high after treatment, and the difference between the artificial intelligence algorithm imaging group and control group was statistically considerable (p < 0.005). Through grouped experiments, it was found that the construction of the AI imaging model was effective for the detection and recognition of lower extremity vein lesions in ultrasound images. To sum up, the ultrasound image evaluation and analysis using AI algorithm during MTS treatment was accurate and efficient, which laid a good foundation for future research, diagnosis, and treatment.

Early and Mid-Term Outcomes of Femoro-Ilio-Caval Vein Stent Implantation.

We sought to investigate mid-term clinical outcomes and identify risk factors in one of the largest comprehensive series reported of femoro-ilio-caval (FIC) vein stent placement. Endovascular intervention with balloon angioplasty and stenting of the iliac and common femoral veins has become first-line treatment for symptomatic deep venous outflow obstruction. We conducted a single-center, retrospective analysis of 180 patients who underwent FIC stent implantation between May 2017 and May 2019; 327 procedures were performed. Our primary objective was to evaluate a composite of stent thrombosis and stent restenosis. Secondary outcomes included individual predictors of in-stent restenosis (ISR) and in-stent thrombosis (IST), primary and secondary patency, access-site complications, major bleeding, pulmonary embolism, cardiovascular death, any death, intracranial bleeding, all-cause mortality, and components of major adverse cardiac and cerebrovascular events (MACCE) in a 24-month period. A total of 327 procedures were performed for 180 patients. At 2-year follow up, 78.3% of cases remained free of any complication. Primary outcome occurred in 53 procedures (16.2%) and was highest at early (<30 days) follow-up. Primary patency at 2-year follow-up was 78.43%. There were no deaths, 1 patient (0.3%) had a subdural hematoma, and 3 patients (0.9%) had MACCE. Age and post-thrombotic syndrome (PTS) were significant predictors of primary outcome. PTS and Venous Clinical Severity score (VCSS) ≥10 were found to have higher rates of thrombosis. Active smokers, the elderly, history of deep vein thrombosis (DVT), and VCSS ≥10 had a statistically significant elevated risk of ISR. Endovascular treatment with stent implantation for non-thrombotic iliac vein lesion and PTS is safe, with low morbidity, zero mortality, low complications, and persistent improvement of symptoms. Age and PTS were significant predictors of primary outcome.

Treatment of Nonthrombotic Iliac Vein Lesions.

Nonthrombotic iliac vein lesions (NIVLs) most frequently result from extrinsic compression of various segments of the common or external iliac vein. Patients develop symptoms associated with chronic venous insufficiency (CVI); female patients may develop symptoms of pelvic venous disease. Given that iliac vein compression can be clinically silent, a thorough history and physical examination is mandatory to exclude other causes of a patient's symptoms. Venous duplex ultrasound, insufficiency examinations, and axial imaging are most commonly used to assess for the presence of a NIVL. Catheter venography and intravascular ultrasound (IVUS) are the mainstay for invasive assessment of NIVLs and planning prior to stent placement. IVUS in particular has become the primary modality by which NIVLs are evaluated; recent evidence has clarified the lesion threshold for stent placement, which is indicated in patients with moderate to severe symptoms. In appropriately selected patients, stent placement results in improved pain, swelling, quality of life, and, when present, healing of venous stasis ulcers. Stent patency is well preserved in the majority of cases, with a low incidence of clinically driven need for reintervention. In this article, we will discuss the clinical features, workup, endovascular management, and treatment outcomes of NIVL.

MO765CENTRAL VEIN STENOSES IN HD PATIENTS

Abstract Background and Aims The prevalence of central vein stenosis (CVS) in patients on hemodialysis (HD) is difficult to be assessed directly. This is mainly caused by the variety of clinical signs and the high frequency of asymptomatic CVS. Aim: to assess the frequency of occurrence of various CVS forms in HD patients. Method The retrospective observational study is based on the results of treatment of 1865 HD patients who underwent diagnostic and therapeutic procedures on vascular access in our center. In case of vascular access dysfunction, patients were examined according to a local protocol: ultrasound of the peripheral (to exclude lesion of peripheral AVF segments) and central veins (over the available length), followed with CT-angiography or percutaneous angiography, if necessary. Results AVF/AVG dysfunction was observed in 29.4% of patients (549 of 1865). 211 patients were diagnosed with CVS. The prevalence of CVS was 11.3% (211 of 1865) among all HD patients and 38.4% (211 of 549) in patients with AVF dysfunction. Among patients with CVS, 37% (78 of 211) had vein lesions without clinical symptoms or with minimal manifestations (a tendency to decrease KT/V). The prevalence of asymptomatic CVS was 4.2% (78 of 1865) in the general population of HD patients and 14.2% (78 of 549) in patients with AVF dysfunction. In case of asymptomatic CVS it was detected by an ultrasound examination during CVC implantation (N=38), during unsuccessful attempts to implant CVC (N=29), in the case of recurrent AVF thrombosis without underlying peripheral segments lesion (N=9) or during echocardiography (N=2). The prevalence of asymptomatic CVS among patients without AVF dysfunction was 5.9% (78 of 1316). True prevalence of subclinical CVS among HD patients without obvious signs of AVF dysfunction may vary widely. A total of 48.8% (103 of 211) of all CVS cases were treated. At the same time, in 10.7% (11 of 103) of cases, patients did not present symptoms of CVS, and surgery was performed due to recurrent AVF thrombosis without damage of the peripheral parts of AVF. Patients with clinically manifest CVS who received endovascular interventions had a significantly higher risk of AVF loss compared to patients with asymptomatic CVS: HR=2.566 [95% CI 1.706; 3.86], log rank p&amp;lt;0.0001. However, patients with an asymptomatic CVS had a higher risk of AVF function loss compared to the general HD population (HR=2,051 [95% CI 1,243; 3,384], log rank p= 0.0004) – fig. 1. The use of CVC is a known risk factor of CVS development. We analyzed the relationship of CVS risk with multiply CVC placements and catheter dwell time using the Cox proportional hazards regression model (fig. 2). In the univariate model, a greater No of CVCs as well as longer time in place increased the risk of CVS. In the multivariate model (χ2=105.516, df=2, p&amp;lt;0.0001), catheter dwell time was no longer associated with an increased risk of CVC, while the mean number of inserted catheters remained an important risk factor. Conclusion The prevalence of both symptomatic and asymptomatic forms of CVS in HD patients is high. Patients with vascular access dysfunction should be carefully examined to identify the asymptomatic CVS. The mean No of catheterizations is a more important risk factor of CVS than longer catheter dwell time.

Outcomes of endovenous laser ablation with additional iliac vein stenting of nonthrombotic lesions in patients presenting with active venous ulcers

ObjectiveWe evaluated the clinical outcomes of superficial and perforator ablation and the effects on wound healing by adding iliac vein stenting of nonthrombotic iliac vein lesions (NIVLs) in patients presenting with active venous ulcers. MethodsA retrospective analysis was performed of patients who had presented with venous ulcers and had a diagnosis of NIVLs from January 2017 to December 2019. Patients with a >50% diameter reduction in the iliac vein as determined by computed tomography venography had undergone transfemoral venography for further confirmation. Patients were divided into the endovenous laser ablation (EVLA) group and EVLA with stenting (EVLAS) group. The EVLA group had undergone endovascular laser treatment of superficial venous reflux, and the EVLAS group had undergone EVLA and stenting for NIVLs. The clinical outcomes were compared between the two groups. The primary end point was cumulative ulcer healing at 12 months. The secondary end points included complications, venous clinical severity score improvements, and pain scores during the follow-up period. Univariable and multivariable regression models were used to determine the refractory ulcer predictors. ResultsA total of 157 patients were included, 93 in the EVLAS group and 64 in the EVLA group. Of the 93 patients in the EVLAS group and patients in the EVLA group, 30 (32.26%) and 17 (26.56%) had presented with iliac venous occlusion, respectively (P = .48). The mean percentage of stenosis was 78.0% ± 13.6% in EVLAS group and 77.0% ± 14.0% in the EVLA group (P = .36). No significant differences in the general preoperative data were observed between the two groups. Cumulative ulcer healing at 1 year was 86.8% and 65.6% in the EVLAS and EVLA groups, respectively (P = .001). After a mean follow-up of 22 months (median, 24 months), the EVLAS group had a significantly improved venous clinical severity score compared with the EVLA group (EVLAS group, 8.3; EVLA group, 11.7; P = .01). Multivariable analysis of the entire cohort showed that obesity and employment that requires standing were predictive of refractory ulcers and that iliac venous stent placement was a protective factor for ulcer healing. ConclusionsThe results of the present study have suggested an association between improvement in the overall success of venous leg ulcer healing when including treatment of NIVLs with stents into a treatment plan that already includes saphenous and perforator vein ablation.

Abstract No. 52 ▪ FEATURED ABSTRACT Three-year results from the prospective, multicenter VERNACULAR trial: treatment of iliofemoral venous disease with the self-expanding Venovo venous stent

To assess performance and safety of the Venovo venous stent, a self-expanding stent specifically designed for the treatment of iliofemoral vein occlusions. Investigators in the international, multicenter VERNACULAR study enrolled 170 patients—93 post-thrombotic syndrome (PTS) and 77 non-thrombotic iliac vein lesion (NIVL) —at 22 centers in the United States, Europe, and Australia. Primary endpoints were major adverse events (MAEs) through 30 days and 12-month primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and duplex-ultrasound derived stenosis >50%. Secondary outcomes included the Venous Clinical Severity Score (VCSS) Pain Assessment, Quality of Life (CIVIQ-20), target lesion revascularization (TLR), and stent fracture assessment (Yale venographic core laboratory) through 36 months. Freedom from MAEs through 30 days was 93.5%, non-inferior to a pre-specified performance goal (PG) of 89% (P = 0.032) while primary patency at 12 months was 88.3%, superior to a PG of 74% derived from the venous stent literature (P < 0.0001). Follow up at two years was 86.4% (147/170 patients). Primary patency at 24 months was 83.2% (90% CI 77.3%, 89.1%); 77.3% for the PTS subgroup and 95.2% for the NIVL patients. Primary patency estimated by Kaplan-Meier survival analysis was 84.3% for the ITT group at 760 days. The 24-month TLR rate was 10.9% resulting in a freedom from TLR of 89.4% (95% CI 83.6%, 93.7%). The mean VCSS Pain Score improved from 0.6 at 12 months to 0.4 (95% CI: 0.46, 0.74) at 24-months with an overall improvement from baseline of 1.9 (median 2.0); CIVIQ-20 scores at two years also improved (15.6 points) from baseline values. No stent fractures were observed at 12 or 24 months. 36-month follow-up is ongoing. The Venovo venous stent was deployed successfully in obstructive iliofemoral vein lesions (acute technical success: 100%). Primary patency was 88.3% at 12 months and 83.2% at 24 months. Reintervention rates were low, with no stent fractures reported through two years. Final, three-year results of the VERNACULAR Study will be presented at SIR 2021.

Comparing the efficacy of endovascular treatment for iliac vein compression syndrome with or without acute deep venous thrombosis: A single-center retrospective study.

To compare the efficacy of endovascular treatment for iliac vein compression syndrome (IVCS) with or without acute deep venous thrombosis of lower extremity. This study retrospectively analyzed the clinical data of 300 IVCS patients, who received endovascular treatment between January 2013 and December 2017. According to whether IVCS was complicated by deep venous thrombosis or not, these patients were divided into non-thrombotic iliac vein lesion group (NIVL group, n = 127) and post-thrombotic iliac vein lesion group (PIVL group, n = 173). After endovascular treatment, all patients were followed up to assess the symptoms improvement and to evaluate the patency of iliac vein. The technical success rate was 98% (294/300), and percutaneous transluminal angioplasty with stenting was adopted in 294 cases. The incidence of perioperative complications was 36.33% (109/300), but no severe complications occurred. During a mean follow-up of 22.3 months (range 6-30 months), 9(6.82%, 9/132) patients in PIVL group had recurrence of deep venous thrombosis, but nobody had deep venous thrombosis and varicose veins recurrence in NIVL group. The effective rate of endovascular treatment in NIVL group and PIVL group was 96.88% and 90.15% (P = 0.050), while the cumulative primary patency of iliac vein in NIVL group was significantly higher than that in PIVL group (P = 0.008). The endovascular treatment is an effective, feasible, safe method for treating IVCS. There is no difference in the efficacy of IVCS patients with or without deep venous thrombosis, but the medium and long-term patency of patients with deep venous thrombosis is lower than that in patients without deep venous thrombosis.

Effect of Pre-Procedure Clopidogrel With Iliac Vein Stenting in Non-Thrombotic Vein Lesions.

Iliac vein stenting is a relatively new procedure in the treatment of chronic venous insufficiency. Research has shown that it is a safe and effective form of treatment, however, one of the well-known risks is in-stent thrombosis. We hypothesize that a single 75 mg dose of Clopidogrel the night prior to the procedures along with a 3-month regimen post-op would decrease the 30-day thrombosis rate. A retrospective study was performed on 3,518 patients from September 2012 to August 2018 who received an iliofemoral stent. Patients were broken down into 2 main groups: those given Clopidogrel post-stent and those given Clopidogrel both pre- and post-stent. In our practice, we prescribe a 3-month course of Clopidogrel after iliac vein stenting. Patients were also checked for any anticoagulant medications pre- and/or post-stent. The 30-day thrombosis rates were recorded for each patient. 1,205 patients received Clopidogrel pre-procedurally and post-procedurally, 1,941 patients received Clopidogrel only post-procedurally. 372 patients were excluded from the study because they were on other anti-coagulant medications. Mean follow-up for this cohort was 17 months. 112 total patients developed some degree of 30 day in-stent thrombosis (3.6%). 74 patients developed a complete thrombosis of the stent and 38 developed a partial (≤60% occlusion) thrombosis. Of the 1,205 patients who were on clopidogrel pre-stenting, 28 had a complete thrombosis and 10 had a partial in-stent thrombosis. Of the 1,941 patients on Clopidogrel only post-stenting, 46 had a complete thrombosis and 28 had a partial in-stent thrombosis. Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day any degree of thrombosis rates (complete and partial thrombosis) (p = .33). Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day complete thrombosis rates (p = .93). There appears to be no statistical difference in 30-day thrombosis rates between those receiving Clopidogrel the night prior vs. those who do not receive Clopidogrel the night prior. Therefore, we conclude that it is not necessary to give this single dose the night prior to iliac vein stenting procedures.

DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers

BackgroundVenous leg ulceration is a widespread, debilitating pathology with high recurrence rates. Conservative treatment using graduated compression dressings may be associated with unacceptable ulcer recurrence rates. Early superficial venous ablation encourages ulcer healing and reduces recurrence. However, many of this cohort display concomitant ilio-caval stenosis, which further contributes to lower limb venous hypertension and ulceration.An approach that combines early superficial venous ablation with early treatment of ilio-caval stenotic disease may significantly improve ulcer healing and recurrence rates. We question whether early iliac vein interrogation with intravascular ultrasound (IVUS), stenting of significant occlusive disease plus superficial venous ablation, in patients with active venous leg ulceration, will produce superior ulcer healing to standard therapy.MethodsThis is a prospective, multi-centre, randomised controlled, feasibility trial recruiting patients with lower limb venous ulceration and saphenous venous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (> 50%) iliac vein lesions plus compression therapy. The primary feasibility outcome will be the rate of eligible patient participation while the primary clinical outcomes will be ulcer healing and procedural safety. Secondary outcomes include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow-up will be over a 5-year period. This feasibility trial is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the trial to definitively address ulcer-healing rates.DiscussionThis trial will be the first randomised trial to examine the role iliac interrogation and intervention in conjunction with standard operative therapy in the management of venous ulceration related to superficial truncal venous incompetence.Ethical committee referenceC.A. 2111 Galway Clinical Research Ethics CommitteeRegistrationClinical Trials.gov registration NCT03640689, Registered on 21 August 2018.

Clinical symptoms and signs and severity of venous disease are not associated with non-thrombotic iliac vein lesions in patients with primary varicose veins

Introduction and purpose. The purpose of this study was to determine relationship between non-thrombotic iliac vein lesions and symptomatology of primary varicose veins (PVV). The identification of such association would be helpful in selecting patients with PVV for further diagnostic evaluation. Material and methods. Thirty-two patients with unilateral PVV scheduled for great saphenous vein high ligation and stripping were enrolled in the study. There were 25 (78%) women. The mean age of the patients was 48 years. The patients were asked about pain, oedema, night cramps, heaviness and a history of superficial thrombophlebitis in PVV limb. A clinical stage of CEAP classification was determined and Venous Clinical Severity Score (VCSS) was calculated. During the surgery right and left iliac venous axes were interrogated with an intravascular ultrasound with Volcano s5 Imaging System (Volcano Corporation, Rancho Cordova, CA, USA) and catheters Visions PV .035 minimal lumen area (MLA) and percentage of stenosis (%S) of examined veins were calculated. An association between clinical symptoms and signs in PVV limb and %S of ipsilateral common iliac vein (CIV) and external iliac vein (EIV) was statistically analysed. Results. Pain, oedema, night cramps, heaviness and history of superficial thrombophlebitis were reported by 14 (44%), 17 (53%), 11 (34%), 19 (59%) and 6 (19%) of patients respectively. Twenty-five (78%) limbs were classified as C2 and 7 (22%) limbs as C4a according to CEAP classification. The median VCSS was 4. The mean MLA and %S was 92,9 mm2 and 47% and 74,2 mm2 and 48% for CIV and EIV respectively. Neither smaller MLA nor greater %S of CIV and EIV were associated with symptoms, more advanced stage of CEAP classification or higher VCSS. Conclusions. Neither clinical symptoms nor severity of venous disease can identify non-thrombotic iliac vein lesions in patients with primary varicose veins.

The pericyte: A critical cell in the pathogenesis of CADASIL.

Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is a hereditary small vessel disease presenting with migraine, mood and cognitive disorders, focal neurological deficits, recurrent ischemic attacks, lacunar infarcts and brain white matter changes. As they age, CADASIL patients invariably develop cognitive impairment and subcortical dementia. CADASIL is caused by missense mutations in the NOTCH3 gene resulting in a profound cerebral vasculopathy affecting primarily arterial vascular smooth muscle cells, which target the microcirculation and perfusion. Based on a thorough review of morphological lesions in arteries, veins, and capillaries in CADASIL, we surmise that arteriolar and capillary pericyte damage or deficiency appears a key feature in the pathogenesis of the disease. This may affect critical pericyte-endothelial interactions causing stroke injury and vasomotor disturbances. Changes in microvascular permeability due to perhaps localized blood-brain barrier alterations and pericyte secretory dysfunction likely contribute to delayed neuronal as well as glial cell death. Moreover, pericyte-mediated cerebral venous insufficiency may explain white matter lesions and the dilatation of Virchow-Robin perivascular spaces typical of CADASIL. The postulated central role of the pericyte offers some novel approaches to the study and treatment of CADASIL and enable elucidation of other forms of cerebral small vessel diseases and subcortical vascular dementia.

Case of endovenectomy and stenting with functioning arteriovenous fistula in extended post-thrombotic occlusion of deep veins

We describe herein a case of surgical treatment of a 32-year-old female patient presenting with multilevel post-thrombotic occlusion of deep veins of the left lower limb. Laboratory study revealed high-risk hereditary thrombophilia (homozygous mutation of PAI-1, MTR, heterozygous mutation of MTHFR, MTRR, ITGA2). The first stage included endovenectomy from the common femoral vein with creation of an arteriovenous fistula between femoral vessels. An attempt of endovascular stenting of iliac veins was initially unsuccessful. After 3 months, the woman was rehospitalized to undergo successful endovascular operation with stenting of the iliac veins and common femoral artery on the background of the functioning arteriovenous fistula. The clinical outcome of the operation was good. Follow-up ultrasonographic examinations (ultrasound duplex scanning) were performed at 3, 6, 10 and 13 months after the second operation. The findings of ultrasound duplex scanning at 13 months showed that the stented segments of deep veins were freely patent, with the arteriovenous fistula functioning well. There were no signs of impairments of central haemodynamics, with significant regression of clinical symptoms. The total score by the Villalta scale as compared with the baseline values decreased from 13 to 5. Given the pattern of deep vein lesions, complexity of open and endovascular operations, and the presence of thrombophilia, we decided to abstain from disuniting the arteriovenous fistula. This case report demonstrates possibility, efficacy and safety of long functioning of an artificial arteriovenous fistula in a particular patient cohort.

Complete transmural epicardial ablation reduces organized areas in atrial fibrillation

Abstract Background The surgical maze is suggested to be effective in persistent atrial fibrillation (AF) by reducing the area for fibrillatory wavelets. However, the mechanism for recurrence and next treatment steps are unclear. Purpose We set out to evaluate the impact of complete transmural epicardial maze lesion sets on the extent atrial organization using novel analyses of wide-area recordings of AF. Methods 19 patients (age 50.9±12.0, 78% male) underwent maze followed by endocardial mapping of AF with a 64-pole basket catheter. Block across roof, floor, and pulmonary vein lesions sets was assessed by high-density voltage mapping and organized zones of AF were assessed by panoramic recordings. Total organized area and mean area of the dominant site were evaluated using automated custom scripts. Results Patients had 3.2±0.9 organized regions in 1 minute of LA recordings. A 54 yo F showed residual conduction to the posterior wall from the roof (purple, Fig. 1A) and a figure-of-8 propagation pattern during AF (arrows, fig B) which terminated with localized ablation (yellow lesions, Fig. 1A, red X, Fig. 1B). Overall, patients with complete block on epicardial lesion set had smaller areas of organization (13.7±8% vs. 45.7±32% of mapped areas, p=0.029) vs. those with gaps. The average size of the dominant area was smaller with complete transmural lines than with gaps (5.7±3% vs. 15.9±10%, p=0.033) (Fig. 1C). Conclusion These results show that complete transmural lesion sets constrain the critical mass available for AF, with smaller resulting organized zones. Future studies that quantify how partitioning the atrial surface affects AF may help personalize lesion sets after maze. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): NIH NRSA F32 United States