Journal of vascular surgery. Venous and lymphatic disorders最新文献

Objective: Demonstrate the effectiveness of complex decongestive therapy (CDT) in patients with chronic venous insufficiency (CVI).

Methods: Asingle-blind randomized controlled trial was conducted, where he participants were subjects with CVI (N= 21/42) that were randomly assigned to an experimental group (N= 11/22) or control group (N=9/18). A treatment of CDT (manual lymphatic drainage (MDL), intermittent pneumatic presotherapy (IPP), bilayer bandage (BB)) was applied to the experimental group for 4 weeks two days per week and no treatment was applied to the control group. The patients were evaluated at baseline (t0), 1 week after finishing the intervention (t1) and 6 weeks after the intervention (t2). The effectiveness of the treatment on symptoms and QoL (haviness, pain and CIVIQ-20 questionary), edema, venous flow (VF) and impedanciometry measurements was evaluated.

Results: An improvement in the patient's QoL was observed: there was a decrease in symptoms such as heaviness and pain, an increase in the average velocity of the left femoral vein (LFV) and left internal saphenous vein (LISV), a decrease in the internal saphenous vein diameter (ISVD) in both extremities and a decrease in body mass index and fat mass (FM) in both extremities. These results were maintained when following up at 6 weeks, except for the improvement of QoL.

Conclusion: CDT treatment improves the QoL of patients with CVI (CIVIQ-20, VCSS). It also improves symptoms (pain and heaviness), VF velocity (superficial veins [ISV] and deep veins [common femoral vein (CFV), femoral vein (FV), popliteal vein (PV)] and decreases body mass index (BMI), fat mass (FM) and ISVD.

Objective: Patients with mixed-type lower extremity deep vein thrombosis (LEDVT) have a higher incidence of post-thrombotic syndrome (PTS) following endovascular treatment (EVT). This study aimed to identify risk factors associated with PTS in these patients post-EVT.

Methods: This retrospective study included patients diagnosed with acute mixed-type LEDVT who underwent EVT between January 2020 and December 2022. Patient assessments were conducted using ultrasound and the Villalta scale. Baseline characteristics, management details, and follow-up findings were compared between patients who developed PTS and those who did not at six months after EVT. Cox regression and nomogram analyses were performed to identify risk factors associated with the development of PTS.

Results: The study enrolled 118 patients, of which 103 completed the follow-up. Among them, 24.3% developed post-thrombotic syndrome (PTS) within six months. Significant differences between the PTS and non-PTS groups were found concerning residual thrombosis in the popliteal, common femoral, and femoral veins. Multivariate Cox regression analysis indicated that residual popliteal vein thrombosis (RPVT) (HR 4.93, 95% CI 1.61-15.11) and preoperative iliac vein stenosis (HR 3.21, 95% CI 1.11-9.33) were significant risk factors for PTS. Additionally, subgroup analysis for preoperative iliac vein stenosis and sensitivity analysis confirmed that RPVT remained a risk factor for PTS (HR 4.48, 95% CI 1.27-15.84).

Conclusion: Our study demonstrated a positive association between residual popliteal vein thrombosis (RPVT) and PTS in patients with extensive mixed-type LEDVT after EVT. These findings suggest that intensive monitoring and aggressive therapeutic interventions may be required for patients with RPVT to reduce the risk of PTS.

Background: While direct stick embolization (DSE) of low-flow vascular malformations (LFVMs) with off-label embolotherapeutic compounds is the current mainstay of therapy, systemic oral mTOR inhibition has evolved into an important adjunctive therapy that is associated with frequent blood draws, systemic toxicity, and rebound signs/symptoms upon cessation. We, herein, report our experience with in-human DSE of LFVMs with an mTOR inhibitor for direct, intralesional targeting of the culprit mutated pathway without repeated systemic exposure.

Methods: Since 2020, 33 procedures involving DSE were performed in 25 patients with LFVMs using a patented formulation and technique involving the intravenously compatible mTOR inhibitor Yale-OCR7737, used as a liquid compound in a collagen matrix emulsion for added viscosity and intralesional residence. Data was prospectively maintained and retrospectively reviewed for technical success (successful catheterization of the lesion and intralesional delivery of compound); clinical success (improvement in signs/symptoms with radiologically documented reduction in flow and/or volume of treated lesion); complications; side effects; and re-interventions.

Results: From 2020 to 2023, 33 procedures involving DSE were performed using Yale-OCR7737 in 25 patients (10[40%] men; 15[60%] women; mean age: 28 years [range 1 -70 years]) with LFMVs involving the head/neck (48%) and limbs (40%); 88% were non-syndromic while 12% had Klippel-Trenaunay Syndrome; 68% exhibited venous malformations, while 32% had lymphatic malformations. Technical and clinical success were 100%. Mean DSE sessions per patient was 1.4 (range 1 to 5). Localized intravascular coagulopathy was present after 16 (49%) DSE procedures; D-dimer improved post-DSE in 7 cases. No perioperative or delayed complications occurred. Side-effects were 7 (21%) cases of self-limited, transient oral aphthous ulcers.

Conclusions: Our findings suggest that DSE of LFVMs with mTOR inhibitors (Yale-OCR7737) may be safe and effective. This may represent the new embolotherapeutic frontier in the endovascular treatment of LFMVs.

Objective: Chronic Venous Insufficiency (CVI) is a common condition affecting more than half of the general population, with approximately 20% of cases being bilateral. The high prevalence, diagnosis, and treatment costs, along with the negative impact on patients' quality of life, underscore its significance. This study evaluates the clinical outcomes, quality of life effects, and postoperative complications of simultaneous and staged bilateral radiofrequency ablation (RFA) in patients with bilateral CVI in the great saphenous vein (GSV) at CEAP stages 2-4.

Methods: This retrospective study included 433 patients with bilateral CVI in the great saphenous vein (GSV) at CEAP stages 2-4, treated with RFA between January 2018 and December 2022. Patients were classified into two groups: Group 1 (n=257) underwent simultaneous bilateral RFA, and Group 2 (n=176) underwent staged bilateral RFA. Clinical outcomes and quality of life effects were evaluated using Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Visual Analog Scale (VAS) scores. Demographic data, type of anesthesia, surgery durations and postoperative complications were analyzed.

Results: Both groups showed significant improvements in AVVQ and VCSS scores at 12 months postoperatively, with no significant differences between the groups in preoperative and postoperative scores. No significant difference was found in postoperative VAS scores. Postoperative complication rates were low and comparable. No pulmonary embolism was observed. Symptomatic DVT was detected in one patient from each group and treated successfully.

Conclusions: Simultaneous bilateral RFA is as effective and safe as staged bilateral RFA for treating CVI, providing similar clinical outcomes and low complication rates. The simultaneous approach offers the advantage of a single treatment session, potentially improving patient satisfaction and operational efficiency. This study supports simultaneous bilateral RFA as a viable and effective option for treating bilateral CVI.

Background: The value of MRI presentation of primary lower extremity lymphedema in assessing the severity of lower extremity lymphedema is uncertain. The purpose of this study was to assess the role of MRI presentation in staging primary lower extremity lymphedema.

Methods: 228 patients with clinically diagnosed primary lower limb lymphoedema from January 2018 to December 2019 in our hospital were enrolled retrospectively. Patients were divided into stages I, II, and III based on the 2020 International Society of Lymphology (ISL) clinical staging standards. Two radiologists assessed the following characteristics of the Short Term Inversion Recovery (STIR) sequence: the extent of edema (longitudinally and transversely), the frequency of MRI manifestations, including the presence of dermal thickening, and the morphology of edema (grid, honeycomb, parallel-lines, banded, crescent, and lymphatic lake). The Kappa test was used to assess interobserver agreement. The chi-square test was used to compare the frequency differences of MRI manifestations between different clinical stages. The Spearman test evaluated the correlation between edema extent and clinical stage.

Results: The extent of edema was positively correlated with clinical stage, both longitudinally and transversely. When comparing stages, the incidence of dermal thickening in stages II and III was significantly higher than in stage I. The incidence of parallel-lines in stage I was significantly higher than that in stages II and III. The grid and banded sign incidence in stages I and II were significantly higher than in stage III. The incidence of honeycomb in stages II and III was significantly higher than in stage I. The incidence of lymphatic lake and crescent in stage III was significantly higher than in stages I and II (P<0.001).

Conclusion: STIR can sensitively diagnose lymphedema and assist in clinical staging. MRI manifestations of primary lower extremity lymphedema in different stages have specific MRI features.

Objective: There are varying anatomical and mechanical demands of stent placement in the iliofemoral venous segment; the Duo Venous Stent System is designed to address these issues. The purpose of the VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) study investigated the safety and efficacy of the Duo Venous Stent System for the treatment of patients with nonmalignant iliofemoral venous obstructive disease.

Methods: This was an international, prospective, multicenter, single-arm study that enrolled patients with symptomatic nonthrombotic (NT), post-thrombotic syndrome (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety end point was freedom from major adverse events at 30 days after the index procedure. The primary efficacy end point was primary patency of stent-bearing segments at 12 months. Secondary and observational end points included symptom relief, primary-assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months.

Results: A total of 162 patients were enrolled at 30 sites in the United States and Poland. The primary safety end point was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P < .0001). The primary safety end point was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy end point was met in 90.2% compared with the performance goal of 77.3% (P = .0002). Primary patency was observed in 95.2% of patients with NT disease, 79.4% of those with PTS, and 86.7% of those with aDVT. No stent fracture, migration, or embolization occurred through 12 months. Patient-reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3 L, and VEINES-QoL/Sym scores from baseline through 6 and 12 months.

Conclusions: Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of nonmalignant iliofemoral venous obstructive disease.

Clinical relevance: The VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) investigational device exemption is the first study of a hybrid, venous stent specifically designed to address the anatomic challenges of the iliofemoral venous system. The Duo Venous Stent System consists of a self-expanding nitinol Hybrid Stent used independently or in conjunction with the flexible extension Duo Extend Stent. This is the first report of primary investigational device exemption VIVID Study, assessing the safety and efficacy of the Duo Venous Stent System to treat patients with nonmalignant, symptomatic iliofemoral venous outflow obstruction. The Duo Venous Stent System successfully met its 12-month safety and effectiveness performance goals.

Objective: Ambulatory venous pressure (AVP) is the drop of pressure observed in the superficial veins of the lower leg during movement. This phenomenon has been linked to the function of the calf muscle pump (CMP) and the competence of venous valves. Nevertheless, the concept of the CMP function remains controversial. This study aimed to elucidate the association between lower leg muscles activity, changes in pressure in distinct venous segments, and lower extremity arterial blood supply in healthy subjects during various types and intensities of exercise.

Methods: Twelve legs of nine healthy volunteers were enrolled in the study. Continuous pressure (intramuscular vein [IV] and three great saphenous vein [GSV] points) and surface electromyography data (gastrocnemius and anterior tibial [ATM] muscles) were recorded during treadmill walking, running, and plantar flexion exercises. The pressure gradient (ΔP, mmHg) between adjacent points of measurement was calculated. Minute unit power of muscle pump ejection and suction (N_E, and N_S, MPa/min) were calculated and compared with the arterial blood supply of the lower extremity (LBF, L/min).

Results: ΔP demonstrated a consistent pattern of changes during walking and running. In GSV, the ΔP was observed to be directed from the thigh to the mid-calf (retrogradely) and from the ankle to the mid-calf (anterogradely) throughout the entire stride cycle. However, its value decreased with increasing stride cycle frequency. The dynamics of ΔP between the IV and GSV were as follows: It was directed from the IV to GSV during gastrocnemius contraction and was reversed during anterior tibial muscle contraction and gastrocnemius relaxation (swing phase). LBF, N_E, and N_S demonstrated similar exponential growth with increasing stride frequency during walking and running.

Conclusions: During natural locomotion, the muscle pump acts as a flow diverter pump, redirecting the flow of blood from the superficial veins to the intramuscular veins via the perforating veins. During ambulation, the pressure in the superficial venous network depends upon the capacity of the muscle pump to provide output that matches the changes in arterial blood flow.