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Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction
by
Dake, Michael D
,
Settlage, Richard A
,
Shammas, Nicolas W
in
Adverse events
,
Embolization
,
Fractures
2021
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.
Journal Article
Splanchnic Vein Thrombosis: Current Perspectives
by
Riva, Nicoletta
,
Valeriani, Emanuele
,
Di Nisio, Marcello
in
Anticoagulants
,
Anticoagulants - therapeutic use
,
Budd-Chiari syndrome
2019
Splanchnic vein thrombosis (SVT) including portal, mesenteric, splenic vein thrombosis and the Budd-Chiari syndrome, is a manifestation of unusual site venous thromboembolism. SVT presents with a lower incidence than deep vein thrombosis of the lower limbs and pulmonary embolism, with portal vein thrombosis and Budd-Chiari syndrome being respectively the most and the least common presentations of SVT. SVT is classified as provoked if secondary to a local or systemic risk factor, or unprovoked if the causative trigger cannot be identified. Diagnostic evaluation is often affected by the lack of specificity of clinical manifestations: the presence of one or more risk factors in a patient with a high clinical suspicion may suggest the execution of diagnostic tests. Doppler ultrasonography represents the first line diagnostic tool because of its accuracy and wide availability. Further investigations, such as computed tomography and magnetic resonance angiography, should be executed in case of suspected thrombosis of the mesenteric veins, suspicion of SVT-related complications, or to complete information after Doppler ultrasonography. Once SVT diagnosis is established, a careful patient evaluation should be performed in order to assess the risks and benefits of the anticoagulant therapy and to drive the optimal treatment intensity. Due to the low quality and large heterogeneity of published data, guidance documents and expert opinion could direct therapeutic decision, suggesting which patients to treat, which anticoagulant to use and the duration of treatment.
Journal Article
A Randomized Trial Comparing Treatments for Varicose Veins
by
Ramsay, Craig R
,
Baker, Sara A
,
Francis, Jill
in
Ablation
,
Adult
,
Biological and medical sciences
2014
This trial of varicose-vein treatments showed no substantial differences in quality of life 6 months after ultrasound-guided foam sclerotherapy, endovenous laser ablation, or surgery, but disease-specific quality of life was slightly worse after foam treatment than after surgery.
Ultrasound-guided foam sclerotherapy and thermal ablation techniques such as endovenous laser ablation have become widely used alternatives to surgery for the treatment of varicose veins. Previous randomized trials and meta-analyses have shown these treatments to be effective in terms of short-term technical success and clinician-reported outcomes.
1
–
19
Clinical practice guidelines recommend the use of patient-reported quality of life to assess the outcomes of treatment of varicose veins.
20
Quality of life was a primary outcome measure in two small randomized trials that compared surgery and endovenous laser ablation,
5
,
9
but to our knowledge, it has not been assessed as a primary . . .
Journal Article
The correlation between metabolic dysfunction-associated steatotic liver disease (MASLD) grades and hemodynamic alterations of the portal, hepatic, and splenic vein and spleen size
by
Sani, Hadi Sabat
,
Elahi, Reza
,
Ghorbani, Saharnaz
in
Abnormalities
,
Biopsy
,
Blood circulation
2025
IntroductionMetabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), is the most prevalent chronic liver condition worldwide, affecting over 25% of the population. Fatty infiltration in MASLD leads to hemodynamic changes in hepatic circulation, which can be quantitatively assessed using Color Doppler Ultrasonography (US). In this study, we aimed to investigate the correlation of Color Doppler US findings of the portal, hepatic, and splenic venous system within various degrees of MASLD.Methods and materialsBetween 2021 and 2024, 104 patients referred to Mousavi Hospital at Zanjan University of Medical Sciences were enrolled. Participants were divided into four groups based on the degree of hepatic fatty infiltration on biopsy results: normal, grade 1, grade 2, and grade 3, with 26 subjects in each group (13 men and 13 women). All patients were biopsy proved. Gray-scale and Color Doppler US were used to assess portal and splenic vein peak systolic velocity (PSV), portal and splenic vein diameter, hepatic vein waveform, and spleen size. The Spearman rank correlation was employed to evaluate the relationship between these variables under non-parametric conditions.ResultsA significant negative correlation was found between portal vein PSV and MASLD grade (r = − 0.499, p = 0.000). A significant difference was also observed in hepatic venous waveform abnormality between different grades of MASLD (p = 0.043). Accordingly, portal vein PSV and splenic vein PSV had a significantly positive correlation (r = 0.209, p = 0.033). We also observed a positive correlation between the portal vein and splenic diameter (r = 0.210, p = 0.032).ConclusionIncreasing MASLD severity is associated with reduced portal vein PSV and more pronounced abnormalities in hepatic vein flow. Routine assessment of portal and hepatic vein flow using Color Doppler US is recommended to accurately diagnose and monitor the effects of MASLD on hepatic circulation, potentially improving disease management and patient outcomes.
Journal Article
SUPERIOR SVG: no touch saphenous harvesting to improve patency following coronary bypass grafting (a multi-Centre randomized control trial, NCT01047449)
2019
Background
Single centre studies support No Touch (NT) saphenous vein graft (SVG) harvesting technique. The primary objective of the SUPERIOR SVG study was to determine whether NT versus conventional (CON) SVG harvesting was associated with improved SVG patency 1 year after coronary artery bypass grafting surgery (CABG).
Methods
Adults undergoing isolated CABG with at least 1 SVG were eligible. CT angiography was performed 1-year post CABG. Leg adverse events were assessed with a questionnaire. A systematic review was performed for published NT graft patency studies and results aggregated including the SUPERIOR study results.
Results
Two hundred and-fifty patients were randomized across 12-centres (NT 127 versus CON 123 patients). The primary outcome (study SVG occlusion or cardiovascular (CV) death) was not significantly different in NT versus CON (NT: 7/127 (5.5%), CON 13/123 (10.6%),
p
= 0.15). Similarly, the proportion of study SVGs with significant stenosis or total occlusion was not significantly different between groups (NT: 8/102 (7.8%), CON: 16/107 (15.0%),
p
= 0.11). Vein harvest site infection was more common in the NT patients 1 month postoperatively (23.3% vs 9.5%,
p
< 0.01). Including this study’s results, in a meta-analysis, NT was associated with a significant reduction in SVG occlusion, Odds Ratio 0.49, 95% Confidence Interval 0.29–0.82,
p
= 0.007 in 3 randomized and 1 observational study at 1 year postoperatively.
Conclusions
The NT technique was not associated with improved patency of SVGs at 1-year following CABG while early vein harvest infection was increased. The aggregated data is supportive of an important reduction of SVG occlusion at 1 year with NT harvesting.
Trial registration
NCT01047449
.
Journal Article
Versican is differentially regulated in the adventitial and medial layers of human vein grafts
by
Pesce, Maurizio
,
Soncini, Monica
,
Kenagy, Richard D.
in
Adventitia - metabolism
,
Antigens, CD34 - metabolism
,
Arterial Pressure - physiology
2018
Changes in extracellular matrix proteins may contribute significantly to the adaptation of vein grafts to the arterial circulation. We examined the production and distribution of versican and hyaluronan in intact human vein rings cultured ex vivo, veins perfused ex vivo, and cultured venous adventitial and smooth muscle cells. Immunohistochemistry revealed higher levels of versican in the intima/media compared to the adventitia, and no differences in hyaluronan. In the vasa vasorum, versican and hyaluronan associated with CD34+ progenitor cells. Culturing the vein rings for 14 days revealed increased versican immunostaining of 30-40% in all layers, with no changes in hyaluronan. Changes in versican accumulation appear to result from increased synthesis in the intima/media and decreased degradation in the adventitia as versican transcripts were increased in the intima/media, but unchanged in the adventitia, and versikine (the ADAMTS-mediated cleavage product of versican) was increased in the intima/media, but decreased in the adventitia. In perfused human veins, versican was specifically increased in the intima/media in the presence of venous pressure, but not with arterial pressure. Unexpectedly, cultured adventitial cells express and accumulate more versican and hyaluronan than smooth muscle cells. These data demonstrate a differential regulation of versican and hyaluronan in human venous adventitia vs. intima/media and suggest distinct functions for these extracellular matrix macromolecules in these venous wall compartments during the adaptive response of vein grafts to the arterial circulation.
Journal Article
Morphologic changes of the no-touch saphenous vein as Y-composite versus aortocoronary grafts (CONFIG Trial)
2025
This randomized controlled trial was aimed to compare 1-year morphologic changes of the no-touch saphenous vein graft as Y-composite (Composite group) versus aortocoronary (Aorta group) configurations in coronary artery bypass grafting.
The primary endpoint was intima-media thickness of the saphenous vein graft as measured by intravascular ultrasound (IVUS) at the 1-year angiographic evaluation. Recruitment of 25 patients in each group was necessary based on a superiority design. Among the 50 patients, IVUS data were obtained in 22 and 24 patients from the Composite and Aorta groups, respectively.
Mean age was 64.8 ± 9.2 years, and the proportion of females was 20.0%. The numbers of distal anastomoses per saphenous vein graft were 2.7 ± 1.1 and 2.6 ± 0.8 in the Composite and Aorta groups, respectively. The intima-media thickness of the saphenous vein graft 1 year after surgery were 0.25 ± 0.04 mm and 0.24 ± 0.06 mm in the Composite and Aorta groups, respectively (P for superiority = .99). Other IVUS parameters of saphenous vein grafts, including vessel diameter, luminal diameter, and the ratio of intima-media thickness to vessel diameter, also demonstrated no differences between the groups. No neointimal hyperplasia or plaque formation was detected using IVUS. All study patients underwent 1-year angiographic evaluation, and the patency rates were 94.7%(89 out of 94 anastomoses) and 100.0%(90 out of 90 anastomoses) in the Composite and Aorta groups, respectively.
The intima-media thickness of the saphenous vein graft 1 year after surgery demonstrated no significant difference between the Y-composite and aortocoronary configurations (NCT04782492). Trial Registration: ClinicalTrials.gov NCT04782492.
Journal Article
Changes in pulmonary vein size and narrowing depend on the cardiac cycle before and after pulmonary vein isolation
by
Ouchi, Kotaro
,
Kisaki, Shunsuke
,
Ojiri, Hiroya
in
Ablation
,
Aged
,
Atrial Fibrillation - diagnosis
2024
Accurate measurement of the pulmonary vein dimension (PVD) is important for determining stenosis and efficacy following pulmonary vein isolation (PVI). Little is known about the quantitative evaluation of the impact of the cardiac cycle on pulmonary vein (PV) morphology before and after PVI. This study aims to investigate variations in the ostial size of the PV during the cardiac cycle before and after PVI and the effect of the cardiac cycle on PV stenosis and reduction rate using cardiac computed tomography (CT). Sixty-eight patients with atrial fibrillation who underwent cardiac CT before and after PVI at our institution between 23 January 2021 and 5 February 2022 were retrospectively analyzed. The maximum and minimum PVD were measured at each segment before and after the PV. Each PV was evaluated according to the PVD reduction rate (ΔPVD), calculated as follows: (1 − post-PVD/pre-PVD) × 100 (%). The average dimension of all PVs at the end-diastolic frame was significantly reduced compared to that at the end-systolic frame before PVI. The average dimensions of the right superior and right inferior PV at the end-diastolic frame were significantly reduced compared with those at the end-systolic frame following PVI. The average reduction rate of dimension-classified stenosis of PVs, except for the left inferior PV at the end-diastolic frame, was significantly reduced compared with that at the end-systolic frame. The cardiac cycle affects PVD assessment, including PV stenosis, after PVI. PVD measurement is recommended to be unified to the end-systolic frame of the cardiac cycle to avoid underestimating PV stenosis before and after PVI, ensuring appropriate management and follow-up.
Journal Article
Rationale and design of the DEFIANCE study: A randomized controlled trial of mechanical thrombectomy versus anticoagulation alone for iliofemoral deep vein thrombosis
2025
Deep vein thrombosis (DVT) is a common medical condition that is associated with clinically significant sequelae, including postthrombotic syndrome (PTS). Anticoagulation alone remains the guideline-recommended treatment for many patients with iliofemoral DVT. Recent technological advances have led to an increase in the use of mechanical thrombectomy for DVT, but mechanical thrombectomy-based procedures have not yet been compared with standard-of-care anticoagulation therapy in randomized studies.
The DEFIANCE study (ClinicalTrials.gov: NCT05701917) is an international and actively enrolling randomized controlled trial (RCT) in lower extremity DVT assessing an interventional strategy that includes mechanical thrombectomy with the ClotTriever System (Inari Medical, Irvine, CA) versus anticoagulation alone. Approximately 300 patients with unilateral iliofemoral DVT and symptom duration ≤ 12 weeks will be randomized 1:1. Study conduct includes an independent core laboratory for duplex ultrasound assessment, an independent medical monitor for safety adjudication, and evaluation of PTS severity on the Villalta scale using best clinical practices. The primary endpoint is a composite outcome structured as a hierarchal win ratio of 1) the occurrence of treatment failure or therapy escalation as adjudicated by the medical monitor, with failure defined as amputation or gangrene of the target leg or venous thromboembolism-related mortality, and 2) the assessment of PTS severity at the 6-month follow-up visit. In addition to being a component of the primary endpoint, the severity of PTS at 6 months is also evaluated as a stand-alone secondary endpoint. An additional secondary endpoint is a composite of outcomes at the 10-day visit and is structured as a hierarchal win ratio of 1) vessel compressibility on duplex ultrasound, 2) patient-reported pain, and 3) improvement of edema. The safety endpoints are access site complications requiring endovascular or surgical repair and the occurrence through the 30-day visit of mortality, major bleeding, or new symptomatic pulmonary embolism.
DEFIANCE will be the first RCT to evaluate a mechanical thrombectomy-based interventional approach versus anticoagulation therapy alone for DVT. The results will inform the treatment of patients with iliofemoral DVT and the prevention of PTS-associated morbidity.
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis (DEFIANCE), ClinicalTrials.gov: NCT05701917, URL: https://clinicaltrials.gov/study/NCT05701917?cond=Deep%20Vein%20Thrombosis&term=defiance&rank=1
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Journal Article
Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice
by
Saugel, Bernd
,
Teboul, Jean-Louis
,
Scheeren, Thomas W. L.
in
Analysis
,
Anesthesiology
,
Carotid arteries
2017
The use of ultrasound (US) has been proposed to reduce the number of complications and to increase the safety and quality of central venous catheter (CVC) placement. In this review, we describe the rationale for the use of US during CVC placement, the basic principles of this technique, and the current evidence and existing guidelines for its use. In addition, we recommend a structured approach for US-guided central venous access for clinical practice. Static and real-time US can be used to visualize the anatomy and patency of the target vein in a short-axis and a long-axis view. US-guided needle advancement can be performed in an \"out-of-plane\" and an \"in-plane\" technique. There is clear evidence that US offers gains in safety and quality during CVC placement in the internal jugular vein. For the subclavian and femoral veins, US offers small gains in safety and quality. Based on the available evidence from clinical studies, several guidelines from medical societies strongly recommend the use of US for CVC placement in the internal jugular vein. Data from survey studies show that there is still a gap between the existing evidence and guidelines and the use of US in clinical practice. For clinical practice, we recommend a six-step systematic approach for US-guided central venous access that includes assessing the target vein (anatomy and vessel localization, vessel patency), using real-time US guidance for puncture of the vein, and confirming the correct needle, wire, and catheter position in the vein. To achieve the best skill level for CVC placement the knowledge from anatomic landmark techniques and the knowledge from US-guided CVC placement need to be combined and integrated.
Journal Article