One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis.

Background: Mechanical thrombectomy is a promising treatment option for deep vein thrombosis; however, long-term data are lacking. Here, we report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy with the ClotTriever System (Inari Medical). Methods: The CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL). Results: In CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL. Conclusions: One-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.

Intravascular Ultrasound Use in Peripheral Arterial and Deep Venous Interventions: Multidisciplinary Expert Opinion From SCAI/AVF/AVLS/SIR/SVM/SVS.

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.

Diagnosis and Management of Pelvic Venous Disorders in Women.

Pelvic venous reflux and obstruction can lead to chronic pelvic pain and extra-pelvic varicosities. This paper will discuss the contemporary understanding of this pathophysiology and its clinical manifestations. It will review evidence-based clinical and imaging criteria of pelvic venous disorders, data supporting benefit from venous interventions, criticisms of the available data and highlight evidence research gaps that exist. Finally, it will argue that comparative outcomes research utilizing standardized patient selection for embolization and stenting, embolization treatment strategies that eliminate the pelvic varices (at least to start), and clinically relevant outcome measures are necessary to establish the benefit of vascular treatments.

Intravascular Ultrasound Use in Peripheral Arterial and Deep Venous Interventions: Multidisciplinary Expert Opinion From SCAI/AVF/AVLS/SIR/SVM/SVS.

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.

Characterizing Trends in Chronic Superficial Venous Disease Treatment among Medicare Beneficiaries from 2010 to 2018.

This study describes trends in surgical versus endovascular interventions for treatment of chronic superficial venous disease (SVD) in the Medicare population. Medicare Part B data from 2010 to 2018 were obtained. Claims for SVD treatment were identified using Healthcare Common Procedure Coding System codes. Total percentage change in utilization rates and market share was determined for each provider group. Utilization of SVD treatments increased by 58%, mostly owing to growing utilization of endovascular treatments. There was a 66% decrease in surgical treatments. The utilization of ablation and sclerotherapy plateaued in 2016 and decreased in 2017-2018 with the advent of mechanochemical ablation, endovenous microfoam, and cyanoacrylate adhesive, respectively. Analysis showed that endovascular utilization increased across most specialties, with the largest growth seen in cardiology by 427%. Radiologists showed utilization growth of 125%, encompassing 11% of the market share. Endovascular treatment for SVD remains predominant, with increased utilization and concomitant decrease in surgical methods.

Techniques for Embolization of the Ovarian Vein and Pelvic Reservoir.

Pelvic venous disorders are a common and under diagnosed cause of chronic pelvic pain in women, presenting with chronic, noncyclical pelvic pain for greater than 6 months and the presence of pelvic varicosities. Pelvic varices and ovarian vein reflux are a strong indicator of venous origin chronic pelvic and may benefit from embolization. This most commonly occurs in multiparous, premenopausal women with symptoms of gravity dependent pelvic pain and postcoital pain. Additional causes of pelvic venous disorders include iliac vein compression, internal iliac vein reflux, and renal vein compression, however for the purposes of this article we will focus on ovarian vein insufficiency. The mainstay of treatment for pelvic venous insufficiency is Ovarian Vein Embolization and embolization of the pelvic venous reservoir. This article will focus on the patient presentation and workup, followed by a detailed summary of how to perform this procedure, current research to support treatment, possible technical challenges and complications, and finally future research priorities.

Society of Interventional Radiology Position Statement on the Management of Chronic Iliofemoral Venous Obstruction with Endovascular Placement of Metallic Stents.

PURPOSE: To state the position of the Society of Interventional Radiology (SIR) on the endovascular management of chronic iliofemoral venous obstruction with metallic stents. MATERIALS AND METHODS: A multidisciplinary writing group with expertise in treating venous disease was convened by SIR. A comprehensive literature search was conducted to identify studies on the topic of interest. Recommendations were drafted and graded according to the updated SIR evidence grading system. A modified Delphi technique was used to achieve consensus agreement on the recommendation statements. RESULTS: A total of 41 studies, including randomized trials, systematic reviews and meta-analyses, prospective single-arm studies, and retrospective studies were identified. The expert writing group developed 15 recommendations on the use of endovascular stent placement. CONCLUSIONS: SIR considers the use of endovascular stent placement for chronic iliofemoral venous obstruction to be likely to help selected patients, but the risks and benefits have not been fully quantified in well-designed randomized studies. SIR recommends urgent completion of such studies. In the meantime, careful patient selection and optimization of conservative therapy are recommended prior to stent placement, with attention to appropriate stent sizing and quality procedural technique. The use of multiplanar venography with intravascular ultrasound is suggested in diagnosing and characterizing obstructive iliac vein lesions and in guiding stent therapy. After stent placement, SIR recommends close patient follow-up to ensure optimal antithrombotic therapy, durable symptom response, and early identification of adverse events.

Diagnosis and Management of Pelvic Venous Disorders: AJR Expert Panel Narrative Review.

Pelvic venous disorders (PeVD), previously known by various imprecise terms including pelvic congestion syndrome, have historically been underdiagnosed as a cause of chronic pelvic pain (CPP), a significant health problem associated with reduced quality of life. However, progress in the field has helped to provide heightened clarity with respect to definitions relating to PeVD, and evolution in algorithms for PeVD workup and treatment has been accompanied by new insights into the causes of a pelvic venous reservoir and associated symptoms. Ovarian and pelvic vein embolization, as well as endovascular stenting of common iliac vein compression, should be considered as management options for PeVD. Both treatments have been shown to be safe and effective for patients with CPP of venous origin, regardless of age. Current therapeutic protocols for PeVD exhibit significant heterogeneity owing to limited prospective randomized data and evolving understanding of the factors driving successful outcomes; forthcoming clinical trials are anticipated to improve understanding of CPP of venous origin as well as algorithms for PeVD management. This Expert Panel Narrative Review provides a contemporary update relating to PeVD, summarizing the entity's current classification, diagnostic workup, endovascular treatments, management of persistent or recurrent symptoms, and future research directions.

Society of Interventional Radiology Position Statement on the Endovascular Management of Acute Iliofemoral Deep Vein Thrombosis.

PURPOSE: To establish the updated position of the Society of Interventional Radiology (SIR) on the endovascular management of acute iliofemoral deep vein thrombosis (DVT). MATERIALS AND METHODS: A multidisciplinary writing group with expertise in treating venous diseases was convened by SIR. A comprehensive literature search was conducted to identify studies on the topic of interest. Recommendations were drafted and graded according to the updated SIR evidence grading system. A modified Delphi technique was used to achieve consensus agreement on the recommendation statements. RESULTS: A total of 84 studies, including randomized trials, systematic reviews and meta-analyses, prospective single-arm studies, and retrospective studies were identified and included in the review. The expert writing group developed 17 recommendations that pertain to the care of patients with acute iliofemoral DVT with the use of endovascular venous interventions. CONCLUSIONS: SIR considers endovascular thrombus removal to be an acceptable treatment option in selected patients with acute iliofemoral DVT. Careful individualized risk assessment, high-quality general DVT care, and close monitoring during and after procedures should be provided.

Pelvic Venous Disorders (PeVD).

Pelvic venous disorders (PeVDs) have replaced the concept of pelvic congestion syndrome encompassing venous origin chronic pelvic pain (VO-CPP) in women. The evaluation of women with VO-CPP includes the assessment for other causes of pelvic pain as well as imaging evaluation for pelvic varicosities measuring greater than 5 mm diameter, ovarian vein diameter, and flow direction, as well as iliac vein diameter and signs of compression. Proper identification of these patients can lead to high degrees of success eliminating chronic pelvic pain following ovarian vein embolization and/or iliac vein stenting. Strong encouragement is provided to use the symptoms, varices, pathophysiology classification for these patients and upcoming research studies on the specific symptoms of patients with VO-CPP will help elucidate patient selection for intervention. Additional future randomized controlled trials are also upcoming to evaluate for outcomes of ovarian vein embolization and iliac vein.

Antithrombotic Therapy After Venous Interventions: AJR Expert Panel Narrative Review.

Interventions for thrombotic and nonthrombotic venous disorders have increased with technical advances and more trained venous specialists. Antithrombotic therapy is essential to clinical and procedural success; however, postprocedural therapeutic regimens exhibit significant heterogeneity due to limited prospective randomized data and incomplete mechanistic understanding of the critical factors driving long-term patency. Postinterventional antithrombotic therapy for thrombotic venous disorders should adhere to existing venous thromboembolism management guidelines, which include 3-6 months of therapeutic anticoagulation at minimum and consideration of extended therapy in patients with higher risk of thrombosis because of procedural or patient factors. The added benefit of antiplatelet agents in the acute and intermediate period is unknown, having shown improved long-term stent patency in some retrospective studies. Dual- and/or triple-agent therapy should be limited based on individual risks of thrombosis and bleeding. The treatment of nonthrombotic disorders is more heterogeneous, though patients with limited flow, extensive stent material, or underlying prothrombotic states such as malignancy or chronic inflammation may benefit from single-agent or multiagent antithrombotic therapy. However, the agent, dose, and duration of therapy remain indeterminate. Future prospective studies are warranted to improve patient risk stratification and standardize postprocedural anti-thrombotic therapy in patients receiving venous interventions.

Imaging of Pelvic Venous Disorders (PeVD); Should Every Patient Get an MRI?

Pelvic venous disease (PeVD) is part of the broad differential diagnosis of chronic pelvic pain with a challenging diagnosis and clinical workup to identify those patients that are most likely to benefit from intervention. Ultrasound, MRI, CT, venography, and intravascular ultrasound can all provide information to aid in the diagnostic algorithm. The purpose of this article is to review imaging as a component of the outpatient workup of patients with chronic pelvic pain to guide appropriate understanding and use of imaging modalities to accurately identify patients suffering from PeVD. A favored approach is to begin with transabdominal sonography with selective use of MRI/MRV in specific patient populations.

Clinical Presentation and Evaluation of Pelvic Venous Disorders in Women.

The term pelvic venous disorders (PeVD) describes a group of related clinical entities with overlapping clinical presentations that were previously characterized by separate imprecise syndromic terminology. The clinical manifestations of PeVD may variously include chronic pelvic pain; pelvic origin extrapelvic lower extremity and genital varices; lower extremity pain and swelling; and left flank pain and hematuria. This manuscript focuses on the primary manifestations of PeVD in women - chronic pelvic pain and pelvic origin lower extremity and vulvar varices - and will review the underlying pathophysiology and related complicating factors (such as maladaptive pain responses) to explain the variety of clinical presentations.

Clinical Presentation, Patient Assessment, Anatomy, Pathophysiology, and Imaging of Pelvic Venous Disease.

Pelvic venous disorders (PeVDs) can result in several different clinical presentations, but can be challenging to distinguish from other etiologies of chronic pelvic pain (CPP). Clinical evaluation of CPP patients optimally should be performed in a multidisciplinary fashion and patients who may have PeVD should be referred for consultation with a vascular interventionalist whose evaluation would utilize an imaging workup to search for pelvic varices. Additionally, it is critical to quantify the quality-of-life effects of all CPP to determine the impact on the patient's overall health. Diagnostic imaging, including transabdominal and transvaginal ultrasound, computed tomography, magnetic resonance imaging, and venography, can be utilized to identify pelvic varices, as well as venous reflux and obstruction leading to CPP. The use of the SVP tool is important to classify PeVD patients based on their clinical symptoms, varicose veins, and pathophysiology for precise clinical communication and for reporting clinical research. The goal of this publication is to delineate the clinical presentation, anatomy, pathophysiology, and imaging evaluation of patients with CPP suspected of having PeVD.

Prevalence of hypercoagulable states in stented thrombotic iliac vein compression syndrome with comparison of re-intervention and anticoagulation regimens.

BACKGROUND: Endovascular therapy is playing an increasing role in the treatment of iliofemoral venous disease. Iliac stent patency is multifactorial, and current management is based on best clinical practices, varying by institution. AIM: To evaluate how thrombophilia influences management and outcomes of patients who undergo venous stenting for thrombotic iliac vein compression syndromes. METHODS: A retrospective observational analysis was performed on 65 patients with thrombotic iliac vein compression syndrome that underwent common iliac vein (CIV) stenting between December 2013 and December 2019 at a large academic center. Search criteria included CIV stenting and iliac vein compression. Non-thrombotic lesions and iliocaval thrombosis and/or occlusions were excluded. A total of 65 patients were selected for final analysis. Demographic information, procedural data points, and post-procedural management and outcomes were collected. Statistical analyses included Fisher's exact and Chi-square tests to compare discrete variables and the Wilcoxon rank-sum test to compare continuous variables between thrombophilia positive and negative patients. RESULTS: 65 patients underwent successful balloon angioplasty and CIV stenting. Of these patients, 33 (50.8%) underwent thrombophilia testing, with 16 (48.5%) testing positive. Stent patency on ultrasound did not significantly differ between thrombophilia positive and negative patients at 1 mo (92.3% vs 81.3%, P = 0.6), 6 mo (83.3% vs 80%, P > 0.9), or 12 mo (77.8% vs 76.9%, P = 0.8). Immediately after stent placement, thrombophilia patients were more likely to be placed on dual therapy (aspirin and anticoagulation) or triple therapy (aspirin, clopidogrel, and anticoagulation) (50% vs 41.2%, P > 0.9), and remain on dual therapy at 6 mo (25% vs 12.5%, P = 0.5) and 12 mo (25% vs 6.7%, P = 0.6). There was no significant difference in re-intervention rates (25% vs 35.3%, P = 0.7) or number of re-interventions (average 2.3 vs 1.3 per patient, P = 0.4) between thrombophilia positive and negative patients. CONCLUSION: Half of patients with stented thrombotic iliac vein compression syndrome and thrombophilia testing were positive. The presence of thrombophilia did not significantly impact stent patency or re-intervention rates.

Endovascular simulation as a supplemental training tool during the COVID-19 national emergency.

The ongoing COVID pandemic raises many concerns as our healthcare system is pushed to its limits and as a consequence, Interventional Radiology training may be compromised. Endovascular simulators allow trainees many benefits to build and maintain endovascular skills in a safe environment. Our experience demonstrates a methodology to maintain IR training with use of didactic and simulation supplementation during the COVID-19 pandemic, which may be helpful for incorporation at other institutions facing similar challenges.

Intraprocedural guidance for recanalization of post-thrombotic venous lesions using live overlay of center lines from pre-operative cross-sectional imaging: a preliminary experience.

PURPOSE: Pre-procedural contrast-enhanced CT and MRI imaging is typically acquired prior to deep venous recanalization procedures for post-thrombotic syndrome. This technical note reports the utility of live-overlay of augmented centerlines extracted from pre-procedural CT and MRI imaging in facilitating fluoroscopic-guided recanalization of post-thrombotic venous lesions. METHODS AND MATERIALS: Six patients with pre-procedural CT or MR venography data were incorporated into a commercially available 3D overlay software (Vessel Assist, GE Healthcare, Buc, France) during venous disease interventions for post-thrombotic venous lesions. Procedures were performed on the GE Discovery IGS 740 fluoroscopy system. After manual determination of the vasculature from preprocedural CT or MR, centerlines were created representing the location and trajectory of the vessels. Steps showcasing the creation of centerlines and their representation during overlay with real-time fluoroscopic guidance in these cases are outlined. Time required to cross the post-thrombotic and occlusive venous segments were reviewed. RESULTS: All iliocaval recanalization procedures were successfully performed utilizing vessel centerline 3D overlay. In one case where occlusion extended to the femoral vein, mis-registration was identified over the femoral anatomy due to a complex leg rotation compared to pre-procedural imaging. No procedural complications related to utilization of software were noted. Average crossing time for occlusions was 3.4 min (range 1.6-5.2). CONCLUSION: 3D overlay with vessel tracking from pre-procedural CT and MRI imaging is technically feasible and assists in catheter navigation for post-thrombotic venous segments. While results from these preliminary experiences support the continued use of this technology, further prospective and comparative evaluation of this technique is warranted to assess for added value in technical success, reductions in procedure time or reductions in radiation exposure.

Trends in Percutaneous Embolization Procedures by Radiologists and Other Specialists.

PURPOSE: To evaluate utilization trends in percutaneous embolization among radiologists and nonradiologist providers. MATERIALS AND METHODS: The nationwide Medicare Part B fee-for-service databases for 2005-2016 were used to evaluate percutaneous embolization codes. Six codes describing embolization procedures were reviewed. Physician providers were grouped as radiologists, vascular surgeons, cardiologists, nephrologists, other surgeons, and all others. RESULTS: The total volume of Medicare percutaneous embolization procedures increased from 20,262 in 2005 to 45,478 in 2016 (+125%). Radiologists performed 13,872 procedures in 2005 (68% of total volume) and 33,254 in 2016 (73% of total volume), a 140% increase in volume. While other specialists also increased the number of cases performed from 2005 to 2016, radiologists strongly predominated, performing 87% of arterial and 30% of venous procedures in 2016, more than any other single specialty. In 2014 and 2015, a sharp increase in venous embolization cases performed by nonradiologists preceded a sharp decrease in 2016, likely the result of complicated billing codes for venous procedures. Radiologists maintained a steady upward trend in the number of cases they performed during those years. CONCLUSIONS: The volume of percutaneous embolization procedures performed in the Medicare population increased from 2005 to 2016, reflecting a trend toward minimally invasive intervention. In 2016, radiologists performed nearly 10 times more arterial embolization procedures than the second highest specialty and more venous embolization procedures than any other single specialty.