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.

Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries.

PURPOSE: To evaluate temporal trends, practice variation, and associated outcomes with the use of intravascular ultrasound (US) during deep venous stent placement among Medicare beneficiaries. MATERIALS AND METHODS: All lower extremity deep venous stent placement procedures performed between January 1, 2017, and December 31, 2019 among Medicare beneficiaries were included. Temporal trends in intravascular US use were stratified by procedural setting and physician specialty. The primary outcome was a composite of 12-month all-cause mortality, all-cause hospitalization, or repeat target vessel intervention. The secondary outcome was a composite of 12-month stent thrombosis, embolization, or restenosis. RESULTS: Among the 20,984 deep venous interventions performed during the study period, 15,184 (72.4%) utilized intravascular US. Moderate growth in intravascular US use was observed during the study period in all clinical settings. There was a variation in the use of intravascular US among all operators (median, 77.3% of cases; interquartile range, 20.0%-99.2%). In weighted analyses, intravascular US use during deep venous stent placement was associated with a lower risk of both the primary (adjusted hazard ratio, 0.72; 95% confidence interval [CI], 0.69-0.76; P < .001) and secondary (adjusted hazard ratio, 0.32; 95% CI, 0.27-0.39; P < .001) composite end points. CONCLUSIONS: Intravascular US is frequently used during deep venous stent placement among Medicare beneficiaries, with further increase in use from 2017 to 2019. The utilization of intravascular US as part of a procedural strategy was associated with a lower cumulative incidence of adverse outcomes after the procedure, including venous stent thrombosis and embolization.

Optimal Medical Therapy Following Deep Venous Interventions: Proceedings from the Society of Interventional Radiology Foundation Research Consensus Panel.

The optimal medical management of patients following endovascular deep venous interventions remains ill-defined. As such, the Society of Interventional Radiology Foundation (SIRF) convened a multidisciplinary group of experts in a virtual Research Consensus Panel (RCP) to develop a prioritized research agenda regarding antithrombotic therapy following deep venous interventions. The panelists presented the gaps in knowledge followed by discussion and ranking of research priorities based on clinical relevance, overall impact, and technical feasibility. The following research topics were identified as high priority: 1) characterization of biological processes leading to in-stent stenosis/rethrombosis; 2) identification and validation of methods to assess venous flow dynamics and their effect on stent failure; 3) elucidation of the role of inflammation and anti-inflammatory therapies; and 4) clinical studies to compare antithrombotic strategies and improve venous outcome assessment. Collaborative, multicenter research is necessary to answer these questions and thereby enhance the care of patients with venous disease.

Qualitative study of patients with venous malformations: symptom experiences and content validity of patient-reported outcome measures.

PURPOSE: To determine important symptoms and functional effects of venous malformations (VMs) to assess the content validity of commonly used patient-reported outcome (PRO) measures for use with VM patients. METHODS: This cross-sectional, qualitative study involved cognitive interviews with participants with VM aged ≥ 14 years. From February to June 2016, 11 participants (8 female) with a mean (± standard deviation) age of 31 ± 15 years were recruited from three clinical sites. The following subgroups were evaluated: 5 adults (aged ≥ 18) with trunk/extremity VMs; 3 adolescents (aged 14-17) with trunk/extremity VMs; and 3 adults with head/neck VMs. We evaluated the content validity of the Worst Pain Numeric Rating Scale (NRS), Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference 8-item short form, and PROMIS Physical Function 8-item short form. RESULTS: The most common participant-reported VM symptoms were swelling (n = 10), skin discoloration (n = 8), acute episodic pain (n = 8), chronic pain (n = 7), numbness (n = 7), and tingling/burning (n = 6). Participants reported that VMs affected their physical function (n = 10), appearance (n = 10), relationships/social activities (n = 7), and emotional health (n = 3). The Worst Pain NRS and PROMIS Pain Interference measures were relevant to all participants' VM experience. Only adults with head/neck VMs found the PROMIS Physical Function measure to be irrelevant. The assessed PRO measures did not address several symptoms commonly reported by VM patients (swelling, skin discoloration, numbness, and appearance). CONCLUSION: These results suggest that several VM symptoms are not assessed fully by commonly used PRO measures, and that the relevance of functional limitation questions may vary by VM location.

Ultrasound for Lower Extremity Deep Venous Thrombosis: Multidisciplinary Recommendations From the Society of Radiologists in Ultrasound Consensus Conference.

Venous ultrasound is the standard imaging test for patients suspected of having acute deep venous thrombosis (DVT). There is variability and disagreement among authoritative groups regarding the necessary components of the test. Some protocols include scanning the entire lower extremity, whereas others recommend scans limited to the thigh and knee supplemented with serial testing. Some protocols use gray-scale ultrasound alone, whereas others include Doppler interrogation. Point-of-care ultrasound is recommended in some settings, and there is heterogeneity of these protocols as well. Heterogeneity of recommendations can lead to errors including incorrect application of guidelines, confusion among requesting physicians, and incorrect follow-up. In October 2016, the Society of Radiologists in Ultrasound convened a multidisciplinary panel of experts to evaluate the current evidence to develop recommendations regarding ultrasound protocols for DVT and the terminology used to communicate results to clinicians. Recommendations were made after open discussion and by unanimous consensus.The panel recommends a comprehensive duplex ultrasound protocol from thigh to ankle with Doppler at selected sites rather than a limited or complete compression-only examination. This protocol is currently performed in many facilities and is achievable with standard ultrasound equipment and personnel. The use of these recommendations will increase the diagnosis of calf DVT and provide better data to explain the presenting symptoms. The panel recommends a single point-of-care protocol that minimizes underdiagnoses of proximal DVT.The panel recommends the term chronic postthrombotic change to describe the residual material that persists after the acute presentation of DVT to avoid potential overtreatment of prior thrombus.Adoption of a single standardized comprehensive duplex ultrasound and a single point-of-care examination will enhance patient safety and clinicians' confidence.

Comparison of outcomes in women and men following carotid interventions in the Washington state's Vascular Interventional Surgical Care and Outcomes Assessment Program.

BACKGROUND: The benefit for carotid endarterectomy (CEA) to prevent a potential stroke has been shown to be less beneficial for women compared with men and the risk of carotid stenting (CAS) is higher in women than men. We hypothesized that a community-based Washington state registry data would also reveal increased morbidity and mortality for women undergoing carotid interventions. METHODS: Deidentified data for CEA and CAS between 2010 and 2015 were obtained from 19 hospitals participating in the Washington State Vascular-Interventional Surgical Care and Outcomes Assessment Program. Data analysis compared in-hospital composite outcome of stroke and mortality from CEA and CAS between women and men. RESULTS: Over the study period, 3704 individuals underwent CEA (n = 2759; 49.5% symptomatic) and CAS (n = 945; 60.9% symptomatic). Women accounted for 39.5% of the cohort. Women were slightly younger than men (70.0 ± 10.2 vs 71.0 ± 9.6 years respectively; P < .01), less likely to be smokers (70.1% vs 75.6%; P < .01), and less likely to have a diagnosis of coronary artery disease (32.9% vs 46.5%; P < .01). Fewer women underwent CEA for symptomatic carotid disease (46.1% vs 51.8%; P < .01). There were no statistically significant differences in the postoperative in-hospital stroke and mortality among women and men undergoing CEA (asymptomatic, 0.8% vs 1.4% [P = .36]; symptomatic, 1.8% vs 2.2% [P = .58]) and CAS (asymptomatic, 1.4% vs 2.2% [P = .56]; symptomatic, 4.6% vs 2.5% [P = .18]). Hospital duration of stay and discharge disposition were similar for women and men. A subanalysis of the octogenarian cohort undergoing CAS demonstrated a substantial increase in-hospital stroke and mortality among women and men (11.6% [CAS] vs 2.2% [CEA]; P = .024). CONCLUSIONS: In the Washington state Vascular-Interventional Surgical Care and Outcomes Assessment Program registry, hospital composite outcome of stroke and mortality following carotid interventions from 2010 to 2015 were noted to be similar for women and men. The notable exception to this finding was observed in subcohort of women undergoing CAS for symptomatic carotid disease at age 80 years or older. These findings should be taken into account when risk stratifying patients for carotid interventions.

Research Priorities in Pelvic Venous Disorders in Women: Recommendations from a Multidisciplinary Research Consensus Panel.

Pelvic venous disorders (PeVDs) in women can present with chronic pelvic pain, lower-extremity and vulvar varicosities, lower-extremity swelling and pain, and left-flank pain and hematuria. Multiple evidence gaps exist related to PeVDs with the consequence that nonvascular specialists rarely consider the diagnosis. Recognizing this, the Society of Interventional Radiology Foundation funded a Research Consensus Panel to prioritize a research agenda to address these gaps. This paper presents the proceedings and recommendations from that Panel.

Preliminary validation of the Claudication Symptom Instrument (CSI).

This article describes the development of the Claudication Symptom Instrument (CSI) and its measurement properties for evaluating the symptom experience of patients diagnosed with intermittent claudication (IC). We conducted semi-structured qualitative interviews with IC patients for item development and cognitive interviews in which patient comprehension of items was tested. We evaluated measurement properties using data collected and analyzed in the context of an observational comparative effectiveness study of IC treatments. Items measuring five symptom important to patients were developed and cognitively tested: Pain, Numbness, Heaviness, Cramping, and Tingling. Item means (higher means worse) ranged from 1.1 (Tingling) to 2.3 (Pain) (range: 0 'none' to 4 'extreme'). Rasch analysis yielded support for an overall score (χ2=26.5, df=20, p=0.15). The total CSI score differed by clinician-rated severity of mild versus moderate ( p<0.05), but not moderate versus severe. Re-administration of the CSI 5-10 days after baseline yielded an intra-class correlation coefficient of 0.86. Changes in CSI total score and VASCUQOL total score between baseline and 6 months post-treatment were correlated at -0.52 ( p<0.05). The CSI preliminarily meets accepted measurement standards for content validity, internal consistency and test-retest reliability, construct validity, and sensitivity for detecting change. Because of its high test-retest reliability, it may also be useful in clinical care with individual patients. It takes approximately 3 minutes to complete.

Influence of Gender on Abdominal Aortic Aneurysm Repair in the Community.

BACKGROUND: Women have been shown to experience inferior outcomes following intact and ruptured abdominal aortic aneurysm (AAA) treatment in endovascular aneurysm repair (EVAR) and open surgical repair (OSR) groups. The goal of our study was to compare gender-specific presentation, management, and early outcomes after AAA repair using a statewide registry. METHODS: We utilized the Washington State's Vascular Interventional Surgical Care and Outcomes Assessment Program registry data collected in 19 hospitals from July 2010 to September 2013. Demographics, presentation, procedural data, and outcomes in elective and emergent AAA repair groups were analyzed. RESULTS: We identified 1,231 patients (19.6% women) who underwent intact (86.4%) or ruptured AAA (13.6%) repairs. Nine thousand seventy-two (79.0%) patients had EVAR and 259 (21.0%) had OSR. Men and women were of equivalent age and had similar comorbidities, except that women had less coronary artery disease (P < 0.01) and were more likely to suffer from chronic obstructive pulmonary disease (P = 0.05). Women had smaller aneurysm diameters (5.8 ± 1.1 vs. 6.2 ± 1.8 cm, P < 0.01) at the time of presentation and men had slightly higher incidence of rupture at larger aneurysm size. Men were more likely to undergo EVAR, with significant differences in elective (82.1% vs. 74.1%, P = 0.01), but not ruptured repair. Women had significantly higher mortality rates following elective EVAR (3.1% vs. 0.6%, P = 0.01), but not after ruptured or elective open repair. Following elective EVAR, women were less likely to be discharged to home after longer hospital stays (3 vs. 2 days, P < 0.01). CONCLUSIONS: Despite presentation at a similar age, with a smaller aneurysm diameter, and similar medical comorbidities, women experience substantially worse hospital outcomes primarily driven by elective endovascular procedures. Utilization of endovascular techniques in women still remains lower compared with men. Improvement of elective outcomes in women will likely depend on technical advancements in repair techniques and management strategies that may differ between genders.

The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.

BACKGROUND: Diabetes mellitus continues to grow in global prevalence and to consume an increasing amount of health care resources. One of the key areas of morbidity associated with diabetes is the diabetic foot. To improve the care of patients with diabetic foot and to provide an evidence-based multidisciplinary management approach, the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine developed this clinical practice guideline. METHODS: The committee made specific practice recommendations using the Grades of Recommendation Assessment, Development, and Evaluation system. This was based on five systematic reviews of the literature. Specific areas of focus included (1) prevention of diabetic foot ulceration, (2) off-loading, (3) diagnosis of osteomyelitis, (4) wound care, and (5) peripheral arterial disease. RESULTS: Although we identified only limited high-quality evidence for many of the critical questions, we used the best available evidence and considered the patients' values and preferences and the clinical context to develop these guidelines. We include preventive recommendations such as those for adequate glycemic control, periodic foot inspection, and patient and family education. We recommend using custom therapeutic footwear in high-risk diabetic patients, including those with significant neuropathy, foot deformities, or previous amputation. In patients with plantar diabetic foot ulcer (DFU), we recommend off-loading with a total contact cast or irremovable fixed ankle walking boot. In patients with a new DFU, we recommend probe to bone test and plain films to be followed by magnetic resonance imaging if a soft tissue abscess or osteomyelitis is suspected. We provide recommendations on comprehensive wound care and various débridement methods. For DFUs that fail to improve (>50% wound area reduction) after a minimum of 4 weeks of standard wound therapy, we recommend adjunctive wound therapy options. In patients with DFU who have peripheral arterial disease, we recommend revascularization by either surgical bypass or endovascular therapy. CONCLUSIONS: Whereas these guidelines have addressed five key areas in the care of DFUs, they do not cover all the aspects of this complex condition. Going forward as future evidence accumulates, we plan to update our recommendations accordingly.

A comparison of Villalta-Prandoni scale and venous clinical severity score in the assessment of post thrombotic syndrome.

BACKGROUND: Post-thrombotic syndrome (PTS) is the most important late complication of acute deep venous thrombosis (DVT), with as many as two-thirds of patients developing symptoms of pain, edema, hyperpigmentation, or ulceration. Although several instruments are available for evaluation of the severity of PTS, including the Villalta-Prandoni scale (VPS) and Venous Clinical Severity Score (VCSS), no studies have yet compared the 2 instruments. The purpose of this study is to compare the 2 instruments as part of a larger randomized controlled study that assessed the impact of graduated compressive stockings in the prevention of PTS. METHODS: Sixty-nine consecutive patients with acute DVT documented by duplex ultrasonography were randomized to treatment with 30-40 mm Hg graduated compressive stockings (GCS) or no stockings. Patients were followed clinically at months 1, 3, 6, 12, 18, and 24 after the diagnosis of DVT. PTS as defined by the VPS and VCSS were assessed at these follow-up visits. Based upon the VPS, PTS was scored as absent (score <3 or 3 without objective criteria), mild to moderate (score ≥3 with 1 objective criteria), or severe (score ≥4). For the VCSS, PTS was considered to be absent (score ≤3), mild to moderate (score 4-7), or severe (score ≥8). The 2 instruments were compared for mild to moderate and severe disease using the Pearson chi-squared test and gamma statistic. RESULTS: Good correlation was detected in the ability of VPS and VCSS instruments to detect mild to moderate disease (gamma statistic = 0.71-0.98; P < 0.05). For severe disease, a statistically significant correlation was not found in the ability of the 2 instruments to detect disease (gamma statistic = 0.5-0.98; P > 0.05), especially at 12 and 24 months. CONCLUSION: Both VPS and the VCSS scoring systems are important tools in the identification and follow-up of PTS. There exists agreement between the 2 instruments for detecting mild to moderate disease. For severe disease however, VCSS may possibly be a more sensitive instrument.

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.

The anterior saphenous vein. Part 1. A position statement endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: There is a lack of clarity regarding the terminology of the anterior accessory saphenous vein (AASV) that can impact treatment outcomes. Although use of the word "accessory" implies that the vein is a superficial tributary, evidence supports its role as a truncal vein, similar to the great and small saphenous veins, and warranting a change in terminology. METHODS: A multisocietal panel was convened by the American Vein and Lymphatic Society (AVLS), the Union International of Phlebology (UIP), and the American Venous Forum (AVF). The group was charged with reviewing the existing anatomic and clinical literature pertaining to the term "anterior accessory saphenous vein" and to consider the need for alternative terminology. CONCLUSIONS: Based on the insights gathered from the literature review and extensive discussions, the panel recommends changing the terminology such that the "anterior accessory saphenous vein" (AASV) now be designated the anterior saphenous vein (ASV).

The anterior saphenous vein. Part 3. Systematic review of the literature and payor coverage policies. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

OBJECTIVE: The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage. METHODS: A literature search was performed using a PRISMA framework. In addition, a cross-sectional analysis of insurance policies for ASV treatment was evaluated. RESULTS: Published evidence and treatment considerations in the literature for ASV treatment are discussed. In 155 of 226 (68.6%) insurance policies reviewed coverage of ASV ablation was allowed while 62/226 (27.4%) did not specify coverage and 9/226 (4.0%) specified ASV treatment was not covered. Of the 155 that provide ASV coverage, 98 (62.2%) provide coverage with criteria such as requiring prior treatment of the great saphenous vein. CONCLUSIONS: Vein treatment experts should continue to advocate to insurance carriers to update their varicose vein treatment policies to reflect the substantial clinical evidence so that patients with ASV reflux can be appropriately treated.

The anterior saphenous vein. Part 4. Clinical and technical considerations in treatment. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: The decision to treat a refluxing anterior saphenous vein (ASV) should be a clinical decision based on the assessment on the ASV's contribution to patient's signs and symptoms. Once the decision to treat has been made, there are anatomic, clinical, and technical considerations in treatment planning. METHODS: Clinical scenarios were discussed by a panel of experts and common anatomic, clinical, and technical considerations were identified. RESULTS: There are unique clinical considerations such as whether both the great saphenous vein (GSV) and ASV should be concomitantly treated, if a normal ASV should be treated when treating a refluxing GSV and when and how to treat the associated tributary varicose tributaries. Being aware of the anatomic, clinical, and technical considerations allows development of a treatment plan that optimizes long-term outcomes in patients with ASV reflux. CONCLUSIONS: Ultimately the treatment plan should be tailored to address these types of variables in a patient-centered discussion.

The anterior saphenous vein. Part 2. Anatomic considerations in normal and refluxing patients. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: The term Anterior Accessory of the Great Saphenous Vein suggests this is a branch tributary vein despite this vessel's anatomic features of a truncal vein. A multisocietal group suggested to designate this the anterior saphenous vein (ASV). This study was aimed to evaluate its ultrasound anatomy in normal and varicose limbs. METHODS: The clinical anatomy of the ASV was evaluated by narrative review of the literature. Additionally, the course of the ASV was evaluated in 62 limbs with no evidence of venous disease and 62 limbs with varicosities. RESULTS: The ASV length, patterns of origin and termination are reported in both normal and patients with varicose veins. Discussion of the patterns is supported by the narrative review of the literature. CONCLUSIONS: The ASV must be considered a truncal vein and its treatment modalities should be the same that for the great and small saphenous veins rather than a tributary vein.

The anterior saphenous vein. Part 1. A position statement endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

BACKGROUND: There is a lack of clarity regarding the terminology of the anterior accessory saphenous vein (AASV) that can impact treatment outcomes. Although use of the word "accessory" implies that the vein is a superficial tributary, evidence supports its role as a truncal vein, similar to the great and small saphenous veins, and warranting a change in terminology. METHODS: A multisocietal panel was convened by the American Vein and Lymphatic Society (AVLS), the Union International of Phlebology (UIP), and the American Venous Forum (AVF). The group was charged with reviewing the existing anatomic and clinical literature pertaining to the term "anterior accessory saphenous vein" and to consider the need for alternative terminology. CONCLUSION: Based on the insights gathered from the literature review and extensive discussions, the panel recommends changing the terminology such that the "anterior accessory saphenous vein" (AASV) now be designated the anterior saphenous vein (ASV).

The Anterior Saphenous Vein. Part 2. Anatomic considerations in normal and refluxing patients. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum and the International Union of Phlebology.

BACKGROUND: The term Anterior Accessory of the Great Saphenous Vein suggest this is a branch tributary vein despite this vessel's anatomic features of a truncal vein. A multisocietal group suggested to designate this the Anterior Saphenous Vein (ASV). This study was aimed to evaluate its ultrasound anatomy in normal and varicose limbs. METHODS: The clinical anatomy of the ASV was evaluated by narrative review of the literature. Additionally, the course of the ASV was evaluated in 62 limbs with no evidence of venous disease and 62 limbs with varicosities. RESULTS: The ASV length, patterns of origin and termination are reported in both normal and patients with varicose veins. Discussion of the patterns is supported by the narrative review of the literature. CONCLUSIONS: The ASV must be considered a truncal vein and its treatment modalities should be the same that for the great and small saphenous veins rather than a tributary vein.