Peri-procedure management of antithrombotic agents and thrombocytopenia for common procedures in oncology: Guidance from the SSC of the ISTH.

Patients with cancer have an increased risk of thrombosis requiring anticoagulants and/or antiplatelet agents, and they can also encounter thrombocytopenia due to cancer itself or cancer therapies. They often undergo many procedures such as tissue or bone marrow biopsies, placement of central access lines, diagnostic or therapeutic draining procedures, lumbar puncture, and more. Management of antithrombotic agents or thrombocytopenia around the time of these procedures is highly variable. In this document, the Hemostasis and Malignancy Subcommittee of the International Society on Thrombosis and Haemostasis aims to provide useful practice guidance in the management of antithrombotic agents and thrombocytopenia around the time of common procedures in patients with cancer.

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.

Performance of two clinical scales to assess quality of life in patients with post-thrombotic syndrome.

OBJECTIVE: We directly compared the Villalta scale and the Venous Clinical Severity Score (VCSS) to determine which of the two measures would be better at capturing clinically important cases of post-thrombotic syndrome (PTS) and PTS severity compared with patient-reported quality of life (QOL) scores. METHODS: We performed a secondary analysis of the ATTRACT (acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) trial study population. We calculated the correlations of the Villalta scores and VCSSs with QOL scores (short-form 36-item health survey [SF-36] physical component summary [PCS] and mental component summary [MCS]; and VEINES [venous insufficiency epidemiological and economic study]-QOL/symptom [VEINES-QOL/Sym] questionnaire) at each study visit (6, 12, 18, and 24 months of follow-up). The correlation of the random intercept (mean scores) and random slope (rate of change of the scores) among the Villalta scores, VCSS, and VEINES-QOL/Sym scores was assessed using a multivariate longitudinal model. RESULTS: The median correlation between Villalta scores and VCSSs was 0.72. The median correlation between the Villalta scores and VEINES-QOL and VEINES-Sym scores at all follow-up visits was -0.68 and -0.71, respectively. The median correlation between the Villalta scores and SF-36 PCS and MCS scores was -0.51 and -0.31, respectively. For the VCSSs, the median correlation with the VEINES-QOL and VEINES-Sym scores at all follow-up visits was -0.39 and -0.41, respectively. The median correlation between the VCSSs and SF-36 PCS and MCS scores was -0.32 and -0.13, respectively. The correlations between the random effects in the multivariate longitudinal models showed a similar pattern. The effect of covariate adjustment by age, sex, and body mass index was minor. CONCLUSIONS: The Villalta scores and VCSSs correlated strongly. The Villalta scale showed a substantially greater correlation with venous disease-specific and general QOL scores compared with the correlation with the VCSS. Our findings suggest that when a single scale is used to assess for clinically meaningful PTS, the Villalta scale will better capture the effects of PTS on patient-reported QOL.

Gastrointestinal Malignancies and Venous Thromboembolic Disease: Clinical Significance and Endovascular Interventions.

Gastrointestinal malignancy encompasses a wide range of disease processes. Its incidence and mortality rate rank among the highest of all cancers. Venous thromboembolic disease is a common complication of gastrointestinal malignancy. Anticoagulation remains the first-line therapy. However, for patients who cannot tolerate or have failed anticoagulation, inferior vena cava (IVC) filter placement may be an option. Furthermore, to improve symptom resolution and reduce the severity of postthrombotic syndrome, catheter-directed thrombolysis (CDT) may be an option. Recent randomized trials including the ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) trial have shed new light on the efficacy and safety of CDT and related methods. Overall, the decision to proceed with IVC filter placement or CDT must be individualized.

Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis.

BACKGROUND: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT. METHODS: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups. RESULTS: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups. CONCLUSIONS: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

Analysis of threshold stenosis by multiplanar venogram and intravascular ultrasound examination for predicting clinical improvement after iliofemoral vein stenting in the VIDIO trial.

BACKGROUND: Selecting patients for iliofemoral vein stenting has traditionally relied on the identification and quantification of stenotic lesions with imaging such as multiplanar venography. Recently, intravascular ultrasound (IVUS) imaging has become more available. However, to date, the usefulness of these imaging modalities using the customary >50% treatment threshold for diameter (multiplanar venography) and area (IVUS) stenosis of iliofemoral veins has not been validated prospectively within the context of clinical improvement. METHODS: The multicenter Venogram Versus Intravascular Ultrasound for Diagnosing and Treating Iliofemoral Vein Obstruction (VIDIO) trial prospectively enrolled 100 symptomatic patients (Clinical Etiologic Anatomic Pathophysiologic [CEAP] classification of 4-6) with suspected iliofemoral venous outflow disease. Venous stenting for presumed significant iliofemoral vein stenosis, based on imaging and clinical findings, was performed on 68 patients. Based on imaging, stenosis was characterized as nonthrombotic in 48 patients and post-thrombotic in 20 patients. Each underwent baseline and poststenting venography and IVUS to compare the diagnostic and clinical usefulness of the tests. The revised Venous Clinical Severity Score was used to assess clinical patient outcome. A >4-point reduction in the revised Venous Clinical Severity Score between baseline and 6 months was used as an indicator of clinically meaningful improvement. Receiver operating characteristic curve analysis was used to determine the optimal diameter and area thresholds for prediction of clinical improvement. RESULTS: Clinical improvement after stenting was best predicted by IVUS baseline measurement of area stenosis (area under the curve, 0.64; P = .04), with >54% estimated as the optimal threshold of stenosis indicating interventional treatment. With measurement of lumen gain from baseline to after the procedure, the optimal reduction in vein stenosis correlative of later clinical improvement was >41%; IVUS measurement of area stenosis was most predictive (area under the curve, 0.70; P = .004). Venographic measurements of baseline stenosis and stenotic change were not predictive of later improvement. In a 48-patient nonthrombotic subset analysis, IVUS diameter rather than area measurements of baseline stenosis were significantly predictive of clinical success, but indicated a higher optimal threshold of stenosis (>61%) may be necessary. CONCLUSIONS: This study suggests that IVUS shows significant usefulness at predicting when stenting iliofemoral vein stenosis in patients clinical-etiologic-anatomic-pathophysiologic classification of 4-6 will result in significant symptom improvement. Our findings corroborate the conventional >50% cross-sectional area threshold by IVUS as defining a clinically significant iliofemoral stenosis that, when stented, has significant predictive value for symptom improvement. In nonthrombotic patients, however, a threshold of >61% diameter stenosis by IVUS may better predict clinical improvement.

Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction.

OBJECTIVE: The Venogram vs IVUS for Diagnosing Iliac vein Obstruction (VIDIO) trial was designed to compare the diagnostic efficacy of intravascular ultrasound (IVUS) with multiplanar venography for iliofemoral vein obstruction. METHODS: During a 14-month period beginning July 2014, 100 patients with chronic Clinical, Etiologic, Anatomic, and Pathophysiologic clinical class C4 to C6 venous disease and suspected iliofemoral vein obstruction were enrolled at 11 U.S. and 3 European sites. The inferior vena cava and common iliac, external iliac, and common femoral veins were imaged. Venograms were measured for vein diameter; IVUS provided diameter and area measurements. Multiplanar venograms included three views: anteroposterior and 30-degree right and left anterior oblique views. A core laboratory evaluated the deidentified images, determining stenosis severity as the ratio between minimum luminal diameter and reference vessel diameter, minimal luminal area, and reference vessel area. A 50% diameter stenosis by venography and a 50% cross-sectional area reduction by IVUS were considered significant. Analyses assessed change in procedures performed on the basis of imaging method and concordance of measurements between each imaging method. RESULTS: Venography identified stenotic lesions in 51 of 100 subjects, whereas IVUS identified lesions in 81 of 100 subjects. Compared with IVUS, the diameter reduction was on average 11% less for venography (P < .001). The intraclass correlation coefficient was 0.505 for vein diameter stenosis calculated with the two methods. IVUS identified significant lesions not detected with three-view venography in 26.3% of patients. Investigators revised the treatment plan in 57 of 100 cases after IVUS, most often because of failure of venography to detect a significant lesion (41/57 [72%]). IVUS led to an increased number of stents in 13 of 57 subjects (23%) and the avoidance of an endovascular procedure in 3 of 57 subjects (5%). Overall, IVUS imaging changed the treatment plan in 57 patients; 54 patients had stents placed on the basis of IVUS detection of significant iliofemoral vein obstructive lesions not appreciated with venography, whereas 3 patients with significant lesions on venography had no stent placed on the basis of IVUS. CONCLUSIONS: IVUS is more sensitive for assessing treatable iliofemoral vein stenosis compared with multiplanar venography and frequently leads to revised treatment plans and the potential for improved clinical outcome.

Deep Vein Thrombosis Interventions in Cancer Patients.

The presence of cancer increases the risk of deep vein thrombosis (DVT), DVT recurrence, and treatment-related bleeding, and therefore offers distinctive clinical considerations when planning treatment. Anticoagulation with a low-molecular-weight heparin is the preferred initial and long-term therapy in cancer patients. Inferior vena cava filters may be used judiciously for patients with cancer-related DVT who have contraindications to anticoagulation or who exhibit breakthrough pulmonary embolism (PE) despite anticoagulation, but should be removed when the PE risk is felt to subside. Because moderate-quality evidence suggests that the use of catheter-directed thrombolysis (CDT) can prevent the postthrombotic syndrome, cancer patients with acute iliofemoral DVT, low expected bleeding risk, and good functional status may reasonably be considered for CDT if DVT-related sequelae are likely to be a dominant contributor to the patient's clinical condition, functional status, and quality of life. In selected patients who have chronic venous symptoms from mass/nodal compression of the pelvic veins, endovascular stent placement may provide symptom relief. As current recommendations are based on very limited data, further studies would be welcome to better delineate the most appropriate use of endovascular therapies in patients with cancer.

Program requirements for fellowship education in venous and lymphatic medicine.

Background In every field of medicine, comprehensive education should be delivered at the graduate level. Currently, no single specialty routinely provides a standardized comprehensive curriculum in venous and lymphatic disease. Method The American Board of Venous & Lymphatic Medicine formed a task force, made up of experts from the specialties of dermatology, family practice, interventional radiology, interventional cardiology, phlebology, vascular medicine, and vascular surgery, to develop a consensus document describing the program requirements for fellowship medical education in venous and lymphatic medicine. Result The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine identify the knowledge and skills that physicians must master through the course of fellowship training in venous and lymphatic medicine. They also specify the requirements for venous and lymphatic training programs. The document is based on the Core Content for Training in Venous and Lymphatic Medicine and follows the ACGME format that all subspecialties in the United States use to specify the requirements for training program accreditation. The American Board of Venous & Lymphatic Medicine Board of Directors approved this document in May 2016. Conclusion The pathway to a vein practice is diverse, and there is no standardized format available for physician education and training. The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine establishes educational standards for teaching programs in venous and lymphatic medicine and will facilitate graduation of physicians who have had comprehensive training in the field.

Endovascular Interventions for Acute and Chronic Lower Extremity Deep Venous Disease: State of the Art.

The societal and individual burden caused by acute and chronic lower extremity venous disease is considerable. In the past several decades, minimally invasive endovascular interventions have been developed to reduce thrombus burden in the setting of acute deep venous thrombosis to prevent both short- and long-term morbidity and to recanalize chronically occluded or stenosed postthrombotic or nonthrombotic veins in symptomatic patients. This state-of-the-art review provides an overview of the techniques and challenges, rationale, patient selection criteria, complications, postinterventional care, and outcomes data for endovascular intervention in the setting of acute and chronic lower extremity deep venous disease. Online supplemental material is available for this article.

Postthrombotic syndrome: feasibility of a strategy of imaging-guided endovascular intervention.

PURPOSE: To describe the short-term efficacy of a strategy of imaging-guided endovascular intervention for the treatment of patients with established postthrombotic syndrome (PTS). MATERIALS AND METHODS: The medical records of 183 patients with venous disease who were seen in a single interventional radiology clinic were retrospectively reviewed. Study inclusion criteria were (i) endovascular intervention performed to treat established PTS from January 1, 2000, to March 10, 2009; (ii) patient age greater than 18 years; and (iii) availability of follow-up records. A total of 44 patients (20 men, 24 women; mean age, 42.2 y ± 14.1) with PTS who had received 72 interventions (iliac vein stent placement [n = 52] and endovenous laser ablation [EVLA; n = 20]) were identified. A reviewer who did not participate in their care evaluated the follow-up records; recorded the presence or absence of pain, swelling, and active ulceration; and categorized the degree of symptom improvement. RESULTS: Of 45 treated limbs in 40 patients with available follow-up, complete, partial, or no improvement of overall symptoms was observed in 46.7%, 33.3%, and 20.0%, respectively. The proportions of limbs with pain (35.0% after treatment vs 82.5% before; McNemar test, P < .01) and swelling (50.0% after treatment vs 90.0% before; P < .01) were significantly reduced after treatment with iliac vein stent placement and/or EVLA. Six of seven ulcerated limbs showed significant healing. CONCLUSIONS: The use of an endovascular strategy to treat patients with established PTS was associated with complete or partial symptom relief in 80% of patients at short-term follow-up.

Inferior vena cava filter placement in the gynecologic oncology patient: A 15-year institutional experience.

OBJECTIVE: Venous thrombosis is a frequent complication of gynecologic cancer. Data regarding the use of inferior vena cava (IVC) filters in this population is limited. The aim of this study was to review our experience with gynecologic oncology patients who received an IVC filter, specifically to evaluate indications for filter placement and survival outcomes. METHODS: This was a retrospective, single-institution study of patients who had an IVC filter placed after a histologically confirmed gynecologic malignancy. Patients were identified from a prospectively collected interventional radiology (IR) database. Clinicopathologic characteristics, procedure details, and outcome data were obtained from outpatient and inpatient medical records. Survival after IVC filter placement was analyzed using the Kaplan-Meier product limit method and compared by log-rank test. RESULTS: A total of 128 patients were identified and 103 were found to be eligible for analysis. Most patients had ovarian cancer (52%), followed by cervical cancer (25%) and endometrial cancer (21%). Two-thirds had advanced stage disease (III/IV). The procedure complication rate was 2%. Median survival after IVC filter placement was 7.8months (95% CI, 4.1-13.6). The most common indication for IVC filter placement was contraindication to anticoagulation secondary to hemorrhage (44%), followed by perioperative indications (30%) and failed anticoagulation (14%). There was no difference in survival by IVC filter placement indication (p=0.18). The majority of the IVC filters placed were permanent (90.5%) and in an infrarenal position (95.8%). There was no difference in survival according to specific thromboembolic event (DVT vs. PE vs. both). Patients able to receive anticoagulation after IVC filter placement had improved survival (HR 0.45, 95%CI 0.45-0.27, p=0.003). CONCLUSIONS: We present the largest series of gynecologic oncology patients treated with IVC filters. Long-term survival after IVC filter placement is uncommon. Patients who receive anticoagulation after IVC filter placement have an improved survival over those who do not receive anticoagulation; this difference in survival may be secondary to worsening disease causing contraindications to anticoagulation.

Deep venous thrombosis: the opportunity at hand.

OBJECTIVE: The use of imaging-guided treatments for deep venous thrombosis (DVT) is accelerating. Increased appreciation of the impact of postthrombotic syndrome on DVT patients' quality of life and advances in thrombolytic methods have together sparked an unprecedented degree of interdisciplinary collaboration in developing contemporary DVT treatment guidelines and a pivotal clinical trial to establish the risk-benefit ratio of interventional DVT therapy. CONCLUSION: Radiologists should improve their DVT education, support ongoing clinical trials, and collaborate with DVT-focused nonradiologists in their institutions.

Image-guided tumor ablation: standardization of terminology and reporting criteria.

The field of interventional oncology with use of image-guided tumor ablation requires standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison between treatments that use different technologies, such as chemical (ethanol or acetic acid) ablation, and thermal therapies, such as radiofrequency (RF), laser, microwave, ultrasound, and cryoablation. This document provides a framework that will hopefully facilitate the clearest communication between investigators and will provide the greatest flexibility in comparison between the many new, exciting, and emerging technologies. An appropriate vehicle for reporting the various aspects of image-guided ablation therapy, including classification of therapies and procedure terms, appropriate descriptors of imaging guidance, and terminology to define imaging and pathologic findings, are outlined. Methods for standardizing the reporting of follow-up findings and complications and other important aspects that require attention when reporting clinical results are addressed. It is the group's intention that adherence to the recommendations will facilitate achievement of the group's main objective: improved precision and communication in this field that lead to more accurate comparison of technologies and results and, ultimately, to improved patient outcomes. The intent of this standardization of terminology is to provide an appropriate vehicle for reporting the various aspects of image-guided ablation therapy.