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Introduction: There are no randomized trials studying the outcomes of mechanical aspiration thrombectomy (MAT) for management of pulmonary embolism (PE). Methods: We performed a systematic review and meta-analysis of existing literature to evaluate the safety and efficacy of MAT in the setting of PE. Inclusion criteria were as follows: studies reporting more than five patients, study involved MAT, and reported clinical outcomes and pulmonary artery pressures. Studies were excluded if they failed to separate thrombectomy data from catheter-directed thrombolysis data. Databases searched include PubMed, EMBASE, Web of Science until April, 2021. Results: Fourteen case series were identified, consisting of 516 total patients (mean age 58.4 ± 13.6 years). Three studies had only high-risk PE, two studies had only intermediate-risk PE, and the remaining nine studies had a combination of both high-risk and intermediate-risk PE. Six studies used the Inari FlowTriever device, five studies used the Indigo Aspiration system, and the remaining three studies used the Rotarex or Aspirex suction thrombectomy system. Four total studies employed thrombolytics in a patient-specific manner, with seven receiving local lysis and 17 receiving systemic lysis, and 40 receiving both. A random-effects meta-analyses of proportions of in-hospital mortality, major bleeding, technical success, and clinical success were calculated, which yielded estimate pooled percentages [95% CI] of 3.6% [0.7%, 7.9%], 0.5% [0.0%, 1.8%], 97.1% [94.8%, 98.4%], and 90.7% [85.5%, 94.3%]. Conclusion: There is significant heterogeneity in clinical, physiologic, and angiographic data in the currently available data on MAT. RCTs with consistent parameters and outcomes measures are still needed.

Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA).The aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE).Patients with symptoms of acute PE with computed tomographic evidence of RV dilatation were enrolled. The Bashir catheter was used to deliver 7 mg tPA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory-assessed change in computed tomographic angiography-derived RV/left ventricular (LV) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events (SAEs) including major bleeding at 72 hours.At 18 U.S. sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT, the RV/LV diameter ratio decreased by 0.56 (33.3%; P 0.0001). PA obstruction as measured by the refined modified Miller index was reduced by 35.9% (P 0.0001). One patient (0.92%) had 2 SAEs: a retroperitoneal bleed (procedure related) and iliac vein thrombosis (device related). Two other procedure-related SAEs were epistaxis and non-access site hematoma with anemia.PM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and a very low rate of adverse events or major bleeding in patients with intermediate-risk acute PE. The notable finding was a significant reduction in PA obstruction with low-dose tPA. (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden [RESCUE]; NCT04248868).

Although inferior vena cava (IVC) thrombosis is infrequently encountered, it carries a significant risk of post-thrombotic syndrome and pulmonary embolus. Recent studies show no difference in the incidence of post-thrombotic syndrome in patients with iliofemoral deep venous thrombosis (DVT) treated with pharmacothrombolysis vs anticoagulation alone; however, there is an associated increased risk of bleeding. The treatment of IVC thrombosis is less well-studied and the hemodynamic changes may be more significant with pharmacothrombolysis, although the bleeding risk remains. The ClotTriever and FlowTriever systems remove thrombus from veins without the use of thrombolytics. Our study evaluates outcomes of patients undergoing mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and FlowTriever devices.A retrospective chart review was performed to identify consecutive patients who underwent mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and/or FlowTriever systems from November 2018 to January 2020 at four data-sharing institutions. The decision of which device(s) to use was at the discretion of the surgeon. Patient demographics, symptomatology, and imaging characteristics were captured at presentation and follow-up.A total of 15 patients met the inclusion criteria; 10 were male, and the average age was 59 years. The majority of patients were symptomatic at presentation (n = 14), had a prior history of DVT (n = 13), and had a preexisting IVC filter (n = 8). Eleven patients presented with acute onset (1 week) of symptoms, whereas three patients had subacute (1-4 weeks) symptoms. Most patients had an associated iliofemoral DVT (n = 13) and were treated with both ClotTriever and FlowTriever (n = 8); others were treated with either ClotTriever or FlowTriever alone (n = 5 and n = 2, respectively). Technical success was achieved in all but two patients, one who had a nonocclusive thrombus densely adherent to a preexisting IVC filter and another who had a chronic rubbery clot in the IVC that could not be cleared. No patient required concomitant lytic therapy or a postoperative stay in the intensive care unit. Furthermore, there were no postoperative bleeding events, myocardial infarctions, pulmonary emboli, renal impairments, or deaths. The median length of stay was 3 days (range, 1-37 days). Patients underwent postoperative follow-up (n = 7) as well as extended follow-up (6 months; n = 8). All patients who achieved technical success were asymptomatic without evidence of reocclusion of the IVC on follow-up imaging.In our multicenter series of 15 patients, The ClotTriever and FlowTriever showed promise in the treatment of IVC thrombosis without the use of fibrinolytic drugs, with no bleeding events and no requirement for intensive care unit stay.

Superior vena cava (SVC) syndrome comprises a constellation of clinical signs and symptoms caused by obstruction of blood flow through the SVC. The management of patients with life-threatening SVC syndrome is evolving from radiation therapy to endovascular therapy as the first-line treatment. There is a paucity of data and societal guidelines with regard to the management of SVC syndrome. This paper aims to update the practicing interventionalists with the contemporary and the evolving therapeutic approach to SVC syndrome. In addition, the review will focus on endovascular techniques, including catheter-directed thrombolysis, angioplasty, and stenting, and their associated complications.

The right ventricular outflow tract (RVOT) velocity time integral (VTI), an echocardiographic measure of stroke distance, correlates with cardiac index. We sought to determine the prognostic significance of low RVOT VTI on clinical outcomes among patients with acute pulmonary embolism (PE).We conducted a retrospective review of echocardiograms on Pulmonary Embolism Response Team (PERT) activations at our institution. The main outcome was a composite of death, cardiac arrest, or hemodynamic deterioration.Of 188 patients, 30 met the combined outcome (16%) and had significantly lower RVOT VTI measurements (9.0 cm v 13.4 cm, p 0.0001). The AUC for RVOT VTI at a cutoff of 10 cm was 0.78 (95% CI 0.67-0.90) with a sensitivity, specificity, negative predictive value, and positive predictive value of 0.72, 0.81, 0.94, and 0.42, respectively. Fifty-two patients of the cohort were classified as intermediate-high-risk PE and 21% of those met the combined outcome. RVOT VTI was lower among outcome positive patients (7.3 cm v 10.7 cm, p = 0.02).Low RVOT VTI is associated with poor clinical outcomes among patients with acute PE.

Coronavirus disease 2019 (COVID-19) is associated with increased rates of deep vein thrombosis (DVT) and pulmonary embolism (PE). Pulmonary Embolism Response Teams (PERT) have previously been associated with improved outcomes. We aimed to investigate whether PERT utilization, recommendations, and outcomes for patients diagnosed with acute PE changed during the COVID-19 pandemic. This is a retrospective cohort study of all adult patients with acute PE who received care at an academic hospital system in New York City between March 1st and April 30th, 2020. These patients were compared against historic controls between March 1st and April 30th, 2019. PE severity, PERT utilization, initial management, PERT recommendations, and outcomes were compared. There were more cases of PE during the pandemic (82 vs. 59), but less PERT activations (26.8% vs. 64.4%, p

Background Pulmonary embolism response teams (PERTs) have become increasingly popular at institutions around the country, although the evidence to support their efficacy is limited. PERTs are mechanisms for rapid involvement of a multidisciplinary team in the management of a time-sensitive condition with many treatment options. Methods We retrospectively reviewed 201 patients with PERT activations since inception, collecting data on demographics, time to treatment, treatment modality, and in-hospital outcomes. Results Massive pulmonary embolism accounted for 16 (8.7%) PERT activations. The majority of patients were treated without invasive intervention; 91.4% (95% confidence interval [CI], 87.1%-95.7%) of patients received anticoagulation alone, 4.5% (95% CI, 0%-18.6%) had catheter-directed therapy (CDT), and 3.0% (95% CI, 0%-16.9%) had systemic administration of tissue plasminogen activator (tPA). The average time to intervention was 665 minutes (95% CI, 249-1080 minutes) for CDT and 22 minutes (95% CI, 0-456 minutes) for systemic TPA. The average time to anticoagulation was 2.3 minutes (95% CI, 0-43 minutes). There was a trend toward higher rates of cardiac events (odds ratio [OR], 12.68; 95% CI, 0.62-65.74) and death (OR, 3.19; 95% CI, 0.28-5.18) among patients with massive PE. There was a higher rate of cardiac events (OR, 5.66; 95% CI, 1.34-23.83) among patients who received tPA or an invasive intervention. There was no difference in mortality rates of patients who underwent aggressive management compared with anticoagulation alone. Conclusions A dedicated PERT results in efficient delivery of care and excellent outcomes, in part owing to the rapid (on average, 8 minutes) time to initiation of a multidisciplinary discussion. Patients who ultimately underwent CDT had an interval of >10 hours on average between diagnosis and CDT. This provisional or delayed approach to CDT in selected patients who were not improving with anticoagulation alone (and therefore had potential for higher net benefit from a procedure with its own inherent risks) may have resulted in a lower rate of CDT.

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.

Acute pulmonary embolism (PE) is a major public health problem and accounts for 100,000–180,000 deaths per year in the United States. Current prognostic stratification separates acute PE into massive, submassive, and low-risk by the presence or absence of sustained hypotension, RV dysfunction, and myocardial necrosis. Massive, submassive and low-risk PE have mortality rates of 25–65%, 3%, and

Objectives Venous thromboembolism, including deep venous thrombosis and pulmonary embolism, is a major source of morbidity, mortality, and healthcare utilization. Given the prevalence of venous thromboembolism and its associated mortality, our study sought to identify factors associated with loss to follow-up in venous thromboembolism patients. Methods This is a single-center retrospective study of all consecutive admitted (inpatient) and emergency department patients diagnosed with acute venous thromboembolism via venous duplex examination and/or chest computed tomography from January 2018 to March 2019. Patients with chronic deep venous thrombosis and those diagnosed in the outpatient setting were excluded. Lost to venous thromboembolism-specific follow-up (LTFU) was defined as patients who did not follow up with vascular, cardiology, hematology, oncology, pulmonology, or primary care clinic for venous thromboembolism management at our institution within three months of initial discharge. Patients discharged to hospice or dead within 30 days of initial discharge were excluded from LTFU analysis. Statistical analysis was performed using STATA 16 (College Station, TX: StataCorp LLC) with a p-value of Results During the study period, 291 isolated deep venous thrombosis, 25 isolated pulmonary embolism, and 54 pulmonary embolism with associated deep venous thrombosis were identified in 370 patients. Of these patients, 129 (35%) were diagnosed in the emergency department and 241 (65%) in the inpatient setting. At discharge, 289 (78%) were on anticoagulation, 66 (18%) were not, and 15 (4%) were deceased. At the conclusion of the study, 120 patients (38%) had been LTFU, 85% of whom were discharged on anticoagulation. There was no statistically significant difference between those LTFU and those with follow-up with respect to age, gender, diagnosis time of day, venous thromboembolism anatomic location, discharge unit location, or anticoagulation choice at discharge. There was a non-significant trend toward longer inpatient length of stay among patients LTFU (16.2 days vs. 12.3 days, p = 0.07), and a significant increase in the proportion of LTFU patients discharged to a facility rather than home ( p = 0.02). On multivariate analysis, we found a 95% increase in the odds of being lost to venous thromboembolism-specific follow-up if discharged to a facility (OR 1.95, CI 1.1–3.6, p = 0.03) as opposed to home. Conclusions Our study demonstrates that over one-third of patients diagnosed with venous thromboembolism at our institution are lost to venous thromboembolism-specific follow-up, particularly those discharged to a facility. Our work suggests that significant improvement could be achieved by establishing a pathway for the targeted transition of care to a venous thromboembolism-specific follow-up clinic.

Background: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE). Methods: Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy. Results: Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 ( P =0.0009 [95% CI, 0.33–0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 ( P =0.0005; [95% CI, 5.5–13.4]; 37.1% reduction). Conclusions: In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03927508.

Introduction We recently proposed a scale for assessment of patient-relevant functional limitations following an episode of venous thromboembolism (VTE). Further development of this post-VTE functional status (PVFS) scale is still needed. Methods Guided by the input of VTE experts and patients, we refined the PVFS scale and its accompanying manual, and attempted to acquire broad consensus on its use. Results A Delphi analysis was performed involving 53 international VTE experts with diverse scientific and clinical backgrounds. In this process, the number of scale grades of the originally proposed PVFS scale was reduced and descriptions of the grades were improved. After these changes, a consensus was reached on the number/definitions of the grades, and method/timing of the scale assessment. The relevance and potential impact of the scale was confirmed in three focus groups totaling 18 VTE patients, who suggested additional changes to the manual, but not to the scale itself. Using the improved manual, the κ-statistics between PVFS scale self-reporting and its assessment via the structured interview was 0.75 (95%CI 0.58–1.0), and 1.0 (95%CI 0.83–1.0) between independent raters of the recorded interview of 16 focus groups members. Conclusion We improved the PVFS scale and demonstrated broad consensus on its relevance, optimal grades, and methods of assessing among international VTE experts and patients. The interobserver agreement of scale grade assignment was shown to be good-to-excellent. The PVFS scale may become an important outcome measure of functional impairment for quality of patient care and in future VTE trials.

Endovascular management of pulmonary embolism can be divided into therapeutic and prophylactic treatments. Prophylactic treatment includes inferior vena cava filter placement, whereas endovascular therapeutic interventions include an array of catheter-directed therapies. The indications for both modalities have evolved over the last decade as new evidence has become available.

This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE).PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking.This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval.A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively.In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566).

Purpose To assess trends in inferior vena cava (IVC) filter placement and retrieval procedures in Medicare beneficiaries over the last two decades. Methods Using Physician/Supplier Procedure Summary Master Files from 1994 through 2015, we calculated utilization rates for IVC filter placement and retrieval procedures in Medicare fee-for-service beneficiaries. Services were stratified by provider specialty group and site of service. Results IVC filter placement rates increased from 1994 to 2008 (from 65.0 to 202.1 per 100,000 beneficiaries, compound annual growth rate [CAGR] +8.4%) and then decreased to 128.9 by 2015 (CAGR −6.2%). This decrease was observed across all specialty groups and sites of service. From 1994 to 2015, placement procedure market share increased for radiologists (from 45.1% to 62.7%) and cardiologists (from 2.5% to 6.7%) but decreased for surgeons (from 46.6% to 27.9%). Overall, procedures shifted slightly from the inpatient (from 94.5% to 86.5% of all procedures) to outpatient hospital (from 4.9% to 14.9%) settings. Between 2012 and 2015, retrieval rates increased from 12.0 to 17.7 (CAGR +13.9%). Retrievals as a percentage of placement procedures were similar across specialties in 2015 (range 13.0%-13.8%). Conclusion Despite prior dramatic growth, the utilization of IVC filters in Medicare beneficiaries markedly declined over the last decade, likely relating to evolving views regarding efficacy and long-term safety. This decline was accompanied by several filter-related market shifts, including increasing placement by radiologists and cardiologists, increasing outpatient placement procedures, and increasing retrieval rates.

Anesthesiologists are familiar with pulmonary emboli prophylaxis paradigms and many have witnessed acute intraoperative embolization. Clinicians must balance conservative anticoagulation and aggressive intervention in perioperative submassive pulmonary emboli, yet the bulk of the literature excludes surgery as a relative contraindication. This review will summarize the current treatment options for acute pulmonary emboli, drawing attention to special considerations in perioperative submassive pulmonary emboli, and discuss right ventricular monitoring to improve assessment of intervention efficacy.Recent reviews have identified the elevated risk and inadequacy of treatment of pulmonary embolism in intra and postoperative patients, in part because of the risks of systemic anticoagulation. Early studies of catheter-directed therapies have shown promising efficacy with a reduction in bleeding risk, which is especially important for perioperative patients. Success relies on defining endpoints, yet the practice of measuring mean pulmonary artery pressure alone to assess intervention efficacy is flawed.Identifying submassive pulmonary emboli that requires treatment and optimizing therapy remains difficult. Researchers must consider avoiding systemic anticoagulation and focus on designing trials that evaluate intervention efficacy in surgical patients. The success of catheter-directed therapy in early trials warrants further investigation into using these therapies in the treatment of perioperative submassive pulmonary emboli.

Pulmonary Embolism Response Teams (PERTs) have emerged to provide rapid multidisciplinary assessment and treatment of PE patients. However, descriptive institutional experience and preliminary outcomes data from such teams are sparse. PERT activations were identified through a retrospective review. Only confirmed submassive or massive PEs were included in the data analysis. In addition to baseline variables, the therapeutic intervention, length of stay (LOS), in-hospital mortality, and bleeding rate/severity were recorded. A total of 124 PERT activations occurred over 20 months: 43 in the first 10 months and 81 in the next 10. A total of 87 submassive (90.8%) and massive (9.2%) PE patients were included. The median age was 65 (51–75 IQR) years. Catheter-directed thrombolysis (CDT) was administered to 25 patients, systemic thrombolysis (ST) to six, and anticoagulation alone (AC) to 54. The median ICU stay and overall LOS were 6 (3–10 IQR) and 7 (4–14 IQR) days, respectively, with no association with any variables except a brain natriuretic peptide (BNP) >100 pg/mL ( p=0.008 ICU LOS; p=0.047 overall LOS). Twelve patients (13.7%) died in the hospital, nine of whom had metastatic or brain cancer, with a median overall LOS of 13 (11–17 IQR) days. There were five major bleeds: one in the CDT group, one in the ST group, and three in the AC group. Overall, (1) PERT activations increased after the first 10 months; (2) BNP >100 pg/mL was associated with a longer LOS; (3) rates of mortality and bleeding did not correlate with treatment; and (4) the majority of in-hospital deaths occurred in patients with advanced cancer.

While pulmonary embolism (PE) causes approximately 100 000-180 000 deaths per year in the United States, mortality is restricted to patients who have massive or submassive PEs. This state of the art review familiarizes the reader with these categories of PE. The review discusses the following topics: pathophysiology, clinical presentation, rationale for stratification, imaging, massive PE management and outcomes, submassive PE management and outcomes, and future directions. It summarizes the most up-to-date literature on imaging, systemic thrombolysis, surgical embolectomy, and catheter-directed therapy for submassive and massive PE and gives representative examples that reflect modern practice.

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.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.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.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.

To evaluate the feasibility and benefits of performing yttrium-90 radioembolization in an office-based lab (OBL) compared to a hospital setting.A radioembolization program was established in March 2019 in an OBL that is managed by the radiology department of a tertiary care center. Mapping and treatment angiograms performed in the OBL from March 2019 through January 2020 were compared to mapping and treatment angiograms performed in the hospital during the same time period.One hundred seventy-six mapping and treatment angiograms were evaluated. There was no difference in the proportion of mapping versus treatment angiograms performed at each site, the proportion of lobar versus selective dose vial administrations, or the mean number of dose vials administered per treatment procedure. Procedure start delays were longer in the hospital than in the OBL (28.6 minutes vs 0.8 minutes; P.0001), particularly for procedures that were not scheduled as the first case of the day (hospital later case delay, 38.8 minutes vs OBL later case delay, 0.5 minutes; P.0001). Procedures performed in the hospital took longer on average than procedures performed in the OBL (2 hours, 1.8 minutes vs 1 hour, 44.4 minutes; P = .0004), particularly for procedures that were not scheduled as the first case of the day (hospital later case duration, 2 hours, 7.4 minutes vs OBL later case duration, 1 hour, 43 minutes; P = .0006).Establishing a radioembolization program within an OBL is feasible and might provide more efficient procedure scheduling than the hospital setting.

Purpose To describe the revenue from a collaboration between a dedicated wound care center and an interventional radiology (IR) practice for venous leg ulcer (VLU) management at a tertiary care center. Materials and Methods This retrospective study included 36 patients with VLU referred from a wound care center to an IR division during the 10-month active study period (April 2017 to January 2018) with a 6-month surveillance period (January 2018 to June 2018). A total of 15 patients underwent endovascular therapy (intervention group), whereas 21 patients did not (nonintervention group). Work relative value units (wRVUs) and dollar revenue were calculated using the Centers for Medicare and Medicaid Services Physician Fee Schedule. Results Three sources of revenue were identified: evaluation and management (E&M), diagnostic imaging, and procedures. The pathway generated 518.15 wRVUs, translating to $37,522. Procedures contributed the most revenue (342.27 wRVUs, $18,042), followed by E&M (124.23 wRVUs, $8,881), and diagnostic imaging (51.65 wRVUs, $10,599). Intervention patients accounted for 86.7% of wRVUs (449.48) and 80.0% of the revenue ($30,010). An average of 33 minutes (38.3 hours total) and 2.06 hours (36.8 hours total) were spent on E&M visits and procedures, respectively. Conclusions In this collaboration between the wound center and IR undertaken to treat VLU, IR and E&M visits generated revenue and enabled procedural and downstream imaging revenue.

Background The AngioVac (AngioDynamics, Latham, NY) device utilizes a venovenous bypass circuit for percutaneous venous thrombectomy and has been applied in the setting of iliocaval thrombosis as well as right heart thrombus and pulmonary emboli. We describe our experience with the AngioVac device in 12 patients with a variety of indications with the goal of identifying factors correlating with successful thrombectomy. Methods From August 2013 to June 2015, 12 patients underwent AngioVac percutaneous thrombectomy at our institution. Preoperative, intraoperative, and postoperative data were retrospectively analyzed. Results Indications for thrombectomy included iliocaval thrombosis in 33% (4), right heart thrombus in 42% (5), and pulmonary embolus in 25% (3). We experienced a 58% complete success rate. Partial success was achieved in 17%, and no thrombus was extracted in 25%. Iliocaval and right heart thrombi were the most amenable to AngioVac thrombectomy with 100% (4/4) and 60% (3/5) complete success rates, respectively. Pulmonary embolus was the least amenable to thrombectomy with a 33% partial success rate (1/3) and 67% failure rate (2/3). Conclusion The AngioVac devices allow for percutaneous thrombectomy in the setting of iliocaval and right heart thrombus in patients for whom medical therapy fails or for those in whom surgical intervention is considered high risk. Pulmonary emboli are less amenable, likely due to limited steeribility of the device. Larger studies are needed to make more definitive conclusions, and newer iterations of the device will likely allow for improved outcomes.

Long-term right ventricular (RV) function, functional capacity, exercise capacity, and quality of life following pulmonary embolism (PE), and the impact of thrombolysis, are unclear. A systematic review of studies that evaluated these outcomes with ⩾ 3-month mean follow-up after PE diagnosis was performed. For each outcome, random effects meta-analyses were performed. Twenty-six studies (3671 patients) with 18-month median follow-up were included. The pooled prevalence of RV dysfunction was 18.1%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of RV dysfunction versus those treated with anticoagulation (odds ratio: 0.51, 95% CI: 0.24 to 1.13, p=0.10). Pooled prevalence of at least mild functional impairment (NYHA II–IV) was 33.2%, and at least moderate functional impairment (NYHA III–IV) was 11.3%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of at least moderate functional impairment versus those treated with anticoagulation (odds ratio: 0.48, 95% CI: 0.15 to 1.49, p=0.20). Pooled 6-minute walk distance was 415 m (95% CI: 372 to 458 m), SF-36 Physical Component Score was 44.8 (95% CI: 43 to 46), and Pulmonary Embolism Quality of Life (QoL) Questionnaire total score was 9.1. Main limitations included heterogeneity among studies for many outcomes, variation in the completeness of data reported, and inclusion of data from non-randomized, non-controlled, and retrospective studies. Persistent RV dysfunction, impaired functional status, diminished exercise capacity, and reduced QoL are common in PE survivors. The effect of thrombolysis on RV function and functional status remains unclear.

Background Chronic venous occlusions can result in debilitating symptoms and can be refractory to standard methods of venous recanalization because of the formation of dense fibrous tissue. A transjugular liver access cannula can be incorporated into recanalization efforts to treat such refractory cases. This report describes our experience using the transjugular liver access cannula technique in nine patients. Methods A review of patients requiring venous recanalization between May 2012 and October 2014 identified nine cases that required the use of a transjugular liver access cannula as a guiding instrument. Lesion characteristics, technical success, and clinical outcomes were evaluated. Results The transjugular liver access cannula was used to traverse a total of nine chronic occlusions in both the upper and lower central venous systems in nine patients. The technical success rate was 100%. There were no clinically significant complications. One patient was lost to follow-up. Of the remaining eight patients, seven experienced symptomatic relief within 1 month of recanalization. Conclusions The transjugular liver access cannula may serve as a useful adjunctive tool during difficult venous recanalizations, especially when traditional guidewire and catheter techniques fail.

This article will focus on 3 avenues for future research: (1) addressing the lack of short- and long-term clinical outcome research on catheter-directed therapy; (2) determining the safety and efficacy of novel thrombus removal devices; and (3) translating our knowledge of the pathobiology and pathophysiology of pulmonary embolism into novel diagnostic and therapeutic strategies.

Limited evidence is available to guide periprocedural management of oral anticoagulants in the setting of interventional radiology (IR) procedures. For direct oral anticoagulants, therapy interruption (TI) is based on medication half-life and procedural bleeding risk. Periprocedural management of warfarin includes INR monitoring, and possible bridging with parenteral anticoagulants. It is unknown if these recommendations apply to IR procedures. To evaluate bleeding complications and thromboembolic events following periprocedural management of the factor Xa (FXa) inhibitors or warfarin in patients undergoing IR procedures. We performed a retrospective, observational study at NYU Langone Health (NYULH) of all adult patients who underwent an IR procedure from January 2015 to July 2017 and were receiving apixaban, rivaroxaban, or warfarin. Patients who were pregnant or who had a mechanical heart valve were excluded. At NYULH, TI is not required for FXa inhibitors, and an INR

Acute pulmonary embolism (PE) is a major public health problem. It is the third most common cause of death in hospitalized patients. In the United States, there are up to 600,000 cases diagnosed per year with 100,000-180,000 acute PE-related deaths. Common risk factors include underlying genetic conditions, acquired conditions, and acquired hypercoagulable states. Acute PE increases the pulmonary vascular resistance and the load on the right ventricle (RV). Increased RV loading causes compensatory RV dilation, impaired contractility, tachycardia, and sympathetic activation. RV dilation and increased intramural pressure decrease diastolic coronary blood flow, leading to RV ischemia and myocardial necrosis. Ultimately, insufficient cardiac output from the RV causes left ventricular under-filling which results in systemic hypotension and cardiovascular collapse. Current prognostic stratification strategy separates acute PE into massive, submassive, and low-risk by presence or absence of sustained hypotension, RV dysfunction, and myocardial necrosis. Massive, submassive, and low-risk acute PE have mortality rates of 25%-65%, 3%, and

The post-Pulmonary Embolism (post-PE) syndrome is being increasingly recognized as a long-term consequence of PE. Its most severe manifestation, chronic thromboembolic pulmonary hypertension (CTEPH), affects a small proportion of PE survivors. However, many more with less severe post-PE syndrome have reduced quality of life and functional capacity. The pathophysiology is incompletely understood, but involves unresolved pulmonary artery thrombi, right ventricular damage, and abnormal gas exchange. Treatment has only been established for CTEPH, and further studies are required to determine how less severe forms of the post-PE syndrome should be treated and if preventive strategies can reduce its incidence.

Patients with venous thromboembolism (VTE) are prone to the development of both short-term and long-term complications that can substantially affect their functional capacity and quality of life. Patients with deep vein thrombosis (DVT) often develop recurrent VTE or the post-thrombotic syndrome, whereas patients with pulmonary embolism (PE) can develop long-term symptoms and functional limitations along a broad spectrum extending to full-blown chronic thromboembolic pulmonary hypertension. Clinicians who care for patients showing severe clinical manifestations of DVT and PE are often faced with challenging decisions concerning whether and how to escalate to more aggressive treatments such as those involving the use of thrombolytic drugs. The purpose of this chapter is to provide guidance on how best to individualize care to these patients.

Acute pulmonary embolism (PE) is the third most common cause of death among hospitalized patients. Treatment escalation beyond anticoagulation therapy is necessary in patients with cardiogenic shock and may be of benefit in select normotensive patients with right heart strain. Percutaneous catheter-based techniques (catheter-directed mechanical thrombectomy, clot maceration, and/or pharmacologic thrombolysis) as an alternative or adjunct to systemic thrombolysis can rapidly debulk central clot in patients with shock. Catheter-directed thrombolysis, which uses a low-dose intraclot prolonged thrombolytic infusion, is a promising but insufficiently studied therapy for patients presenting with acute intermediate-risk PE.

The carotid body (CB) has previously been found to be enlarged and hyperactive in various disease states such as heart failure (HF), hypertension (HTN), and respiratory disease. Evaluation of CB size in these disease states using imaging has not been performed. The purpose of this case-control study was to compare CB sizes in patients with HF and HTN with those of controls using CT angiography.A retrospective review was performed on 323 consecutive patients who had neck computed tomography angiography (CTA) exams in 2011. Following extensive review, 17 HF and HTN patients and 14 controls were identified. Two radiologists blinded to the patient disease status made consensus bilateral carotid body (CB) measurements on the CTA exams using a previously described standardized protocol. CB axial cross-sectional areas were compared between HF and HTN cases and controls using a paired t test.The right CB demonstrated a mean cross-sectional area of 2.79 mm(2) in HF and HTN patients vs. 1.40 mm(2) in controls (p = 0.02). The left CB demonstrated a mean cross-sectional area of 3.13 mm(2) in HF and HTN patients vs. 1.53 mm in controls (p = 0.03).Our results provide imaging evidence that the carotid bodies are enlarged in patients with HF and HTN. Our case-control series suggests that this enlargement can be detected on neck CTA.

Patients who present with severe manifestations of acute venous thromboembolism (VTE) are at higher risk for premature death and long-term disability. In recent years, catheter-based interventional procedures have shown strong potential to improve clinical outcomes in selected VTE patients. However, physicians continue to be routinely faced with challenging decisions that pertain to the utilization of these risky and costly treatment strategies, and there is a relative paucity of published clinical trials with sufficient rigor and directness to inform clinical practice. In this article, using 3 distinct clinical scenario presentations, we draw from the available published literature describing the natural history, pathophysiology, treatments, and outcomes of VTE to illustrate the key factors that should influence clinical decision making for patients with severe manifestations of deep vein thrombosis and pulmonary embolism. The results of a recently completed pivotal multicenter randomized trial are also discussed.

This single-center, retrospective study describes using the VASCADE Vascular Closure System (Cardiva Medical, Inc, Santa Clara, California) to close 32 venous access sites in 21 consecutive patients (11 females; 10 males; age 45 y ± 19) after catheter-directed interventions. Sheath sizes were 5-10 F (8.7 F ± 1.7). Hemostasis was achieved in 30 of 32 deployments (93.8%). Complications were observed after 6 of 32 procedures, including 5 minor events in 4 patients and 1 major event in 1 patient which was likely unrelated to device deployment. The VASCADE device efficaciously closes venotomies after deep venous procedures, but further studies comparing it with manual compression are required to define its optimal use.

Patients with advanced post-thrombotic syndrome (PTS) and chronic iliac vein obstruction suffer major physical limitations and impairment of health-related quality of life. Currently there is a lack of evidence-based treatment options for these patients. Early studies suggest that imaging-guided, catheter-based endovascular therapy can eliminate iliac vein obstruction and saphenous venous valvular reflux, resulting in reduced PTS severity; however, these observations have not been rigorously validated. A multidisciplinary expert panel meeting was convened to plan a multicenter randomized controlled clinical trial to evaluate endovascular therapy for the treatment of advanced PTS. This article summarizes the findings of the panel, and is expected to assist in developing a National Institutes of Health-sponsored clinical trial and other studies to improve the care of patients with advanced PTS.

Submassive pulmonary embolism (PE) remains a vexing entity, and the appropriate use of thrombolytic therapy for this subgroup continues to be actively debated. Catheter-directed thrombolysis has shown efficacy for submassive PE and is gaining momentum because of theoretically improved safety. This review poses and responds to four questions that explore the complex issues surrounding optimal therapy of submassive PE.

Most percutaneous mechanical thrombectomy devices entail thrombolysis and/or thrombus fragmentation followed by subsequent aspiration, with the associated risks of bleeding and embolization. We describe the use of the AngioVac system (Angiodynamics, Latham, NY USA) for extraction of extensive iliocaval thrombus associated with an inferior vena cava filter followed by percutaneous inferior vena cava filter extraction in a patient with an absolute contraindication to thrombolysis. The AngioVac may be considered in this scenario as it does not require thrombolytics and can remove whole thrombus, thus overcoming some of the limitations of percutaneous mechanical thrombectomy devices in the setting of subacute and early chronic thrombus.

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.

Systemic thrombolysis for acute pulmonary embolism (PE) carries up to a 20% risk of major bleeding, including a 2% to 5% risk of hemorrhagic stroke. We evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment of acute PE.One hundred one consecutive patients receiving CDT for acute PE were prospectively enrolled in a multicenter registry. Massive PE (n = 28) and submassive PE (n = 73) were treated with immediate catheter-directed mechanical or pharmacomechanical thrombectomy and/or catheter-directed thrombolysis through low-dose hourly drug infusion with tissue plasminogen activator (tPA) or urokinase. Clinical success was defined as meeting all the following criteria: stabilization of hemodynamics; improvement in pulmonary hypertension, right-sided heart strain, or both; and survival to hospital discharge. Primary safety outcomes were major procedure-related complications and major bleeding events.Fifty-three men and 48 women (average age, 60 years [range, 22-86 years]; mean BMI, 31.03 ± 7.20 kg/m2) were included in the study. The average thrombolytic doses were 28.0 ± 11 mg tPA (n = 76) and 2,697,101 ± 936,287 International Units for urokinase (n = 23). Clinical success was achieved in 24 of 28 patients with massive PE (85.7%; 95% CI, 67.3%-96.0%) and 71 of 73 patients with submassive PE (97.3%; 95% CI, 90.5%-99.7%). The mean pulmonary artery pressure improved from 51.17 ± 14.06 to 37.23 ± 15.81 mm Hg (n = 92) (P.0001). Among patients monitored with follow-up echocardiography, 57 of 64 (89.1%; 95% CI, 78.8%-95.5%; P.0001) showed improvement in right-sided heart strain. There were no major procedure-related complications, major hemorrhages, or hemorrhagic strokes.CDT improves clinical outcomes in patients with acute PE while minimizing the risk of major bleeding. At experienced centers, CDT is a safe and effective treatment of both acute massive and submassive PE.ClinicalTrials.gov; No.: NCT01097928; URL: www.clinicaltrials.gov.

Pulmonary embolism is a leading cause of maternal death in the United States, contributing to the death of approximately 2 women per 100,000 live births each year. Thrombosis during pregnancy traditionally is treated conservatively with unfractionated heparin or low-molecular-weight heparin; however, cardiovascular collapse associated with a large pulmonary embolus may require immediate aggressive intervention to save the mother and fetus. We report the use of catheter infusion thrombolysis in the successful management of a third-trimester pregnant patient with a hemodynamically significant saddle pulmonary embolus.

To determine treatment preferences among endovascular and medical physicians who manage acute submassive pulmonary embolism (PE).From July through August 2016, 83 sites across the United States were surveyed, and 60 completed the survey. Endovascular and medical physicians were asked to rate their predilection for catheter-directed thrombolysis (CDT) on a 5-point scale and for systemic thrombolysis (ST) as "yes" or "no" in seven case scenarios of submassive PE. A CDT score ≥ 4 was considered to represent a predilection for CDT. Mean scores were used to compare CDT preferences between physicians. Percentages of physicians who preferred CDT or ST were calculated. P values.05 were considered statistically significant.Across all scenarios (numbered S1-S7) combined, endovascular physicians had a significantly higher CDT score (mean, 3.52) than medical physicians (mean, 3.01; P.0001). Scenario-by-scenario analysis revealed that the mean CDT score was significantly higher for endovascular physicians (S1, 4.25; S2, 3.72; S3, 2.82; S4, 2.68; S5, 3.45; S6, 3.67; S7, 4.02) compared with medical physicians (S1, 3.62 [P.001]; S2, 3.18 [P.001]; S3, 2.45 [P = .001]; S4, 2.37 [P = .011]; S5, 2.97 [P.001]; S6, 3.20 [P.001]; S7, 3.53 [P.001]). Overall, a significantly higher percentage of endovascular physicians (56.7%) indicated a predilection for CDT compared with medical physicians (37.9%; P.001). Also, a significantly higher percentage of physicians, regardless of specialty, indicated a predilection for CDT (47.2%) than did for ST (5.3%; P.0001).Endovascular physicians exhibited a greater predilection for CDT to treat acute submassive PE compared with their medical colleagues. Endovascular and medical physicians seemed to more frequently choose CDT than ST.