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.

Modern Treatment of Pulmonary Embolism (USCDT vs MT): Results From a Real-World, Big Data Analysis (REAL-PE).

Background: Advanced therapies are increasingly utilized to treat pulmonary embolism (PE). A unique data platform allows access to electronic health record data for comparison of the safety of PE therapies. Methods: All data from Truveta (Truveta, Inc) were analyzed (16 systems, 83,612,413 patients, 535,567 with PE). All patients treated with ultrasound-assisted catheter-directed thrombolysis (USCDT) (Boston Scientific) or mechanical thrombectomy (MT) (Inari Medical) for PE were identified. The primary analysis was based on index procedures performed from January 2009 to May 2023, and contemporary analysis on those performed from January 2018 to May 2023. Bleeding was assessed via direct laboratory analysis and transfusion administration documentation. International Society for Thrombosis and Hemostasis (ISTH) and Bleeding Academic Research Consortium (BARC) 3b definitions were recreated. Multiple logistic regression analysis of major bleeding was performed. In-hospital death and median length of stay were measured. Results: For the primary analysis, 2259 patients (N = 1577 USCDT, N = 682 MT) and for the contemporary analysis 1798 patients (N = 1137 USCDT, N = 661 MT) met the criteria. Incidence of hemoglobin reduction (>2 and >5 g/dL) and transfusions received were significantly higher among MT-treated patients in both analyses, as was ISTH and BARC 3b major bleeding (primary: ISTH MT 17.3% vs USCDT 12.4% P = .002; BARC 3b MT 15.4% vs USCDT 11.8% P = .019) (contemporary: ISTH MT 17.2% vs USCDT 11.0% P = .0002; BARC 3b MT 15.4% vs USCDT 10.6% P = .002). Regression analysis demonstrated that MT is associated with major bleeding. Median length of stay, all-cause 30-day readmission and in-hospital mortality were similar between groups. Intracranial hemorrhage was more common with MT. Conclusions: Major bleeding derived from direct laboratory and transfusion data occurred more frequently with MT vs USCDT. Intracranial hemorrhage was more common among MT-treated patients. In the absence of randomized data, these results provide guidance regarding the bleeding risk and safety of strategies for advanced PE therapy.

Consensus Statement on the Management of Nonthrombotic Iliac Vein Lesions From the VIVA Foundation, the American Venous Forum, and the American Vein and Lymphatic Society.

A nonthrombotic iliac vein lesion is defined as the extrinsic compression of the iliac vein. Symptoms of lower extremity chronic venous insufficiency or pelvic venous disease can develop secondary to nonthrombotic iliac vein lesion. Anatomic compression has been observed in both symptomatic and asymptomatic patients. Causative factors that lead to symptomatic manifestations remain unclear. To provide guidance for providers treating patients with nonthrombotic iliac vein lesion, the VIVA Foundation convened a multidisciplinary group of leaders in venous disease management with representatives from the American Venous Forum and the American Vein and Lymphatic Society. Consensus statements regarding nonthrombotic iliac vein lesions were drafted by the participants to address patient selection, imaging for diagnosis, technical considerations for stent placement, postprocedure management, and future research/educational needs.

Fatigue Test Method to Evaluate the 50 Year Durability of Venous Stents.

OBJECTIVE: Iliofemoral venous obstructive disease can result in significant, potentially debilitating symptoms that can negatively affect quality of life. Unlike arterial disease, patients with deep venous disease have a significantly lower median age, therefore the need for long term stent patency becomes a matter of decades rather than years. Furthermore, iliofemoral lesions frequently require stent placement across the inguinal ligament. Such stents are subject to dynamic stress from leg movement and associated concerns for device fatigue, resulting in stent fracture. The aim of this study was to describe an in vitro 50 year stent fatigue test method designed to assess durability against dynamic stress induced device fracture. METHODS: Through literature review, cadaver studies, and computer modelling, the most challenging loading was confirmed to be hip flexion across the inguinal ligament. This occurs when the patient adjusts between a seated and standing position. Sit to stand hip flexion at the inguinal ligament was effectively simulated on the bench in this in vitro experimental study. RESULTS: When tested under challenge parameters, hip flexion was reliably found to cause fractures in non-venous nitinol stents. However, a dedicated self expanding nitinol venous stent, engineered for improved durability, underwent up to 50 years of simulated loading on the bench with 15% (3/20) of stents experiencing fractures at 50 years, compared with fractures in 35% (14/40) of non-venous stents tested to 1.4 years; no statistical testing was performed as durations do not match and the objective was to demonstrate the test method. CONCLUSION: The presented fatigue test method is a suitable approach for evaluating the durability of stents intended for venous use. Venous stents demonstrated superior fatigue resistance compared with non-venous stents via in vitro hip flexion testing.

Single-procedure 8Fr rheolytic pharmacomechanical thrombectomy for treatment of acute iliofemoral deep venous thrombosis.

PURPOSE: We hypothesize that single-procedure venous-specific rheolytic thrombectomy for treatment of acute iliofemoral deep venous thrombosis (DVT) will result in improved clinical symptoms as measured by the venous clinical severity score (VCSS), as well as durable venous patency, with decreased hemorrhagic risks and costs associated with conventional catheter-directed therapy and prolonged lytic exposure. MATERIALS AND METHODS: Thirty-three consecutive patients with symptomatic, unilateral, iliofemoral DVT who were treated with single-procedure therapy using the 8Fr rheolytic thrombectomy catheter were retrospectively analyzed from 2012-2021. Abstracted data included technical success (> 95% clearance of acute thrombus), adverse events (AEs), and clinical and imaging outcomes at 1-month and 1-year. RESULTS: Technical success was achieved in all 33 patients. Mean pre-procedure VCSS was 7.5 with mean edema and pain sub-scores of 2.6 and 1.8, respectively. Post-procedural total mean VCSS at one month was significantly improved (mean post-procedure VCSS = 0.3, mean reduction of 7.2, P < 0.01). Clinical improvement was sustained at 1-year (mean total VCSS = 0.2, P < 0.01). Primary patency was achieved in all patients at 1-month and 30 (91%) patients at 1-year. Among the 3 patients in which primary patency was not achieved at 1-year, primary-assisted patency was achieved in 2 patients. Secondary patency was achieved in the remaining patient at 1-year. No hemorrhagic AEs occurred in this study. CONCLUSION: This study suggests that single-procedure venous-specific rheolytic thrombectomy for treatment of acute iliofemoral DVT is safe and effective, resulting in durable clinical and radiographic results at one year, while also limiting hemorrhagic risks, mitigating costs of admission, and expediting patient discharge.

Immunotherapy Efficacy in Advanced Hepatocellular Carcinoma in a Diverse and Underserved Population in the United States.

Background :   Incidence of hepatocellular cancer (HCC) in the Bronx is 61% higher than the rest of New York State. Underserved populations are not well represented in clinical trials of immune checkpoint inhibitors (ICI). Methods: Demographics were tabulated for 194 patients treated with ICI at the Montefiore-Einstein Comprehensive Cancer Center (MECCC) between 2017 and 2022. Categorical variables were analyzed by Chi-squared test, and survival was analyzed using Kaplan-Meier (KM) curves. Results: MECCC patients were 40.7% Hispanic and 20.6% Black, compared with 3% and 2%, respectively, in the landmark IMbrave 150 study. Median overall survival (mOS) on ICI was 9.0 months, 25.0 months for the 100 (51.5%) favorable-prognosis Child Pugh A (CPA) patients included in HCC clinical trials. Disease control rate (DCR) was 58.5% among 123 evaluable patients per mRECIST 1.1. Baseline liver function, as defined by CP and the Model for End-Stage Liver Disease-Sodium (MELD-Na), correlated with survival (p < 0.001). Hepatitis C Virus (HCV) and alcoholism were over-represented relative to National Cancer Institute (NCI) data (56.2% vs 4.7% and 38.7% vs 8.2%, respectively). HCV treatment correlated with prolonged survival in infected patients (p = 0.0017). AFP decline correlated with response (p = 0.001). Hispanic patients lived longer when clinical variables were controlled for (mOS 52 vs 23 months; p = 0.011). Conclusion: In an underserved HCC population, ICI yielded a DCR of 58.5% and low rates of severe toxicity. This work highlights ICI efficacy in minority groups, a need for earlier HCC diagnosis and for studies of genetic and environmental factors in Hispanics with HCC.

Inferior Vena Cava Filter Retrieval: Simple to Complex.

Retrievable inferior vena cava filters were designed to provide mechanical prophylaxis from pulmonary embolism with the intent for retrieval once no longer indicated, and have been utilized at a high rate since their introduction. Unfortunately, retrieval rates have historically lagged behind, in part due to significant rates of failed standard retrieval techniques for filters with prolonged dwell time. Refinement in advanced retrieval techniques has now allowed (in experienced centers) for safe removal of filters previously considered irretrievable. An individualized approach is necessary for each potential advanced filter retrieval to determine appropriate course of action. This review will emphasize complex filter retrieval techniques amidst a larger discussion of inferior vena cava filters and their management.

The clinical and economic impact of chronic venous insufficiency-associated lymphedema and the prevalence of persistent edema after venous intervention.

OBJECTIVES: To determine the demographics, outcomes, and healthcare utilization of patients with chronic venous insufficiency-associated lymphedema (CVI-LED) and the prevalence of lymphedema-specific therapy use after venous intervention. METHODS: The IBM MarketScan Commercial and Medicare Claims Databases were examined for patients with CVI-LED. Patient demographics and the use of lymphedema-specific therapy before and after venous intervention were collected. RESULTS: Of 85,601 LED patients identified, 8,406 also had a diagnosis of CVI. In the CVI-LED group, 1051 underwent endovenous ablation or venous stent placement. The use of lymphedema-specific therapy before and after venous intervention was 52% and 39%, respectively (p < .05). The mean time of initiation of LED-specific therapy following venous intervention was 265 days after ablation and 347 days after stent placement. CONCLUSION: Treating venous hypertension improves certain venous-related signs and symptoms of CVI. However, a significant proportion of patients have persistent edema which may reflect underlying, sub-optimally treated LED.

Excelencia en Neurocirugía: María Cristina García-Sancho, the First Latina Neurosurgeon in the World.

BACKGROUND: Neurosurgery is a specialty that has been dominated by males. Although there has been an increase in the number of women in the field, it is not yet close to being equal. Some noteworthy women who have carved the path for other women to follow in their footsteps include Drs. Sofía Ionescu and Diana Beck, the first and second female neurosurgeons worldwide, respectively. However, there are limited publications on Dr. María Cristina García-Sancho, the first Latina neurosurgeon. METHODS: The purpose of this review was to illuminate the neurosurgical community on the life of Dr. García-Sancho. A thorough literature was performed on medical and non-medical publications that were either authored by Dr. García-Sancho or mentioned her directly. RESULTS: Dr. García-Sancho earned her medical degree at the School of Medicine of the National Autonomous University of Mexico under the guidance of Dr. Clemente Robles, who founded Mexico's first neurosurgical department. Her training took her worldwide. CONCLUSIONS: Her expertise allowed her to pioneer a revolutionary advancement known as the one-step bilateral cordotomy. Her perseverance led her to becoming the head of the Department of Neurosurgery at the National Cancer Institute of Mexico and co-found the Mexican Society of Neurological Surgery, where she served on the board of directors. This review aims to advocate for an equitable environment in the field of neurosurgery with Dr. García-Sancho's story.

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.

The role of iliac vein stent placement in pelvic venous disorder management.

Pelvic venous disease (PeVD) has historically been challenging to diagnose and treat. This paper describes a comprehensive approach to the diagnosis of PeVD and reviews the role of iliac vein stent placement in treatment. Patient selection is vital for non-thrombotic iliac vein lesions (NIVLs) as only a small subset of patients with an NIVL will benefit from stent placement. There is limited, inconclusive data on optimal treatment for patients with both primary ovarian vein reflux and an NIVL. Patients with chronic post-thrombotic outflow obstruction typically have a more favorable risk/benefit ratio for intervention but require anticoagulation and close follow-up due to poorer long-term stent patency. Intravascular ultrasound is a useful tool for identifying obstructive lesions, sizing stents, and planning landing zones. More research is needed to characterize underlying pathophysiology, validate thresholds for intervention, develop reliable methods for outcomes assessment, and determine treatment response. Until this data is produced, an individualized treatment approach is warranted.

Research Consensus Panel Follow-up: 8-Year Update on Submassive Pulmonary Embolism.

The 2015 Research Consensus Panel (RCP) on submassive pulmonary embolism (PE) set priorities for research in submassive PE and identified a rigorous randomized trial of catheter-directed therapy plus anticoagulation versus anticoagulation alone as the highest research priority. This update, written 8 years after the RCP was convened, describes the current state of endovascular PE practice and the Pulmonary Embolism-Thrombus Removal with Catheter-Directed Therapy trial, the main output from the RCP.

Luminal Changes in Patients with Inferior Vena Cava Filters and Development of Chronic Venous Disease.

BACKGROUND: This study aimed to analyze the luminal changes in the iliocaval veins and their effects on the development of signs and symptoms of chronic venous disease manifesting from inferior vena cava (IVC) filter placement. METHODS: This was a retrospective observations study; deidentified patients with an IVC filter placed with subsequent luminal changes were included. All patients had a computerized tomography (CT) scan with or without ultrasound and those who underwent an intervention for the obstruction had also venography and intravascular ultrasound (IVUS). The diameter of IVC and iliac veins was measured from the near wall to the far wall. IVC diameters measured less than 12 mm were considered to be retractions. Signs and symptoms of chronic venous disease were obtained from patient charts and were reported according to the highest CEAP class. The data were analyzed using descriptive statistics, presenting diameter changes as a mean with standard deviation and a range of diameters included. RESULTS: Overall, 76 patients were included in this study, of whom 66 had occlusion of the IVC or the Iliac veins. Luminal changes of the IVC were observed in all patients. A total of 58 patients presented with chronic post-thrombotic changes in both the IVC and iliac veins. There were 4 patients that had a luminal reduction with no filling defects or post-thrombotic changes. Average IVC diameter and iliac vein diameter was measured to be 8.3 ± 1.4 mm and 4.6 ± 1.4 mm, respectively. Patients most frequently presented with extremity swelling, but other signs such as venous ulceration or skin damage were observed. CONCLUSIONS: Permanent luminal changes of the IVC and iliac veins were observed as a result of IVC filter placement and such patients commonly present with signs and symptoms of chronic venous disease. Together, with other known filter complications, these observations add more reasons for a timely retrieval. When such changes occur, patients' appropriate symptoms can be successfully treated. The permanent changes made by filter placement in the IVC and iliac veins further support filter retrieval in a timely fashion. The luminal changes induced by filter placement should be recognized early, particularly in symptomatic patients who can be safely treated with endovenous procedures.

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

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

Radioembolization for Intermediate-Stage Hepatocellular Carcinoma Maintains Liver Function and Permits Systemic Therapy at Progression.

PURPOSE: To assess the liver function trends in patients with intermediate-stage (Barcelona Clinic Liver Cancer [BCLC] Stage B) hepatocellular carcinoma (HCC) who underwent yttrium-90 transarterial radioembolization (TARE) in response to a growing concern that liver-directed therapies negatively affect liver function and prevent patients with HCC from systemic therapy candidacy. MATERIALS AND METHODS: An HCC/TARE database (2004-2017) was retrospectively reviewed. Patients with BCLC Stage B/Child-Pugh (CP)-A HCC with laboratory test and imaging data at baseline and for at least 1 month after TARE were included. Follow-ups were at 3-month intervals. CP stage was assessed at each time point. End points included time to persistent CP-B status, time to CP-C status, and median overall survival (OS). Time-to-end point analyses were performed using the Kaplan-Meier method. RESULTS: Seventy-four patients (80% men, with a mean age of 63 years) with mostly (62%) bilobar disease underwent 186 TARE treatments (median, 2; range, 1-8). The median time to second TARE was 2.3 months (range, 1.7-6.4 months), and the median times to third and fourth TAREs were 11.7 months (range, 7.5-15 months) and 17.3 months (range, 11.5-23.1 months), respectively. Forty-three (58%) patients developed persistent CP-B HCC at a median time of 15.4 months (95% CI, 9.2-25.3 months); 17 (23%) patients developed CP-C HCC at a median time of 87.2 months (95% CI, 39.8-136.1 months). The median OS censored to transplantation was 30.4 months (95% CI, 22.7-37.4 months). On univariate and multivariate analyses, baseline albumin was a significant prognosticator of OS, whereas baseline albumin and bilirubin were significant prognosticators of time to persistent CP-B HCC and time to CP-C HCC. CONCLUSIONS: In patients with CP-A HCC who underwent TARE for BCLC Stage B HCC, the median time to persistent CP-B HCC was 15.4 months. These findings indicate that patients would be candidates for systemic therapy at progression if indicated.

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

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

A Procedural Checklist for Transurethral Resection of Bladder Tumors (TURBT) Enhances Operative Dictation and Assesses Surgeon Accuracy of Tumor Characteristic Predictions.

BACKGROUND: A lack of standardization is pervasive in procedural application and reporting templates for TURBT with the use of a surgical checklist proposed as a means for quality improvement. OBJECTIVE: To introduce a TURBT checklist to assess surgeon prediction accuracy and the impact of standardized documentation on quality of resection and oncologic outcomes. METHODS: Nine critical elements of a high-quality TURBT identified by literature review were incorporated into a prospectively implemented checklist for operative reports. The checklist included both visualized and predicted tumor characteristics. A retrospective single-institution analysis compared quality of dictation pre- and post-checklist implementation. Surgeon predictions were compared to final pathology reports to determine rates of concordance. Kaplan-Meier curves examined the association of checklist use with recurrence free survival (RFS). RESULTS: 333 operative reports were included in this analysis, of which 107 (32.1%) were completed pre-checklist implementation. The average number of critical elements reported was 8.69 with checklist use compared to 4.99 without (p < 0.001). There was no significant difference in RFS between the pre- and post-checklist cohorts (log-rank test p = 0.53). Surgeons were least and most accurate in predicting low grade tumor (43.5%) and absence of muscle invasion (96.6%), respectively. CONCLUSIONS: Incorporation of a TURBT surgical checklist improves operative dictation and quality of reporting but did not directly impact RFS. With quality of initial resection a proven correlate to recurrence rates, checklist implementation to improve surgical performance and long-term oncologic outcomes reveals an interesting area of exploration highlighting the need for more standardized methodology when performing these procedures.