Safety and Effectiveness of Irreversible Electroporation in Lymph Node Metastases.

PURPOSE: Demonstrating the safety and efficacy of percutaneous irreversible electroporation (IRE) for the treatment of lymph node metastases. MATERIALS AND METHODS: An IRB-approved, single-center retrospective review was performed on patients with lymph node metastases gastrointestinal, and genitourinary primary cancers. Primary objective safety was evaluated by assessing complications graded according to the Clavien-Dindo Classification, and efficacy was determined by tumor response on follow-up imaging and local progression-free survival (LPFS). Secondary outcome measures were technical success (complete ablation with an adequate ablative margin > 5 mm), length of hospital stay and distant progression-free survival (DPFS). RESULTS: Nineteen patients underwent percutaneous IRE between June 2018 and February 2023 for lymph node metastases, close to critical structures, such as vasculature, bowel, or nerves. The technical success was achieved in all cases. Complications occurred in four patients (21.1%), including two self-limiting grade 1 hematomas, a grade 1 abdominal pain, and grade 2 nerve pain treated with medication. Seventeen patients were hospitalized overnight, one patient stayed two nights and another patient stayed fourteen nights. Median follow-up was 25.5 months. Median time to local progression was 24.1 months (95% CI: 0-52.8) with 1-, 2-, and 5-year LPFS of 57.9%, 57.9% and 20.7%, respectively. Median time to distant progression was 4.3 months (95% CI: 0.3-8.3) with 1-, 2-, and 5-year DPFS of 31.6%, 13.2% and 13.2%, respectively. CONCLUSION: IRE is a safe and effective minimally-invasive treatment for lymph node metastases in locations, where temperature dependent ablation may be contraindicated. Care should be taken when employing IRE near nerves.

Establishing Updated Safety Standards for Independent 99mTc-MAA SPECT/CT Treatment Planning in Radioembolization.

PURPOSE: Significant improvements within radioembolization imaging and dosimetry permit the development of an accurate and personalized pretreatment plan using technetium 99m-labeled macroaggregated albumin (99mTc-MAA) and single-photon emission computed tomography (SPECT) combined with anatomical CT (SPECT/CT). Despite these potential advantages, the clinical transition to pretreatment protocols with SPECT/CT is hindered by their unknown safety constraints. This study aimed to address this issue by establishing novel dose limits for 99mTc-MAA SPECT/CT to enable quantitative pretreatment planning. METHODS AND MATERIALS: Stratification criteria to determine images most viable for dosimetry analysis were created from a cohort of 85 patients. SPECT/CT, cone beam CT, and activity calculations derived from the local deposition method were used to create an accurate pretreatment protocol. Planar and SPECT/CT images were compared using linear regression and modified Bland-Altman analyses to convert accepted planar dose limits to SPECT/CT. To validate these new dose limits, activity calculations based on SPECT/CT were compared with those calculated with the body surface area and planar methods for three treatment plans. RESULTS: A total of 38 of 85 patients were deemed viable for dosimetry analysis. SPECT yielded greater lung shunt fractions (LSFs) than planar imaging when LSFs were <4.89%, whereas SPECT yielded lower LSFs than planar imaging when LSFs were >4.89%. Planar to SPECT/CT dose conversions were 0.76×, 0.70×, and 0.55× for the whole liver, normal liver, and lungs, respectively. Patients with SPECT LSFs ≤4.89% were safely treated with the direct application of planar lung dose limits. Activity calculations with the newly established SPECT/CT dose limits were greater than those of the body surface area method by a median range of 33.1% to 61.9% and were lower than planar-based activity calculations by a median range of 12.5% to 13.7% for the whole liver and by 29.4% to 32.2% for the normal liver. CONCLUSIONS: This study demonstrated a safe method for translating dose limits from 99mTc-MAA planar imaging to SPECT/CT. A robust pretreatment protocol was further developed guided by the current knowledge in the field. Established SPECT/CT dose limits safely treated 97.5% of patients and permitted the application of independent pretreatment planning with 99mTc-MAA SPECT/CT.

Trends in Percutaneous Device Use for the Treatment of Venous Thromboembolism Over Time in the PINC AI Healthcare Database and the National Inpatient Sample.

The number of different methods of reperfusion therapy to treat venous thromboembolism (VTE) has increased substantially. Nevertheless, investigation of data representativeness and device-level use in administrative databases has been limited. Using the National Inpatient Sample (NIS) and the PINC AI Healthcare Database (PHD), all hospital encounters with a diagnosis code of VTE were identified between January 1, 2016 and December 31, 2020. Patient demographics and trends in treatment modalities were evaluated over time. An algorithm was developed to identify specific devices used for VTE treatment in the PHD cohort. A total of 145,870 patients with VTE treated with reperfusion therapy were identified in the NIS (pulmonary embolism [PE] 88,725, isolated deep vein thrombosis [iDVT] 57,145) and 39,311 in the PHD (PE 25,383, iDVT 13,928). Patient demographics were qualitatively similar in the NIS and PHD. Over time, there was a significant increase in the use of mechanical thrombectomy in the PE and iDVT populations (p <0.05 in both databases), with catheter-directed thrombolysis use plateauing in PE (p = 0.83 and p = 0.14 in NIS and PHD, respectively) and significantly decreasing for the iDVT population (p <0.05 in both databases). In the PHD cohort, specific reperfusion devices were identified in 14,105 patients (PE 9,098, iDVT 5,007). In conclusion, the use of mechanical thrombectomy for the treatment of VTE has increased over time, whereas the rates of catheter-directed thrombolysis therapy have remained stagnant or decreased. Further research is needed to understand the uptake of these treatment modalities and the unique abilities of the PHD to study specific device therapy in the VTE population.

A cross-sectional study of outcomes for patients undergoing mechanical thrombectomy for pulmonary embolism during 2018-2022: Insights from the PINC AI Healthcare Database.

Background and Aims: Mechanical thrombectomy (MT) treatments for pulmonary embolism (PE) have yet to be compared directly. We aimed to determine if patient outcomes varied following treatment of PE with different MT devices. Methods: All PE encounters with an index treatment of MT between January 2018 and March 2022 were analyzed for in-hospital mortality, discharge to home, and 30-day readmission outcomes in the PINC AI™ Healthcare Database. MT devices used in each encounter were extracted from hospital charge description free-text fields using keyword text and fuzzy matching. Unadjusted and adjusted logistic regression was used to model outcomes by device. Results: A total of 5893 encounters were identified using MT as the sole index PE treatment and 1812 using MT with another treatment. Of these, 41% had insufficient information to identify the devices used (unspecified MT), 33% used the FlowTriever System (large-bore volume-controlled aspiration MT), 23% the Indigo System (continuous aspiration MT), and 3% some other MT. Large-bore volume-controlled aspiration MT was used with other treatments 13% of the time compared with 23% and 39% for unspecified MT and continuous aspiration MT, respectively. Adjusted logistic regression modeling revealed the odds of in-hospital mortality were significantly higher for patients treated with unspecified MT ([OR] = 1.42, 95% confidence interval [CI]: [1.10-1.83], p = 0.008) or continuous aspiration MT (OR = 1.63, 95% CI: [1.21-2.19], p = 0.001) compared with large-bore volume-controlled aspiration MT. Discharge to home was significantly lower in these same groups (OR = 0.84, 95% CI: [0.73-0.96], p = 0.01, and OR = 0.63, 95% CI: [0.53-0.74], p < 0.001, respectively), but readmission risks at 30 days were comparable (OR = 1.08, 95% CI: [0.84-1.38], p = 0.56, and OR = 1.20, 95% CI: [0.89-1.62], p = 0.24, respectively). Conclusion: PE outcomes and treatment patterns differ significantly based on the type of MT utilized. Clinical studies directly comparing MT treatments are needed to further understand optimal treatment of PE.

Double-Balloon Catheter-Mediated Transarterial Chemotherapy Delivery in a Swine Model: A Mechanism Recruiting the Vasa Vasorum for Localized Therapies.

PURPOSE: Treatment of hypovascular tumors, such as pancreatic adenocarcinoma, is challenging owing to inefficient drug delivery. This report examines the potential mechanism of localized drug delivery via transarterial microperfusion (TAMP) using a proprietary adjustable double-balloon occlusion catheter in a porcine model. MATERIALS AND METHODS: Adult Yorkshire swine (N = 21) were used in the Institutional Animal Care & Use Committee-approved protocols. The RC-120 catheter (RenovoRx, Los Altos, California) was positioned into visceral, femoral, and pulmonary arteries with infusion of methylene blue dye, gemcitabine, or gold nanoparticles. Transmural delivery was compared under double-balloon occlusion with and without side-branch exclusion, single-balloon occlusion, and intravenous delivery. Intra-arterial pressure and vascular histologic changes were assessed. RESULTS: Infusion with double-balloon occlusion and side-branch exclusion provided increased intra-arterial pressure in the isolated segment and enhanced perivascular infusate penetration with minimal vascular injury. Infusates were predominantly found in the vasa vasorum by electron microscopy. CONCLUSIONS: TAMP enhanced transmural passage mediated by localized increase in arterial pressure via vasa vasorum.

Selective internal radiation therapy with yttrium-90 resin microspheres followed by anatomical hepatectomy: A potential curative strategy in advanced hepatocellular carcinoma.

About 80% of hepatocellular carcinoma (HCC) patients are in advanced stages and ineligible for curative surgery. Palliative treatments just maintained limited survival, thus an effective downstaging therapy is badly needed. Here we report an initially unresectable patient who underwent radical hepatectomy after successful downstaging with selective internal radiation therapy (SIRT). A 34-year-old man was diagnosed with China Liver Cancer Staging (CNLC) IIIa HCC. Due to insufficient future liver remnant and vascular involvement, the patient was suggested to be unresectable. SIRT with yttrium-90 resin microspheres was given. At three months post-SIRT, a complete response was achieved. The tumor was downstaged to CNLC Ia stage. The patient underwent anatomical hepatectomy 5 months after SIRT. Histopathological examination of the resected specimen showed 4% viable tumor cells inside a necrotic mass. To our knowledge, this is the first case who underwent SIRT with yttrium-90 resin microspheres in China mainland. The success of the downstaging in this case renders a possible cure to be achieved in an initially unresectable patient. In addition, the nearly complete tumor necrosis in the resected specimen indicates a good prognosis post-surgery. This is the first case who underwent SIRT with yttrium-90 resin microspheres in China mainland. SIRT followed by anatomical hepatectomy is a potentially curative strategy for unresectable HCC, which deserves a confirmative trial in the future.

Effect of Pharmacomechanical Catheter-Directed Thrombolysis on Segmental Artery Occlusions: Insights From the RESCUE Trial.

BACKGROUND: Reduction in distal vascular volume in acute pulmonary embolism (PE) is a significant predictor of 30- and 90-day mortality. The likely cause of this is pulmonary arterial obstruction. The effect of pharmacomechanical catheter-directed thrombolysis (PM-CDT) on the occlusions of these pulmonary artery (PA) branches is not known. OBJECTIVES: The RESCUE study evaluated PM-CDT with the Bashir endovascular catheter in patients with acute intermediate-risk PE. This analysis assessed PA occlusions using core laboratory data before and after PM-CDT therapy. METHODS: The baseline and 48-hour post-treatment contrast-enhanced chest computed tomography angiography of PE patients with right ventricular dilatation enrolled in the RESCUE trial were used. The primary analysis was the change in the number of segmental and proximal PA branches with total or subtotal (>65%) occlusions after 48 hours compared to baseline using McNemar's test. RESULTS: A total of 107 patients enrolled across 18 United States sites comprised this analysis. At 48 hours post-PM-CDT, the number of segmental PA branches with total or subtotal occlusions decreased from 40.5% to 11.7% (P < 0.0001). Proximal PA branch total or subtotal occlusions decreased from 28.7% to 11.0% (P < 0.0001). The reduction in segmental artery occlusions correlated significantly with the magnitude of reduction in right ventricular/left ventricular ratio (correlation coefficient of 0.287 [95% CI: 0.102-0.452]; P= 0.0026), whereas that in the proximal PA arteries did not (correlation coefficient of 0.132 [95% CI: 0.059-0.314] P= 0.173). CONCLUSIONS: PM-CDT with the Bashir catheter was associated with a significant reduction in total and subtotal occlusion of segmental and proximal PAs.

Overcoming Barriers and Advancements in Endovascular Robotics: A Review of Systems and Developments.

Endovascular robots have the potential to revolutionize the field of vascular interventions by enhancing procedural efficiency, accuracy, and standardization. They aim to reduce radiation exposure, as well as physical strain on operators and medical staff, while enabling precise navigation of catheters through challenging anatomical structures. However, the widespread adoption of these robots faces barriers, such as real estate constraints, setup time, limited range of compatible tools, and high costs. This paper discusses these barriers and highlights Hansen Medical's Magellan and the Liberty robotic systems as notable examples. New developments will offer cost-effective, intuitive, and disposable approaches to endovascular procedures. Despite challenges, endovascular robots hold promise for improving access to endovascular therapy and transforming patient care in various healthcare settings.

Effect of Previous Transarterial Chemoembolization on Survival and Toxicity after Yttrium-90 Transarterial Radioembolization of Hepatocellular Carcinoma in the Radiation-Emitting SIR-Spheres in Nonresectable Liver Tumor Registry.

PURPOSE: To determine overall survival (OS), best response, and toxicities in patients with hepatocellular carcinoma (HCC) previously treated with chemoembolization (TACE+) or yttrium-90 resin transarterial radioembolization (TARE) compared with those of TACE-naïve (T-N) participants. MATERIALS AND METHODS: In this prospective, observational study, 262 adult participants with HCC were divided into TACE+ (n = 93, 35%) or T-N (n = 169, 65%) groups, included from 36 centers in the United States. Overall survival (OS) was assessed using Kaplan-Meier analysis from the date of TARE. Best response at 6 months was evaluated using modified Response Evaluation Criteria in Solid Tumors. Six-month toxicities were reported using Common Terminology Criteria for Adverse Events, version 5. RESULTS: Median OS for patients in the TACE+ and T-N groups was 22.3 months (95% CI: 17.2 to not reachable) and 21.5 months (95% confidence interval [CI]: 14.9-29.9), respectively (P = .6). Imaging at 6 months ± 2 weeks was available in 156 of 262 (60%) participants. Partial or complete response was seen in 27 of 55 patients (49%) in the TACE+ group and 65 of 101 patients (64%) in the T-N group (P = .2). Six-month toxicities were available in 69 of 93 patients (74%) in the TACE+ group and 135 of 167 patients (81%) in the T-N group. Attributable Grade 3 or greater liver function toxicities were similar between the study groups (all P > .05). CONCLUSIONS: OS and imaging response at 6 months in the TACE+ group was similar to that in the T-N group with similar toxicities. Radioembolization is an acceptable treatment option for patients with HCC previously treated with TACE.

Outcomes of Intravascular Lithotripsy in the Treatment of Chronic Limb-Threatening Ischemia: A Single-Center Retrospective Study.

PURPOSE: Vascular calcification is an important risk factor for endovascular treatment failure and complications in patients with chronic limb-threatening ischemia (CLTI). Intravascular lithotripsy (IVL) is a pulsatile balloon-based device that has emerged as a tool in the treatment of calcified vessels. The purpose of this study is to evaluate the efficacy and safety of IVL in the treatment of peripheral calcified lesions in CLTI patients. MATERIALS AND METHODS: A retrospective study was performed within a single institution. Thirty-six CLTI patients treated with IVL for peripheral calcified lesions from 2018 to 2022 were identified. Data on pre- and post-IVL luminal stenosis measured by digital subtraction angiography, lesion location, adjunctive therapies, ankle-brachial index (ABI), and intra-procedural complications were obtained. A total of 41 target lesions in twenty-eight patients were included, with ABI data available in 20 treated lower extremities. RESULTS: Across all 41 target lesions, IVL produced clinically significant luminal gain of 75.5% ± 23.0. Luminal gain by vessel location was 87.3% ± 15.8, 57% ± 25.7, and 78.5% ± 20.6 in the aortoiliac (n = 8), common femoral (n = 9), and femoropopliteal (n = 24) segments, respectively. Lesions treated with IVL alone yielded a luminal gain of 71.4% ± 25.6 (n = 10), while IVL alongside adjunctive therapy produced a luminal gain of 76.8% ± 22.4. In 20 treated lower extremities, ABI improvement of 0.20 ± 0.26 (p = 0.002) was recorded. Intra-procedural complications occurred in 1/36 patients, which was one instance of thrombus occurring prior to IVL. CONCLUSION: IVL may be an effective option for creating safe luminal gain and vessel preparation in patients with CLTI. Level of Evidence 2: Retrospective Cohort Study.

Overall survival and toxicity of hepatocellular carcinoma Barcelona Clinic Liver Cancer B patients receiving Y90 radioembolization: analysis of the radiation-emitting SIR-spheres in non-resectable liver tumor (RESiN) registry.

Background: To evaluate overall survival (OS), progression-free survival (PFS) and toxicity after resin Yttrium-90 (Y-90) radioembolization in Barcelona Clinic Liver Cancer B (BCLC B) hepatocellular carcinoma (HCC) patients using the Bolondi subgroup classification. Methods: A total of 144 BCLC B patients were treated between 2015-2020. Patients were broken into 4 subgroups by tumor burden/liver function tests with 54, 59, 8 and 23 in subgroups 1, 2, 3 and 4. OS and PFS were calculated with Kaplan-Meier analysis with 95% confidence intervals. Toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5. Results: Prior resection and chemoembolization were performed in 19 (13%) and 34 (24%) of patients. There were no deaths within 30 days. Median OS and PFS for the cohort were 21.5 and 12.4 months. Median OS was not reached for subgroup 1 at a mean 28.8 months, and was 24.9, 11.0 and 14.6 months for subgroups 2-4 (χ2=19.8, P=0.0002). PFS by BCLC B subgroup was 13.8, 12.4, 4.5, and 6.6 months (χ2=16.8, P=0.0008). The most common Grade 3 or 4 toxicities were elevated bilirubin (n=16, 13.3%) and decreased albumin (n=15, 12.5%). Grade 3 or greater bilirubin (32% vs. 10%, P=0.03) and albumin (26% vs. 10%, P=0.03) toxicity were more common in the subgroup 4 patients. Conclusions: The Bolondi subgroup classification stratifies OS, PFS and development of toxicity in patients treated with resin Y-90 microspheres. OS in subgroup 1 approaches 2.5 years and Grade 3 or greater hepatic toxicity profile in subgroups 1-3 is low.

Survival and Toxicities after Yttrium-90 Transarterial Radioembolization of Cholangiocarcinoma in the RESiN Registry.

PURPOSE: To report outcomes in patients with intrahepatic cholangiocarcinoma treated with yttrium-90 resin microspheres (transarterial radioembolization [TARE]) from a multicenter, prospective observational registry. MATERIALS AND METHODS: Ninety-five patients (median age, 67 years [interquartile range {IQR}, 59-74]; 50 men) were treated in 27 centers between July 2015 and August 2020. Baseline demographic characteristics included imaging findings, performance status, and previous systemic or locoregional treatments. Dosimetry method was tracked. Overall survival (OS) and progression-free survival were calculated using the Kaplan-Meier method. The best imaging response was calculated using the Response Evaluation Criteria in Solid Tumors v1.1. Grade ≥3 toxicities were assessed using Common Terminology Criteria for Adverse Events v5. Cox regression analysis was performed. RESULTS: Fifty-two of 86 (60%) patients had multifocal tumors, and 24/89 (27%) had extrahepatic tumors. The median index tumor diameter was 7.0 cm (IQR, 4.9-10 cm). The activity calculation method was reported in 59/95 (62%) patients, with body surface area being the most frequently used method (45/59, 76%). Median OS for the cohort was 14 months (95% confidence interval, 12-22). OS at 3, 6, 12, and 24 months was 94%, 80%, 63%, and 34%, respectively. Median OS was longer in patients without cirrhosis (19.1 vs 12.2 months, P = .05). Cirrhosis, previous chemotherapy (OS, 19.1 vs 10.6 months for treatment-naïve; P = .07), and imaging response at 6 months (OS, 16.4 vs 9.5 months for no response; P = .06) underwent regression analysis. Imaging response predicted OS at regression (hazard ratio, 0.39; P = .008). Grade 3-4 bilirubin toxicities were noted in 5 of 72 (7%) patients. Grade 3 albumin toxicity was noted in 1 of 72 (1.4%) patients. CONCLUSIONS: Objective response at 6 months predicted longer OS after TARE for intrahepatic cholangiocarcinoma. The incidence of liver function toxicity was <10%.

REBOA: Expanding Applications From Traumatic Hemorrhage to Obstetrics and Cardiopulmonary Resuscitation, From the AJR Special Series on Emergency Radiology.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged over the past decade as a technique to control life-threatening hemorrhage and treat hemorrhagic shock, being increasingly used to treat noncompressible traumatic torso hemorrhage. Reports during this time also support the use of a REBOA device for an expanding range of indications including nontraumatic abdominal hemorrhage, postpartum hemorrhage, placenta accreta spectrum (PAS) disorder, and cardiopulmonary resuscitation (CPR). The strongest available evidence supports REBOA as a lifesaving adjunct to definitive surgical management in trauma and as a method to help avoid hysterectomy in select patients with postpartum hemorrhage or PAS disorder. In comparison with initial descriptions of complete REBOA inflation, techniques for partial REBOA inflation have been introduced to achieve hemodynamic stability while minimizing adverse events relating to reperfusion injuries. Fluoroscopy-free REBOA has been described in various settings, including trauma, obstetrics, and out-of-hospital cardiac arrest. As the use of REBOA expands outside the trauma setting and into nontraumatic abdominal hemorrhage, obstetrics, and CPR, it is imperative for radiologists to become familiar with this technology, its proper placement, and its potential adverse sequelae.

Overall survival and toxicity of Y90 radioembolization for hepatocellular carcinoma patients in Barcelona Clinic Liver Cancer stage C (BCLC-C).

INTRODUCTION: National Comprehensive Cancer Network HCC guidelines recommend Y90 to treat BCLC-C patients only in select cases given the development of systemic regimens. We sought to identify ideal candidates for Y90 by assessing survival and toxicities in this patient group. MATERIALS AND METHODS: The Radiation-Emitting Selective Internal radiation spheres in Non-resectable tumor registry is a prospective observational study (NCT: 02,685,631). Patients with advanced HCC were stratified into 3 groups based on tumor location, Eastern Cooperative Oncology Group (ECOG) performance status, and liver function. Group 1: liver isolated HCC, ECOG 0 and Child Pugh (CP) A (n = 12, 16%), Group 2: liver isolated HCC, ECOG ≥ 1 or CP B/C (n = 37, 49%), and Group 3: extrahepatic HCC with any ECOG or CP score (n = 26, 35%). Patients in any group could have macrovascular invasion. Overall survival (OS) and progression-free survival (PFS) with 95% confidence intervals (95% CI) were calculated. Grade 3 + toxicities were tracked using Common Terminology Criteria for Adverse Events v5. Cox proportional hazard model was performed to determine factors affecting OS. RESULTS: Seventy-five BCLC-C patients treated between 2015 and 2019 were reviewed. The groups were similar in age, sex, race, and ethnicity (all p > 0.05). Bilobar disease was least common in Group 1 (p < 0.001). Median OS of the entire cohort was 13.6 (95% CI 7.5-16.1) months. Median OS of Groups 1-3 were 21.8, 13.1 and 11.5 months respectively (p = 0.6). Median PFS for the cohort was 6.3 (4.8-14.7) months. Median PFS for group 1 was not reached. Mean PFS for Group 1 was 17.3 ± 4.8 months. Median PFS for Groups 2 and 3 was 6.8 and 5.9 months (X2 = 1.5, p = 0.5). Twenty-four Grade 3 or greater toxicities developed, most commonly hyperbilirubinemia (8/75, 11%) and thrombocytopenia (2/75, 3%). The incidence of toxicities between groups was similar (all p > 0.05). Cox Proportional Hazard analysis predicted shorter OS with CP class B/C (X2 = 6.7, p = 0.01), while macrovascular invasion (X2 = 0.5, p = 0.5) and ECOG score of ≥ 1 (X2 = 2.1, p = 0.3) was not associated with OS. CONCLUSIONS: OS of CPA patients with advanced HCC and performance status of 0 was 21.8 months following Y90. CP A cirrhosis is the best predictor of prolonged OS in advanced (BCLC-C) HCC.

Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study.

BACKGROUND: 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). OBJECTIVES: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).

Endovascular Treatment of Infrainguinal Peripheral Arterial Disease (PAD): Update on Stent Technology.

Peripheral artery disease (PAD) is a progressive vascular disease affecting millions of individuals and is a considerable cause of morbidity and mortality worldwide. While balloon angioplasty remains the cornerstone option for endovascular management of arterial stenosis, advances in percutaneous endovascular stent technology have broadened the toolbox of therapeutic options for PAD and have significantly improved function and quality of life. Indeed, covered stents, bioabsorbable stents and drug eluting stents are several of the innovations in stent technology made since the advent of nitinol bare metal stents in the 1980s. The indications for use, technical considerations, treatment outcomes, and current concerns regarding current stent devices will herein be discussed in this review.

Technical Approach to Percutaneous Femoropopliteal Bypass and Deep Vein Arterialization.

In the management of patients with critical limb ischemia endovascular revascularization plays a crucial role improving amputation-free survival, ischemic rest pain, and wound healing. Endovascular standard of care of peripheral arterial occlusive disease involves angioplasty and/or stent placement. The following discussion is intended to familiarize interventional physicians with the rationale, physiological concepts, and technical approach to developing endovascular procedures-percutaneous femoropopliteal bypass and percutaneous deep vein arterialization. Percutaneous arterial bypass procedure is designed to treat long complex Trans-Atlantic Inter-Society Consensus C and D hemodynamically significant superficial femoral artery lesions by redirecting the flow of blood from the diseased arterial segment through a femoral vein conduit. Percutaneous deep vein arterialization is used for selected "no-option" critical limb ischemia patients who cannot undergo or have failed conventional endovascular and/or surgical revascularization due to extensive occlusion of the outflow arteries. It involves creation of an arteriovenous fistula between a tibial artery and a tibial vein, disruption of venous valves, and elimination of venous collaterals. The consequent arterialization of the distal venous bed enables delivery of oxygenated pressurized arterial blood to the ischemic tissues, stimulating angiogenesis and increasing flow in the existent collateral vessels, which in turn will improve limb salvage and amputation free survival.

Survival and Toxicities after 90Y Transarterial Radioembolization of Metastatic Colorectal Cancer in the RESIN Registry.

Background Patients with unresectable, chemorefractory hepatic metastases from colorectal cancer have considerable mortality. The role of transarterial radioembolization (TARE) with yttrium 90 (90Y) microspheres is not defined because most reports are from a single center with limited patient numbers. Purpose To report outcomes in participants with colorectal cancer metastases treated with resin 90Y microspheres from a prospective multicenter observational registry. Materials and Methods This study treated enrolled adult participants with TARE using resin microspheres for liver-dominant metastatic colorectal cancer at 42 centers, with enrollment from July 2015 through August 2020. TARE was used as the first-, second-, or third-line therapy or beyond. Overall survival (OS), progression-free survival (PFS), and toxicity outcomes were assessed by line of therapy by using Kaplan-Meier analysis for OS and PFS and Common Terminology Criteria for Adverse Events, version 5, for toxicities. Results A total of 498 participants (median age, 60 years [IQR, 52-69 years]; 298 men [60%]) were treated. TARE was used in first-line therapy in 74 of 442 participants (17%), second-line therapy in 180 participants (41%), and third-line therapy or beyond in 188 participants (43%). The median OS of the entire cohort was 15.0 months (95% CI: 13.3, 16.9). The median OS by line of therapy was 13.9 months for first-line therapy, 17.4 months for second-line therapy, and 12.5 months for third-line therapy (χ2 = 9.7; P = .002). Whole-group PFS was 7.4 months (95% CI: 6.4, 9.5). The median PFS by line of therapy was 7.9 months for first-line therapy, 10.0 months for second-line therapy, and 5.9 months for third-line therapy (χ2 = 8.3; P = .004). TARE-attributable grade 3 or 4 hepatic toxicities were 8.4% for bilirubin (29 of 347 participants) and 3.7% for albumin (13 of 347). Grade 3 and higher toxicities were greater with third-line therapy for bilirubin (P = .01) and albumin (P = .008). Conclusion Median overall survival (OS) after transarterial radioembolization (TARE) with yttrium 90 microspheres for liver-dominant metastatic colorectal cancer was 15.0 months. The longest OS was achieved when TARE was part of second-line therapy. Grade 3 or greater hepatic function toxicity rates were less than 10%. Clinical trial registration no. NCT02685631 Published under a CC BY 4.0 license. Online supplemental material is available for this article. See also the editorial by Liddell in this issue.