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.

Modified Bethesda criteria for thyroid aspirates significantly decrease nondiagnostic rates without decreasing sensitivity.

INTRODUCTION: Previous studies suggest that the adequacy rate of thyroid aspirates can be improved by altering the adequacy criteria of the Bethesda System. We sought to measure the performance of these altered criteria in a prospective fashion. MATERIALS AND METHODS: Over a 6-year period, cases with 1 to 59 follicular cells were prospectively classified as "nondiagnostic, favor benign" or "scant but adequate". "Scant but adequate" cases were classified as either benign (Bethesda category 2) or atypia of undetermined significance (AUS) (Bethesda category 3). Bethesda category 3 cases were referred for Afirma testing (Veracyte, San Francisco, CA). RESULTS: Of 5147 cases, 131 (3%) were classified as "nondiagnostic, favor benign"; 45 (65%) of these had follow-up with a risk of malignancy of 2.6%. Additionally, 436 (8%) of all 5147 cases were classified as "scant but adequate" and "benign"; 49 (11%) of these had follow-up with a risk of malignancy of 0%. Lastly, 197 (4%) of all 5147 cases were classified as "scant but adequate" with AUS; 177 (90%) of these 197 cases had an adequate Afirma result. The "suspicious" rate was not significantly different than that of cases classified as "adequate" and AUS (Bethesda category 3 and 4) (35 of 197 [18%] versus 140 of 848 [17%] P = 0.67), and there was no significant difference in the risk of malignancy for these 2 categories ("scant but adequate" 9 of 18, "adequate" 50% versus 27 of 85, 32%, P = 0.10). Overall, the modified Bethesda criteria reduced the nondiagnostic rate from 22% to 10% (P <0.001) without lowering the sensitivity of the test. CONCLUSIONS: Modified Bethesda adequacy criteria can significantly lower nondiagnostic rates without lowering sensitivity.

Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.

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.

The Vascular Lab and the Interventional Radiologist.

A vascular laboratory (VL) can be defined as a place where physicians and technologists have a commitment to perform and interpret non-invasive testing with objective techniques that are most appropriate to the facility and the skills of the laboratory personnel. It provides the entry point for many patients as well as being the sight for diagnosis and follow up for patients with vascular disease for Interventional Radiologists (IRs). VLs may be run by a multi-specialty service, may be hospital-based, or may be private practice-based providing more of a concierge service. Resident education in the VL is essential and allows IRs to function on equal footing with other medical colleagues who see and treat similar patients from an early stage and throughout an IR's career. In this article we will discuss the IRs imperative connection to the VL.

Intracranial and Extracranial Evaluation.

The vascular lab is an essential tool in diagnosing intracranial and extracranial disease including vasospasm from subarachnoid hemorrhage and carotid artery stenosis in the setting of stroke or transient ischemic attack. This article discusses the indications, protocol, and diagnostic criteria for transcranial doppler (TCD) and carotid artery duplex ultrasound. Intracranial and extracranial arterial testing by way of TCD and carotid imaging carries enormous implications and can provide life or death information. The learning curve for these techniques is steep but can be mastered with repetition and precise technique.

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.

Stent Graft Outcomes in Dialysis Circuits: A Review of Clinical Trials and Literature.

End-stage renal disease is a prevalent medical condition causing significant problems as the majority of patients are being treated with dialysis. While dialysis provides a means to compensate for the renal impairment, arteriovenous grafts and fistulas are often complicated by neointimal hyperplasia, loss of primary patency, and graft failure. Over the last decade, stent grafts have emerged as an alternative to balloon angioplasty and bare metal stents for revascularization in the event of arteriovenous graft occlusion or stenosis. Several randomized controlled trials have investigated the efficacy of stent grafts compared with balloon angioplasty for improving the function and durability of dialysis circuits. In this review, we present a comprehensive review of clinical trials. Stent grafts appear to offer increased primary patency over balloon angioplasty in the treatment of dialysis circuit stenosis. However, there is generally no significant difference between the two treatment modalities on other clinically relevant measures like complication rates and overall survival.

Radioembolization of Secondary Hepatic Malignancies.

Cancer has become the leading cause of mortality in America, and the majority of patients eventually develop hepatic metastasis. As liver metastases are frequently unresectable, the value of liver-directed therapies, such as transarterial radioembolization (TARE), has become increasingly recognized as an integral component of patient management. Outcomes after radioembolization of hepatic malignancies vary not only by location of primary malignancy but also by tumor histopathology. This article reviews the outcomes of TARE for the treatment of metastatic colorectal cancer, metastatic breast cancer, and metastatic neuroendocrine tumors, as well as special considerations when treating metastatic disease with TARE.

Improving IR Ergonomics Using a Flexible C-Arm System.

PURPOSE: To evaluate the impact of a versatile flexible ceiling-mounted C-arm on active table and gantry repositioning during interventions and its effect on operator discomfort, system usability, and patient safety compared with a traditional ceiling-mounted system. MATERIALS AND METHODS: There were 100 IR procedures studied: 50 in a traditional IR system (standard group) and 50 with a novel multiaxis ceiling-mounted system (test group). FlexArm was capable of multiple gantry rotation points allowing increased access to the patient in addition to 236 cm of lateral x-ray detector travel. For each procedure, both the table and the gantry repositioning were measured. Patient safety, patient/equipment repositioning effort, and physical discomfort were evaluated through an operator survey. RESULTS: Table repositioning was reduced from 42 to 16 instances per procedure (P < .001) in the test group compared with the standard group. The operators perceived less table and gantry repositioning effort (P < .0001) and decreased risks of equipment collisions, displacement of vascular access, and dislodgment of tubes/lines with the test group (P < .0001). Operator discomfort was reduced for all body areas in the test group over the standard group (P < .0001). CONCLUSIONS: The FlexArm system geometry enhances operator ergonomics, as there was a decrease need to move the table, leading to a perceived decrease in patient risk and decrease operator physical discomfort when compared to a traditional imaging system.

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial.

OBJECTIVES: This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). BACKGROUND: PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking. METHODS: 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) ratio >0.9. 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. RESULTS: 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. CONCLUSIONS: 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).

Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial.

BACKGROUND: Spine metastasis is a common occurrence in cancer patients and results in pain, neurologic deficits, decline in performance status, disability, inferior quality of life (QOL), and reduction in ability to receive cancer-directed therapies. Conventional external beam radiation therapy (EBRT) is associated with modest rates of pain relief, high rates of disease recurrence, low response rates for those with radioresistant histologies, and limited improvement in neurologic deficits. The addition of radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA) to index sites together with EBRT may improve pain response rates and corresponding quality of life. METHODS/DESIGN: This is a single-center, prospective, randomized, controlled trial in patients with spine metastasis from T5-L5, stratified according to tumor type (radioresistant vs. radiosensitive) in which patients in each stratum will be randomized in a 2:1 ratio to either RFA/PVA and EBRT or EBRT alone. All patients will be treated with EBRT to a dose of 20-30 Gy in 5-10 fractions. The target parameters will be measured and recorded at the baseline clinic visit, and daily at home with collection of weekly measurements at 1, 2, and 3 weeks after treatment, and at 3, 6, 12, and 24 months following treatment with imaging and QOL assessments. DISCUSSION: The primary objective of this randomized trial is to determine whether RFA/PVA in addition to EBRT improves pain control compared to palliative EBRT alone for patients with spine metastasis, defined as complete or partial pain relief (measured using the Numerical Rating Pain Scale [NRPS]) at 3 months. Secondary objectives include determining whether combined modality treatment improves the rapidity of pain response, duration of pain response, patient reported pain impact, health utility, and overall QOL. TRIAL REGISTRATION: ClinicalTrials.gov NCT04375891 . Registered on 5 May 2020.

"How We Do It" - A Practical Approach to Percutaneous Adrenal Ablation Techniques.

Incidental adrenal masses are common and are found in 4% of the CT scans.1 While clinical history, laboratory results, and imaging characteristics are typically sufficient for diagnosis of an adrenal lesion, a biopsy is sometimes warranted. In some cases, adrenal mass ablation is subsequently indicated. This article serves as a brief but comprehensive review of preprocedural work-up and planning before an adrenal mass ablation, as well as a discussion on ablation techniques, associated challenges and solutions, and management of expected and unexpected outcomes.

Management of High Hepatopulmonary Shunts in the Setting of Y90 Radioembolization.

Treatment paradigms for primary and metastatic malignancies involving the liver have evolved in recent years to include targeted liver therapies. Transarterial radioembolization is at the forefront of therapy in many treatment algorithms. However, due to significant hepatopulmonary shunting, some patients are excluded from this proven treatment due to the possibility of radiation-induced lung injury. In this article, we review techniques to mitigate hepatopulmonary shunts to improve the likelihood of inclusion and successful treatment in these patients.

Fenestrated Endovascular Abdominal Aortic Aneurysm Repair.

In order to offer more patients a durable endovascular abdominal aortic aneurysm repair parallel, branched, and fenestrated grafts have been utilized. These treatments aim at increasing the quality of the proximal aortic graft landing zone by incorporating the healthy aortic neck at the renal and visceral arteries. Fenestrated endovascular aneurysm repair has provided a standardized and approved treatment option for patients who may otherwise not be candidates for endovascular repair. We discuss the technique of fenestrated endovascular aneurysm repair and the challenges involved in selecting the appropriate patients.