Monday, January 19, 2026

Renal Upper Pole IGTA

 Image-Guided Thermal Ablation of Upper Pole Renal Lesions ≤4 cm: Safety and Effectiveness



🔍 **Clinical Question:**  

To compare the safety and effectiveness of image-guided thermal ablation (IGTA) for upper pole versus nonupper pole renal lesions ≤4 cm given the technical challenges of the former.


💡 **Key Insight:**  

Upper pole renal lesions ≤4 cm treated with image-guided thermal ablation showed comparable adverse event rates to nonupper pole lesions (Grade 3 [severe], 2.4% vs 1.3%, P > .99).

Primary effectiveness was 100% for upper pole lesions versus 97.3% for nonupper pole lesions (P = .54), with no difference in 3-year overall survival (92.9% vs 87.0%, P = .22) and local progression-free survival (90.0% vs 100.0%, P = .17).

Polar location (upper vs nonupper) and R.E.N.A.L./m.R.E.N.A.L. nephrometry scores had no association with adverse events or local progression.


👉 **Why it matters:**  

Image-guided thermal ablation for upper pole renal lesions ≤ 4 cm demonstrated safety and oncologic outcomes comparable to non-upper pole lesions despite its increased technical complexity. Polar location alone should not exclude patients from consideration for image-guided thermal ablation.


➡️ **Full Article:** 

https://doi.org/10.1016/j.jvir.2025.10.026


#InterventionalRadiology #IO #RCC #IGTA #RenalTumor #TumorBoard #MedEd  


Friday, January 16, 2026

TARE Breast Cancer Liver Mets

Transarterial Microembolization Therapy for Chronic First Metatarsophalangeal Joint Pain



🔍 **Clinical Question:**  

To evaluate the association between tumor-absorbed dose (TAD) relative to response and survival among patients with breast cancer liver metastasis (BCLM) treated with yttrium-90 (90Y) transarterial radioembolization (TARE).


💡 **Key Insight:**  

Overall survival was found to be significantly improved in responders compared with nonresponders among patients with breast cancer liver metastasis treated with yttrium-90 glass microspheres.

Tumor-absorbed dose showed a significant survival advantage above 145 Gy.

No significant difference was found in tumor-absorbed dose between responders and nonresponders.


👉 **Why it matters:**  

Metabolic response predicts survival, dose thresholds matter, and higher dose alone does not guarantee response. These results highlight the need for personalized dosimetry in 90Y therapy for breast cancer liver metastases. 


➡️ **Full Article:** 

https://doi.org/10.1016/j.jvir.2025.08.045


#InterventionalRadiology #IO #TARE #SIRT #Y90 #BreastCancer #TumorBoard #MedEd  


Monday, January 12, 2026

TAME for Chronic Toe Pain

 Transarterial Microembolization Therapy for Chronic First Metatarsophalangeal Joint Pain



🔍 **Clinical Question:**  

To evaluate the feasibility, safety, and preliminary effectiveness of transarterial microembolization (TAME) for refractory first metatarsophalangeal joint (MTPJ) pain in patients with inflammatory arthritis, gout, or osteoarthritis.


💡 **Key Insight:**  

Transarterial microembolization (TAME) targets hypervascularity and pathological nerve ingrowth, key contributors to chronic pain, by selectively embolizing feeder arteries, thereby disrupting pain pathways and reducing inflammatory mediators.

TAME demonstrated significant reduction in pain and weekly analgesic use, establishing it as a safe and effective minimally invasive alternative for managing chronic metatarsophalangeal joint pain refractory to conventional treatments.


👉 **Why it matters:**  

The favorable safety profile and effectiveness of TAME suggest potential applications in other small joint pathologies.


➡️ **Full Article:** 

https://doi.org/10.1016/j.jvir.2025.08.047


#InterventionalRadiology #MSKIR #Pain #OA #MedEd

Friday, January 9, 2026

Percutaneous Cystis Duct Stent

Outcomes of Percutaneous Cystic Duct Stent Placement for Acute Cholecystitis




🔍 **Clinical Question:**


To evaluate whether PCDS placement is safe and effective for nonsurgical patients with acute cholecystitis and cystic duct (CD) anatomy predicts technical success.
 

💡 **Key Insight:**


Percutaneous cystic duct stent (PCDS) placement was attempted in patients with acute cholecystitis who were nonsurgical candidates.

PCDS placement is technically feasible, with 95.3% success in patients with open cystic duct and normal course.
 

👉 **Why it matters:**


Patients who are diagnosed with acute cholecystitis who are nonsurgical candidates should be offered the option of PCDS placement to avoid the long-term presence of a percutaneous cholecystostomy tube. This can often be achieved in a single procedure after initial percutaneous cholecystostomy tube placement.
 

➡️ **Full Article:** 



#InterventionalRadiology #Biliary #Gallbladder #CholeTube #MedEd

Monday, December 15, 2025

SIR Guidelines on Percutaneous Dialysis AVF

A Society of Interventional Radiology Practice Guidance Document on Percutaneous Arteriovenous Fistulae for Dialysis Access



🔍 **Clinical Question:**  

What are the up-to-date society-based consensus recommendations for the creation and maturation of percutaneous arteriovenous fistulae (pAVFs) for hemodialysis access?


💡 **Key Insight:**  

Vessel mapping is essential for successful pAVF creation, evaluating inflow arteries, perforator vein(s), and superficial outflow veins.

Although technical success of pAVF creation is >95%, patients should be aware that many of the fistulae will require additional procedures to ensure fistula maturation. Successful cannulation rates are approximately 80%.

The interventionalist is responsible for postprocedural pAVF management, which usually includes a follow-up visit 1–2 weeks after creating a pAVF. 

Use the appropriate Current Procedural Terminology (CPT) code (36836 or 36837) for percutaneous creation of upper extremity AVFs (these codes refer to procedures performed via single or dual access sites.)


👉 **Why it matters:**  

Percutaneous AVF creation offers many benefits over surgical AVFs with ongoing evidence of its safety and effectiveness. This practice guidance document serves as a summary of what is required to develop a pAVF program, including patient preparation, performance of the procedure, adverse event management, and follow-up care.


➡️ **Full Article:** 

https://doi.org/10.1016/j.jvir.2025.08.019


#InterventionalRadiology #VascularIR #AVF #Hemodialysis #PercutaneousAVF #PracticeGuideline #PracticeBuilding #MedEd  


Monday, December 8, 2025

Prospective GAE Trial

A Prospective Single-Arm Trial of Genicular Artery Embolization for Symptomatic Knee Osteoarthritis: Clinical and Biomarker Outcomes



🔍 **Clinical Question:**  

What are the longitudinal effects of genicular artery embolization (GAE) on biomarkers implicated in knee osteoarthritis (KOA) pathogenesis?


💡 **Key Insight:**  

Genicular artery embolization (GAE) provided significant and sustained clinical improvements in patients with symptomatic knee osteoarthritis.

GAE demonstrated a favorable safety profile, with adverse events being predominantly mild and transient.

GAE was associated with a significant reduction in key inflammatory and angiogenic biomarkers (vascular endothelial growth factor and interleukin-1 receptor antagonist) at 12 months.


👉 **Why it matters:**  

GAE is a safe treatment for symptomatic KOA, providing clinically significant pain relief for a subset of patients. The observed reductions in serum VEGF and IL-1Ra levels following GAE may contribute to local pain relief and decreased inflammation in the knee joints.


➡️ **Full Article:** 

https://doi.org/10.1016/j.jvir.2025.08.009


#InterventionalRadiology #MSKIR #GAE #OA #MedEd  


Wednesday, November 19, 2025

GAE with Resorbable Beads

First-in-Human Evaluation of a New Resorbable Microspherical Embolic Agent for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteroarthritis





🔍 **Clinical Question:**


Is genicular artery embolization (GAE) using a resorbable microspherical embolic agent a safe and effective treatment for pain secondary to knee osteoarthritis (KOA)?


💡 **Key Insight:**


This first-in-human study reports on the feasibility, safety, and effectiveness of a new resorbable embolic agent, SakuraBead (CrannMed, Galway, Ireland), specifically designed for musculoskeletal embolotherapy.

Fifteen patients underwent successful genicular artery embolization with 100% technical success.

There was a statistically significant reduction (P < .001) in mean visual analog scale score of 73.8%, 75.7%, and 63.1% at 1, 3, and 6 months, respectively. There was a 79.1% reduction in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at both 1 and 3 months, and 75.8% reduction was maintained at 6 months (P < .01); this was accompanied by a reduction in WOMAC pain score of 80.3%, 82.4%, and 78.7% at 1, 3, and 6 months, respectively (P < .01).


👉 **Why it matters:**


This limited pilot study demonstrated that genicular artery embolization using alginate resorbable microspheres was safe and provided significant improvement in pain and function in patients with knee osteoarthritis maintained to 6-month follow-up.


➡️ **Full Article:** 


https://doi.org/10.1016/j.jvir.2025.07.010

#InterventionalRadiology #MSKIR #GAE #OA #MedEd

Tuesday, November 18, 2025

Mesenteric Lymphangiography

Mesenteric Lymphangiography as a New Diagnostic and Therapeutic Tool for Refractory Chylous Lymphatic Leakages and Protein-Losing Enteropathy






🔍 **Clinical Question:**


Is mesenteric lymphangiography (mLAG) is technically feasible and clinically useful for patients with refractory chylous ascites, chylothorax, and protein-losing enteropathy (PLE)?


💡 **Key Insight:**


Mesenteric lymphangiography (mLAG), via a percutaneous or intraoperative approach, is technically feasible and safe.

The utility of mLAG is in imaging the blind spots of conventional lymphatic studies, especially for chylous ascites and protein-losing enteropathy, and it allows for embolization of mesenteric lymphatics.


👉 **Why it matters:**


mLAG is technically feasible and safe. It can be a useful tool to image the mesenteric lymphatics or perform mesenteric lymphatic embolization.


➡️ **Full Article:** 


https://doi.org/10.1016/j.jvir.2025.08.008

#InterventionalRadiology #Lymphangiography #ChylousAscites #LymphaticIntervention #MedEd

Wednesday, October 29, 2025

RFA for Multinodular Goiter

Radiofrequency Ablation in the Management of Extensive Multinodular Goiter: A Midterm Single-Center Experience




🔍 **Clinical Question:**


Is radiofrequency (RF) ablation effective in providing cosmetic and symptom relief for patients with extensive multinodular goiter?



💡 **Key Insight:**


This study evaluated the effectiveness of radiofrequency (RF) ablation in patients with extensive multinodular goiter, targeting at least 3 nodules in bilobar distribution with a follow-up of 40.5 months.

RF ablation demonstrated a mean volume reduction of 85.3% in treated thyroid nodules, significantly improving both cosmetic appearance and local symptoms.

Repeated RF ablation sessions were required in 32.5% of patients due to additional target nodules, incomplete ablation, or new nodule growth.



👉 **Why it matters:**


Radiofrequency (RF) ablation in patients with extensive multinodular goiter avoids the need for thyroid hormone replacement therapy or surgery and provides a rate of cosmetic and symptom relief comparable with that achieved by RF ablation in cases of uninodular or binodular goiter.



➡️ **Full Article:** 


https://doi.org/10.1016/j.jvir.2025.06.020

#InterventionalRadiology #IO #Ablation #RFA #Goiter #Thyroid #MedEd

Wednesday, October 15, 2025

GAE with Mesenchymal Stem Cells for OA

Genicular Artery Embolization Using Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Prospective Study



🔍 **Clinical Question:**


Is genicular artery embolization (GAE) using mesenchymal stem cells safe and feasible in patients with bilateral knee osteoarthritis (OA)?


💡 **Key Insight:**


Mesenchymal stem cells were safely delivered via genicular arteries (GAE) to subjects with Kellgren-Lawrence Stage 3 knee osteoarthritis (OA). During a 12-month follow-up period, there were no study-related adverse events.

There were significant improvements in objective pain, stiffness, and function compared with the contralateral control knee.


👉 **Why it matters:**


Direct delivery of stem cells via genicular artery embolization (GAE) by interventional radiology (IR) may represent a new avenue for treatment in patients with osteoarthritis (OA).



➡️ **Full Article:** 


https://doi.org/10.1016/j.jvir.2025.05.031

#InterventionalRadiology #MSKIR #GAE #OA #MedEd

Tuesday, September 23, 2025

iCARE

Interventional Radiology Reporting Standards and Checklist for Artificial Intelligence Research Evaluation (iCARE)



🔍 **Clinical Question:**  

How do we ensure the robustness of novel technological and artificial intelligence systems in Interventional Radiology specific contexts presented in peer-reviewed journals?


💡 **Key Insight:**  

This report introduces comprehensive standards and an evaluation checklist (iCARE) that covers the application of modern AI methods in IR-specific contexts.


👉 **Why it matters:**  

Comprehensive standards in reporting support the development of safe, generalizable technologies for enhancing IR workflows, the delivery of care, and patient outcomes.


➡️ **Full Article:**

brnw.ch... #InterventionalRadiology #AI #Checklist #MedEd

Wednesday, September 17, 2025

High-Dose Radioembolization Limited by Lung Shunt for HCC Supplied by IPA

High-Dose Radioembolization Limited by Lung Shunt for Hepatocellular Carcinoma Supplied by the Inferior Phrenic Artery



🔍 **Clinical Question:**  

Is radioembolization with lung-shunt limited high dose safe and effective via the inferior phrenic artery (IPA) supplying hepatocellular carcinoma (HCC)?


💡 **Key Insight:**  

Radioembolization via the inferior phrenic artery was performed with acceptable toxicity in 43 of 44 patients with single nodular or oligonodular hepatocellular carcinoma of 4–12 cm in diameter.

The complete response rate and objective response rate by 1 session of radioembolization were 44.2% and 97.7%, respectively. The 2-year and 5-year overall survival rates were 83.9% and 70.9%, respectively.


👉 **Why it matters:**  

Radioembolization with lung-shunt limited high dose can be performed with acceptable toxicity in patients with HCC supplied by the IPA.


➡️ **Full Article:**

brnw.ch... #InterventionalRadiology #IO #Y90 #HCC #MedEd

Thursday, September 11, 2025

MRI-guided TULSA of Localized Prostate Cancer Thibault Tricard

Magnetic Resonance Imaging-guided Transurethral Ultrasound Ablation (TULSA) of Localized Prostate Cancer: A prospective Trial



🔍 **Clinical Question:**  

Is the TULSA-PRO device safe and effective in treating organ-confined low-risk to intermediate-risk prostate cancer (PCa)


💡 **Key Insight:**  

After 12 months, 43.5% of patients still had a biopsy-detectable cancerous tumor. However, there was a 40% recurrence-free rate and a 72% treatment-free survival rate at a median follow-up of 37 months.

Urinary and sexual dysfunction was common, with 26% developing stress incontinence, 35% developing overactive bladder, and 54% of potent patients developing erectile dysfunction.


👉 **Why it matters:**  

The TULSA-PRO device shows promising results for the focal treatment of localized prostate cancer, although it is not universally curative and was associated with urinary and sexual functional deficits.


➡️ **Full Article:** 

https://brnw.ch/21wVBIy

#InterventionalRadiology #IO #Ablation #ProstateCancer #MedEd

Monday, August 25, 2025

PAVM Transarterial Embolization - Meta Analysis

Transarterial Embolization for Pulmonary Arteriovenous Malformation: A Systematic Review and Meta-Analysis 





🔍 **Clinical Question:** 


Does an updated meta-analysis continue to show that transcatheter embolization for treatment of pulmonary arteriovenous malformations (PAVMs) is safe and effective? What additional insights does it offer? 

💡 **Key Insight:** 


Transcatheter embolization for pulmonary arteriovenous malformations demonstrated a high technical success rate (>98%), whereas the reported rate of postembolization catastrophic events was low (1.0%). The use of vascular plugs was associated with significantly lower persistence rates than coils only (13.6% vs 32.7%). 

Venous sac embolization showed a markedly lower persistence rate than feeding artery embolization (3.8% vs 24.3%). 

👉 **Why it matters:** 


PAVM embolization, especially using vascular plugs and encompassing venous sac embolization, has favorable technical and treatment success rates and low risk of severe AEs. 

➡️ **Full Article:** 


Thursday, August 21, 2025

Transperineal MRI–Guided Prostate Biopsy

Transperineal MR Imaging–Guided Prostate Biopsy: A Prospective Randomized Controlled Study on Safety and Effectiveness Compared with Transrectal Biopsy






🔍 **Clinical Question:** 


Is magnetic resonance (MR) imaging–guided in-bore transperineal prostate biopsies (TP-Bx) safe and tolerable?


💡 **Key Insight:** 


Adverse events occurred in 8.9% of patients undergoing transrectal prostate biopsy and 4.4% of patients undergoing transperineal prostate biopsy, with no significant difference between groups. Transperineal approach demonstrated a higher cancer detection rate (42.5%) than transrectal approach (28.2%) and a significantly higher clinically significant cancer detection rate (27.5% vs 7.7%, P = .019). 

Quality-of-life and pain assessments showed no significant differences between groups, although changes in management were more frequent following transperineal prostate biopsy (32.5% vs 15.4%, P = .050).


👉 **Why it matters:** 


MR imaging–guided transperineal prostate biopsy is a safe and effective procedure with an enhanced detection rate in non–biopsy-naïve patients, with significant impact on clinical management strategies.


➡️ **Full Article:**

brnw.ch... 


Post author
Annie Phan
MS4 Medical Student
University of Massachusetts Chan Medical School

Friday, May 9, 2025

Vox Voxel: Calculating Y90 Tumor Dose and Sphere Distribution with Voxel Dosimetry

Using Voxel-Based Dosimetry to Evaluate Sphere Concentration and Tumor Dose in Hepatocellular Carcinoma Treated with Yttrium-90 Radiation Segmentectomy with Glass Microspheres


Clinical question

How can we use voxel-based dosimetry to better understand sphere distribution and tumor dose in Y90 glass microsphere radiation segmentectomy; and does it validate the current literature on radiologic and pathologic outcomes following radiation segmentectomy?

Take away point

Voxel dosimetry is a crucial tool in better understanding of Y90 sphere activity/distribution and their effects on tumor treatment response and lasting oncologic outcomes. It is indispensable

Reference

Sandow, T., Gimenez, J., Nunez, K., Tramel, R., Gilbert, P., Oliver, B., Cline, M., Fowers, K., Cohen, A., & Thevenot, P. (2024). Using Voxel-Based Dosimetry to Evaluate Sphere Concentration and Tumor Dose in Hepatocellular Carcinoma Treated with Yttrium-90 Radiation Segmentectomy with Glass Microspheres. Journal of vascular and interventional radiology : JVIR, 35(11), 1602–1612.e1. https://doi.org/10.1016/j.jvir.2024.05.020

Click here for the full article

Study Design

Retrospective, observational, single institution

Funding Source

None

Setting

Academic setting, Oschner Health, New Orleans, LA.

Figure



Summary


This retrospective study looked at 56 patients with treatment-naive, solitary hepatocellular carcinoma (HCC) with Barcelona clinic Liver Cancer (BCLC) Stage 0-A tumor burden over a two-year period from January 2020 to October 2022. The included patients were treated with Y90 glass microspheres in a segmental or subsegmental delivery for ablation radiation segmentectomy. Treatment was done in two-step fashion starting with a mapping angiography session, which included calculation of a lung shunt fraction, followed by a treatment session. Initially, target radiation doses were > 200 Gy. This was increased to > 400 Gy after the publication of the LEGACY study in 2021. Immediately following treatment, patients were imaged using Bremsstrahlung SPECT/CT. For post-treatment dosimetry, pre-treatment diagnostic CT or MRI studies were incorporated with the post-treatment nuclear medicine SPECT/CT.

Using voxel dosimetry and the Mirada DBx Build 1.2.0 Simplicit90Y software, total liver volume, perfused volumes, and tumor volume were calculated. Tumor absorbed dose (TAD) and normal tissue absorbed dose were calculated using the multicompartment dosimetry model. Additional calculations included the sphere concentration per tumor volume, the number of spheres delivered to normal and tumoral tissue, minimum absorbed doses at 70% (D70), 90% (D90), and 99% (D99) of the total tumor volume, and minimum dose threshold to the entire tumor for 200 Gy (V200 100%) and 400 Gy (V400 100%). The primary endpoint for the study was progression of HCC based on mRECIST imaging criteria. In patients successfully bridged to transplant, pathologic information related to degree of necrosis was obtained. Statistical analysis included linear regression, Kaplan-Meier survival curves, Mann-Whitney test for continuous variables, and chi-square or Fisher exact test for categorical variables. Adverse events were monitored for 180 days and graded based on the Common Terminology Criteria for Adverse Events version 5.0.

Key findings:
· Smaller perfused volumes correlated with higher sphere concentrations in nontumoral liver and tumor.
· Larger tumors showed a nonlinear increase in total spheres deposited.
· Tumoral and nontumoral sphere concentrations had a direct linear relationship.

Clinical outcomes:
· Objective response rate: 96% (83% complete response [CR], 14% partial response).
· CR correlated with higher D70, D90, D99, and V400 100%.
· Histopathology (15 patients): 33% achieved complete pathologic necrosis (CPN); remaining tumors showed 80-99% necrosis.
· CPN was associated with smaller tumors and higher D99.
· All adverse events were treatment-related (≤Grade 3) and unrelated to nontumoral TAD.

Commentary


As the literature on Y90 radioembolization for grows in both quantity and nuance, sphere activity (SA) and sphere distribution has grown in importance. To understand why, it’s useful to review both the goal of radioembolization and the current techniques of treatment. The goal of Y90 treatment in HCC is to deliver a critical radiation dose to the tumor, with the ideal goal being complete pathologic necrosis (CPN). The LEGACY trial included a cohort of patients who received median doses of 400 Gy, 100% of which had CPN. Since the LEGACY trial, 400 Gy has become the benchmark dose for achieving CPN.

In an ideal treatment scenario, each part of the tumor would see at least 400 Gy and become completely necrotic. However, HCC’s intrinsic heterogeneity—driven by “solid stress” from tumor growth compressing vessels—creates cold areas with limited sphere deposition. Enough activity needs to be deposited into all parts of the tumor, even the cold areas, so the surrounding tumor cells get adequate absorbed dose to achieve complete pathologic necrosis. Balancing sufficient SA to penetrate these regions while avoiding uneven distribution remains a challenge.

Utilizing voxel dosimetry, the article by Sandow et al. reproduced and further delineated many of the findings from the Y90 literature. Voxel dosimetry metrics of D70, D90, D99, and V400 100% correlated strongly with radiologic and pathologic response. Smaller tumors, likely due to homogeneous hypervascularity, achieved higher sphere concentrations and CPN rates. Sphere concentration linearly predicted dose coverage (D70/ D99), emphasizing the need for both activity and distribution optimization.

The study validates voxel dosimetry as a robust analytic tool for future research in personalized Y90 radioembolization for the treatment of HCC and other types of malignancies, offering granular insights into radioembolization dose thresholds and tumor biology.

Post Author
Sean Roger, MD
Interventional Radiology Fellow, PGY-6
University of Massachusetts

Monday, December 9, 2024

GLASS Classification Correlates with Primary Patency in Chronic Limb-Threatening Ischemia Patients Treated Endovascularly

Primary Limb-Based Patency for Chronic Limb-Threatening Ischemia Treated with Endovascular Therapy Based on the Global Limb Anatomic Staging System


Clinical question

In a large population and with long follow-ups, does the GLASS classification correlate with primary patency in patients with chronic limb-threatening ischemia who underwent endovascular therapy? And what were the risk factors for primary patency loss?

Take away point

GLASS classification may be an indicator of prognosis after intervention in patients with chronic limb-threatening ischemia.

Reference

Peng M, Li C, Nie C, Chen J, Tan J. Primary Limb-Based Patency for Chronic Limb-Threatening Ischemia Treated with Endovascular Therapy Based on the Global Limb Anatomic Staging System. J Vasc Interv Radiol. 2024 Jul 24:S1051-0443(24)00472-X. doi: 10.1016/j.jvir.2024.07.015. Epub ahead of print. PMID: 39059464.

Click here for abstract

Study design

Retrospective, observational, descriptive study

Funding Source

N/A

Setting

Chongqing University Three Gorges Hospital, Wanzhou, Chongqing, China (academic institution)

Figure


Kaplan-Meier curves for primary limb-based patency stratified by Global Limb Anatomic Staging System (GLASS) stage for limbs with chronic limb-threatening ischemia undergoing endovascular therapy. (a) At 1 year after intervention: GLASS Stage I versus II, 78.8% versus 69.5%; P = .232; GLASS Stage I versus III, 78.8% versus 41.6%; P < .001; GLASS Stage II versus III, 69.5% versus 41.6%; P = .001. (b) At the end of follow-up: GLASS Stage I versus II, 54.2% versus 38.6%; P = .042; GLASS Stage I versus III, 54.2% versus 10.5%; P < .001; GLASS Stage II versus III, 38.6% versus 10.5%; P < .001. G = grade; HR = hazard ratio.

Summary


The Global Limb Anatomic Staging System (GLASS) classification system, proposed in 2019, aims to standardize the assessment of limb anatomy in patients with critical limb threatening ischemia (CLTI) in order to guide treatment decisions. It consists of three stages, with Stage III representing the highest severity of disease. Prior studies were inconclusive regarding the ability of GLASS to predict limb-based patency. This study was conducted in order to assess the potential of the GLASS classification system to predict prognostic outcomes of patients with CLTI who underwent endovascular therapy with a larger patient population and longer follow-up.

Using a retrospective analysis, the investigators reviewed data from a total of 1,029 patients who underwent revascularization therapy for CLTI between January 1, 2018 and May 31, 2022 at the Chongqing University Three Gorges Hospital. After excluding patients with confounding variables, 231 patients (236 limbs) were included in the final analysis. The GLASS classification of the ischemic limbs was assessed using CTA or digital subtraction angiography prior to intervention. Of these patients, 52 (22%) were classified as GLASS Stage I, 59 (25%) were classified as GLASS Stage II, and 125 (53%) were classified as GLASS Stage III. Patients were followed up at 1-, 3-, 6-, and 12-months post-intervention and annually thereafter. Patient interviews, physical examinations, and vascular ultrasonography were used to assess patency at follow up.

The mean patient age was 74.45 years, with a predominance of male patients (76.7%). Notably, 36.9% of limbs were classified as clinical Stage IV according to the WIfI system, and common comorbidities included hypertension (64.8%) and diabetes (41.1%). For procedural details, 23.3% of limbs received no stents, while 58.1% were treated with bare nitinol stents. There were significant differences in the number of stents used across GLASS stages (P < .001) and in postoperative antithrombotic regimens (P = .004), but not in the type of stents used (P = 0.101). The median follow-up time was 1,279 days, with primary limb-based patency rates declining significantly with higher GLASS stages; for example, 1-year limb-based patency rates were 78.8% for Stage I and 41.6% for Stage III (P < .001). Univariate analysis identified GLASS stage III, diabetes, and smoking as independent risk factors for long-term patency loss, while male sex was associated with a lower risk. Multivariate analysis confirmed all these to be independent factors associated with limb-based patency.

The authors cited multiple prior studies that found evidence that the use of GLASS staging can predict limb-based patency rates in CLTI patients undergoing endovascular treatment. This study, which had a larger sample size and longer follow-up times than those cited, supports these findings and provides additional insight.

Commentary


The results from this study, along with those referenced within it, provide a strong argument for using the GLASS staging criteria as a prognostic tool for patients with CLTI undergoing endovascular treatment. Systems like GLASS are important for personalized procedural strategy, post-procedural medical management, and follow-up schedule, and the questions addressed in this study contribute to holistic approaches around patients with CLTI.

While the study's methodology was robust with a large patient population and long follow-up, further evaluation of endovascular strategies (specific types of stents and balloons, as well as potential changes of certain strategies during the study period, i.e. paclitaxel-coated devices), antiplatelet/antithrombotic strategies (especially given statistically significant differences in antithrombotic medications post-procedural), and patient-relevant quality-of-life outcome measures will provide further insights to the endovascular community. Additionally, some patient groups were excluded from the analysis; one in particular was the group with hepatocyte growth factor therapy involved. Offering clear explanations for each exclusion would strengthen the validity of the findings by demonstrating how these decisions improved the overall rigor of the study.

The discussion of confounding variables raises an important consideration: should GLASS staging criteria incorporate some of these factors? Perhaps a scoring system, rather than a purely staging-based approach, would offer physicians a more comprehensive tool for making informed treatment decisions. At the minimal, the study can benefit from a discussion on the impact of the study’s results in daily clinical practice. Should patients with higher GLASS staging criteria receive more aggressive antithrombotic regimen or more frequent clinical follow-up for potential repeat revascularization? Or was there a cost-effective time point at which procedural intervention should be discouraged? Ultimately, this paper addresses a scientific question methodically but leaves room for future research regarding the practical aspects.

Post Author
Isabel Okinedo, BA
UMass Chan Medical School
@isabelokinedo

Friday, November 15, 2024

Eye90 Beads Provide Safe and Effective Direct Visualization in Radioembolization

Imageable Radioembolization Microspheres for Treatment of Unresectable Hepatocellular Carcinoma: Interim Results from a First-in-Human Trial


Clinical question 

Can radiopaque yttrium-90 microspheres safely and effectively treat unresectable hepatocellular carcinoma while providing real-time visibility of treatment?

Take away point 

Eye90, a radiopaque Y90 microsphere, enables real-time evaluation and treatment adjustment during radioembolization, potentially improving tumor targeting and serving as a tumor response biomarker. Initial study showed 50% complete response at 3 months with no severe adverse events.

Reference 

Abraham, R.J., Arepally, A., Liu, D., Lewandowski, R., Kappadath, S.C., Verma, A., Dobrowski, D. and Holden, A., 2024. Imageable Radioembolization Microspheres for Treatment of Unresectable Hepatocellular Carcinoma: Interim Results from a First-in-Human Trial. Journal of Vascular and Interventional Radiology, 35(10), pp.1464-1473.


Study design 

Prospective, observational, descriptive study

Funding Source 

ABK Biomedical

Setting 

Auckland City Hospital, Auckland, New Zealand

Figure


A 53-year-old man with chronic hepatitis B. Axial contrast-enhanced computed tomography (CT) (arterial phase) demonstrated a 4.3-cm Segment 8 hepatocellular carcinoma (white arrow) adjacent to previous transarterial chemo- embolization scar (white arrowhead). CT image demonstrating radiopaque Eye90 microsphere distribution in hepatocellular carcinoma (arrow) and surrounding treated liver volume.

Summary

Current 90Y microspheres have limitations. Glass microspheres lack flexibility in quantity and activity customization, often necessitating multiple vials and kits for larger volumes. Resin 90Y provides quantity and activity customization, but at the cost of increased burden on nuclear medicine labs and operator risk. Both microspheres also have limitations in visibility, requiring post-treatment SPECT/ PET for assessing 90Y distribution, tumor targeting, and dosimetry.

Addressing these challenges, Eye90 Microspheres introduces radiopaque properties for direct CT visualization with a customizable dose with radioactivity between 0.4-9.6 GBq at 3 preset mass ranges: (a) small (100–200 mg), (b)medium (201–400 mg), and (c) large (401–600 mg). Personalized dose vial quantity and activity is determined using a 3-compartment partition model that considers various patient-specific factors based on the technetium-99m macro- aggregated albumin SPECT/CT. This personalized approach reportedly eliminates the need for dose-draw or multiple vials.

Accompanying the Eye90 Microspheres is the Eye90 delivery device, which utilizes a dual-syringe system to achieve a controlled uniform delivery concentration of 60 mg/mL. The delivery device also allows the users to pause, assess microcatheter location with contrast media, examine microsphere distribution using CT modalities, and resume administration as needed.

This study reports 6-month safety, effectiveness, and imageability results for Eye90 in 6 subjects with unresectable HCC (median size of 3.1 cm, range: 1.2 – 4.3 cm). Subjects underwent planning procedure (90Y mapping) followed by selective treatment (≤2 segments) using partition dosimetry by SurePlan LiverY90 aiming to deliver at least 205 Gy and preferably > 250 Gy to the tumor. Post-therapy SPECT/CT, unenhanced lung CT, and 4-phase liver CT within 24 hours of treatment were obtained to correlate microsphere radiopacity with radioactivity. Follow-up were scheduled on days 21, 42, 90, and 180 after treatment.

Post-treatment SPECT/CT demonstrated mean and median dose of 283 Gy and 132 Gy to the tumor, respectively. Microsphere density within the tumor was calculated at 26,988 per mL. All subjects reported adverse events, but no treatment-related Grade ≥3 AEs occurred. At 90 days, 50% achieved complete response (CR) and 33.3% partial response (PR). At 180 days, 50% maintained CR and 16.7% PR. The other patient with PR, and the patient with stable disease at 90 days, underwent TACE and could not be evaluated. Qualitative analysis showed agreement between microsphere radiopacity on CT and radioactivity on SPECT/CT, with CT revealing heterogeneous dose distribution, and absence of radiopacity in the region of a particular tumor despite SPECT/CT activity noted throughout this region. This particular tumor did not respond to treatment.

Commentary 

Eye90 Microspheres represent another advancement in transarterial radioembolization, offering direct visualization of microsphere and tumor targeting on CT modalities. This capability could lead to more precise treatment execution, real-time therapy adjustments, and potentially serve as a biomarker for predicting tumor response and a foundation for more accurate dose-response relationships. The dual-syringe administration system allows for customized quantity and activity of microspheres, enhancing treatment personalization.

While the initial results are promising, the small sample size, short follow-up period, lower-than-planned tumor doses, and mediocre treatment response necessitate further research. The ongoing U.S. Pivotal IDE Route90 trial will provide more comprehensive data on a larger cohort. If these results hold up in larger studies, Eye90 Microspheres could redefine the standard of care in HCC treatment. The potential for improved precision, personalization, and real-time assessment makes this a technology to watch closely in the coming years.

Post author
Leila Haghani, MD 
Research Fellow 
University of Massachusetts Chan Medical School
@dr_Leila_IRad

Monday, October 28, 2024

Paclitaxel Containing Devices in Femoropopliteal Arterial Disease: The Trees and the Forest

An Up To Date Meta-Analysis on Paclitaxel Containing Devices in Femoropopliteal Arterial Disease, And A Commentary On The Entirety of the Data to Date.

Clinical question

Is paclitaxel safe when used in drug eluting stents and drug coated balloons for revascularization of the femoropopliteal artery?

Take away point

Paclitaxel containing devices are safe and effective devices, especially in their current usage and at their current generation. Previous versions of the devices may have conveyed some mortality risk, but it’s important to understand both the meta-analyses and the individual studies that comprise the data reporting, and how clinical practice is nuanced and so does the literature..

Reference

Katsanos, K. (2024). Paclitaxel meta-analyses in the lower limbs: Missing the trees for the forest. Journal of Vascular and Interventional Radiology.
Click here to access article

Briody, H., Kearns, C. A., & Lee, M. J. (2024). Mortality, safety and efficacy of paclitaxel-containing balloons and stents in the femoropopliteal artery: systematic review and meta-analysis of randomized controlled trials since 2018. Journal of Vascular and Interventional Radiology. 
Click here to access article

Study design

Meta-analysis, commentary/perspective

Setting

Meta-analysis was performed at Beaumont Hospital, Dublin Ireland and the Royal College of Surgeons in Ireland.
Commentary is from University Hospital Patras, School of Medicine, Rio, Greece.

Figure



Summary


In revascularization efforts for peripheral arterial disease, paclitaxel has proven to be an excellent anti-restenotic agent in the femoropopliteal artery when used in drug coated balloons and drug eluting stents in multiple randomized controlled trials. While effective, its safety profile was called into question in a 2018 meta-analysis. The meta-analysis, published by Katsanos et al, found statistically significant increases in all-cause death in patients with paclitaxel coated devices, and urged further investigations. In 2023, a patient level, industry funded meta-analysis concluded there was no excess mortality. Based on this study, the FDA published their official statement that there is no discernible excess of mortality.

The current meta-analysis was performed to provide an independent analysis of safety and effectiveness outcomes, including but not limited to mortality. The literature search was performed from 2018 (a choice made so this study would act as an update of the aforementioned Katsanos study) and included 19 randomized controlled trials for a total of 4,284 participants. When selecting studies, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was utilized (see figure). Effectiveness outcomes were primary patency which was analyzed using risk ratios via inverse variance, random-effects model. Safety outcomes were all cause mortality, target limb amputation, target lesion revascularization, clinically driven target lesion revascularization, and thrombosis. These were also analyzed using risk ratios via inverse variance, random effects model, as well as heterogeneity assessment via visual inspection of forest plots, chi squared test and I^2 statistic.

The results found no evidence for all-cause mortality in paclitaxel containing devices in the femoropopliteal region from 12 to 60 months, nor did they find any other safety concerns. The study redemonstrated the effectiveness of paclitaxel devices in maintaining primary patency with a pooled risk ratio of 1.55. Taken together, this meta-analysis concluded that paclitaxel containing devices work, and are safe to use. They compare this study directly to the Katsanos study due to its similar methodology and design, however they offer no suggestions as to the source of the different findings.

In response to the multiple meta-analyses looking at the use of paclitaxel containing devices in the femoropopliteal arteries with no evidence of increased all-cause mortality, Dr. Konstantinos Katsonas provided a companion commentary. In the piece, he presents 27 studies from 2008-2021 which show an increase in all-cause mortality in the paclitaxel containing device arm, arguing that the recent studies demonstrate dilution of the mortality signal, but do not eradicate it completely. He presents a meta-regression of long-term risk ratio of all cause death against publication year and shows that the observed mortality risk decreases with publication year, which would seem to suggest earlier generation devices or clinical practices may be the cause for the mortality signal. He further subgroups the studies by paclitaxel dosage and shows that the relative mortality risks may be different among the different devices with variable paclitaxel dosing. He concludes that the reader must not miss the trees for the forest, meaning that the individual studies may have points of interest that become diluted in meta-analysis.

Commentary


The academic discussion around paclitaxel can make it difficult for providers to know if these devices are safe or not. This most recent meta-analysis is an excellent consolidation of the most recent literature on paclitaxel containing devices in femoropopliteal artery treatment. The results add to the body of evidence that these paclitaxel devices are safe and effective tools in peripheral arterial disease, especially at their current generations. Providers can use these devices and expect good outcomes for their patients without an increased mortality risk.

That being said, Dr. Katsonas does raise interesting questions. The 2018 Katsonas et al meta-analysis did show a significant increase in all-cause mortality. In his commentary, this effect appeared again when looking at all studies from 2008-2021. While there were shortcomings in the Katsonas paper, the fact remains that a mortality signal was present and hasn’t been fully accounted for. The fact that it seems to disappear when looking at studies from only 2018 onward could be indicative of the root cause. Moreover, the more recent studies did not subgroup based on device or paclitaxel dosing. The data he presents on the decrease of all-cause mortality risk over the years, as well as the trend of lower risk ratios with lower paclitaxel dosing, are suggestive that the mortality signal may be device-, device-generation, and/or paclitaxel dosage-dependent. Of course, this is only speculation based on available data, but could make excellent areas of inquiry should the question of safety in paclitaxel containing devices remain.

Dr. Katsonas’ final point is to not miss the “trees” (individual studies) for the “forest” (meta-analysis), as individual studies can yield insights that may be diluted in meta-analyses. However, he doesn’t really support this in his commentary, as most of his points are made by using grouping statistics based on multiple studies. Regardless, it is an important point to keep in mind when reading meta-analyses. Procedural practice and published literature are nuanced, and evidence-based medicine should be supported by both high-level meta-analyses as well as individual studies that befit the patient population and institutional experience.

Post Author
Sean Rogers, MD
Interventional Radiology Fellow, PGY-6
University of Massachusetts Chan Medical School

Wednesday, September 25, 2024

Radiofrequency Lung Ablation in ILD

Radiofrequency Ablation in Patients with Interstitial Lung Disease and Lung Neoplasm: A Retrospective Multicenter Study


Clinical Question

Is percutaneous radiofrequency ablation safe and effective against lung neoplasms in patients with interstitial lung diseases?

Take Away Point

Radiofrequency ablation is a feasible technique in combating lung neoplasms in patients with interstitial lung diseases but there are risks of post-procedural acute exacerbations which has a relatively high mortality rate of 45%.

Reference

Yamamoto A, Hiraki T, Ikeda O, et al. Radiofrequency ablation in patients with interstitial lung disease and lung neoplasm: A retrospective multicenter study. Journal of Vascular and Interventional Radiology. 2024;35(9):1305-1312. doi:10.1016/j.jvir.2024.06.010

Click here for abstract

Study Design

Retrospective, observation, cohort study

Funding Source

No reported funding

Setting

Academic, Osaka Metropolitan University, et al, Japan

Figure



Summary


Interstitial lung diseases are generally irreversible with poor prognosis. There is no optimal therapeutic approach for concomitant lung neoplasms, which has a frequency of 10-20%. Radiofrequency ablation is a safe and effective treatment strategy for inoperable primary and metastatic lung lesions. The authors of this paper decided to investigate the safety and efficacy of radiofrequency ablation in combating lung tumors in patients with interstitial lung diseases due to lack of pertinent data.

The authors performed a multi-institutional retrospective observational study acquiring data of all the patients diagnosed with lung neoplasm and interstitial lung disease from April 2002 and October 2017 who underwent radiofrequency ablation, with their respective images reassessed by radiologic review. After central radiologic review excluded patients who did not have interstitial lung disease, 49 patients remained in the sample, 43 men and 6 women. Within the 49 patients, there were 64 tumors—34 of which were primary neoplasms and 30 of which were metastatic—with 66 treatment sessions.

Technical success was defined as completion of the radiofrequency procedure. Adverse events were based on the parameters set by the modified definitions of Society of Interventional Radiology, including unexpected increase in the level of care, prolonged hospital stay, or death. The following variables were also included in the study: local tumor progression, overall survival, and acute exacerbation of interstitial lung disease after ablation. Acute exacerbation diagnosis was based on radiologic or clinical diagnosis.

Technical success rate was 100%. While no adverse events occurred during the procedure, multiple events occurred after the procedure, the most frequent being pneumothorax in 53% (35/66 treatment sessions). The rest of the listed adverse events are summarized in Table 3 provided in this article. Acute exacerbations occurred in 8% of the study (5 patients). Among these 5 patients, 3 passed away despite initiation of steroid treatment (60%). The events of acute exacerbations did not differ significantly between patients with UIP (8%) and those without UIP (7%). Additionally, onset of acute exacerbation always occurred at least 8 days after radiofrequency ablation. Univariate analysis determined that pleural effusion and fever were statistically significant risk factors for development of acute exacerbations. Local tumor progression rate was 43% at one year. The overall survival rate at one, three, and five-years were 83%, 62%, and 36%, respectively.

While the results have demonstrated that radiofrequency ablation can be feasible for treating lung neoplasm in patients with interstitial lung disease, the results do not provide consensus recommendations. With regards to procedural safety, prior literature has demonstrated that ablation for lung neoplasms is safe, with mortality rate <1%, which is significantly lower than the mortality rate in patients with interstitial lung disease reported in this series, at 5% per session. The rate of 8% for acute exacerbation and an associated mortality rate of 45% may seem alarming at first. However, the rate of acute exacerbation after surgery was similar to that of ablation at 9.3%, with a similar mortality rate at 43.9%. Similarly, acute exacerbation can occur after thoracic radiotherapy and pharmacotherapy. After all, patients with idiopathic pulmonary fibrosis and non-idiopathic pulmonary fibrosis interstitial lung diseases develop acute exacerbations at a rate of 10-20%, and 3-5%, respectively annually during the natural course. The safety profile of radiofrequency ablation for lung neoplasm should be considered within this specific patient population and not taken out-of-context.

With regards to the local tumor progression rates, various factors may have contributed, both from the operator and from the lesion pathology. The operator may not have had sufficient margin, partly due to the intention to minimize adverse events. Additionally, patients with severe emphysema or UIP may present challenges to the accurate identification of the overall tumor burden, complicating the assessment of local tumor progression. Furthermore, fibrotic changes such as those seen in usual interstitial pneumonia may reduce the ablation’s electrical and thermal conductivity, limiting the tumoricidal effect of radiofrequency ablation.

This study had several limitations apart from its retrospective design. Firstly, interstitial lung disease diagnosis was not based on pathological findings. Secondly, central reading to evaluate interstitial lung disease was only applied to those that were already diagnosed as such, making the study prone to additional selection bias. Multivariate analysis to identify independent risk factors for acute exacerbations could improve the quality of the study. Sub-analyses, which may require a larger study, focusing on patients with primary neoplasms, and patients with metastatic lesions, separately, will provide further clinically relevant information and guidance.

Commentary


Despite several limitations, this article assessing radiofrequency ablation for the treatment of lung neoplasms in patients with concomitant pulmonary pathologies like interstitial lung disease is of significant clinical relevance. Risk factors that predispose patients to interstitial lung disease such as smoking are very prevalent, especially in certain countries like Japan. Referring and treatment physicians of patients with interstitial lung disease need information specific to the patient population. Clinical guidelines and treatment algorithms also require such information for development and refinement. In conclusion, radiofrequency ablation appears feasible in patients with interstitial lung disease with a risk of post-procedural acute exacerbation grossly similar to other treatment modalities.

Post author
Naeem Patel, DO
Radiology Resident, PGY4
Department of Radiology, Interventional Radiology Division
Hartford Hospital, Hartford, CT
@Naeemp7Patel