Is TARE in patients with TACE-refractory HCC safe and effective?

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

Clinical Question

Does prior transarterial chemoembolization impact outcomes in patients undergoing transarterial Y90 radioembolization in the context of nonresectable liver tumor?

Take Away Point

Outcomes in patients undergoing transarterial SIR-Sphere Y90 radioembolization with and without prior transarterial chemoembolization were similar. This suggests that transarterial radioembolization is a safe and effective treatment option for patients with hepatocellular carcinoma who previously received transarterial chemoembolization treatment.

Reference

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, Hund et al. Journal of Vascular and Interventional Radiology, Volume 34, Issue 12, P2147-2154



Link to abstract

Study Design

Prospective, observational, cohort study

Funding Source

Sirtex Medical

Setting

36 medical centers in the United States



Figure 2

Overall survival (OS) for previous TACE (red line) and TACE-naïve (black line) participants, with a median OS of (95% confidence interval [CI]: 15.4–25.2) and 21.5 months (95% CI: 14.9–29.9), respectively. TACE = transarterial chemoembolization.

Summary

Transarterial chemoembolization is an established treatment for hepatocellular carcinoma, serving as both a bridge to transplantation and as a definitive therapy. For patients whose disease burden is refractory to transarterial chemoembolization, systemic therapy, ablation, and transarterial radioembolization with yttrium-90 may be offered. Two single-center studies have shown radioembolization to be successful after chemoembolization however both studies had a relatively small sample size. This study aimed to analyze the outcomes of radioembolization in a larger multicenter patient population, comparing those with and without prior transarterial chemoembolization.



This study included 262 participants from 36 medical centers throughout the United States, using data obtained from the Radiation-Emitting SIR-Spheres in Nonresectable liver tumor registry. The study cohort included patients with treatment-naïve hepatocellular carcinoma or those who underwent prior transarterial chemoembolization. Patients with previous procedures, ablation, external beam radiation, or systemic therapy were excluded. The chemoembolization and treatment-naive groups consisted of 93 and 169 participants, respectively. There was no significant difference in age, sex, Child-Pugh, or Barcelona Clinic Liver Cancer Stages between the two groups. Both groups had significant proportion of participants with Barcelona Clinic Liver Cancer stages of B and C. The only notable difference between the two groups was that the chemoembolization group had more multifocal disease, while the treatment naïve group had a larger index tumor diameter.



Participants underwent treatment with resin Y90 microspheres and the median delivered activity was similar for two groups. The primary outcome of this study was overall survival, measured in months from date of radioembolization treatment to the date of death, completion of the study, or last follow-up. Secondary outcomes included best tumor response by the modified Response Evaluation Criteria in Solid Tumors and treatment toxicities at 6 months after radioembolization. Objective response rate was defined as the sum of complete and partial responses, while disease control rate further included stable disease.



In this study, the median overall survival for patients in the chemoembolization (22.3 months) and treatment-naive (21.5 months) groups showed no significant difference. Stratifying by Child-Pugh classification or Barcelona Clinic Liver Cancer stages did not change the results. Objective response rate at 6 months showed no significant difference between the two groups, at 49% and 64%, respectively. Disease control rates were achieved in 73% for the chemoembolization group and 86% for the treatment-naive group. Cox Proportional Hazard analysis identified Barcelona Clinic Liver Cancer Stage A, index tumor ≤5 cm, and Child-Pugh Class A as the strongest predictors of overall survival. Solitary lesion and no previous chemoembolization did not predict overall survival. Grade 3 or greater hepatic toxicities were comparable.



Even though radioembolization is gaining popularity as a first-line treatment given the favorable overall survival compared to drug-eluting embolic chemoembolization, as seen in the TRACE and LEGACY trials, transarterial chemoembolization remains the first-line option in many centers given its high profile in multispecialty treatment recommendations. This study has provided more robust evidence for the practice of transitioning patients with chemoembolization refractory hepatocellular carcinoma to radioembolization as the latter can achieve similar rates of overall survival, imaging response, and safety profile in this patient population compared to patients who were treatment naïve.



The study acknowledged the inherent limitations associated with real-world data and registries. As well as differences in practice patterns at some of the institutions and a lack of centralized interpretation of image findings. The authors suggested future research focusing on initiating radioembolization for patients with prior chemoembolization treatments and comparing radioembolization with systemic therapies.

Commentary

The purpose of this study was to assess the impact of prior chemoembolization on outcomes in patients with hepatocellular carcinoma undergoing radioembolization. Given that this area has been previously studied but in small patient populations at single institutions, the current study provided the much-needed supporting evidence from a large multi-institutional patient cohort. The methods and execution of the study were adequate given the data was based on a prospective observational registry. However, as the authors have pointed out, some standardizing measures could have improved the study, such as having independent radiologist(s) re-evaluate the response on imaging. The study comprehensively discussed the statistical analysis methods, which were appropriate for the data collected. The results supported previous findings demonstrating that radioembolization is a safe and effective treatment after chemoembolization. Future research focusing on radioembolization in patients with prior chemoembolization should employ robust study parameters such as an randomized clinical trial for more conclusive evidence. The authors also described that Kudo et al. performed a retrospective matched-pair study that determined overall survival was longer in Lenvatinib (37.9 months) compared with transarterial chemoembolization (21.3 months). Future research comparing radioembolization with systemic therapy and examining the effects of combination therapy may further impact the hepatocellular carcinoma treatment algorithm. Overall, while the study provided evidence that radioembolization is a safe and effective option in patients with chemoembolization refractory hepatocellular, it also highlights research areas in need of comparative data and robust conclusions.

Post Author

Aric Patel, MS
OMS-IV
University of New England
College of Osteopathic Medicine

Biomarker analysis in GAE

Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers

Clinical Question

Is genicular artery embolization (GAE) a safe and effective disease modifying treatment for symptomatic knee osteoarthritis (OA)?

Take Away Point

GAE achieved minimal clinical important difference (MCID) in 5 of the 6 patients who completed their 12-month follow-up with significant reduction in mean WOMAC pain score and plasma nerve growth factor (NGF).

Reference

Taslakian B, Swilling D, Attur M, et al. Genicular artery embolization for treatment of knee osteoarthritis: Interim analysis of a prospective pilot trial including effect on serum osteoarthritis-associated biomarkers. Journal of Vascular and Interventional Radiology. Published online August 23, 2023. Link to article

Study Design

Single arm, prospective, observational and ongoing study containing 16 patients, 6 of whom completed treatment course

Funding Source

No reported funding

Setting

Academic, New York University Langone Health, New York, NY

Figure

Summary

Knee osteoarthritis is one of the most common causes of disability. Despite current options prescribed to combat this condition, many patients are either resistant to existing conservative management or poor surgical candidates to more invasive options such as total knee arthroplasty.



Osteoarthritis is a pathological condition hypothesized to be caused by a triad of inflammation, angiogenesis, and neural growth around the cartilage of the joint. The subsequent neural growth adjacent to the neovessels is thought to be the source of the pain. Arresting these new vessel formations secondary to secreted inflammatory cytokines should theoretically subside the pain and is the basis for the treatment strategy of geniculate artery embolization. Furthermore, embolization retarding the cytokine-induced vessel formation should theoretically correlate with decrease in prognostic biomarkers used to measure inflammation and matrix degradation, providing evidence for the disease-modifying role of genicular artery embolization in knee osteoarthritis.



The authors of this paper performed a prospective, single-arm clinical trial. Out of 27 patients, 16 were enrolled with the inclusion criteria being moderate to severe osteoarthritis associated with knee pain resistant to conservative therapy for greater than 3 months. After undergoing genicular artery embolization, patients were followed up at 1 month, 3 months, and 12 months to assess for change in symptoms. Blood samples were collected at baseline and each follow-up visit for biomarker analyses.



Amongst the six patients who completed the 12 month follow up, technical success rate was 100%. Five of them demonstrated clinical success defined as achieving minimal clinically important difference with improvement in pain, stiffness, and function at early follow-up. However, improvement in WOMAC scores at 12-month follow-up did not achieve statistical significance, possibly related to the nature of interim analysis and small cohort. A single sampled biomarker achieved statistically significant decrease: neural growth factor. This decrease in neural growth factor, correlating with pain reduction experienced in patients after genicular artery embolization, highlighted the clinical relevance of NGF and suggested the disease-modifying nature of the procedure. Of note, there was no significant reduction in NGF levels at the 3-month follow-up, demanding further analyses with larger cohort size and timepoint study to determine the relationship of inflammation reduction and reduction in NGF.



Despite the promising results this trial is showing, there are several limitations, the most important of which is the small sample size of six patients who completed the 12-month follow-up. The power of this study will inevitably improve through the ongoing trial of the remaining 10 patients, after which results can be further tabulated and finetuned. The second limitation is the lack of a control group to compare the progress with given the nature of the study. Finally, the third limitation is the possibility that the accumulated fluid in the synovium that was not procured in the study may contain different levels of biomarkers than the ones collected in the plasma and serum.

Commentary

Genicular artery embolization shows immense potential for its widespread use and versatility. Despite the allure of the benefits this procedure can bring to both the members of the healthcare force and the patients, more data is still needed before definitively concluding the efficacy compared to other more established available options. Clinical trials with basic science correlates are also needed to better understand the specific role of embolization in modifying local inflammation, angiogenesis, and neural growth in the context of osteoarthritis. Results from prospective clinical trials, such as the one presented by this article, may eventually alter the algorithmic approach to the treatment of knee osteoarthritis.

Post author

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

Parametric Analysis of Intraprocedural DSA in GAE

Quantifying Change in Perfusion after Genicular Artery Embolization with Parametric Analysis of Intraprocedural Digital Subtraction Angiograms

Clinical question

After Genicular Artery Embolization, will perfusion be decreased in hyperemic target vessels but preserved in parent vessels?

Take away point

Objective parametric measures showed patent parent vessel with unchanged flow after embolization of distal hyperemic target vessels, validating the pruning technique in genicular artery embolization and demonstrating utility in quantification of intraoperative perfusion.

Reference

Quantifying Change in Perfusion after Genicular Artery Embolization with Parametric Analysis of Intraprocedural Digital Subtraction Angiograms. Badar W M.D. et al. Journal of Vascular and Interventional Radiology, Volume 34, Issue 12, 2189-2195.

Click here for abstract

Study design

Single center, single arm, retrospective study with 12 patients

Funding Source

No reported funding.

Setting

Academic hospital, University of Chicago, Illinois, United States

Figures

Figure 1:(a) Pre–genicular artery embolization selective digital subtraction angiography run of the right superior medial genicular artery, with region of interest (ROI) 1 (red) corresponding to the parent vessel (PV) and ROI 2 (green) corresponding to the hyperemic target vessel (TV). (b) Post-GAE selective digital subtraction angiography run of the same vessel, with ROI 3 (red) corresponding to the PV and ROI 4 (green) corresponding to the “pruned” TV.



Figure 2: (a) Time–intensity curves for the parent vessel before genicular artery embolization (GAE) (red) and after GAE (blue). (b) Time–intensity curves for the target vessel before GAE (red) and after GAE (blue). The deep spikes in the post curves represented artifact from patient movement at the end of the digital subtraction angiography acquisition when the regions of interest were shifted momentarily to empty or subtracted areas where there was no contrast density.

Summary

Geniculate Artery Embolization has shown promising results for the treatment of medically refractory knee osteoarthritis. Instead of attempting near-complete stasis, genicular artery embolization aims to achieve “pruning” where distal hyperemic vessels are embolized, but parent vessel flow is preserved. Parametric analysis of digital subtraction angiography is an established post processing method to quantitatively evaluate tissue perfusion changes and determine angiographic endpoints. But it has never been applied in the context of genicular artery embolization, specifically to validate the pruning method and to correlate with clinical success.

The authors performed this study in a single academic center with 12 patients who were diagnosed with mild to moderate osteoarthritis, age > 40, and pain refractory to 6 months of conservative management that included physical therapy and/or non-steroidal anti-inflammatory medication.

The genicular artery embolization procedure was performed through ipsilateral femoral access with a DSA run to identify the genicular arteries of interest, evaluate hyperemic vasculature, and ensure the resolution of hyperemia after administration of the embolic agent. genicular artery embolization was performed with 200-µm microspheres with a 1:3 dilution in contrast medium, in 0.1ml aliquoted to near stasis. Each patient received a call 1-day post-procedure and follow up visits at 1 week and 1, 3, 6, and 12 months.

For each vessel treated, regions of interest were marked within the lumen of the parent vessels and hyperemic vessels on digital subtraction angiography images. Perfusion parameters were computed for each region of interest before and after the embolization. These included area under the curve, peak intensity, and time to arrival, a measure of total blood volume, of highest blood concentration, and of blood velocity, respectively. 36 total vessels were identified with 2 vessels excluded due to motion artifacts.

Paired student t-tests were used to compare the area under the curve, peak intensity, and time to arrival. In the hyperemic vessels, there were significantly lower area under the curve and peak intensity, as well as significantly longer time to arrival on the post-embolization images compared to the pre-embolization images. There was no significant difference in area under the curve, peak intensity, or time to arrival in the parent vessels. These results provided quantitative support for the “pruning method” for genicular artery embolization. Skin changes were the most common adverse events and all instances resolved within 3 weeks. Each incidence occurred with an embolic volume greater than 3.0 ml. A Pearson correlation coefficient test showed no correlation between the volume of embolic agent administered and the parent vessel diameter. Unpaired student T-tests were used to show that higher volumes of embolic administered were associated with increased non-target embolization but no further reduction in hyperemia. Hence, overtreating vessels provides no additional benefit but increases the risk of non-target embolization. Baseline clinical symptoms were assessed with the Western-Ontario and McMaster Universities Arthritis index, showing significant reductions in total and pain scores at 1 and 3 months postoperatively.

Commentary

The authors in this study provided quantitative evidence of the pruning method often described in genicular artery embolization. These findings have implications in minimizing non-target embolization while ensuring treatment efficacy. The results also support the utility of intraprocedural quantitative perfusion parametric imaging to provide objective measures of embolization endpoints. While these results are encouraging, the study acknowledges that future studies with a larger sample size, knee immobilization techniques to reduce motion artifact, and use of different types of embolic agents would be helpful. Future research in other areas of interventional radiology may learn from this study and experiment the use of intraprocedural parametric imaging for objective procedural endpoint measures.

Post Author

Anthony M. Camargo, BA
MD candidate, Class of 2025
University of Massachusetts Chan Medical School
@anthonymcamargo

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

Clinical Question

What is the current state of endovascular pulmonary embolism practice and the Pulmonary Embolism–Thrombus Removal with Catheter-Directed Therapy trial, now 8 years since the 2015 Research Consensus Panel?

Take Away Point

The article discussed the catheter-directed therapy (CDT) trials and their outcomes since the 2015 Research Consensus Panel. Catheter-directed lysis (CDL) studies showed reduction in RV/LV ratio but inconsistent major bleeding rates. Mechanical thrombectomy (MT) studies demonstrated safety and effectiveness but lack comparison to AC alone. PE-TRACT and other upcoming randomized clinical trials (RCT) will define role of CDT in submassive PE.

Reference

Research Consensus Panel Follow-up: 8-Year Update on Submassive Pulmonary Embolism. Sista et al. Journal of Vascular and Interventional Radiology, Volume 34, Issue 10, P1658-1663, 10.1016/j.jvir.2023.06.032

Study Design

Narrative Review

Funding Source

The authors of this article report grants and funding from various organizations, including the NIH, AngioDynamics, Cook Medical, Boston Scientific, Gore, Medtronic, Penumbra, Becton Dickinson, Philips, Cordis, Bayer, NHLBI, BMS, Janssen, and Pfizer.

Setting

United States

Figure 2
Completed, Enrolling, and Upcoming Randomized Controlled Trials

Summary

In 2015, a panel of 19 pulmonary embolism (PE) experts from multiple disciplines convened to discuss the current knowledge and determine the future questions that need to be answered. This article is a follow-up to the 2015 Research Consensus Panel (RCP), discussing what has changed since then. Several consequential studies of catheter-directed therapy (CDT) have been published, and two mechanical thrombectomy devices have been cleared by the FDA to treat PE. In addition, the PE-TRACT trial has begun enrolling patients.

Several catheter-directed thrombolysis (CDL) trials and studies have been published. The article briefly discusses trials such as the ULTIMA, SEATTLE II, OPTALYSE, RESCUE, PEERLESS, SUNSET, and CANARY. All of which evaluated different aspects of CDL, including dosing, duration, and associated thrombus clearance. Despite promising results reported in some studies, limitations, such as low power and variable dosing were noted. Most trials demonstrated a reduction in the right ventricular to left ventricular ratio with CDL. Major bleeding rates were inconsistent across the different trials, up to 10% in SEATTLE II. Some concluded no significant difference in outcomes between CDL and standard treatment of anticoagulation (CANARY). Of note, SUNSET demonstrated no difference in thrombus clearance or bleeding between US-assisted and standard CDL.

Mechanical thrombectomy (MT) serves as an alternative to CDL in treating PE. Since the RCP, several studies, including the FLARE and EXTRACT trials, have looked at the efficacy of MT. These studies specifically evaluated two FDA-cleared devices, the Flowtriever and the Indigo Aspiration System, respectively. Both of these have shown promising results in single-arm trials, including reduction in right ventricular to left ventricular ratio, similar to those of CDL in prior published studies, and low major adverse event rates. However, the studies were limited by low power and a lack of anticoagulation-only control groups. The PEERLESS II and STORM-PE trials aim to compare mechanical thrombectomy devices to anticoagulation alone.

The 2015 RCP emphasized the critical need for rigorous study of CDT for submassive PE. Two complementary randomized clinical trials are ongoing. The HI-PEITHO trial seeks to evaluate ultrasound-guided CDL plus anticoagulation versus anticoagulation alone. The second study, the PE-TRACT trial, stems from the 2015 RCP incorporating many of the clinical questions and goals discussed by the PE experts. It is a phase III, multicenter, randomized, open-label, 2-arm controlled clinical trial. The study will evaluate two primary outcomes: the first being physiologic outcomes measured by peak oxygen uptake during cardiopulmonary exercise testing at 3 months; the second being patient-reported functional outcomes measured at 12 months. The study aims to enroll 500 patients across 30-50 clinical sites in the US, with completion expected by the end of 2026. 

Commentary

This article is an informative narrative review of the current state of knowledge on submassive pulmonary embolism. The authors briefly outlined the specific questions identified by the RCP as high interest and high impact. Additionally, the authors described the primary outcomes and limitations of the studies that followed the 2015 RCP. Furthermore, the authors analyzed the study designs of the upcoming trials. As a narrative review and update to the 2015 RCP, this article effectively presents the current knowledge and upcoming research concerning submassive PE treatment. Moving forward, the next step would likely involve conducting a comprehensive systematic review to provide robust, objective data and insights in study design for future studies focusing on submassive PE. Overall, the authors accomplished their goal of providing a summary of the current state of knowledge on submassive PE as well as providing key insights into the future direction of research.

Post Author

Aric Patel, MS
OMS IV
University of New England
College of Osteopathic Medicine

Intraoperative Multivessel Embolization Reduces Blood Loss by Half Compared to Balloon Placement During Caesarian Hysterectomy for Placenta Accreta Spectrum

Intraoperative Multivessel Embolization Reduces Blood Loss and Transfusion Requirements Compared to Internal Iliac Artery Balloon Placement during Caesarian Hysterectomy for Placenta Accreta Spectrum

Clinical Question

Is prophylactic multivessel selective embolization (MVSE) safer and more effective than internal iliac artery occlusion balloon (IIABO) placement in patients undergoing caesarian hysterectomy for placenta accreta spectrum (PAS)?

Take Away Point

MVSE demonstrated more than 50% reduction in median blood loss compared to the IIABO along with significantly reduced percentage of cases requiring packed red blood cells transfusions and median number of cases used. However, the former demonstrated increased procedural time, radiation dosage, and contrast usage.

Reference

Berman Z, Boone C, Melber DJ, et al. Intraoperative Multivessel Embolization Reduces Blood Loss and Transfusion Requirements Compared to Internal Iliac Artery Balloon Placement during Cesarean Hysterectomy for Placenta Accreta Spectrum. Journal of Vascular and Interventional Radiology. 2023;34(11). doi:https://doi.org/10.1016/j.jvir.2023.07.024

Study Design

Retrospective, observation, and cohort studies ultimately comprising of 54 patients, 20 of which received embolization and 34 of which received balloon placement

Funding Source

No reported funding

Setting

Academic, Keck School of Medicine, Los Angeles, CA
Academic, Stanford University, Stanford, CA

Figure

Summary

Placenta accreta spectrum (PAS) has been associated with an increased risk of severe hemorrhage during delivery. Traditionally, it was managed by Caesarian section followed by hysterectomy, leaving placenta in situ in order to minimize hemorrhage. A meta-analysis of 13 studies consisting of over 800 patients demonstrated significantly lower mean estimated blood loss (EBL) among patients who underwent balloon-occlusion in internal iliac artery or infrarenal aorta compared to the patients in the control group who did not undergo any endovascular intervention prior to C-section. At present, no optional treatment strategies are available, and the authors of this paper set out to compare the safety and efficacy of multivessel selective embolization (MVSE) versus internal iliac artery balloon occlusion (IIABO).

The authors of this study performed a retrospective study. The researchers searched through the database from January 2010 to January 2021 of all the patients with PAS that underwent C-section, yielding 20 patients in the embolization group and 34 patients in the balloon-occlusion group. The primary endpoints of this study were EBL and transfusion requirements, with the secondary endpoints being fluoroscopic time, radiation doses, and IR procedural time. Adverse events were also recorded.

The results of the study demonstrated the following: Median EBL was significantly less in the MVSE group compared to IIABO group (713 mL versus 2 L, respectively). The percentage of cases requiring transfusion among embolization cases was 20% versus 65% in the balloon occlusion cases. These results were well within statistical significance. The embolization group demonstrated higher contrast usage, increased fluoroscopic times, and subsequently increased radiation dosages compared to the balloon occlusion group.

Despite the disadvantages of MVSE including increased procedural timing and radiation dosages on the patient, MVSE was shown by this study to be a safe and more effective alternative for the management of PAS patients undergoing Caesarian hysterectomy.

Commentary

The authors in this study were investigating the safety and efficacy of MVSE compared to IIABO in patients with PAS. The data demonstrated favorable results of the former when comparing EBL and transfusion requirements at the cost of fluoroscopy time and radiation dosage.

In my opinion, the advantages of potentially reducing adverse events and blood transfusion requirements outweigh the disadvantages posed by length of procedure time and radiation dosage, provided that optimal strategies are implemented to minimize radiation exposure. Additionally, MVSE was shown to be associated with decreased length of stay in the hospital, an important benefit to the patient and to the healthcare system in general.

Post author

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

Pre-Procedural Intravenous Thrombolysis Does Not Change Function and Cognitive Outcome As Long As Thrombectomy is Performed within 6 Hours of Stroke Onset

Direct Thrombectomy versus Bridging Thrombectomy within 6 Hours of Stroke Onset: A Prospective Cohort Study on Cognitive and Physical Function Outcomes

Clinical Question

Are there significant differences in outcomes regarding the physical and cognitive function of patients with acute large vessel occlusion who underwent either direct thrombectomy or bridging thrombectomy (with intravenous thrombolysis prior to thrombectomy)?

Take Away Point

Patients with anterior circulation large vessel occlusions treated within 6 hours of symptom onset demonstrated comparable outcomes regarding physical and cognitive function with both direct thrombectomy or bridging thrombectomy.

Reference

Direct Thrombectomy versus Bridging Thrombectomy within 6 Hours of Stroke Onset: A Prospective Cohort Study on Cognitive and Physical Function Outcomes. Li, Bing-Hu et al. Journal of Vascular and Interventional Radiology, Volume 34, Issue 11, P1875-1881, 10.1016/j.jvir.2023.07.008

Study Design

Prospective, observational, cohort study

Funding Source

This study was supported by grants from Department of Sichuan Provincial Science and Technology and Bureau of Chengdu Science and Technology.




Figure 2
Comparison of modified Rankin Scale between direct thrombectomy and bridging thrombectomy

Setting

Academic Medical Center, Chengdu, China

Summary

Acute ischemic strokes (AIS) account for 69.6% of all strokes in China, with endovascular thrombectomy being the standard and effective treatment for patients with large vessel occlusion (LVO). However, the question of whether intravenous thrombolysis before endovascular thrombectomy has a role in patients with acute anterior circulation LVO remains controversial. Recognizing the inconsistent data and limited data on bridging thrombectomy’s effects on cognitive function, the authors conducted this prospective study to assess both physical and cognitive function in anterior circulation LVO patients undergoing direct or bridging thrombectomy within 6 hours of stroke onset.

A total of 125 patients with LVO of the anterior circulation, including the intracranial internal carotid, middle cerebral artery segment 1 and/or segment 2, were confirmed by computed tomography angiography (CTA) or digital subtraction angiography (DSA) and included in the study. The median age of the patients was 71.0 (24.0-95.0) years, and among them 60 were men. The median time interval between stroke onset and reperfusion was 348 minutes (150 - 1,295). Patients in the bridging group underwent thrombectomy after receiving a standard dose of intravenous alteplase (0.9mg/kg; 10% as a bolus followed by a 1-hour infusion) within 4.5 hours or intravenous urokinase (1,000,000-1,500,000 units) within 6 hours. Meanwhile, patients in the direct group solely underwent thrombectomy.

The study assessed physical function at the 3-month mark using the Modified Rankin Score (mRS), a 7-point global disability scale that ranges from 0 (no symptoms) to 7 (death). Cognitive function was evaluated at the 6-month mark using the Clinical Dementia Rating (CDR), which ranges from 0 to 3. A score of 0 indicating absence of symptoms, 0.5 indicating questionable dementia, 1 indicating mild dementia, 2 indicating moderate dementia, and 3 indicating severe dementia. Both mRS and CDT assessments were performed via telephone calls by two trained neurologists using a blinded method. Symptomatic intracranial hemorrhage (sICH) was defined as the presence of intracranial hemorrhage with neurologic deterioration of 4 or more points on the NIH stroke scale.

The study included 75 patients in the direct group and 50 patients in the bridging group. The study determined that the direct group exhibited shorter reperfusion times (323.0 [160.0-820.0 minutes) compared to the bridging group (390.0 [150.0-1,295.0] minutes). Analysis of the results found no statistically significant differences between the direct and bridging groups in terms of the percentage of patients with an mRS score of 0-2 (25.3% vs 22.0%, P=.83.) or 0-3 (37.3% vs 44.0%, P=.58), the incidence of sICH within 24 hours (17.3% vs 14.0%, P=.80), or 90-day all-cause mortality rates (36.3% vs 30.0%, P=.34). Furthermore, the proportion of patients with normal cognition at 6 months was comparable between the direct and bridging group. Additionally, the proportion of patients with post-stroke dementia was comparable between the direct and bridging groups (42.1% vs 22.6%, P=.12).

Conflicting outcomes from various RCTs has resulted in an ongoing debate surrounding whether intravenous thrombolysis should precede thrombectomy for acute LVO strokes. While some previously published studies favor direct thrombectomy, others conclude that direct thrombectomy is noninferior to bridging thrombectomy. This prospective cohort study demonstrated that both direct thrombectomy and bridging thrombectomy have comparable physical function outcomes. Additionally, the study demonstrated that the bridging group observed a trend of lower cognitive impairment, however, the results were not statistically significant. The authors noted that the presence of diabetes was associated with a lower CDR score, suggesting a potential influence of antidiabetic drugs on preserving cognitive function. Overall, the study findings indicate that direct thrombectomy is comparable to bridging thrombectomy in patients with acute LVO strokes treated within 6 hours in regards to physical and cognitive function.

Commentary

The study was appropriately designed and executed effectively. While the original sample size was appropriate, the study experienced a considerable number of deaths and losses to follow-up in both treatment groups, impacting the power of the study. The authors employed appropriate statistical tests, including the X2, Fischer exact test, and Mann-Whitney U test, to analyze the data. Given the conflicting results in the published literature regarding direct and bridging thrombectomy for the treatment of LVO strokes, this study aimed to compare the effects of both treatment modalities on physical and cognitive function to determine their relative efficacy. Although the study did not definitively establish a superior treatment modality it effectively demonstrated that both treatment options are comparable. The results, while not statistically significant, offer convincing data that could potentially impact clinical decision-making. Ultimately, the paper provides valuable evidence that can contribute to the ongoing discussion about the management of patients with acute LVO strokes. However, further research with a more robust study design, such as an RCT, a larger sample size, a more diverse patient population, and more diversity in clinical sites, could lead to more robust conclusions and potentially significant changes in patient care.

Post Author 

Aric Patel, MS
OMS-IV
University of New England
College of Osteopathic Medicine

A Review of Materials and Medications with Religious or Dietary Significance in the Interventional Radiology Suite

Clinical Question

How can appropriate holistic considerations be implemented in a patient-centered care when incorporating different medications and medical devices with culturally or religiously sensitive ingredients in an interventional radiology suite?

Take Away Point

Different religions and cultures have different sets of restrictions with regards to specific sensitive ingredients present in appropriate medications or devices. This provides a spectrum of challenges depending on what the respective culture/religion allows or what it is willing to tolerate in specific scenarios which may prompt a necessary conversation between the physician and the patient.

Reference

Wilson R, Hu Z, Cormac O’Brien, Meer E, Agarwal A, Murray T. A Review of Materials and Medications with Religious or Dietary Significance in the Interventional Radiology Suite. Journal of Vascular and Interventional Radiology. 2023;34(10):1717-1721. doi:https://doi.org/10.1016/j.jvir.2023.06.035

click here for abstract

Study Design

Social Science Study

Funding Source

No reported funding

Setting

Academic, St. Paul’s Hospital, Vancouver, British Columbia, Canada
Academic, University of British Columbia, Vancouver, British Columbia, Canada
Academic, Schooland School of Medicine, Kingston, Ontario, Canada

Table 1.Dietary Restrictions of Specific Religions

Religion	Specific restriction
Christianity	Some denominations have specific restrictions during Lent or choose to forgo animal products and ethanol. Certain weekdays or holy days may also preclude meat/dairy consumption.
Jehovah’s Witnesses (Christian Denomination)	Avoid blood products (ie, blood transfusions).
Seventh-day Adventist (Christian Denomination)	Some choose to refrain from consuming animal products (excluding eggs).
Judaism	Strict followers may only consume kosher products. All porcine and shellfish products are prohibited. Land animals consumed must be mammals that chew their cud and have cloven hooves. Birds of prey are prohibited.
Islam	Strict followers may only consume animal products obtained through ritualistic method (halal). Porcine products and ethanol are prohibited.
Hinduism	Majority of followers are vegetarian and abstain from all animal products, including eggs. Those who are not vegetarian still abstain from bovine and porcine products, along with ethanol.
Buddhism	No universal restrictions. Those who are vegetarian refrain from consuming all animal products, including eggs.
Sikhism	Dietary restrictions are an individual choice. Those who are vegetarian refrain from consuming all animal products, including eggs. Those who are not vegetarian may abstain from consuming bovine and porcine products, along with ethanol. All products obtained from other religious guidelines (halal, kosher) are prohibited.
Veganism	All animal products, including eggs, are prohibited.

Figure

Table 1: Brief summary of different common religions/cultures and their associated restrictions

Summary

Globalization has exposed people to a wide variety of approaches to life dependent on personal and religious preferences. These different sets of practices implement specific restrictions and permissions which ultimately impact the decision one makes in his or her daily life. One of those specific sets of restrictions is the avoidance of certain animal-derived products which differ from practice to practice but are well-known ingredients in certain medications and medical devices.

The article briefly details consumptive restrictions and conditions that exist in major denominations of secular or religious groups. Afterwards the topic of autonomy is then brought forth, which the article alludes to as the basis for the potential need for this discussion. Specifically, competent patients have the right to make informed decisions, and part of the information that would help them impact their decision-making involves religiously or culturally sensitive ingredients that make up certain medications or devices. One proposed method is preprocedural screening flagging patients with relevant restrictions to animal-derived products.

Despite the important holistic consideration outlining sensitive ingredients would provide, there are multiple challenges. Firstly, the specific and even the magnitude of certain restrictions not only differ from religion to religion, but even amongst different sects of a particular religion. This makes it difficult to completely standardize restrictions for any one particular group. Secondly, new medications and devices are introduced at a high rate, further compounding the challenge of keeping a comprehensive list of all sensitive products to inform specific patients with.

Commentary

The authors in this study explored the prospect of culturally or religiously sensitive animal-derived products and the challenges that come with either informing patients appropriately or being up-to-date with all of them in the medical devices or medications. While autonomy is one of the central tenets of medicine and serves as the basis for justification of informing patients of culturally or religiously sensitive ingredients, the article explains why this is severely challenging.

Firstly, for the most part most, if not all, of the major world religions do not have an entire group agreeing on the specific details pertaining to permission or restrictions. For example, the article referenced how Muslims avoid porcine products, but the concept and application of “Dharurah,” which involves how certain forbidden products become permissible in the context of life-saving situations is not necessarily entirely agreed upon amongst all schools of thought in the Islamic scholarship. Thus, even if a physician were to meet a Muslim patient and were to inform them about a product, there is no guarantee that the patient follows a specific school of thought that would otherwise ameliorate options presented to him or her.

Secondly, with the rapidity of new medications and medical devices introduced to the market over time, it is nearly impossible to keep a comprehensive list of all the ingredients that may be present in such facets, even if the financial and other costs of such task were feasible.

These challenges brought forth explain why I do not have a perfect solution for addressing this challenge, even though this can significantly improve the holistic approach physicians can bring to their patients. However, were this to be successfully implemented, this can significantly improve the holistic care model brought about upon the patients.

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

Evaluation of an Artificial Intelligence Chatbot for Delivery of IR Patient Education Material: A Comparison with Societal Website Content

Clinical question

How does the completeness, accuracy and reliability of a large language chatbot model as a tool for patient education in the field of interventional radiology compare to a traditional societal website.

Take away point

While employing a large language chatbot model for patient education in interventional radiology shows promise, it also has limitations. Readers should be aware that while the chatbot's responses are generally thorough and factual, they can occasionally be incomplete or incorrect. Additionally, content provided by ChatGPT was found to be longer and more difficult to read when compared to a traditional societal website. As of now, patients and providers should be cautious when relying solely on chatbot generated content and consider augmenting it with other trusted sources.

Reference

McCarthy CJ, Berkowitz S, Ramalingam V, Ahmed M. Evaluation of an Artificial Intelligence Chatbot for Delivery of IR Patient Education Material: A Comparison with Societal Website Content. J Vasc Interv Radiol. 2023 Oct;34(10):1760-1768.e32. doi: 10.1016/j.jvir.2023.05.037. Epub 2023 Jun 16. PMID: 37330210.

Click here for abstract

Study design

Artificial intelligence study.

Funding Source

No reported funding.

Setting

Not explicitly mentioned.

Figure

Summary of Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P) scores

Summary

The study involved analyzing 104 questions posed to ChatGPT and comparing its responses to content from the Society of Interventional Radiology Patient Center website. The goal was to assess whether ChatGPT could effectively serve as a resource for patient education in the field of interventional radiology. Readability was assessed using five validated scales, and understandability and actionability were evaluated using the Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P).

ChatGPT generally provided longer and more complex responses compared to the website. Additionally, chatbot generated content was found to be more challenging to read and nearly one grade level above the comparison. Surprisingly, content from both models was written at a higher grade level than recommended for patient education materials. The study also revealed that while uncommon, ChatGPT could provide incomplete or inaccurate information.

Most importantly, the study highlighted both the potential and limitations of utilizing current chatbots for patient education in the field of interventional radiology. Concerns were raised about the chatbot's tendency to provide verbose responses and guess answers when faced with ambiguous questions. The authors suggested that ChatGPT and similar chatbot models hold promise as patient education tools while underscoring the importance of improvements in accuracy and readability through customization.

Commentary

The study addresses an important and relevant clinical question while providing valuable insights into the challenges and limitations of using AI chatbots for patient education. This technology remains new to the general public, and this study may serve as a starting point for ongoing research in this field as transformative changes occur. Future research could involve a larger pool of reviewers to assess accuracy, reassess after adding visual aids to patient education, and propose solutions for optimizing and improving AI-driven patient education content.

Post Author:
Ryan R. Babayev, MD, MSc
Diagnostic Radiology Resident
Hartford Hospital
@RyanBabayevMD

An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry

Clinical question

Is sacroplasty an effective and safe procedure for reducing pain and improving function in the treatment of patients with sacral insufficiency fractures?

Take away point

Sacroplasty effectively and safely reduced painful sacral insufficiency fractures while maintaining patient-reported outcomes over 6 months.

Reference

An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry. Beall D. P et al. Journal of Vascular and Interventional Radiology, Volume 34, Issue 9, 1477 – 1484. doi.org/10.1016/j.jvir.2023.05.024

Click here for the abstract

Study design

Multicenter, prospective, single-arm registry.

Funding Source

D.P.B. reports compensation from Medtronic related to consultancy, research, and teaching; grants from Benvenue, Alphatech Spine, Medical Metrics, Liventa, Vexim, and Mesoblast; grants and personal fees from Medtronic, Halyard, Vivex, and Vertiflex; consultancy fees from Dfine and Osseon; and other from Lilly, Smith & Nephew, Biomet, Vertiflex, Synthes, and Integral Spine Solutions. N.H.S. reports compensation related to royalties from Globus and consulting, research, and teaching from Medtronic.

Setting

10 sites in the United States consisting of small community practices, radiology group practices, multispecialty group practices, and large academic medical centers.

Figure 2

Mean Numerical Rating Scale scores at the 1-, 3-, and 6-month time points.

Summary

    Sacral insufficiency fractures (SIFs) are painful fractures of the sacrum that can occur in patients with osteoporosis or neoplastic involvement. These fractures often go undiagnosed and are a common source of low back pain in elderly patients. Sacroplasty has been shown to be an effective and safe treatment for sacral fractures with minimal adverse effects. However, no prospective observational trials (registries) have reported basic safety and efficacy data. The authors performed a multicenter, prospective, single-arm registry study with 102 patients to assess the efficacy and safety of sacroplasty for the treatment of sacral insufficiency fractures.

    The study included 102 patients presenting with SIF. Patient-reported outcome (PRO) data was collected via phone call surveys at the 1-, 3-, and 6-month mark after the initial sacroplasty procedure. The PROs obtained included pain, assessed using the Numerical Rating Scale (NRS), and function, assessed using the Roland-Morris Disability Questionnaire (RMDQ). The minimal clinically important difference was defined as a change of greater than or equal to 2 points from baseline on the NRS for pain and greater than or equal to 5 points from baseline on the RMDQ for function. The secondary endpoints were cement leakage, adverse effects, hospital readmission, new neurologic deficits, and death.

    Patients were analyzed using frequencies for categorical variables and means for continuous variables, while PROs were reported at baseline, 1, 3, and 6 months. Generalized estimating equation models were used to analyze the effects of time on repeated measurements for pain and function. Post hoc tests with Bonferroni adjustments were used to compare the mean differences between PROs.

    The most common treated levels were both S1 and S2, and prior to cement augmentation, nonsurgical management was attempted in 93.1% of the patients, and 78.4% of patients with sacral fractures had an osteoporosis diagnosis. The study demonstrated statistically significant (P < .001) improvements in NRS and RMDQ scores at 6 months compared to baseline. Mean RMDQ scores decreased from 17.7 to 5.2 over a 6-month period and mean NRS scores decreased from 7.8 to 0.9 over the same period. Out of the 102 patients, only one experienced an adverse effect of cement extravasation leading to new neurologic deficits. Cement leakage was observed in 17.7% of the patients but remained asymptomatic except for one patient with new-onset neurological deficits. There were no patient deaths, and hospital readmission after sacroplasty occurred in 8 of the 102 patients (7.8%) at 6 months and one patient each after 1 and 3 months.

Commentary

    The purpose of the study was to provide prospective observational data on the efficacy and safety of sacroplasty for treating sacral insufficiency fractures using patient-reported outcomes. The study used a prospective registry approach, enabling the collection of real-world data from a diverse patient population across the United States. Considering the inherent limitations of a registry study the methods and study approach was well-structured. The statistical model and equation models used to analyze the data appear to be appropriate. However, the study does not provide further detail on the statistical analysis process. The presented outcomes are convincing, indicating significant improvements in pain and function following sacroplasty in SIF patients. The study’s results align with data from previous studies and meta-analyses. Areas of improvement include a clearer explanation of the statistical analyses and independent radiographic evaluations of patients. Overall, the paper provides compelling evidence that support the safety and efficacy of sacroplasty for patients with SIF.

Post author

Aric Patel, MS
University of New England College of Osteopathic Medicine

Double-Barrel Nitinol Stent Placement for Iliocaval Reconstruction: The Effect of Deployment Sequence and Direction

Clinical question

What is the influence of biomechanical forces on deployment outcomes of synchronous parallel stent deployment versus asynchronous or antiparallel stent deployment in cases of chronic, bilateral iliocaval occlusion?

Take away point

Synchronous parallel deployment is most likely to provide the desired stent configuration and shows superior clinical outcomes when performing double-barrel nitinol stent placement for treatment of chronic, bilateral iliocaval occlusion due to a balance in biomechanical forces.

Reference

Li N, Huber T, Campos L, Yamada K, Kaufman J, Farsad K, Bochnakova T. Double-Barrel Nitinol Stent Placement for Iliocaval Reconstruction: The Effect of Deployment Sequence and Direction on Final Configuration. J Vasc Interv Radiol. 2023 Sep;34(9):1511-1515.e1. doi: 10.1016/j.jvir.2023.05.018. Epub 2023 May 15. PMID: 37196821.

Click here for abstract.

Study design

In-vivo experimental with ex-vivo assessment utilizing swine models.

Funding Source

No reported funding.

Setting

Single academic center

Figure

Graphic illustration of the three (3) different double-barrel self-expanding nitinol venous stent deployment strategies across the iliocaval confluence (synchronous parallel, asynchronous parallel, and synchronous antiparallel) and their associated technical outcome tested in this study using a swine animal model.

Summary

    Despite the widespread use of double-barrel stents in venous interventions for chronic bilateral iliocaval occlusion, the differences in deployment outcomes between synchronous parallel stent deployment and asynchronous or parallel deployment, as well as the underlying biomechanical interactions of the stents, are not well understood.

    Using a live swine model, the diameters of the inferior vena cava (IVC) and common iliac veins were measured. Subsequently, 14 mm diameter double-barrel nitinol stents were deployed using three different techniques: (1) asynchronous parallel deployment from bilateral common femoral accesses, (2) antiparallel, synchronous deployment with the right common iliac stent deployed from the right internal jugular access and the left common iliac stent deployed from the left common femoral access, and (3) synchronous parallel deployment from bilateral common femoral accesses.

    Initial stent expansion was assessed under fluoroscopy, and all deployment strategies underwent simultaneous balloon angioplasty to 12 mm before being reassessed for their diameters. Following this, the peripheral IVC and bilateral common iliac veins were harvested and examined ex-vivo. The assessment was qualitative in nature, as statistical analysis was not performed due to the small sample size.

    Synchronous parallel stent deployment successfully achieved the desired double-barrel stent configuration due to an equilibrium among various biomechanical forces, including radial resistive force, chronic outward force, and crush resistance. However, both asynchronous parallel and antiparallel deployment strategies exhibited irreversible stent deployment issues, resulting in a crushed configuration due to unequal forces that compromised proper stent expansion.

    The authors recommend the use of intravascular ultrasound and multiprojection venography to confirm stent expansion and positioning. They also suggest that designing stents to mitigate force imbalances could be beneficial.

Commentary

    In this study, the authors investigated techniques and biomechanical forces impacting venous stent deployment. Although performed in a swine model, the principles are expected to apply to stent deployment in humans. This research has the potential to benefit patient care through technique optimization and product development. While study limitations may prevent direct correlation with human patient care, conducting future studies with larger sample sizes and controlled designs to allow for statistical analyses could be beneficial. In the interim, the principles demonstrated in this study can help achieve better stent placement and reduce potential complications.

Post author

Ryan R. Babayev, MD, MSc
Diagnostic Radiology Resident
Hartford Hospital
@RyanBabayevMD

Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis

Clinical Question

Is middle meningeal artery embolization (MMAE) via liquid embolic agents a safe and effective alternative to conventional neurosurgery for treating chronic subdural hematomas?

Take Away Point

MMAE demonstrated 100% success rate, significantly lower reoperation, recurrence, and mortality rates compared to conventional neurosurgery.

Reference

Mowla A, Abdollahifard S, Farrokhi A, Yousefi O, Valibeygi A, Azami P. Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. J Vasc Interv Radiol. 2023;34(9):1493-1500.e7. doi:10.1016/j.jvir.2023.05.010

Click here for abstract

Study Design

Systematic review and meta-analysis of 14 studies containing 276 patients

Funding Source

No reported funding

Setting

Academic, Keck School of Medicine, Los Angeles, CA
Academic, Shiraz Research Center for Neuromodulation and Pain, Shiraz, Iran
Academic, Shiraz University of Medical Sciences, Shiraz, Iran
Academic, Fasa University of Medical Sciences, Fasa, Iran

Figure

Figure E1.Heterogeneity, proportion, and 95% confidence interval related to the success rate of chronic subdural hematoma treatment following middle meningeal artery liquid embolization after excluding the study by Fan et al. CI = confidence interval. (Fan G, Wang H, Ding J, et al. Application of absolute alcohol in the treatment of traumatic intracranial hemorrhage via interventional embolization of middle meningeal artery. Front Neurol 2020; 11:824.)

Summary

    Chronic subdural hematoma (cSDH) is one of the most common neurological conditions encountered in the elderly, with some requiring neurosurgical intervention due to the severity of the nonspecific symptoms. Middle meningeal artery (MMA) has been stated to be the predominant supplier contributing to the prevalence of cSDH, and multiple studies have studied the efficacies and safety of MMAE as an alternative option.

    The authors performed a systematic review and meta-analysis. Initially, 628 studies were retrieved using Preferred Reporting Items for Systematic Reviews and Meta-Analyses Criteria. The researchers ultimately extracted 14 eligible articles comprising of 276 patients undergoing 305 embolization procedures. They then evaluated the clinical success rate, adverse events rates, recurrence rates, reoperation rate, and reduction in size of cSDH.

    The results of the study demonstrated the following: Mean age of 66 years, 100% technical success rate, 1% adverse event rate, 3% recurrence rate, 4% reoperation rate, 94% reduction rate in the size of the hematoma, 78% achieving complete elimination of the hematoma, 0% mortality rate. All of these results were within the 95% confidence interval.

    These results demonstrated highly favorable results when compared to invasive neurosurgical interventions. For example, the article demonstrated that the recurrence rates of common neurosurgical techniques ranged from 11.7-28.1% compared to MMAE’s 3%. The reoperation rate with conventional methods was up to 26.4% compared to to MMAE’s 4%.

Commentary

    The authors in this study evaluated the efficacy and safety of MMAE and demonstrated extremely favorable outcomes when compared to conventional neurosurgical techniques. Most notably they report a 100% success rate and 0% mortality rate. The findings of this study can help patients who are poor surgical candidates, and as the article briefly alluded to, can significantly limit the risk associated with longer hospital stays.

Post author

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

Safety and Effectiveness of Expandable Intravertebral Implant Use for Thoracolumbar Burst Fractures

Clinical question

Are expandable intravertebral implants (Spinejack; Stryker, Kalamazoo, Michigan) a safe and effective treatment option for patients with thoracolumbar spine burst fractures without fracture-related neurologic deficit.

Take away point

Expandable intravertebral devices are safe and effective for improving pain, vertebral body height, fracture fragment retropulsion, and central canal diameter compromise in patients without fracture-related neurologic deficit.

Reference

Wei H, Hsu D, Katta H, Lowenthal J, Kane I, Kazmi S, Sundararajan S, Koziol J, Gupta G, Johnson S, Kang F, Moubarak I, Roychowdhury S. Safety and Effectiveness of Expandable Intravertebral Implant Use for Thoracolumbar Burst Fractures. J Vasc Interv Radiol. 2023 Aug;34(8):1409-1415.

Click here for abstract

Study design

Retrospective, observational, descriptive study

Funding Source

None

Setting

Single center

Figure

Postprocedural thoracic spine computed tomography using expandable intervertebral implantation demonstrated an improved degree of retropulsion.

Summary

Imaging studies before and after expandable intravertebral implantation and medical records of 33 patients, 11 (33.3%) men and 22 (66.6%) women with an overall mean age of 71.7 years ± 8.3, were reviewed for 60 thoracolumbar Magerl Type A3 injuries secondary to osteoporosis, trauma, or malignancy. The mean follow-up time was 299 days.

Implantation of an expandable intravertebral device resulted in a statistically significant reduction in bone fragment retropulsion (mean ± SD, 0.64 mm ± 16.4; P < .001), reduction in the extent of canal compromise (mean, 5.5%; P < .001), increased central canal diameter (mean ± SD, 0.71 mm ± 1.3; P < .001), and restoration of vertebral body height, with a mean increase of 5.0 mm (P < .001). However, the implantation did not result in a statistically significant kyphosis reduction (mean, 1.38°; P = .10). All patients except for 1 reported improvement in pain after surgery, with a mean improvement of 1.54 on a 4-point pain scale (P < .001). No clinically significant adverse events were reported.

Commentary

Expandable, intervertebral implants are a new method of treating vertebral compression fractures. This study evaluates their use in burst fractures that are not causing neurologic deficits. The authors found improvements in pain, central canal compromise, and degree of retropulsion. The authors do admit that the improvements in central canal compromise and retropulsion were small. Kyphosis was not significantly changed after the procedure. This study is a promising early step toward more rigorous comparison of intervertebral implants with vertebroplasty or kyphoplasty in similar settings.

Post author

Timothy Huber, MD
Jefferson Radiology
@IR_Huber

Comparison between Suprapapillary and Transpapillary Uncovered Self-Expandable Metallic Stent Placement for Perihilar Cholangiocarcinoma

Clinical question

How do suprapapillary and transpapillary uncovered self-expandable metallic stent placement compare for perihilar cholangiocarcinoma?

Take away point

Suprapapillary and transpapillary stent placement procedures were similar in terms of procedural success, occlusion rate, revision rate, postprocedural AEs, and 30-day mortality.

Reference

Borges AP, Silva AV, Donato P. Comparison between Suprapapillary and Transpapillary Uncovered Self-Expandable Metallic Stent Placement for Perihilar Cholangiocarcinoma. J Vasc Interv Radiol. 2023 Aug;34(8):1400-1408.

Click here for abstract

Study design

Retrospective, observational, descriptive study

Funding Source

None

Setting

Single academic center

Figure

A self-expanding metallic stent was placed with its lower margin (black arrow) above the level of the sphincter (white arrow).

Summary

A single-center retrospective study of 54 patients with inoperable perihilar cholangiocarcinoma who underwent percutaneous transhepatic biliary stent placement between January 1, 2019, and August 31, 2021, was conducted. According to stent location, the patients were classified into 2 groups: suprapapillary (S) and transpapillary (T). Demographic data, Bismuth-Corlette classification, type and location of the stent, laboratory data, postprocedural AEs, procedural success, stent occlusion, reintervention rate, and mortality were compared between the groups.

Stent placement was suprapapillary in 13 (24.1%) patients and transpapillary in 41 (75.9%) patients. Mean age was higher in Group T (78 vs 70.5 years; P = .046). Stent occlusion rates were similar in the 2 groups (Group S, 23.8%; Group T, 19.5%), as were AE rates, the most common being cholangitis (Group S, 23.1%; Group T, 24.4%). There were no significant differences in revision rate (Group S, 7.7%; Group T, 12.2%) and 30-day mortality rate (Group S, 15.4%; Group T, 19.5%). Ninety-day mortality rate was statistically significantly higher in Group T (46.3% vs 15.4%; P = .046). Preprocedural bilirubin level was higher in Group T, as were postprocedural leukocyte and C-reactive protein (CRP) levels.

Commentary

This study evaluates transpapillary biliary stenting versus suprapapillary stenting for cholangiocarcinoma. Both methods has theoretical benefits, but have not been directly compared. The authors did not find significant differences in outcomes or adverse events between the two groups. However, there was a small sample size, and there were significantly more patients in the transpapillary group (41) compared to the suprapapillary group (3). Incomplete follow up data also limits the detection of adverse events. Further studies of this topic with larger sample size and more consistent follow up are needed, but this study suggests that stent position may not matter as much as once thought.

Post author

Timothy Huber, MD
Jefferson Radiology
@IR_Huber

Transjugular Intrahepatic Portosystemic Shunt and Thrombectomy (TIPS-Thrombectomy) for Symptomatic Acute Noncirrhotic Portal Vein Thrombosis

Clinical question

Is transjugular intrahepatic portosystemic shunt and mechanical thrombectomy (TIPS-thrombectomy) safe and effective for symptomatic acute noncirrhotic portal vein thrombosis (NC-PVT).

Take away point

TIPS-thrombectomy is a safe and effective method for treating patients with symptomatic acute NC-PVT.

Reference

Shalvoy MR, Ahmed M, Weinstein JL, Ramalingam V, Malik MS, Ali A, Shenoy-Bhangle AS, Curry MP, Sarwar A. Transjugular Intrahepatic Portosystemic Shunt and Thrombectomy (TIPS-Thrombectomy) for Symptomatic Acute Noncirrhotic Portal Vein Thrombosis. J Vasc Interv Radiol. 2023 Aug;34(8):1373-1381.e3.

Click here for abstract

Study design

Retrospective, observational, descriptive study

Funding Source

None

Setting

Single academic center

Figure

(Left) Preprocedural coronal reconstruction showed extensive portal, splenic, and mesenteric venous thrombosis (arrow). (Right) Postprocedural coronal image at 1 year showed a well-opacified SMV, splenic vein, and portal vein without evidence of residual thrombosis.

Summary

Patients with acute NC-PVT who underwent TIPS-thrombectomy between 2014 and 2021 at a single academic medical center were retrospectively reviewed. Thirty-two patients were included (men, 56%; median age, 51 years [range, 39–62 years]). The causes for PVT included idiopathic (n = 12), prothrombotic disorders (n = 11), postsurgical sequelae (n = 6), pancreatitis (n = 2), and Budd-Chiari syndrome (n = 1). The indications for TIPS-thrombectomy included refractory abdominal pain (n = 14), intestinal venous ischemia (n = 9), ascites (n = 4), high-risk varices (n = 3), and variceal bleeding (n = 2). Variables studied included patient, disease, and procedure characteristics. Patients were monitored over the course of 1-year follow-up.

Successful recanalization of occluded portal venous vessels occurred in all 32 patients (100%). Compared with pretreatment patency, recanalization with TIPS-thrombectomy resulted in an increase in patent veins (main portal vein [28% vs 97%, P < .001], superior mesenteric vein [13% vs 94%, P < .001], and splenic vein [66% vs 91%, P < .001]). Three procedure-related adverse events occurred (Society of Interventional Radiology grade 2 moderate). Hepatic encephalopathy developed in 1 (3%) of 32 patients after TIPS placement. At 1-year follow-up, return of symptoms occurred in 3 (9%) of 32 patients: (a) ascites (n = 1), (b) variceal bleeding (n = 1), and (c) intestinal venous ischemia (n = 1). The intention-to-treat 1-year portal vein and TIPS primary and secondary patency rates were 78% (25/32) and 100% (32/32), respectively. Seven patients required additional procedures, and the 1-year mortality rate was 3% (1/32).

Commentary

In this study of TIPS-thrombectomy for symptomatic, acute, noncirrhotic portal vein thrombosis the authors report significant improvements in patency of the portal system after thrombectomy. They reports a secondary patency rate of 100% at 1 year. These results support the safety and efficacy of TIPS-thrombectomy; however, the study is limited by retrospective nature, small sample size, and short follow up. Longer term follow up, or comparison to anticoagulation alone could be promising future directions.

Post author

Timothy Huber, MD
Jefferson Radiology
@IR_Huber

Change in Platelet Count after Transjugular Intrahepatic Portosystemic Shunt Creation: An Advancing Liver Therapeutic Approaches (ALTA) Group Study

 

Clinical question

How does TIPS affect platelet count and recovery?

Take away point

TIPS only increased platelets for patients with a pre-procedure count less than 50,000 per microliter.

Reference

Wong RJ, Ge J, Boike J, German M, Morelli G, Spengler E, Said A, Desai A, Couri T, Paul S, Frenette C, Verna EC, Goel A, Fallon M, Thornburg B, VanWagner L, Lai JC, Kolli KP. Change in Platelet Count after Transjugular Intrahepatic Portosystemic Shunt Creation: An Advancing Liver Therapeutic Approaches (ALTA) Group Study. J Vasc Interv Radiol. 2023 Aug;34(8):1364-1371

Click here for abstract

Study design

Case control study

Funding Source

This study was funded by National Institutes of Health KL2TR001870 (to J.G.) and P30DK026743 (to J.G. and J.C.L.). The ALTA Study Group, however, is funded by an investigator-initiated grant from W.L. Gore and Associates. The Northwestern Research Electronic Data Capture is funded, in part, by the National Center for Advancing Translational Sciences of the National Institutes of Health research grant UL1TR001422 to the Northwestern University Clinical and Translational Sciences Institute. The sponsor (W.L. Gore & Associates) had no inpu into the overall design and conduct of the ALTA study.

Setting

Multicenter study

Figure

Histogram of change in platelet count at 4 months after transjugular intrahepatic portosystemic shunt (percentage).

Summary

TIPS creation is an effective intervention for ascites and variceal bleeding in patients with cirrhosis. However, research regarding the impact of TIPS creation on thrombocytopenia is limited, and results have yielded conflicting results. This study was conducted in a multicenter cohort of patients with cirrhosis who underwent TIPS creation and attempted to identify factors associated with platelet count increase after TIPS creation.

Demographic and clinical data were obtained from participating study sites and uploaded to a central study database using Research Electronic Data Capture software hosted at the organizing center. Platelet counts were evaluated at 4 months after TIPS creation to allow sufficient time for post-TIPS recovery and "recalibration".

Percentage change in platelet counts was chosen rather than absolute change because it takes into account the baseline of the patient. The top quartile for platelet count increase was isolated and assessed for patient factors associated with inclusion in this group.

601 patients with cirrhosis underwent TIPS creation at 9 U.S. hospitals from 2010 to 2015, of which 184 (15%) died within 4 months and 115 (9%) underwent transplantation within 4 months. Two hundred twenty-seven (38%) patients were women, with a median age of 57 years.

The median absolute change in platelet count from before to after TIPS was 1,000/microliter. In the subgroup of those with severe thrombocytopenia, there was a significant absolute change in platelet count. In univariable and multivariable logistic regression analyses, older age, lower pre-TIPS platelet count, and higher pre-TIPS MELD were significantly associated with being in the top quartile for platelet increase 4 months after TIPS creation.

Commentary

Previous studies have presented conflicting evidence as to whether TIPS has a positive impact on thrombocytopenia. This large multicenter study of 601 patients who underwent TIPS did not show a significant increase in platelet counts after TIPS. However, when assessing subgroups, patients with platelet counts less than 50,000/microliter prior to TIPS did have improvement in thrombocytopenia. The study suggests that certain subgroups may see a greater improvement in platelet counts following TIPS. The study does have significant limitations, including retrospective nature, lacking information on splenic embolization, and lacking information on medical treatment of thrombocytopenia. These issues could be addressed subsequent prospective studies.

Post author

Timothy Huber, MD
Jefferson Radiology
@IR_Huber