Monday, August 26, 2019

Left Gastric Artery Embolization in Obese, Prediabetic Patients: A Pilot Study


Clinical question
Does HbA1c change after Left Gastric artery embolization (LGAE) in obese, prediabetic patients?

Take away point
At 6 months LGAE significantly decreased HbA1c, BMI and body weight with no major adverse events.

Reference
Left Gastric Artery Embolization in Obese, Prediabetic Patients: A Pilot Study
Zaitoun, Mohamed M.A. et al. Journal of Vascular and Interventional Radiology, Volume 30, Issue 6, 790 - 796


Study design
Single arm, prospective, cohort study of 10 obese prediabetic patients.

Funding Source
No reported funding

Setting
Academic hospital, Cairo University, Egypt.



Figure 2
Left gastric artery angiogram in a 49 year old patient showing normal anatomy (a). Left gastric artery injection shows normal fundal blush supplying the posterior branch (b). The anterior branch of the LGA prior to embolization, shows normal anatomy and fundal blush (c). Post-LGA embolization shows absence of the normal fundal blush.

Summary

Left gastric artery embolization (LGAE) has shown promising results for weight loss in patients with a BMI >40, however glycemic control in pre-diabetic patients with BMI <40 has not been studied. The authors performed a prospective study of 10 obese pre-diabetic patients that underwent LGAE and evaluated weight, BMI, HgA1c and adverse events. 

Patients included in this study were adults that had failed conservative weight loss treatment (exercise, weight loss programs, medications), were not interested in surgical management, had a BMI >30 kg/m2, HbA1c <5.7 and >6.4 and had normal liver, renal and hematological parameters. Patients were excluded if they had chronic diseases, prior bariatric or gastric surgery, peptic ulcer disease or reflux, diabetes or family history of diabetes and pregnancy. 

Patients in this study were not instructed to change their dietary or exercise habits and did not take any medications for glycemic control. Endoscopy was performed pre and 1 month post LGAE and any patients with pre-LGAE abnormalities were excluded. Patients were placed on oral omeprazole and sucralfate for 2 weeks prior to the procedure and 6 weeks after. LGAE of the fundal branches was performed with 300-500 micron Embospheres until 5 beats of stasis was obtained. 

There was 100% technical success, the gastric fundus was always supplied from the LGA, and no major adverse events were experienced. After one week, endoscopic findings were normal. At 6 months all patients showed a reduction in weight, BMI and HgA1c. The mean body weight significantly decreased from 107.4 kg to 98 kg (p<0.0001), BMI significantly decreased from 37.4 to 34.1 (p<0.0001) and HbA1c decreased from 6.1 to 4.7 (p<0.0001). The observed mean percent reduction in weight was 8.9%, 8.8% in BMI and 21.4 % difference in HgA1c.

Commentary

The authors in this study evaluated LGAE in 10 pre-diabetic adult patients with a BMI < 40, which is a cohort that has not been studied before. The findings are encouraging and were able to show that on average at 6 months, HgA1c significantly improved by 21.4%, body weight improved by 8.9% and BMI by 8.8%. Multidisciplinary management of obesity is necessary, and LGAE is proving to be an important element in the control of this epidemic. Diabetes, and its multiple associated co-morbidities, is difficult to control and this study was able to show that LGAE might be a good option when conservative measurements have failed. It is important that all LGAE research be conducted in a multidisciplinary manner, with strict longitudinal follow up, and adequate assessment by all involved physicians, as it was done by the authors of this study.

Post Author
Carlos J. Guevara, MD, FSIR
Assistant Professor of Radiology and Surgery
Department of Radiology, Interventional Radiology Division
Washington University in St. Louis, Mallinckrodt Institute of Radiology,
@CarlosGuevaraIR

Monday, August 19, 2019


Safety and Efficacy of Radiofrequency Ablation for Nonfunctioning Benign Thyroid Nodules in Children and Adolescents in 14 patients over a 10-Year Period


Clinical question
Is it safe and effective to perform radiofrequency ablation for nonfunctioning benign thyroid nodules in children and adolescents?

Take-away point
RFA is likely safe and effective for the treatment of nonfunctioning benign thyroid nodules in children and adolescents

Reference
Min Ji Hong, et al. Safety and Efficacy of Radiofrequency Ablation for Nonfunctioning Benign Thyroid Nodules in Children and Adolescents in 14 patients over a 10-Year Period. Journal of Vascular and Interventional Radiology. Jun3, 2019: 30; 6.

Click here for abstract

Study design
Retrospective

Funding source
Self-funded or unfunded

Setting
Single-center








Figure 1A 17-year-old female patient with a palpable nonfunctioning thyroid mass.

Summary

Currently, surgery is the preferred treatment method for pediatric thyroid nodules. Radiofrequency ablation (RFA) is rising in popularity for treatment of adult benign thyroid nodules. Ablation may be able to avoid risks associated with thyroid surgery, including hypothyroidism and vocal cord palsy, while still being able to reduce compressive and cosmetic problems caused by a benign nodule. This study evaluated a single center’s experience with using RFA in 14 pediatric patients.

All patients underwent biopsy to confirm benign pathology and had pressure symptoms or cosmetic problems secondary to the thyroid nodule. Ablation was performed with local anesthesia with ultrasound guidance using an 18-gauge 7 cm probe with a 0.5, 1, or 1.5 cm tip (Well-Point RF Electrodes). A moving shot technique was utilized, by placing the tip at the deepest portion of the nodule and withdrawn to the superficial aspect. A mean number of 2.1 treatment sessions were performed and no major complications were encountered. Over the mean follow up period of 36.9 months, the average nodule size was reduced from 3.7 cm pre-procedure to 1.7 cm on final follow up. Symptom and cosmetic scores were also significantly reduced from baseline. There was no significant change in serum thyroid levels.

Commentary

This is the first study evaluating ablation of benign nonfunctioning thyroid nodules in the pediatric population. While small in size, the study did demonstrate efficacy and safety. RFA may prove to be a preferred treatment for many benign nodules over surgery as it avoids hypothyroidism and minimizes the risk of recurrent laryngeal nerve damage. Additional benefits include avoidance of general anesthesia and absence of an incisional scar. A larger cohort would be needed to determine true complication rate, especially if performed by less experienced physicians. Thyroid ablation continues to be a growing field with numerous possible applications in the future.

Post Author
David M Mauro, MD
Assistant Professor
Department of Radiology, Vascular and Interventional Radiology
University of North Carolina
@DavidMauroMD

Monday, August 12, 2019

Muscle Gain after Transjugular Intrahepatic Portosystemic Shunt Creation: Time Course and Prognostic Implications for Survival in Cirrhosis


Clinical question
Is transjugular intrahepatic portosystemic shunt (TIPS) placement associated with truncal muscle gain and potentially improved mortality?

Take-away point
TIPS resulted in truncal muscle gains, seen maximally at 6 months after shunt placement. At one year, muscle gain was independently associated with decreased mortality.

Reference
Jahangiri Y, et al. Muscle gain after transjugular intrahepatic portosystemic shunt creation: time course and prognostic implications for survival in cirrhosis. J Vasc Interv Radiol. 2019 Jun; 30(6): 866-872.

Click here for abstract

Study design
Retrospective review

Funding source
None identified

Setting
University hospital setting – Oregon, United States.






Table 2
Comparison of Cross-Sectional Truncal Muscle Area and Attenuation by CT before and after TIPS at a Median 13.5 Months after TIPS


Summary

This is a retrospective review of a cohort of patients who underwent TIPS at a single institution over a 12 year period. Only patients with native livers who had pre and post CT imaging were included (N=76). The authors then evaluated core abdominal muscles in three regions: psoas, paraspinal, and abdominal wall musculature. Volumes as well as attenuation of these muscle groups were then calculated before and after TIPS. The authors found statistically significant gains in both volume and attenuation of the truncal musculature after TIPS, with maximal increase at approximately 6 months. These volume gains were also found on multivariate analysis to be associated with lower mortality.


Commentary

This retrospective study increases the body of literature regarding the association of core muscle mass with overall survival in cirrhotic patients. In addition, it also supports that TIPS creation may help, either directly or indirectly, allow patients to improve their muscle mass. The limitations of this article are its study design and relatively small number of patients. That said, statistical significant was achieved on multivariate analysis. The study also improves the knowledge regarding the time frame of the muscle gains in patients undergoing TIPS.

Post Author
Daniel P. Sheeran, MD
Assistant Professor
Department of Radiology and Medical Imaging
Division of Vascular and Interventional Radiology
University of Virginia

Monday, August 5, 2019

iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study



Clinical Question
To evaluate the safety and efficacy of the iCAST Covered Stent for the treatment of iliac artery atherosclerotic lesions



Take-away Point
The iCAST balloon-expandable stent was found to be a safe and effective treatment for iliac atherosclerotic lesions with PPR of 96% at 9 months, and clinical improvement in 72.4% at three years. 



Reference
Laird J, Loga M, Zeller T, Naizi K, Foster M, Ansel G, Stone D, Dave R, Popma J, Jaff M, Massaro J. (2019). iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. J Vasc Interv Rad. 30, 822-829. Doi:10.1016/j.jvir.2018.12.707




Study Design 
Single-arm, prospective, multicenter study



Funding Source
Sponsor Atrium Medical Corporation



Setting
24 US cities and 1 German center





Table 4

Subject-Based Secondary Outcomes in Per Protocol Population.


Summary

The iCARUS trial enrolled 165 subjects at 25 different sites, ultimately having 152 subjects with 223 lesions meet inclusion criteria. This included Rutherford class 2-4, stenotic lesions in the common or external iliac arteries <110 mm in length and 5-12 mm in diameter with ≥50 stenosis with concurrent patent profunda or SFA. Baseline ABI of 0.73 ± 0.23 was noted with a total occlusion rate of 17.1%. Primary endpoint was a compositive of the occurrence of death within 30 days, target lesion revascularization (TLR) within 9 months or restenosis of the iliac on US or angio at 9 months. 

264 iCAST stents were implanted with mean percent reduction in stenosis from 69.3 ± 16.7% to 2.5 ± 5.7%. Device success was 98.7% with a 9-month, 2-year and 3-year clinical success rate of 76.6%, 70.8% and 72.4% respectively. There was a 9-month primary patency rate of 96.4%. Two patients had device nonsuccess; one was due to delivery balloon rupture and the other the stent dislodged from the balloon, was removed, and replaced with another stent. 

The iCAST balloon-expandable stent was found to be a safe and effective treatment for iliac atherosclerotic lesions with satisfactory 9-month primary patency and sustained clinical improvement with low TLR up to three years. 


Commentary

While studies funded by device companies must be taken with a grain of salt, the iCARUS data shows promising clinical performance up to three years post intervention. It does not have ultrasound or angiographic imaging past 9 months which somewhat confounds the information as patients could have developed in stent stenosis or occlusion while developing collateral vessels. Of note, the baseline ABI of 0.73 seemed relatively high, perhaps indicating that the patients within the study already had a fair degree of collateralization, which may mask late stenosis of the stent.

Other studies such as the COBEST trial compared the iCAST stent (marketed as Advanta V12 outside of the US) to bare metal stents for TASC C and D lesions and demonstrated superiority in patency and clinical outcomes. The forthcoming DISCOVER trial which randomizes covered and uncovered balloon-expandable stent use in the CIA will should allow direct comparison of the iCAST to uncovered stents, further clarifying its use in clinical management of CIA and EIA stenosis. 


Post Author

Nicole A. Keefe, MD
Fellow Physician, Interventional Radiology
Department of Radiology and Medical Imaging
University of Virginia
@NikkiKeefe