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Monday, April 8, 2019

Proton Pump Inhibitor Use Is Associated with an Increased Frequency of New or Worsening Hepatic Encephalopathy after Transjugular Intrahepatic Portosystemic Shunt Creation


Clinical question
Does proton pump inhibitor (PPI) use increase the rate of new or worsening hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS) creation?

Take-away point
PPI usage is associated with new or worsening HE after TIPS.

Reference
Lewis, Douglas S., et al. Proton Pump Inhibitor Use is Associated with an Increased Frequency of New or Worsening Hepatic Encephalopathy after Transjugular Intrahepatic Portosystemic Shunt Creation. Journal of Vascular and Interventional Radiology. February, 2019. Volume 30, Issue 2, 163-169.

Click here for abstract

Study design: Retrospective

Funding source: Self-funded or unfunded

Setting: Single institution

Summary


HE after TIPS remains a common and challenging problem and can result in significant quality of life issues for patients’ refractory to medical therapy.

This retrospective review identified 284 patients who had undergone TIPS over a 1 year period, with a median follow-up time of 479 days. PPI types and dosage, in addition to dates of use were noted through review of the electronic medical record. Dates of new or worsening HE after TIPS were also identified. Mixed-effects negative binomial regression was used to test for an association between PPI usage and HE. The authors reported that, among the 284 patients analyzed in this study, there were 375 episodes of new or worsening HE, for an average of 1.32 episodes per person. Among 168 patients on PPIs chronically, there were 235 episodes of new or worsening HE in 106,101 person-days (0.81 episodes per person-year), 55 patients who were never on PPIs had 37 episodes (0.43/person-year), 61 patients intermittently on PPIs had 78 episodes (0.75/person-year), and 16 patients who never took PPIs had 25 episodes (0.26/person-year). Uni- and multivariate regression were performed. PPI usage was associated with a 3.34-fold increase in the rate of new or worsening HE and increasing age, higher MELD score, and history of HE or HE-preventative medication therapy before TIPS were also associated with increased HE after TIPS.




Commentary


This study showed that PPI usage was associated with a statistically significant increase in the rate of new or worsening HE after TIPS. This is an extremely important finding given how common HE is after TIPS and how debilitating HE can be for patients and their families. Of note, the rate of TIPS coarctation or embolization was not significantly different between those patients who were on PPIs and those who were not. However, we know HE significantly affects quality of life and can be difficult to manage medically. The authors cited a number of reasons the patients they studied were prescribed PPIs, including varices, GE reflux, ulcer disease, etc. Surprisingly, almost 40% of patients had no documented indication for PPI use. Recognizing that PPIs can increase the risk of new or worsening HE in post-TIPS patients should prompt us to carefully consider what medications our patients are taking and to discontinue nonessential PPI therapy.

Post Author:
Zagum Bhatti, MD
Assistant Professor
Department of Radiology, Interventional Radiology Division
University of Texas Health Science Center at Houston, Houston, TX
@ZagumBhatti

Friday, April 5, 2019

Use of Drug-Coated Balloons in Dysfunctional Arteriovenous Dialysis Access Treatment: The Effect of Consecutive Treatments on Lesion Patency


Clinical question
What is the outcome in arteriovenous (AV) access circuits that undergo repeat drug-coated balloon (DCB) angioplasty?

Take-away point
In this retrospective study of AV circuits undergoing consecutive DCB, there was no significant difference in the postintervention primary patency (PIPP).

Reference
Park, Joong-Won, et al. Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial. Journal of Hepatology. December, 2018. In Press.

Click here for abstract

Study design: Retrospective Longitudinal Analysis

Funding source: None identified.

Setting: University hospital setting - Greece.

Summary 


This is a retrospective longitudinal study evaluating the recurrent use of DCB in dysfunctional AV circuits. The authors evaluated 165 patients undergoing 257 procedures. From this cohort, the authors then selected the 38 patients who had a single lesion treated at minimum 2 times with a DCB. They then evaluated from this study population the postintervention primary patency (PIPP), with the goal to evaluate noninferiority of the second (repeat) intervention. 22/38 patients underwent two treatments with DCB, the remaining ranging from 3-6 treatments. The most common treatment site was cephalic vein. The authors concluded the use of repetitive DCB was safe from an AV access circuit standpoint and that recurrent use was noninferior to the first use with regard to PIPP. The authors did note that there was a significant increase in PIPP in patients undergoing a total of two interventions, favoring the second intervention (N= 22 for this population).


Commentary


This is a retrospective study with a relatively small number of patients that evaluates the use of repeat DCB in dysfunctional AV circuits. The authors noted that repeat use of DCB on the same lesion did not result in inferior primary patency rates. They did note a significant trend towards increased postintervention primary patency in patients who required a total of two interventions over the study period. This study suggests that consecutive DCB is safe with regard to the patency of the access circuit. However, given the recent literature surrounding overall risk regarding the use of DCB, it is unclear to me the impact on clinical practice change this article will have.

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

Friday, March 15, 2019

Safety and durability of infrarenal aorta as distal landing zone in fenestrated or branched endograft repair for thoracoabdominal aneurysm 


Clinical Question:
Does using the infrarenal aorta as a distal landing zone, instead of iliac arteries, for fenestrated or branched endovascular aortic repair (FB-EVAR) decrease the rate of spinal cord and mesenteric ischemia?

Take-away Point:
Termination of an aortic endograft in the infrarenal aorta for fenestrated and branched EVAR is technically feasible with similar rates of paraplegia and mesenteric ischemia however more data is needed to evaluate for future type 1B endoleaks due to aortic degeneration.

Reference:
Law Y, Kölbel T, Rohlffs F, Behrendt C, Heidemann F, Debus ES, Tsilmparis N. (2018). A Safety and durability of infrarenal aorta as distal landing zone in fenestrated or branched endograft repair for thracoabdominal aneurysm. J Vasc Surg, 69(2), 334-341. doi:10.1016/j.jvs.2018.04.052

Click here for abstract

Study Design: Retrospective single-center cohort study

Funding Source: Self-funded

Setting: Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center of Hamburg, Germany

Summary


Conventional knowledge and manufacturer recommendation supports use of the iliac arteries as the distal landing zone for fenestrated and branched endovascular aneurysm repair (FB-EVAR) however there is no data in the literature to support iliac over distal aorta landing zone. This study retrospectively evaluated 40 patients who received FB-EVAR with the native infrarenal aorta as the distal landing zone. Grafts included the Zenith custom-made, Zenith T-branch and surgeon-modified endografts. Criteria for use of the infrarenal aorta included ≥2 cm of healthy infrarenal aorta, preferably free of thrombus, dissection and calcification. The distal stent graft was oversized by 15-30% diameter; in the event of a severe size mismatch of the distal stent graft modules a Giant Palmaz stent was placed to correct infolding and strengthen the connection.

No immediate or delayed type 1B endoleaks (range 0-72 months) were identified on surveillance CTA. Spinal cord ischemia occurred in 15% of patients (5 temporary and 1 permanent) and zero incidence of mesenteric ischemia, both of which are comparable to literature with iliac distal landing zones. 30-day mortality was 7.5% (sepsis, pneumonia, and multiorgan failure following laparotomy for GDA bleed). Post-operative CTA showed that 92.5% had at least 1 lumbar artery preserved and 74.2% had the IMA preserved. Of note, there was gradual degeneration of the infrarenal aorta at the stent graft landing zone, likely attributable to the aorta expanding to the size of the stent graft from the outward radial force. 


Figure 4. Denervation of infrarenal aorta and iliac arteries over time. The averaged nominal diameter of stent grafts was indicated. The error bars indicate the 95% confidence interval (CI).

Commentary


Termination of the stent graft in the infrarenal aorta for FB-EVAR is technically feasible with similar paraplegia and mesenteric ischemia rates to current reported literature on iliac landing zones. While the rates of paraplegia and mesenteric ischemia reported by the authors are comparable, they question whether their rates may be higher due to a high proportion of emergent cases. Preserving the IMA and lumbar arteries intuitively would minimize this risk. Degeneration of the infrarenal aorta at the site of the stent graft however appears problematic for younger patients as they will likely need distal extension for future type 1B endoleaks. Infrarenal aortic landing zone seems best suited for those patients at highest risk for paraplegia (long total coverage area, prior repair, etc) and mesenteric ischemia. Further work is needed however with comparison studies and longer term follow-up to determine the viability of this treatment option.

Post Author:
Nicole A. Keefe, MD
Resident Physician
Department of Radiology and Medical Imaging
University of Virginia
@NikkiKeefe

Thursday, March 14, 2019

Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial 


Clinical question
Is it more efficient and cost effective to maintain arteriovenous graft hemodialysis access circuits after rescue with percutaneous transluminal angioplasty with or without concurrent Viabahn stent grafts over 24 months?

Take-away point
Over 24 months, the use of stent grafts significantly reduced the number of reinterventions for all patients and reduced overall treatment costs for patients presenting with thrombosis.

Study design:
Prospective Randomized Control Study

Funding source:
W. L. Gore & Associates Inc. (Flagstaff, Arizona).

Setting:
Multicenter trial

Citation: 
Mohr, Belinda A. et al. Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial. Journal of Vascular and Interventional Radiology , Volume 30 , Issue 2 , 203 - 211.e4


Summary


Arteriovenous grafts (AVGs) are an important option for patients on hemodialysis. Unfortunately, AVGs are susceptible to complications that can lead to reinterventions, increased costs and ultimately graft failure/abandonment. The conventional approach for failing grafts related to venous anastomotic stenoses has been percutaneous transluminal angioplasty (PTA). Recently stent grafts (SGs) have emerged as a promising supplemental approach to revising dysfunctional or thrombosed AVGs. In this study, inclusion criteria were patients with an AVG > 30 days old that was dysfunctional or thrombosed with a primary lesion having >50% stenosis and < 30 mm from the venous anastomosis. Patients were split into four groups with either dysfunctional/stenotic or thrombosed grafts and were treated with PTA alone or PTA with SG.

Overall, patients in the SG arm required significantly fewer total reinterventions compared to the patients in the PTA arm and the mean time to reintervention with SG vs PTA was 203 to 108 days. Specifically, patients with thrombosed AVGs treated with SG required 40% less reinterventions of any kind compared to those treated with PTA alone. Patients with graft dysfunction/stenosis initially treated with SG resulted in 16% less reinterventions compared to PTA, which was not statistically significant. Reintervention with PTA was reduced by 44% in patients presenting with thrombosed circuits who were treated with SG (statistically significant). Dysfunctional grafts had reduced PTA reintervention by 17% when the index procedure was augmented with SG (not statistically significant). Thrombosed grafts at presentation resulted in significantly more interventions overall, particularly more thrombectomy/thrombolysis procedures. SG placement in thrombosed grafts reduced future thrombectomy/thrombolysis by 36%.

When randomized by treatment, SG costs were 4% lower than initial PTA alone at 24 months although this was not statistically significant. However, when randomized by presentation, treatment of thrombosed grafts with SG reduced costs by 18% compared to PTA at 24 months. There was no significant cost difference between the two treatment groups with purely stenotic AVGs.



Figure 1
Stent graft placement significantly reduced total reinterventions over 24 months. Subgroup presentation show that reinterventions were significantly reduced at 24 months when thrombosed grafts were treated with stent grafts. Stent graft also decreased reinterventions in dysfunctional grafts, though not significantly. Cost was only statistically significantly reduced when stent grafts were used to treat thrombosed grafts.

Commentary


Maintaining patent vascular access in ESRD patients is an obstacle that has proven to be fraught with difficulties and frustration for both patients and providers. These challenges inevitably translate into multiple vascular interventions and increased healthcare costs. The REVISE trial has demonstrated that AVGs treated with angioplasty and SG placement can reduce subsequent reinterventions and cost over 24 months, most significant in thrombosed circuits. Given that there are an estimated 457,957 ESRD patients on hemodialysis, consistently reducing reintervention would dramatically decrease the overall healthcare cost. The trial calculated that SG placement could reduce cost by $6,877 for each patient with a thrombosed AVG over two years. This would result in millions of dollars saved if even a small portion of the total ESRD population were treated with SG. Cost savings were contingent upon AVG survival to 2 years as initial upfront costs were expectedly higher with SG placement. This trial specifically looked at AVGs, and there is a larger prevalence of patients who receive dialysis via arteriovenous fistulas (AVFs). A similarly structured trial focused on AVFs and central stenoses could further evaluate initial intervention options and the subsequent effect on reinterventions and cost with AVFs. This could potentially lead to findings that would have larger cost savings to the system.

Post Author:
Bradley Unruh, MD PGY-3
Department of Radiology
Wake Forest Baptist Medical Center
@WakeForest_IR


Wednesday, March 13, 2019

Early-Recurrent Overt Hepatic Encephalopathy Is Associated with Reduced Survival in Cirrhotic Patients after Transjugular Intrahepatic Portosystemic Shunt Creation 


Clinical question: How well does the presence of overt hepatic encephalopathy (OHE) occurring within 3 months of a transjugular intrahepatic portosystemic shunt (TIPS) placement predict survival?

Take-away point: Early recurrence of OHE was related to poorer long-term survival for cirrhotic patients who underwent the TIPS procedure.

Reference: Zuo L, Lv Y, Wang Q, et al. Early-Recurrent Overt Hepatic Encephalopathy Is Associated with Reduced Survival in Cirrhotic Patients after Transjugular Intrahepatic Portosystemic Shunt Creation. J Vasc Interv Radiol. 2019 Feb;30(2):148-153.e2. doi: 10.1016/j.jvir.2018.08.023. Epub 2019 Jan 9. PubMed PMID: 30638778.

Click here for abstract

Study design: Retrospective cohort study

Funding sources: Self-funded/NA

Setting: Single institution

Summary

Hepatic encephalopathy (HE) has been shown to have a major impact on survival in patients with decompensated cirrhosis, however the effect of HE following TIPS placement on survival has not been clearly delineated. 304 patients who underwent TIPS placement for variceal hemorrhage or refractory ascites were retrospectively analyzed for the development of OHE within 3 months of TIPS placement, as defined by grade 2-4 HE according to the West Haven Criteria. Multivariate, time-dependent models were applied to assess the impact of early OHE, early-single OHE, and early recurrent OHE. The cumulative rate of OHE occurring within 3 months of TIPS was 27.6% (n=84) with a total of 149 episodes of OHE occurring within this population. Early-recurrent OHE (64.9%) was associated with a statistically significant higher rate of mortality than those without early-recurrent OHE (20.6%) (HR = 4.31; 95% CI: 2.64–7.06; P < .001). In the multivariate analysis, early-recurrent OHE (HR = 2.81; 95% CI: 1.67–4.73; P < .001), MELD score (HR = 1.16; 95% CI: 1.06–1.26; P = .001), age (HR = 1.04; 95% CI: 1.02–1.06; P < .001), and ascites (HR = 1.91; 95% CI: 1.04–3.53, P =.037) were associated independently with survival. Landmark and propensity score analysis confirmed that early-recurrent OHE remained a significant predictor of survival.



Figure 1
(a) Cumulative probability of OHE and survival in 304 cirrhotic patients with TIPS. (b) Cumulative probability of secondary OHE in 304 cirrhotic patients with TIPS. (c) Cumulative probability of survival in 304 patients with cirrhosis undergoing TIPS.





Figure 2
(a) Probability of survival in patients with and without early OHE. (b) Probability of survival in patients with and without early-single OHE. (c) Probability of survival in patients with and without early-recurrent OHE.

Commentary


This study provides valuable insight into a patient’s prognosis following the development of HE after TIPS. Previous research has debated the association between HE and mortality following TIPS, however the results of the present study further supports the conclusion that HE following TIPS is associated with increased mortality. The large sample size coupled with rigorous statistical analyses bolsters the results of this study. Patient’s that develop recurrent OHE within 3 months of TIPS have significantly poorer survival than those with only one occurrence of OHE. Given that 44% of patients who had a first OHE episode after a TIPS would experience recurrent OHE within 3 months, intense surveillance and therapy should be pursued during this time period. It should be noted that a majority of the patients in this study developed cirrhosis secondary to Hepatitis B (84%), so the results may not be completely generalizable to patients with other chronic liver disease.

Post Author:
Jacob Bundy, MD, MPH
PGY-1
Department of Surgery
University of Michigan Health System
@JBundyRad

Friday, March 8, 2019

Polyethylene Glycol Epirubicin-Loaded Transcatheter Arterial Chemoembolization Procedures Utilizing a Combined Approach with 100 and 200 µm Microspheres: A Promising Alternative to Current Standards


Clinical question
How effective and safe is transarterial chemoembolization using 100 µm and 200 µm epirubicin-loaded polyethylene glycol using combined microsphere sizing strategy for hepatocellular carcinoma?

Take-away point
Staged embolization with 100 µm embolic followed by 200 µm embolic with epirubicin was technically feasible and demonstrated excellent imaging response compared to commonly sited data within the literature suggesting an advantage to sequential administration during embolization.

Reference
Lucatelli, Pierleone, et al. Polyethylene Glycol Epirubicin-Loaded Transcatheter Arterial Chemoembolization Procedures Utilizing a Combined Approach with 100 and 200 µm Microspheres: A Promising Alternative to Current Standards. Journal of Vascular and Interventional Radiology. 2019

Click here for abstract

Study design: Prospective

Funding source: Self-funded or unfunded

Setting: Single-center 

Summary


Drug eluting embolic (DEE) transarterial chemoembolization (TACE) is a well-established procedure for the treatment of hepatocellular carcinoma. However, there is no consensus protocol for embolic sizing with a wide range employed throughout the literature. The authors hypothesized that a combination of particle calibers, 100 µm and 200 µm, could combine tumoral blood stasis and proximal embolization. In this single center, prospective trial, a combined embolization protocol using LifePearl (Terumo, Tokyo, Japan) 100 µm and 200 µm particles loaded with epirubicin was evaluated for clinical outcomes in patients with hepatocellular carcinoma. 

36 patients with 54 hepatocellular carcinoma tumors were enrolled. DEE TACE was performed with epirubicin, first with 100 µm particles followed by 200 µm particles with embolization endpoint of 10 heart beats stasis. Study primary endpoints were tumoral response at follow up intervals, tumoral diameter and administered dose correlated with mRECIST response, and toxicity. By mRECIST criteria, complete response at 1 month, 3-6 months, 9-12 months and 15-18 months was 61.1% 65.9%, 63.6%, and 62.5%. Disease control rate was 100%, 92.7%, 90.0%, and 93.7% (1, 3-6, 9-12, and 15-18 month follow up). Notably, 47.6% of tumors < 2 cm reached 10 beats stasis with 100 µm particles alone, while only 18.5% of all tumors required only 100 µm particles. Among all treatments, only 3 adverse events occurred, all mild (grade 2) which resolved within 24 hours.



Commentary


There is a significant amount of heterogeneity among the protocols used within the literature for TACE procedure. The complete response rate and disease control rates demonstrated in this study were superior to much of the current TACE literature. With multiple factors being involved, such as drug of choice (epirubicin versus doxorubicin), embolic of choice (LifePearl a polyethylene glycol particle versus numerous other beads and conventional TACE), and embolization protocol (sequential usage of two sizes), it is difficult to determine which or which combination are responsible for the results. The authors did include pathologic data demonstrating the smaller particles were predominantly found intratumorally which the larger particles were seen in the peritumoral arterioles, suggesting the two sizes could serve different purposes during treatment combing enhanced intra-tumoral dose delivery with effective proximal ischemic embolization. While mainly limited do to the small sample size of 36 patients, this does provide evidence that we can optimize our embolization protocols. While further research is necessary, large randomized control trials would be difficult and unlikely to parse out the optimal medication, particle size(s), and bead for TACE.

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



Wednesday, March 6, 2019

Endovascular treatment of TransAtlantic Inter-Society Consensus II D femoropopliteal lesions in patients with critical limb ischemia


Clinical question
Is endovascular treatment technically feasible and effective in treating TASC II D femoropopliteal lesions in patients with critical limb ischemia?

Take-away point
Endovascular treatment of TASC II D femoropopliteal lesions is feasible and with good results. The primary patency in patients with popliteal artery occlusions involving the trifurcation vessels was better but the need for stent in this subgroup was associated with a low rate of limb salvage.

Reference
Biagioni RB, Brandão GD, Biagioni LC, Nasser F, Burihan MC, Ingrund JC. Endovascular treatment of TransAtlantic Inter-Society Consensus II D femoropopliteal lesions in patients with critical limb ischemia. J Vasc Surg. 2019 Jan 2. pii: S0741-5214(18)32245-6. doi: 10.1016/j.jvs.2018.08.176. [Epub ahead of print] PubMed PMID: 30611581.

Click here for abstract

Study design: Retrospective

Funding source: Self-funded or unfunded

Setting: Single center

Summary


Researches from Brazil published their results on endovascular approach to treat TASC II D lesions involving the femoropopliteal segment. The primary objective was to evaluate limb salvage and primary patency. A total of 91 patients were included (91 procedures). All patients had critical limb ischemia and were considered poor surgical candidates. The mean length of occlusions was 27.2 cm +/- 7.6 cm. Plain balloon angioplasty was performed in all patients and stenting in 61 patients. Limb salvage at 30 days, 1 year, 2 years, 3 years, and 4 years was 95.2%, 82.2%, 76.9%, 71.8%, and 63.7%, respectively. Primary patency at 30 days, 1 year, 2 years, and 3 years was 91%, 60.1%, 55.7%, and 50.6%, respectively. Unsuccessful recanalization occurred in 4 patients (4.3%). Reintervention rate was 11.1%. Complications occurred in seven patients (7.7%), including acute thrombosis, perforation and slow-flow phenomenon. All successfully resolved after appropriate management. Sub-analysis demonstrated significant higher 60-day primary patency in patients with popliteal/infra-popliteal lesions compared to SFA lesions (standard error, <10%; log-rank, P = .039). Nevertheless, when stents were used in the popliteal/infra-popliteal segment the rate of major limb loss was significantly higher(log-rank, P = .033). The authors concluded that endovascular treatment of TASC II D femoropopliteal lesions is feasible and with good results. The primary patency in patients with popliteal artery occlusions involving the trifurcation vessels was better compared to the isolated SFA lesions, but the need for stent in the popliteal group was associated with a low rate of limb salvage.



Fig 1. A, Initial angiogram. A 20-cm occlusion from the middle superficial femoral artery (SFA) to the P2 popliteal segment. B, Arteriography after 5- 100-mm balloon inflation. Limiting flow dissection of the SFA. C, Nitinol 6- 200-mm stent. D, Completion angiogram. E, Diagnostic angiogram. F, After dilation. Note the limiting flow dissection at P3 popliteal segment. G, Spotting stent with a nitinol 4- 8-mm stent. H, Completion angiogram.

Commentary


This paper presents the results of a retrospective analysis of 91 patients with critical limb ischemia submitted to endovascular treatment of TASC II D lesions involving the femoropopliteal segment. These types of lesions are better suited to surgical repair according to the most recent TransAtlantic Inter-Society Consensus. However, ideal surgical candidates would present with acceptable overall state of health and an appropriate autologous bypass. Therefore, endovascular treatment is the only option for many patients with this condition. The study shows that this approach has high successful recanalization rate (95.7%) and acceptable low complication rate (7.7%). Overall limb salvage, which is the critical clinical outcome in this patient population was comparable to surgical repair. In addition, sub-analysis demonstrated that primary patency in patients with popliteal artery occlusions involving the trifurcation vessels was better compared to isolated SFA lesions, but the need for stent in the popliteal group was associated with low rate of limb salvage. Limitations of the study included the selection bias (only non-surgical candidates) and the utilization of conventional angioplasty balloons and stents instead of drug-coating balloons and drug-eluting stents. However, clinical results were still comparable to surgical repair reinforcing that even complex lesions are suitable for endovascular recanalization which will eventually become the first therapeutic option for all patients.

Post Author:
Ricardo Yamada, MD
Assistant Professor
Department of Radiology
Division of Vascular and Interventional Radiology
Medical University of South Carolina