Vascular-Interventional Retrospective Studies
A Retrospective, US Multicenter Data Analysis in Patients Diagnosed with Hepatocellular Carcinoma (HCC) and Treated with a radiopaque (RO) bead (LC Bead LUMITM) (PI: Ari Isaacson)
Purpose: The purpose of this retrospective data analysis is to collate data on the use of LC Bead LUMI™ in routine clinical practice for the treatment of hepatocellular carcinoma (HCC) in 5 sites in the US. Data on safety, effectiveness and procedural information will be collected from participating centers.
Participants: Patients with hepatocellular carcinoma treated with LC Bead LUMI™ between February 1, 2016 and June 30, 2017. No active patient participation is required. A minimum of 100 patients from 5 sites. Patient follow up information from after the procedure will be collected that occurred up until March 20, 2018.
Procedures (methods): To retrospectively collect safety, efficacy, and procedure information related to patients that underwent placement of LC Bead LUMI for HCC.
Cost Benefit Analysis of type 2 Endoleak Repair with Histocryl and Trufill (PI: Ari Isaacson)
Purpose: To describe the UNC experience of prostatic artery embolization (PAE) using the transradial approach (TRA).
Participants: Patients that were treated with Endo Vascular Aneurysm Repair (EVAR) with follow up data from 1/15/2015 to 8/8/2017
Procedures (methods): We would like to do a retrospective analysis comparing Histocryl with lipoidol and Trufill and the outcome in these two patient groups. Coils are used in both these patient groups and wold be a common factor. Outcome is determined by the progression, non-progression or regression of the aneurysm in the follow-up CT scans at 3 months, 6 months and 12 months after the endoleak repair.
Blood Stream Infection Associated with Central Venous Catheters: Comparison Between Tunneled and Non-tunneled Central Venous Catheters (PI: Hyeon Yu)
Purpose: The purpose of this study is to evaluate the incidence of blood stream infection associated with central venous catheters and to compare infection rates between tunneled and non-tunneled central venous catheters. Contributing factors for blood stream infection will be analyzed and prevention methods will be sought.
Participants: Patients who underwent image-guided central venous catheter placement at UNC VIR between January 1, 2014 and January 31, 2017.
Procedures (methods): This is a retrospective study of patients who underwent tunneled or non-tunneled central venous catheter placement at UNC vascular and interventional radiology.
Factors Associated with Technical Difficulty of Prostatic Artery Embolization. (PI: Ari Isaacson)
Purpose: To determine the factors that contribute to the technical difficulty of prostatic artery embolization (PAE).
Participants: A chart review of no more than 300 patients who have undergone PAE by Dr. Ari Isaacson at UNC IR or Dr. Bagla at VIV. During Jan 1st 2010 to Apr 25th 2017
Procedures (methods): Patient charts/imaging will be examined for factors that contribute to the technical difficulty of the procedure. Measured features will be procedure time, contrast volume used, cumulative radiation dose, and radiation dose per area. Patient demographics will also be collected and used during analysis, specifically BMI, length, anatomic schema of prostatic arteries, radial vs femoral arterial access, prostate size, patient age, early vs late cases, and number of cone beam spins performed during the procedure. A multivariate analysis will then be conducted on the data collected to determine which patient/procedural factors contribute most to the difficulty of prostatic artery embolization. All data will be coded.
Image-Guided Percutaneous Drainage of Abscess/Fluid Collection: Evaluation of Safety and Efficacy (PI: Hyeon Yu)
Purpose: This is a single center retrospective study to evaluate the safety and efficacy of image-guided percutaneous drainage tube placement for abscess or fluid collection. The success rate, incidence of complications, indwelling duration of drainage catheters, and the rate of catheter exchange will be evaluated.
Participants: Consecutive patients (expected 1900) with abscess or fluid collection who underwent image-guided placement of a percutaneous drainage catheter during study period.
Procedures (methods): Retrospective study that will review medical records and imaging studies in PACS of consecutive patients with abscess or fluid collection who underwent image-guided placement of a percutaneous drainage catheter during the study period of January 1 2014 through January 31 2017.
Change in Density and Volume of Type II Endoleaks Between Arterial and Delayed Phase Images of Computed Tomography Angiography after Endovascular Abdominal Aortic Aneurysm Repair: As a Predictor for Persistent Endoleak and Aneurysm Sac Enlargement (PI: Hyeon Yu)
Purpose: To evaluate the changes in density and volume of the type II endoleak nidus and their relationship with aneurysm sac change and endoleak embolization in patients treated with EVAR of AAAs.
Participants: Consecutive patients with aortic aneurysm who underwent EVAR and follow-up contrast-enhanced CT Angiography during study period from January 1st, 2009 to June 30, 2016 will be included in this retrospective study.
Procedures (methods): Medical record and imaging study will be evaluated retrospectively using WEBCIS or Epic systems (for medical record) and PACS (for imaging study and interventional procedure information) for analysis of volume and CT density. T test and chi squared test will be used. The primary endpoint will be developing a grading system based on changes in density and volume of type II endoleak nidus between arterial and delayed phase CTA images.
Factors that Influence the Experience of Patients Receiving Implanted Venous Access Ports (Arvilla Johnson)
Purpose: The insertion site for an implanted venous access port (IVAP) should be a factor or consideration for patients. Current practice in VIR places IVAP’s with minimal patient engagement. However, selecting a site without patient input could have negative consequences. Patients may prefer to move or hide the catheters visibility for cosmetic purposes, (i.e. location of port placement may interfere with garments, such as clothes, bra straps, and purses) or for comfort purposes (like sleeping or activities of daily living). Managing these factors may lead to a positive impact on patient’s quality of life and overall feelings. The purpose of this quantitative study is to identify if the insertion site of an IVAP influences patients experience.
Participants: The sample will include 50 participants between the ages of 18-60 who have had an implanted venous access port. Participants will be identified through daily procedure schedules for Interventional Radiology.
Procedures (methods): This quantitative research design will utilize a survey tool along with semi-structured interviews to meet the study goals. The survey will be conducted 30 days post IVAP placement on 50 patients.
Comparison of Efficacy and Cost of Embolic Materials for Translumbar Type 2 Endoleak Repairs Performed with Trufill vs Histocryl n-butyl cyanoacrylate (PI: Ari Isaacson)
Purpose: Retrospective study to compare efficacy and cost effectiveness of type 2 endoleak repairs from a translumbar approach and performed using either Trufill or Histocryl n-BCA.
Participants: Patients with type 2 endoleaks that underwent a translumbar endoleak repair utilizing n-BCA glue of either the Trufill or Histocryl formulations. Retrospective review including patients between January 1, 2007 and October 30, 2018.
Procedures (methods): Patients will be excluded if the endoleak is not type 2, if the procedure was not performed via a translumbar approach, and if n-BCA was not used. We plan to evaluate cost of procedure between the two formulations. Efficacy will be evaluated by noting complications, and presence of absence of continued endoleak, aneurysm enlargement, or rupture with retrospective review of follow-up studies. Additionally, characteristics of the procedure including additional embolic materials used (coils), vessels involved, fluoroscopy time, and other factors will be explored
Comparison of Type 2 Endoleak Embolizations: Translumbar versus Transarterial Approach (PI: Hyeon Yu)
Purpose: To evaluate the effectiveness of type 2 endoleak treatment using the translumbar approach compared with the transarterial approach. To evaluate the effectiveness of type 2 endoleak treatment using the translumbar approach compared with the transarterial approach.
Participants: 200 patients with abdominal aortic aneurysm and endovascular repair of aortic aneurysm (EVAR) who underwent image-guided percutaneous type 2 endoleak embolization at UNC Vascular and Interventional Radiology (VIR) between January 2002 and April 2019.
Procedures (methods): Medical records and imaging studies in PACS will be reviewed for consecutive patients who underwent type 2 endoleak embolization either via the translumbar or transarterial approach at UNC VIR during the study period.
Computational Methods for Estimating Vascular Perfusion (PI: Clayton Commander)
Purpose: To develop computational methods to estimate vascular flow/end-organ perfusion based on diagnostic images.
Participants: Patients who have undergone diagnostic angiography and contrast-enhanced CT or MRI scans at UNC from April 2010 – August 2018
Procedures (methods): Using novel computational techniques, we will attempt to approximate vascular flow and subsequent end organ perfusion by extrapolating data from diagnostic angiograms.
Analyze Data from Prostate Artery Embolization (PAE) Procedure as a Multicenter Study (PI: Ari Isaacson)
Purpose: The purpose of this study is to answering unanswered question regarding the treatment efficacy, durability and the rate of success for repeat of Prostatic artery embolization (PAE) procedure over the past year at UNC.
Participants: 1000 adult male subjects who underwent PAE procedure between January 1st 2013 and February 8th 2020 will be enrolled in this study.
Procedures (methods): Collecting data to compare the efficacy of the two FDA-approved embolic particles, Embospheres microspheres and Nonspherical Polyvinol alcohol (nsPVA) particles, during PAE. In addition, the durability of the procedure (rate at which patients develop recurring symptoms) and the rate of success for repeat PAE needs to be investigated. The data gathered through the registry would also help answer how ischemic changes seen after PAE affect low grade indwelling prostatic cancers.
Vascular Malformation Mimicking Lesions on Radiological Imaging (PI: Hortensia Alvarez)
Purpose: To investigate vascular malformation mimicking lesions on radiological imaging. The diagnosis of vascular malformation is based on history, physical examination, and radiological imaging. Radiological imaging plays an essential role in the management of vascular malformations, such as diagnosis, evaluation of the lesion’s extent and therapeutic planning. Sometimes, biopsy is necessary to exclude tumorous condition or other non-vascular malformation lesions.
Participants: Up to 50 patients who had radiological imaging and biopsy for the diagnosis of vascular malformation from January 1, 2013 to February 28, 2018.
Procedures (methods): This is a retrospective review of patients who underwent radiological imaging and biopsy for the diagnosis of vascular malformation at UNC. We will review the data such as patient demographics, final diagnosis, treatment, and follow-up. The age of the patients will be pediatric and adult population.
Comparison of Medicare Reimbursement for Prostatic Artery Embolization and Transurethral Resection of the Prostate in the Treatment of Benign Prostatic Hyperplasia (PI: Rachel Brader)
Purpose: Prostatic artery embolization (PAE) was recently approved by the FDA for treatment of benign prostatic hyperplasia (BPH). Research shows it is a cost-effective therapy for BPH when compared to transurethral resection of the prostate (TURP), though there is no information on insurance reimbursement for the procedure. The purpose of this study is to compare Medicare reimbursement rates for PAE vs TURP from 2015-2018.
Participants: Men 65 and older with Medicare who have been treated with PAE, TURP, simple prostatectomy, or Holmium Laser Enucleation for BPH.
Procedures (methods): We will conduct a retrospective review of 80 patients looking at Medicare reimbursement for PAE and TURP using hospital billing data from UNC Hospitals from January 1, 2015 to August 21, 2018.
Clinical Outcomes Following IVC Filter Placement and Retrieval (PI: Clayton Commander)
Purpose: To assess the clinical outcomes of patients who have undergone IVC filter placement and retrieval at UNC from August 2008 – August 2018.
Participants: Patients who have undergone IVC filter placement and retrieval at UNC from August 2008 August 2018
Procedures (methods): Retrospective review of patients treated at UNC from August 2008 – August 2018
Retrospective Evaluation of Lung Shunt Fractions in Patients with Hepatic Neuroendocrine Metastases (PI: Ari Isaacson)
Purpose: The purpose of this study is to review the LSFs of all NET patients who have undergone TARE at UNC and to determine how many were above the maximum limit for treatment (20%). Additionally, characteristics of the tumors will be evaluated for any relationship with increased LSF.
Participants: NET patients who have undergone TARE at UNC. Data will be collected from procedures between 1/1/2005 and 9/15/2018 from a maximum of 50 patients.
Procedures (methods): To retrospectively collect data to determine how many were above the maximum limit for treatment (20%) and to evaluate characteristics of the tumors for any relationship with increased LSF.
Embolization Treatment for the Patients with Upper GI Bleeding (PI: Kyung Kim)
Purpose: The purpose of the study is to investigate clinical results of embolization treatment for the treatment of upper GI bleeding in UNC in a large series for the last 15 years.
Participants: Patients who underwent arteriogram/embolization for the treatment of upper GI bleeding confirmed by endoscopy or physical exam seen at UNC between January 1, 2000 and December 31, 2015
Procedures (methods): We will retrospectively review patient charts to investigate clinical results of embolization treatment.
Bronchial Artery Embolization for the Treatment of Hemoptysis: Angiographic Findings and Factors Related to Survival (PI: Kyung Kim)
Purpose: The aim of this study is to report angiographic findings and factors related to survival.
Participants: Patients with massive hemoptysis treated with bronchial artery embolization seen at UNC between January 1, 2005 and March 1, 2016.
Procedures (methods): We will retrospectively review patient charts for patients with massive hemoptysis treated with bronchial artery embolization to report angiographic findings and factors related to survival.
Interventional Management of Enterocutaneous Fistula: Evaluation of Safety and Efficacy (PI: Hyeon Yu)
Purpose: The purpose of the study is to retrospectively evaluate the safety and efficacy of interventional management options in patients with persistent enterocutaneous fistulas. Factors associated with recurrence of enterocutaneous fistula will also be determined.
Participants: 50 Consecutive patients with enterocutaneous fistulas who underwent fluoroscopic-guided embolization of the fistula tract using either collagen plug, nBCA glue, or both from 2014 January – 2018 July
Procedures (methods):This is a retrospective study.We will review medical records and imaging studies in PACS to evaluate the safety and efficacy of interventional management options in patients with persistent enterocutaneous fistulas.
Evaluation of Adrenal Vein Sampling: Single Center Experience (PI: Hyeon Yu)
Purpose: The purpose of the study is to retrospectively review the data of adrenal vein sampling performed in vascular and interventional radiology at UNC to evaluate technical success rate and safety of the procedure. For technically unsuccessful procedures and repeated adrenal vein sampling, factors contributing to technical failure will be determined.
Participants: 200 Consecutive patients with primary aldosteronism who underwent fluoroscopic-guided adrenal vein sampling between January 2001 -July 2018.
Procedures (methods):This is a retrospective study.We will review medical records in Epic and imaging studies in PACS to evaluate the safety and efficacy of adrenal vein sampling in patients with primary aldosteronism.
Long-term Follow-up after Renal Artery Embolization for the Treatment of Renal Angiomyolipoma (PI: Hyeon Yu)
Purpose: Selective arterial embolization of renal angiomyolipoma with ethanol mixed with iodized oil (Ethiodol), as well as, with polyvinyl alcohol (PVA) particles are accepted methods of treatment. However, there is debate about which method provide the best outcomes and reduces risk of recurrence. In this retrospective study we intend to compare the difference in initial treatment response, as well as, differences in long term follow-up of patients treated with Ethiodol versus PVA particles.
Participants: 100 patients with renal angiomyolipoma underwent renal artery embolization
Procedures (methods): Retrospective review of patients treated at UNC from January 1, 2007 to August 17, 2017.
Splenic Artery Embolization for the Treatment of Gastric Variceal Bleeding Secondary to Splenic Vein Thrombosis (PI: Hyeon Yu)
Purpose: The purpose of this study is to assess the viability of splenic artery embolization for the treatment of gastric variceal bleeding secondary to splenic vein thrombosis.
Participants: 100 patients with gastric variceal bleeding secondary to splenic vein thrombosis
Procedures (methods): Retrospective review of patients treated at UNC from January 1, 2007 to September 13, 2017.
Outcomes of Proximal versus Distal Splenic Artery Embolization (PI: Hyeon Yu)
Purpose: The purpose of this study is to assess outcomes of splenic artery embolization with respect to proximal versus distal embolization technique for both nontraumatic and traumatic indications.
Participants: 200 patients seen at UNC between January 1, 2007 and September 13, 2017 for splenic artery embolization.
Procedures (methods): This is a retrospective review of patients treated at UNC. We will conduct a comparative analysis of outcomes data between proximal and distal splenic artery embolization technique will be stressed. An emphasis will be placed on data such as: patient demographics, indications for splenic artery embolization (including trauma/non-trauma, pre-embolization pertinent imaging, and grading schema for traumatic injuries), site of embolization, types of embolic agents, complications (re-bleeding, splenic infarcts, infections), subsequent interventions (nominal medical therapies, percutaneous interventions, repeat embolization, surgical interventions), post-embolization pertinent imaging, and necessity of utilization of vaccinations against encapsulated bacteria.