Integrative clinical genomics of advanced prostate cancer.

Toward development of a precision medicine framework for metastatic, castration-resistant prostate cancer (mCRPC), we established a multi-institutional clinical sequencing infrastructure to conduct prospective whole-exome and transcriptome sequencing of bone or soft tissue tumor biopsies from a cohort of 150 mCRPC affected individuals. Aberrations of AR, ETS genes, TP53, and PTEN were frequent (40%-60% of cases), with TP53 and AR alterations enriched in mCRPC compared to primary prostate cancer. We identified new genomic alterations in PIK3CA/B, R-spondin, BRAF/RAF1, APC, ß-catenin, and ZBTB16/PLZF. Moreover, aberrations of BRCA2, BRCA1, and ATM were observed at substantially higher frequencies (19.3% overall) compared to those in primary prostate cancers. 89% of affected individuals harbored a clinically actionable aberration, including 62.7% with aberrations in AR, 65% in other cancer-related genes, and 8% with actionable pathogenic germline alterations. This cohort study provides clinically actionable information that could impact treatment decisions for these affected individuals.

Patient Radiation Doses in IR Procedures: The American College of Radiology Dose Index Registry-Fluoroscopy Pilot.

PURPOSE: To update normative data on fluoroscopy dose indices in the United States for the first time since the Radiation Doses in Interventional Radiology study in the late 1990s. MATERIALS AND METHODS: The Dose Index Registry-Fluoroscopy pilot study collected data from March 2018 through December 2019, with 50 fluoroscopes from 10 sites submitting data. Primary radiation dose indices including fluoroscopy time (FT), cumulative air kerma (Ka,r), and kerma area product (PKA) were collected for interventional radiology fluoroscopically guided interventional (FGI) procedures. Clinical facility procedure names were mapped to the American College of Radiology (ACR) common procedure lexicon. Distribution parameters including the 10th, 25th, 50th, 75th, 95th, and 99th percentiles were computed. RESULTS: Dose indices were collected for 70,377 FGI procedures, with 50,501 ultimately eligible for analysis. Distribution parameters are reported for 100 ACR Common IDs. FT in minutes, Ka,r in mGy, and PKA in Gy-cm2 are reported in this study as (n; median) for select ACR Common IDs: inferior vena cava filter insertion (1,726; FT: 2.9; Ka,r: 55.8; PKA: 14.19); inferior vena cava filter removal (464; FT: 5.7; Ka,r: 178.6; PKA: 34.73); nephrostomy placement (2,037; FT: 4.1; Ka,r: 39.2; PKA: 6.61); percutaneous biliary drainage (952; FT: 12.4; Ka,r: 160.5; PKA: 21.32); gastrostomy placement (1,643; FT: 3.2; Ka,r: 29.1; PKA: 7.29); and transjugular intrahepatic portosystemic shunt placement (327; FT: 34.8; Ka,r: 813.0; PKA: 181.47). CONCLUSIONS: The ACR DIR-Fluoro pilot has provided state-of-the-practice statistics for radiation dose indices from IR FGI procedures. These data can be used to prioritize procedures for radiation optimization, as demonstrated in this work.

Patient Radiation Doses in Interventional Radiology Procedures: Comparison of Fluoroscopy Dose Indices between the American College of Radiology Dose Index Registry-Fluoroscopy Pilot and the Radiation Doses in Interventional Radiology Study.

PURPOSE: To compare radiation dose index distributions for fluoroscopically guided interventions in interventional radiology from the American College of Radiology (ACR) Fluoroscopy Dose Index Registry (DIR-Fluoro) pilot to those from the Radiation Doses in Interventional Radiology (RAD-IR) study. MATERIALS AND METHODS: Individual and grouped ACR Common identification numbers (procedure types) from the DIR-Fluoro pilot were matched to procedure types in the RAD-IR study. Fifteen comparisons were made. Distribution parameters, including the 10th, 25th, 50th, 75th, and 95th percentiles, were compared for fluoroscopy time (FT), cumulative air kerma (Ka,r), and kerma area product (PKA). Two derived indices were computed using median dose indices. The procedure-averaged reference air kerma rate (Ka,r¯) was computed as Ka,r / FT. The procedure-averaged x-ray field size at the reference point (Ar) was computed as PKA / (Ka,r × 1,000). RESULTS: The median FT was equally likely to be higher or lower in the DIR-Fluoro pilot as it was in the RAD-IR study, whereas the maximum FT was almost twice as likely to be higher in the DIR-Fluoro pilot than it was in the RAD-IR study. The median Ka,r was lower in the DIR-Fluoro pilot for all procedures, as was median PKA. The maximum Ka,r and PKA were more often higher in the DIR-Fluoro pilot than in the RAD-IR study. Ka,r¯ followed the same pattern as Ka,r, whereas Ar was often greater in DIR-Fluoro. CONCLUSIONS: The median dose indices have decreased since the RAD-IR study. The typical Ka,r rates are lower, a result of the use of lower default dose rates. However, opportunities for quality improvement exist, including renewed focus on tight collimation of the imaging field of view.

Non-Contact Irreversible Electroporation in the Esophagus With a Wet Electrode Approach.

Our objective was to develop a technique for performing irreversible electroporation (IRE) of esophageal tumors while mitigating thermal damage to the healthy lumen wall. We investigated noncontact IRE using a wet electrode approach for tumor ablation in a human esophagus with finite element models for electric field distribution, joule heating, thermal flux, and metabolic heat generation. Simulation results indicated the feasibility of tumor ablation in the esophagus using an catheter mounted electrode immersed in diluted saline. The ablation size was clinically relevant, with substantially lesser thermal damage to the healthy esophageal wall when compared to IRE performed by placing a monopolar electrode directly into the tumor. Additional simulations were used to estimate ablation size and penetration during noncontact wet-electrode IRE (wIRE) in the healthy swine esophagus. A novel catheter electrode was manufactured and wIRE evaluated in seven pigs. wIRE was performed by securing the device in the esophagus and using diluted saline to isolate the electrode from the esophageal wall while providing electric contact. Computed tomography and fluoroscopy were performed post-treatment to document acute lumen patency. Animals were sacrificed within four hours following treatment for histologic analysis of the treated esophagus. The procedure was safely completed in all animals; post-treatment imaging revealed intact esophageal lumen. The ablations were visually distinct on gross pathology, demonstrating full thickness, circumferential regions of cell death (3.52 ± 0.89 mm depth). Acute histologic changes were not evident in nerves or extracellular matrix architecture within the treatment site. Catheter directed noncontact IRE is feasible for performing penetrative ablations in the esophagus while avoiding thermal damage.

MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: a phase 2b, multicentre study.

BACKGROUND: Men with grade group 2 or 3 prostate cancer are often considered ineligible for active surveillance; some patients with grade group 2 prostate cancer who are managed with active surveillance will have early disease progression requiring radical therapy. This study aimed to investigate whether MRI-guided focused ultrasound focal therapy can safely reduce treatment burden for patients with localised grade group 2 or 3 intermediate-risk prostate cancer. METHODS: In this single-arm, multicentre, phase 2b study conducted at eight health-care centres in the USA, we recruited men aged 50 years and older with unilateral, MRI-visible, primary, intermediate-risk, previously untreated prostate adenocarcinoma (prostate-specific antigen ≤20 ng/mL, grade group 2 or 3; tumour classification ≤T2) confirmed on combined biopsy (combining MRI-targeted and systematic biopsies). MRI-guided focused ultrasound energy, sequentially titrated to temperatures sufficient for tissue ablation (about 60-70°C), was delivered to the index lesion and a planned margin of 5 mm or more of normal tissue, using real-time magnetic resonance thermometry for intraoperative monitoring. Co-primary outcomes were oncological outcomes (absence of grade group 2 and higher cancer in the treated area at 6-month and 24-month combined biopsy; when 24-month biopsy data were not available and grade group 2 or higher cancer had occurred in the treated area at 6 months, the 6-month biopsy results were included in the final analysis) and safety (adverse events up to 24 months) in all patients enrolled in the study. This study is registered with ClinicalTrials.gov, NCT01657942, and is no longer recruiting. FINDINGS: Between May 4, 2017, and Dec 21, 2018, we assessed 194 patients for eligibility and treated 101 patients with MRI-guided focused ultrasound. Median age was 63 years (IQR 58-67) and median concentration of prostate-specific antigen was 5·7 ng/mL (IQR 4·2-7·5). Most cancers were grade group 2 (79 [78%] of 101). At 24 months, 78 (88% [95% CI 79-94]) of 89 men had no evidence of grade group 2 or higher prostate cancer in the treated area. No grade 4 or grade 5 treatment-related adverse events were reported, and only one grade 3 adverse event (urinary tract infection) was reported. There were no treatment-related deaths. INTERPRETATION: 24-month biopsy outcomes show that MRI-guided focused ultrasound focal therapy is safe and effectively treats grade group 2 or 3 prostate cancer. These results support focal therapy for select patients and its use in comparative trials to determine if a tissue-preserving approach is effective in delaying or eliminating the need for radical whole-gland treatment in the long term. FUNDING: Insightec and the National Cancer Institute.

Evaluation of an Integrated Spectroscopy and Classification Platform for Point-of-Care Core Needle Biopsy Assessment: Performance Characteristics from Ex Vivo Renal Mass Biopsies.

PURPOSE: To evaluate a transmission optical spectroscopy instrument for rapid ex vivo assessment of core needle cancer biopsies (CNBs) at the point of care. MATERIALS AND METHODS: CNBs from surgically resected renal tumors and nontumor regions were scanned on their sampling trays with a custom spectroscopy instrument. After extracting principal spectral components, machine learning was used to train logistic regression, support vector machines, and random decision forest (RF) classifiers on 80% of randomized and stratified data. The algorithms were evaluated on the remaining 20% of the data set held out during training. Binary classification (tumor/nontumor) was performed based on a decision threshold. Multinomial classification was also performed to differentiate between the subtypes of renal cell carcinoma (RCC) and account for potential confounding effects from fat, blood, and necrotic tissue. Classifiers were compared based on sensitivity, specificity, and positive predictive value (PPV) relative to a histopathologic standard. RESULTS: A total of 545 CNBs from 102 patients were analyzed, yielding 5,583 spectra after outlier exclusion. At the individual spectra level, the best performing algorithm was RF with sensitivities of 96% and 92% and specificities of 90% and 89%, for the binary and multiclass analyses, respectively. At the full CNB level, RF algorithm also showed the highest sensitivity and specificity (93% and 91%, respectively). For RCC subtypes, the highest sensitivity and PPV were attained for clear cell (93.5%) and chromophobe (98.2%) subtypes, respectively. CONCLUSIONS: Ex vivo spectroscopy imaging paired with machine learning can accurately characterize renal mass CNB at the time of tissue acquisition.

A Tale of Two Pulmonary Artery Catheters.

Innovative catheter-based therapies are increasingly being used for the treatment of patients with submassive pulmonary embolism. These patients may be monitored in the intensive care unit following insertion of specialized pulmonary artery catheters. However, the infusion catheters utilized in catheter-based therapies differ greatly from traditional pulmonary artery catheters designed for hemodynamic monitoring. As such, the critical care team will have to be familiar with the monitoring and management of these novel catheters. Important distinctions between the catheters are illustrated using a clinical case report.

A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY).

PURPOSE: Prostate specific membrane antigen-targeted positron emission tomography/computerized tomography has the potential to improve the detection and localization of prostate cancer. OSPREY was a prospective trial designed to determine the diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography for detecting sites of metastatic prostate cancer. MATERIALS AND METHODS: Two patient populations underwent 18F-DCFPyL-positron emission tomography/computerized tomography. Cohort A enrolled men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy. Cohort B enrolled patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Three blinded central readers evaluated the 18F-DCFPyL-positron emission tomography/computerized tomography. Diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography was based on imaging results compared to histopathology. In cohort A, detection of pelvic nodal disease (with specificity and sensitivity as co-primary end points) and of extrapelvic metastases were evaluated. In cohort B, sensitivity and positive predictive value for prostate cancer within biopsied lesions were evaluated. RESULTS: A total of 385 patients were enrolled. In cohort A (252 evaluable patients), 18F-DCFPyL-positron emission tomography/computerized tomography had median specificity of 97.9% (95% CI: 94.5%-99.4%) and median sensitivity of 40.3% (28.1%-52.5%, not meeting prespecified end point) among 3 readers for pelvic nodal involvement; median positive predictive value and negative predictive value were 86.7% (69.7%-95.3%) and 83.2% (78.2%-88.1%), respectively. In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively. CONCLUSIONS: The primary end point for specificity was met while the primary end point for sensitivity was not. The high positive predictive value observed in both cohorts indicates that 18F-DCFPyL-positive lesions are likely to represent disease, supporting the potential utility of 18F-DCFPyL-positron emission tomography/computerized tomography to stage men with high-risk prostate cancer for nodal or distant metastases, and reliably detect sites of disease in men with suspected metastatic prostate cancer.

Defining the Value of Interventional Radiology to Healthcare Stakeholders: Proceedings from a Society of Interventional Radiology Research Consensus Panel.

Interventional radiology (IR) has collectively struggled to articulate and prove its value to several external stakeholders. The goal of this research consensus panel was to provide a summary of the existing knowledge, identify current gaps in knowledge, identify the strengths and weaknesses in existing data, and prioritize research needs related to the value of IR. Panelists were asked to identify the critical relationships/alliances that should be fostered to advance the prioritized research and determine how the Society of Interventional Radiology and the Society of Interventional Radiology Foundation can further support these initiatives. Following presentations and discussions, it was determined that proving and quantifying how IR decreases the length of stay and prevents hospital admissions are the most salient, value-related research topics to pursue for the specialty.

Treatment of Chylous Ascites with Peritoneovenous Shunt (Denver Shunt) following Retroperitoneal Lymph Node Dissection in Patients with Urological Malignancies: Update of Efficacy and Predictors of Complications.

PURPOSE: We investigated the efficacy and analyzed the complication risk factors of peritoneovenous shunt in treating refractory chylous ascites following retroperitoneal lymph node dissection in patients with urological malignancies. MATERIALS AND METHODS: From April 2001 to March 2019 all patients with refractory chylous ascites after retroperitoneal lymph node dissection treated with peritoneovenous shunt were reviewed. Demographic characteristics, technical success, efficacy, patency period and complications were studied. Univariate and multivariate logistic regression analysis was performed to identify predictors of complications. RESULTS: Twenty patients were included in this study. Testicular cancer was the most common malignancy (85%). The mean number of days from surgery to detection of chylous ascites was 21 days (SD 15, range 4 to 65). Ascites permanently resolved after peritoneovenous shunt in 18 patients (90%), leading to shunt removal in 17 patients (85%) between 46 and 481 days (mean 162, SD 141). The mean serum albumin level increased 24% after shunt placement (mean 3.0±0.6 gm/dl before, 3.9±0.8 gm/dl after, p <0.05). The most common complication was occlusion (30%). Relative risk of complications increased significantly when shunt placement was more than 70 days after surgery and in patients with more than 5 paracenteses before peritoneovenous shunt placement (AR 0.71% vs 0.25%, RR 2.9, p <0.048 and AR 0.6% vs 0.125%, RR 4.8, p <0.04, respectively). CONCLUSIONS: Peritoneovenous shunt permanently treated chylous ascites in 90% of patients after retroperitoneal lymph node dissection. Peritoneovenous shunt was removed in 85% of patients. Shunt placement is an effective and safe treatment option for refractory chylous ascites. These patients might benefit from earlier intervention, after 4 to 6 weeks of conservative management as opposed to 2 to 3 months.

What Physicians and Health Organizations Should Know About Mandated Imaging Appropriate Use Criteria.

The Appropriate Use Criteria Program, enacted by the Centers for Medicare & Medicaid Services in response to the Protecting Access to Medicare Act of 2014 (PAMA), aims to reduce inappropriate and unnecessary imaging by mandating use of clinical decision support (CDS) by all providers who order advanced imaging examinations (magnetic resonance imaging; computed tomography; and nuclear medicine studies, including positron emission tomography). Beginning 1 January 2020, documentation of an interaction with a certified CDS system using approved appropriate use criteria will be required on all Medicare claims for advanced imaging in all emergency department patients and outpatients as a prerequisite for payment. The Appropriate Use Criteria Program will initially cover 8 priority clinical areas, including several (such as headache and low back pain) commonly encountered by internal medicine providers. All providers and organizations that order and provide advanced imaging must understand program requirements and their options for compliance strategies. Substantial resources and planning will be needed to comply with PAMA regulations and avoid unintended negative consequences on workflow and payments. However, robust evidence supporting the desired outcome of reducing inappropriate use of advanced imaging is lacking.

Macrophage-secreted TGF-ß1 contributes to fibroblast activation and ureteral stricture after ablation injury.

Iatrogenic injury to the healthy ureter during ureteroscope-guided ablation of malignant or nonmalignant disease can result in ureteral stricture. Transforming growth factor (TGF)-ß1-mediated scar formation is considered to underlie ureteral stricture, but the cellular sources of this cytokine and the sequelae preceding iatrogenic stricture formation are unknown. Using a swine model of ureteral injury with irreversible electroporation (IRE), we evaluated the cellular sources of TGF-ß1 and scar formation at the site of injury and examined in vitro whether the effects of TGF-ß1 could be attenuated by pirfenidone. We observed that proliferation and α-smooth muscle actin expression by fibroblasts were restricted to injured tissue and coincided with proliferation of macrophages. Collagen deposition and scarring of the ureter were associated with increased TGF-ß1 expression in both fibroblasts and macrophages. Using in vitro experiments, we demonstrated that macrophages stimulated by cells that were killed with IRE, but not LPS, secreted TGF-ß1, consistent with a wound healing phenotype. Furthermore, using 3T3 fibroblasts, we demonstrated that stimulation with paracrine TGF-ß1 is necessary and sufficient to promote differentiation of fibroblasts and increase collagen secretion. In vitro, we also showed that treatment with pirfenidone, which modulates TGF-ß1 activity, limits proliferation and TGF-ß1 secretion in macrophages and scar formation-related activity by fibroblasts. In conclusion, we identified wound healing-related macrophages to be an important source of TGF-ß1 in the injured ureter, which may be a paracrine source of TGF-ß1 driving scar formation by fibroblasts, resulting in stricture formation.

Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial.

Purpose To compare the effect of autologous blood patch injection (ABPI) with that of a hydrogel plug on the rate of pneumothorax at CT-guided percutaneous lung biopsy. Materials and Methods In this prospective randomized controlled trial ( https://ClinicalTrials.gov , NCT02224924), a noninferiority design was used for ABPI, with a 10% noninferiority margin when compared with the hydrogel plug, with the primary outcome of pneumothorax rate within 2 hours of biopsy. A type I error rate of 0.05 and 90% power were specified with a target study population of 552 participants (276 in each arm). From October 2014 to February 2017, all potential study participants referred for CT-guided lung biopsy (n = 2052) were assessed for enrollment. Results The data safety monitoring board recommended the trial be closed to accrual after an interim analysis met prespecified criteria for early stopping based on noninferiority. The final study group consisted of 453 participants who were randomly assigned to the ABPI (n = 226) or hydrogel plug (n = 227) arms. Of these, 407 underwent lung biopsy. Pneumothorax rates within 2 hours of biopsy were 21% (42 of 199) and 29% (60 of 208); chest tube rates were 9% (18 of 199) and 13% (27 of 208); and delayed pneumothorax rates within 2 weeks after biopsy were 1.4% (three of 199) and 1.5% (three of 208) in the ABPI and hydrogel plug arms, respectively. Conclusion Autologous blood patch injection is noninferior to a hydrogel plug regarding the rate of pneumothorax after CT-guided percutaneous lung biopsy. © RSNA, 2018 Online supplemental material is available for this article.

Volumetric 3D assessment of ablation zones after thermal ablation of colorectal liver metastases to improve prediction of local tumor progression.

PURPOSE: The goal of this study was to develop and evaluate a volumetric three-dimensional (3D) approach to improve the accuracy of ablation margin assessment following thermal ablation of hepatic tumors. METHODS: The 3D margin assessment technique was developed to generate the new 3D assessment metrics: volumes of insufficient coverage (VICs) measuring volume of tissue at risk post-ablation. VICs were computed for the tumor and tumor plus theoretical 5- and 10-mm margins. The diagnostic accuracy of the 3D assessment to predict 2-year local tumor progression (LTP) was compared to that of manual 2D assessment using retrospective analysis of a patient cohort that has previously been reported as a part of an outcome-centered study. Eighty-six consecutive patients with 108 colorectal cancer liver metastases treated with radiofrequency ablation (2002-2012) were used for evaluation. The 2-year LTP discrimination power was assessed using receiver operating characteristic area under the curve (AUC) analysis. RESULTS: A 3D assessment of margins was successfully completed for 93 out of 108 tumors. The minimum margin size measured using the 3D method had higher discrimination power compared with the 2D method, with an AUC value of 0.893 vs. 0.790 (p = 0.01). The new 5-mm VIC metric had the highest 2-year LTP discrimination power with an AUC value of 0.923 (p = 0.004). CONCLUSIONS: Volumetric semi-automated 3D assessment of the ablation zone in the liver is feasible and can improve accuracy of 2-year LTP prediction following thermal ablation of hepatic tumors. KEY POINTS: • More accurate prediction of local tumor progression risk using volumetric 3D ablation zone assessment can help improve the efficacy of image-guided percutaneous thermal ablation of hepatic tumors. • The accuracy of evaluation of ablation zone margins after thermal ablation of colorectal liver metastases can be improved using a volumetric 3D semi-automated assessment approach and the volume of insufficient coverage assessment metric. • The new 5-mm volume-of-insufficient-coverage metric, indicating the volume of tumor plus 5-mm margin that remained untreated, had the highest 2-year local tumor progression discrimination power.

Imaging of Small Renal Masses before and after Thermal Ablation.

Thermal ablation of small renal masses is increasingly accepted as an alternative to partial nephrectomy, particularly in patients with multiple comorbidities. Many professional societies support this alternate treatment with updated guidelines. Before performing thermal ablation, it is important to stratify risk and assess technical feasibility by evaluating tumor imaging features such as size, location, and centrality. Routine postablation imaging with CT or MRI is necessary for assessment of residual or recurrent tumor, evidence of complications, or new renal masses outside the ablation zone. The normal spectrum and evolution of findings at CT and MRI include a halo appearance of the ablation zone, ablation zone contraction, and ablation zone calcifications. Tumor recurrence frequently manifests at CT or MRI as new nodular enhancement at the periphery of an expanding ablation zone, although it is normal for the ablation zone to enlarge within the first few months. Recognizing early tumor recurrence is important, as small renal masses are often easily treated with repeat ablations. Potential complications of thermal ablation include vascular injury, urine leak, ureteral stricture, nerve injury, and bowel perforation. The risk of these complications may be related to tumor size and location.©RSNA, 2019.

Percutaneous Ablation Versus Partial and Radical Nephrectomy for T1a Renal Cancer: A Population-Based Analysis.

Background: Stage T1a renal cell carcinoma (RCC) (tumors <4 cm) is usually curable. Nephron-sparing partial nephrectomy (PN) has replaced radical nephrectomy (RN) as the standard of care for these tumors. Radical nephrectomy remains the first alternative treatment option, whereas percutaneous ablation (PA), a newer, nonsurgical treatment, is recommended less strongly because of the relative paucity of comparative PA data. Objective: To compare PA, PN, and RN outcomes. Design: Observational cohort analysis using inverse probability of treatment-weighted propensity scores. Setting: Population-based SEER (Surveillance, Epidemiology, and End Results) cancer registry data linked to Medicare claims. Patients: Persons aged 66 years or older who received treatment for T1a RCC between 2006 and 2011. Interventions: PA versus PN and RN. Measurements: RCC-specific and overall survival, 30- and 365-day postintervention complications. Results: 4310 patients were followed for a median of 52 months for overall survival and 42 months for RCC-specific survival. After PA versus PN, the 5-year RCC-specific survival rate was 95% (95% CI, 93% to 98%) versus 98% (CI, 96% to 99%); after PA versus RN, 96% (CI, 94% to 98%) versus 95% (CI, 93% to 96%). After PA versus PN, the 5-year overall survival rate was 77% (CI, 74% to 81%) versus 86% (CI, 84% to 88%); after PA versus RN, 74% (CI, 71% to 78%) versus 75% (CI, 73% to 77%). Cumulative rates of renal insufficiency 31 to 365 days after PA, PN, and RN were 11% (CI, 8% to 14%), 9% (CI, 8% to 10%), and 18% (CI, 17% to 20%), respectively. Rates of nonurologic complications within 30 days after PA, PN, and RN were 6% (CI, 4% to 9%), 29% (CI, 27% to 30%), and 30% (CI, 28% to 32%), respectively. Ten percent of patients in the PN group had intraoperative conversion to RN. Seven percent of patients in the PA group received additional PA within 1 year of treatment. Limitations: Analysis of observational data may have been affected by residual confounding by provider or from selection bias toward younger, healthier patients in the PN group. Findings from this older study population are probably less applicable to younger patients. Use of SEER-Medicare linked files prevented analysis of patients who received treatment after 2011, possibly reducing generalizability to the newest PA, PN, and RN techniques. Conclusion: For well-selected older adults with T1a RCC, PA may result in oncologic outcomes similar to those of RN, but with less long-term renal insufficiency and markedly fewer periprocedural complications. Compared with PN, PA may be associated with slightly shorter RCC-specific survival but fewer periprocedural complications. Primary Funding Source: Association of University Radiologists GE Radiology Research Academic Fellowship and Society of Interventional Radiology Foundation.

Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals: Epidemiology and Recent Trends.

BACKGROUND: Public awareness of inferior vena cava (IVC) filter-related controversies has been elevated by the Food and Drug Administration (FDA) safety communication in 2010. OBJECTIVES: To examine population level trends in IVC filter utilization, complications, retrieval rates, and subsequent pulmonary embolism (PE) risk. DESIGN: A retrospective cohort study. SUBJECTS: Patients receiving IVC filters during 2005-2014 in New York State. MEASURES: IVC filter-specific complications, new PE occurrences and IVC filter retrievals were evaluated as time-to-event data using Kaplan-Meier analysis. Estimated cumulative risks were obtained at various timepoints during follow-up. RESULTS: There were 91,873 patients receiving IVC filters between 2005 and 2014 in New York State included in the study. The average patient age was 67 years and 46.6% were male. Age-adjusted rates of IVC filter placement increased from 48 cases/100,000 in 2005 to 52 cases/100,000 in 2009, and decreased afterwards to 36 cases/100,000 in 2014. The estimated risks of having an IVC filter-related complication and filter retrieval within 1 year was 1.5% [95% confidence interval (CI), 1.4%-1.6%] and 3.5% (95% CI, 3.4%-3.6%). One-year retrieval rate was higher post-2010 when compared with pre-2010 years (hazard ratio, 2.70; 95% CI, 2.50-2.91). Among the 58,176 patients who did not have PE events before or at the time of IVC filter placement, the estimated risk of developing subsequent PE at 1 year was 2.0% (95% CI, 1.9%-2.1%). CONCLUSIONS: Our findings suggest that FDA communications may be effective in modifying statewide clinical practices. Given the 2% observed PE rate following prophylactic IVC filter placement, large scale pragmatic studies are needed to determine contemporary safety and effectiveness of IVC filters.

Transmural ablation of the normal porcine common bile duct with catheter-directed irreversible electroporation is feasible and does not affect duct patency.

BACKGROUND AND AIMS: The aim of this study was to evaluate the feasibility and early safety of catheter-directed irreversible electroporation (IRE) of the normal common bile duct (CBD) in swine. METHODS: IRE (2000 V, 90 pulses, 100 µs pulse) was performed in the CBD of 6 Yorkshire pigs using a catheter electrode under endoscopic guidance. Ductal patency was assessed with immediate retrograde cholangiography and contrast-enhanced CT imaging at 1 or 7 days after treatment. Animals were killed at either 1 day (n = 4, 2 ablations/animal) or 7 days (n = 2, 1 ablation/animal) after treatment. The biliary tract was extracted en bloc and the length of the ablation along the CBD mucosa was measured. The depth of ablation was quantified using cross-sections of the treated CBD wall stained with hematoxylin and eosin. Single-sample hypothesis testing was performed to verify whether the depth of ablation in the CBD was a representative outcome of IRE treatment. RESULTS: IRE of the CBD did not result in perforation or obstruction of the organ at 1 or 7 days after treatment. The length of ablation along the CBD mucosa was 17.27 ± 5.55 mm on day 1 samples, and transmural ablation of the CBD wall was a representative outcome of the treatment (7/8 samples, P < .05). Day 1 samples demonstrated loss of epithelium, transmural necrosis, with preservation of lumen integrity. Day 7 samples demonstrated re-epithelialization, with diffuse transmural fibrosis of the CBD wall. These findings were absent from sham tissue samples. CONCLUSIONS: Intraluminal catheter-directed IRE is feasible and safe for full-thickness ablation of the normal porcine CBD without affecting lumen patency up to 1 week after treatment.