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Abstract Background Prolonged dwelling time of inferior vena cava (IVC) filters has been shown to increase the need for the use of complex IVC filter retrieval techniques. In this report, we describe a case of complex retrieval of an IVC filter with prolonged dwelling time, which was temporarily accompanied by severe bradycardia and hypotension. Case presentation Fifty-nine-year-old male patient past medical history of morbid obesity, atrial fibrillation status post-ablation, obstructive sleep apnea, and end-stage renal disease presented for IVC filter retrieval 16 years after placement. When the IVC filter was covered by sheaths, and the IVC was temporarily collapsed and occluded, the patient developed severe bradycardia and hypotension without compensatory tachycardia. Contrast injection through the common femoral vein sheath showed complete occlusion of IVC while the IVC filter was covered by both sheaths, likely due to the embedment of the IVC filter in the wall by extensive fibrinous tissues. IVC filter was successfully retrieved, and the blood pressure and heart rate were improved immediately afterward. A large non-occlusive IVC thrombus was identified on the final venogram, which was aspirated using a mechanical thrombectomy device. Conclusion Complex retrieval of IVC filters with prolonged dwelled time can result in acute severe bradycardia and hypotension due to vasovagal reaction, acute collapse, and occlusion of IVC in the setting of IVC filter embedment in the wall by extensive fibrinous tissues.

Endovascular coil erosion into the biliary system after hepatic artery embolization is a rare complication which may result in inflammation, strictures, choledocholithiasis, biliary colic, and cholangitis. Removal of coils may result in cessation of these symptoms, but is challenging in patients who cannot undergo removal via standard endoscopic approaches. This case report describes the retrieval of coils placed across a hepatic artery pseudoaneurysm, which over several years eroded into the biliary tree, resulting in calculi formation and post-prandial pain. Using combined fluoroscopy and cholangioscopy via percutaneous transhepatic accesses, the calculi were fragmented and the coils were retrieved, resulting in cessation of symptoms.

Abstract Background:The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical devices. Objectives:The purpose of our study was to (1) quantify characteristics of pivotal clinical trials (PCTs) supporting the premarket approval of endovascular medical devices and (2) analyze trends over the last two decades in light of the FDASIA. Methods:We surveyed the study designs of endovascular devices with PCTs from the US FDA pre-market approval medical devices database. The effect of FDASIA on key design parameters (e.g., randomization, masking, and number of enrolled patients) was estimated using an interrupted time series analysis (segmented regression). Results:We identified 117 devices between 2000–2018. FDASIA was associated with a decrease in double blinding (p < 0.0001) and a decrease in historical comparators (p < 0.0001). Discussion:Our results reveal an overall trend of decreased regulatory requirements as it relates to clinical trial characteristics, but a compensatory increased rate of post-approval across device classes. Furthermore, there was an emphasis on proving equivalence or non-inferiority rather than more use of active comparators in clinical trials. Medical device stakeholders, notably clinicians, must be aware of the shifting regulatory landscape in order to play an active role in promoting patient safety.

Purpose. This study aims to identify clinical and imaging prognosticators associated with the successful bridging or downstaging to liver transplantation (LT) in patients undergoing Yttrium-90 radioembolization (Y90-RE) for hepatocellular carcinoma (HCC). Methods. Retrospectively, patients with Y90-RE naïve HCC who were candidates or potential candidates for LT and underwent Y90-RE were included. Patients were then divided into favorable (maintained or achieved Milan criteria (MC) eligibility) or unfavorable (lost eligibility or unchanged MC ineligibility) cohorts based on changes to their MC eligibility after Y90-RE. Penalized logistic regression analysis was performed to identify the significant baseline prognosticators. Results. Between 2013 and 2018, 135 patients underwent Y90-RE treatment. Among the 59 (42%) patients within MC, LT eligibility was maintained in 49 (83%) and lost in 10 (17%) patients. Within the 76 (56%) patients outside MC, eligibility was achieved in 32 (42%) and unchanged in 44 (58%). Among the 81 (60%) patients with a favorable response, 16 (20%) went on to receive LT. Analysis of the baseline characteristics revealed that lower Albumin-Bilirubin score, lower Child–Pugh class, lower Barcelona Clinic Liver Cancer stage, HCC diagnosis using dynamic contrast-enhanced imaging on CT or MRI, normal/higher albumin levels, decreased severity of tumor burden, left lobe HCC disease, and absence of HBV-associated cirrhosis, baseline abdominal pain, or fatigue were all associated with a higher likelihood of bridging or downstaging to LT eligibility (p’s

Abstract Background The purpose was to validate 90Y PET gradient-based tumor segmentation in phantoms and to evaluate the impact of the segmentation method on reported tumor absorbed dose (AD) and biological effective dose (BED) in 90Y microsphere radioembolization (RE) patients. A semi-automated gradient-based method was applied to phantoms and patient tumors on the 90Y PET with the initial bounding volume for gradient detection determined from a registered diagnostic CT or MR; this PET-based segmentation (PS) was compared with radiologist-defined morphologic segmentation (MS) on CT or MRI. AD and BED volume histogram metrics (D90, D70, mean) were calculated using both segmentations and concordance/correlations were investigated. Spatial concordance was assessed using Dice similarity coefficient (DSC) and mean distance to agreement (MDA). PS was repeated to assess intra-observer variability. Results In phantoms, PS demonstrated high accuracy in lesion volumes (within 15%), AD metrics (within 11%), high spatial concordance relative to morphologic segmentation (DSC > 0.86 and MDA 0.99, MDA

PURPOSE:We aimed to report approach, safety, technical success, and clinical outcomes of prone trans- radial access (PTRA) and demonstrate feasibility for procedures requiring simultaneous arterial intervention and prone percutaneous access. METHODS:Fifteen patients underwent PTRA, seven females (47%) and eight males (53%), mean age of 55 years (range, 19–78 years). All patients underwent PTRA for combined transarterial and posterior-approach percutaneous interventions. Variables included sheath size (French, F), type of anesthesia, arterial intervention technical success, posterior-approach percutaneous intervention technical success, estimated blood loss (mL), fluoroscopy and procedure time, complications, and follow-up.RESULTS:Mean sheath size was 4 F (range, 4–6 F; SD = 0.5). Arterial interventions included transarterial embolization of renal (n=6), hepatic (n=2), and pelvic vessels (n=2), diagnostic arteriography (n=4), and embolization of an arteriovenous malformation (n=1). Posterior-approach intervention technical success was 100% (15/15). PTRA technical success was 100% (15/15). Posterior-approach percutaneous interventions included retroperitoneal (n=5) and pelvic (n=1) mass biopsies, nephrostomy tube placement (n=2), cryoablation of pelvic (n=2) and renal (n=1) masses, sclerotherapy of arteriovenous malformations (n=2), foreign body removal from the renal collecting system (n=2), ablation of a renal tumor (n=1), intracavitary injection of pulmonary mycetoma (n=1), and ablation and cementoplasty of a vertebral body tumor (n=1). The biopsies were diagnostic (6/6). There were no minor or major access-site complications.CONCLUSION:PTRA is a safe and feasible method for performing combined arterial and posterior approach percutaneous interventions without the need for repositioning.

Percutaneous image-guided ablation is performed throughout many areas of the body for various pathologies including hepatic malignancies. Heat and cold-based ablative technologies are effective and well-tolerated with an acceptable safety profile. However, ablative therapies may be technically more challenging and cause collateral thermal injury if the targeted lesion is adjacent to critical organs. Previously, techniques including artificial ascites and pneumoperitoneum have been utilized to displace or insulate critical structures from the ablation zone. This technical innovation describes (10–30 mL) fibrillar collagen dissolved in fluid as a focal thermal insulation technique. Small volume fibrillar collagen instillation, and thermal ablation were technically successful in three cases without complication. Clinical follow-up and 3-month imaging confirmed complete ablation of all hepatic malignancies without collateral injury.

N-butyl cyanoacrylate glue is well established as a transcatheter or direct injection embolic agent. Herein, targeted glue embolization was performed by direct needle injection into peripheral portal branches and along the surface of the liver to directly treat actively extravasating portal venous injury. In both cases, hemodynamically unstable patients underwent exploratory laparotomy, which was not able to definitively treat the hemorrhage. Subsequently, emergent visceral angiography and indirect portography revealed active portal phase extravasation. Transhepatic direct needle injection of the peripheral portal active extravasation with glue was successful in both cases and the patients stabilized, demonstrating this as an efficacious salvage approach.

Ablative treatment methods have emerged as safe and effective therapies for patients with primary and secondary liver tumors who are not surgical candidates at the time of diagnosis. This article reviews the current literature and describes the techniques, complications and results for radiofrequency ablation, microwave ablation, cryoablation, and irreversible electroporation.