Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry.

PURPOSE: To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). MATERIALS AND METHODS: Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. RESULTS: Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. CONCLUSIONS: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.

Budd-Chiari Syndrome as an Initial Presentation of Non-Promyelocytic Acute Myelogenous Leukemia.

Budd-Chiari syndrome (BCS) is a rare disease characterized by hepatic venous outflow tract obstruction, frequently due to an underlying thrombophilic disorder. Acute myeloid leukemia rarely presents as acute BCS due to hyperfibrinolysis, hyperleukocytosis, nonspecific proteolytic activity, and disseminated intravascular coagulation causing acute hepatic vein thrombosis. In patients presenting with acute BCS with acute liver failure (ALF), a high index of suspicion and exclusion of underlying malignancy is a must, as it is a contraindication for liver transplantation. We report a case of a 19-year-old Caucasian male who presented with acute BCS causing ALF as an initial presentation of acute myelogenous leukemia.

Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry.

OBJECTIVES: The multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients. METHODS: All-comer patients with lower extremity DVT were enrolled, including those with bilateral DVT, those with previously failed DVT treatment, and regardless of symptom duration. The primary effectiveness end point is complete or near-complete (≥75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events through 30 days and clinical outcomes include post-thrombotic syndrome severity, symptoms, pain, and quality of life through 6 months. RESULTS: The median age was 62 years and 40% of patients had contraindications to thrombolytics. A range of thrombus chronicity (33% acute, 35% subacute, 32% chronic) was observed. No patients received thrombolytics and 99.6% were treated in a single session. The median thrombectomy time was 28 minutes. The primary effectiveness end point was achieved in 86% of limbs. Through 30 days, one device-related serious adverse event occurred. At 6 months, 24% of patients had post-thrombotic syndrome. Significant and sustained improvements were observed in all clinical outcomes, including the Revised Venous Clinical Severity Score, the numeric pain rating scale, and the EuroQol Group 5-Dimension Self-Report Questionnaire. CONCLUSIONS: The 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicities demonstrate favorable effectiveness, safety, and sustained clinical improvements.

Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.

A pilot study of ex-vivo MRI-PDFF of donor livers for assessment of steatosis and predicting early graft dysfunction.

BACKGROUND: The utility of ex vivo Magnetic resonance imaging proton density fat fraction (MRI-PDFF) in donor liver fat quantification is unknown. PURPOSE: To evaluate the diagnostic accuracy and utility in predicting early allograft dysfunction (EAD) of ex vivo MRI-PDFF measurement of fat in deceased donor livers using histology as the gold standard. METHODS: We performed Ex vivo, 1.5 Tesla MRI-PDFF on 33 human deceased donor livers before implantation, enroute to the operating room. After the exclusion of 4 images (technical errors), 29 MRI images were evaluable. Histology was evaluable in 27 of 29 patients. EAD was defined as a peak value of aminotransferase >2000 IU/mL during the first week or an INR of ≥1.6 or bilirubin ≥10 mg/dL at day 7. RESULTS: MRI-PDFF values showed a strong positive correlation (Pearson's correlation coefficient) when histology (macro-steatosis) was included (r = 0.78, 95% confidence interval 0.57-0.89, p<0.0001). The correlation appeared much stronger when macro plus micro-steatosis were included (r = 0.87, 95% confidence interval 0.72-0.94, p<0.0001). EAD was noted in 7(25%) subjects. AUC (Area Under the Curve) for macro steatosis (histology) predicted EAD in 73% (95% CI: 48-99), micro plus macro steatosis in 76% (95% CI: 49-100). AUC for PDFF values predicted EAD in 67(35-98). Comparison of the ROC curves in a multivariate model revealed, adding MRI PDFF values to macro steatosis increased the ability of the model in predicting EAD (AUC: 79%, 95% CI: 59-99), and addition of macro plus micro steatosis based on histology predicted EAD even better (AUC: 90%: 79-100, P = 0.054). CONCLUSION: In this pilot study, MRI-PDFF imaging showed potential utility in quantifying hepatic steatosis ex-vivo donor liver evaluation and the ability to predict EAD related to severe allograft steatosis in the recipient.

Case of Spigelian hernia with incarcerated appendix.

Spigelian hernias are uncommon lateral ventral wall hernias with a significant rate of incarceration; these hernias often produce nonspecific clinical signs and symptoms as well as elusive imaging findings. Although there are reported cases of incarcerated appendices within Spigelian hernias, this case specifically illustrates the diagnostic difficulty these hernias present to both surgeons and radiologists. Additionally, we discuss important anatomy, demographics and risk factors, clinical symptoms, imaging pitfalls and recommendations for repair based on a review of literature.

Percutaneous hepatic and renal biopsy procedures: an 18-year analysis of changing utilization, specialty roles, and sites of service.

PURPOSE: To evaluate national trends in percutaneous hepatic and renal biopsy procedures with regard to utilization, specialty group roles, and sites of service. MATERIALS AND METHODS: Service-specific claims data for percutaneous hepatic and renal biopsy procedures were identified using Medicare Physician Supplier Procedure Summary Master Files for the period 1994-2012. Longitudinal national utilization rates were calculated using annual Medicare enrollment data. Procedure volumes by specialty group and site of service were analyzed. RESULTS: Between 1994 and 2012, the number of hepatic and renal biopsies performed on Medicare Part B beneficiaries increased 22% (from 43,478 to 53,055) and 68% (19,508 to 32,762), respectively. Per 100,000 beneficiaries, the utilization of hepatic and renal biopsy increased 19.6% (from 134.6 to 161.0) and 69.3% (from 60.4 to 102.2). Procedures performed by radiologists disproportionately increased 81% (from 25,484 to 46,181) and 236% (from 6,855 to 23,003), respectively. Although utilization in the inpatient setting declined 28.7% (from 68.2 to 48.6 per 100,000) for hepatic biopsies and 9.4% (from 43.1 to 39.1) for renal biopsies, there were larger concurrent increases of 73.9% (from 59.2 to 103.0) and 303.9% (from 15.1 to 61.0) in utilization in the outpatient setting. CONCLUSIONS: Between 1994 and 2012, national utilization of percutaneous hepatic and renal biopsy procedures in the Medicare population increased as services increasingly shifted from the hospital inpatient to outpatient setting. Radiologists are presently and increasingly the dominant providers of both services.

Ischemic bowel: uncommon imaging findings in a case of cocaine enteropathy.

While the clinical findings of cocaine-induced enteropathy from mesenteric ischemia are fairly well understood, there is a paucity of imaging description and detail in the literature that describes these findings. Imaging characteristics of cocaine-induced mesenteric ischemia on CT examination include bowel edema, mucosal enhancement, venous engorgement, mesenteric free fluid, and dilatation of the small bowel lumen. A thorough history, physical examination, and laboratory testing are critical for the diagnosis and prompt surgical intervention may be necessary. We present a case of cocaine-induced mesenteric ischemia in a 49 year old male which resolved within 24 hours of supportive therapy.