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.

Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device.

PURPOSE: To report initial experience with safety and efficacy in the treatment of pulmonary embolism (PE) using the FlowTriever device. MATERIALS AND METHODS: A single-center retrospective study was performed in all patients with acute central PE treated using the FlowTriever device between March 2018 and March 2019. A total of 46 patients were identified (massive = 8; submassive = 38), all with right ventricular (RV) strain and 26% with thrombolytic contraindications. Technical success (according to SIR reporting guidelines) and clinical success (defined as mean pulmonary artery pressure intraprocedural improvement) are reported, as are major device and procedure-related complications within 30 days after discharge. RESULTS: Technical success was achieved in 100% of cases (n = 46). Average mean pulmonary artery pressure improved significantly from before to after the procedure for the total population (33.9 ± 8.9 mm Hg before, 27.0 ± 9.0 mm Hg after; P < .0001; 95% confidence interval [CI], 5.0-8.8), submassive cohort (34.7 ± 9.1 mm Hg before, 27.4 ± 9.2 mm Hg after; P < .0001; 95% CI, 5.2-9.5) and massive cohort (30.4 ± 6.9 mm Hg before, 25.4 ± 8.2 mm Hg after; P < .05; 95% CI:0.4-9.6). Intraprocedural reduction in mean pulmonary artery pressure was achieved in 88% (n = 37 of 42). A total of 100% of patients (n = 46 of 46) survived to hospital discharge. In total, 71% of patients (n = 27 of 38) experienced intraprocedural reduction in supplemental oxygen requirements. Two major adverse events (4.6%) included hemoptysis requiring intubation, and procedure-related blood loss requiring transfusion. No delayed procedure-related complications or deaths occurred within 30 days of hospital discharge. CONCLUSIONS: Initial clinical experience using the FlowTriever to perform mechanical thrombectomy showed encouraging trends with respect to safety and efficacy for the treatment of acute central, massive, and submassive pulmonary embolism.

Ethylene-vinyl alcohol copolymer endobiliary obliteration of hepatic segments in a patient with isolated bile leaks.

A 54-year-old woman with a symptomatic giant hepatic hemangioma underwent an extended left hepatic trisegmentectomy complicated by 250-350 mL/d postoperative bilious drainage. After 5 months of therapy, drainage was unabated, and the patient was no longer a surgical candidate. Sinography revealed three distinct isolated bile duct leaks involving segments 6, 7, and 8. Endobiliary segmentectomy was achieved by obliterating the isolated systems with ethylene-vinyl alcohol copolymer (Onyx; ev3, Plymouth, Minnesota) during three fluoroscopic procedures. Bilious leaks were successfully eliminated, and compensatory hypertrophy of noninvolved liver occurred. At 2 years from the last embolization procedure, the patient remained asymptomatic with no bilious leak.

Carpal tunnel syndrome and cubital tunnel syndrome: work-related musculoskeletal disorders in four symptomatic radiologists.

OBJECTIVE: This report describes work-related upper extremity musculoskeletal disorders in four radiologists and identifies risk factors and preventive measures for these syndromes. SUBJECTS AND METHODS: Four radiologists with complaints of upper extremity pain, numbness, and weakness or a combination of symptoms were examined by an occupational therapist. The work activities and duties of all 12 staff radiologists in our filmless department were subsequently evaluated. Time working as staff, workday hours, and academic activities were recorded. Nonoccupational activities were also noted. An industrial hygienist evaluated the department work areas and staff offices. RESULTS: One radiologist had bilateral carpal tunnel syndrome, and all four radiologists had cubital tunnel syndrome (two [50%] unilateral, two [50%] bilateral). The four spent 3.4 +/- 0.3 years (mean +/- standard error of the mean) as staff radiologists in our filmless department, performing computer keyboard and mouse or trackball image manipulation and work list navigation, typing preliminary reports and telephone notifications, and editing electronically and approving dictated final reports. All four are academically active and had significantly greater workday hours (p < 0.05) and performed more research (p < 0.003) than the asymptomatic radiologists. Three (75%) of four radiologists routinely performed sonography. The industrial hygienist identified hazardous working conditions, especially related to ergonomics, in the reviewing areas and staff offices. CONCLUSION: Current technology renders staff radiologists at risk for work-related, upper extremity musculoskeletal disorders, including carpal and cubital tunnel syndromes. Proper equipment, ergonomics, and professional consultation should be used in all radiology departments.

Digital radiography for the field: a portable prototype.

The US military has been investigating methods for improving radiographic support for field medical operations. The purpose of this project was to develop and test a portable digital radiography (DR) system to determine its feasibility for field operations. A prototype portable digital radiography device was designed and assembled using a commercially available DR sensor. The sensor and necessary hardware were mounted into a ruggedized aluminum case. The device underwent testing in the hospital and field environments. The prototype rapidly provided digital radiographs in a variety of settings. Shortcomings of the device affecting usability and reliable operation were identified. The successful construction and operation of a portable digital radiography prototype shows that such a device is feasible for field applications. The prototype requires further modification and testing to improve its usability and reliability, and to explore other potential applications, both military and civilian.