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.

Catheter-directed therapies for pulmonary embolism: considerations for patients with patent foramen ovale.

Pulmonary embolism can be fatal, especially in high-risk patients who have contraindications to systemic thrombolysis or surgical embolectomy. For this population, interventionalists can provide catheter-directed therapies, including catheter-directed thrombolysis and thrombectomy, using a wide array of devices. Endovascular treatment of pulmonary embolism shows great promise through fractionated thrombolytic drug delivery, fragmentation, and aspiration mechanisms with thrombectomy devices. Although successful outcomes have been reported after using these treatments, evidence is especially limited in patients with both a patent foramen ovale (PFO) and acute pulmonary embolism. In patients with PFO, it is important to consider whether catheter-directed therapy is appropriate or whether surgical embolectomy should instead be performed. An increased risk of paradoxical embolus in these patients supports the use of diagnostic echocardiography with possible surgical closure of PFO after one episode of pulmonary embolism. Percutaneous PFO closure, which can be performed at the time of catheter-based therapy, theoretically reduces risk of future paradoxical embolization, although more data are needed before making a recommendation for this specific group of patients.

Selective Trans-Catheter Coil Embolization of Cystic Duct Stump in Post-Cholecystectomy Bile Leak.

BACKGROUND: Percutaneous drainage is a first-line treatment for bilomas developed post-cholecystectomy in the setting of bile leak from the cystic duct stump. Percutaneous drainage is usually followed by surgical or endoscopic treatment to address the leak. AIMS: This study aimed to evaluate outcome of selective coil embolization of the cystic duct stump via the percutaneously placed drainage catheters in patients with post-cholecystectomy bile leak. METHODS: Seven patients with persistent bile leak after laparoscopic cholecystectomy who underwent percutaneous catheter placement for biloma/abscess formation in the region of the gallbladder fossa were followed. These patients underwent selective trans-catheter cystic duct stump coil embolization from Feb 2013 to Feb 2019. Procedural management, complications, and success rates were analyzed. RESULTS: All patients underwent placement of a percutaneous catheter for drainage of biloma formation in the gallbladder fossa post-cholecystectomy. Selective coil embolization of the cystic duct was performed through the existing percutaneous tract on average 3.5 weeks after percutaneous catheter placement, resulting in resolution of the biloma. All bile leaks were immediately closed. None of the patients showed recurrent bile leak or further clinical symptoms. Coil migration to the common bile duct was diagnosed in a single case, after 2.5 years, with no bile leak reported. CONCLUSIONS: Selective trans-catheter coil embolization of the cystic stump is a feasible and safe procedure, which successfully seals leaking cystic duct stumps and can circumvent the need for repeat surgical or endoscopic intervention in selected patient populations.

Pulmonary artery pseudoaneurysm causing massive hemoptysis in hyperimmunoglobulin E syndrome: a case report.

BACKGROUND: Hyperimmunoglobulin E syndrome (HIES) is a rare primary immunodeficiency disorder defined by high serum immunoglobulin E titers that is associated with recurrent respiratory infections, formation of pneumoatoceles, recurrent skin abscesses, and characteristic dental and skeletal abnormalities. CASE PRESENTATION: We report a case of a 56-year-old male with a history of HIES, cavitary mycetomas, and allergic bronchopulmonary aspergillosis who presented with recurrent massive hemoptysis. Bronchial artery angiography and bronchoscopy failed to identify active hemorrhage, and two embolizations of the bronchial artery did not resolve the bleeding. Subsequently, selective pulmonary artery angiography was conducted that demonstrated a subsegmental pulmonary artery branch pseudoaneurysm with extravasation into an adjacent lung cavity. This was treated successfully with transcatheter embolization. CONCLUSIONS: To our knowledge, this is the first case reported of pulmonary artery pseudoaneurysm in HIES in the medical literature. Pulmonary artery pseudoaneurysm should be considered in the differential diagnosis in patients with HIES and massive hemoptysis.

Image-Guided Transvesicular Drainage of Pelvic Fluid Collections: A Safe and Effective Alternative Approach.

To evaluate the safety and efficacy of percutaneous transvesicular drainage of pathologic pelvic fluid collections, a series of 15 patients who underwent 16 transvesicular drainage catheter placements was retrospectively reviewed. All patients had collections suspicious for infection that were posterior to the bladder or superior to the bladder behind loops of bowel, and were otherwise inaccessible. All 15 collections were percutaneously accessed via the bladder with standard drainage catheters. All collections resolved completely with no complications. Percutaneous transvesicular drainage was a safe and effective technique in this series, and can be considered when no direct percutaneous access routes are available.

Consider the perspectives: interventional radiology.

Image-guided percutaneous local and regional modalities are major treatments for hepatocellular carcinoma. Patients having better liver function and performance are usually eligible and can gain significant survival benefit, especially with more limited tumor burden. The most common local therapies are ethanol and radiofrequency ablation, with the latter providing better local tumor control and survival. Radiofrequency ablation has also occasionally been found to be equivalent to surgical resection for appropriate tumors, with additionally lower morbidity. Chemoembolization is the prevalent transarterial therapy and has been shown to increase survival compared with conservative management. Chemoembolization using drug-eluting beads and radioembolization with ß-emitting yttrium-90 microspheres seems to reduce side effects and expand the pool of eligible patients, whereas controversy remains regarding the role of bland particle embolization. Combinations of local and regional therapies may be appropriate for treating a particular tumor or different tumors over time and they may be combined with surgical and medical options.

Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism.

BACKGROUND: Evidence supporting interventional pulmonary embolism (PE) treatment is needed. AIMS: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. METHODS: FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement. RESULTS: Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m2 mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001).  Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.

Catheter-directed embolectomy for massive pulmonary embolism in a pediatric patient.

Pulmonary embolisms can affect 0.9 in 100,000 children and carry high risk for mortality. However, management of pediatric pulmonary embolism is largely derived from adult studies and treatment often includes local or systemic thrombolytics or anticoagulation, which may pose unique bleeding risks in children and adolescents compared with adults. This report describes a case in which catheter-directed embolectomy was used to successfully manage a pediatric patient with high-risk/massive pulmonary embolism. This case suggests that catheter-directed embolectomy is an effective therapy in patients outside the adult population and more research is required to expand inclusion criteria for current catheter-directed embolectomy treatment paradigms. Moreover, this case emphasizes the need for dedicated pediatric pulmonary embolism response teams to best serve the pediatric population.

The effect of chronic viral hepatitis on prognostic value of inflammatory biomarkers in hepatocellular carcinoma.

BACKGROUND: Inflammation and the immune system significantly impact the development, progression, and treatment response of hepatocellular carcinoma (HCC). This retrospective study investigated the neutrophil-to-lymphocyte ratio (NLR) as a prognostic biomarker in Western patients with HCC in the setting of chronic viral hepatitis. METHODS: Patients diagnosed with HCC from 2005 to 2016 were selected from a tertiary care institution. NLR was calculated within 30 days prior to treatment and dichotomized at the median. Kaplan-Meier overall survival (OS) curves and Cox hazard proportional models were utilized. Tumor and liver reserve parameters were included in multivariable analyses (MVA). RESULTS: A total of 581 patients met inclusion criteria (median age 61.0 yr; 78.3% male; 66.3% Caucasian) with median OS = 34.9 mo. 371 patients (63.9%) had viral hepatitis, of which 350 had hepatitis C (94.3%). The low-NLR group (

Thermal ablation alone vs thermal ablation combined with transarterial chemoembolization for patients with small (<3 cm) hepatocellular carcinoma.

PURPOSE: Thermal ablation (TA) and transarterial chemoembolization (TACE) may be used alone or in combination (TACE+TA) for the treatment of hepatocellular carcinoma (HCC). The aim of our study was to compare the time to tumor progression (TTP) and overall survival (OS) for patients who received TA alone or TACE+TA for HCC tumors under 3 cm. MATERIALS AND METHODS: This HIPAA-compliant IRB-approved retrospective analysis included 85 therapy-naïve patients from 2010 to 2018 (63 males, 22 females, mean age 62.4 ± 8.5 years) who underwent either TA alone (n = 64) or TA in combination with drug-eluting beads (DEB)-TACE (n = 18) or Lipiodol-TACE (n = 3) for locoregional therapy of early stage HCC with maximum tumor diameter under 3 cm. Kaplan-Meier analysis was performed using the log-rank test to assess TTP and OS. RESULTS: All TA and TACE+TA treatments included were technically successful. TTP was 23.0 months in the TA group and 22.0 months in the TACE+TA group. There was no statistically significant difference in TTP (p = 0.64). Median OS was 69.7 months in the TA group and 64.6 months in the TACE+TA group. There was no statistically significant difference in OS (p = 0.14). The treatment cohorts had differences in AFP levels (p = 0.03) and BCLC stage (p = 0.047). Complication rates between patient groups were similar (p = 0.61). CONCLUSION: For patients with HCC under 3 cm, TA alone and TACE+TA have similar outcomes in terms of TTP and OS, suggesting that TACE+TA may not be needed for these tumors unless warranted by tumor location or other technical consideration.

Subaortic Membranes in Patients With Hereditary Hemorrhagic Telangiectasia and Liver Vascular Malformations.

Background Patients with hereditary hemorrhagic telangiectasia have liver vascular malformations that can cause high-output cardiac failure (HOCF). Known sequelae include pulmonary hypertension, tricuspid regurgitation, and atrial fibrillation. Methods and Results The objectives of this study were to describe the clinical, echocardiographic, and hemodynamic characteristics and prognosis of hereditary hemorrhagic telangiectasia patients with HOCF who were found to have a subaortic membrane (SAoM). A retrospective observational analysis comparing patients with and without SAoM was performed. Among a cohort of patients with HOCF, 9 were found to have a SAoM in the left ventricular outflow tract by echocardiography (all female, mean age 64.8±4.0 years). The SAoM was discrete and located in the left ventricular outflow tract 1.1±0.1 cm below the aortic annular plane. It caused turbulent flow, mild obstruction (peak velocity 2.8±0.2 m/s, peak gradient 32±4 mm Hg), and no more than mild aortic insufficiency. Patients with SAoM (n=9) had higher cardiac output (12.1±1.3 versus 9.3±0.7 L/min, P=0.04) and mean pulmonary artery pressures (36±3 versus 28±2 mm Hg, P=0.03) compared with those without SAoM (n=19) during right heart catheterization. Genetic analysis revealed activin receptor-like kinase 1 mutations in each of the 8 patients with SAoM who had available test results. The presence of a SAoM was associated with a trend towards higher 5-year mortality during follow-up. Conclusions SAoM with mild obstruction occurs in patients with hereditary hemorrhagic telangiectasia and HOCF. SAoM was associated with features of more advanced HOCF and poor outcomes.

Comparison of four embolic materials at uterine artery embolization by using postprocedural MR imaging enhancement.

PURPOSE: To test the hypothesis that not all embolic materials are equivalent by using postprocedural magnetic resonance (MR) imaging enhancement of uterine fibroids in patients treated with uterine artery embolization (UAE). MATERIALS AND METHODS: Approval and a waiver of consent from the institutional human investigations committee was received for this study. The study was HIPAA compliant. A total of 84 women who underwent 6-month MR imaging follow-up constituted this retrospective study. Within this group, 25 women were treated with Contour polyvinyl alcohol (PVA) particles, 23 were treated with Contour SE particles, 19 were treated with Embosphere microspheres, and 17 were treated with Bead Block microspheres. Pre- and postprocedural MR imaging results were analyzed for the total number of fibroids present in the uterus of each patient and for the percentage of individual fibroid enhancement. Enhancement of individual fibroids was measured with quartile intervals. Greater than 25% residual enhancement of a fibroid after embolization was considered an incomplete infarction. The overall percentage change in enhancement was calculated for each patient. Bivariate analysis by using generalized linear modeling and one-way analysis of variance was used to assess differences in infarction with different embolic materials. RESULTS: Among patients treated with Contour and Embosphere, there was a mean reduction in enhancement by 76.60% and 83.07%, respectively, compared with a mean reduction of 52.53% and 49.78% in patients treated with Bead Block and Contour SE, respectively. There was a significant difference in postembolization enhancement between Bead Block and Embosphere, Bead Block and Contour, Contour SE and Embosphere, and Contour SE and Contour. CONCLUSION: Patients treated with Bead Block or Contour SE demonstrated a reduced degree of infarction at follow-up MR imaging compared with patients treated with Contour or Embosphere.

Clinical outcome of the Tal Palindrome chronic hemodialysis catheter: single institution experience.

PURPOSE: To report the authors' clinical experience with the Tal Palindrome chronic dialysis catheter with a symmetric tip. MATERIALS AND METHODS: During a 39-month period, 126 Palindrome catheters were placed consecutively in 85 patients. Follow-up was available for 115 catheters. Insertion complications, patency, catheter-related bacteremia, exit site infections, and reasons for catheter removal were recorded. The patient's initial cause of end-stage renal disease, underlying diseases, and site of access were recorded as well. RESULTS: Patient ranged in age from 35 to 91 years (median, 69 years). Fifty percent of patients had diabetes. One hundred twenty-six Palindrome catheters were placed for a total of 12,046 catheter-days. The technical success rate of catheter placement was 100%. The average catheter indwell time was 105 days (range, 1-673 days). Catheters were inserted via the right (n = 107) or left (n = 19) jugular vein in all patients without insertional complication. Catheter-related infections occurred in 16 of the 115 catheters (13.9%) during the study period and culture-proved bacteremia occurred in four (3.5%). Seven exit site infections were recorded, and 10 catheters (8.7%) developed fibrin sheaths that necessitated catheter exchanges. CONCLUSIONS: Clinical experience with the Tal Palindrome hemodialysis catheter demonstrated safe and reliable use with low infection rates.

Catheter-Based Therapies for Pulmonary Emboli.

More aggressive therapy for acute pulmonary embolism beyond anticoagulation is indicated in patients at higher risk for mortality and morbidity, namely those suffering from massive and possibly submassive disease. Catheter-based thrombolysis, catheter-based mechanical thrombus debulking, or combinations of these offer opportunities for rapid clot reduction and clinical improvement with a lower bleeding risk than systemic thrombolysis and perhaps greater efficacy. Optimal low-dose regimens for direct thrombolysis have not been defined just as optimal techniques and devices for mechanical therapy have not been developed, underscoring the need for further work.

The role of ultrasound in the diagnosis and treatment of chronic venous insufficiency.

Chronic venous insufficiency (CVI) is an exceedingly common and underdiagnosed disorder with a wide range of symptoms and prognosis ranging from cosmetic issues to skin ulceration with tissue loss. Ultrasound plays a pivotal role in the diagnosis, classification, and guidance of percutaneous treatment of CVI. It is therefore of critical importance to the practicing radiologist to have a sound understanding of the pathophysiology, pertinent venous anatomy, and classification of CVI. We review the superficial and deep venous anatomy of the lower extremity, introduce a pattern recognition approach for mapping of varicosities, and review the protocol for ultrasound evaluation for CVI. In addition, we discuss the pathophysiology of CVI and the role of ultrasound in guidance for and follow-up of percutaneous treatment.

Management of malignant pleural effusions.

Malignant pleural effusions (MPEs) are commonly seen as complications of advanced malignancy, especially in lung cancer and breast cancer. The management will depend on the performance status of the patient, severity of the symptoms, and the primary tumor's response to systemic therapy. Thoracentesis is usually the first step for both diagnostic and therapeutic reasons. Chest tube placement with sclerotherapy is successful in 60 to 90% of cases, but it requires hospitalization for ~1 week. Alternatively, long-term tunneled pleural drainage catheters can be performed on an outpatient basis and are effective in controlling symptoms in 80 to 100% of patients. Additional advantages are the ability to treat trapped lung, large loculated effusions, and bilateral effusions simultaneously, as well as lower charges. Spontaneous pleurodesis can occur in up to 50% of the patients. Tunneled catheters should be considered in all patients with MPE and particularly those who have a reasonable expectancy of being outpatient.

Initial experience with 3% sodium tetradecyl sulfate foam and fibered coils for management of adolescent varicocele.

PURPOSE: To report the results of treatment of adolescent patients with varicocele with use of 3% sodium tetradecyl sulfate foam (STS) in combination with pushable fibered coils. MATERIALS AND METHODS: From September 2004 to September 2006, 16 adolescent patients (age 12-19 y) with symptomatic varicocele, testicular atrophy, or surgical recurrence underwent embolization with STS foam and coils. The left internal spermatic vein (ISV) was coaxially catheterized from the right femoral vein. Three percent STS foam was placed distally in the ISV during compression so minimal foam entered the pampiniform plexus. A second nest of coils was placed in the ISV at a position over the sacroiliac (SI) joint that occluded most of the parallel collateral vessels. Coils were not placed above the SI joint in most instances. Additional foam was injected in the ISV at the upper level of the SI joint. The upper ISV was left unoccluded. Our standard follow-up consisting of ultrasound and/or physical examination after varicocele occlusion was performed 2-12 months after the procedure. RESULTS: All occlusions were technically successful, and 15 of 16 patients (94%) exhibited proven disappearance of the varicocele. All patients were asymptomatic except one who had pain despite disappearance of the varicocele. One patient with a bleeding disorder had 48 hours of scrotal discomfort as a result of pampiniform phlebitis caused by the deliberate passage of foam into the pampiniform plexus. CONCLUSIONS: The use of 3% STS foam in combination with pushable fibered coils is a safe and effective sclerosing procedure for adolescent subjects with varicocele.

Clinical and anatomic outcomes after embolotherapy of pulmonary arteriovenous malformations.

PURPOSE: To assess long-term clinical and imaging results of technically successful pulmonary arteriovenous malformation (AVM) embolization. MATERIALS AND METHODS: One hundred fifty-five patients with pulmonary AVMs underwent embolization during a period of 3 years. Recommended follow-up included clinical assessment, helical computed tomography, and physiologic evaluation within 1 year and then every 5 years. RESULTS: Hereditary hemorrhagic telangiectasia was present in 148 patients (95%). Four hundred fifteen pulmonary AVMs were occluded during 205 procedures. Clinical follow-up was available in all patients over 3-7 years and imaging follow-up was available in 144 patients (393 lesions) over 1-7 years (mean, 2.9 y). Problems related to pulmonary AVMs occurred in 35 patients (23%) at 42 time points: 22 patients with 23 symptomatic events and 17 patients with 19 asymptomatic events. Symptoms resulted from growth of nonembolized pulmonary AVMs (n = 19), residual embolized pulmonary AVMs (n = 5), or both (n = 2). Symptoms consisted of respiratory manifestations (n = 13), cerebral ischemia (n = 4), brain abscess (n = 5), hemoptysis (n = 3), and seizure (n = 1). Imaging showed pulmonary AVM involution in 97% of embolized lesions and 11 residual lesions (2.8%) in 10 patients (6.9%). These were caused by recanalization (n = 7), presence of an accessory feeding artery (n = 1), pulmonary collateral vessels (n = 1), and bronchial collateral vessels (n = 2). CT detected 10 of the 11 residual lesions. Imaging detected 97 previously small pulmonary AVMs that had enlarged to a significant size in 28 patients (18%), 15 of whom were symptomatic and 13 of whom were asymptomatic. CONCLUSIONS: Clinical and anatomic evaluation after pulmonary AVM embolization is important to detect persistent or reperfused lesions and enlarging lesions, with the latter more common. Patients with persistent, reperfused, or enlarging lesions often have symptoms, but a significant minority of patients are asymptomatic. More frequent assessment may improve detection before the onset of symptoms.

Use of N-acetylcholine and sodium bicarbonate to protect renal transplant function during endovascular renal artery aneurysm exclusion.

We describe the successful use of hydration with sodium bicarbonate and N-acetylcholine to prevent contrast-induced nephrophathy in a patient with a kidney transplant undergoing endovascular native renal artery aneurysm exclusion. The implications for surveillance studies for endovascular procedures are discussed.