This single-center retrospective study evaluated whether elevated baseline postvoid residual (PVR) volume is associated with reduced prostatic artery embolization (PAE) durability. Of 573 PAE procedures performed from 2015 to 2023, 176 patients who fit the inclusion criteria were included in the analysis. They were stratified by baseline PVR of ≥300 mL (n = 25) versus <300 mL (n = 151). The primary outcome was a composite of subsequent prostate surgery and/or need for indwelling urinary catheter. Secondary outcomes were changes in International Prostate Symptom Score (IPSS), quality-of-life (QoL) score, and PVR at 3-6 and 12 months. After inverse probability of treatment weighting, composite endpoint risk was higher in the PVR ≥ 300-mL group (38.7% vs 11.3%; risk ratio, 3.43; 95% CI, 1.76-6.70; P = .0003), whereas IPSS and QoL improvements were similar. Patients with baseline PVR ≥ 300 mL experienced comparable early symptomatic improvement after PAE but had a higher observed risk of later surgery or recurrent catheter placement.
Purpose This study aimed to determine the costs associated with prostatic artery embolization (PAE) performed in hospital and outpatient-based lab (OBL) settings. Methods Procedures were performed in similarly equipped procedure suites located within a tertiary hospital or OBL. Time-driven activity-based costing (TDABC) was utilized to calculate procedural costs incurred by the institution. Process maps were created describing personnel, space, equipment, and materials. The time duration of each procedural step was recorded independently by a nurse caring for the patient at the time of the procedure, and mean values were included in our model. Using institutional and publicly available financial data, costs, and capacity cost rates were determined. Results Thirty-seven PAE procedures met inclusion criteria with a mean patient age of 70.4 (+/- 6.7) years and a mean prostate gland size of 129.7 (+/-56.4) cc. Twenty-six procedures were performed within the hospital setting, and 11 procedures were performed within the OBL. Reduction in International Prostate Symptom Score (IPSS) was not significantly different following hospital and OBL procedures (57.2% vs. 82.4%, P = 0.0796). Mean procedural time was not significantly different between the hospital and OBL settings (136.6 vs. 147.3 minutes, P = 0.1893). However, the duration between admission and discharge was significantly longer for procedures performed in a hospital (468.8 vs. 325.4 minutes, P <0.0001). Total costs for hospital-based procedures were marginally higher ($3,858.28 vs. $3,642.67). Conclusion Total PAE cost was similar between the hospital and OBL settings. However, longer periprocedural times for hospital-based procedures and differences in reimbursement may favor the performance of PAE in an OBL setting.
To determine if treatment-naive Child-Pugh class A patients aged 60 to 80 with hepatocellular carcinoma (HCC) within Milan criteria, who had thermal ablation with complete response at 6 months, benefited from subsequent orthotopic liver transplantation (OLT) versus surveillance with on-demand re-treatment. Patients aged 60 to 80 with Child-Pugh class A cirrhosis who underwent radiofrequency or microwave ablation of previously untreated, unresectable HCC within Milan criteria at a single institution between 1/1/2011 and 12/31/2020 were retrospectively reviewed. Those patients who achieved complete mRECIST response at 6-months made up the study population, which was separated into two groups according to those who did and who did not receive subsequent OLT. Patients in both groups received routine follow-up and treatment of HCC recurrence was performed on an as-needed basis. Review of the electronic medical record was performed to determine date of death or last known follow-up for patients in both groups. Kaplan-Meier survival curves and a log-rank test with a significance level of 0.05 were used to compare overall survival from date of ablation between the two groups, as well as sub-group analysis of Child-Pugh A5 patients and Child-Pugh A6 patients. A total of 101 patients met the study criteria and composed the study population. 24 patients received OLT at a mean of 2.4 years post-ablation, while 77 patients did not receive OLT. Mean follow-up time from the ablation date was 8.2 years for the OLT group and 5.6 years for the non-OLT group. Kaplan-Meier survival analysis showed similar survival between the two groups (p=0.18). 5-year survival was 90.5% for the OLT group versus 76.6% for the non-OLT group. Subgroup analysis of Child-Pugh A5 patients (n=81) showed identical survival between the OLT and non-OLT groups (p=0.98), with 5-year survival of 88.2% for the OLT group and 86.8% for the non-OLT group. Subgroup analysis of Child-Pugh A6 patients (n=20) showed superior survival for the OLT group (p=0.008), with 5-year survival of 100% for the OLT group versus 33.3% for the non-OLT group. Child-Pugh class A cirrhotic patients of advanced age in whom complete response is achieved with thermal ablation showed similar long-term survival with surveillance and on-demand re-treatment compared with OLT. Subgroup analysis showed that Child-Pugh class A5 patients had equal survival with surveillance versus OLT, while Child-Pugh class A6 patients demonstrated significant survival benefit with OLT.
PURPOSE:To report the 24-month outcomes and subgroup analysis evaluating the safety and effectiveness of the genicular artery embolization (GAE) for the treatment of symptomatic knee osteoarthritis (OA). MATERIALS AND METHODS:Forty participants with symptomatic moderate-to-severe knee OA from a single-center, single-arm, prospective investigational device exemption trial of GAE were included in this study. Abnormal genicular artery neovascularity was identified at the subject's focal knee pain with digital subtraction angiography and cone-beam computed tomography (CT). Embolization was performed with 100-μm microspheres. The primary end point was treatment effectiveness as measured by sustained improvement in OA symptoms at 24 months, quantified using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Treatment success was defined as ≥50% decrease in WOMAC relative to baseline. Clinical outcomes were assessed with mean age of 66.0 years (SD ± 8.1) and body mass index of 30.1 kg/m2 (SD ± 6.2). RESULTS:Of the 40 patients, 2 (5.0%) were lost to follow-up. Overall, 18 of 38 (47.4%) patients demonstrated ≥50% reduction in WOMAC at 24 months. In the subset of patients with initial clinical success at 12 months, 18 of 25 (72.0%) reported sustained clinical success at 24 months. Seven of 25 (28.0%) patients had symptom recurrence between 12 and 24 months and were determined to be clinical failures. All treatment-related adverse events occurred within 12 months after GAE, without additional events after 12 months. CONCLUSIONS:GAE is effective in achieving sustained symptom relief related to moderate-to-severe knee OA for up to 24 months with an acceptable safety profile.
BackgroundMechanical thrombectomy is a promising treatment option for deep vein thrombosis; however, long-term data are lacking. Here, we report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy with the ClotTriever System (Inari Medical).MethodsThe CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL).ResultsIn CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL.ConclusionsOne-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.
Acute lower extremity deep vein thrombosis (DVT) is a common disorder with significant associated morbidity, including pain and swelling, as well as the risk of pulmonary embolism (PE), recurrent venous thromboembolism (VTE) and chronic debilitating post-thrombotic syndrome (PTS). Anticoagulation is standard of care for DVT treatment. It assists in reducing thrombus progression and the occurrence of PE, but incomplete DVT resolution increases the risk of recurrent VTE, valvular insufficiency, and PTS. Endovascular DVT interventions, such as catheter-directed thrombolysis, pharmacomechanical thrombectomy, and large-bore mechanical thrombectomy offer an alternative therapeutic strategy for DVT management. This paper will discuss technical factors and current issues when performing lower extremity DVT interventions including patient selection, anticoagulation, choice of device for endovascular thrombus removal, adjunctive techniques, and venous stent management. Level of Evidence: No level of evidence for: review articles, basic science, laboratory investigations, and experimental study articles.
Acute lower extremity deep vein thrombosis (DVT), specifically proximal iliofemoral DVT, is a relatively common disorder that can result in a chronic debilitating post-thrombotic syndrome (PTS), with a significant effect on a patient’s quality of life. Anticoagulation is first-line therapy; however, percutaneous interventions have emerged as treatment options for patients where there is concern that anticoagulation alone will not resolve the DVT as well as prevent PTS. This paper will discuss the existing data on these interventions and review current endovascular techniques, including catheter-directed thrombolysis, pharmacomechanical thrombectomy, and large-bore mechanical thrombectomy in the management of DVT.
PURPOSE:Genicular artery embolization (GAE) is a new treatment option for symptomatic knee osteoarthritis. Genicular arterial anatomy is complex with limited published reports. This study describes the genicular artery anatomy utilizing intraprocedural cone-beam computed tomography (CBCT) during GAE.MATERIALS AND METHODS:This retrospective single-center study was approved by the institutional review board. All patients who underwent GAE between May 2018 and April 2022 were reviewed. Patients with a technically adequate CBCT were included in the analysis. CBCTs were analyzed to determine the presence, course, and branching patterns of the genicular arteries.RESULTS:A total of 222 patients underwent GAE and 205 (92%) were included for analysis. The descending genicular artery was present in 197 (96%) CBCTs with two branches in 152 (77%). The superior medial genicular artery (SMGA) was present in 186 (91%), superior lateral genicular artery (SLGA) in 203 (99%), inferior medial genicular artery (IMGA) in 195 (95%), inferior lateral genicular artery (ILGA) in 196 (95%), and median genicular artery (MGA) in 200 (97%). Four unique branching patterns were identified: common origin of SLGA and MGA (115, 56%), unique origins (45, 22%), trifurcation of SLGA, SMGA, and MGA (32, 15.5%), and common origin of SMGA and MGA (12, 6%). The recurrent ascending tibial was identified in 156 (76%) CBCTs and superior patellar artery in 175 (85%) CBCTs.CONCLUSION:Genicular artery anatomy is complex with numerous common variants. CBCT is a powerful adjunct in GAE to rapidly identify target vessels for embolization and potentially decrease the risk of nontarget embolization.
Purpose: To evaluate if the addition of cone-beam computed tomography (CT) to digital subtraction angiography (DSA) improves the identification of the genicular arteries during genicular artery embolization (GAE) for knee pain secondary to osteoarthritis (OA). Materials and Methods: This single-center study retrospectively analyzed 222 patients who underwent GAE for painful knee OA between May 2018 and April 2022. Intraprocedural cone-beam CT and DSA images were reviewed independently by 2 sets of interventional radiologists. DSA was performed for all patients. Technically adequate cone-beam CT was available for 205 patients (92.3%). The presence of the genicular arteries identified by cone-beam CT and DSA was compared using Phi coefficients. Embolization targets identified by both cone-beam CT and DSA were evaluated against those identified by DSA alone. Results: Genicular arteries with the highest concordance between cone-beam CT and DSA were the inferior lateral (196 vs 198; Phi = 0.3530; P < .0001), superior lateral (197 vs 200; Phi = 0.3060; P < .0001), and superior medial genicular (186 vs 161; Phi = 0.2836; P < .0001) arteries. Cone-beam CT demonstrated higher rates of detection of the inferior medial (195 vs 178; Phi = 0.04573; P = .5150) and median genicular arteries (200 vs 192; Phi = 0.04573; P = .5150). Meanwhile, genicular arteries less frequently identified by cone-beam CT were the descending genicular (197 vs 200; Phi = -0.03186; P = .6502), superior patellar (175 vs 184; Phi = 0.1332; P = .0569), and recurrent anterior tibial (156 vs 186; Phi = 0.01809; P = .7969) arteries. Cone -beam CT in combination with DSA identified 13.4% (372 vs 328) more targets compared to DSA alone. Conclusions: Based on the results of the current study, cone-beam CT serves as a valuable adjunct for visualizing the genicular arteries during GAE, and together with DSA, it identifies more potential embolization targets.
Background: Right heart thrombi can be a source of considerable morbidity and mortality, especially when associated with pulmonary embolism. Methods: To understand the safety and procedural efficacy associated with vacuum-assisted thrombectomy using the AngioVac System (AngioDynamics, Latham, NY, USA) to remove right heart thrombi, we conducted a subanalysis of the Registry of AngioVac Procedures in Detail (RAPID) multicenter registry representing 47 (20.1%) of 234 participants in the registry. Forty-two (89.4%) patients had thrombi located in the right atrium alone, three (6.4%) in the right ventricle alone, and two (4.3%) in both the right atrium and ventricle. Four (8.5%) patients had concomitant caval thrombi, three (6.4%) also had catheter-related thrombi, and one (2.1%) patient had both caval and catheter-related thrombi with their right heart thrombi. Results: Extracorporeal bypass time was less than 1 hour for 39 (83.0%) procedures. Seventy to 100% removal of thrombus was achieved in 59.6% of patients. Estimated blood loss was less than 250 cc for 43 procedures (91.6%). Mean hemoglobin decreased from 10.7 ± 2.2 g/dL preoperatively to 9.6 ± 1.6 g/dL postoperatively. Transfusions were administered for eight procedures (17.0%), with only one (2.1%) patient receiving more than 2 units of blood. Six patients (12.8%) experienced procedure-related adverse events, including three (6.4%) patients who experienced distal emboli and three (6.4%) patients who developed bleeding-related complications. All adverse events resolved prior to discharge. There was one death (2.1%) reported that was not procedure related. Conclusion: Vacuum-assisted thrombectomy can be performed safely in patients with right heart thrombi. ClinicalTrials.gov Identifier: NCT04414332.
To evaluate the accuracy of cone-beam computed tomography (CBCT) and digital subtraction angiography (DSA) in identifying the genicular arteries during genicular artery embolization (GAE) for knee pain secondary to osteoarthritis (OA)
Genicular artery embolization (GAE) is an emerging safe and effective intervention to treat patients with symptomatic knee osteoarthritis. Arterial supply to the knee is complex and published reports describing genicular artery anatomy are very limited. The purpose of this study was to define genicular artery anatomy in a large cohort and describe the added value of utilizing intra-operative contrast-enhanced cone-beam computed tomography (CBCT) during GAE.
The "gunsight approach" was initially described as the use of overlapping snares and through- and-through puncture of the portal vein and inferior vena cava for the creation of a transcaval portosystemic shunt. This technique can be adapted for the creation of an extra-anatomic chan- nel between any 2 locations where snares can be deployed. We explain the technique, discuss finer technical points, and describe 2 cases where refractory vascular occlusions are crossed using this technique. The first case involves an extensively calcified femoral arterial chronic total occlusion where subintimal tracking past the occlusion is achieved, but luminal re-entry is ham- pered by dense calcific plaque refractory to multiple re-entry devices. The second case involves a chronic venous occlusion along the femoral vein with loss of in-line flow due to prior stenting. In both cases, the gunsight technique was successfully used as a bailout option after standard recanalization techniques were unsuccessful.
Purpose of review Describe the role of inferior vena cava filter (IVCF) retrieval in patients on chronic anticoagulation given the overlap of these treatment options in the management of patients with venous thromboembolic disease. Recent findings Despite the increase in IVCF retrievals since the Food and Drug Administration safety communications in 2010 and 2014, retrieval rates remain low. Previous studies have shown that longer filter dwell times are associated with greater risk for filter complications and more difficulty with filter retrievals. Recent findings suggest that complications are more frequent in the first 30 days after placement. Summary The decision to retrieve an optional IVCF is individualized and requires diligent follow-up with consistent re-evaluation of the need for the indwelling IVCF, particularly in those on long-term anticoagulation therapy.
Background: Genicular artery embolization (GAE) is a novel therapy to treat patients with symptomatic knee osteoarthritis (OA) by reducing synovial arterial hypervascularity. This study evaluates the safety and efficacy of GAE for the treatment of symptomatic knee OA. Methods: A prospective, single-center, open-label U.S. Food and Drug Administration-approved investigational device exemption study was conducted. Patients enrolled in the study were 40 to 80 years old, with moderate or severe knee OA (Kellgren-Lawrence grade 2, 3, or 4), who previously had failure of conservative therapy. Baseline pain (visual analog scale [VAS]) and symptom scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) were assessed. After femoral arterial access was achieved, GAE of 1, 2, or 3 genicular arteries supplying the location of the subject’s pain, as determined by digital subtraction angiography and cone-beam computed tomography, was performed using 100-μm particles. Adverse events and symptoms scores were assessed at 1 week, 1 month, 3 months, 6 months, and 1 year after GAE. Results: Over a 10-month period, 40 subjects were enrolled. The median age was 69 years (range, 49 to 80 years). The median body mass index was 29 kg/m2 (range, 19 to 44 kg/m2). Knee OA severity was grade 2 in 18% of the patients, grade 3 in 43%, and grade 4 in 40%. Technical success was achieved in 100% of the subjects. Transient skin discoloration and transient mild knee pain after the procedure were common and expected. Treatment-related adverse events included a groin hematoma requiring overnight observation in 1 subject, self-resolving focal skin ulceration in 7 subjects, and an asymptomatic small bone infarct on magnetic resonance imaging at 3 months in 2 subjects. The WOMAC total and VAS pain scores decreased by 61% and 67% at 12 months from a median baseline of 52 (of 96) and 8 (of 10), respectively. Twenty-seven patients (68%) had a reduction of ≥50% in both WOMAC total and VAS pain scores. Conclusions: This prospective trial demonstrates that GAE is effective and durable in reducing pain symptoms from moderate or severe knee OA that is refractory to other conservative therapy, with an acceptable safety profile. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Ehlers-Danlos syndrome type IV (EDS-IV), the vascular type, is a rare genetic disorder affects the large and medium size arteries resulting in dissections, often with aneurysmal degeneration, intramural hematomas and pseudoaneurysms. Embolization or ligation is standard management for aneurysm formation. We present a case of an EDS-IV patient with a posterior tibial artery dissection with associated aneurysm successfully treated with Flow Diversion stent (FDS) preserving vessel patency and excluding the aneurysm. FDS technology allows for low profile, micro-catheter deliverable treatment options to exclude aneurysms in EDS-IV patients that are may be prone to spasm and dissection using more conventional stent graft technology.