Comparison of Anticoagulation Regimens Following Stent Placement for Nonthrombotic Lower Extremity Venous Disease.

PURPOSE: To determine whether subtherapeutic anticoagulation regimens are noninferior to therapeutic anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease. MATERIALS AND METHODS: Fifty-one consecutive patients (88% women; mean age, 44 years) who underwent stent placement for nonthrombotic lower extremity venous disease between 2002 and 2016 were retrospectively identified. The patients were divided into 2 cohorts: those who received prophylactic enoxaparin or no anticoagulation (subtherapeutic) after the procedure and those who received therapeutic doses of anticoagulation with enoxaparin, warfarin, and/or rivaroxaban (therapeutic) after the procedure. Baseline demographic characteristics, procedure characteristics, and outcomes were compared between the 2 groups using the Student t test, Fisher exact test, and χ2 test. The subtherapeutic and therapeutic anticoagulation groups did not differ significantly in the baseline demographic characteristics (eg, sex, race, and age) or procedure characteristics (eg, number of stents placed, stent brand, stent diameter, etc). RESULTS: The mean clinical follow-up time was 4.4 years (range, 0-16.3 years). There were no thrombotic adverse events or luminal obstructions due to in-stent restenosis in either group. There were 5 minor bleeding adverse effects in the therapeutic group and no bleeding adverse effects in the subtherapeutic group (P = .051). There were no statistically significant differences in subjective symptom improvement (P = .75). CONCLUSIONS: In this retrospective cohort, the subtherapeutic and therapeutic anticoagulation regimens produced equivalent outcomes in terms of adverse event rates, reintervention rates, and symptomatic improvement, suggesting that therapeutic doses of anticoagulation do not improve outcomes compared with subtherapeutic anticoagulation regimens following nonthrombotic venous stent placement.

Ibero-American Society of Interventionism (SIDI) and the Spanish Society of Vascular and Interventional Radiology (SERVEI) Standard of Practice (SOP) for the Management of Inferior Vena Cava Filters in the Treatment of Acute Venous Thromboembolism.

OBJECTIVES: to present an interventional radiology standard of practice on the use of inferior vena cava filters (IVCFs) in patients with or at risk to develop venous thromboembolism (VTE) from the Iberoamerican Interventional Society (SIDI) and Spanish Vascular and Interventional Radiology Society (SERVEI). METHODS: a group of twenty-two interventional radiologist experts, from the SIDI and SERVEI societies, attended online meetings to develop a current clinical practice guideline on the proper indication for the placement and retrieval of IVCFs. A broad review was undertaken to determine the participation of interventional radiologists in the current guidelines and a consensus on inferior vena cava filters. Twenty-two experts from both societies worked on a common draft and received a questionnaire where they had to assess, for IVCF placement, the absolute, relative, and prophylactic indications. The experts voted on the different indications and reasoned their decision. RESULTS: a total of two-hundred-thirty-three articles were reviewed. Interventional radiologists participated in the development of just two of the eight guidelines. The threshold for inclusion was 100% agreement. Three absolute and four relative indications for the IVCF placement were identified. No indications for the prophylactic filter placement reached the threshold. CONCLUSION: interventional radiologists are highly involved in the management of IVCFs but have limited participation in the development of multidisciplinary clinical practice guidelines.

Laser-Assisted Removal of Embedded Vena Cava Filters: A First-In-Human Escalation Trial in 500 Patients Refractory to High-Force Retrieval.

Background Many patients are subject to potential risks and filter-related morbidity when standard retrieval methods fail. We evaluated the safety and efficacy of the laser sheath technique for removing embedded inferior vena cava filters. Methods and Results Over an 8.5-year period, 500 patients were prospectively enrolled in an institutional review board-approved study. There were 225 men and 275 women (mean age, 49 years; range, 15-90 years). Indications for retrieval included symptomatic acute inferior vena cava thrombosis, chronic inferior vena cava occlusion, and/or pain from filter penetration. Retrieval was also offered to prevent risks from prolonged implantation and potentially to eliminate need for lifelong anticoagulation. After retrieval failed using 3X standard retrieval force (6-7 lb via digital gauge), treatment escalation was attempted using laser sheath powered by 308-nm XeCl excimer laser system (CVX-300; Spectranetics). We hypothesized that the laser-assisted technique would allow retrieval of >95% of embedded filters with <5% risk of major complications and with lower force. Primary outcome was successful retrieval. Primary safety outcome was any major procedure-related complication. Laser-assisted retrieval was successful in 99.4% of cases (497/500) (95% CI, 98.3%-99.9%) and significantly >95% (P<0.0001). The mean filter dwell time was 1528 days (range, 37-10 047; >27.5 years]), among retrievable-type (n=414) and permanent-type (n=86) filters. The average force during failed attempts without laser was 6.4 versus 3.6 lb during laser-assisted retrievals (P<0.0001). The major complication rate was 2.0% (10/500) (95% CI, 1.0%-3.6%), significantly <5% (P<0.0005), 0.6% (3/500) (95% CI, 0%-1.3%) from laser, and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 98.7% (77/78) (95% CI, 93.1%-100.0%) and alleviated filter-related morbidity in 98.5% (138/140) (95% CI, 96.5%-100.0%). Conclusions The excimer laser sheath technique is safe and effective for removing embedded inferior vena cava filters refractory to high-force retrieval. This technique may allow cessation of filter-related anticoagulation and can be used to prevent and alleviate filter-related morbidity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01158482.

Society of interventional radiology clinical practice guideline for inferior vena cava filters in the treatment of patients with venous thromboembolic disease

To provide evidence-based recommendations on the use of inferior vena cava (IVC) filters in the treatment of patients with or at substantial risk of venous thromboembolic disease. A multidisciplinary expert panel developed key questions to address in the guideline, and a systematic review of the literature was conducted. Evidence was graded based on a standard methodology, which was used to inform the development of recommendations. The systematic review identified a total of 34 studies that provided the evidence base for the guideline. The expert panel agreed on 18 recommendations. Although the evidence on the use of IVC filters in patients with or at risk of venous thromboembolic disease varies in strength and quality, the panel provides recommendations for the use of IVC filters in a variety of clinical scenarios. Additional research is needed to optimize care for this patient population.

Society of Interventional Radiology Clinical Practice Guideline for Inferior Vena Cava Filters in the Treatment of Patients with Venous Thromboembolic Disease: Developed in collaboration with the American College of Cardiology, American College of Chest Physicians, American College of Surgeons Committee on Trauma, American Heart Association, Society for Vascular Surgery, and Society for Vascular Medicine.

PURPOSE: To provide evidence-based recommendations on the use of inferior vena cava (IVC) filters in the treatment of patients with or at substantial risk of venous thromboembolic disease. MATERIALS AND METHODS: A multidisciplinary expert panel developed key questions to address in the guideline, and a systematic review of the literature was conducted. Evidence was graded based on a standard methodology, which was used to inform the development of recommendations. RESULTS: The systematic review identified a total of 34 studies that provided the evidence base for the guideline. The expert panel agreed on 18 recommendations. CONCLUSIONS: Although the evidence on the use of IVC filters in patients with or at risk of venous thromboembolic disease varies in strength and quality, the panel provides recommendations for the use of IVC filters in a variety of clinical scenarios. Additional research is needed to optimize care for this patient population.

Spanish multicenter real - life registry of retrievable vena cava filters (REFiVeC).

BACKGROUND: The treatment of venous thromboembolic disease the treatment of choice is systemic anticoagulation. However, the interruption of the inferior vena cava with filters has been recommended when anticoagulation fails or there is a contraindication. Due to the rising inferior vena cava filter (IVCF) complications, physicians are encouraged to retrieve them when there is no longer recommended. In daily practice, it may be a difficult close follow-up of these patients. In this study, the primary objective was to evaluate the IVCF retrieval rate of all implanted filters in a Spanish registry. Secondary objectives were to analyze the causes of failed retrieval, procedure-related complications, and outcomes at a 12-month follow-up. RESULTS: Three hundred fifty-six vena cava filters were implanted in 355 patients. The types of filter were: Gunther Tulip (Cook Medical) 160 (44.9%), Optease (Cordis) 77 (21.6%), Celect (Cook Medical) 49 (13, 7%), Aegisy (Lifetech Scientific) 33 (9.2%), Option ELITE (Argon Medical devices) 16 (4.4%), Denali filter (BD Bard) 11 (3.08%), ALN filter (ALN) 10 (2.8%). Removal was achieved in 274/356 (76,9%). eighty-two (23,1%) IVCF were not retrieved due to the following: 41 (11,5%) patients required ongoing filtration, 24 IVCF (6,7%) patients died before retrieval, and 17 (4,7%) impossibility of retrieval because of a tilted and embedded filter apex. There were no major complications observed. CONCLUSIONS: The global retrieval rate of IVCF was achieved in 76.9%, and the adjusted retrieval rate was of 94.15% with no major complications. IVCF tilting was associated with failure of filter removal in less than 5% of cases. This study demonstrates that the retrieval procedure of IVCF is controlled by the clinician and not by the interventional radiologist.

Diagnostic performance of lower extremity Doppler ultrasound in detecting iliocaval obstruction.

OBJECTIVE: To retrospectively evaluate the performance of two commonly used Doppler ultrasound parameters, namely, venous flow phasicity and response to Valsalva maneuver, in detecting iliocaval obstruction. METHODS: All imaging studies of patients seen by interventional radiology for lower extremity venous disease at a single institution from 1996 to 2018 were retrospectively identified. Lower extremity ultrasounds with a concurrent magnetic resonance, computed tomography, or conventional venogram performed within the next 7 days, which served as gold standard, were further identified (n = 192 examinations, including 313 limbs). Iliocaval obstruction were assessed by two ultrasound criteria: (1) nonphasic flow and/or (2) nonresponsive flow to Valsalva in the common femoral vein. The sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for diagnosing iliocaval obstruction were calculated for each ultrasound criterion, and also for when the two criteria were assessed jointly. RESULTS: Of the 313 limbs assessed for venous flow phasicity, 133 (42.5%) had an iliocaval obstruction confirmed on subsequent venography. Nonphasic flow demonstrated a sensitivity of 69.2%, specificity of 82.8%, NPV of 78.4%, and PPV of 74.8% for diagnosing iliocaval obstruction. Of the 212 limbs assessed for Valsalva response, 88 (41.5%) had a confirmed iliocaval obstruction. Nonresponsive flow to Valsalva demonstrated a sensitivity of 13.6%, specificity of 97.6%, NPV of 61.6%, and PPV of 80.0% for diagnosing iliocaval obstruction. Joint assessment using phasicity and Valsalva criteria demonstrated a sensitivity of 68.2%, specificity of 87.2%, NPV of 79.6%, and PPV of 78.9%. CONCLUSIONS: In this tertiary care setting, Doppler ultrasound examination was not a reliable diagnostic tool for detecting iliocaval obstruction.

Developing and Evaluating a Simulator for Complex IVC Filter Retrieval.

RATIONALE AND OBJECTIVES: Simulation models allow trainees to acquire and develop procedural skills without compromising patient safety. Complex inferior vena cava (IVC) filter retrieval requires the operator to be proficient at using devices, such as endobronchial forceps, and advanced techniques to carefully dissect free embedded filter tips encased in fibrous tissue adherent to the IVC. Therefore, it is important to develop an effective, inexpensive model to simulate tip-embedded IVC filter retrieval. MATERIALS AND METHODS: Silicone tubes (Flexi-Seal SIGNAL, ConvaTec Inc., Skilman, NJ), IVC filters (Cook Günther Tulip Vena Cava Filter, Cook Medical, Bloomington, IN), and endobronchial forceps (Lymol Medical, Woburn, MA) were obtained to assemble the model. A total of 12 combinations of adhesive binding methods were used to adhere IVC filter fragments to the silicone tubes, and these were blind tested. A single operator with over 10 years of experience using forceps scored the adhesives subjectively on a three-point scale for adherence, elasticity, and tactile feel. The adhesive most similar to IVC fibrous tissue was selected to assemble the final tip-embedded IVC filter model. 20 trainees were then assigned to practice on the model. A 3-point scale scoring metric objectively measured confidence before and after training on the model. RESULTS: Sil-poxy Silicone Adhesive (Smooth-On, Macungie, PA) was found to be the most similar to human IVC fibrous tissue with an average score of 3 of 3 on all metrics. Comparing scores from before and after use of the model, trainee confidence improved significantly (p < 0.1) in all three categories from 1.20 to 2.10 (handling forceps), 1.05 to 2.15 (understanding tactile feel of fibrous tissue), and 1.05 to 1.70 (overall confidence). CONCLUSION: The development of a low-cost simulator for embedded IVC filters is feasible and can be used to improve trainee confidence and skill for complex IVC filter retrieval.

Deep Learning for Automated Classification of Inferior Vena Cava Filter Types on Radiographs.

PURPOSE: To demonstrate the feasibility and evaluate the performance of a deep-learning convolutional neural network (CNN) classification model for automated identification of different types of inferior vena cava (IVC) filters on radiographs. MATERIALS AND METHODS: In total, 1,375 cropped radiographic images of 14 types of IVC filters were collected from patients enrolled in a single-center IVC filter registry, with 139 images withheld as a test set and the remainder used to train and validate the classification model. Image brightness, contrast, intensity, and rotation were varied to augment the training set. A 50-layer ResNet architecture with fixed pre-trained weights was trained using a soft margin loss over 50 epochs. The final model was evaluated on the test set. RESULTS: The CNN classification model achieved a F1 score of 0.97 (0.92-0.99) for the test set overall and of 1.00 for 10 of 14 individual filter types. Of the 139 test set images, 4 (2.9%) were misidentified, all mistaken for other filter types that appear highly similar. Heat maps elucidated salient features for each filter type that the model used for class prediction. CONCLUSIONS: A CNN classification model was successfully developed to identify 14 types of IVC filters on radiographs and demonstrated high performance. Further refinement and testing of the model is necessary before potential real-world application.

Lower Extremity Venous Stent Placement: A Large Retrospective Single-Center Analysis.

PURPOSE: To study short-term and long-term outcomes of lower extremity venous stents placed at a single center and to characterize changes in vein diameter achieved by stent placement. MATERIALS AND METHODS: A database of all patients who received lower extremity venous stents between 1996 and 2018 revealed 1,094 stents were placed in 406 patients (172 men, 234 women; median age, 49 y) in 513 limbs, including patients with iliocaval stents (9.4% acute thrombosis, 65.3% chronic thrombosis, 25.3% nonthrombotic lesions). Primary, primary assisted, and secondary patency rates were assessed for lower extremity venous stents at 1, 3, and 5 years using Kaplan-Meier analyses and summary statistics. Subset analyses and Cox regression were performed to identify risk factors for patency loss. Vein diameters and Villalta scores before and up to 12 months after stent placement were compared. Complication and mortality rates were calculated. RESULTS: Primary, primary assisted, and secondary patency rates at 5 years were 57.3%, 77.2%, and 80.9% by Kaplan-Meier methods and 78.6%, 90.3%, and 92.8% by summary statistics. Median follow-up was 199 days (interquartile range, 35.2-712.0 d). Patency rates for the subset of patients (n = 46) with ≥ 5 years of follow-up (mean ± SD 9.1 y ± 3.4) were nearly identical to cohort patency rates at 5 years. Patients with inferior vena cava stent placement (hazard ratio 2.11, P < .0001) or acute thrombosis (hazard ratio 3.65, P < .0001) during the index procedure had significantly increased risk of losing primary patency status. Vein diameters were significantly greater after stent placement. There were no instances of stent fracture, migration, or structural deformities. In patients with chronic deep vein thrombosis, Villalta scores significantly decreased after stent placement (from 15.7 to 7.4, P < .0001). Perioperative mortality was < 1%, and major perioperative complication rate was 3.7%. CONCLUSIONS: Cavo-ilio-femoral stent placement for venous occlusive disease achieves improvement of vein disease severity scores, increase in treated vein diameters, and satisfactory long-term patency rates.

Inferior Vena Cava Atresia: Characterisation of Risk Factors, Treatment, and Outcomes.

PURPOSE: To characterise (1) the risk factors associated with inferior vena cava (IVC) atresia, (2) the radiographic and clinical presentations of deep vein thrombosis (DVT) in patients with IVC atresia, and (3) the treatment and outcome of DVT in patients with IVC atresia. METHODS: The electronic medical record was systematically reviewed for thrombotic risk factors in patients who presented with lower-extremity DVT (n = 409) at a single centre between 1996 and 2017. Patients with IVC atresia were identified based on imaging and chart review. Differences in demographics and thrombotic risk factors between patients with and without IVC atresia were statistically assessed. Extent and chronicity of DVT on imaging, clinical presentation, treatment, and outcomes were evaluated for all patients with IVC atresia. RESULTS: 4.2% of DVT patients (17/409) were found to have IVC atresia; mean age at diagnosis was 25.5 ± 9.4 years. The rate of heritable thrombophilia was significantly higher in patients with IVC atresia compared to patients without IVC atresia (52.9% vs. 17.9%, p < 0.0001). There were bilateral DVT in 70.6% of IVC atresia patients; DVT was chronic in 41.2% and acute on chronic in 58.8%. Pre-intervention Villalta scores were 13.9 ± 9.8 in the left limb and 8.5 ± 7.0 in the right limb. DVT in IVC atresia patients was typically treated with catheter-directed thrombolysis followed by stent placement, achieving complete or partial symptom resolution in 78.6% of cases. CONCLUSION: Thrombotic risk factors such as heritable thrombophilia are associated with IVC atresia. IVC atresia patients can experience high burdens of lower-extremity thrombotic disease at a young age which benefit from endovascular treatment. LEVEL OF EVIDENCE: Level 4.

Toward Data-Driven Learning Healthcare Systems in Interventional Radiology: Implementation to Evaluate Venous Stent Patency.

We developed a code and data-driven system (learning healthcare system) for gleaning actionable clinical insight from interventional radiology (IR) data. To this end, we constructed a workflow for the collection, processing and analysis of electronic health record (EHR), imaging, and cancer registry data for a cohort of interventional radiology patients seen in the IR Clinic at our institution over a more than 20-year period. As part of this pipeline, we created a database in REDCap (VITAL) to store raw data, as collected by a team of clinical investigators and the Data Coordinating Center at our university. We developed a single, universal pre-processing codebank for our VITAL data in R; in addition, we also wrote widely extendable and easily modifiable analysis code in R that presents results from summary statistics, statistical tests, visualizations, Kaplan-Meier analyses, and Cox proportional hazard modeling, among other analysis techniques. We present our findings for a test case of supra versus infra-inguinal ligament stenting. The developed pre-processing and analysis pipelines were memory and speed-efficient, with both pipelines running in less than 2 min. Three different supra-inguinal ligament veins had a statistically significant improvement in vein diameters post-stenting versus pre-stenting, while no infra-inguinal ligament veins had a statistically significant improvement (due either to an insufficient sample size or a non-significant p value). However, infra-inguinal ligament stenting was not associated with worse restenosis or patency outcomes in either a univariate (summary-statistics and Kaplan-Meier based) or multivariate (Cox proportional hazard model based) analysis.

Percutaneous Pulmonary Embolism Thrombectomy and Thrombolysis: Technical Tips and Tricks.

Catheter-directed therapy (CDT) is now acknowledged as a treatment option for select patients with acute massive or submassive pulmonary embolism (PE), and more patients are being considered for CDT if there is available expertise. Therefore, interventionalists should be aware of the variety of catheter-based treatment options, specific pitfalls to avoid during therapy, and the appropriate treatment endpoints. This article reviews currently available techniques and protocols for treating acute massive and submassive PE, with tips to safely and successfully perform percutaneous PE interventions.

Endovascular Removal of Fractured Inferior Vena Cava Filter Fragments: 5-Year Registry Data with Prospective Outcomes on Retained Fragments.

PURPOSE: To evaluate the safety and efficacy of attempted percutaneous filter fragment removal during retrieval of fractured inferior vena cava (IVC) filters and to report outcomes associated with retained filter fragments. MATERIALS AND METHODS: Over a 5-year period, 82 consecutive patients presenting with a fractured IVC filter were prospectively enrolled into an institutional review board-approved registry. There were 27 men and 55 women (mean, 47 y; range, 19-85 y). After main filter removal, percutaneous removal of fragments was attempted if they were deemed intravascular and accessible on preprocedural computed tomography (CT), cone-beam CT, and/or intravascular ultrasound; distal pulmonary artery (PA) fragments were left alone. A total of 185 fragments were identified (81 IVC, 33 PA, 16 cardiac, 2 hepatic vein, 1 renal vein, 1 aorta, 51 retroperitoneal). Mean filter dwell time was 2,183 days (range, 59-9,936 d). Eighty-seven of 185 fragments (47%) were deemed amenable to attempted removal: 65 IVC, 11 PA, 8 cardiac, 2 hepatic, and 1 aortic. Primary safety outcomes were major procedure-related complications. RESULTS: Fragment removal was successful in 78 of 87 cases (89.7%; 95% confidence interval [CI], 81.3-95.2). There were 6 minor complications with no consequence (6.9%; 95% CI, 2.6-14.4) involving intraprocedural fragment embolization and 1 major complication (1.1%; 95% CI, 0.0-6.2), a cardiac tamponade that was successfully treated. The complication rate from attempted cardiac fragment removal was 12.5% (1 of 8; 95% CI, 0.3-52.7). Among patients with retained cardiopulmonary fragments (n = 19), 81% remained asymptomatic during long-term clinical follow-up of 845 days (range, 386-2,071 d). CONCLUSIONS: Percutaneous removal of filter fragments from the IVC and proximal PAs is safe and effective overall, but attempted intracardiac fragment removal carries a higher risk of complication. Most residual filter fragments not amenable to percutaneous removal remain asymptomatic and may be monitored clinically.

Prophylactic IVC filter placement in bariatric surgery patients: results from a prospective filter registry.

BACKGROUND: Bariatric surgery patients are at increased risk for VTE, but potential risks versus benefits of IVC filters in this group remain unclear. Indwelling filters may increase risk of VTE, and removal of filters in obese patients can be challenging. This study evaluated the incidence of VTE in select bariatric patients receiving prophylactic IVC filters, their risk of filter-related complications, and outcomes from attempted filter retrieval. RESULTS: Postsurgical DVT occurred in 3 patients within 3 months postoperatively (3%)(95%CI:1-9%), and 1 patient(1%)(95%CI:0-5%) developed acute low-risk PE at 31 days postoperatively, prior to filter removal. All VTE patients were successfully managed with therapeutic anticoagulation alone except one who required thrombolysis. Median filter dwell time was 54 days (range:22-1548), and there were no major filter-related complications (0%)(95%CI:0-3%). Retrieval was attempted in 104 cases (97%)(95%CI:92-99%) and successful in 104 cases (100%)(95%CI:97-100%). Thirty-three patients (32%)(95%CI:23-42%) required advanced techniques for filter removal, and there were no major procedural complications (0%)(95%CI:0-3%). Median follow-up occurred at 344 days (range:3-1570) days after filter retrieval. CONCLUSIONS: No cases of life-threatening post-op PE occurred in this cohort of high-risk bariatric surgery patients receiving prophylactic IVC filters in combination with mechanical and chemoprophylaxis. The risk of filter-related complications was low and retrieval success was high with adjunctive use of advanced techniques. CLINICAL TRIAL REGISTRATION: NCT01158482.