The TOPOS study.

Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1-90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4-11), 5 (IQR: 3-7), 3 (IQR: 2-5), and 17 (IQR: 6-22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.

The toolbox of acute DVT intervention.

Although the thrombectomy system is very important, there are many other devices and supportive tools that build the foundation for a successful interventional procedure. We suggest a toolbox of acute DVT intervention to aid in all likely strategies to effectively remove thrombus from the deep venous vasculature.

Editor's Choice - Management of Lower Extremity Venous Outflow Obstruction: Results of an International Delphi Consensus.

OBJECTIVE: The endovascular treatment of venous obstruction has expanded significantly in recent years. Best practices for optimal patient outcomes are not well established and the evidence base is poor. The purpose of this study was to obtain consensus on management criteria for patients with lower extremity venous outflow obstruction. METHODS: The study was conducted as a two round Delphi consensus. Statements addressed imaging, symptoms and other baseline measures, differential diagnosis, treatment algorithm, indications for stenting, inflow and outflow assessment, successful procedural outcomes, post-procedure therapies and stent surveillance, and clinical success factors. Statements were prepared by six expert physicians (round 1, 40 statements) and an expanded panel of 24 physicians (round 2, 80 statements) and sent to a pre-identified group of venous experts who met qualifying criteria. A 9 point Likert scale was used and consensus was defined as ≥ 70% of respondents rating a statement between 7 and 9 (agreement) or between 1 and 3 (disagreement). Round 1 results were used to guide rewording and splitting compound statements for greater clarity in round 2. RESULTS: In round 1, 75 of 110 (68%) experts responded, and 91 of 121 (75%) experts responded in round 2. Round 1 achieved consensus in 32/40 (80%) statements. Consensus was not reached in the treatment algorithm section. Round 2 achieved consensus in 50/80 (62.5%). Statements reaching consensus were imaging (2/3, 66%), symptoms and other baseline measures (12/24, 50%), differential diagnosis (2/8, 25%), treatment algorithm (10/17, 59%), indications for stenting (10/10, 100%), inflow and outflow assessment (2/2, 100%), procedural outcomes (2/2, 100%), post-procedure therapies and stent surveillance, (5/7, 71%), and clinical success factors (5/7, 71%). CONCLUSION: This study demonstrated that considerable consensus was achieved between venous experts on the optimal management of lower extremity venous outflow obstruction. There were multiple domains where consensus is lacking, highlighting important areas for further investigation and research.

Safety and Efficacy of Rotational Thrombectomy for Treatment of Arterial Occlusions of the Lower Extremities: A Large Single-Center Retrospective Study.

PURPOSE: To evaluate the safety and efficacy of rotational thrombectomy (RT) in a large single-center real-world cohort for total vascular occlusions of the lower extremity. MATERIALS AND METHODS: The clinical records and images of all patients between 2010 and 2020 treated via RT (Rotarex, BD) were assessed. Patient demographics, clinical data, procedural characteristics, and outcome parameters were documented. In total, 397 procedures in 293 patients were included (mean age 69.8 ±â€Š12.0 years; 64.8 % male). Occlusions were acute (47.5 %), subacute and acute-on-chronic (22.2 %), and chronic (30.3 %). The target lesions were the iliac artery (7.1 %), iliac/femoropopliteal (5.0 %), femoropopliteal (59.4 %), femoropopliteal/below-the-knee (27.0 %), below-the-knee (1.5 %), and after bypass surgery (14.9 %). Lesion length was > 20 cm in 61.5 % of cases. RESULTS: Clinically successful revascularization was achieved in 90.4 % of cases. Additional thrombolysis was necessary for 32.0 % of procedures. The arithmetic mean ankle-brachial index increased from 0.33 ±â€Š0.29 to 0.81 ±â€Š0.25 (p < 0.0001). Bypass grafts were less likely to be fully treatable and required additional lysis (p < 0.001). The overall primary patency (no clinically driven target lesion revascularization) was 93.2 %, 88.8 %, 79.1 %, and 72.4 % at 1, 3, 6, and 12 months, respectively. Adverse events occurred in 46.1 % of cases, of which peripheral embolization (22.4 %) was most frequent, requiring interventional treatment in 67.4 % of cases. RT was directly associated with 7.1 % (n = 28) of complications, which consisted of perforations 2.8 %, arteriovenous fistula 1.3 %, and dissections 2.0 %. CONCLUSION: Rotational thrombectomy is a safe and efficient method for the treatment of occlusions of the arterial circulation of the lower extremity with bypass occlusions having a higher propensity for residual thrombi requiring further lysis therapy. KEY POINTS: · Rotational thrombectomy was safe and efficacious for treating occlusions of the lower extremities.. · Rotational thrombectomy was associated with 7.1 % of complications.. · Distal embolization occurred in 22.4 % of cases with 67.4 % requiring interventional treatment.. · Primary patency was 93.2 %, 88.8 %, 79.1 %, 72.4 % after 1, 3, 6, and 12 months, respectively.. CITATION FORMAT: · Artzner C, Martin I, Hefferman G et al. Safety and Efficacy of Rotational Thrombectomy for Treatment of Arterial Occlusions of the Lower Extremities: A Large Single-Center Retrospective Study. Fortschr Röntgenstr 2023; 195: 406 - 415.

Braided nitinol stent for chronic iliofemoral venous disease - the real-world BLUEFLOW registry.

Background: In patients with iliofemoral chronic venous disease (CVD) secondary to post-thrombotic or non-thrombotic obstruction, venous outflow obstruction after adequate anticoagulation alone is still frequent and post-thrombotic syndrome is a common complication. Thus, we aimed to evaluate mid-term effectiveness and safety of a novel braided venous stent for venous outflow obstruction treatment. Patients and methods: Consecutive patients who underwent venous recanalization with a new braided, closed cell, venous stent for non- or post-thrombotic CVD were eligible for inclusion in our retrospective, observational study. Effectiveness outcomes were primary patency and change in the revised venous clinical severity score (rVCSS) and the clinical score of the comprehensive classification system for chronic venous disease (CEAP) at 6- and 12-month follow-up. Safety outcomes were recurrent DVT, clinically driven target vein revascularization, index limb major amputation, or death. Results: A total of 67 participants (50.7% female, aged 46.7±18.1 years) who underwent blueflow Venous Stent implantation between February 2018 and March 2019 were enrolled. Primary patency of the target segment was present in 91.7% (95%CI: 76.8-97.7) of participants at the 6-month examination and in 79.8% (95%CI: 66.4-93.2) at the 12-month examination. Twelve-month primary patency was 91.7% (95%CI: 76.0-100) in non-thrombotic, and 72.6% (95%CI: 53.9-91.3) in postthrombotic disease (log-rank p=0.14). Median rVCSS improved from 8 (interquartile range [IQR]: 9-7) at baseline to 4 (IQR: 6.3-2.8) at 12 months (p<0.001) with a substantial clinical improvement of ≥2 points in 86.1% (31 of 36 participants). No significant association of rVCSS improvement with thrombotic pathogenesis could be found. Median clinical CEAP score improved from 3 (IQR: 3-3) to 2 (IQR: 3-2), p>0.001. No safety signal occurred. Conclusions: blueflow Venous Stent implantation for the treatment of iliofemoral CVD was associated with promising patency and favorable clinical improvement over the mid-term.

Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis - a systematic review and meta-analysis.

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I2 = 68.4 %], PMT 96 %, [I2 = 0 %]; Qbet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I2 = 15.6 %] versus 94 %; Qbet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I2 = 0 %] versus 1.0 % [I2 = 0 %]; Qbet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I2 = 56 %] versus 91.3 % [I2 = 91.7 %]; Qbet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Qbet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Qbet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.

Outcome of stenting in central venous obstruction of benign etiology.

Background: The aim of this study is to evaluate long term outcome in patients treated for benign superior vena cava (SVC) syndrome by endovascular techniques. Patients and methods: Between 2015 and 2018, 62 patients suffering from central venous obstruction of benign etiology underwent balloon angioplasty with stent placement for venous obstruction in our department. Patency was assessed clinically, using duplex ultrasound in all patients or with CT-phlebography in selected cases. Results: Median age was 60 years (23-83), forty-one patients (66%) had central venous devices. Swelling of the arm and face were the main symptoms (71%). During the median follow up of 22 months (9-38), cumulative primary patency was 71% after venous stenting. The cumulative assisted primary and the secondary patency were 85% and 92%, respectively. Conclusions: Recanalization and stenting of central vein obstruction has turned out to be the technique of reference and provides satisfactory mid-term patency rates. After adjusting for the risk factors, presence of AV-fistula remained a significant risk factor for recurrent stenosis or loss of patency after intervention.

Venovo venous stent for treatment of non-thrombotic or post-thrombotic iliac vein lesions - long-term efficacy and safety results from the Arnsberg venous registry.

Background: Endovascular venous stenting with dedicated venous stents for the treatment of chronic venous outflow obstruction is developing as efficacious alternative to conservative therapy or open surgery. However, so far, mid- and long-term evidence on effectiveness and safety is poor. Patients and methods: The prospective, single-center, observational study enrolled consecutive patients with chronic non-thrombotic iliac vein lesions (NIVL) or post-thrombotic iliofemoral obstructions (PTO). From February 2016 to April 2017, patients underwent implantation of open cell, self-expandable dedicated venous stents. Short-term symptomatic improvement, patency, and complication rate were favorable. Evaluation at 2-years included improvement in the revised venous clinical severity score (rVCSS), patency, stent migration, major target limb events, clinically important pulmonary embolism, major bleeding, and all-cause mortality. Results: A total of 79 patients (57 ± 16 years, 44 female) were evaluated. At 2 years, rVCCS improved by 4.3 ± 2.7 (p < 0.001). Substantial clinical improvement of ≥ 2 score points was achieved in 86.4% (38 of 44) of patients. Improvement was not associated with thrombotic pathogenesis (regression coefficient [B] with PTO = 0.6 [95%CI: -1.1 to 2.3], p = 0.48). At 2 years, all ulcers (in 8 of 79 patients) were healed and none recurred. Two-year primary patency was 95.5% (95%CI: 86.5 to 98.5) with no difference between NIVL- and PTO-patients (log-rank p = 0.83). Target vessel revascularization was conducted in two PTO- and one NIVL-patients in the period of 34 days to 156 days from index procedure, resulting in a secondary patency of 100%. No stent migration, target limb deep vein thrombosis, major amputation, pulmonary embolism, or death occurred. Conclusions: Venovo venous open cell self-expanding stent implantation for chronic outflow obstruction was efficacious and provided a sufficient level of safety throughout 2 years.

Iliocaval Skip Stent Reconstruction Technique for Chronic Bilateral Iliocaval Venous Occlusion.

PURPOSE: To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions. MATERIALS AND METHODS: A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter. RESULTS: Recanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%. CONCLUSIONS: Findings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.

Early clinical outcomes for treatment of post-thrombotic syndrome and common iliac vein compression with a hybrid Oblique self-expanding nitinol stent - the TOPOS study.

Background: Physical attributes of conventional stents used in the ilio-caval territory are often unfavorable in the presence of external compression close to the bifurcation. A hybrid oblique stent was developed for the treatment of common iliac vein compression without compromising the contralateral iliac vein inflow. Patients and methods: The ongoing international monitored TOPOS study enrolled 60 patients with post-thrombotic syndrome (PTS) treated with the sinus-Obliquus stent (optimed) and provisional distal stent extension. At 3-month follow-up, patency rates were obtained from duplex ultrasound, and clinical outcomes were assessed by the Villalta score, revised venous severity score (rVCSS), pain intensity score and chronic venous disease quality of life questionnaire (CIVIQ-20). Results: Mean age was 46.6 ± 14.9 years (68.3 % women). Mean number of implanted stents was 1.9 ± 0.6; 12 (20 %) patients received the hybrid oblique stent only. Forty-eight (80 %) patients had distal stent extension, and 42 (70 %) had stents below the inguinal ligament. Four (7 %) patients (all with stent extension) developed stent thrombosis. Primary and secondary patency rates at 3 months were 93.1 % (95 %CI 83.3-98.1 %), and 100 % (95 %CI 93.8-100 %), respectively. Improvement in Villalta, rVCSS, CIVIQ-20, and pain intensity score from baseline to 3-month follow-up was 6.9 ± 1.4 points (95 %CI 4.1-9.8; p < 0.0001), 3.4 ± 1.0 points (95 %CI 1.3-5.4 points; p < 0.01), 13.6 ± 2.7 points (95 %CI 8.2-19.0 points; p < 0.0001), and 2.4 ± 0.5 (95 %CI 1.4-3.3; p < 0.0001), respectively. At follow-up, 38 (63 %) patients were free from the PTS and none developed contralateral deep vein thrombosis. Conclusions: In patients with PTS and common iliac vein compression, treatment with the hybrid oblique stent with provisional stent extension resulted in high patency rates and improvement in PTS severity and quality of life at 3-month. Two-year results of TOPOS will assess the durability of this treatment.

Safety, procedural success and outcome of the Aspirex®S endovascular thrombectomy system in the treatment of iliofemoral deep vein thrombosis - data from the Arnsberg Aspirex registry.

Background: Percutaneous mechanical thrombectomy (PMT) represents a treatment option in addition to conventional therapy for patients with iliofemoral deep vein thrombosis (DVT). We sought to determine the safety, patency and short-term outcome of the Aspirex®S catheter as a rotational mechanical thrombectomy device in the endovascular treatment of iliofemoral DVT. Patients and methods: 56 patients (66 % female, median age 51 years) undergoing mechanical thrombectomy with the Aspirex®S catheter for endovascular treatment of iliofemoral DVT were included in the analysis. Device- and procedure-related complications, prevention of post-thrombotic syndrome (PTS) and patency rates were determined at baseline and at 1, 6 and 12 months after intervention. Results: No device-related complications or malfunction occurred. Procedure-related complications (rehospitalization, re-occlusion of target vein, prolonged hospitalization resulting from access site complication) were seen in 14 % of patients. PMT was followed by implantation of a dedicated venous stent in all patients. Low PTS reflected by a revised venous clinical severity score (rVCSS) of < 3 and a clinical, etiologic, anatomic and pathophysiologic (CEAP) score of < 3 were achieved in 64 % of the patients at 12 months. Patency was 95 % after 1 month, 94 % after 6 months and 87 % after 12 months. Conclusions: Even though long-term studies are missing, PMT of iliofemoral DVT using the Aspirex®S rotational thrombectomy device as a standalone approach exhibited an excellent patency at short term associated with substantial prevention of moderate to severe PTS and low device-related complications including bleeding.

Venovo venous stent in the treatment of non-thrombotic or post-thrombotic iliac vein lesions - short-term results from the Arnsberg venous registry.

BACKGROUND: We sought to determine the patency and clinical symptom relief of the Venovo venous stent in the endovascular treatment of non-thrombotic (NIVL) or post-thrombotic venous obstruction (PTO) of the iliofemoral track over a period of 6 months. PATIENTS AND METHODS: A total of 80 patients (45 female, mean age 57 years) treated in 2016 and 2017 were included in the Arnsberg venous registry. Clinical improvement was determined by the revised venous clinical severity score (rVCSS) as well as the clinical, etiologic, anatomic and pathophysiologic (CEAP) score. Primary and secondary stent patency was evaluated using duplex ultrasound. RESULTS: Overall 6-months patency rates were 98 % for primary and 100 % for secondary patency. For NIVL primary patency was 97 %, whereas for PTO primary patency was 96 %. Early stent re-occlusion occurred in 3 patients within 34, 59 and 156 days after intervention. Two of these patients were successfully treated by endovascular mechanical thrombectomy and stent in stent implantation. Clinical improvement with a gain of ≥ 2 rVCSS levels was observed in 51 %. CEAP scores decreased from 4.3 to 2.7. CONCLUSIONS: In this first time report the novel Venovo venous stent showed adequate patency rates associated with reasonable clinical improvement and low device-related complications throughout a 6-months-follow-up in both NIVL and PTO.

Patency rates, safety and clinical results of the sinus-Obliquus venous stent in the treatment of chronic ilio-femoral venous outflow obstruction - data from the Arnsberg venous registry.

Background: We sought to determine the patency and clinical symptom relief following the usage of the sinus-Obliquus venous stent in the endovascular treatment of venous obstruction of the ilio-femoral track in short-term. Patients and methods: 48 patients (62 % female, mean age 57 years) with chronic unilateral post-thrombotic obstruction (PTO) and non-thrombotic iliac vein obstructive lesions (NIVL) without involvement of inferior vena cava receiving a sinus-Obliquus venous stent was included in the analysis. Clinical improvement determined by the revised venous clinical severity score (rVCSS) as well as the clinical, etiologic, anatomic and pathophysiologic score (CEAP), safety, and stent patency rates were determined at baseline and at 1, 6 and 12 months after stent placement. Ten of the 48 included patients had a venous ulceration. Results: Primary patency rates were 98 % at FU1, 94 % at FU2 and 94 % at FU3, respectively. Secondary patency was 100 % at FU1, 96 % at FU2 and remained 96 % at FU3. At 12 months, the mean rVCSS dropped from 9.0 to 4.8 points (p < 0.001) whereas the mean CEAP improved from 3.45 to 2.96 (p < 0.001). A substantial healing of ulcerations was observed in 8 of 10 patients with initial venous ulceration. There were no relevant safety concerns noticed. Conclusions: Even though long-term studies are missing, the sinus-Obliquus venous stent already showed very promising patency rates at short term, associated with substantial clinical improvement and low device-related complications in both NIVL and PTS.