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.

Editor's Choice - Quality of Life after Stenting for Iliofemoral Venous Obstruction: A Randomised Controlled Trial with One Year Follow Up.

OBJECTIVE: Deep venous obstruction (DVO) is a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO. METHODS: Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in score changes for EuroQoL 5-Dimension 5 Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score. RESULTS: After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n = 42) or control group (n = 21). Overall, 50 patients had available data for primary outcome analysis. The adjusted mean difference between 12 month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p = .026), respectively, in favour of the stent group. The differences were significant, but a pre-defined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p = .040), -11.83 (95% CI -20.81 - 2.86, p = .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p = .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p = .17) for the Villalta score. CONCLUSION: Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points. STUDY REGISTRATION NUMBER: NCT03026049.

Single-center experience with catheter-directed thrombolysis and balloon angioplasty for acute upper-extremity deep vein thrombosis: a case series study.

BACKGROUND: Effective treatment of upper extremity deep vein thrombosis (UEDVT) is crucial to prevent further complications. Various treatments, including percutaneous mechanical thrombectomy (PMT), catheter-directed thrombolysis (CDT), decompression surgery, and venoplasty are suggested for UEDVT. However, no prospective study has yet favored any of these treatments. This study presents a review of our experience with CDT followed by balloon venoplasty in patients with acute primary UEDVT. METHODS: We enrolled all patients diagnosed with acute UEDVT from January 2020 to June 2021. Subjects with UEDVT due to secondary causes like malignancies, indwelling catheters, or leads were excluded. CDT was performed through brachial vein access, using a perfusion catheter, and rt-PA administration. Balloon venoplasty was performed if the treated segment had remaining stenosis after CDT. Patients were followed up at the vein clinic for any signs and symptoms in the upper extremity and lifestyle changes. Follow-up ultrasonography was done 12 months after discharge. RESULTS: Twelve patients with a mean age of 41.08 ± 14.0 years were included in the study. The mean duration of CDT was 25.00 ± 10.56 h. After CDT, all patients had remaining occlusions, with seven having more than 50% remaining stenosis. However, after balloon venoplasty, no patient had significant (more than 50%) stenosis. There was no serious complication after both procedures. Patients were followed up for a mean duration of twelve months after their admission, with a mean time of maintenance anticoagulation was 10.73 ± 5.77 months. Only one patient had recurrent symptoms in his target limb which required a decompression surgery, while the rest were free of symptoms in their treated extremity. No subject developed pulmonary emboli (PE) during admission or the follow-up period. There was no evidence of hospital readmission for any reason. Upper extremity color-doppler sonography of the patients at twelve months after their procedure showed normal venous flow without any significant stenosis in 8 (66.7%), and partially normal flow with patent target vein in 4 (33.3%) patients. CONCLUSIONS: CDT followed by balloon venoplasty may be an effective treatment for selected patients with acute primary UEDVT, providing desirable long-term results and potentially avoiding the need for decompression surgery in the short or long term.

Effect of Stent Strut Interval on Neointima Formation After Venous Stenting in an Ovine Model.

OBJECTIVE: The impact of stent design on venous patency is not well studied. The purpose of this study was to investigate the effect of stent material burden on endothelial coverage of stented venous segments, which may contribute to vessel healing and patency. METHODS: Segmented self expanding bare nitinol stents (18 × 50 mm) comprising 5 mm long attached metallic rings separated by 2, 5, or 8 mm gaps were implanted in the inferior vena cava (IVC) of 10 sheep. These stents were designed and manufactured for the purposes of this study. At six, 12, and 24 weeks after implantation the animals were euthanised and the stented vessels harvested for histomorphometric analysis. Three sections from the metallic part as well as the gaps between the struts were reviewed for quantification of endothelialisation after six, 12, and 24 weeks. The intimal thickness over and between the stent struts was measured. The endothelialisation score (graded from 1 for complete luminal endothelialisation to 5 for absence of endothelial cells) was determined. RESULTS: All stents were successfully deployed and all 10 sheep survived until the time of harvesting. Macroscopic inspection after 24 weeks showed only partial endothelialisation over stents with 2 mm and 5 mm skipped segments, whereas the stents with 8 mm skipped segments were totally incorporated into the vein wall. After 24 weeks, the mean (SD) neointimal thicknesses over stent struts with 2 mm, 5 mm, and 8 mm skipped segments were 254.0 (51.6), 182.2 (98.1), and 194.6 (101.1) µm, respectively. Comparison of endothelialisation scores of stents over time showed statistically significantly better endothelialisation over stents with 8 mm gaps after 12 and 24 weeks. CONCLUSION: Stent designs providing structural support to veins with larger gaps between the scaffold material appear to lead to faster and more complete endothelialisation as well as a thinner intimal layer.

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.

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.

New Large Animal Model for Aortic Aneurysms in the Viscerorenal Segment.

BACKGROUND: Aortic aneurysms in the viscerorenal-segment are nowadays treatable by endovascular means. Previously, new endograft techniques were only tested in healthy animals. We aimed to establish a new large animal model for testing complex endovascular stent techniques preclinically. METHODS: In sheep, four juxtarenal and two type IV thoracoabdominal aortic aneurysms were surgically created via a retroperitoneal approach. Two pieces out of a 10 × 15-cm bovine pericardial patch were sewn with the healthy aorta longitudinally. The viscerorenal segment was clamped, and the aorta was incised longitudinally. Then, the patches were longitudinally sewn together. In the meantime, antegrade flow through the native part of the aorta was already established by tangential clamping. Computed tomography angiography was performed after 4, 8, and 52 wk. RESULTS: Technical success was 100%. The median surgical procedure time was 3 h, the median blood loss was 210 mL, and the viscerorenal-segment clamping time was 2-4 min. The animals started drinking 1 h after arousal from anesthesia. One animal died after 1 wk because of delayed bleeding and another died after 1 y because of aneurysm rupture by a secondary bacterial infection. Four animals survived. The proximal landing zone diameter and the clock position of the vessel were stable over 52 wk. CONCLUSIONS: Surgical creation of an aortic aneurysm in the viscerorenal-segment in sheep was successful, without an ischemia/reperfusion injury. This animal model offers a new platform for evaluating innovative endovascular therapy options in vivo.

The Role of May-Thurner Syndrome in Recurrent Thrombosis after Catheter-Directed Thrombolysis of Deep Vein Thrombosis.

BACKGROUND: May-Thurner syndrome (MTS) leads to an increased incidence of deep vein thrombosis (DVT). Early thrombus removal decreases the post-thrombotic morbidities. Our aim was to better elucidate the relationship between MTS and venous patency after catheter-directed thrombolysis (CDT). METHODS: The medical records of all patients who underwent CDT from January 2005 to December 2011 due to acute DVT were reviewed retrospectively. Patient characteristics and clinical variables were evaluated to determine association with vein patency. RESULTS: A total of 51 male and 31 female with a mean age of 34.9 years were treated with CDT. During a median follow-up of 91.7 months, primary patency and secondary patency of all patients were 79.3% and 87.3%, respectively. The presence of MTS was the only significant predictor factor of patency. CONCLUSIONS: The residual stenosis caused by MTS is a risk for recurrent DVT and should be treated with stenting to improve the outcome.

Closed Incision Negative Pressure Therapy Reduces Surgical Site Infections in Vascular Surgery: A Prospective Randomised Trial (AIMS Trial).

BACKGROUND: Surgical site infections (SSIs) of the groin remain a crucial problem in vascular surgery, prompting great interest in preventative techniques, such as closed incision negative pressure therapy (ciNPT). This prospective randomised study aimed to assess the potential benefits of ciNPT application after groin incisions for vascular surgery. METHOD: The study included 204 patients who underwent vascular surgery for peripheral artery disease (PAD) at two sites between July 2015 and May 2017. These patients received post-operative treatment with ciNPT (intervention group) or standard wound dressings (control group). After exclusion, 188 patients were assessed for SSIs using the Szilagyi classification. RESULTS: The mean patient age was 66.6 ± 9.4 years (range 43-85 years), and 70% were male (n = 132). Regarding PAD stage, 52% were stage IIB, 28% stage III, and 19% stage IV. Among the patients, 45% (n = 85) had had a previous groin incision. Bacterial swabs were performed in each case of suspected SSI (22.8% [43/188]), while 76.7% (33/188) were negative, there were 5% [5/98] positive swabs in the intervention group and 5.5% [5/90] in the control group). Antibiotics were given to 13.2% of the intervention group, and 31.1% of the control group (p = .004). The control group experienced more frequent SSIs (33.3%; 30/90) than the intervention group (13.2%; 13/98; p = .0015; absolute risk difference -20.1 per 100; 95% CI -31.9 to 8.2). This difference was based on an increased rate of Szilagyi I SSI in the control group (24.6% vs. 8.1%, p = .0012). CONCLUSION: The results confirmed a reduced superficial SSI rate after vascular surgical groin incision using ciNPT compared with standard wound dressings.

Extra-Thoracic Supra-aortic Bypass Surgery Is Safe in Thoracic Endovascular Aortic Repair and Arterial Occlusive Disease Treatment.

OBJECTIVE: The safety and feasibility of supra-aortic debranching as part of endovascular aortic surgery or as a treatment option for arterial occlusive disease (AOD) remains controversial. The aim of this study was to assess the clinical outcome of this surgery. METHODS: This single centre, retrospective study included 107 patients (mean age 69.2 years, 38.4% women) who underwent supra-aortic bypass surgery (carotid-subclavian bypass, carotid-carotid bypass, and carotid-carotid-subclavian bypass) because of thoracic or thoraco-abdominal endovascular aortic repair (57%; 61/107) or as AOD treatment (42.9%; 46/107) between January 2006 and January 2015. Mortality, morbidity with a focus on neurological complications, and patency rate were assessed. Twenty-six of 107 (14.2%) of the debranching patients were treated under emergency conditions because of acute type B dissection or symptomatic aneurysm. Follow up, conducted by imaging interpretation and telephone interviews, continued till March 2017 (mean 42.1, 0-125, months). RESULTS: The in hospital mortality rate was 10.2% (11/107), all of these cases from the debranching group and related to emergency procedures (p < .0001). One procedure related death of a patient in the debranching group, who had a lethal stroke 72 months post-operatively following bypass occlusion was observed. Early neurological complications were recognised in 10 patients, including two transient cases of Horner syndrome and vocal cord paralysis as well as six cases of phrenic nerve apraxia. Three cases of stenosis and one case of occlusion were successfully treated. In three AOD patients, the graft had to be exchanged because of peri-graft reaction. Primary and secondary patency rates of 96 patients after 36 months were 95% (SE 2.6%) and 98% (SE 1.8%), respectively. CONCLUSIONS: Extra-thoracic supra-aortic bypass surgery involves low complication rates and high mid-term bypass patency rates. It is a safe and feasible treatment option in the form of debranching in combination with endovascular aortic aneurysm repair and in AOD.

[Endovascular Therapy of Chronic Venous Outflow Obstruction]. / Endovaskuläre Rekanalisation chronischer Beckenvenenverschlüsse.

Current national and international guidelines recommend endovascular therapy of iliofemoral thromboses in young patients, as a treatment option to avoid the post-thrombotic syndrome. Possible techniques include endovascular local lysis therapy, as well as pharmacomechanical or purely mechanical procedures. Endovascular therapy of chronic obstruction of the inferior V. cava or pelvic veins is an effective therapy for patients suffering from post-thrombotic syndrome. If there is involvement of the V. femoralis communis, hybrid operations may be considered in which an AV fistula is formed or endophlebectomy is carried out.

[Deep Veins: Hybrid Procedure for Treatment of Iliofemoral Obstruction]. / Tiefes Venensystem: Hybridverfahren zur Therapie der iliofemoralen chronischen venösen Obstruktionen.

Background Endovascular recanalisation of chronic obstruction of iliofemoral or caval veins gives very good patency. However, patency decreases if the common femoral vein and its side branches are also involved. Endophlectomy during a hybrid procedure can improve outcome and avoid early reocclusion due to restored inflow. The review presents the technical details and the published results of this technique. Results The hybrid procedure combines venous recanalisation and stent angioplasty with endophlebectomy. There have only been 4 studies with more than 10 patients and follow-up between 6 and 24 months. Primary and secondary patency ranges from 0 to 70% and 30 to 93%, respectively, but most patients showed clinical benefit. Conclusion Although there have only been a few studies on the hybrid procedure with endophlebectomy, this technique seems to improve the outcome of venous recanalisation if femoral inflow is disturbed.

Operative and Midterm Outcomes of the Fenestrated Anaconda Stent-Graft in the Endovascular Treatment of Juxtarenal, Suprarenal, and Type IV Thoracoabdominal Aortic Aneurysms.

PURPOSE: To report operative and midterm outcomes of fenestrated endovascular aneurysm repair (FEVAR) with the Anaconda device. METHODS: A retrospective analysis was conducted of 39 consecutive patients (median age 74 years; 36 men) treated with the fenestrated Anaconda stent-graft between July 2011 and December 2015 at a single center. Indications for FEVAR were abdominal aortic aneurysms (AAAs) with neck anatomy unsuitable for a standard stent-graft. Median infrarenal neck length was 4 mm (range 0-9). Four (10%) patients presented with type IV thoracoabdominal aortic aneurysm (TAAA), 12 (31%) with suprarenal aneurysms, and 23 (59%) with juxtarenal aneurysms. Four (10%) patients had previous infrarenal aortic repair. Five (13%) patients had an infrarenal neck angulation >60°. A total of 106 fenestrations were incorporated into the stent-grafts (73 renal arteries, 25 superior mesenteric arteries, and 8 celiac trunks). Technical success, perioperative and midterm mortality and morbidity, target vessel patency, endoleaks, and reinterventions were documented. RESULTS: Technical success was 95% (37/39). Three (8%) patients died in-hospital from mesenteric embolism in 2 and renal artery rupture with consequent multiorgan failure in 1. Two (5%) patients suffered an intraoperative embolic stroke. During a median follow-up of 33 months (range 4-55), adjunctive maneuvers were performed in 9 (23%) patients, including reintervention for type II endoleak with enlarged aneurysm sac in 2 (5%). Four additional patients died of causes unrelated to the aortic pathology (overall mortality 18%). In 34 (94%) of the 36 patients seen in follow-up, aneurysm sac size was stable or decreased. Target vessel stent patency was 99% (95/96). CONCLUSION: FEVAR with the Anaconda device delivers satisfactory short-term technical and clinical success rates in patients with juxtarenal, suprarenal, and type IV TAAA. Midterm efficacy and durability with respect to aneurysm sac regression and target vessel patency appear very good. Overall mortality and the need for reintervention were significant in this patient cohort.

Blunt Thoracic Aortic Injury in Case of a 15-Year-Old Boy: Difficulties and Possibilities of the Endovascular Approach.

BACKGROUND: Blunt thoracic aortic injuries (BTAIs) are rare but life threatening. Most BTAI are caused by high-energy trauma. Among children with blunt trauma, the incidence of BTAI is below 1 percent. The present case deals with covered thoracic aortic rupture of a 15-year-old boy. Emphasizing the value and the difficulties of endovascular surgery in children is the motivation for this case report. CASE REPORT: We are presenting the case of a 15-year-old boy, who suffered multiple traumata after accident. Beneath multiple fractures and a liver laceration, a thoracic aortic rupture with pseudoaneurysm of the aortic wall was diagnosed. Owing to the comorbidities, an endovascular therapy in combination with a transposition of the left subclavian artery to the common carotid artery was performed. The chronological line-up of the events and the endovascular treatment as well as the in-hospital follow-up are described. DISCUSSION: Injury-induced BTAI in pubescent children rarely occurs. Only few cases can be found in literature, none of which were associated with the presented pattern of injury. CONCLUSIONS: The optimal treatment for childhood BTAI is a case-by-case decision. We critically discuss the value of endovascular therapy in the present case.

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.

The emerging role of mechanical thrombectomy in acute DVT management.

Catheter directed thrombolysis (CDT) and pharmacomechanical thrombectomy in various technical combinations have been the main driver of acute deep venous interventions for over a decade. While the majority of high-level evidence was based on it, CDT requires longer procedural care and is associated to a small but not negligible bleeding risk. Contemporary DVT intervention, following the paradigm shift in myocardial infarction and stroke management, has steadily migrated towards minimizing or eliminating thrombolytics due to the introduction of mechanical/aspiration thrombectomy. Mechanical thrombectomy (MT) devices are undoubtedly improving our ability to remove thrombus more efficiently in a single session without the adverse events and complex logistics related to the use of thrombolytics.