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.

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.

Practical Applications of Tack Implants for Infrainguinal Dissection Repair: A Single-Center Experience.

Purpose: To assess the practical application and acute outcomes of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting. Materials and Methods: Fifty-one consecutive patients who underwent endovascular revascularization for symptomatic peripheral artery disease and experienced 63 dissections requiring treatment were included in the prospective, single-center, single-arm study between January and June 2019. Thirty-nine (76.5%) lesions were ≥10 cm in length, 33 (64.7%) were totally occluded, and 13 (25.5%) were severely calcified. Fifty-six (88.9%) dissections were classified as severe. Dissections were treated either by means of the 6-F above-the-knee (ATK) or the 4-F below-the-knee (BTK) Tack Endovascular System. Observational outcomes were conditions and scopes of application. Clinical outcomes were acute technical and procedural success as well as safety. Results: Lesions were revascularized with 2.3±0.8 attempts such as standard balloon angioplasty, drug-coated balloon angioplasty, atherectomy, and/or lithotripsy. The Endovascular System was applied in 60 (95.2%) of 63 dissections. All dissections of the femoral artery were treated with the ATK system, and all infrapopliteal dissections with the BTK system. Both systems were successfully applied in popliteal artery dissections. Dissection length predicted the number of Tack implants deployed. Technical success was achieved in 98.3% (59 of 60 dissections). No major adverse event or device-related complication occurred during the procedure. Conclusion: Acute results in effectiveness and safety of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting are promising.

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.