First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries.

PURPOSE: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. MATERIALS AND METHODS: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. RESULTS: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). CONCLUSION: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.

Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention.

OBJECTIVE: Data on paclitaxel coated balloons (PCBs) for below knee (BTK) angioplasty exhibited conflicting efficacy results, and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of PCBs for BTK interventions in a real world cohort. METHODS: Within a single centre cohort study, 552 consecutive patients were included undergoing BTK interventions with and without PCB use. Two year safety and efficacy results were compared in unadjusted and propensity score matched (PSM) analysis. RESULTS: BTK interventions were performed in 157 patients with PCB angioplasty (100% Lutonix 0.014 inch drug coated balloon; Bard Lutonix, New Hope, MN, USA) and 395 patients with plain old balloon angioplasty (POBA). The majority of interventions (> 70%) were performed for chronic limb threatening ischaemia. Mean lesion length was 20.8 ± 12.6 cm; 61.2% in the PCB and 66.7% in the POBA group were occlusions. In the PCB group, more procedures were performed for re-stenotic lesions than POBA (28.5 vs. 17.2%). In PSM analysis (128 matched pairs), the primary efficacy endpoint was freedom from clinically driven target lesion revascularisation (CD TLR), which occurred in 70.1% in the PCB and 73.1% in the POBA group at one year (p = .85; McNemar test). Survival analysis suggested lower rates of major amputations in the PCB group in unadjusted (94.4% ± 2.1 vs. 89.2% ± 1.9 in the POBA group) and PSM analyses (97.2% ± 1.6 vs. 89.3% ± 3.5) through two years, while no differences were seen for CD TLR and all cause mortality between the groups. CONCLUSION: In this all comer analysis, PCBs were found to be safe for BTK interventions with a signal towards lower amputation rates but no benefit was seen for repeat revascularisation.

ELECT: prospective, randomized trial comparing microvascular plug versus platinum-fibered microcoils for embolization of aneurysm sac side branches before endovascular aortic aneurysm repair.

BACKGROUND: Preemptive selective embolization of aneurysm sac side branches (ASSBs) has been proposed to prevent type II endoleak after endovascular aortic aneurysm repair (EVAR). This study aimed to explore if an embolization strategy using microvascular plugs (MVP) reduces intervention time and radiation dose compared to platinum-fibered microcoils. Furthermore, the effectiveness of the devices in occluding the treated artery was assessed. METHODS: Sixty patients scheduled for EVAR underwent percutaneous preemptive embolization of ASSBs using MVPs or coils after a 1:1 randomization. Follow-up imaging was performed during aortic stentgraft implantation. RESULTS: Overall, 170 ASSBs were successfully occluded (83 arteries by MVPs and 87 by coils) and no acute treatment failure occurred. The mean procedure time was significantly lower in the group treated with MVPs (55 ± 4 min) compared to coil occlusion (67 ± 3 min; p = 0.018), which was paralleled by a numerically lower radiation dose (119 Gy/cm2 vs. 140 Gy/cm2; p = 0.45). No difference was found for contrast agent use (34 ml MVP group vs 35 ml coil group; p = 0.87). At follow-up, reopening of lumbar arteries was seen in nine cases (four after coil embolization; five after MVPs). CONCLUSION: Both microvascular plugs and coils can be effectively used for preemptive embolization of aneurysm sac side branches before EVAR. Use of plugs offers a benefit in terms of intervention time. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03842930 Registered 15 February 2019.

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

Impact of Optimal Medical Therapy on Reintervention and Survival Rates after Endovascular Infrapopliteal Revascularization.

Within this single-center cohort study, we investigated the impact of optimal medical therapy on all-cause mortality, major amputation-free survival and clinically driven target lesion revascularization (CD TLR) in 552 patients with peripheral arterial disease (PAD) undergoing endovascular infrapopliteal revascularization. From the overall cohort, 145 patients were treated for intermittent claudication (IC) and 407 were treated for critical limb ischemia (CLI). Optimal medical therapy (OMT) was defined as the presence of at least one antiplatelet agent, statin and ACE inhibitor or AT-2 antagonist based on guideline recommendations. About half (55.5%) of all patients were prescribed OMT at discharge, with a higher proportion in claudicants (62.1%) versus CLI patients (53.2%). Over three years of follow-up, survival was significantly better in patients with IC (80.6 ± 3.8% vs. 59.9 ± 2.9%; p < 0.001). There was a signal towards better survival in those patients receiving OMT (log-rank p = 0.09). Similarly, amputation-free survival (AFS) was significantly better in patients with IC (p = 0.004) and also in patients receiving OMT (78.8 ± 3.6%) compared to that in those without OMT (71.5 ± 4.2%; p = 0.046). Freedom from CD TLR within three years was significantly better in the IC group (p = 0.002), but there were no statistically significant differences for CD TLR dependent on the presence of OMT (p = 0.79). In conclusion, there is still an important underuse of OMT in patients undergoing infrapopliteal interventions, which is even more pronounced in CLI despite a signal for its benefit regarding all-cause mortality and major amputation-free survival.

Feasibility and Safety of Percutaneous Axillary Artery Access in a Prospective Series of 100 Complex Aortic and Aortoiliac Interventions.

We aimed to review the feasibility and safe use of the percutaneous axillary artery (AxA, 100 patients) approach for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA, 90 patients) using fenestrated, branched, and chimney stent grafts and other complex endovascular procedures (10 patients) necessitating AxA access. Percutaneous puncture of the AxA in its third segment was performed using sheaths sized between 6 to 14F. For closing puncture sites greater than 8F, two Perclose ProGlide percutaneous vascular closure devices (PVCDs) (Abbott Vascular, Santa Clara, CA, USA) were deployed in the pre-close technique. The median maximum diameter of the AxA in the third segment was 7.27 mm (range 4.50-10.80). Device success, defined as successful hemostasis by PVCD, was reported in 92 patients (92.0%). As recently reported results in the first 40 patients suggested that adverse events, including vessel stenosis or occlusion, occurred only in cases with a diameter of the AxA < 5 mm, in all subsequent 60 cases AxA access was restricted to a vessel diameter ≥ 5 mm. In this late group, no hemodynamic impairment of the AxA occurred except in six early cases below this diameter threshold, all of which could be repaired by endovascular measures. Overall mortality at 30 days was 8%. In conclusion, percutaneous approach of the AxA in its third segment is feasible and represents a safe alternative access to open access for complex endovascular aorto-iliac procedures. Complications are rare, especially if the maximum diameter of the access vessel (AxA) is ≥5 mm.

Popliteal Artery Entrapment Syndrome: A Rare Cause of Interwoven Nitinol Stent Fracture After Femoropopliteal Interventions.

Stent fractures have been described after femoropopliteal interventions with relevant clinical sequelae, including restenosis and reocclusion. We report 2 cases of fractures of a novel interwoven nitinol stent with high radial strength and fracture resistance as a result of entrapment syndrome of the popliteal artery. (Level of Difficulty: Advanced.).

Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial.

BACKGROUND: So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies. OBJECTIVES: The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 µg/mm2 and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed. METHODS: Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes. RESULTS: At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups. CONCLUSIONS: The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543).

Voluntary consensus based geospatial data standards for the global illegal trade in wild fauna and flora.

We have more data about wildlife trafficking than ever before, but it remains underutilized for decision-making. Central to effective wildlife trafficking interventions is collection, aggregation, and analysis of data across a range of source, transit, and destination geographies. Many data are geospatial, but these data cannot be effectively accessed or aggregated without appropriate geospatial data standards. Our goal was to create geospatial data standards to help advance efforts to combat wildlife trafficking. We achieved our goal using voluntary, participatory, and engagement-based workshops with diverse and multisectoral stakeholders, online portals, and electronic communication with more than 100 participants on three continents. The standards support data-to-decision efforts in the field, for example indictments of key figures within wildlife trafficking, and disruption of their networks. Geospatial data standards help enable broader utilization of wildlife trafficking data across disciplines and sectors, accelerate aggregation and analysis of data across space and time, advance evidence-based decision making, and reduce wildlife trafficking.

Comparison of Interim PET Response to Second-Line Versus First-Line Treatment in Classic Hodgkin Lymphoma: Contribution to the Development of Response Criteria for Relapsed or Progressive Disease.

In first-line treatment of Hodgkin lymphoma (HL), Deauville scores 1-3 define complete metabolic remission. Interim 18F-FDG PET is also used for relapse-treatment adaptation; however, PET response criteria are not validated for relapse treatment. Methods: We performed a pairwise comparative analysis of early response to first- and second-line treatments in 127 patients with classic HL who experienced relapse. The patients participated in the prospective, multicenter EuroNet-PHL-C1 study. Residual uptake was measured retrospectively using the qPET method, a validated semiautomatic quantitative extension of the Deauville score. Empiric cumulative distribution functions of the qPET values were used to systematically analyze the response to first- and second-line treatments. Results: Individual patients responded variably to first- and second-line treatments. However, the empiric cumulative distribution functions of the qPET values from all patients were nearly superimposable. Conclusion: The findings support that first- and second-line treatments in HL do not require different response criteria.

Retrograde Tibioperoneal Access for Complex Infrainguinal Occlusions: Short- and Long-Term Outcomes of 554 Endovascular Interventions.

OBJECTIVES: This study sought to report short- and long-term efficacy and safety outcomes of retrograde tibioperoneal access for endovascular treatment of chronic total occlusions (CTOs). BACKGROUND: Antegrade recanalization of peripheral CTO is associated with a high failure rate and retrograde puncture of tibioperoneal arteries has been adopted to overcome this limitation. METHODS: Within a retrospective single center cohort study, data of 554 infrainguinal occlusions were acquired in which a retrograde puncture of at least 1 infrapopliteal artery became necessary. Techniques used for access, retrograde lesion crossing, and antegrade treatment modalities were recorded. Next to short-term outcomes, long-term results through 4 years were described using survival analysis. RESULTS: The majority of patients (71.5%) had critical limb ischemia (CLI) and occlusion locations were the femoropopliteal segment (35.9%), infrapopliteal segment (42.6%), or both segments (21.5%). Retrograde access was most commonly performed via the proximal (28%) or distal (34%) anterior tibial artery. Retrograde access could be established in 98.6% and subsequent lesion crossing was successful in 95.1%. Complications due to distal puncture were rare (3.3%). At 1 year, freedom from target lesion revascularization and restenosis were 74.6 ± 3.7% and 67.5 ± 4.4% in claudicants and 62.2 ± 2.8% and 36.0 ± 4.4% in CLI patients, respectively. Late complications at the distal puncture site after a median follow-up time of 234 days comprised 1 stenosis, 7 occlusions, and 3 clinically nonrelevant arteriovenous fistula occurring only in CLI patients. CONCLUSIONS: Retrograde tibioperoneal access is a safe option for recanalization of complex CTOs after a failed antegrade approach. Complications at the puncture site were rare.

Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease.

BACKGROUND: Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES: The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS: Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. RESULTS: More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. CONCLUSIONS: Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441).