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Purpose: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB)., Materials and Methods: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants., Results: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34)., Conclusions: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018)., (© 2022. The Author(s).)

Purpose: Evidence on efficacy and long-term safety of paclitaxel-coated devices is still conflicting. Therefore, this study aims to assess whether sirolimus-coated balloon angioplasty is safe and effective for the treatment of infra-popliteal occlusions in patients with chronic limb-threatening ischemia (CLTI)., Study Design: The randomized controlled, single-blinded, multicentre, investigator-initiated study aims to enrol 230 participants with CLTI and infra-popliteal occlusions at up to 25 centres. Patients will be randomized in a 1:1 ratio to either sirolimus-coated balloon angioplasty or to plain old balloon angioplasty (POBA). Bailout stenting in case of flow-limiting dissection or ≥ 50% residual diameter stenosis is permitted., Outcome Measures: Primary outcome is the Kaplan-Meier estimate of primary patency at 6 months, defined as the absence of target lesion occlusion with restoration of in-line flow to the ankle. Key secondary outcome is non-inferiority in the proportionate occurrence of major adverse limb events and perioperative all-cause death at 30 days. Overall, participants will be followed for 36 months to assess further secondary efficacy and safety outcomes., Assumed Gain of Knowledge: If sirolimus-coated balloon angioplasty turns out to be superior to uncoated-balloon angioplasty regarding patency of infra-popliteal lesions without safety signals, it could become a welcome treatment option for patients with CLTI. Trial Registration ClinicalTrial.gov Identifier: NCT04772300, German Clinical Trials Register: DRKS00024629. Level of Evidence Level 2a, randomized controlled trial., (© 2022. The Author(s).)

Purpose: To investigate drug contamination of the working environment with paclitaxel drug-coated balloon (DCB) angioplasty due to loss of paclitaxel containing particles from the coating during DCB preparation, insertion, and inflation., Material and Methods: In an experimetal laboratory setting, drug loss during removal of the protective cover and insertion of the DCB through the hemostatic valve of the introducer sheath and after inflation was examined. In seven DCB types of different manufacturers, semi-quantitative image analysis was performed during five standardized tests cycles. Additionally, every DCB type passed one cycle of a wipe test and one cycle of air sampling., Results: By removing the protective cover, the paclitaxel-covered balloon surface was significantly reduced in 3 out of 7 products (P = 0.043). Overall, extend of decline ranged from 0.4 to 12%. In 6 of 7 products, powdered paclitaxel clusters dropped down upon removal of the protective cover (0.099 ng/cm 2 up to approx. 22 ng/cm 2 ). Contamination of the air was detected in none of the DCB types. When pushed through the vascular sheath, none of the investigated DCB types showed a significant loss of paclitaxel from the coated balloon surface. After balloon inflation, the paclitaxel-coated surface area varied between manufacturers ranging from 25.9 to 97.8%., Conclusion: In some DCB types, the removal of the protective cover already leads to a significant loss of paclitaxel and paclitaxel-coated surfaces. As a result, there will be a contamination of the workplace and a reduction in the therapeutic dose., Level of Evidence: No level of evidence., (© 2022. The Author(s).)

Purpose: To assess radiation exposure in men undergoing prostate artery embolization (PAE) for the treatment for symptomatic, benign prostatic hyperplasia depending on growing experience of interventional radiologists over a 4-year period., Methods: A total of 250 consecutive patients underwent PAE at a single center. Data on radiation exposure [dose area product (DAP), effective dose (ED), entrance skin dose (ESD), and fluoroscopy time (FT)] were retrospectively evaluated. Primary outcomes of interest were patient radiation exposure in five consecutive groups of 50 patients each and Pearson correlation with the number of patients treated., Results: Median DAP, ED, and ESD during prostate artery embolization were significantly higher in the first compared to the second 50 patients (56 298 µGym 2 vs. 24 709 µGym 2 , p < 0.001, 146.4 mSv vs. 64.2 mSv, p < 0.001, and 5.1 Gy vs. 2.4 Gy, p < 0.001, respectively). The following consecutive groups did not differ significantly from the respective preceding group in terms of DAP, ED, and ESD. Number of digital subtraction angiography series, FT, and procedure time decreased with increasing operator experience (Pearson's r = - 0.240, p < 0.001, r = - 0.269, p < 0.001, and r = - 0.504, p < 0.001, respectively). Bilateral prostate artery embolization was associated with less ESD and shorter FT than unilateral embolization (median 2.5 vs. 3.5 Gy, p = 0.02, and 26 min vs. 42 min, p < 0.001, respectively)., Conclusion: Exposure to radiation in men who underwent PAE decreased with growing operator experience and decreasing complexity of procedures.

Purpose: The post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty., Methods: In the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months., Results: A total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI - 0.04 to 1.3], p = 0.06 and - 0.3 per 10 years [95% CI - 0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: - 0.1 per 10 mm [95% CI - 0.1 to - 0.03], p = 0.001 and - 0.1 [95% CI - 1.7 to - 0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04)., Conclusion: DCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.

Purpose: This study intended to assess effectiveness and safety of the drug-coated balloon (DCB) angioplasty of infrapopliteal atherosclerotic lesions in patients with critical limb ischaemia (CLI) in a real-world setting., Methods: Consecutive patients with critical limb ischaemia who underwent infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB were enrolled into the prospective, multicentre, single-arm observational registry. Primary outcome was clinical improvement at 6 and 12 months. Secondary outcomes were change in quality of life, primary patency, freedom from repeat revascularisation, and amputation-free survival at 6 and 12 months., Results: A total of 164 patients (74.7 ± 9.2 years) with CLI were included at nine German sites between November 2015 and September 2017. The majority (79.9%) of patients had diabetes mellitus, 57.3% had renal insufficiency, and 35.3% had coronary artery disease. Mean lesion length was 71.2 ± 76.5 mm. The Rutherford category improved by 3.0 ± 2.0 (p < 0.0001) within 12 months, resulting in a clinical improvement by at least one Rutherford category in 80.2% of the patients. Walking impairment questionnaire score, European Quality of Life index, and patient-reported pain improved significantly from baseline to 6 and 12 months. Primary patency was 68.5%, freedom from target lesion revascularisation 90.6%, and amputation-free survival 83.5% at 12 months., Conclusion: Infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB in patients with critical limb ischaemia was efficacious and safe over the medium term. The study is registered with Clinical.Trials.gov (Identifier: NCT02539940).

A great variety of central venous access devices such as tunneled and non-tunneled central venous catheters (CVC) as well as port systems are implanted by interventional radiologists at an increasing rate. There are some possible immediate, early, and late complications related to the implantation technique, care, and maintenance of CVCs. This review will illustrate possible complications of CVCs and will discuss risk factors. Different strategies will be shown regarding the prevention and treatment of complications.