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PURPOSE: To report the outcome of a prospective randomized safety and performance trial of 2 access site closure devices versus a wound dressing. METHODS: Between October 2005 and July 2006, 852 consecutive patients (605 men; mean age 67 years) undergoing diagnostic or interventional catheterization procedures thru a 5- or 6-F femoral sheath were randomized to one of the 3 closure methods: a collagen plug device (Angio-Seal), a clip (StarClose), or a wound dressing (D-Stat Dry). The efficacy of the devices was assessed, as well as the complications occurring at the puncture site during the hospital stay. The primary endpoint of the study was the cumulative incidence of access site pseudoaneurysm, major access site bleeding requiring transfusion, access site vascular surgery, or death from all causes. RESULTS: There were no significant differences in baseline characteristics between the 3 treatment groups. The primary endpoint was reached in 20 (7.1%) of 281 patients treated with D-Stat Dry and in 11 (1.9%) of 571 patients treated with the mechanical closure devices (p<0.0001). There was no significant difference among the mechanical closure devices concerning the incidence of the primary endpoint (Angio-Seal 1.1% versus StarClose 2.8%; p = 0.13). CONCLUSION: The collagen plug device had the lowest rates of major and minor access site-related complications after removal of 5- or 6-F femoral sheaths. The difference between the mechanical closure devices concerning the incidence of the primary endpoint did not reach statistical significance. The wound dressing showed significantly higher major and minor complication rates. [ABSTRACT FROM AUTHOR]

Purpose: To determine if angioplasty of atherosclerotic renal artery stenosis, which reduces the activation of the renin-angiotensin-aldosterone system (RAAS), may lead to regression of left ventricular hypertrophy. Methods: The study included 102 patients (58 men; mean age 67 years, range 66-69) who underwent stent-supported percutaneous transluminal renal angioplasty (PTRA) and were included in a clinical follow-up program (mean 24+/-14 months, range 6-60). As a control group, 101 contemporaneous patients (68 men; mean age 68 years, range 66-70) with essential hypertension were investigated. The primary endpoint was the change in left ventricular mass index (LVMI) determined by echocardiography. Results: Mean follow-up intervals were 24+/-14 months (range 6-60) in the study group and 27+/-14 months (range 6-60) in the controls (p = 0.09). LVMI decreased significantly by -10+/-26 g/m(2) in the study group, while it increased significantly by 9+/-28 g/m(2) in the control group (p = 0.001 between groups). In the study group, mean arterial blood pressure was significantly reduced from 99+/-11 mmHg to 90+/-11 mmHg (p<0.0001) during follow-up despite a significant reduction in medication, whereas it increased significantly from 102+/-11 mmHg to 105+/-11 mmHg (p = 0.008) in the control group, although medication was significantly increased. After adjustment for various factors and covariables, PTRA prevailed as an independent predictor for regression of LVMI (p = 0.038). Conclusion: PTRA induces regression of LVMI that is independent of the reduction in blood pressure induced by this procedure. Reduced activity of the RAAS may account for this regression. [ABSTRACT FROM AUTHOR]

Purpose: To report the 12- and 24-month results after directional atherectomy (DA) of below-the-knee (BTK) arterial lesions with the SilverHawk device.Methods: Forty-nine BTK lesions in 36 patients (58% men; mean age 70+/-11 years) with peripheral occlusive disease of the lower limbs were treated with DA; 19 (53%) of the limbs were classified with Rutherford-Becker 4 or 5 ischemia. Target lesions were in the popliteal artery (n = 6, 12%), tibioperoneal trunk (n = 25, 51%), peroneal artery (n = 10, 20%), anterior tibial artery (n = 5, 10%), and posterior tibial artery (n = 3, 6%). Nine (18%) lesions were located in a stent. Twelve lesions extended to 2 artery segments. The average degree of diameter stenosis was 89%+/-10% (range 70%-100%); there were 11 (22%) occlusions. The mean lesion length was 48+/-28 mm.Results: Sixteen (33%) lesions were treated after predilation; 33 (67%) lesions were treated with primary DA. All but 1 (2%) lesion could be treated with DA. In 19 (39%) lesions, additional balloon angioplasty was performed, and 2 (4%) lesions required stent implantation as a result of dissection. The mean stenosis diameter after DA was 12%+/-18% (range 0%-100%). After additional therapy, the mean stenosis diameter was 8%+/-9% (range 0%-100%). A residual stenosis

Background In many patients today, elective percutaneous transluminal coronary angioplasty is followed by implantation of coronary stents to achieve optimal results. The current medical strategy to prevent early reocclusion is the inhibition of platelet aggregation by administration of ticlopidine, in addition to aspirin, immediately after the procedure. In order to inhibit platelet aggregation as early as possible, many centres begin to treat patients with additional ticlopidine the day before elective coronary intervention. The aim of this study was to determine the effect of this strategy on platelet aggregation before angioplasty.Method Fifty-two consecutive patients admitted to hospital for elective balloon angioplasty were prospectively randomized to receive either standard oral aspirin 100mg per day or standard therapy plus 250mg ticlopidine at the time of admission and the morning before angioplasty. Adenosine diphosphate-, collagen- and epinephrine-induced platelet aggregation was measured immediately before the procedure by an investigator who was blinded concerning the arm of therapy.Results The two groups of patients were comparable in terms of age, sex, body mass index, anginal state, time interval between application of study drug and coronary intervention. Patients on aspirin and ticlopidine had a mean maximal platelet aggregation of 36±12% with adenosine diphosphate as agonist. For the control group, 54±12% was measured (P<0·001). Myocardial infarction or emergency coronary bypass grafting did not occur in either group. Local haemorrhagic complications at the arterial access site occurred in five (aspirin) and six (aspirin and ticlopidine) patients (P=ns) none of them requiring blood transfusion.Conclusion The additional application of ticlopidine to chronic aspirin therapy the day before elective coronary balloon angioplasty leads to a significantly higher inhibition of platelet aggregation at the time of the intervention. It seems to be safe compared to the standard procedure. [ABSTRACT FROM PUBLISHER]

Objective : Patients with peripheral artery occlusive disease (PAD) are at risk of developing foot ulcers, which can subsequently lead to foot infections and an increased risk of amputation. In cases of severe ischemic foot infections (IFIs), the empirical use of antibiotics can be limb-saving. However, there is currently no evidence-based guidance on the choice of empirical antibiotic therapy for IFI. Methods and Design: This retrospective single-center cohort study included 216 hospitalized patients with severe IFI undergoing endovascular revascularization. Weighted-Incidence Syndromic Combination Antibiograms (WISCAs) were calculated to guide empirical antibiotic choice. Results: The two most common causative pathogens for IFI were S. aureus and P. aeruginosa , with frequencies of 19.8% and 6.1%, respectively. The calculation of WISCAs revealed a low empirical coverage of amoxicillin (AMX) or clindamycin (CLN) with 21.6% and 27.7%, respectively. The empirical coverage of amoxicillin/clavulanic-acid (AMC), trimethoprim/sulfmethoxazole (SXT), and ciprofloxacin (CIP) was 50.6%, 53.1%, and 55.4%, respectively. Piperacillin/tazobactam (PT) exhibited the highest empirical coverage, with 82.5% as calculated by WISCAs. The calculated WISCAs did not significantly alter when stratified by the clinical characteristics of the patients. Conclusions: The empirical antibiotic coverage of CLN and AMX was low. SXT represents a promising empirical alternative in the case of IFI, irrespective of comorbidities and the WIfI score. WISCAs can assist in the decision-making process regarding empirical antibiotic therapy choices in cases of IFI.

Objectives : To evaluate the safety and efficacy of catheter-directed thrombolysis (CDT) with the recombinant tissue plasminogen activator (rt-PA) in all patients with symptomatic peripheral artery disease in real world practice. Methods: Consecutive patients treated with CDT between January 2013 and December 2020 were included in this retrospective analysis. The primary endpoint was the rate of serious adverse events (SAEs) until discharge. Secondary endpoints included interventional success, predictors for SAEs, bleeding and reperfusion edema/compartment syndrome, limb salvage, and clinical outcomes including target lesion revascularization rate (TLR). Results: Overall, 1238 patients were treated with CDT. SAEs occurred in 511 (41.3%) of the patients, 314 (25.4%) being bleeding complications. There were 95 cases of reperfusion edema/compartment syndrome. Forty-two patients underwent amputation and 33 patients (2.7%) died. CDT was successful in 1177 cases (95.1%). Multivariate logistic regression analysis identified age, abciximab and alprostadil usage, and lysis duration as predictors for SAEs and the use of abciximab as a predictor of reperfusion edema/compartment syndrome. Predictors for bleeding were age, alprostadil usage, and lysis duration. At 12 and 24 months, the limb salvage rate was 91.6% and 88.8%, and TLR rate was 46% and 57.2%, respectively. Conclusions: CDT is an effective endovascular method for the treatment of thrombotic peripheral artery occlusions but is associated with a high complication rate. For SAEs in general and bleeding specifically, increasing age, alprostadil use, and lysis duration were independent risk factors.

Purpose: Vessel recoil is a common phenomenon occurring in the tibial vessels following balloon angioplasty. This study examined the occurrence and short-term impact of acute vessel recoil in a subset of patients treated with retrievable scaffold therapy (RST) via the Spur Peripheral Retrievable Scaffold System (Spur)., Methods: Patients with tibial disease underwent angiography immediately following RST, and then 15 minutes post-treatment. Vessel recoil was defined as a ≥10% decrease in lumen diameter after 15 minutes. Recoil was further analyzed by late lumen loss method, subsegmental late lumen loss method, and smallest segment to same segment method. Patient and vessel characteristics were evaluated. Functional recoil (acute vessel spasm), defined as no significant change in minimal lumen diameter (MLD) at baseline compared with 15 minutes post-treatment, was also evaluated., Results: Of the 38 patients (40 lesions; 33 men [87%]; mean [SD] age 75.3 [8.2] years; 26 (68.4%) with diabetes mellitus); recoil was noted in 42.5% of vessels. Prior to treatment, 13 lesions (32.5%) were total occlusions, the mean lesion length was 64.7±30.4 mm, and 27.5% (11/40) were moderate or severely calcified. Mean treated lesion length was 97.8±39.6 mm. For lesions evaluable by duplex ultrasound, 86.7% of vessels (26/30) were patent at 6 months. There was no significant difference in patency between lesions with recoil and lesions without recoil (81.8% vs 89.5%); there was a trend toward patency in the non-recoil group. Two lesions had functional recoil (acute vessel spasm) and were patent at 6 months. There was no statistically significant correlation of recoil to comorbidities or lesion characteristics, including calcification, for which there was also no correlation to patency., Conclusion: Vessel recoil was noted in 42.5% of vessels treated with RST, whereas previous published rates with balloon angioplasty demonstrated vessel recoil up to 97%, suggesting that RST may impact vessel recoil. This exploratory study did not demonstrate a correlation between vessel recoil and patency at 6 months., Clinical Impact: Retrievable scaffold therapy may replace scoring devices and cutting devices for vessel preparation before definite (drug) therapy. Retrievable scaffold therapy supplements already established vessel preparation strategies in order to follow the concept of leaving nothing behaind. A temporary retrievable scaffold for changing vessel compliance and potentially releasing antiproliferative drugs represents a new interventional concept., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: No conflicts of interest related to this study. T.Z. received honoraria from Abbott Vascular, Biotronik, Boston Scientific Corp, Cook Medical, Deutsche Hochdruckliga, Gore & Associates, Medtronic, Philips-Spectranetics, Shockwave, and Veryan; consulted for Boston Scientific Corp, CSI, Gore & Associates, Medtronic, Veryan, Philips-Intact Vascular, Shockwave, Bayer, Vesper Medical, VentureMed, and ANT; and received institutional grants for research, clinical trial, or drug studies from Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun, CSI, Boston Scientific, University of Jena, Pluristem, PQ Bypass, SurModics, Reflow Medical, and Ablative Solutions. C.M. is the Sr Director for Clinical Affairs, Reflow Medical. I.W. is the Medical Director for VasCore and consultant for Penumbra, Inc, Magneto Thrombectomy Solutions, and Daiichi Sankyo. R.K. is the President of Syntropic.

Background: Patients with critical limb-threatening ischemia (CLTI) and infected leg ulcers are at risk of amputation and postinterventional sepsis., Methods: This retrospective, single-center study included patients with CLTI and infected leg ulcers who underwent endovascular treatment (EVT) between 2012 and 2021., Results: The study included 712 patients, 286 (40.2%) of whom underwent amputation (minor, n = 212; major, n = 74). Gram-negative bacteria (GNB) were significantly more prevalent in amputees (36.4% vs 30.9%, p < 0.05). Patients with gram-positive bacteria (GPB) had a 4-year freedom from any amputation rate of 72% (95% CI 64-81%) compared to 52% (95% CI 42-66%) in patients with GNB identification ( p < 0.05). Cox proportional regression analysis showed that GNB, male sex, mean Wound, Ischemia, and foot Infection (WIfI) score, diabetes mellitus, and end-stage renal disease were independently and positively associated with amputation ( p < 0.05). The mean WIfI score and end-stage renal disease were independently and positively associated with death from any cause ( p < 0.05). Staphylococcus aureus or GNB, end-stage renal disease, and diabetes mellitus were independent risk factors for sepsis after EVT ( p < 0.05). Inpatient-administered antibiotic regimes had significantly higher microbiological activity in cases of GPB identification compared to GNB identification (28% vs 9%, p < 0.05)., Conclusion: Although the isolation of both GNB and S. aureus is a risk factor for sepsis following EVT, the isolation of GNB is independently associated with higher rates of amputation, demonstrating the importance of identifying pathogens to recognize patients at high risk., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: When antegrade recanalization of femoropopliteal and/or infrapopliteal occlusions fails, retrograde access has become an established option. To evaluate the results of combined antegrade and retrograde recanalization of femoropopliteal and infrapopliteal occlusions, patients undergoing secondary retrograde recanalization attempts were analyzed retrospectively., Methods: The primary end point was the success of the procedure (successful occlusion crossing using the antegrade/retrograde technique). Secondary end points include complication rate, primary patency and target lesion revascularization (TLR) rate, amputation rate, changes in ankle-brachial index, and Rutherford-Becker class. Predictors for procedure failure and TLR were analyzed., Results: We included 888 patients: 362 with femoropopliteal (group 1), 353 with infrapopliteal (group 2), and 173 with multilevel (group 3) recanalization. Critical limb-threatening ischemia was present in group 1, 2, and 3 in 36%, 62%, and 76% of patients, respectively. The intervention was successful in 92.5%, 93.8%, and 90.8% of the respective cases (P = .455). The overall peri-interventional complication rate was 7.2%. At 6, 12, and 24 months, primary patency was highest in group 1 (63.9%, 45.8%, and 33.3%), followed by group 3 (59.8%, 46.1%, and 33.3%), and group 2 (58.5%, 43.1%, and 30.4%; P = .537). The risk of undergoing repeated TLR within 24 months was 31.4% for group 1, 39.1% for group 2, and 45.7% for group 3. At 24 months, the survival rates in groups 1, 2, and 3 were 93.8%, 79.4%, and 87.5%, respectively. Over 24 months, 75 patients (8.4%) had to undergo amputation. Significant improvements in both ankle-brachial index and Rutherford-Becker class were present at discharge as well as at 6, 12, and 24 months (P < .001). Dialysis dependency was a predictor of unsuccessful antegrade/retrograde recanalization (P = .048). Lesion length (P = .0043), dialysis (P = .033), and recanalization level (P = .013) increase the risk of TLR., Conclusions: Using a combined antegrade/retrograde access, recanalization of occluded femoropopliteal and/or infrapopliteal arteries can be achieved in a large number of cases. Owing to the high rate of repeated TLR across all lesion localizations, the indication for antegrade and retrograde recanalization may be limited to patients with critical limb-threatening ischemia., Competing Interests: Disclosures E.N. reports honoraria received from Bard-BD, Boston Scientific Corp, Abbott Vascular, Medtronic, ShockWave, and iVascular. T.Z. reports honoraria received from Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, W. L. Gore & Associates, Medtronic, Philips-Spectranetics, and Shockwave. T.Z. has consulted for Boston Scientific Corp., W. L. Gore & Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, and Vesper Medical and has received Research, clinical trial, or drug study funds received from 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, W. L. Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, and B. Braun. T.Z. Owns common stock in QT Medical. D.W. reports honoraria received from Abiomed, AstraZeneca, Boston, Biotronik, Böhringer, Novartis, and Medtronic., (Copyright © 2024. Published by Elsevier Inc.)

Patients with chronic limb-threatening ischaemia (CLTI) are at risk of foot infections, which is associated with an increase in amputation rates. The use of antibiotics may lead to a higher incidence of antimicrobial resistance (AMR) in subsequent episodes of ischaemic foot infections (IFI). This retrospective single-centre cohort study included 130 patients with IFI undergoing endovascular revascularisation. Staphylococcus aureus and Pseudomonas aeruginosa were the two most common pathogens, accounting for 20.5% and 10.8% of cases, respectively. The prevalence of antimicrobial resistance (AMR) and multi-drug resistance did not significantly increase between episodes (10.2% vs. 13.4%, p = 0.42). In 59% of subsequent episodes, the identified pathogens were unrelated to the previous episode. However, the partial concordance of identified pathogens significantly increased to 66.7% when S. aureus was identified (p = 0.027). Subsequent episodes of IFI in the same patient are likely to differ in causative pathogens. However, in the case of S. aureus, the risk of reinfection, particularly with S. aureus, is increased. Multi-drug resistance does not appear to change between IFI episodes. Therefore, recommendations for empirical antimicrobial therapy should be based on local pathogen and resistance statistics without the need to broaden the spectrum of antibiotics in subsequent episodes., (© 2024 The Author(s). International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Objective: To evaluate the safety and effectiveness of drug-coated balloon angioplasty (DCB) in isolated popliteal lesions., Background: The benefit of using DCB in femoropopliteal arteries including the proximal popliteal artery has been demonstrated, but has not yet been evaluated for isolated popliteal lesions., Methods: This retrospective, single-center study includes patients requiring treatment with DCB of isolated popliteal lesions. Two cohorts matched (Plain old balloon angioplasty (POBA) versus DCB) by their baseline and lesion characteristics were compared. Lesions receiving bail-out stents were excluded. Primary endpoint was the 1-year target lesion revascularization (TLR) rate. Secondary endpoints included the procedural success and complication rate, primary patency, changes in Rutherford-Becker class (RBC) and ankle-brachial index (ABI)., Results: One hundred and seven patients were included in this study. More than one third of the patients had critical limb threatening ischaemia (CLTI) (35 % (POBA) versus 40.4 % (DCB), p = 0.354. The technical success rate of the procedure was 85.1 % (n = 40/47) in the DCB group and 83.3 % (n = 60) in the POBA group (p = 0.510). There were three complications in the POBA group (5.0 %) but none in the DCB group (p = 0.172). After 12 months, in the entire cohort 14 patients (13.1 %) had to undergo a TLR. The TLR-free survival was 81.7 % in the POBA and 93.6 % in the DCB group (p = 0.060). Primary patency rates after POBA and DCB were 65.1 % and 87.5 % at 6 months (p = 0.024), respectively. At 12 months, the patency rates were 71.7 % and 85.1 % (p = 0.076), respectively. For both treatment arms, there was a significant improvement in ABI and RBC compared to baseline. Four patients from the DCB group and two from the POBA group received a minor amputation (p = 0.232). One patient in the DCB group died within 12 months., Conclusion: After one year the use of DCB is by trend more effective for the treatment of isolated popliteal stenosis compared to POBA. A larger scale prospective study is mandatory., Competing Interests: Declaration of competing interest Elias Noory: Honoraria received from: BARD, Boston Scientific, Abbott, Medtronic. Thomas Zeller: Honoraria received from: Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, Shockwave. Consulted for: Boston Scientific Corp., Gore & Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, Vesper Medical. Research, clinical trial, or drug study funds received from (institution): 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun. Common stock: QT Medical. The other authors have no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the mortality after treatment with a paclitaxel (PTX)-coated device and with uncoated devices of iliac, femoropopliteal, and below-the-knee lesions in dialysis patients., Methods: Retrospective mortality analysis of dialysis patients with peripheral artery disease who underwent treatment of iliac, femoropopliteal, and/or infrapopliteal lesions with PTX-coated or uncoated devices., Results: Between 2010 and 2018, 1125 dialysis patients were treated with iliac and/or femoropopliteal and/or infrapopliteal lesions. In all, 359 patients were selected for this retrospective analysis. Of those, 122 patients were treated with uncoated devices without crossover to a PTX-coated device during follow-up and 237 patients were treated with a PTX-coated device. Mean follow-up time was 27.38±24.76 months (range=0-103). For the entire cohort, the overall mortality was 95.1% after uncoated treatment and 75.9% after PTX treatment (p<0.001). After propensity score matching (n=119), overall mortality was 95.0% after uncoated treatment and 78.2% after PTX treatment (p<0.001). For the entire cohort, multivariate logistic regression analysis revealed age (p=0.002) and critical limb ischemia (p<0.001) as independent predictors for mortality. PTX treatment was a protective factor for mortality (p<0.001)., Conclusion: Mortality in dialysis patients is in general high and higher after use of uncoated devices compared with PTX-coated devices. Mortality predictors were risk factors and disease severity but not PTX treatment., Clinical Impact: After the publication of Katsanos's metaanalyses, the uncertainty regarding PTX device safety in peripheral interventions in patients mainly without end-stage renal insufficiency was initially considerable. The present study for the first time investigates the potential long-term mortality risk of dialysis patients following PTX device treatment of PAD. In contrast to a recent meta-analysis, this real-world study could show a better survival after PTX treatment in comparison to uncoated devices., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Elias Noory: Honoraria received from: BARD, Boston Scientific, Abbott, and Medtronic. Thomas Zeller: Honoraria received from: Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, and Shockwave. Consulted for: Boston Scientific Corp., Gore & Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, and Vesper Medical. Research, clinical trial, or drug study funds received from (institution): 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, and B. Braun. Common stock: QT Medical. The other authors have no conflict of interest.

Background: The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty., Purpose: To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries., Methods: A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years., Results: Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs., Conclusion: In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results., Clinical Trial Registration: German Clinical Trials Register: DRKS00031245., Clinical Impact: The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Elias Noory: Honoraria received from: Bard-BD, Boston Scientific Corp, Abbott Vascular, Medtronic, ShockWave Thomas Zeller: Honoraria received from: Abbott Vascular, BIBA Medical, Biotronik, Boston Scientific Corp., Cook Medical, Efemoral, Gore & Associates, Medtronic, Philips-Spectranetics, Shockwave, Veryan. Consulted for: CSI, Gore & Associates, Intact Vascular, Bayer, Vesper Medical. Common stock: QT Medical. The other authors have no conflict of interest.

Purpose: To evaluate the potential differences in characteristics of femoropopliteal in-stent restenosis (ISR) stratified by stent design with a focus on the swirling flow-inducing BioMimics 3D helical centerline stent., Methods: Patients with ISR of the superficial femoral and popliteal arteries undergoing reintervention were included in this study. The primary endpoint was the angiographic localization and extent of restenosis or reocclusion with the following five different stent systems: SMART Control stent, Supera peripheral stent, GORE ® VIABAHN ® endoprosthesis, BioMimics 3D stent, and Zilver ® PTX ® stent., Results: 414 ISR lesions were analyzed, affecting 236 Supera stents, 67 BioMimics 3D stents, 48 Zilver ® PTX ® stents, 38 SMART Control stents, and 25 VIABAHN ® endoprostheses. The mean stent diameter and length were 5.7 ± 0.77 mm and 121.4 ± 94.8 mm, respectively. ISR included 310 (74.9%) lesions with 1 stent, 89 (21.5%) lesions with 2 stents, 14 (3.4%) lesions with 3 stents, and 1 lesion (0.2%) with 4 stents. Most lesions presented as reocclusions (67.4%) rather than focal (13.3%) or diffuse restenoses (19.3%). No significant differences in ISR lesion morphology were found. By trend, BioMimics 3D stent lesion extension was more focal (16.4% versus 12.7%, p = 0.258), with the highest proportion of lesions in which only the proximal stent third was affected (9.0% versus 5.8%, p = 0.230), as compared to the average of the other four devices. The occlusion rate was the second lowest for the BioMimics 3D stent (64.2 vs. 68.0%, p = 0.316). Risk factors for restenosis or occlusion were active smoking, pre-interventional occlusion, and popliteal intervention., Conclusion: Our results suggest that the helical centerline stent design of the BioMimics 3D stent, which results in a swirling flow with increased wall shear stress, may offer protective properties over straight stent designs, including DES and endoprosthesis, regarding localization and extension of restenosis. Prospective, randomized studies are warranted.

Background: In addition to manual compression, various vascular closure devices (VCD) are available to seal the puncture site following arterial vascular procedures. Purpose: To evaluate the efficacy and safety of the extravascular MYNX CONTROL closure system for achieving primary hemostasis after femoral arterial access following peripheral arterial procedures, compared to the intravascular FemoSeal Aclosure system. Patients and Methods: A retrospective analysis of consecutive patients who underwent endovascular intervention between April and November 2022 was performed. The primary endpoint was the incidence of significant puncture site complication defined as a complication resulting in medical treatment. Secondary endpoints included peri-interventional incidence of hematoma, peri-interventional changes in hemoglobin, incidence of emergency diagnostics and predictors for closure system failure. Results: Five hundred and forty-eight patients were included in this analysis. False aneurysm occurred in 18/273 cases (6.6%) following the use of the MYNX closure system, compared to 6/275 cases after using the FemoSeal closure system (2.2%, p = 0.006). The incidence of post-interventional hematoma was not significantly different (28 (10.3%) in the MYNX group versus 32 (11.6%) in the FemoSeal group, p = 0.358). Peri-interventional hemoglobin drop did not differ between groups ( p = 0.449). Emergency diagnostics were not significantly performed more often in the MYNX group (14 (5.1%) versus 8 (2.9%), p = 0.134). A post-interventional duplex sonography showed stenosis at the puncture site in one patient after use of the MYNX system. For the entire cohort, oral anticoagulation was the only predictor for the failure of the closure device ( p = 0.036). Conclusions: Device failure was more common after using the extravascular MYNX CONTROL system than after using the intravascular FemoSeal system. However, the need for surgical or interventional therapy due to device failure was low.

Objective: Severe wound infections in patients with peripheral artery disease (PAD) are common, potentially life- and limb-threatening, and difficult to treat. Evidence on patients with infected leg ulcers in PAD is scarce. This study aims to provide insight into the microbiological patterns and antimicrobial resistance (AMR) of specific pathogens in patients with arterial leg ulcers., Methods and Design: In this retrospective, consecutive, single-centre study 16,553 patients underwent an endovascular revascularization procedure between 2012 and 2021. Of these, 1,142 patients had PAD Rutherford category 5 or 6 with infected leg ulcers. Logistic regression was used to identify risk factors for Staphylococcus aureus-associated infections., Results: A total of 3,431 bacterial isolates were detected, of which 2,335 (68.1%) bacterial isolates were gram-positive and 1,096 (31.9%) were gram-negative species. The most prevalent bacteria were S. aureus (18.6%), Enterococcus faecalis (9.1%) and S. epidermidis (7.8%). Pseudomonas aeruginosa (5.6%), Proteus mirabilis (3.7%) and Escherichia coli (3.4%). The resistance of S. aureus isolates to clindamycin was 11.0%. Resistance to oxacillin was rare (1.5%). P. aeruginosa is frequently resistant to ciprofloxacin (14.4%) whilst intrinsically resistant to trimethoprim/sulfamethoxazole. P. mirabilis and E. coli were frequently resistant to both ciprofloxacin (7.3; 20.7%) and trimethoprim/sulfamethoxazole (24.6; 22.6%), respectively. Resistance to amoxicillin/clavulanic acid was high among E. coli isolates (36.8%). Multi-drug resistance (MDR) was rare among S. aureus and P. aeruginosa isolates. In contrast, the proportion of MDR was high in E. coli isolates. End-stage renal disease was independently positively associated with S. aureus identification (p = .042)., Conclusion: S. aureus was the most common pathogen in arterial leg ulcers with end-stage renal disease being an independent risk factor. Clindamycin resistance was common, making empirical therapy likely to fail. Isolated E. coli species had a high proportion of MDR., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Salm et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Dysfunction in arteriovenous (AV) access is a common reason for subsequent intervention. To evaluate the results of endovascular treatment of AV access lesions using cutting balloon (CB) and drug-coated balloon (DCB) angioplasty compared to standard treatment using plain-old balloon angioplasty (POBA). Patients and methods: Patients who retrospectively were selected from a prospectively maintained database. Primary endpoint was primary patency rate at the target lesion up to 12 months after index procedure. Secondary endpoints were the acute treatment success, the "bail out" stent rate, primary patency at 6 months, freedom from target lesion revascularization (TLR), AV access replacement and surgical revision during a follow-up period up to 12 months, and all-cause mortality rate stratified to patients treated with and without DCB. Results: One hundred and eighty-four patients met the inclusion criteria. POBA as stand alone or combined with DCB angioplasty was performed in 71 patients (38.6%), CB in 54 patients (29.3%), and in 59 patients (32.1%), both CB and DCB were used. Primary patency rate at 12 months was 31.6% for the POBA/DCB-group, 52.3% for the CB-group, and 64.8% for the CB/DCB-group, respectively. In total, 80 patients (51.6%) had a TLR including endovascular or surgical revision, or a shunt replacement. All-cause mortality at 12 months was 7.2% in the DCB group and 9.1% in the group of patients treated without a DCB (p=0.747). Conclusions: The use of CB seems to be crucial for a better outcome. The combination of CB and DCB achieves the best patency results at mid-term.

Objectives: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval., Methods: Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm 2 ) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE)., Results: Fifty-two subjects were enrolled, 69% men, median age 69 (49-83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (-0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively., Conclusion: The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Calcified lesions are a major limitation of endovascular therapy of peripheral artery disease. Recently published studies evaluating the impact of lithotripsy (Disrupt III) and directional atherectomy (REALITY) as vessel preparation devices for calcified femoro-popliteal lesions prior to the final treatment with drug-coated balloons (DCB). Disrupt III, a randomized controlled trial comparing lithotripsy and regular balloon angioplasty for vessel preparation prior to DCB, and REALITY, a single-arm study of directional atherectomy prior to DCB angioplasty resulted in low provisional stent and dissection rates. Moreover, lithotripsy did result in a better 2-year patency rate as compared to predilatation with a regular balloon. Importantly, both vessel preparation strategies resulted in a low rate of post-procedural residual stenosis of >30%, the major predictor for loss of patency following DCB angioplasty in long-term.Lithotripsy is an emerging therapy concept for vessel preparation of calcified pelvic arteries prior to trans-femoral aortic valve implantation.In summary, vessel preparation of calcified arterial lesions by improving vessel compliance or reducing the plaque load represent promising technical methods reducing provisional stent rates and improving longer-term outcomes., Competing Interests: Zeller: Der Autor erklärt, dass er innerhalb der vergangenen 3 Jahren als Berater tätig war und Honorare erhalten hat von Abbott Vascular, ANT, Bayer, BIBA Medical, Biotronik, Boston Scientific Corp., Cook Medical, CSI, Efemoral, Gore & Associates, Medtronic, Philips, Shockwave, Venture Med, Veryan, Vesper Medical. Er erhielt insitutionelle Research Grants für Forschung und Studien von Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun; CSI, Boston Scientific, University of Jena, Pluristem, Philips, PQ Bypass, Surmodics, Ablative Solutions, Reflow Medical. Noory: Der Autor erklärt, dass er innerhalb der vergangenen 3 Jahre Honorare von BARD-BD, Boston Scientific, Abbott, Medtronic, ShockWaves und Cordis erhalten hat. Beschorner: keine, (Thieme. All rights reserved.)

Objective: To better manage the burden of the COVID-19 pandemic on hospitals, numerous scheduled procedures have been postponed nationwide., Design and Methods: Retrospective analysis of patient characteristics and outcomes of patients hospitalized with peripheral arterial disease (PAD) in the period prior to the COVID-19 pandemic (2018 and 2019) and during the pandemic (2020 and 2021). This study assesses the in-hospital outcomes. Main endpoints are Rutherford stages at admission for intervention, incidence of amputation, of total occlusion, and duration of intervention. The data were analyzed descriptively., Results: The total number of interventions due to PAD had decreased in 2020, but not significantly during the pandemic period ( n = 5351) compared to the period prior to COVID-19 pandemic ( n = 5351) ( p = 0.589). The proportion of interventions treated for critical limb-threatening ischaemia (CLTI) increased from 2018/2019 ( n = 2112) to 2020/2021 ( n = 2426) ( p < 0.001). However, the proportion of patients with wounds requiring amputation was not higher during the pandemic ( n = 191) than before ( n = 176) (minor amputations p = 0.2302, major amputations p = 0.9803). The proportion of total occlusions did not differ significantly between the pre-COVID-19 ( n = 3082) and the COVID-19 pandemic periods ( n = 2996) ( p = 0.8207). Multilevel interventions did not increase significantly from 2018/2019 ( n = 1930) to 2020/2021 ( n = 2071). Between 2018/2019 and 2020/2021, the procedure duration and fluoroscopy duration increased significantly. However, parameters such as contrast agent volume and radiation dose did not differ significantly. The average length of stay was 4.6 days., Conclusion: The COVID-19 pandemic had an impact on the in-patient care of PAD patients in terms of disease stage severity and complexity. However, the amputation rate was not affected.

Background: Renal denervation (RDN) has been shown to lower blood pressure (BP), but its effects on cardiovascular events have only been preliminarily evaluated. Time in therapeutic range (TTR) of BP is associated with cardiovascular events., Objectives: This study sought to assess the impact of catheter-based RDN on TTR and its association with cardiovascular outcomes in the GSR (Global SYMPLICITY Registry)., Methods: Patients with uncontrolled hypertension were enrolled and treated with radiofrequency RDN. Office and ambulatory systolic blood pressure (OSBP and ASBP) were measured at 3, 6, 12, 24, and 36 months postprocedure and used to derive TTR. TTR through 6 months was assessed as a predictor of cardiovascular events from 6 to 36 months using a Cox proportional hazard regression model., Results: As of March 1, 2022, 3,077 patients were enrolled: 42.2% were female; mean age was 60.5 ± 12.2 years; baseline OSBP was 165.6 ± 24.8 mm Hg; and baseline ASBP was 154.3 ± 18.7 mm Hg. Patients were prescribed 4.9 ± 1.7 antihypertensive medications at baseline and 4.8 ± 1.9 at 36 months. At 36 months, mean changes were -16.7 ± 28.4 and -9.0 ± 20.2 mm Hg for OSBP and ASBP, respectively. TTR through 6 months was 30.6%. A 10% increase in TTR after RDN through 6 months was associated with significant risk reductions from 6 to 36 months of 15% for major adverse cardiovascular events (P < 0.001), 11% cardiovascular death (P = 0.010), 15% myocardial infarction (P = 0.023), and 23% stroke (P < 0.001)., Conclusions: There were sustained BP reductions and higher TTR through 36 months after RDN. A 10% increase in TTR through 6 months was associated with significant risk reductions in major cardiovascular events from 6 to 36 months. (Global SYMPLICITY Registry [GSR] DEFINE; NCT01534299)., Competing Interests: Funding Support and Author Disclosures This study was funded by Medtronic. Prof Mahfoud has received support from the Deutsche Gesellschaft für Kardiologie, Deutsche Forschungsgemeinschaft (SFB TRR219), and Deutsche Herzstiftung; and has received scientific support and/or speaker honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic and ReCor Medical. Prof Mancia has received speaker fees from Servier, Sanofi, Medtronic, Menarini, Merck, and Recordati. Prof Schmieder has received speaker and consulting honoraria from Medtronic, ReCor Medical , and Ablative Solutions; and has received research grants given to his institution from Medtronic, ReCor Medical, and Ablative Solutions. Prof Narkiewicz has received speaker and consulting honoraria from Berlin-Chemie/Menarini, Egis, Idorsia, Gedeon Richter, Krka, Medtronic, Novo Nordisk, Polpharma, Recordati, Sandoz, and Servier. Prof Schlaich has received support from a National Health and Medical Research Council Senior Research Fellowship; and has received consulting fees and/or travel and research support from Medtronic, Abbott, Novartis, Servier, Pfizer, and Boehringer Ingelheim. Dr Ribichini has received consulting fees and research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Volcano-Philips. Dr Weil has received support from Medtronic, ReCor Medical, Novartis, and AstraZeneca. Dr Kao has received honoraria from Asahi INTECC, Terumo, MicroPort, and Abbott; has received research grants from Medtronic, Elixir, and Abiomed; and is a member of Medtronic International Advisory Board. Dr Rodriguez-Leor has received speaker fees from Medtronic. Dr Noory has received speaker fees from Medtronic. Dr Ong has received speaker and consultant fees from Medtronic; and his institution received educational grants from Medtronic. Dr Zirlik has received consulting fees and/or research support from Medtronic, Abbott, Edwards, Abiomed, Cardiac Dimensions, Novartis, AstraZeneca, Astellas, Sanofi, Boehringer Ingelheim, Pfizer, Janssen Cilag, Novo Nordisk, Amgen, Bristol Myers Squibb, and Daichi-Sankyo. Dr Almerri is a member of the Advisory Committee in the Gulf Cooperation Council; and has received speaker and proctor honoraria from Medtronic. Dr Sharif has received speaker and consulting fees and research support from Medtronic. Dr Lauder has received speaker honoraria from Medtronic and ReCor Medical. Ms Wanten is an employee of Medtronic. Mr Fahy is an employee of Medtronic. Prof Böhm has received support from the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939); and has received personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor Medical, Servier, and Vifor during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Meta-analyses of randomized controlled trials have suggested an increased long-term mortality risk following femoropopliteal and infrapopliteal angioplasty using paclitaxel-coated devices. This study was conducted to evaluate long-term mortality after paclitaxel drug-coated balloon (DCB) and plain old balloon angioplasty (POBA) of infrapopliteal lesions in real-world practice., Methods: A retrospective mortality analysis of patients with at least 3 years of follow-up who underwent balloon-based endovascular therapy of infrapopliteal lesions was performed., Results: Overall, 2,424 patients with infrapopliteal lesions were treated within the study period. Five hundred seventy-six patients fulfilled the study criteria. Of those, 269 patients were treated with uncoated devices without crossover to a paclitaxel-coated device during follow-up and 307 patients with DCB angioplasty. Mean (SD) follow-up was 46.48 (32.77) months. The mortality rate was 66.9% after POBA and 46.9% after DCB (P < .001). In the matched-pair cohort, 164 patients died after uncoated treatment (66.7%), and 119 in the DCB group died (48.4%; P < .001). There was no correlation between DCB length and mortality rate (P = .357). For the entire cohort, multivariate logistic regression analysis showed type of treatment (uncoated device vs DCB; P = .002), age (P < .001), stroke (P = .005), renal insufficiency (P = .014), and critical limb ischemia (P = .001) to be independent predictors of all-cause mortality. There was no significant difference in mortality among the paclitaxel exposure groups., Conclusion: In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of infrapopliteal lesions., (© 2022 by the Texas Heart® Institute, Houston.)

In many vascular segments, endovascular therapy is the treatment of choice for arteriosclerotic lesions. For the treatment of common femoral artery (CFA) lesions, surgical reconstruction is still considered the gold standard. The purpose of this study is to evaluate the safety and efficacy of stent angioplasty for the treatment of common femoral artery (CFA) lesions in a real-world population during a two-year follow up. This retrospective, single-center study includes 250 patients requiring treatment with stent angioplasty of CFA lesions. The primary end point was the target lesion revascularization (TLR) rate. Secondary end points were the overall procedural complication rate, the rate of ipsilateral CFA punctures during follow-up, changes in the Rutherford−Becker class (RBC) and ankle−brachial index (ABI), primary patency rates, amputation rate, time to and the type of TLR. A total of 236 interventions (94.4%) were successfully defined as a residual stenosis < 30%. Periinterventionally, there were 23 complications (9.1%), 3 of which had to be treated surgically. Median follow up was 21 months (average 19.2 ± 7.8). In total, 41 patients (16.4%) needed a TLR. The primary patency rate was 90.8%, 81.2% and 72% at 6, 12 and 24 months, respectively. ABI and RBC were significantly better at all time points compared to baseline. During follow up, seven amputations (three minor and four major) had to be performed. More than half of the patients (56.0%) were punctured at the stented CFA during the follow up. Multivariate logistic regression analysis showed continued nicotine use and coronary heart disease as predictors for TLR. Stent angioplasty for the treatment of CFA lesions is safe and effective. Further studies are needed to compare this endovascular option with surgical therapy.

Introduction: The standard endovascular treatment for obstructed peripheral arterial disease (PAD) lesions and stenosed arteriovenous (AV) fistulae is percutaneous transluminal angioplasty (PTA). Despite consistent effectiveness in restoring blood flow, PTA does introduce risk of uncontrolled dissections that require stenting. The FLEX Vessel Prep™ System (FLEX VP) is a novel, dynamic, self-sizing, nonballoon device designed to modify obstructive stenoses and plaque, improve vessel compliance and facilitate delivery of drug therapies by creating longitudinal, controlled-depth, circumferential microincisions along the entire length of a lesion., Areas Covered: In this profile, the mechanism of action of the FLEX VP system is described and differentiated. Acute procedural complications and long-term clinical outcomes following FLEX VP+PTA are presented. Specifically, the unmet clinical need for safe and effective vessel preparation in long, complex, mixed morphology PAD lesions is highlighted., Expert Opinion: The FLEX VP system is an innovative approach to create predictable and consistent longitudinal microincisions in long lesions that improve acute luminal gain and vessel compliance by releasing circumferential tension in the lesion. This nonballoon-based device for plaque modification is safe, effective, easy-to-use, and minimizes PTA-associated dissections, therefore reducing stenting, supporting the 'leave nothing behind' incentive of physicians, and improving long-term clinical outcomes with less vessel trauma.

Objectives: To evaluate safety and efficacy of endoprosthesis implantation for the exclusion of popliteal artery aneurysm (PAA)., Methods: Elective asymptomatic patients with aneurysm > 20 mm and symptomatic patients with endovascular therapy of PAA were included. The proportion of patients with critical limb ischemia (presence of rest pain or tissue loss) was high at 32.1%, 21.6% of the patients had acute ischemia with symptoms persisting shorter than 14 days. The primary study endpoint was the target lesion revascularization (TLR) rate at 12 months. Secondary endpoints included technical success, periinterventional adverse events, primary patency at 6, 12 and 24 months, TLR rate at 24 months, predictors on reintervention, change in in clinical symptoms using the Rutherford-Becker classification (RBC), amputation and mortality rate. One hundred thirty-four patients (68.3±10.6 years, 88.8% male) were treated with a Viabahn ® endoprosthesis (W.L. Gore & Associates Inc., Flagstaff, AZ, USA)., Results: The average aneurysm diameter was 2.5±0.87 cm. In 41%, occlusion of the aneurysm was present. TLR rate was 31.3% and 38.8% after 12 and 24 months, respectively. Primary patency rates were 69.1%, 52.3% and 42.6% at 6, 12 and 24 months, respectively. Univariate logistic regression analysis revealed age as a predictor of reintervention and in the multivariable analysis it was treatment with lysis. An improvement in RBC was seen at all-time points. Two major amputations (1.5%) were performed and the mortality rate at 24 months was 5.2%., Conclusion: Primary patency rate after endovascular exclusion of PAA is low. However, limb salvage rate is high.

Purpose: To evaluate the all-cause mortality after treatment with paclitaxel-coated devices depending on paclitaxel exposure in real-world practice., Materials and Methods: A retrospective analysis of mortality of patients with at least a 3-year follow-up was performed. Patients were categorized into terciles according to the paclitaxel dosage received during the index procedure and every subsequent intervention. The incidence of mortality of these patients was compared with that of a paclitaxel-naïve control group., Results: In total, 2,376 patients were treated with drug-coated devices and 980 patients with uncoated devices. The overall all-cause mortality rate at a mean follow-up of 46.27 months ± 24.71 was 29.2% (n = 696) for the paclitaxel group and 49.4% (n = 484) for the paclitaxel-naive control group. The mortality rate between the groups according to the initial paclitaxel exposure was not significantly different (P = .205). In comparison to the group of surviving patients, the total lifetime paclitaxel dosage was lower in the group of patients who died (P < .001)., Conclusions: In this real-world retrospective analysis, long-term mortality was not correlated with the paclitaxel exposure during the index procedure. Regarding the total paclitaxel exposure, lower mortality was observed in the highest tercile of paclitaxel exposure., (Copyright © 2021 SIR. Published by Elsevier Inc. All rights reserved.)

Cryptochromes (CRYs) are photoreceptors that mediate light regulation of the circadian clock in plants and animals. Here we show that CRYs mediate blue-light regulation of N 6 -methyladenosine (m 6 A) modification of more than 10% of messenger RNAs in the Arabidopsis transcriptome, especially those regulated by the circadian clock. CRY2 interacts with three subunits of the METTL3/14-type N 6 -methyladenosine RNA methyltransferase (m 6 A writer): MTA, MTB and FIP37. Photo-excited CRY2 undergoes liquid-liquid phase separation (LLPS) to co-condense m 6 A writer proteins in vivo, without obviously altering the affinity between CRY2 and the writer proteins. mta and cry1cry2 mutants share common defects of a lengthened circadian period, reduced m 6 A RNA methylation and accelerated degradation of mRNA encoding the core component of the molecular oscillator circadian clock associated 1 (CCA1). These results argue for a photoregulatory mechanism by which light-induced phase separation of CRYs modulates m 6 A writer activity, mRNA methylation and abundance, and the circadian rhythms in plants., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

Background: Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard., Aims: The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions., Methods: A retrospective analysis of patients who underwent DA of the CFA between March 2009 and June 2017 was performed. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularisation (cdTLR). Secondary endpoints included the overall procedural complication rate at 30 days, change in ankle-brachial index (ABI), and Rutherford-Becker class (RBC) during follow-up., Results: This analysis included 250 patients. The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months). The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26). All but one complication could be treated conservatively or endovascularly. One surgical revision was necessary. Freedom from major adverse events (death, cdTLR, myocardial infarction and major target limb amputation) at 30 days was 99.6%. The rate of cdTLR during follow-up was 13.6% (n=34). A significant improvement of the mean ABI and the RBC was observed. Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdTLR., Conclusions: The use of DA for the treatment of CFA lesions leads to promising midterm results with an acceptable complication rate.