Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

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.

Antimicrobial resistance is not increasing in subsequent cases of ischaemic foot infections, a single-centre cohort from 2012 to 2021.

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.

High frequency of Enterococcus faecalis detected in urinary tract infections in male outpatients - a retrospective, multicenter analysis, Germany 2015 to 2020.

BACKGROUND: Urinary tract infections (UTI) in men differ relevantly to women by their pathogens. Gram-positive uropathogens play a relevant role in UTI in men. In this study, we aimed to analyze the epidemiology of Enterococcus faecalis in UTI in male outpatients. METHODS: We conducted a retrospective observational multicenter study during 2015 to 2020 consisting of urine samples of 99,415 adult male outpatients sent from 6,749 outpatient practices from Germany. Proportions were compared using the z-Test and 95% confidence intervals were calculated using the Clopper-Pearson method. RESULTS: E. faecalis is the 2nd most frequent bacteria (16%) detected in suspected UTI in male outpatients. Young men are predominantly at risk (17%) for isolation of E. faecalis in suspected UTI. In polymicrobial infections E. faecalis is isolated in 47% of all suspected UTI in men. Recurrency of suspected UTI is significantly more frequent when E. faecalis is isolated compared to Escherichia coli (22% vs 26%; p < .001). Recurrency rates of E. faecalis associated UTI increases by age from 12% (18-29 years) to 28% ([Formula: see text] 70 years); p < .001. Congruently the resistance of E. faecalis against ciprofloxacin increases by age from 22% (18-29 years; 2019) to 37% ([Formula: see text] 70 years; 2019); p < .001. CONCLUSIONS: E. faecalis is frequently isolated in suspected UTI in male patients. Consequently, Nitrate-sticks results cannot be recommended to exclude UTI in men. The empirical use of ciprofloxacin in young adults can be reasonable. Frequent recurrences in E. faecalis associated suspected UTI emphasizes the importance of microbiological pathogen identification and susceptibility testing in men suffering from UTI.

High antimicrobial resistance in urinary tract infections in male outpatients in routine laboratory data, Germany, 2015 to 2020.

BackgroundEvidence on the distribution of bacteria and therapy recommendations in male outpatients with urinary tract infections (UTI) remains insufficient.AimWe aimed to report frequency distributions and antimicrobial resistance (AMR) of bacteria causing UTI in men and to identify risk factors for resistance of Escherichia coli against trimethoprim (TMP) and ciprofloxacin (CIP).MethodsWe conducted a retrospective observational study using routinely collected midstream urine specimens from 102,736 adult male outpatients sent from 6,749 outpatient practices to nine collaborating laboratories from all major regions in Germany between 2015 and 2020. Resistance in E. coli was predicted using logistic regression.ResultsThe three most frequent bacteria were E. coli (38.4%), Enterococcus faecalis (16.5%) and Proteus mirabilis (9.3%). Resistance of E. coli against amoxicillin (45.7%), TMP (26.6%) and CIP (19.8%) was common. Multiple drug resistance was high (22.9%). Resistance against fosfomycin (0.9%) and nitrofurantoin (1.9%) was low. Resistance of En. faecalis against CIP was high (29.3%). Isolates of P. mirabilis revealed high resistance against TMP (41.3%) and CIP (16.6%). The CIP and TMP resistance was significantly higher among bacteria derived from recurrent UTI (p < 0.05). Age ≥ 90 years, recurrent UTI and regions East and South were independently associated with AMR of E. coli against TMP and CIP (p < 0.05).ConclusionThe most frequent UTI-causing pathogens showed highresistance against TMP and CIP, empirical therapy is therefore likely to fail. Apart from intrinsically resistant pathogens, susceptibility to fosfomycin and nitrofurantoin remains sufficient. Therefore, they remain an additional option for empirical treatment of uncomplicated UTI in men.

Impact of COVID-19 Pandemic on Clinical Care of Peripheral Arterial Disease Patients: A Single-Center Experience.

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.

Evaluation of Femoropopliteal In-Stent Restenosis Characteristics Stratified by Stent Design.

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.

Arterial leg ulcers-Bacterial patterns, antimicrobial resistance and clinical characteristics, a retrospective single-centre cohort, 2012-2021.

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.

Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System.

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.

Enteroids Generated from Patients with Severe Inflammation in Crohn's Disease Maintain Alterations of Junctional Proteins.

BACKGROUND: The mechanisms underlying loss of intestinal epithelial barrier [IEB] function in Crohn's disease [CD] are poorly understood. We tested whether human enteroids generated from isolated intestinal crypts of CD patients serve as an appropriate in vitro model to analyse changes of IEB proteins observed in patients' specimens. METHODS: Gut samples from CD patients and healthy individuals who underwent surgery were collected. Enteroids were generated from intestinal crypts and analyses of junctional proteins in comparison to full wall samples were performed. RESULTS: Histopathology confirmed the presence of CD and the extent of inflammation in intestinal full wall sections. As revealed by immunostaining and Western blot analysis, profound changes in expression patterns of tight junction, adherens junction and desmosomal proteins were observed in full wall specimens when CD was present. Unexpectedly, when enteroids were generated from specimens of CD patients with severe inflammation, alterations of most tight junction proteins and the majority of changes in desmosomal proteins but not E-cadherin were maintained under culture conditions. Importantly, these changes were maintained without any additional stimulation of cytokines. Interestingly, qRT-PCR demonstrated that mRNA levels of junctional proteins were not different when enteroids from CD patients were compared to enteroids from healthy controls. CONCLUSIONS: These data indicate that enteroids generated from patients with severe inflammation in CD maintain some characteristics of intestinal barrier protein changes on a post-transcriptional level. The enteroid in vitro model represents an appropriate tool to gain further cellular and molecular insights into the pathogenesis of barrier dysfunction in CD.