Uncoated Catheters Research Articles

Dual-Layer Nanoengineered Urinary Catheters for Enhanced Antimicrobial Efficacy and Reduced Cytotoxicity.

Catheter-associated urinary tract infection (CAUTI) is the most common healthcare-associated infection; however, current therapeutic strategies remain insufficient for standard clinical application. A novel urinary catheter featuring a dual-layer nanoengineering approach using zinc (Zn) and silver nanoparticles (AgNPs) is successfully fabricated. This design targets microbial resistance, minimizes cytotoxicity, and maintains long-term efficacy. The inner AgNPs layer provides immediate antibacterial effects against the UTI pathogens, while the outer porous Zn layer controls zero-order Ag release and generates reactive oxygen species, thus enhancing long-term bactericidal performance. Enhanced antibacterial properties of Zn/AgNPs-coated catheters are observed, resulting in 99.9% of E. coli and 99.7% of S. aureus reduction, respectively. The Zn/AgNPs-coated catheter significantly suppresses biofilm with sludge formation compared to AgNP-coated and uncoated catheters (all, p<0.05). The Zn/AgNP-coated catheter in a rabbit model demonstrated a durable, effective barrier against bacterial colonization, maintaining antimicrobial properties during the catheter indwelling period with significantly reduced inflammation and epithelial disruption compared with AgNP and uncoated groups. This innovation has the potential to revolutionize the design of antimicrobial medical devices, particularly for applications requiring long-term implantation. Although further preclinical studies are required to verify its efficacy and safety, this strategy seems to be a promising approach to preventing CAUTI-related complications.

Comparing an Integrated Amphiphilic Surfactant to Traditional Hydrophilic Coatings for the Reduction of Catheter-Associated Urethral Microtrauma.

Hydrophilic-coated intermittent catheters have improved the experience of intermittent urinary catheterization for patients compared to conventional gel-lubricated uncoated catheters. However, the incorporation of polyvinylpyrrolidone (PVP) within hydrophilic coatings can lead to significant issues with coating dry-out. Consequently, increased force on catheter withdrawal may cause complications, including urethral microtrauma and pain. Standard methods of evaluating catheter lubricity lack physiological relevance and an understanding of the surface interaction with the urethra. The tribological performance and urethral interaction of commercially available hydrophilic PVP-coated catheters and a coating-free integrated amphiphilic surfactant (IAS) catheter were evaluated by using a biomimetic urethral model designed from a modified coefficient of friction (CoF) assay. T24 human urothelial cells were cultured on customized silicone sheets as an alternate countersurface for CoF testing. Hydrophilic PVP-coated and coating-free IAS catheters were hydrated and the CoF obtained immediately following hydration, or after 2 min, mimicking in vivo indwell time for urine drainage. The model was observed for urethral epithelial cell damage postcatheterization. The majority of hydrophilic PVP-coated catheters caused significantly greater removal of cells from the monolayer after 2 min indwell time, compared to the IAS catheter. Hydrophilic PVP-coated catheters were shown to cause more cell damage than the coating-free IAS catheter. A biomimetic urethral model provides a more physiologically relevant model for understanding the factors that govern the frictional interface between a catheter surface and urethral tissue. From these findings, the use of coating-free IAS catheters instead of hydrophilic PVP-coated catheters may help reduce urethral microtrauma experienced during catheter withdrawal from the bladder, which may lead to a lower risk of infection.

Generalized Multifunctional Coating Strategies Based on Polyphenol-Amine-Inspired Chemistry and Layer-by-Layer Deposition for Blood Contact Catheters.

Blood-contacting catheters play a pivotal role in contemporary medical treatments, particularly in the management of cardiovascular diseases. However, these catheters exhibit inappropriate wettability and lack antimicrobial characteristics, which often lead to catheter-related infections and thrombosis. Therefore, there is an urgent need for blood contact catheters with antimicrobial and anticoagulant properties. In this study, we employed tannic acid (TA) and 3-aminopropyltriethoxysilane (APTES) to create a stable hydrophilic coating under mild conditions. Heparin (Hep) and poly(lysine) (PL) were then modified on the TA-APTES coating surface using the layer-by-layer (LBL) technique to create a superhydrophilic TA/APTES/(LBL)4 coating on silicone rubber (SR) catheters. Leveraging the superhydrophilic nature of this coating, it can be effectively applied to blood-contacting catheters to impart antibacterial, antiprotein adsorption, and anticoagulant properties. Due to Hep's anticoagulant attributes, the activated partial thromboplastin time and thrombin time tests conducted on SR/TA-APTES/(LBL)4 catheters revealed remarkable extensions of 276 and 103%, respectively, when compared to uncoated commercial SR catheters. Furthermore, the synergistic interaction between PL and TA serves to enhance the resistance of SR/TA-APTES/(LBL)4 catheters against bacterial adherence, reducing it by up to 99.9% compared to uncoated commercial SR catheters. Remarkably, the SR/TA-APTES/(LBL)4 catheter exhibits good biocompatibility with human umbilical vein endothelial cells in culture, positioning it as a promising solution to address the current challenges associated with blood-contact catheters.

Development of an in vitro ventricular shunt material testing model and utility of PEG as antifouling coating.

CSF shunts, most commonly the ventriculoperitoneal shunt, remain a first and last line of management for children and adults with hydrocephalus. However, the failure rates of these shunts are extremely high, leaving many patients with the need for revision surgical procedures. The objective of this study was to develop a model to assess the efficacy of a nonfouling ventricular catheter. A second objective was to test polyethylene glycol (PEG) as an antifouling coating. Microglial cells were grown on medical-grade catheter silicone with biofouling simulated by collagen incubation over a range of concentrations from 31 to 103 µg/ml and durations from 2 to 18 hours. After ideal fouling conditions were identified, catheter silicone was then coated with PEG as an antifouling surface, and cell growth on this surface was compared to that on uncoated standard catheter silicone. Collagen biofouling increased cell growth on silicone surfaces with an ideal concentration of 69 µg/ml and incubation of 6 hours. PEG coating of silicone catheter material yielded 70-fold lower cell growth (p < 0.0001), whereas collagen-fouled PEG-coated silicone yielded 157-fold lower cell growth (p < 0.0001). Catheter coating significantly reduced cell growth, particularly in the setting of biofouling. The application of antifouling surfaces to ventricular shunts shows considerable promise for improving efficacy.

Polymer-Coated Urinary Catheter Reduces Biofilm Formation and Biomineralization: A First-in-Man, Prospective Pilot Study

Purpose: Biofilm formation and biomineralization on urinary catheters may cause severe complications including infection and obstruction. Here, we describe an in vitro evaluation and prospective pilot clinical study of a silicone catheter coated with a biofilm-resistant polymer. Materials and Methods: Biofilm biomass and biomineralization on uncoated and coated catheters were quantified by confocal microscopy using fluorescently tagged bacteria or stained for biofilm and minerals. Biomineral identity was determined using scanning electron microscopy and X-ray spectroscopy. Biofilm formation and biomineralization were evaluated in vitro using uropathogens Proteus mirabilis and Pseudomonas aeruginosa and on catheters recovered from hospitalized patients. Fibrinogen in patient urine and on catheters was quantified using an immunofluorescence assay. Results: In vitro P. mirabilis and P. aeruginosa formed significantly less biofilm and biomineral and failed to block coated compared with uncoated catheters in a bladder model after 89 h. Biofilm-resistant polymer-coated catheters (n = 83) recovered from hospitalized patients exhibited significantly lower biofilm biomass and biomineralization compared with uncoated silicone catheters (n = 78). Electron microscopy with elemental analysis of recovered catheters revealed calcium oxalate crystals on coated compared with the struvite and apatite crystals on uncoated catheters associated with catheter blockage. Lower levels of biofilm-promoting fibrinogen in postcatheterization urine and on catheters from patients receiving coated catheters was observed compared with those receiving uncoated catheters indicative of a reduced inflammatory response. Conclusions: These data provide evidence that polymer-coated urinary catheters exhibit enhanced resistance to fibrinogen deposition, biofilm formation, and encrustation, reducing the risks associated with catheter-associated urinary tract infections and obstruction.

Hierarchically-structured laccase@Ba3(PO4)2 hybrid nanoflowers coating on the urinary foley catheter with high durability, biocompatibility, anti-adhesion activity, and contrasting behavior

Catheter-associated urinary tract infections (CAUTIs) are common causes of long-term indwelling urinary catheter failure. In such cases, pathogenic bacteria adhere to the urinary tract or catheter surface forming recalcitrant biofilms which may lead to secondary bloodstream infections. Today, antibiofilm coatings based on effective enzymes show promise in preventing CAUTIs. In the present study, laccase@Ba3(PO4)2•hybrid nanoflowers (HNFs) were applied as a novel infection-responsive coating for urinary catheters. Scanning electron microscopy images (SEM) exhibited a homogeneous surface of layered catheters without any broad or fine cracks. Compared to the uncoated catheter, the surface coating inhibited the adhesion of Pseudomonas aeruginosa, Escherichia coli, Bacillus subtilis, and Staphylococcus aureus by 64.8 %, 78.2 %, 86.4 %, and 75 %, respectively. Furthermore, the laccase@Ba3(PO4)2•HNFs layered catheter showed negligible release of Ba2+ (12.9 μM) after a 7-day immersion in an artificial urine medium. This durable coating produced a strong computed tomography (CT) signal which would be useful for visualizing the placement of urinary catheters in patients. The high viability of human dermal fibroblast (HDF) cells (>80 %) demonstrated the biocompatibility of the modified catheters. Therefore, it is suggested that surfaces coated with laccase@Ba3(PO4)2•HNFs hold appropriate potential for use in medical devices.

#6572 FLUORINATED GRAPHENE REDUCES PLATELET ACTIVATION AND ADHESION ON HEMODIALYSIS CATHETER

Abstract Background and Aims Catheter thrombosis remains one of the major complications of hemodialysis. Superhydrophobic surfaces are suggested to be capable of creating an energy barrier that prevents cells and proteins from contacting with the catheter surface directly, making catheter less thrombotic. Fluorinated graphene (FG) is a superhydrophobic material. It has been applied to create self-cleaning surfaces. It also shows good biocompatibility. Based on these features of FG, we prepared an FG coating on hemodialysis catheter attempting to reduce clinical thrombotic events. Method FG suspension was made in a solution of 95 wt.% ethanol, 5 wt.% deionized water and 3 wt.% 1H,1H,2H,2H-Perfluorooctyltriethoxysilane (POTS, C14H15F17O3Si). Immediately following the plasma activation, catheter segments of 1 cm²(Gamcath, GDHK1325) were spray coated with FG suspension both inside and outside the catheter lumen. Samples were air-dried for later use. We tested the hemolysis rate, platelet activation and adhesion performances, and the partial thromboplastin time (PTT) of the FG-coated samples. Test for hemolysis was performed with FG-coated catheter and the isotonic extract of the FG coating in direct contact with fresh rabbit blood respectively. Platelet activation and adhesion was performed according to the ASTM F2888-19 standard and also assessed by scanning electron microscope. PTT assay was performed according to the ASTM F2382-18 standard. Results FG-coated catheter is hydrophobic and shows a water contact angle of 150° (Figure 1a). It reduced 83.5% of platelet adhesion per 100 μm² catheter surface area and avoided 35.86% of platelet loss from the blood when compared to uncoated catheter (Figure 1b, 1c). It has a hemolysis rate of less than 2% in both direct blood contact test and the extract test (Figure 1d). The PTT of FG-coated sample was 88.92±1.31s versus 83.03±9.49s of the uncoated catheter yet with no statistical significance (P&amp;gt;0.05) (Figure 1e). Conclusion FG coating has great hemocompatibility. Though no significant improvement was observed in the PTT assay, FG coating still significantly reduced the adherent and activated platelet on catheter, which seems promising to reduce thrombotic events. Yet, more tests needed to be performed, and the antithrombotic ability of FG coating in the fluid state needs to be further confirmed in the following study.

Auranofin coated catheters inhibit bacterial and fungal biofilms in a murine subcutaneous model.

Microbe entry through catheter ports can lead to biofilm accumulation and complications from catheter-related bloodstream infection and ultimately require antimicrobial treatment and catheter replacement. Although strides have been made with microbial prevention by applying standardized antiseptic techniques during catheter implantation, both bacterial and fungal microbes can present health risks to already sick individuals. To reduce microbial adhesion, murine and human catheters were coated with polyurethane and auranofin using a dip coating method and compared to non-coated materials. Upon passage of fluid through the coated material in vitro, flow dynamics were not impacted. The unique antimicrobial properties of the coating material auranofin has shown inhibitory activity against bacteria such as Staphylococcus aureus and fungi such as Candida albicans. Auranofin coating on catheters at 10mg/mL reduced C. albicans accumulation in vitro from 2.0 x 108 to 7.8 x 105 CFU for mouse catheters and from 1.6 x 107 to 2.8 x 106 for human catheters, showing an impact to mature biofilms. Assessment of a dual microbe biofilm on auranofin-coated catheters resulted in a 2-log reduction in S. aureus and a 3-log reduction in C. albicans compared to uncoated catheters. In vivo assessment in a murine subcutaneous model demonstrated that catheters coated with 10 mg/mL auranofin reduced independent S. aureus and C. albicans accumulation by 4-log and 1-log, respectively, compared to non-coated catheters. In conclusion, the auranofin-coated catheters demonstrate proficiency at inhibiting multiple pathogens by decreasing S. aureus and C. albicans biofilm accumulation.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval

ABSTRACT 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/mm2) 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.

Bacteria‐Responsive Multidrug Delivery Nanosystem for Combating Long‐Term Biofilm‐Associated Infections

AbstractMicrobial biofilm formation on implantable devices causes chronic infections that cannot be treated with existing antimicrobials. Quorum sensing inhibitors (QSIs) have recently emerged as novel antimicrobials for the prevention of biofilm formation. But blocking QS alone is insufficient to inhibit biofilm‐associated chronic infections. Herein, chitosan hollow nanospheres are capped by bacteria‐responsive β‐casein to form a synergistic antifouling nanosystem consisting of a QSI and bactericide. β‐casein is degraded by protease in a bacteria‐colonized microenvironment in situ thus, QSI and bactericide are released sequentially. The release of QSI sensitises bacteria effectively through reduction of surface hydrophobicity, eDNA content, and lipopolysaccharide production in biofilms, amplifying the chemotherapeutic action of the bactericide. Compared to the uncoated surface, the coated surface inhibits biofilm formation and removes preformed biofilms of Pseudomonas aeruginosa PAO1 and methicillin‐resistant Staphylococcus aureus by 1.8 logs and 1.9 logs of biomass inhibition, respectively. The coated catheters are found to stay clean for 30 days under artificial urine flow, while the uncoated catheters are clogged by bacterial biofilms within 5 days. Finally, the long term antifouling activity in vivo is confirmed. Overall, the nanosystem is devoted to making urinary catheters resistant to bacterial biofilm formation for the long term.

A prospective observation of PICC related anaphylactoid reactions.

To explore the incidence, signs and symptoms, causes and prognosis of anaphylactoid reactions in PICC catheterization. Prospectively observe the occurrence of anaphylactoid reactions in coated and uncoated PICC during insertion from November 2018 to April 2020. A diagnosis of anaphylactoid reactions was based on the signs and symptoms and laboratory results, and then collect data for analysis. A total of 1439 coated catheters were inserted, of which 30 resulted in anaphylactoid reactions (2.08%). The signs and symptoms were mainly skin system symptoms, combined with respiratory, cardiovascular, and digestive system symptoms. The anaphylactoid reaction rates of coated catheters were higher than those of uncoated catheters (χ2 = 38.417, 19.352, p < .01). A 29 of 30 patients completed catheterization after symptoms were resolved, these catheters were removed after treatment completion. Catheterization was terminated in one patient. There were no anaphylactoid reactions in 2850 uncoated catheters. Anaphylactoid reactions may occur during catheterization when using the coated PICC, which should be paid attention to in clinical application.

MP60-03 ORGANO-SELENIUM URINARY CATHETERS INHIBIT GROWTH AND BIOFILM FORMATION OF E. COLI , K. PNEUMONIAE , P. AERUGINOSA, AND H. INFLUENZAE IN-VITRO

You have accessJournal of UrologyCME1 Apr 2023MP60-03 ORGANO-SELENIUM URINARY CATHETERS INHIBIT GROWTH AND BIOFILM FORMATION OF E. COLI, K. PNEUMONIAE, P. AERUGINOSA, AND H. INFLUENZAE IN-VITRO Rachel Vopni, Unique Jacobo, Phat Tran, Shruti Patel, Suyash Jain, Cornelia De Riese, Ted Reid, and Werner De Riese Rachel VopniRachel Vopni More articles by this author , Unique JacoboUnique Jacobo More articles by this author , Phat TranPhat Tran More articles by this author , Shruti PatelShruti Patel More articles by this author , Suyash JainSuyash Jain More articles by this author , Cornelia De RieseCornelia De Riese More articles by this author , Ted ReidTed Reid More articles by this author , and Werner De RieseWerner De Riese More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003318.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Catheter-associated urinary tract infections (CAUTIs) are of significant medical burden in cost, morbidity, and mortality. Experimental selenium-coated medical devices have demonstrated nontoxic in-vitro and in-vivo antimicrobial activity due to the ability of selenium to catalyze formation of superoxide radicals. While antimicrobial-coated catheters have shown efficacy in preventing CAUTIs, selenium has not been tested in this context. The purpose of this in-vitro study is to evaluate selenium-incorporated urinary catheters for inhibition of uropathogenic bacterial growth and biofilm formation. METHODS: Urinary catheters incorporated with 1% organo-selenium and standard (uncoated) catheters were incubated in-vitro with E. coli, K. pneumoniae, P. aeruginosa, H. influenzae, and combinations of these bacteria. Growth was evaluated by colony forming unit count and visualized with confocal laser and scanning electron microscopy. Organo-selenium catheter material integrity was also tested by soaking the tubing in phosphate-buffered saline for 12-weeks at 37°C. RESULTS: Organo-selenium-incorporated catheters demonstrated total reduction (100%) of in-vitro bacterial growth and biofilm formation for E. coli, K. pneumoniae, H. influenzae, and a combination of these species when compared to control. P. aeruginosa growth was inhibited by approximately 4 logs (99.99%). Complete inhibition of E. coli growth was maintained after long-term phosphate-buffered saline soaking. CONCLUSIONS: The results demonstrate that organo-selenium was stably incorporated into catheter tubing and inhibited bacterial attachment, growth, and biofilm formation for multiple uropathogenic organisms. Furthermore, long-term soaking of organo-selenium tubing in phosphate-buffered saline did not show any decline in bacterial growth inhibition or biofilm formation. These findings suggest that organo-selenium-incorporated catheters may be advantageous in preventing CAUTIs and warrant further in-vivo and clinical evaluation. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e843 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rachel Vopni More articles by this author Unique Jacobo More articles by this author Phat Tran More articles by this author Shruti Patel More articles by this author Suyash Jain More articles by this author Cornelia De Riese More articles by this author Ted Reid More articles by this author Werner De Riese More articles by this author Expand All Advertisement PDF downloadLoading ...

Nondrug Intervention for Opportunistic Infections in Individuals With Hematological Malignancy: Systematic Review.

Hematological malignancies disturb the blood, lymph nodes, and bone marrow. Taking medications for treating opportunistic infections (OIs) in these individuals may enhance the risk of medication interaction as well as adverse drug reactions. This review aims to evaluate the effectiveness of nondrug interventions in reducing OIs among patients with hematological cancers. The PubMed, CENTRAL (Cochrane Central Register of Controlled Trials), and Embase databases were searched on December 26, 2022, for all randomized controlled trials (RCTs). The primary endpoint was OIs. The quality of included studies was assessed by the Cochrane Risk-of-Bias tool. A total of 6 studies were included in this review with 4 interventions: (1) types of mouthwash received, (2) presence of coating on central venous catheters (CVCs), (3) use of well-fitted masks, and (4) types of diet consumed. The results were presented in 8 different comparisons: (1) chlorhexidine-nystatin versus saline mouth rinse, (2) chlorhexidine versus saline mouth rinse, (3) nystatin versus saline mouth rinse, (4) chlorhexidine silver sulfadiazine-coated CVCs versus uncoated catheters, (5) well-fitted masks versus no mask, (6) amine fluoride-stannous fluoride versus sodium fluoride mouthwash, (7) low-bacterial diet versus standard hospital diet, and (8) herbal versus placebo mouthwash. No clear differences were reported in any of the outcomes examined in the first 3 comparisons. There were also no clear differences in the rate of catheter-related bloodstream infection or insertion site infection between the use of chlorhexidine silver sulfadiazine-coated CVCs versus uncoated catheters in the patients. Further, no significant differences were seen between patients who used a well-fitted mask and those without a mask in the incidence of OI. The all-cause mortality and mortality due to OI were similar between the 2 groups. There was no clear difference in all-cause mortality, although common adverse effects were reported in patients who used sodium fluoride mouthwash compared with those using amine fluoride-stannous fluoride mouthwash. There was no evidence of any difference in the incidence of possible invasive aspergillosis or candidemia between patients who consumed a low-bacterial diet and a standard diet. For the last comparison, no significant difference was seen between patients who received herbal and placebo mouthwash. Very limited evidence was available to measure the effectiveness of nondrug interventions in hematological cancers. The effectiveness of the interventions included in this review needs to be evaluated further in high-quality RCTs in a dedicated setting among patients with hematological malignancies. PROSPERO International Prospective Register of Systematic Reviews CRD42020169186; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=169186.

Efficacy of organo-selenium-incorporated urinary catheter tubing for in vitro growth inhibition of E. coli, K. pneumoniae, P. aeruginosa, and H. influenzae.

Catheter-associated urinary tract infections are of significant medical burden in cost, morbidity, and mortality. Experimental selenium-coated medical devices have demonstrated non-toxic in vitro and in vivo antimicrobial activity. While antimicrobial-coated catheters have shown efficacy in preventing CAUTIs, selenium has not been tested in this context. The purpose of this in vitro study is to evaluate selenium-incorporated urinary catheters for inhibition of uropathogenic bacterial growth and biofilm formation. Urinary catheters incorporated with 1% organo-selenium and standard (uncoated) catheters were incubated in vitro with E. coli, K. pneumoniae, P. aeruginosa, H. influenzae, and combinations of these bacteria. Growth was evaluated by colony-forming unit count and visualized with confocal laser and scanning electron microscopy. Organo-selenium catheter material integrity was also tested by soaking the tubing in phosphate-buffered saline for 12weeks at 37°C. Organo-selenium-incorporated catheters demonstrated total reduction (100%) of in vitro bacterial growth and biofilm formation for E. coli, K. pneumoniae, H. influenzae, and a combination of these species when compared to control. P. aeruginosa growth was inhibited by approximately 4 logs (99.99%). Complete inhibition of E. coli growth was maintained after long-term phosphate-buffered saline soaking. The results demonstrate that organo-selenium was stably incorporated into catheter tubing and inhibited bacterial attachment, growth, and biofilm formation for multiple uropathogenic organisms. Furthermore, long-term soaking of organo-selenium tubing in phosphate-buffered saline did not show any decline in bacterial growth inhibition or biofilm formation. These findings suggest that organo-selenium-incorporated catheters may be advantageous in preventing catheter-associated urinary tract infections and warrant further in vivo and clinical evaluation.

Cost-effectiveness analysis of hydrophilic-coated catheters in long-term intermittent catheter users in the UK

Objective To estimate the cost-effectiveness of single-use hydrophilic-coated intermittent catheters (HCICs) versus single-use uncoated intermittent catheters (UICs) for urinary catheterization. Methods The evaluation took a UK national health service (NHS) perspective. The population of interest were people using intermittent catheters, with either a spinal cord injury or multiple sclerosis. A Markov model was developed that estimated costs and clinical evidence over the lifetime of a hypothetical cohort and applied health-related quality of life estimates. Model inputs were sourced from published evidence, including a network meta-analysis to inform the treatment effect (reduction in catheter-associated urinary tract infections [CAUTIs]), and were supported by expert opinion. The model outputs included per-patient lifetime costs, quality-adjusted life years (QALYs) and the incremental cost effectiveness ratio (ICER). Event counts were also produced. Results Using HCICs instead of UICs could prevent seven CAUTI events per patient over a lifetime horizon (1.8 requiring secondary care). Overall, lifetime use of HCICs is £3,183 more expensive than use of UICs per patient. However, for these additional costs, 0.55 QALYs are gained. The ICER is £5,755 per additional QALY gained. Key drivers of the model results were identified and subject to sensitivity analyses. The results were found to be robust to parameter uncertainty. Conclusion HCICs are likely to be a cost-effective alternative to UICs, a result driven by substantial reductions in the number of CAUTIs. Their adoption across clinical practice could avoid a substantial number of infections, freeing up resources in the NHS and reducing antibiotic use in urinary catheter users.

Urinary Catheters Coated with a Novel Biofilm Preventative Agent Inhibit Biofilm Development by Diverse Bacterial Uropathogens.

Despite the implementation of stringent guidelines for the prevention of catheter-associated (CA) urinary tract infection (UTI), CAUTI remains one of the most common health care-related infections. We previously showed that an antimicrobial/antibiofilm agent inhibited biofilm development by Gram-positive and Gram-negative bacterial pathogens isolated from human infections. In this study, we examined the ability of a novel biofilm preventative agent (BPA) coating on silicone urinary catheters to inhibit biofilm formation on the catheters by six different bacterial pathogens isolated from UTIs: three Escherichia coli strains, representative of the most common bacterium isolated from UTI; one Enterobacter cloacae, a multidrug-resistant isolate; one Pseudomonas aeruginosa, common among patients with long-term catheterization; and one isolate of methicillin-resistant Staphylococcus aureus, as both a Gram-positive and a resistant organism. First, we tested the ability of these strains to form biofilms on urinary catheters made of red rubber, polyvinyl chloride (PVC), and silicone using the microtiter plate biofilm assay. When grown in artificial urine medium, which closely mimics human urine, all tested isolates formed considerable biofilms on all three catheter materials. As the biofilm biomass formed on silicone catheters was 0.5 to 1.6 logs less than that formed on rubber or PVC, respectively, we then coated the silicone catheters with BPA (benzalkonium chloride, polyacrylic acid, and glutaraldehyde), and tested the ability of the coated catheters to further inhibit biofilm development by these uropathogens. Compared with the uncoated silicone catheters, BPA-coated catheters completely prevented biofilm development by all the uropathogens, except P. aeruginosa, which showed no reduction in biofilm biomass. To explore the reason for P. aeruginosa resistance to the BPA coating, we utilized two specific lipopolysaccharide (LPS) mutants. In contrast to their parent strain, the two mutants failed to form biofilms on the BPA-coated catheters, which suggests that the composition of P. aeruginosa LPS plays a role in the resistance of wild-type P. aeruginosa to the BPA coating. Together, our results suggest that, except for P. aeruginosa, BPA-coated silicone catheters may prevent biofilm formation by both Gram-negative and Gram-positive uropathogens.

A scoping review on the impact of hydrophilic versus non-hydrophilic intermittent catheters on UTI, QoL, satisfaction, preference, and other outcomes in neurogenic and non-neurogenic patients suffering from urinary retention

BackgroundFor patients suffering from urinary retention due to neurogenic [e.g., spinal cord injury (SCI), spina bifida (SB), multiple sclerosis (MS)] or non-neurogenic [e.g., cancer, benign prostate hypertrophy (BPH)] causes, intermittent catheterization is the primary choice for bladder emptying. This scoping review compared hydrophilic-coated intermittent catheters (HCICs) with non-hydrophilic (uncoated) catheters in neurogenic and non-neurogenic patients with respect to satisfaction, preference, adverse events, urinary tract infection (UTI), quality of life (QoL), cost effectiveness, pain, and discomfort.MethodsA systematic literature search was conducted using PubMed, Cochrane Library, Google Scholar, Embase, and available clinical practice guidelines and was limited to systematic reviews/meta-analysis and clinical studies (randomized trials, cohort and case–control studies) published in English between 2000 and 2020. A narrative synthesis was performed, comparing HCIC with non-hydrophilic catheters in each pathology. The articles where critically appraised and weighted according to their level of evidence based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence grading.ResultsThirty seven original articles and 40 reviews were included. The comparison of HCICs versus non-hydrophilic catheters was well-documented in patients with mixed pathology, SCI, and to some extent SB. The available evidence predominantly indicates better outcomes with HCICs as reported by study authors, particularly, greater UTI reduction and improved satisfaction, cost-effectiveness, and QoL. However, SB studies in children did not report reduction in UTIs. Children complained about slippery catheters, indicating possible touching of the surface during insertion, which may compromise cleanliness of the procedure and affect outcomes such as UTI. Limited studies were available exclusively on BPH and none on MS; however, most studies performed on mixed pathologies, including BPH and MS, indicated strong preference for HCICs compared to non-hydrophilic catheters.ConclusionsThe findings generally support HCICs over non-hydrophilic catheters; however, most studies were fairly small, often used a mix of pathologies, and the conclusions were often based on studies with high drop-out rates that were therefore underpowered. Larger studies are needed to support the general finding that HCICs are the preferred choice in most populations. Additional training in children or redesigned catheters may be necessary for this age-group to fully benefit from the advantages of HCICs.

Mechanisms Related to Inhibition of Fungal Biofilm Formation on Medical Device Coated with Poly(Methylmethacrylate-co-Dimethylacrylamide)

Candida albicans (C. albicans) are the most common cause of urinary fungal infections. C. albicans biofilms are of increasing clinical importance due to their resistance to antifungal therapy. Since the use of medical devices causes most hospital infections, polymeric coatings that reduce microorganisms adhesion and biofilm formation are considered an attractive strategy. In this work, the ability and possible mechanisms of poly(methylmethacrylate-co-dimethylacrylamide) (PMMDMA) to inhibit C. albicans biofilms on medical devices have been studied. Scanning electron microscopy was used to evaluate fungal adhesion at various pH conditions, while the surface roughness of the coated and uncoated catheters was analyzed by atomic force microscopy. The surface charge was assessed, and the contact angle was determined to evaluate the surface hydrophobicity. PMMDMA coated catheters showed reduced binding of C. albicans at all pH values studied and presented a hydrophilic contact angle of ϴ = 71°. Negative zeta potential values of PMMDMA enhanced the reduction in C. albicans binding. AFM images demonstrated a smoother and homogeneous surface of PMMDMA-coated catheters. Coating with PMMDMA provided a smoother, more hydrophilic, and negative-charged surface, contributing to a substantial reduction of C. albicans binding.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

PurposeThis study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).Materials and MethodsThe 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.ResultsKaplan–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).ConclusionsPrimary 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).

Cost-effectiveness of long-term intermittent catheterisation with hydrophilic and uncoated catheters in traumatic spinal cord injury in Australia

Aims:To model the cost-effectiveness of hydrophilic coated intermittent catheters (HCIC) compared with uncoated catheters (UC) for intermittent catheterisation in Australians with neurogenic bladder from traumatic spinal cord injury (SCI). Methods:A published probabilistic Markov model was adapted for Australia to compare lifetime costs and quality-adjusted life years for the two catheter types in SCI Australians who intermittently catheterise. The primary analysis was from the Australian healthcare perspective with a supplementary societal perspective analysis that incorporated costs from lost productivity. Results:Lifetime UTI events were reduced by 10% with HCIC use. If every Australian with SCI who undertakes self-catheterisation used HCIC over their lifetime, the modelled decrease in UTI incidence would result in a cost saving of approximately $299,000,000. The incremental cost-effectiveness ratio (ICER) of $48,542 was below the threshold of $50,000 to $60,000 cost per quality-adjusted life year (QALY) informally interpreted as showing cost-effectiveness of medical technologies and pharmaceuticals in Australia. When the societal perspective was taken, HCIC use produced superior clinical outcomes at a lower total cost compared with UCs. Conclusion:UTI was the most common complication leading to readmission in the 2 years following traumatic SCI, hence reducing UTI incidence has a significant impact on both an individual’s quality of life and on total healthcare costs. The ICER results from the base case and sensitivity analyses suggest that use of HCIC in Australia is cost-effective.