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1.
Int J Mol Sci ; 22(9)2021 May 06.
Article in English | MEDLINE | ID: mdl-34066374

ABSTRACT

Low-cost, environmentally friendly and easily applicable coating for Mg alloys, able to resist in real world conditions, are studied. Coatings already used for other metals (aluminum, steel) and never tested on Mg alloy for its different surface and reactivity were deposited on AM60 magnesium alloys to facilitate their technological applications, also in presence of chemically aggressive conditions. A biobased PA11 powder coating was compared to synthetic silicon-based and polyester coatings, producing lab scale samples, probed by drop deposition tests and dipping in increasingly aggressive, salty, basic and acid solutions, at RT and at higher temperatures. Coatings were analyzed by SEM/EDX to assess their morphology and compositions, by optical and IR-ATR microscopy analyses, before and after the drop tests. Migration analyses from the samples were performed by immersion tests using food simulants followed by ICP-OES analysis of the recovered simulant to explore applications also in the food contact field. A 30 µm thick white lacquer and a 120 µm PA11 coating resulted the best solutions. The thinner siliconic and lacquer coatings, appearing brittle and thin in the SEM analysis, failed some drop and/or dipping test, with damages especially at the edges. The larger thickness is thus the unique solution for edgy or pointy samples. Finally, coffee cups in AM60 alloy were produced, as real word prototypes, with the best performing coatings and tested for both migration by dipping, simulating also real world aging (2 h in acetic acid at 70° and 24 h in hot coffee at 60 °C): PA11 resulted stable in all the tests and no migration of toxic metals was observed, resulting a promising candidate for many real world application in chemically aggressive environments and also food and beverage related applications.


Subject(s)
Alloys/chemistry , Alloys/economics , Coated Materials, Biocompatible/chemistry , Coated Materials, Biocompatible/economics , Costs and Cost Analysis , Environment , Food , Magnesium/economics , Magnesium/chemistry , Spectroscopy, Fourier Transform Infrared
2.
J Mater Chem B ; 8(6): 1146-1156, 2020 02 14.
Article in English | MEDLINE | ID: mdl-32011620

ABSTRACT

A paper-based platform was developed and tested for studies on basic cell culture, material biocompatibility, and activity of pharmaceuticals in order to provide a reliable, robust and low-cost cell study platform. It is based upon a paper or paperboard support, with a nanostructured latex coating to provide an enhanced cell growth and sufficient barrier properties. Wetting is limited to regions of interest using a flexographically printed hydrophobic polydimethylsiloxane layer with circular non-print areas. The nanostructured coating can be substituted for another coating of interest, or the regions of interest functionalized with a material to be studied. The platform is fully up-scalable, being produced with roll-to-roll rod coating, flexographic and inkjet printing methods. Results show that the platform efficiency is comparable to multi-well plates in colorimetric assays in three separate studies: a cell culture study, a biocompatibility study, and a drug screening study. The color intensity is quantified by using a common office scanner or an imaging device and the data is analyzed by a custom computer software without the need for expensive screening or analysis equipment.


Subject(s)
Coated Materials, Biocompatible/economics , Dimethylpolysiloxanes/economics , Materials Testing , Paper , Pharmaceutical Preparations/economics , Cells, Cultured , Coated Materials, Biocompatible/chemistry , Dimethylpolysiloxanes/chemistry , Drug Evaluation, Preclinical , Humans , Hydrophobic and Hydrophilic Interactions , Particle Size , Pharmaceutical Preparations/chemistry , Surface Properties
4.
Eur J Vasc Endovasc Surg ; 56(1): 87-93, 2018 07.
Article in English | MEDLINE | ID: mdl-29622512

ABSTRACT

OBJECTIVE/BACKGROUND: Heparin coating has recently been shown to reduce the risk of graft failure in arterial revascularisation, at least transiently. The aim of this study was to assess the cost-effectiveness of heparin coated versus standard polytetrafluoroethylene grafts for bypass surgery in peripheral artery disease from a long-term healthcare system perspective. METHODS: Cost-effectiveness evaluation was conducted alongside the Danish part of the Scandinavian Propaten trial in which 431 patients planned for femoro-femoral or femoro-popliteal bypass surgery were randomised to either type of graft and followed for 5 years. Based on the intention to treat principle, the differences in healthcare costs (general practice, prescription medication, hospital admission, rehabilitation, and long-term care in 2015 Euros), life years (LYs), and quality adjusted life years (QALYs) were analysed as arithmetic means with bootstrapped 95% confidence intervals. Cost-effectiveness acceptability curves were used to illustrate the probability of cost-effectiveness for a range of threshold values of willingness to pay (WTP). RESULTS: No statistically significant differences between the randomisation groups were observed for costs or gains of LYs or QALYs. The average cost per QALY was estimated at €10,792. For a WTP threshold of €40,000 per QALY, the overall probability of cost-effectiveness was estimated at 62%, but owing to cost savings in patients with critical ischaemia (cost per QALY <€0), it increased to 89% for this subgroup. CONCLUSION: Until further evidence, heparin coated grafts appear overall, to be cost-effective over standard grafts, but important heterogeneity between claudication and critical ischaemia should be noted. While the optimal choice for claudication remains uncertain, heparin coated grafts should be used for critical ischaemia.


Subject(s)
Anticoagulants/administration & dosage , Anticoagulants/economics , Blood Vessel Prosthesis Implantation/economics , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis/economics , Coated Materials, Biocompatible/economics , Femoral Artery/surgery , Health Care Costs , Heparin/administration & dosage , Heparin/economics , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/surgery , Popliteal Artery/surgery , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Cost Savings , Cost-Benefit Analysis , Denmark , Female , Heparin/adverse effects , Humans , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Polytetrafluoroethylene/economics , Prosthesis Design , Quality of Life , Quality-Adjusted Life Years , Time Factors , Treatment Outcome
5.
JACC Cardiovasc Interv ; 11(5): 496-499, 2018 03 12.
Article in English | MEDLINE | ID: mdl-29519384

ABSTRACT

On Wednesday, November 1, 2017, the Centers for Medicare and Medicaid Services (CMS) made a public decision to end the transitional pass-through add-on payment for drug-coated balloons beginning January 1, 2018, without creating a new ambulatory payment classification rate for these devices. In this Viewpoint, the authors highlight the disconnect between the CMS's decision not to create a new ambulatory payment classification category for drug-coated balloons despite demonstrated clinical superiority. The authors believe this decision is more in line with a rigid fee-for-service payment system than a value-based system that encourages quality over quantity, and disadvantages both the elderly and the poor. They call on all who advocate for patients with peripheral artery disease to action, encouraging their engagement on CMS decisions regarding payment.


Subject(s)
Angioplasty, Balloon/economics , Angioplasty, Balloon/instrumentation , Cardiovascular Agents/economics , Centers for Medicare and Medicaid Services, U.S./economics , Coated Materials, Biocompatible/economics , Health Care Costs , Health Policy/economics , Vascular Access Devices/economics , Angioplasty, Balloon/legislation & jurisprudence , Centers for Medicare and Medicaid Services, U.S./legislation & jurisprudence , Drug Costs , Equipment Design , Government Regulation , Health Care Costs/legislation & jurisprudence , Health Policy/legislation & jurisprudence , Health Services Accessibility/economics , Healthcare Disparities/economics , Humans , Policy Making , Reimbursement Mechanisms/economics , United States
6.
Cardiovasc Intervent Radiol ; 41(7): 1008-1014, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29589098

ABSTRACT

PURPOSE: The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel-resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment. The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany. MATERIALS AND METHODS: Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to drug-coated balloon (DCB, n = 78) or plain old balloon angioplasty (POBA, n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system. RESULTS: There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups (DCB: 19.1 vs. POBA 40.6%, p = 0.007). At 2 years, the patency rate was significantly higher in the DCB group (72.3 vs. 48.4%, p = 0.006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 vs. 52 ± 136 m, p = 0.001). We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA. CONCLUSIONS: The use of paclitaxel-resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency and substantial cost savings at 2 years. ClinicalTrials.gov Identifier NCT01970579.


Subject(s)
Angioplasty, Balloon/economics , Angioplasty, Balloon/methods , Femoral Artery/diagnostic imaging , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Aged , Angiography , Angioplasty, Balloon/instrumentation , Coated Materials, Biocompatible/economics , Female , Femoral Artery/pathology , Germany , Humans , Kaplan-Meier Estimate , Male , Popliteal Artery/pathology , Prospective Studies , Time Factors , Treatment Outcome
7.
Trials ; 18(1): 224, 2017 05 19.
Article in English | MEDLINE | ID: mdl-28526046

ABSTRACT

BACKGROUND: Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources. METHODS: The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with 'multilevel' disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years. DISCUSSION: BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease. TRIAL REGISTRATION: ISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.


Subject(s)
Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Drug-Eluting Stents , Ischemia/therapy , Lower Extremity/blood supply , Peripheral Arterial Disease/therapy , Stents , Vascular Access Devices , Amputation, Surgical , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/economics , Cardiovascular Agents/adverse effects , Clinical Protocols , Coated Materials, Biocompatible/economics , Cost-Benefit Analysis , Disease-Free Survival , Drug-Eluting Stents/economics , Health Care Costs , Humans , Ischemia/diagnosis , Ischemia/economics , Ischemia/physiopathology , Limb Salvage , Metals , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/physiopathology , Prosthesis Design , Quality-Adjusted Life Years , Regional Blood Flow , Sample Size , Severity of Illness Index , State Medicine/economics , Stents/economics , Time Factors , Treatment Outcome , United Kingdom , Vascular Access Devices/economics , Vascular Patency
8.
Burns ; 43(3): 539-548, 2017 May.
Article in English | MEDLINE | ID: mdl-28043735

ABSTRACT

INTRODUCTION: An ever-increasing number of commercially available dressings have been applied to treat superficial burns with the aim to reduce pain and inflammation and lead to a fast wound healing and scar reduction. Nevertheless the search for cheap and effective wound dressing proceeds. Dressilk® consisting of silkworm silk showed good results for wound healing in regards to scarring, biocompatibility and reduction of inflammation and pain. Therefore it seemed to be an interesting product for the treatment of superficial burns. METHODS: In a prospective intra-individual study the healing of superficial burns was evaluated after the treatment with Dressilk® and Biobrane® in 30 patients with burns of the hand and face. During wound healing pain, active bleeding, exudation, dressing change and inflammation were evaluated using the Verbal Rating Scale 1-10. Three months later scar appearance was assessed by VSS (Vancouver Scar Scale) and POSAS (Patient and Observer Scar Scale). RESULTS: With regard to re-epithelialization, pain, inflammation and acute bleeding both dressings were equivalent. High subjective satisfaction rates were reported for both Dressilk® and Biobrane® dressings in regard to comfort and mobility of the face. Biobrane®, applied as a glove was subjectively preferred for burns of the hand. Regarding their cost efficiency Dressilk® was clearly superior to Biobrane®. Long-term results were similar. CONCLUSION: The "ideal" wound dressing maximizes patients' comfort while reducing pain and promoting wound healing. Dressilk® and Biobrane® both provided an effective and safe healing environment, showing low overall complication rates with respect to infection and exudation on superficial burns of the hand and face. Therefore Dressilk®, being clearly superior to Biobrane® in cost efficiency is an interesting alternative especially for the treatment of superficial burns of faces.


Subject(s)
Bandages , Burns/therapy , Coated Materials, Biocompatible/therapeutic use , Facial Injuries/therapy , Hand Injuries/therapy , Re-Epithelialization , Silk/therapeutic use , Adult , Burns/complications , Cicatrix/etiology , Coated Materials, Biocompatible/economics , Cost-Benefit Analysis , Exudates and Transudates , Facial Injuries/complications , Hand Injuries/complications , Hemorrhage , Humans , Inflammation , Male , Middle Aged , Pain , Prospective Studies , Silk/economics , Wound Healing , Young Adult
9.
JACC Cardiovasc Interv ; 9(22): 2343-2352, 2016 11 28.
Article in English | MEDLINE | ID: mdl-27884360

ABSTRACT

OBJECTIVES: The aim of this study was to evaluate the cost-effectiveness of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA). BACKGROUND: Recent trials have reported lower rates of target lesion revascularization with DCB angioplasty versus standard PTA. However, the cost-effectiveness of DCB angioplasty is unknown. METHODS: A prospective economic study was performed alongside the IN.PACT SFA II (IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA]) trial, which randomized 181 patients with femoropopliteal disease to the IN.PACT DCB versus standard PTA. Resource use data were collected over 2-year follow-up, and costs were assigned using resource-based accounting and billing data. Health utilities were assessed using the EuroQol 5-dimensions questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a decision-analytic model on the basis of empirical data from the trial assuming identical long-term mortality. RESULTS: Initial costs were $1,129 per patient higher with DCB angioplasty than standard PTA, driven by higher costs for the DCB itself. Between discharge and 24 months, target limb-related costs were $1,212 per patient lower with DCB angioplasty such that discounted 2-year costs were similar for the 2 groups ($11,277 vs. $11,359, p = 0.97), whereas QALYs tended to be greater among patients treated with DCBs (1.53 ± 0.44 vs. 1.47 ± 0.42, p = 0.40). The probability that DCB angioplasty is cost-effective compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% at a threshold of $150,000 per QALY gained. CONCLUSIONS: For patients with femoropopliteal disease, DCB angioplasty is associated with better 2-year outcomes and similar target limb-related costs compared with standard PTA. Formal cost-effectiveness analysis on the basis of these results suggests that use of the DCB angioplasty is likely to be economically attractive.


Subject(s)
Angioplasty, Balloon/economics , Angioplasty, Balloon/instrumentation , Cardiovascular Agents/economics , Coated Materials, Biocompatible/economics , Femoral Artery , Health Care Costs , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/therapy , Popliteal Artery , Vascular Access Devices/economics , Aged , Angioplasty, Balloon/adverse effects , Cardiovascular Agents/administration & dosage , Constriction, Pathologic , Cost Savings , Cost-Benefit Analysis , Decision Support Techniques , Drug Costs , Equipment Design , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Male , Middle Aged , Models, Economic , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prospective Studies , Quality-Adjusted Life Years , Time Factors , Treatment Outcome , United States
10.
Vasa ; 45(5): 365-72, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27351416

ABSTRACT

Restenosis or re-occlusion after femoropopliteal angioplasty or stent implantation is the main limitation of endovascular treatment strategies for peripheral artery disease. Within the last years, balloon catheters with anti-proliferative drug coating on the balloon surface have shown to be associated with higher patency rates compared to plain balloon angioplasty. Thus, drug-coated balloons were gradually adopted in many interventional centres for the treatment of femoropopliteal obstructions. The current review summarises the existing evidence for drug-coated balloons in the infrainguinal vessels and their indication in special lesion cohorts.


Subject(s)
Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Femoral Artery , Peripheral Arterial Disease/therapy , Popliteal Artery , Vascular Access Devices , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/economics , Cardiovascular Agents/adverse effects , Cardiovascular Agents/economics , Coated Materials, Biocompatible/economics , Cost-Benefit Analysis , Drug Costs , Equipment Design , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Recurrence , Risk Factors , Stents , Treatment Outcome , Vascular Access Devices/economics
11.
J Cardiovasc Surg (Torino) ; 57(4): 569-77, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27128105

ABSTRACT

Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.


Subject(s)
Alloys , Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Femoral Artery , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Stents , Vascular Access Devices , Alloys/economics , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/economics , Cardiovascular Agents/economics , Coated Materials, Biocompatible/economics , Constriction, Pathologic , Cost-Benefit Analysis , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Health Care Costs , Humans , Male , Middle Aged , Paclitaxel/economics , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/physiopathology , Prosthesis Design , Stents/economics , Treatment Outcome , Vascular Access Devices/economics
12.
Eur J Gastroenterol Hepatol ; 28(3): 297-304, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26735159

ABSTRACT

OBJECTIVES: The most common complication after percutaneous endoscopic gastrostomy (PEG) placement is peristomal wound infection (up to 40% without antibiotic prophylaxis). Single-dose parenteral prophylactic antibiotics as advised by current guidelines decrease the infection rate to 9-15%. We assume a prolonged effect of local antibiotic treatment with antibacterial gauzes. This study is the first to describe the effect of antibacterial gauzes in preventing infections in PEG without the use of antibiotics. METHODS: A retrospective data analysis was carried out of all patients with PEG insertion between January 2009 and October 2014 in the Catharina Hospital Eindhoven. Data include placement and the period of the first 2 weeks after PEG placement, and long-term follow-up. All patients received a locally applied antibacterial gauze polyhexamethylene biguanide immediately following PEG insertion for 3 days. No other antibiotics were administered. The main outcomes were wound infection, peritonitis, and necrotizing fasciitis; secondary outcomes included other complications. RESULTS: A total of 331 patients with only antibacterial gauzes were analyzed. The total number of infections 2 weeks after PEG insertion was 9.4%, including 8.2% minor and 1.2% major infections (peritonitis). No wound infection-related mortality or bacterial resistance was found. Costs are five times lower than antibiotics, and gauzes are more practical and patient friendly for use. CONCLUSION: Retrospectively, antibacterial gauzes are at least comparable with literature data on parenteral antibiotics in preventing peristomal wound infection after PEG placement, with an infection rate of 9.4%. Rates of other complications found in this study were comparable with current literature data.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Anti-Infective Agents, Local/administration & dosage , Antibiotic Prophylaxis/methods , Coated Materials, Biocompatible , Fasciitis, Necrotizing/prevention & control , Gastroscopy/adverse effects , Gastrostomy/adverse effects , Peritonitis/prevention & control , Surgical Mesh , Surgical Wound Infection/prevention & control , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/economics , Anti-Infective Agents, Local/adverse effects , Anti-Infective Agents, Local/economics , Antibiotic Prophylaxis/economics , Coated Materials, Biocompatible/economics , Cost Savings , Cost-Benefit Analysis , Drug Costs , Fasciitis, Necrotizing/diagnosis , Fasciitis, Necrotizing/economics , Fasciitis, Necrotizing/microbiology , Female , Hospital Costs , Humans , Male , Middle Aged , Netherlands , Peritonitis/diagnosis , Peritonitis/economics , Peritonitis/microbiology , Retrospective Studies , Surgical Mesh/economics , Surgical Wound Infection/diagnosis , Surgical Wound Infection/economics , Surgical Wound Infection/microbiology , Time Factors , Treatment Outcome , Young Adult
13.
Cardiovasc Revasc Med ; 16(7): 421-5, 2015.
Article in English | MEDLINE | ID: mdl-26238266

ABSTRACT

Peripheral arterial disease (PAD) is responsible for 20% of all US hospital admissions. Management of PAD has evolved over time to include many medical and transcatheter interventions in addition to the traditional surgical approach. Non-invasive interventions including supervised exercise programs and antiplatelets use are economically attractive therapies that should be considered in all patients at risk. While surgery offers so far a clinically and economically appropriate option, the improvement of percutaneous transluminal angioplasty (PTA) technique with the addition of drug-coated balloons offers a reasonably clinically and economically attractive alternative that will continue to evolve in the future.


Subject(s)
Angioplasty, Balloon/economics , Cardiovascular Agents/economics , Cardiovascular Agents/therapeutic use , Health Care Costs , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/therapy , Vascular Surgical Procedures/economics , Angioplasty, Balloon/instrumentation , Coated Materials, Biocompatible/economics , Cost-Benefit Analysis , Drug Costs , Hospital Costs , Humans , Peripheral Arterial Disease/diagnosis , Time Factors , Treatment Outcome , Vascular Access Devices/economics
14.
Ther Adv Cardiovasc Dis ; 9(3): 87-94, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25731186

ABSTRACT

OBJECTIVES: The clinical efficacy and safety of drug-coated balloon (DCB) angioplasty in patients with coronary in-stent restenosis (ISR) has been demonstrated. The objective of this article is to provide comparative cost efficacy data for DCB angioplasty in various countries based on the original methodology of the Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) in 2010. STUDY DESIGN: Published and unpublished Health Technology Assessment (HTA) reports were evaluated for comparison in selected countries. Furthermore, a systematic review of economic evaluations of DCB angioplasty versus standard treatments (uncoated balloon angioplasty or drug-eluting stent implantations) was conducted. METHODS: National cost efficacy data were evaluated using Markov state transition models which were adapted to fit each country's device and procedure related costs. The clinical input for adverse events was defined with two relevant trials for in-stent restenosis of bare metal stents (BMS-ISR) and of drug-eluting stents (DES-ISR). RESULTS: In the UK, Germany, Switzerland, South Africa, Japan and Brazil, DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR. CONCLUSIONS: DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers' point of view.


Subject(s)
Angioplasty, Balloon, Coronary/economics , Coated Materials, Biocompatible/economics , Coronary Restenosis/economics , Coronary Restenosis/therapy , Paclitaxel/economics , Practice Guidelines as Topic , Tubulin Modulators/economics , Angioplasty, Balloon, Coronary/instrumentation , Cost Savings , Cost-Benefit Analysis , Global Health , Humans
15.
J Med Econ ; 18(8): 586-95, 2015.
Article in English | MEDLINE | ID: mdl-25786331

ABSTRACT

OBJECTIVE: To assess the real-world medical services utilization and associated costs of Medicare patients with diabetic foot ulcers (DFUs) treated with Apligraf (bioengineered living cellular construct (BLCC)) or Dermagraft (human fibroblast-derived dermal substitute (HFDS)) compared with those receiving conventional care (CC). METHODS: DFU patients were selected from Medicare de-identified administrative claims using ICD-9-CM codes. The analysis followed an 'intent-to-treat' design, with cohorts assigned based on use of (1) BLCC, (2) HFDS, or (3) CC (i.e., ≥1 claim for a DFU-related treatment procedure or podiatrist visit and no evidence of skin substitute use) for treatment of DFU in 2006-2012. Propensity score models were used to separately match BLCC and HFDS patients to CC patients with similar baseline demographics, wound severity, and physician experience measures. Medical resource use, lower-limb amputation rates, and total healthcare costs (2012 USD; from payer perspective) during the 18 months following treatment initiation were compared among the resulting matched samples. RESULTS: Data for 502 matched BLCC-CC patient pairs and 222 matched HFDS-CC patient pairs were analyzed. Increased costs associated with outpatient service utilization relative to matched CC patients were offset by lower amputation rates (-27.6% BLCC, -22.2% HFDS), fewer days hospitalized (-33.3% BLCC, -42.4% HFDS), and fewer emergency department visits (-32.3% BLCC, -25.7% HFDS) among BLCC/HFDS patients. Consequently, BLCC and HFDS patients had per-patient average healthcare costs during the 18-month follow-up period that were lower than their respective matched CC counterparts (-$5253 BLCC, -$6991 HFDS). LIMITATIONS: Findings relied on accuracy of diagnosis and procedure codes contained in the claims data, and did not account for outcomes and costs beyond 18 months after treatment initiation. CONCLUSION: These findings suggest that use of BLCC and HFDS for treatment of DFU may lower overall medical costs through reduced utilization of costly healthcare services.


Subject(s)
Coated Materials, Biocompatible/economics , Collagen/economics , Diabetic Foot/economics , Diabetic Foot/therapy , Skin, Artificial/economics , Age Factors , Aged , Aged, 80 and over , Amputation, Surgical/economics , Amputation, Surgical/statistics & numerical data , Comorbidity , Female , Health Expenditures , Health Services/statistics & numerical data , Humans , Insurance Claim Review/statistics & numerical data , Male , Medicare/statistics & numerical data , Propensity Score , Sex Factors , Socioeconomic Factors , Trauma Severity Indices , United States , Wound Healing
16.
Mater Sci Eng C Mater Biol Appl ; 48: 41-7, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25579894

ABSTRACT

The goal of this work is to prepare antimicrobial, corrosion-resistant and low-cost Cu65Zn35 brass film on poly(ethylene terephthalate) (PET) fabric by high-power impulse magnetron sputtering (HIPIMS), which is known to provide high-density plasma, so as to generate a strongly adherent film at a reduced substrate temperature. The results reveal that the brass film grows in a layer-plus-island mode. Independent of their deposition time, the obtained films retain a Cu/Zn elemental composition ratio of 1.86 and exhibit primarily an α copper phase structure. Oxygen plasma pre-treatment for 1min before coating can significantly increase film adhesion such that the brass-coated fabric of Grade 5 or Grade 4-5 can ultimately be obtained under dry and wet rubbing tests, respectively. However, a deposition time of 1min suffices to provide effective antimicrobial properties for both Staphylococcus aureus and Escherichia coli. As a whole, the feasibility of using such advanced HIPIMS coating technique to develop durable antimicrobial textile was demonstrated.


Subject(s)
Anti-Infective Agents/chemistry , Anti-Infective Agents/pharmacology , Polyethylene Terephthalates/chemistry , Textiles , Coated Materials, Biocompatible/chemistry , Coated Materials, Biocompatible/economics , Copper , Corrosion , Escherichia coli/drug effects , Materials Testing/methods , Staphylococcus aureus/drug effects , Zinc
17.
Burns ; 41(4): 749-53, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25458501

ABSTRACT

INTRODUCTION: In many circumstances early burn excision and autografting is unsafe or even impossible. In these situations, skin substitute dressings can be utilized for temporary wound coverage. Two commonly used dressings for this purpose are cadaveric allograft and Biobrane™. MATERIALS AND METHODS: Five year retrospective cohort study evaluating upper extremity burns treated with temporary wound coverage (Biobrane™ or allograft). The primary outcome was to determine the impact choice of wound coverage had on operative time and cost. The secondary outcome was the need for revision of upper extremity debridement prior to definitive autografting. RESULTS: 45 patients were included in this study: 15 treated with cadaveric allograft and 30 treated with Biobrane™ skin substitute. Biobrane™ had a significantly lower procedure time (21.12 vs. 54.78 min per %TBSA excised, p=0.02) and cost (1.30 vs. 2.35 dollars per minute per %TBSA excised, p=0.002). Both techniques resulted in 2 revisions due to complications. CONCLUSION: Biobrane™ is superior to cadaveric allograft as a temporizing skin substitute in the acute burn wound, both in terms of procedure time and associated cost. We believe that this is largely due to the relative ease of application of Biobrane™. Furthermore, given its unique characteristics, Biobrane™ may serve as a triage and transport option for severe burns in the military and mass casualty settings.


Subject(s)
Biological Dressings/economics , Burns/therapy , Coated Materials, Biocompatible/economics , Debridement , Operative Time , Adult , Aged , Burns/economics , Cadaver , Cohort Studies , Female , Humans , Male , Middle Aged , Retrospective Studies , Skin Transplantation , Skin, Artificial , Transplantation, Autologous
18.
Value Health ; 17(8): 801-13, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25498775

ABSTRACT

OBJECTIVES: Determine the cost-effectiveness of three topically applied cellular/tissue-derived products (CTPs) used as adjunct therapies to standard care in the management of venous leg ulcers (VLUs). METHODS: A three-state Markov model derived from the medical literature was developed to estimate the comparative cost-effectiveness of three CTPs in relation to VLU standard care. CTPs evaluated in the study included extracellular matrix (ECM), human skin equivalent (HSE), and living skin equivalent (LSE). The three Markov states included unhealed, healed, and death. A 1-year time horizon was used to determine the number of ulcer-free weeks and the expected costs of therapies. The payer perspective was taken in the analysis and only the direct costs of care were considered. Sensitivity analyses were performed to gauge model parameter uncertainty. RESULTS: The expected costs for standard care, ECM, HSE, and LSE VLU therapy were $6,132, $6,732, $10,638, and $11,237, while the expected outcomes were 24, 31, 29, and 27 ulcer-free weeks, respectively. ECM was economically dominant among the three CTPs. In the base case of ECM versus standard care, the incremental cost-effectiveness ratio for ECM therapy was $86 per ulcer-free week. Sensitivity analysis did not alter ECM dominance. Clinic visits and home health utilization exhibited the greatest influence on cost. CONCLUSIONS: ECM is the most cost-effective CTP when used in the management of VLUs as an adjunct to standard care. These findings suggest that VLU standard care therapy with ECM can yield potential cost savings and produce better outcomes than do other CTPs.


Subject(s)
Leg Ulcer/economics , Leg Ulcer/therapy , Varicose Ulcer/economics , Varicose Ulcer/therapy , Wound Healing , Chronic Disease , Coated Materials, Biocompatible/economics , Compression Bandages/economics , Cost-Benefit Analysis , Extracellular Matrix , Humans , Markov Chains , Models, Economic , Skin, Artificial/economics
19.
BMC Musculoskelet Disord ; 15: 237, 2014 Jul 14.
Article in English | MEDLINE | ID: mdl-25027459

ABSTRACT

BACKGROUND: 187,000 hip and knee joint replacements are performed every year in the National Health Service (NHS). One of the commonest complications is surgical site infection (SSI), and this represents a significant burden in terms of patient morbidity, mortality and cost to health services around the world. The aim of this randomised controlled trial (RCT) is to determine if the addition of triclosan coated sutures to a standard regimen can reduce the rate of SSI after total knee replacement (TKR) and total hip replacement (THR). METHODS: 2400 patients due to undergo a total hip or knee replacement are being recruited into this two-centre RCT. Participants are recruited before surgery and randomised to either standard care or intervention group. Participants, outcome assessors and statistician are blind to treatment allocation throughout the study. The intervention consists of triclosan coated sutures vs. standard non-coated sutures. The primary outcome is the Health protection Agency (HPA) defined superficial surgical site infection at 30 days. Secondary outcomes include HPA defined deep surgical site infection at 12 months, length of hospital stay, critical care stay, and payer costs. DISCUSSION: To date there are no orthopaedic randomised controlled trials on this scale assessing the effectiveness of a surgical intervention, particularly those that can be translated across the surgical specialities. The results from this trial will inform evidence-based recommendations for suture selection in the management of patients undergoing total hip or knee replacement. If triclosan coated sutures are found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip and knee replacement. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 17807356.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Arthroplasty, Replacement, Hip/instrumentation , Arthroplasty, Replacement, Knee/instrumentation , Coated Materials, Biocompatible , Research Design , Surgical Wound Infection/prevention & control , Suture Techniques/instrumentation , Sutures , Triclosan/administration & dosage , Anti-Infective Agents, Local/economics , Arthroplasty, Replacement, Hip/adverse effects , Arthroplasty, Replacement, Hip/economics , Arthroplasty, Replacement, Knee/adverse effects , Arthroplasty, Replacement, Knee/economics , Clinical Protocols , Coated Materials, Biocompatible/economics , Double-Blind Method , England , Health Care Costs , Humans , Length of Stay , Surgical Wound Infection/economics , Surgical Wound Infection/etiology , Suture Techniques/adverse effects , Suture Techniques/economics , Sutures/economics , Time Factors , Treatment Outcome , Triclosan/economics
20.
J Cardiovasc Surg (Torino) ; 55(4): 461-4, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24941235

ABSTRACT

Peripheral arterial disease most commonly affects the femoropopliteal segment. Despite enormous improvements in device and treatment technology the long-term patency rate and clinical benefit of endovascular treatment in the respective vascular bed is not satisfying. Drug coated balloon technology as a treatment option in femoropopliteal disease has shown encouraging results in first-in-man trials, which have now been proven in large randomized controlled trials.


Subject(s)
Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Femoral Artery , Peripheral Arterial Disease/therapy , Vascular Access Devices , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/economics , Cardiovascular Agents/economics , Coated Materials, Biocompatible/economics , Equipment Design , Femoral Artery/physiopathology , Health Care Costs , Humans , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/physiopathology , Time Factors , Treatment Outcome , Vascular Access Devices/economics , Vascular Patency
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