Cost-Effectiveness Evaluation of Heparin Coated Versus Standard Graft for Bypass Surgery in Peripheral Artery Disease Alongside a Randomised Controlled Trial.

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.

[Cost comparison of different graft materials in femoropopliteal bypass: experience with G-DRG]. / Kostenanalyse verschiedener Bypassmaterialien in femoropoplitealer Position unter G-DRG-Bedingungen.

BACKGROUND: The German DRG classification refrains from medical accuracy of different surgical procedures by concentrating mainly on economic aspects. The process cost calculation of femoropopliteal bypass should as an example illuminate the charge of a surgical procedure under hospital conditions. METHODS: From 07/03 to 03/04 we analysed out of 71 peripheral arterial reconstructions 10 alloplastic grafts (PBP) and 10 autologous vein grafts (VBP) for femoropopliteal above-knee bypass through the process cost calculation. This required a classification of the procedure in different diagnostic and treatment sections (ward, intensive care, diagnosis, treatment (surgical procedure)). RESULTS: The average length of hospitalisation with VBP amounted to 12.2 +/- 3.6 (7-19) days, and with PBP to 14.0 +/- 8.0 (8-35) days. The duration of the surgical procedure was almost identical with 118 +/- 26 minutes (VBP) compared to 110 +/- 31 minutes (PBP), but in average 0.4 more assistants participated in VBP. One bleeding caused revision in VBP; one PBP led to extended length of hospitalisation because of wound complication. We diagnosed one asymptomatic bypass occlusion in VBP. The average total costs in VBP amounted to 4 368.10 euro (profit: 4 468.15 euro), in PBP to 5 069.50 euro (profit: 3 802.94 euro). CONCLUSION: The reconstruction of the superficial femoral artery with alloplastic or autologous vein graft is profitable in G-DRG. Although less medical staff in required in PBP the price of the prosthesis weakens the profit. The autologous vein graft shows furthermore a shorter length of hospitalisation. Further investigation into cost-effectiveness regarding long-term follow-up and patency rates could lead to consequences for the German health system.

A prospective, within-patient comparison between metal butterfly needles and Teflon cannulae in subcutaneous infusion of drugs to terminally ill hospice patients.

We performed a prospective study of hospice in-patients requiring a syringe driver (SD), to determine the site duration and tolerability of metal butterfly needles compared to Teflon cannulae. Using patients as their own control, prescribed medications were divided equally between two SDs (Graseby MS16a), for delivery over 24 h. A butterfly infusion (Flosafer, 25 gauge) was connected to one SD and a Teflon cannula (Abbocath-T, 24 gauge), to the second. These were inserted subcutaneously (s.c.) on opposite sides of the body at comparable sites; oedematous, broken or painful sites were excluded. SD sites were examined at 4-hourly intervals. The study was terminated when both devices had required resiting. Needle and cannula times were compared using the Wilcoxon signed rank test. Thirty patients entered the study, 13 males and 17 females, mean age (standard deviation): 70 (11) years. Thirteen patients completed the study. Nine patients died and eight patients discontinued the study before both needle and cannula had been resited. All 30 patients are included in the analysis. The time from insertion to resiting of the cannula was significantly longer than the needle: P < 0.0002, median (range) 93.5 (22.8-263.5) h versus 42.8 (7.5-162.3) h, respectively. The cost of the needle versus cannula is 1.93 Pounds versus 2.51 Pounds, respectively. Teflon cannulae have a median life span twice that of metal butterfly needles and are a cost-effective alternative for administration of medications by s.c. infusion in terminally ill patients.

Long-term patency rates, complications and cost-effectiveness of polytetrafluoroethylene (PTFE) grafts for hemodialysis access: a prospective study that compares Impra versus Gore-tex grafts.

Manufacturers of polytetraflouroethylene (PTFE) grafts used for chronic hemodialysis access describe specific advantages for their respective grafts, which presumably result in greater graft patency rates, reduced complications and decreased overall costs. There are few data available in the literature to support or contradict these alleged benefits. Therefore, this prospective study was undertaken to evaluate and compare patency rates, complications and costs between two of the leading brands of PTFE that are currently being marketed for use as hemodialysis access grafts. Totals of 190 primary PTFE grafts (100 Gore-tex (W. L. Gore and Associates, Flagstaff, AZ) and 90 Impra (C. R. Bard Inc., Tempe, AZ)) were implanted in 168 consecutive patients with end-stage renal disease. A policy of non-interventions was employed for patent grafts, as no attempt was made to assist primary patency. Grafts that occluded during follow-up underwent secondary revision to maintain patency. There was no difference in primary and secondary patency by life-table analysis between Gore-tex and Impra grafts at 2 years (P > 0.53 and P > 0.13, respectively). There was also no significant difference between Gore-tex and Impra in the number of days before the first thrombectomy or in the number of thrombectomies or revisions per graft (P > O.50). Likewise, the incidence of complications was similar between the two grafts. The cost of graft implantation and maintenance of patency was not significantly different between Gore-tex and Impra grafts. It is concluded that either graft can be used for hemodialysis access with similar expected outcomes for at least 2 years following implantation.

Market study: biomaterials supply for permanent medical implants.

The withdrawal of DuPont as a supplier of key raw materials created a major dislocation in the medical device industry. We studied the present and future impact caused by the market removal of polyethylene terephthalate (PET) yarn ("Dacron"), polytetrafluorethylene (PTFE) fiber and resin ("Teflon"), and polyacetal resin ("Delrin"). Findings were: 1) Dollar values of the permanent medical implant markets for PET yarn, PTFE fiber and resin, and polyacetal resin are a minute fraction, of their values for their other commercial markets; 2) The implant market value is clearly not commensurate with the liability risk; and 3) The majority of these materials consumed by this market are used in the production of lifesaving, permanent medical implants [e.g., vital blood vessel replacements made from knitted polyester (PET)]. The remainder is used in life-enhancing, permanent implants [e.g., hernia patches made of polyester (PET) fabric].