Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass.

OBJECTIVE: To assess the impact of heparin-bonded endoprosthesis compared with femoropopliteal bypass on key hospital resources and revenues up to 1-year follow-up. DESIGN: A 2-arm scenario resource consumption data analysis was modeled based on a multicentre prospective randomized controlled trial. SETTING: Six centers in the Netherlands. PARTICIPANTS: A total of 100 patients were assigned to 2 arms (50 each arm). The first arm evaluated endovascular treatment using the heparin-bonded Viabahn endoprosthesis and the second the femoropopliteal bypass. Resource consumption rates were compared between arms. PRIMARY AND SECONDARY OUTCOMES MEASURES: Resource consumption rates, including hospital stay for bypass procedure, operating room time, type of anesthesia, number of used (endo)grafts, use of different types of bed locations (vascular ward, medium or intensive care), readmission for wound infections, and reinterventions over a period of 12 months. RESULTS: Endovascular repair used fewer hospital resources, with an overall difference of €149.983. Hospital stay was 118 days less (261 vs 379), including 21 fewer days in medium/intensive care (5 vs 26) and 50 fewer operating room hours (100 vs 150). Fewer patients required general anesthesia (31 vs 39), and there were less surgical site infections (3 vs 12). In the surgical bypass group, there were 18 fewer days of hospital stay related to reinterventions (80 vs 62), and the cost of the devices was €309.996, cheaper. The total monetary difference was € 160.013, in favor of the femoropopliteal bypass (€3.200, per patient). CONCLUSIONS: Endovascular repair of the superficial femoral artery reduces the use of valuable hospital resources. Its major limitation is the cost of the devices, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall. These benefits may outweigh the fewer reinterventions in the surgical bypass group. REGISTRATION: The SuperB Trial was registered in clinicaltrials.gov; NCT-ID: NCT01220245. CLINICAL IMPACT: Modeling is a useful technique to predict the impact of treatment modalities on hospital resources and revenue. This study uses real-world data from the SuperB Trial to compare two treatment strategies of superficial femoral artery disease, reflecting actual clinical practice and patient outcomes. The analysis focused on direct costs associated with hospital resources and device usage without considering indirect costs or long-term cost-effectiveness. The analysis showed that endovascular repair reduces the use of valuable hospital resources. Its major limitation is device costs, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall.

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery.

BACKGROUND: Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass. METHODS: Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model. RESULTS: Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years. CONCLUSIONS: In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.

Are early cannulation arteriovenous grafts (ecAVG) a viable alternative to tunnelled central venous catheters (TCVCs)? An observational "virtual study" and budget impact analysis.

BACKGROUND: Early cannulation arteriovenous grafts (ecAVGs) are advocated as an alternative to tunnelled central venous catheters (TCVCs). A real-time observational "virtual study" and budget impact model was performed to evaluate a strategy of ecAVG as a replacement to TCVC as a bridge to definitive access creation. METHODOLOGY: Data on complications and access-related bed days was collected prospectively for all TCVCs inserted over a six-month period (n = 101). The feasibility and acceptability of an alternative strategy (ecAVGs) was also evaluated. A budget impact model comparing the two strategies was performed. Autologous access in the form of native fistula was the goal wherever possible. RESULTS: We found 34.7% (n = 35) of TCVCs developed significant complications (including 17 culture-proven bacteraemia and one death from line sepsis). Patients spent an average of 11.9 days/patient/year in hospital as a result of access-related complications. The wait for TCVC insertion delayed discharge in 35 patients (median: 6 days). The ecAVGs were a practical and acceptable alternative to TCVCs in over 80% of patients. Over a 6-month period, total treatment costs per patient wereGBP5882 in the TCVC strategy and GBP4954 in the ecAVG strategy, delivering potential savings ofGBP927 per patient. The ecAVGs had higher procedure and re-intervention costs (GBP3014 vs. GBP1836); however, these were offset by significant reductions in septicaemia treatment costs (GBP1322 vs. GBP2176) and in-patient waiting time bed costs (GBP619 vs. GBP1870). CONCLUSIONS: Adopting ecAVGs as an alternative to TCVCs in patients requiring immediate access for haemodialysis may provide better individual patient care and deliver cost savings to the hospital.