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May 6, 2024
COSTLY-TLR Study Evaluates Costs of TLR After Femoropopliteal PAD Intervention
A recent retrospective, multicenter study published in the European Journal of Vascular and Endovascular Surgery by Saratzis et al analyzed health care payers’ costs of target lesion revascularization (TLR) procedures for femoropopliteal peripheral artery disease (PAD) after stenting and found that the main contributor of the very considerable costs was procedure time.1
KEY FINDINGS
- The mean cost for all procedures was €21,917 ± €2,110, and the mean cost per operating minute of TLR was €177.
- Duration during the TLR procedure was the main contributor to the high overall TLR costs, and that was consistent across all countries and participating hospitals.
- The overall costliest devices used in procedures were wires and sheaths/guiding catheters, as many different specialty wires or catheters were required per case.
Investigators retrospectively collected cost and clinical data from consecutive patients undergoing femoropopliteal TLR for symptomatic in-stent restenosis, occlusion, or stent thrombosis at 13 European vascular centers from January 2017 to December 2021.
Data were collected on the exact cost of each device or surgical equipment used during the procedure, TLR procedure duration (min), TLR procedure location, cost per minute of staff present during the procedure, daily inpatient cost per hospital, postprocedure event costs leading up to discharge, and cost of all medical treatment administered. The actual costs incurred per patient/TLR procedure were recorded at each site by the local investigators.
The statistical analysis assumed a minimum procedure cost of €3,000 per TLR procedure (SD €500). Linear regression was used to assess associations between preselected variables of interest and TLR costs.
The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge from a health care payer’s perspective.
A total of 482 TLR procedures were included for analysis (56% female; mean age, 75 ± 2 years). A total of 292 (61%) patients were Rutherford class 5 or 6 on presentation, and Tosaka class 3 disease was observed in 67% of the femoropopliteal stents. The breakdown of location and characteristics were as follows: 62% with proximal superficial femoral artery (SFA) involvement, 65% with mid-SFA, 63% with distal SFA, 94% with distal popliteal artery, 10% with common femoral artery, and 6% with iliac artery disease (defined as stenoses ≥ 50%; all symptomatic). There was at least one below-the-knee artery involved in 41% of the procedures, but no common femoral artery occlusions were noted. Hybrid procedures totaled 52% for the TLRs, and 6% were addressed via open surgery only.
Technical success (during TLR) was demonstrated in 339 (70%) patients, the 30-day mortality rate was 1% (n = 7), and the 30-day major amputation rate was 4% (n = 17).
Operating time during the TLR incurred the most cost, inclusive of staff salaries, procedure location costs, and indirect and estate costs. Mean cost for all procedures was €21,917 ± €2,110 (mean costs by procedure type: open, €23,337 ± €8,920; endovascular, €12,903 ± €3,108; hybrid, €22,806 ± €3,977).
Linear regression analysis revealed that procedure duration was the main contributor to higher overall TLR costs (coefficient, 2.77; standard error, 0.88; P < .001). Procedure location or country did not appear to affect cost. The mean cost per operating minute was €177, the mean cost per night stay in the hospital (not intensive care unit [ICU]) was €356, and mean cost per ICU stay (8-hour minimum) was €1,193.
The investigators noted several limitations including increased risk of reporting and/or recollection bias due to the study’s retrospective nature; differences in procedure costs and policies across centers causing reporting bias; lack of in-depth economic analysis; and lack of collection of societal and individual patients’ costs.
The study was supported by Boston Scientific Corporation, but the company was not involved in data collection or adjudication and had no input in design or analysis.
Based on the analysis, the investigators concluded that procedure time is the main factor influencing TLR periprocedural costs. Postoperative complication costs are also an important factor to consider, with them being responsible for 33% of all overall costs of PAD treatments.2 An in-depth analysis of all PAD treatment costs in routine practice is needed to improve current reimbursement policies, noted the investigators, alongside ensuring that a durable procedure is considered at baseline, based on the patient’s characteristics and the lesion anatomy.
1. Saratzis A, Torsello GB, Cardona-Gloria Y, et al. Cost analysis of target lesion revascularisation in patients with femoropopliteal in stent re-stenosis or occlusion: the COSTLY-TLR study. Eur J Vasc Endovasc Surg. Published online February 7, 2024. doi: 10.1016/j.ejvs.2024.02.001
2. Flu H, van der Hage JH, Knippenberg B, et al. Treatment for peripheral arterial obstructive disease: an appraisal of the economic outcome of complications. J Vasc Surg. 2008;48:368-376. doi: 10.1016/j.jvs.2008.03.029
ENDOVASCULAR TODAY ASKS…
Study author Athanasios Saratzis, MBBS, FHEA, PhD, FRCS, with the University of Leicester in Leicester, United Kingdom, comments on the study’s results and provides insight into future studies on this topic.
Procedure duration was the main driver of costs associated with TLR in this study, and the costliest endovascular materials were wires/sheaths. What factors may have led to longer procedure duration in the costlier cases, and did these overlap with the increased use of wires/sheaths? Are any of these factors addressable with modifications in approach?
Almost all the TLR procedures were complex procedures with multilevel involvement and high-grade in-stent stenoses or even occlusions (in most cases). As a result, multiple specialty wires had to be used to cross and treat the lesions (predominantly chronic total occlusions), and multiple guiding catheters were also necessary. The use of specialty devices such as atherectomy, also requiring the use of filter and/or additional wire(s) was quite prevalent. These costs reflect the complex nature of a TLR procedure in this context and were expected. The main consideration is to ensure that clinicians use the most durable technologies or approaches at baseline (first patient presentation), based on the patient’s characteristics and lesion anatomy. Furthermore, when intervening after a restenosis or occlusion, the least costly approach to the health care payer is the one that takes the least time to complete. This should not be at the expense of durability, of course.
Were notable differences seen in costs based on type of revascularization, whether fully endovascular, hybrid, or in the few instances of open-only? If so, were any differences seen based on the nature of index procedure/devices used?
There was no association between the nature of the original stent used and subsequent TLR cost(s); however, open surgical and complex hybrid procedures (ie, those that lasted longer) were more likely to incur more costs when a TLR did take place.
The investigators concluded that an in-depth analysis of all treatment costs is needed to improve reimbursement policies. What would such a study look like in a back-of-the-napkin design?
We are referring to a full cost-effectiveness analysis, taking societal and personal costs into account. A TLR is not only exceedingly expensive for the health care payer/system, but also greatly impacts on patients’ quality of life (such as days lost from regular activities, days lost from work, and impact on autonomy, to name a few). Our PAD research environment urgently needs more randomized studies looking at cost and clinical effectiveness of certain technologies, such as the EVOCC trial, which is currently ongoing in the United Kingdom. Vascular specialists need to ensure their sites take part in such high-quality randomized studies and randomize as many eligible participants as possible.
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