Editor's Choice – A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial

Abstract

WHAT THIS PAPER ADDS AMBUVASC was the first cost effectiveness analysis associated with a prospective randomised controlled trial in France that compared outpatient vs. inpatient hospitalisation for the endovascular repair of lower extremity arterial disease (LEAD). From a societal perspective, considering a one month time horizon, outpatient hospitalisation was not cost effective compared with inpatient hospitalisation for a V50 000 per quality adjusted life year (QALY) threshold (the incremental cost effectiveness ratio was V67 741 per QALY). This result was mainly explained by the higher number of re-admissions in the outpatient arm. More data are required to support the cost effectiveness for LEAD endovascular revascularisation. Objective: The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). Methods: AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. Results: From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n ¼ 76; inpatient hospitalisation: n ¼ 77).The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p ¼ .81). Overall costs (difference: V187.83; 95% confidence interval [CI] À275.68e651.34) and QALYs (difference: 0.00277; 95% CI e0.00237 e 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was V67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of V50 000 per QALY and the probability of being cost effective was only 59% for a V100 000/QALY threshold. Conclusion: Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a V50 000/QALY threshold.

Hospitalization and Death in the First 30 days After Outpatient Lower Extremity Arterial Stenting

“…In France, outpatient surgery units remain under the administrative control of hospitals and no financial incentive was given before 2019 to promote outpatient endovascular surgery. Nevertheless, we excluded high-risk patients using medical criteria similar to those of other studies [8,11,19,27] (i.e. the American Society of Anesthesiology score and recent guidelines [28]).…”

“…Some studies showed that procedural and postoperative complications of endovascular revascularization within 30 days of surgery occur in 10% to 13% of the patients [15,16]. In addition, outpatient endovascular repair for LEAD does not seem to increase the risk of complications and hospital readmission [8,[16][17][18]; however, the AMBUVASC randomized clinical trial (RCT) showed more readmissions in the outpatient than in the inpatient arm [19].…”

Geographical Ambulatory Endovascular Revascularisation Disparities in France From 2015 to 2019

“…11,32,33 Second, the cost effictiveness of ambulatory endovascular revasculatisation remains a question. For instance, The AMBUVASC randomised control trial showed that on one month time horizon, ambulatory interventions was not cost effective compared with conventional hospitalisation for a €50 000 per quality adjusted life year threshold 7 . The authors reported that this result was mainly explained by the higher number of re-admissions in the outpatient arm.…”

“…For more than a decade, technological developments and the expertise of vascular teams have improved the management of LEAD, offering endovascular treaments and outpatient hospitalisation. Although the benefits of outpatients hospitalisations are still debated, notably about the complication rates or the burden of premature discharge on primary health care services [6][7][8][9] , several studies had demonstrated both increased resource efficiency and hospital cost savings, thanks to ambulatory endovascular treatments, while preserving patient safety [10][11][12][13] . Consequently, the development of endovascular interventions in ambulatory setting has accelerated significantly, mainly in the United States 14,15 .…”