Endovascular Treatment of Iliac and Aorto-Iliac Aneurysms Using Iliac-Branched Devices in France: Analysis of a French National Insurance Claims Database Comparing Two Iliac-Branched Devices

Speaker(s)

de Léotoing L1, Jean-Baptiste E2, Raguideau F3, Benmerad M4, Millon A5, Lajoinie A6
1W.L. Gore & Associates, Paris, 75, France, 2University Hospital of Nice, Nice, France, 3HEVA, Lyon, France, 4RCTs, Lyon, France, 5University Hospital of Lyon, Lyon, France, 6RCTs, Lyon, 69, France

OBJECTIVES: Endovascular repair of iliac and aorto-iliac aneurysms using a dedicated iliac branch device (IBD) has become the standard for preserving the hypogastric arteries. The main objective of this study was to compare real-life morbidity and mortality after implantation of two IBDs available in France.

METHODS: This population-based study used the SNDS database, which contains individualized data on reimbursable treatments for almost the entire French population. Patients implanted with the e-PTFE IBD (Group 1) or the polyester IBD (Group 2) between November 1, 2017 and the end of 2019 were identified from a combination of implant and procedure codes. Individual propensity score matching was performed based on demographics and clinical characteristics at index. Inpatient and outpatient care were determined during follow-up from index procedure to the end of 2020. The primary endpoint was a composite of morbidity/mortality using mortality, endovascular aortic reintervention, branch thrombectomy, open aortic reintervention and any type of endoleak embolization, including type II.

RESULTS: A total of 231 patients were identified in each group. Mean age was 71.9 ± 8.8 and 73.5 ± 9.0 years, respectively; in both groups, 96.1% were men. The crude mortality rate at one year was 5% in group 1 versus 6% in group 2, and at two years 7% in group 1 versus 14% in group 2. The proportion of patients with no morbidity/mortality event was 85.0% (95CI [80.0; 89.0]) versus 79.0% [73.0; 83.0] at one year and 81% [75.0; 86.0] versus 63% [55.0; 69.0] at two years, respectively. It differed significantly during follow-up in favor of group 1 (HR: 0.51, 95CI [0.35; 0.73], p=0.0003).

CONCLUSIONS: In this large sample of patients with aorto-iliac aneurysms undergoing endovascular repair, the e-PTFE IBD was associated with a lower relative risk of morbidity/mortality compared to the polyester IBD in the real-life setting.

Code

RWD141

Topic

Clinical Outcomes, Medical Technologies, Real World Data & Information Systems, Study Approaches

Topic Subcategory

Clinical Outcomes Assessment, Health & Insurance Records Systems, Medical Devices

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory), Medical Devices