Endovascular Management of Iliac and Aorto-Iliac Aneurysms and Impact on Morbidity/Mortality in France: A French National Insurance Claims Database Analysis (SNDS)

Author(s)

Lajoinie A1, Millon A2, Raguideau F3, Bernard A1, Benmerad M4, Jean-Baptiste E5, de Léotoing L6
1RCTs, LYON, France, 2University Hospital of Lyon, Lyon, France, 3HEVA, Lyon, France, 4RCTs, Lyon, France, 5University Hospital of Nice, Nice, France, 6W.L. Gore & Associates, Paris, 75, France

OBJECTIVES: Rupture of common iliac or aortoiliac aneurysm is fatal in more than eight out of 10 cases. Main objectives were to describe inhospital management and estimate morbidity/mortality in patients implanted with an iliac branched endoprosthesis (IBE).

METHODS: We performed a population-based study using the SNDS database, which contains individualized data on refundable healthcare use for almost the entire (>99%) French population. Patients implanted with the GORE® EXCLUDER® Iliac Branch Endoprosthesis from November 1, 2017 to December 31, 2019 were identified by a concomitant combination of implant code and relevant medical procedures codes. Inpatient and outpatient care were retrieved to assess morbidity/mortality via a composite criterion (events: mortality, aortic endovascular reintervention (AER), embolization of any type of endoleak – including type II, branch thrombectomy, bypass).

RESULTS: A total of 361 patients were implanted with the IBE: mean age was 72.4 ± 9.0 years old, 96.1% were males. Median follow-up was 23.1 months (interquartile range: 13.3). Most frequent comorbidities were hypertension (78.1%), coronary artery disease (35.5%), cardiac rhythm disorders (27.1%), smoking (25.8%), peripheral artery disease (24.9%). Mean length of stay for implantation was 5 ± 3.4 days and 47.6% of patients spent 2 ± 1.5 days on average in the intensive care unit. Among 315 patients from the General Insurance Scheme (i.e., with reliable death data), the proportion of patients free from any morbidity/mortality event was estimated at 84.0% (95CI [80.0; 88.0]) and 79.0% [74.0; 84.0] at one year and two years after implantation, respectively. Overall, AER, death and endoleak embolization were the most frequent events: 8.6%, 7.3% and 4.8%, respectively.

CONCLUSIONS: This first real-life study conducted in France since the inception of GORE® EXCLUDER® Iliac Branch Endoprosthesis among refundable devices confirms morbidity/mortality results observed in other countries. Upcoming analysis on longer follow-up will allow the assessment of long-term morbidity/mortality.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

MT18

Topic

Clinical Outcomes, Medical Technologies, Study Approaches

Topic Subcategory

Clinical Outcomes Assessment, Medical Devices

Disease

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

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