Infectious complications of endoarterial interventional radiology: protocol for an observational study of a longitudinal national cohort of patients assessed in the French hospital discharge database (MOEVA study)

Abstract

Around seven million patients undergo endoarterial interventional radiology procedures (EAIRP) annually worldwide. These procedures have become part of the standard repertoire of vascular surgery. However, the healthcare-associated infections related to these procedures are relatively unknown. Prevalence and adverse outcome of infectious complication (IC) post-EAIRP may be underestimated. We aim to provide national trend estimation of EAIRP incidence and outcome in France. METHODS AND ANALYSIS: From the French Common Classification of Medical Acts, we will define four categories of EAIRP. We will collect procedures via the French nationwide hospital discharge database, called Programme de Médicalisation des Systèmes d'Information (PMSI) and derived from the Diagnosis Related Group system. Various combinations to identify the numerator will be employed according to a pre-established algorithm. Technical data wrangling tools facilitating the use of PMSI will be developed to obtain a clean and well-structured database ready for statistical analysis. This protocol will require competences in medicine, epidemiology, statistics, data processing and techniques through various stages of the study. The cohort will contain the denominator (the first act of the first stay of each patient) and the corresponding numerator (the IC which will occur during the first stay). ETHICS AND DISSEMINATION: No nominative, sensitive or personal data on patients have been collected. The study of the MOrtality and infectious complications of therapeutic EndoVAscular interventional radiology (MOEVA) study does not involve humans, and falls within the scope of the French Reference Methodology MR-004 according to 2016-41 law dated 26 January 2016 on the modernisation of the French health system. Our study involves the reuse of already recorded data, which require neither information or non-opposition of the included individuals. Access to linked ANOnymous (ANO) file in the PMSI databases was approved by the French National Commission for Data Protection and Liberties (CNIL number 1564135). The results will be disseminated through a peer-reviewed publication.

Keywords: PMSI; endo-arterial; infection; interventional; radiology.

Figure 1

Chronological description of patient pathway with endoarterial interventional radiology procedures (EAIRP). Subjects who had an EAIRP with one of the interventions retained in the study will be screened for denominator’s eligibility. Only those who developed at least an infectious complication will be retained for statistics analysis. The definition of infectious complication (IC) follows an algorithm of case. The checkpoints of IC will be applied to 7 days and 1, 3, 6 and 12 months after EAIRP. If cardiovascular (CV) intervention occurred between 12 and 9 months before EAIRP, it will be regarded as a risk factor. If CV intervention occurred during 3 months before EAIRP, it will be excluded from statistical analysis. If the CV intervention will occur after EAIRP, this one will be counted among the complications and will be regarded as a repair act of the initial act. The follow-up of each patient will be made over 24 months. 12-month feedback before EAIRP for the collection of the comorbidities according to the scores of Elixhauser and Charlson. FCCMA, French Common Classification of Medical Acts.

Figure 2

Flow chart of the various stages of exploitation protocol of the PMSI database for EAIRP. DAS, Diagnostic Associé Significatif; EAIRP, endoarterial interventional radiology procedures; FCCMA, French Common Classification of Medical Acts; FINESS, Fichier d’Identification National des Etablissements Sanitaires et Sociaux; MU, medical unit; PMSI, Programme de Médicalisation des Systèmes d’Information.