Justifi cation and design of the prospective multicentre cohort study to evaluate the results of percutaneous closure in endovascular aortic repair procedures. SPAIN Registry

Abstract

Introduction: Percutaneous closure is an essential tool in current endovascular treatment. Aortic pathology procedures require large-caliber arterial approaches, leading to a greater possibility of closure complications. For this reason, nowadays, both open surgical and the preclose technique coexist in almost every center worldwide, as it does in Spain with no contrasted results. The current literature provides good results for the pre-closing technique in aortic pathology, however there are still doubts regarding certain risk factors such as obesity, severe calcification or small-caliber arteries. There is not enough data to study how this procedure affects quality of life, an essential point, especially in older patients. Minimizing surgical aggression and improving their immediate post-procedure quality of life can be decisive because most of the patients are elderly with concomitant pathologies (fragile patients). Objetives: Primary objectives: To estimate the technical success rate of the percutaneous closure procedure in aortic interventions, estimate the impact on quality of life and find possible differences in morbidity and mortality at 30 days in relation to the score of each patient on the frailty scale; secondary objectives: To evaluate the pre-suture time, hemostasis time, complications derived from closure, hospital stay and post-operative pain. Material and methods: The SPAIN Registry is a prospective multicenter study of patients undergoing percutaneous procedures on the aorta and its branches with ≥ 10 French (F) devices. Variables related to the closure of their inguinal access will be collected. The follow-up period will be 30 days. The duration of the recruitment period will be one year initially. Participants must certify that they have performed the closure of at least 10 large caliber percutaneous approaches (≥ 10 F) in national units of the specialties of Angiology and Vascular Surgery and Cardiology. Conclusion: The SPAIN Registry aims to value all current evidence and uniformly state, through the analysis of data from a prospective, standardized and validated cohort, the variables that influences the success of the technique. It aims to standardize the expected results of the technique in the majority of possible centers in Spain to finally show what are the success rates and the effect on the quality of life of the patient, especially the fragile one.