An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA)
Authors: D’Oria Mario , Lembo Rosalba , Hörer Tal M. , Rasmussen Todd , Mani Kevin , Parlani Gianbattista , Ierardi Anna Maria , Veraldi Gian Franco , Melloni Andrea , Bonardelli Stefano , Lepidi Sandro , Bertoglio Luca , Antonello Michele , Mees Barend , Bath Jonathan , Goncalves Frederico Bastos , Beck Adam W , Bellmunt Sergi , Berard Xavier , Bose Joseph Du , Budtz-Lilly Jacob , Calvagna Cristiano , Czerny Martin , Dawson David , McGreevy David T , Greenberg George , Savlania Ajay , Davies Mark G , Dias Nuno , Farber Mark A , Fajer Simone , Ferreira Marcelo , Franchin Marco , Gallitto Enrico , Goldin Ilya , Jakimowicz Tomasz , van Herzeele Isabelle , Hockley Joseph A , Holden Andrew , Kahlberg Andrea , Charlton-Ouw Kristofer M , Khashram Manar , Kotelis Drosos , Giacomo Isernia , Maldonado Thomas S , Magee Gregory , Maurel Blandine , Mezzetto Luca , Milner Ross , Panuccio Giuseppe , Helmio Paivi , Pratesi Giovanni , Reijnen Michel M P J , Resch Timothy , Riambau Vincente , Starnes Benjamin , Settembre Nicla , Smeds Matthew R. , Scali Salvatore , Psyllas Anastasios , Sobocinski Jonathan , Guliani Sundeep , Tan Glenn Wei Leong , Tinelli Giovanni , Tsilimparis Nikolaos , Trimarchi Santi , Vriens Patrick , Wahlgren Carl , Van den Eynde Wouter , Vasudevan Thodur , Verhagen Hence JM , Zacà Sergio , Troisi Nicola , Wanhainen Anders , Witheford Miranda , Zimmermann Alexander 
Published: December 2023

Objective: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA). Methods: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts’ responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round’s answers was also graded using Cohen’s kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa. Results: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making. Conclusions: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology. Clinical Impact This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.