Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group

Michele Piazza; Francesco Squizzato; Giovanni Pratesi; Gianbattista Parlani; Gioele Simonte; Rocco Giudice; Wassim Mansour; Gian Franco Veraldi; Stefano Gennai; Michele Antonello; B.R.I.O. (BRanched Inner – Outer) Investigators

doi:10.1016/j.ejvs.2024.04.005

Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group

Eur J Vasc Endovasc Surg. 2024 Apr 16:S1078-5884(24)00341-1. doi: 10.1016/j.ejvs.2024.04.005. Online ahead of print.

Collaborators

B.R.I.O. (BRanched Inner – Outer) Investigators:
Andrea Spertino², Franco Grego², Sara Di Gregorio³, Massimo Lenti⁴, Giacomo Isernia⁴, Ciro Ferrer⁵, Gabriele Piffaretti⁹, Francesca Mauri⁹, Luca Mezzetto⁷, Davide Mastrorilli⁷, Roberto Silingardi⁸, Nicola Leone⁸, Yamume Tshomba¹⁰, Tommaso Donati¹⁰, Simona Sica¹⁰, Giovanni Tinelli¹⁰, Raffaele Pulli¹¹, Aaron Fargion¹¹, Carlo Pratesi¹¹, Luca Di Marzo⁴, Alessia Di Girolamo¹², Assunta Orticelli¹², Stefano Mechelagnoli¹³, Emiliano Chisci¹³, Stefano Fazzini¹⁴, Fabio Massimo Oddi¹⁴, Arnaldo Ippoliti¹⁴

Affiliations

¹ Division of Vascular and Endovascular Surgery, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy. Electronic address: michele.piazza@unipd.it.
² Division of Vascular and Endovascular Surgery, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
³ Vascular and Endovascular Surgery Unit, Ospedale Policlinico San Martino, University of Genoa, Genoa, Italy.
⁴ Unit of Vascular and Endovascular Surgery, Santa Maria della Misericordia Hospital, Perugia, Italy.
⁵ Vascular and Endovascular Surgery Unit, San Giovanni Addolorata Hospital, Rome, Italy.
⁶ Vascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I -"La Sapienza" University of Rome, Rome, Italy.
⁷ Vascular Surgery, Integrated University Hospital of Verona, Verona, Italy.
⁸ Division of Vascular Surgery, University Hospital of Modena and Reggio Emilia, Baggiovara (MO), Italy.
⁹ Vascular Surgery, Department of Medicine and Surgery, ASST Settelaghi University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy.
¹⁰ Unit of Vascular Surgery, Fondazione Policlinico Universitario A. Gemelli I.R.C.C.S., Università Cattolica del Sacro Cuore, Rome, Italy.
¹¹ Department of Vascular Surgery, Careggi University Hospital, Florence, Italy.
¹² Vascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I - "La Sapienza" University of Rome, Rome, Italy.
¹³ Department of Surgery, Vascular and Endovascular Surgery Unit, Usl Toscana Centro, "San Giovanni di Dio" Hospital, Florence, Italy.
¹⁴ Vascular Surgery Unit, Biomedicine and Prevention Department, University of Rome Tor Vergata, Rome, Italy.

PMID: 38636923
DOI: 10.1016/j.ejvs.2024.04.005

Abstract

Objective: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices.

Methods: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as 1 year freedom from target vessel instability and main endograft instability.

Results: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter bridging length of renal arteries (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, mortality was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At 1 year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46) respectively.

Conclusion: Both off the shelf devices provided excellent early and 1 year results. The E-nside may require shorter thoracic aorta coverage and bridging length for the renal arteries, and less frequent implantation of concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

Keywords: Aortic aneurysm; Branched endovascular aortic repair; Endovascular repair; Multicentre study; Stent; Thoraco-abdominal aortic aneurysm.