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) Study Group 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) Study Group Investigators:
Andrea Spertino⁹, Franco Grego⁹, Davide Esposito³, Martina Bastianon³, Massimo Lenti⁴, Giacomo Isernia⁴, Ciro Ferrer⁵, Gabriele Piffaretti¹⁰, Francesca Mauri¹⁰, Luca Mezzetto⁷, Davide Mastrorilli⁷, Roberto Silingardi⁸, Nicola Leone⁸, Yamume Tshomba¹¹, Tommaso Donati¹¹, Simona Sica¹¹, Giovanni Tinelli¹¹, Raffaele Pulli¹², Aaron Fargion¹², Carlo Pratesi¹², Luca Di Marzo¹³, Alessia Di Girolamo¹³, Assunta Orticelli¹³, Stefano Michelagnoli¹⁴, Emiliano Chisci¹⁴, Stefano Fazzini¹⁵, Fabio Massimo Oddi¹⁵, Arnaldo Ippoliti¹⁵

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. Electronic address: https://www.twitter.com/dr_fsquizzato.
³ Vascular and Endovascular Surgery Unit, IRCCS Ospedale Policlinico San Martino, 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 Division of Vascular and Endovascular Surgery, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.
¹⁰ Vascular Surgery, Department of Medicine and Surgery, ASST Settelaghi University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy.
¹¹ Unit of Vascular Surgery, Fondazione Policlinico Universitario A. Gemelli I.R.C.C.S., Università Cattolica del Sacro Cuore, Rome, Italy.
¹² Department of Vascular Surgery, Careggi University Hospital, Florence, Italy.
¹³ Vascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I - "La Sapienza" University of Rome, Rome, Italy.
¹⁴ Department of Surgery, Vascular and Endovascular Surgery Unit, Usl Toscana Centro, "San Giovanni di Dio" Hospital, Florence, Italy.
¹⁵ 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 one 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 renal artery bridging lengths (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, the mortality rate 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 one 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 one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a 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.