Objective: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion). Methods: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months. Results: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year. Conclusions: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair.
Outcomes of off-the-shelf preloaded inner branch device for urgent endovascular thoraco-abdominal aortic repair in the ItaliaN Branched Registry of E-nside EnDograft / Michele Antonello, Michele Piazza, Francesco Squizzato, Matteo Spezia, Franco Grego, Giovanni Pratesi, Giovanni Spinella, Davide Esposito, Martina Bastianon, Yamume Tshomba, Tommaso Donati, Simona Sica, Giovanni Tinelli, Michelangelo Ferri, Simone Quaglino, Andrea Gaggiano, Vincenzo Vento, Luciano Carbonari, Emanuele Gatta, Massimo Lenti, Gioele Simonte, Giacomo Isernia, Giambattista Parlani, Gabriele Piffaretti, Paolo Frigatti, Paola Scrivere, Federico Furlan, Gian Franco Veraldi, Luca Mezzetto, Stefano Gennai, Nicola Leone, Roberto Silingardi, Gustavo Iacono, Giorgio Ubaldo Turricchia, Domenico Angiletta, Massimo Maione, Dimitri Apostolou, Raffaele Pulli, Aaron Fargion, Federico Filippi, Filippo De Angelis, Vittorio Arici, Antonio Bozzani, Alessandro Carlo Luigi Molinari, Giovanni Rossi, Emidio Costantini Brancadoro, Matteo Ferraris, Vittorio Dorrucci, Graziana Derone, Valerio Stefano Tolva, Nicola Monzio Compagnoni, Vittorio Maria Segramora, Gaetano Deleo, Umberto Bracale, Giuseppe Guzzardi, Ciro Ferrer, Rocco Giudice, Enrico Sbarigia, Simone Cuozzo, Roberto Gattuso, Wassim Mansour, Luca Di Marzo, Sabrina Grimaldi, Mario Corona, Emiliano Chisci, Stefano Mechelagnoli, Gianmarco De Donato, Giancarlo Palasciano, Edoardo Pasqui, Laura Candeloro, Carmelo Ricci, Eugenio Neri, Nicola Mangialardi, Matteo Orrico, Sonia Ronchey, Stefano Fazzini, Arnaldo Ippoliti, Andrea Discalzi, Denis Rossato, Elias Vio, Edoardo Galeazzi, Fabrizio Farneti, Elias Vio, Edoardo Galeazzi, Fabrizio Farneti, Luca Bertoglio, Pietro Volpe, Mafalda Massara, Domenico Milite, Andrea Xodo. - In: JOURNAL OF VASCULAR SURGERY. - ISSN 0741-5214. - STAMPA. - (In corso di stampa), pp. 0-0.
Outcomes of off-the-shelf preloaded inner branch device for urgent endovascular thoraco-abdominal aortic repair in the ItaliaN Branched Registry of E-nside EnDograft.
Raffaele Pulli;
In corso di stampa
Abstract
Objective: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion). Methods: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months. Results: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year. Conclusions: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair.I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.