Objectives: To report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside, Artivion - Kennesaw, GA - USA). 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 (48.4%) patients, a contained rupture in 8 (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I-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 (97.2%) target vessels 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 min per target vessel. Thirty-days cumulative MAE rate was 28% and mortality occurred in 5 patients (9.1%). There were 1 postoperative stroke (1.6%) and SCI rate was 8% (n=5). For the 249 target vessels successfully incorporated through an inner branch, one-year freedom from target vessel instability was 93±3% after 1 year. Conclusion: 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 / Piazza, Michele; Squizzato, Francesco; Ferri, Michelangelo; Pratesi, Giovanni; Gatta, Emanuele; Orrico, Matteo; Giudice, Rocco; Antonello, Michele; Antonello, Michele; Piazza, Michele; Squizzato, Francesco; Spezia, Matteo; Grego, Franco; Pratesi, Giovanni; Spinella, Giovanni; Esposito, Davide; Bastianon, Martina; Tshomba, Yamume; Donati, Tommaso; Sica, Simona; Tinelli, Giovanni; Ferri, Michelangelo; Quaglino, Simone; Gaggiano, Andrea; Vento, Vincenzo; Carbonari, Luciano; Gatta, Emanuele; Lenti, Massimo; Simonte, Gioele; Isernia, Giacomo; Parlani, Giambattista; Piffaretti, Gabriele; Frigatti, Paolo; Scrivere, Paola; Furlan, Federico; Veraldi, Gian Franco; Mezzetto, Luca; Gennai, Stefano; Leone, Nicola; Silingardi, Roberto; Iacono, Gustavo; Turricchia, Giorgio Ubaldo; Angiletta, Domenico; Maione, Massimo; Apostolou, Dimitri; Pulli, Raffaele; Fargion, Aaron; Filippi, Federico; De Angelis, Filippo; Arici, Vittorio; Bozzani, Antonio; Luigi Molinari, Alessandro Carlo; Rossi, Giovanni; Costantini Brancadoro, Emidio; Ferraris, Matteo; Dorrucci, Vittorio; Derone, Graziana; Tolva, Valerio Stefano; Compagnoni, Nicola Monzio; Segramora, Vittorio Maria; Deleo, Gaetano; Bracale, Umberto; Guzzardi, Giuseppe; Ferrer, Ciro; Giudice, Rocco; Sbarigia, Enrico; Cuozzo, Simone; Gattuso, Roberto; Mansour, Wassim; Di Marzo, Luca; Grimaldi, Sabrina; Corona, Mario; Chisci, Emiliano; Mechelagnoli, Stefano; De Donato, Gianmarco; Palasciano, Giancarlo; Pasqui, Edoardo; Candeloro, Laura; Ricci, Carmelo; Neri, Eugenio; Mangialardi, Nicola; Orrico, Matteo; Ronchey, Sonia; Fazzini, Stefano; Ippoliti, Arnaldo; Discalzi, Andrea; Rossato, Denis; Vio, Elias; Galeazzi, Edoardo; Farneti, Fabrizio; Vio, Elias; Galeazzi, Edoardo; Farneti, Fabrizio; Bertoglio, Luca; Volpe, Pietro; Massara, Mafalda; Milite, Domenico; Xodo, Andrea. - In: JOURNAL OF VASCULAR SURGERY. - ISSN 0741-5214. - (2024). [10.1016/j.jvs.2024.05.056]
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
Bracale, Umberto;
2024
Abstract
Objectives: To report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside, Artivion - Kennesaw, GA - USA). 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 (48.4%) patients, a contained rupture in 8 (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I-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 (97.2%) target vessels 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 min per target vessel. Thirty-days cumulative MAE rate was 28% and mortality occurred in 5 patients (9.1%). There were 1 postoperative stroke (1.6%) and SCI rate was 8% (n=5). For the 249 target vessels successfully incorporated through an inner branch, one-year freedom from target vessel instability was 93±3% after 1 year. Conclusion: 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 IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
