Editor's Choice – Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)
Michele Piazza, Francesco Squizzato, Giovanni Pratesi, Yamume Tshomba, Andrea Gaggiano, Emanuele Gatta, Gioele Simonte, Gabriele Piffaretti, Paolo Frigatti, Gian Franco Veraldi, Roberto Silingardi, Michele Antonello, Edoardo Forcella, Franco Grego, Giovanni Spinella, Sara Di Gregorio, Tommaso Donati, Simona Sica, Giovanni Tinelli, Michelangelo Ferri, Simone Quaglino, Vincenzo Vento, Luciano Carbonari, Massimo Lenti, Giacomo Isernia, Giambattista Parlani, Paola Scrivere, Federico Furlan, Luca Mezzetto, Davide Mastrorilli, Stefano Gennai, Nicola Leone, Gustavo Iacono, Giorgio Ubaldo Turricchia, Domenico Angiletta, Massimo Maione, Dimitri Apostolou, Raffaele Pulli, Aaron Fargion, Carlo Pratesi, Federico Filippi, Filippo De Angelis, Vittorio Arici, Antonio Bozzani, Alessandro Carlo Luigi Molinari, Giovanni A. Rossi, Emidio Costantini Brancadoro, Matteo Ferraris, Vittorio Dorrucci, Graziana Derone, Valerio Tolva, Vittorio Maria Segramora, Gaetano Deleo, Umberto Marcello 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, Eugénio Neri, Nicola Mangialardi, Matteo Orrico, Stefano Fazzini, Arnaldo Ippoliti, Andrea Discalzi, Denis Rossato, Elias Vio, Edoardo Galeazzi, Fabrizio Farneti
Abstract
Objective The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. Methods Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. Results In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I – III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft’s technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. Conclusion In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft. The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I – III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft’s technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.