Standard “off-the-shelf“ multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience

Roberto Silingardi, Stefano Gennai, Nicola Leone, Mauro Gargiulo, Gianluca Faggioli, Piergiorgio Cao, Fabio Verzini, Arnaldo Ippoliti, Nicola Tusini, Carmelo Ricci, Michele Antonello, Roberto Chiesa, Enrico Maria Marone, Nicola Mangialardi, Francesco Speziale, Gian Franco Veraldi, Stefano Bonardelli, Luigi Marcheselli

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Abstract

Objective: The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available “off-the-shelf“ multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach. Methods: A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up. Results: Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P = .018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P < .001 and P = .015, respectively), and the staged approach was identified as protective (P = .026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months. Conclusions: The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.

Original languageEnglish
JournalJournal of Vascular Surgery
DOIs
Publication statusAccepted/In press - Jan 1 2017

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ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

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Silingardi, R., Gennai, S., Leone, N., Gargiulo, M., Faggioli, G., Cao, P., Verzini, F., Ippoliti, A., Tusini, N., Ricci, C., Antonello, M., Chiesa, R., Marone, E. M., Mangialardi, N., Speziale, F., Veraldi, G. F., Bonardelli, S., & Marcheselli, L. (Accepted/In press). Standard “off-the-shelf“ multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience. Journal of Vascular Surgery. https://doi.org/10.1016/j.jvs.2017.08.068