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

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

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.