Endograft treatment of ruptured abdominal aortic aneurysms using the talent aortouniiliac system:: An international multicenter study

Objective: To understand the potential of endovascular aneurysm repair (EVAR) in patients presenting with a ruptured abdominal aortic aneurysm (rAAA), the proportion in whom this procedure was applicable was assessed. Mortality and morbidity was also determined in patients treated with emergency EVAR (eEVAR) when anatomic and hemodynamic conditions allowed (ie, in the entire cohort with patients receiving endovascular and open repair combined). In addition, a comparison was made between the treatment group with eEVAR and open repair. Methods. Between February 2003 and September 2004, 10 participating institutions enrolled a representative sample of 100 consecutive patients in whom eEVAR was considered. Patients in the New Endograft treatment in Ruptured abdominal aortic Aneurysm (ERA) trial were offered eEVAR or open repair in accordance with their clinical condition or anatomic configuration. Written informed consent was obtained from all patients or their legal representatives. The study included patients who were treated by stent-graft technique or by open surgery in the case of adverse anatomy for endoluminal stent-grafting or severe hemodynamic instability, or both. Data were collated in a centralized database for analysis. The study was sponsored and supported by Medtronic, and eEVAR was uniquely performed with a Talent aortouniiliac (AUI) system in all patients. Crude and adjusted 30-day or in-hospital and 3-month mortality rates were assessed for the entire group as a whole and the EVAR and open repair category separately. Complication rates were also assessed. Results: Stent-graft repair was performed in 49 patients and open surgery in 51. No significant differences were observed between these treatment groups with regard to comorbidity at presentation, hemodynamic instability, and the proportion of patients who could be assessed by preoperative computed tomography scanning. Patients with eEVAR more frequently demonstrated a suitable infrarenal neck for endovascular repair, a longer infrarenal neck, and suitable iliac arteries for access than patients with open repair. The primary reason to perform open aneurysm repair was an unfavorable configuration of the neck in 80% of the patients. In patients undergoing eEVAR, operative blood loss was less, intensive care admission time was shorter, and the duration of mechanical ventilation was shorter (P <= .02, all comparisons). The 30-day or in-hospital mortality was 35% in the eEVAR category, 39% in patients with open repair, and 37% overall. There was no statistically significant difference between the treatment groups with regard to crude mortality rates or rates adjusted for age, gender, hemodynamic shock, and pre-existent pulmonary disease. The cumulative 3-month all-cause mortality was 40% in the eEVAR group and 42% in the open repair group (no significant differences at crude and adjusted comparisons). The 3-month primary complication rate in the two treatment groups was similar at 59%. Conclusions. In approximately half the rAAA patients, eEVAR appeared viable. An unsuitable infrarenal neck was the most frequent cause to select open repair. In dedicated centers using a Talent AUI system, eEVAR appeared to be a feasible method for treatment of a rAAA. The overall first-month mortality did not differ across treatment groups (patients with endovascular and open repair combined), yet was somewhat lower than observed in a recent meta-analysis reporting on open repair.