New endograft study validates emergency endovascular repair


The results from the New ERA Study (Endograft treatment in Ruptured Abdominal aortic aneurysms), a multi-center study assessing the proportion of patients presenting with a ruptured abdominal aortic aneurysm in whom emergency endovascular aneurysm repair is applicable, and to determine mortality and morbidity in a cohort of patients treated with emergency endovascular aneurysm repair when anatomic and haemodynamic conditions allowed, will be presented at the forthcoming SVS annual meeting. This prospective cohort study enrolled patients from 10 participating institutions between January 2003 and September 2004. Included in the study were patients treated by stent-graft technique (Talent AUI System – Medtronic) or, in the case of adverse anatomy for endoluminal stent-grafting and/or severe haemodynamic instability, by open surgery. Data were collected and enrolled in a centralised database for analysis. Thirty-day/in-hospital outcome was assessed for the entire group as a whole and the EVAR and open repair categories separately.

Thirty-day/in-hospital results for 100 patients were assessed. Stent-graft repair, utilising the Talent AUI system was performed in 48 patients and open surgery in 52 patients, with no significant differences observed with regard to age and gender distribution. The prevalence of preoperative cardiac risk factors (43 versus 34%), renal factors (19 versus 26%), and pulmonary symptoms (33 versus 32%) in the emergency endovascular aneurysm repair and open surgery group, respectively, was comparable. The mean maximum aneurysm diameter was 75.6mm in the endovascular versus 80.7mm in the open surgery categories, respectively.

Concerning anatomical unsuitability for endovascular aneurysm repair, the reason was too short a neck for stent-graft placement in 76% of the patients. Nine percent of patients were hemodynamically too unstable for endovascular aneurysm repair. Procedural technical failure (insertion or deployment failure) occurred in only one patient in the stent-graft group. Three patients in the emergency endovascular aneurysm repair group required conversion to open surgery: two due to persistent Type I endoleaks and one due to the inability to advance the delivery system in the external iliac artery. The mean ICU admission time was 7.5 versus 9.7 days for endovascular and open repair respectively (p=NS). The hospitalisation time was 16.3 days versus 18.5 days for endovascular and open repair, respectively (p=NS). The overall 30-day or in-hospital mortality was also similar: 29% in the endovascular repair group and 35% in the open repair group.

The study found that emergency endovascular aneurysm repair was applicable in approximately half of the patients with an aortic aneurysm, with a short infrarenal neck the most frequent cause to select open repair. An early mortality of 32% for the entire study group was lower than in most series reporting on open repair. The mortality was not significantly different between patients with endovascular and open aneurysm repair. The study concluded that preferential emergency endovascular aneurysm repair is a valid option to treat patients with ruptured abdominal aortic aneurysm and a prospective randomized trial comparing the two treatment modalities appears justified.

Following the presentation of the New ERA Study at the SVS, Co-Principal Investigator Dr Jaap Buth will be talking exclusively to Vascular News about the organisation and outcome of the study.