Das rupturierte Aortenaneurysma – Therapie, Ergebnisse (Zertifizierung: Modul A Spezialkurs)

Rupture is an often fatal complication of an abdominal aortic aneurysm for which an acute surgical intervention is needed. The mortality from surgical treatment of acute ruptured aneurysms is reported to be high. (>40%) A less invasive technique, endovascular aneurysm repair (EVAR) could potentially reduce peri-operative mortality and complications. Retrospective, single center and small cohort studies have reported decrease in per-operative mortality and morbidity after EVAR of Ruptured Acute Abdominal Aneurysms.(RAAA) It is well known that this sort of study design is often flawed by all sorts of bias, especially selection and follow-up bias. In the Amsterdam region we performed the first prospective RCT to compare patients with a proven ruptured aneurysm on CT for EVAR or Surgery.

In this regional multicenter randomized controlled trial we randomly assigned 116 patients with a Ruptured abdominal aortic aneurysm (RAAA), proven on CT-angiography (CTA), to either EVAR or Surgery. These randomised 116 patients are a subset of patients suitable for both treatments out of all 521 patients presenting with RAAA between April 2004 and February 2011 in the trial region (1.24 million inhabitants). EVAR was performed with an aorto-uni-iliac graft combined with a femoro-femoral crossover bypass, Surgery by conventional mid-line laparotomy and implantation of a conventional tube or bifurcated graft. Primary endpoint: combined death and severe complications at 30 days with additional analysis at 6 months and analysis of secondary outcome measures (hospital and ICU stay, mechanical ventilation, use of blood products),

The primary endpoint rate for EVAR was 42% and for Surgery 47% The combined in hospital and 30-day mortality was 28% following EVAR, and 29% following Surgery EVAR performed better than OR for all secondary outcomes.

In conclusion our trial showed a reduction in combined death and severe complications at 30 days in patients treated with EVAR. However, this benefit was not statistically significant. Patients assigned to EVAR also performed better on secondary clinical endpoints.

The main reason we were not able to show any difference between EVAR and Surgery is the fact that the Surgery group did much better (29%) than was previously reported in the literature. We tried to investigate why Surgery did so much better. Looking back at all our data we believe that the centralization of care, needed to perform our initial trial, is probably the best explanation for this finding. In the trail we had 3 trail centers with a 24/7 service, performing randomization and 7 regional hospitals refering patients to the trail centers. We re-analyzed our data base for All patients suspected of a RAAA in the Amsterdam trial region. All patients were transported to a trial center; only patients deemed unfit for transport based on the judgment of the local vascular surgeon were treated in a regional hospital. Multivariable logistic regression including age, sex, comorbidity, hemodynamic stability (based upon preoperative systolic blood pressure and preoperative resuscitation) and year of intervention was done to assess the influence of hospital setting, patient transfer and type of intervention. Among 510 patients with a RAAA in the region, 407 patients were treated in one of the 3 trail centers with a death rate of 39% and in the regional hospitals 60.6%. After multivariable adjustment, patients surgically treated in a trial center had a decreased risk of dying compared to patients treated in a regional hospital. A regional referral network with centralized care in hospitals with a 24/7 emergency full vascular service improves survival of RAAA.

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