Elektive endovaskuläre Versorgung des Bauchaortenaneurysmas - Beeinflusst die Nichteinhaltung der „Instructions For Use“ das Ergebnis?

Abstract

Background: There has been a steady increase in endovascular treatment of abdominal aortic aneurysms because of its low perioperative mortality rate. Quite often the stent manufacturers` instructions are broadly interpreted or even ignored. Therefore resulting technical complications have to be critically examined. The aim of this study was to analyze a possible relation between the development of type IA endoleaks and the disregard of the manufacturers` instructions. Materials and methods: The patient population consisted of 81 patients (mean age: 74.1 years; 92.6 % men). The data of the whole elective endovascular infrarenal abdominal aortic aneurysm surgeries, which were performed at General Hospital Augsburg from 2009 to 2010, were recorded retrospectively. Results: According to the Allenberg classification infrarenal aortic aneurysms type I added up to 24.7 % and type II up to 75.3 %. The median overall survival rate was 91.6 % within our follow-up period of 1.7 years. The primary technical success rate came to 86.4 % and the secondary to 91.4 %. The analysis revealed a statistically significant association between keeping with the conservative "Instructions For Use" and non-occurrence of primary (p Fisher exact test = 0.0143 and p mid -p test = 0.0071) and all type IA endoleaks (p mid -p test = 0.0302). Sticking with “Instructions For Use” and disregard of the manufacturers` instructions had no effect on the survival rate of the patients. It has to be mentioned that less interventions were recorded in the cases, where the manufacturers` instructions had been respected. Conclusions: This study was able to prove a statistically significant association between adherence to the conservative "Instructions for Use" and the non-occurrence of primary respectively all type IA endoleaks. Transition to fenestrated stent systems and Chimney techniques seems to make sense in potential violation of the conservative manufacturers` instructions.