Lewis D A, Ding Y H, Dai D, Kadirvel R, Danielson M A, Cloft H J, Kallmes D F
Neuroradiology Research Laboratory, Department of Radiology, Mayo Clinic, Rochester, MN 55905, USA.
AJNR Am J Neuroradiol. 2009 Jan;30(1):91-4. doi: 10.3174/ajnr.A1369. Epub 2008 Nov 11.
Elastase-induced aneurysms in rabbits have been proposed as a useful preclinical tool for device development. The object of this study was to report rates of morbidity and mortality associated with the creation and embolization of elastase-induced rabbit aneurysms and to assess the impact of operator experience on these rates.
Elastase-induced model aneurysms were created in New Zealand white rabbits (n = 700). One neuroradiologist/investigator, naive to the aneurysm-creation procedure at the outset of the experiments, performed all surgeries. All morbidity and deaths related to aneurysm creation (n = 700) and embolization procedures (n = 529) were categorized into acute and chronic deaths. Data were analyzed with single-regression analysis and analysis of variance. To assess the impact of increasing operator experience, we broke the number of animals into 50-animal increments.
There were 121 (17%) deaths among 700 subjects. Among 700 aneurysm-creation procedures, 59 deaths (8.4%) were noted. Among 529 aneurysm-embolization procedures, 43 deaths (8.1%) were noted. Nineteen additional deaths (2.7% of 700 subjects) were unrelated to the procedures. Simple regression-indicated mortality associated with procedures diminished with increasing operator experience (R(2) = 0.38, P = .0180), and that for each 50-rabbit increment mortality was reduced, on average, by 0.6%.
Mortality rates of approximately 8% are associated with both experimental aneurysm creation and with embolization in the rabbit elastase-induced aneurysm model. Increasing operator experience is inversely correlated with mortality, and the age of the rabbit is positively associated with morbidity.
兔弹性蛋白酶诱导性动脉瘤已被提议作为器械研发中一种有用的临床前工具。本研究的目的是报告与兔弹性蛋白酶诱导性动脉瘤的创建及栓塞相关的发病率和死亡率,并评估术者经验对这些比率的影响。
在新西兰白兔(n = 700)中创建弹性蛋白酶诱导性模型动脉瘤。一名神经放射科医生/研究者在实验开始时对动脉瘤创建过程并不熟悉,进行了所有手术。所有与动脉瘤创建(n = 700)和栓塞手术(n = 529)相关的发病率和死亡情况被分为急性死亡和慢性死亡。数据采用单回归分析和方差分析。为评估术者经验增加的影响,我们将动物数量按50只的增量进行划分。
700只实验对象中有121只(17%)死亡。在700次动脉瘤创建手术中,记录到59例死亡(8.4%)。在529次动脉瘤栓塞手术中,记录到43例死亡(8.1%)。另有19例死亡(占700只实验对象的2.7%)与手术无关。简单回归表明,与手术相关的死亡率随着术者经验的增加而降低(R² = 0.38,P = 0.0180),并且每增加50只兔子,死亡率平均降低0.6%。
在兔弹性蛋白酶诱导性动脉瘤模型中,实验性动脉瘤创建和栓塞的死亡率约为8%。术者经验的增加与死亡率呈负相关,而兔子的年龄与发病率呈正相关。