Kalinowski Marc, Alfke Heiko, Hamann Christine, Viehofer Kerstin, Klose Klaus Jochen, Barry James J, Wagner Hans-Joachim
Department of Diagnostic Radiology, Philipps-University Hospital, Baldingerstrasse, 35033, Marburg, Germany.
Atherosclerosis. 2004 Jan;172(1):71-8. doi: 10.1016/j.atherosclerosis.2003.09.025.
Efficient local gene or drug therapy requires optimized application modalities to avoid vessel damage, which might lead to increased neointimal hyperplasia. Aim of the study was to evaluate different application parameters for local delivery using the channeled balloon catheter in order to minimize vessel trauma induced by local application.
Sixty cholesterol fed rabbits were randomly enrolled into twelve groups of different local application parameters: group I, application pressure 2atm/application volume 1ml physiologic saline; group II, 2atm/2ml; group III, 2atm/5ml; group IV, 4atm/1ml; group V, 4atm/2ml; group VI, 4atm/5ml. The other six groups received Ringer's solution instead of saline. Administration of the solution was randomly performed in one iliac artery using the channeled balloon catheter with simultaneous balloon angioplasty (8atm). The contralateral iliac artery served as a control and was treated with balloon angioplasty only. Four weeks after local therapy, calibrated angiography was performed; the animals were sacrificed, vessel segments were excised and quantitative morphometric measurements were obtained. In none of the animals acute complications, e.g. dissection, thrombosis or perforation of the vessel, was noted. Up to an application pressure of 4atm and an application volume of 5ml, no significant neointima formation was seen compared to arteries which underwent angioplasty only. Additionally, no significant differences between saline and Ringer's solution were detected. In a multivariate analysis, neither application pressure nor volume were found to have a statistically significant influence on the amount of neointimal hyperplasia.
Local application of "drugs" using the channeled balloon catheter is safe and feasible without significant induction of neointimal hyperplasia compared to angioplasty, if an application volume of 5ml and a pressure of 4atm is not exceeded.
有效的局部基因或药物治疗需要优化应用方式以避免血管损伤，而血管损伤可能导致新生内膜增生加剧。本研究的目的是评估使用带通道球囊导管进行局部递送的不同应用参数，以尽量减少局部应用引起的血管创伤。
60只喂食胆固醇的兔子被随机分为12组，每组具有不同的局部应用参数：第一组，应用压力2个大气压/应用体积1毫升生理盐水；第二组，2个大气压/2毫升；第三组，2个大气压/5毫升；第四组，4个大气压/1毫升；第五组，4个大气压/2毫升；第六组，4个大气压/5毫升。另外六组接受林格氏液而非生理盐水。使用带通道球囊导管并同时进行球囊血管成形术（8个大气压），将溶液随机注入一条髂动脉。对侧髂动脉作为对照，仅进行球囊血管成形术治疗。局部治疗四周后，进行校准血管造影；处死动物，切除血管段并进行定量形态学测量。在所有动物中均未观察到急性并发症，例如血管夹层、血栓形成或穿孔。与仅接受血管成形术的动脉相比，在应用压力高达4个大气压且应用体积为5毫升的情况下，未观察到明显的新生内膜形成。此外，在生理盐水和林格氏液之间未检测到显著差异。在多变量分析中，未发现应用压力和体积对新生内膜增生量有统计学上的显著影响。
如果不超过5毫升的应用体积和4个大气压的压力，使用带通道球囊导管局部应用“药物”是安全可行的，与血管成形术相比不会显著诱导新生内膜增生。
