Wissgott C, Kamusella P, Andresen R
Institute of Diagnostic and Interventional Radiology/Neuroradiology, Westküstenklinikum HeideAcademic Teaching Hospital of Universities of Kiel, Lübeck and Hamburg, Heide, Germany.
J Cardiovasc Surg (Torino). 2012 Apr;53(2):177-86.
For the treatment of chronic lesions, various ablative procedures have been developed with the aim of improving the outcome of percutaneous transluminal angioplasty (PTA)/stent and/or reducing the length and number of implanted stents by removing stenotic or occlusive material. The objective of this study was to compare two mechanical rotational catheters (Rotarex and Pathway) with regard to their safety and effectiveness in the treatment of stenoses and occlusions of the femoropopliteal arteries.
A total of 156 patients with chronic stenoses or occlusions of the femoropopliteal vasculature were treated, 114 of them with the Rotarex catheter and 42 with the Pathway catheter. The pre-interventional Rutherford classification was on average 3.32 (2-5) in the Rotarex group and 2.93 (2-5) in the Pathway group. The mean lesion length was 13.9 cm (2-30 cm) and 5.1 cm (1-10 cm), respectively (P<0.05). The Ankle-Brachial Index (ABI) was determined pre- and postinterventionally and after 12 months. Colour-coded duplex ultrasound was additionally performed as a follow-up.
The technical success rate was 98.2 % in the Rotarex group and 97.6% in the Pathway group. In the Rotarex group, additional balloon dilatation was performed in 75 patients (65.8%) and stent implantation was necessary in 12 patients (10.5%). In the Pathway group, 27 patients (64.3%) underwent additional balloon dilatation and 5 (11.9%) stent implantation. Clinically, there was an increase in the ankle-brachial index from 0.59 to 0.84 ± 0.15 postinterventionally and 0.80 ± 0.16 12 months after Rotarex treatment, compared with an increase from 0.62 ± 0.14 to 0.84 ± 0.15 postinterventionally and 0.81 ± 0.12 12 months after Pathway treatment. In addition, there was a reduction in the Rutherford stage to 1.73 (1-3) and 1.43 (1-3), respectively. During the follow-up period, 21 (21.4%) restenoses occurred in the Rotarex group and 8 (19.0%) in the Pathway group. Peri-interventional complications included 7 dissections (4 after Rotarex, 3 after Pathway). Two distal embolisations were observed (both after Pathway). Throughout the entire duration of the study there were no amputations or fatalities.
The atherectomy of lesions of the femoropopliteal arteries using the Rotarex and Pathway systems is safe. The low stent rate peri-interventionally and the low restenosis rate after 12 months, with a significantly longer lesion length, indicate a better effectiveness of the Rotarex system as a whole.
对于慢性病变的治疗，已开发出各种消融手术，旨在改善经皮腔内血管成形术（PTA）/支架置入的效果，和/或通过去除狭窄或闭塞物质来减少植入支架的长度和数量。本研究的目的是比较两种机械旋转导管（Rotarex和Pathway）在治疗股腘动脉狭窄和闭塞方面的安全性和有效性。
总共156例患有股腘血管慢性狭窄或闭塞的患者接受了治疗，其中114例使用Rotarex导管，42例使用Pathway导管。Rotarex组介入前Rutherford分级平均为3.32（2 - 5级），Pathway组为2.93（2 - 5级）。平均病变长度分别为13.9厘米（2 - 30厘米）和5.1厘米（1 - 10厘米）（P<0.05）。在介入前后以及12个月后测定踝肱指数（ABI）。另外还进行了彩色编码双功超声作为随访。
Rotarex组的技术成功率为98.2%，Pathway组为97.6%。在Rotarex组中，75例患者（65.8%）进行了额外的球囊扩张，12例患者（10.5%）需要植入支架。在Pathway组中，27例患者（64.3%）进行了额外的球囊扩张，5例患者（11.9%）植入了支架。临床上，Rotarex治疗后介入后踝肱指数从0.59增加到0.84±0.15，12个月后为0.80±0.16，而Pathway治疗后介入后从0.62±0.14增加到0.84±0.15，12个月后为0.81±0.12。此外，Rutherford分级分别降至1.73（1 - 3级）和1.43（1 - 3级）。在随访期间，Rotarex组发生21例（21.4%）再狭窄，Pathway组发生8例（19.0%）。介入期并发症包括7例夹层（Rotarex后4例，Pathway后3例）。观察到2例远端栓塞（均在Pathway后）。在整个研究期间没有截肢或死亡病例。
使用Rotarex和Pathway系统对股腘动脉病变进行旋切术是安全的。介入期支架置入率低以及12个月后再狭窄率低，且病变长度明显更长，表明Rotarex系统总体有效性更好。
