Chamié Daniel, Abizaid Alexandre, Costa José Ribamar, Feres Fausto, Abizaid Andréa, Staico Rodolfo, Costa Ricardo, Mattos Luiz Alberto P, Sousa Amanda G M R, Sousa J Eduardo
Interventional Cardiology Department, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brasil.
Catheter Cardiovasc Interv. 2008 Aug 1;72(2):156-63. doi: 10.1002/ccd.21560.
Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario.
The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 "guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion.
A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 +/- 2.1 months. The mean vessel reference diameter was 2.76 +/- 0.31 mm and the mean lesion length was 16.64 +/- 7.70 mm (range 4.37-35.0 mm). Thirteen patients (81.2%) had "tapered stump" morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 +/- 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up.
The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.
尽管在一些有症状的患者中，闭塞血管再通的益处已有充分记录，但只有少数患者尝试进行再通。慢性完全闭塞病变（CTO）的经皮冠状动脉介入治疗（PCI）并发症发生率高且手术成功率低，主要原因是无法穿过病变部位。我们试图评估新型RVT CTO导丝装置（RVT - GDW，ReVascular Therapeutics公司，加利福尼亚州桑尼维尔市）在这种复杂情况下的有效性和安全性。
RAPID - CTO研究是一项非随机、单中心的人体首次评估新型导丝系统治疗CTO的研究。RVT - GDW是一种新型装置，旨在通过以下方式增强穿过CTO的穿透力和定位控制：（1）一根0.014英寸的导丝，其远端具有机械活性；（2）近端连接在导丝上的手柄，带有可调节的扭矩器，并与（3）一个非一次性、电池供电的控制单元相连，该控制单元在CTO穿过过程中提供激活控制和音频反馈。按照方案，只有在使用市售传统导丝尝试至少5分钟（透视时间）仍无法穿过目标病变后，才使用RVT - GDW装置。
共有16例患者（16个病变）接受了RVT - GDW治疗。平均年龄为56.25岁，男性占56.2%，糖尿病患者占25%。平均闭塞持续时间为4.7±2.1个月。平均血管参考直径为2.76±0.31毫米，平均病变长度为16.64±7.70毫米（范围4.37 - 35.0毫米）。13例患者（81.2%）在闭塞近端具有“锥形残端”形态，12例（75.0%）累及侧支。所有病变均有对侧循环；3例（18.7%）可见桥接侧支。10个病变（62.5%）手术成功，平均手术时间为111.43±35.76分钟。在院内和30天临床随访中均未发生重大不良心脏事件。
人体首次进行的RAPID - CTO研究表明，新型RVT - GDW装置在穿过慢性闭塞冠状动脉方面在技术上是可行的、安全有效的。有必要进行更大规模的研究。
