Fonseca Alberto, Costa José de Ribamar, Abizaid Alexandre, Feres Fausto, Abizaid Andrea S, Costa Ricardo, Staico Rodolfo, Mattos Luis Alberto, Sousa Amanda G R M, Grube Eberhard, Sousa J Edouardo
Instituto Dante Pazzanese de Cardiologia, Sao Paulo-SP, Brasil.
J Invasive Cardiol. 2008 Jan;20(1):21-7.
Despite the advances in interventional cardiology, stent expansion remains an important predictor of success, impacting restenosis and thrombosis rates after either bare-metal (BMS) or drug-eluting stent implantation. Especially for the treatment of complex lesions (e.g., calcified lesions, in-stent restenosis, etc.), adequate lesion preparation might help improve procedural results as well as clinical outcomes. We sought to investigate the safety, feasibility and mechanism of action of a new scoring-balloon catheter, the AngioSculpt, comprised of a semicompliant balloon and a nitinol spiral cage designed to address complex lesions.
A total of 60 consecutive patients at two centers were prospectively enrolled in this first-in-man coronary study and divided into two groups according to the type of lesion treated: Group I: patients with de novo coronary lesions (n = 47) as a pretreatment strategy before BMS implantation, and Group II: patients with BMS restenosis (n = 17) as a standalone therapy. A subgroup of patients in each cohort was assigned to intravascular (IVUS) analysis. Patients in Group II were submitted to routine 6-month follow-up angiography. In Group I, angiographic restudy was contingent upon the presence of ischemia. Lesions longer than 20 mm in very tortuous vessels, in arterial or vein grafts, in the setting of acute myocardial infarction or with visible thrombus were excluded from this study.
Success was achieved in all cases. The mean age of the study populations was 62 +/- 11.6 years (Group I) and 53 +/- 9.4 years (Group II), with 26% and 18% diabetics, respectively. In Group I, 73% of lesions were diffuse and fibrocalcified, while in Group II, 72% were classified as diffuse. No serious complications were observed in either group. Balloon slippage (or the "watermelon seed" phenomenon) was not observed. Significant acute gain was achieved in both groups (0.7 mm in Group I and 1.64 mm in Group II). A minimum final area (in-stent) 6.5 mm2 was achieved in 85% of the cases in Group I and in 82% of the cases in Group II.
In this preliminary in vivo study, the use AngioSculpt(R) proved to be feasible and safe for the treatment of complex coronary lesions. Six-month results suggest the use of this novel device as an attractive option for the percutaneous approach of restenotic coronary lesions and should be assessed in a larger, more complex cohort of patients.
尽管介入心脏病学取得了进展，但支架扩张仍然是成功的重要预测指标，影响裸金属支架（BMS）或药物洗脱支架植入后的再狭窄和血栓形成率。特别是对于复杂病变（如钙化病变、支架内再狭窄等）的治疗，充分的病变预处理可能有助于改善手术效果以及临床结局。我们试图研究一种新型刻痕球囊导管AngioSculpt的安全性、可行性及作用机制，该导管由半顺应性球囊和旨在处理复杂病变的镍钛合金螺旋笼组成。
两个中心共60例连续患者前瞻性纳入这项首次人体冠状动脉研究，并根据治疗病变类型分为两组：第一组：新发冠状动脉病变患者（n = 47），作为BMS植入前的预处理策略；第二组：BMS再狭窄患者（n = 17），作为独立治疗。每个队列中的一部分患者被分配进行血管内（IVUS）分析。第二组患者接受常规6个月随访血管造影。第一组中，血管造影复查视缺血情况而定。本研究排除了非常迂曲血管、动脉或静脉移植物、急性心肌梗死情况下或有可见血栓中长度超过20 mm的病变。
所有病例均获成功。研究人群的平均年龄在第一组为62±11.6岁，在第二组为53±9.4岁，糖尿病患者分别占26%和18%。在第一组中，73%的病变为弥漫性纤维钙化病变，而在第二组中，72%被分类为弥漫性病变。两组均未观察到严重并发症。未观察到球囊滑脱（或“西瓜籽”现象）。两组均实现了显著的急性管腔增加（第一组为0.7 mm，第二组为1.64 mm）。第一组85%的病例和第二组82%的病例实现了最小最终（支架内）面积6.5 mm²。
在这项初步的体内研究中，使用AngioSculpt治疗复杂冠状动脉病变被证明是可行且安全的。6个月的结果表明，使用这种新型器械作为经皮治疗再狭窄冠状动脉病变的一种有吸引力的选择，应在更大、更复杂的患者队列中进行评估。
