Gilmore P S, Bass T A, Conetta D A, Percy R F, Chami Y G, Kircher B J, Miller A B
Division of Cardiology, University of Florida Health Science Center, Jacksonville.
Clin Cardiol. 1993 Apr;16(4):311-6. doi: 10.1002/clc.4960160405.
This report describes a single site experience as part of a multicenter clinical trial with high-speed rotational atherectomy in human coronary arteries. A total of 108 patients with 143 lesions had interventions, were grouped by success or failure, and were analyzed by patient, lesion, and procedural variables. Satisfactory results were achieved in 131 of 143 lesions (92%) and 99 of 108 (92%) patients. Neither patient-related variables (age, gender, diabetes, hypertension, cigarette use, restenosis, previous myocardial infarction, and left ventricular function) nor lesion characteristics (length, ostial or bifurcation location, calcification, lesion classification, and coronary location) were predictive of poor outcome. Tears, acute closure, percentage stenosis after rotational atherectomy and after adjunctive balloon angioplasty were the procedural variables that were statistically associated with outcome by univariate methods. Multivariate analysis isolated postintervention residual stenosis as the only variable that was statistically different between groups. Serious complications included one death in the catheterization laboratory, one Q-wave myocardial infarction, three non-Q myocardial infarctions, and three emergency coronary bypass operations for sustained vessel closure. One patient required emergency surgery for a pacing wire perforation not related to the use of the device. The potential benefits of high-speed rotational atherectomy include increased safety in complex lesions, the ability to address lesions not amenable to balloon techniques, and the possibility of reducing the incidence of restenosis.
本报告描述了作为一项多中心临床试验一部分的单中心人体冠状动脉高速旋磨术经验。共有108例患者的143处病变接受了干预，按成功或失败分组，并根据患者、病变和手术变量进行分析。143处病变中的131处（92%）以及108例患者中的99例（92%）取得了满意结果。患者相关变量（年龄、性别、糖尿病、高血压、吸烟、再狭窄、既往心肌梗死和左心室功能）和病变特征（长度、开口或分叉位置、钙化、病变分类和冠状动脉位置）均不能预测不良预后。撕裂、急性闭塞、旋磨术后及辅助球囊血管成形术后的狭窄百分比是通过单变量方法与预后有统计学关联的手术变量。多变量分析确定干预后残余狭窄是两组间唯一有统计学差异的变量。严重并发症包括导管室1例死亡、1例Q波心肌梗死、3例非Q波心肌梗死以及3例因持续性血管闭塞而行的急诊冠状动脉搭桥手术。1例患者因与该器械使用无关的起搏导线穿孔而需要急诊手术。高速旋磨术的潜在益处包括提高复杂病变的安全性、处理不适用于球囊技术的病变的能力以及降低再狭窄发生率的可能性。
