Department of Cardiothoracic Surgery, Drexel University College of Medicine, Philadelphia, PA 19106, USA.
Eur J Cardiothorac Surg. 2013 Sep;44(3):e189-92; discussion e192. doi: 10.1093/ejcts/ezt292. Epub 2013 Jun 5.
We previously presented early results employing a technique designed for beating heart, ventricular volume reduction (surgical ventricular restoration, SVR) without ventriculotomy for patients with antero-septal scar and dilated ischaemic cardiomyopathy. Significant volume reduction and clinical improvement were achieved. We now report durability in the first 11 patients available for assessment at 6 and 12 months after operation.
After the Ethics Committee approval, 31 symptomatic patients with left ventricular (LV) dilatation and antero-septal scars underwent operation. The scarred lateral LV wall was apposed to the septal scar with serial paired anchors placed through epicardial transmural catheters, excluding non-viable portions of the chamber. Patients were followed at 1, 3, 6 and 12 months postoperatively with echocardiograms. Data are presented for the first 11 patients for whom core lab echocardiographic data were available at 12 months of follow-up.
LV end-systolic index (LVESVI), percent decreases from baseline at 6 and 12 months were 36.2 ± 18.3 (P < 0.001) and 39.6 ± 14.8 (P < 0.001). LV end-diastolic volume index (LVEDVI) percent decreases from baseline at 6 and 12 months were 28.6 ± 18.8 (P < 0.001) at 6 months and 32.2 ± 14.9 (P < 0.005) at 12 months. All comparisons were by one-tailed t-tests using paired data.
These results demonstrate the persistence of volume reduction employing a technique designed to be used on beating hearts without ventriculotomy or cardiopulmonary bypass. The extent of volume reduction was consistent with results of conventional SVR in experienced centres. These early data validate the further development of technical iterations leading to a clinical study employing a closed chest endovascular platform.
我们之前介绍了一种用于心脏跳动时的技术的早期结果,即通过经心外膜贯穿导管放置系列配对的锚钉,使室壁瘤疤痕侧的心室壁与室间隔疤痕贴合,从而实现室壁瘤疤痕侧的心室壁与室间隔疤痕的贴合,对前间隔疤痕和扩张性缺血性心肌病患者进行心室容量减少(外科室壁瘤修复,SVR),而无需进行心室切开术。显著的容量减少和临床改善已经实现。现在我们报告在手术 6 个月和 12 个月后,对最初的 11 名可供评估的患者进行的随访结果。
经伦理委员会批准,31 名有症状的左心室(LV)扩张和前间隔疤痕的患者接受了手术。通过经心外膜贯穿导管放置系列配对的锚钉,使室壁瘤疤痕侧的心室壁与室间隔疤痕贴合,排除心室的非存活部分,从而使有疤痕的 LV 外侧壁与室间隔疤痕贴合。术后 1、3、6 和 12 个月对患者进行超声心动图随访。为 11 名最初的患者提供了核心实验室的超声心动图数据,这些患者在 12 个月的随访中有核心实验室的超声心动图数据。
LV 收缩末期指数(LVESVI)在 6 个月和 12 个月时与基线相比的百分比降低分别为 36.2 ± 18.3(P < 0.001)和 39.6 ± 14.8(P < 0.001)。LV 舒张末期容积指数(LVEDVI)在 6 个月和 12 个月时与基线相比的百分比降低分别为 28.6 ± 18.8(P < 0.001)和 32.2 ± 14.9(P < 0.005)。所有比较均采用单侧 t 检验,使用配对数据。
这些结果表明,在不进行心室切开术或体外循环的情况下,使用一种专为心脏跳动设计的技术,可以持续实现容量减少。容量减少的程度与经验丰富的中心进行的传统 SVR 结果一致。这些早期数据验证了进一步开发技术迭代的合理性,这将导致一项采用闭胸血管内平台的临床研究。