Kerckhoff Heart Center, Department of Cardiology, Bad Nauheim, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Rhein Main, Frankfurt am Main, Germany; Kerckhoff Heart Center, Department of Cardiac Surgery, Bad Nauheim, Germany; Justus-Liebig University of Giessen, Department of Cardiology, Giessen, Germany.
Kerckhoff Heart Center, Department of Cardiology, Bad Nauheim, Germany; Justus-Liebig University of Giessen, Department of Cardiology, Giessen, Germany.
Int J Cardiol. 2017 Sep 15;243:156-160. doi: 10.1016/j.ijcard.2017.05.092. Epub 2017 May 27.
The aim of the present study was to investigate whether transfemoral implantation of the Acurate neo transcatheter heart valve without pre-dilation is feasible.
Between December 2014 and December 2016, 294 patients were treated with the Acurate neo prosthesis at our center. Of these, 72 cases were performed without pre-dilation. The decision to omit pre-dilation was at the discretion of the operator, preferably in the case of mild to moderate aortic valve calcification (AVC). Propensity matching (1:1) resulted in 48 cases in each group. Main outcomes of interest were device success according to VARC-2 criteria, residual aortic regurgitation (AR) ≥ 2°, and rate of post-dilation.
Median [IQR] age in patients without pre-dilation was 82.7 years [78.6–85.6], STS score was 4.6% [3.4–6.1], and AVC-score was 1436 AU [1043–1682] with mild and moderate AVC in 63.9% and 36.1% of cases, respectively. Device success was achieved in 94.4% of cases, post-dilation was necessary in 26.4%, and one (1.4%) patient had moderate AR. In the matched population, there were no differences regarding device success, rate of AR ≥ 2°, need for post-dilation, and post-procedural mean gradient, but the group without pre-dilation had shorter procedure (34.0 min [27.0–38.8] vs. 43.0 min [34.3–52.0]; p < 0.001) and fluoroscopy times (7.4 min [5.7–9.0] vs. 9.9 min [7.9–13.5]; p < 0.001).
In select patients with mild to moderate AVC, transfemoral implantation of the Acurate neo without pre-dilation is feasible and safe. This allows for a straightforward procedure that may be performed without rapid pacing in the majority of cases.
本研究旨在探讨经股动脉植入未经预扩张的 Acurate neo 经导管心脏瓣膜是否可行。
2014 年 12 月至 2016 年 12 月，在本中心对 294 例患者使用 Acurate neo 假体进行治疗。其中 72 例未行预扩张。是否进行预扩张由术者决定，最好是在主动脉瓣钙化（AVC）轻中度的情况下。采用 1:1 倾向性匹配，每组各 48 例。主要观察终点为根据 VARC-2 标准的器械成功率、残余主动脉瓣反流（AR）≥2°和后扩张率。
无预扩张组患者的中位（IQR）年龄为 82.7 岁[78.6-85.6]，STS 评分为 4.6%[3.4-6.1]，AVC 评分为 1436 AU[1043-1682]，其中轻中度 AVC 分别占 63.9%和 36.1%。94.4%的病例达到器械成功，26.4%需要后扩张，1 例（1.4%）患者出现中度 AR。在匹配人群中，两组在器械成功率、AR≥2°发生率、后扩张率和术后平均梯度方面无差异，但无预扩张组的手术时间更短（34.0 分钟[27.0-38.8] vs. 43.0 分钟[34.3-52.0]；p<0.001），透视时间更短（7.4 分钟[5.7-9.0] vs. 9.9 分钟[7.9-13.5]；p<0.001）。
在轻中度 AVC 的选择患者中，经股动脉植入未经预扩张的 Acurate neo 是可行且安全的。这使得大多数情况下可以在不进行快速起搏的情况下直接进行手术。
