Background

Little is known about the impact of the ID on outcomes and device success using balloon-expandable devices. This study sought to analyze the impact of implantation depth (ID) on procedural outcomes.

Methods

In consecutive patients (n = 969) undergoing transfemoral TAVR with new-generation balloon-expandable prostheses, the mean ID (ID_Mean) was determined by aortography and categorized into low, correct, and high device position. Outcomes of interest were device success (VARC-2), paravalvular regurgitation (PVR) ≥ moderate, severe prosthesis-patient mismatch (PPM), permanent pacemaker implantation (PPI), and the composite of the three latter outcome measures (COMP_PPP).

Results

ID_Mean was greater among patients with PPI (median 4.0 [interquartile range 2.0; 4.0] vs. 3.5 [1.5; 5.5] mm; p = 0.002), severe PPM (3.5 [1.5; 5.0] vs. 4.0 [2.0; 6.0] mm; p = 0.028), and COMP_PPP (4.0 [2.0; 6.0] vs. 3.0 [1.5; 5.5] mm; p < 0.001) when compared with the respective groups without these complications. There was no significant association between ID_Mean and device success or PVR ≥ moderate.

Categorization into low (7.3%), correct (90.7%), and high (2.0%) device position showed significant discrimination with an increase of severe PPM, PPI, and COMP_PPP with lower position, whereas device success was not significantly affected by position. Only PVR ≥ moderate showed an asymmetric distribution with highest rates in the high and low position group, which was non-significant. However, among patients without correct position the rate of device success was 45.6%.

Conclusions

A higher device position was associated with improved outcomes. Malpositioning without functional impairment should not be classified as device failure.

Graphic abstract

The odds ratio of ID_Mean was calculated by univariate logistic regression for each outcome variable, showing that with higher values of ID_Mean (i.e., low implantation depth), the risk of severe PPM, PPI, and COMP_PPP increases. The bar charts under the heading “Position category” denote the frequency of each outcome measure across patients with high, correct, and low device position. The p values are derived from chi-squared test.

中文翻译：

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植入深度对新一代球囊扩张经导管心脏瓣膜结局的影响

背景

关于 ID 对使用球囊扩张设备的结果和设备成功的影响知之甚少。本研究旨在分析植入深度 (ID) 对手术结果的影响。

方法

在 使用新一代球囊扩张式假体接受经股动脉 TAVR 的连续患者 ( n = 969) 中，平均 ID (ID _Mean ) 由主动脉造影确定，​​并分为低、正确和高装置位置。感兴趣的结果是装置成功 (VARC-2)、瓣周反流 (PVR) ≥ 中度、重度假体-患者不匹配 (PPM)、永久起搏器植入 (PPI) 以及后三个结果测量的复合 (COMP _PPP )。

结果

ID_均值在 PPI（中位数 4.0 [四分位距 2.0; 4.0] vs. 3.5 [1.5; 5.5] mm; p  = 0.002）、重度 PPM（3.5 [1.5; 5.0] vs. 4.0 [2.0; 6.0]）中更高毫米；p  = 0.028）和 COMP _PPP（4.0 [2.0; 6.0] vs. 3.0 [1.5; 5.5] mm；p  < 0.001）与没有这些并发症的各组相比。ID _Mean与设备成功或 PVR ≥ 中等之间没有显着关联。

低 (7.3%)、正确 (90.7%) 和高 (2.0%) 设备位置的分类显示出显着的区分，严重 PPM、PPI 和 COMP _{PPP 增加}且位置较低，而设备成功不受位置的显着影响. 只有 PVR ≥ 中等表现出不对称分布，高位组和低位组的比率最高，不显着。然而，在位置不正确的患者中，装置成功率为 45.6%。

结论

更高的设备位置与改善的结果相关。无功能障碍的错位不应归类为器械故障。

图形摘要

ID _Mean的优势比是通过单变量逻辑回归计算每个结果变量的，表明 ID _Mean值越高（即植入深度低），严重 PPM、PPI 和 COMP _PPP的风险就会增加。“位置类别”标题下的条形图表示设备位置高、正确和低的患者中每个结果测量的频率。p 值来自卡方检验。