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经导管主动脉瓣置换术与快速扩张式主动脉瓣置换术:来自德国主动脉瓣登记处的倾向性匹配分析。

Transcatheter Versus Rapid-Deployment Aortic Valve Replacement: A Propensity-Matched Analysis From the German Aortic Valve Registry.

机构信息

Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.

Department of Cardiac Surgery, University Hospital Lübeck, Lübeck, Germany.

出版信息

JACC Cardiovasc Interv. 2020 Nov 23;13(22):2642-2654. doi: 10.1016/j.jcin.2020.09.018.

Abstract

OBJECTIVES

This study sought to compare patient characteristics, procedural outcomes, and valve hemodynamics of surgical aortic valve replacement (SAVR) with current-generation rapid-deployment valves (RDVs) versus transcatheter aortic valve replacement (TAVR) with current-generation transcatheter heart valves (THVs).

BACKGROUND

The patient population currently treated with RDVs may have potential similarities with the current TAVR population, but comparative studies in a large patient population remain scarce.

METHODS

A total of 16,473 patients who underwent isolated SAVR using current-generation RDVs or isolated transfemoral TAVR with current-generation THVs between 2011 and 2017 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for RDVs and THVs before and after 1:1 propensity score matching. Furthermore, RDVs and THVs with similar design characteristics were compared with each other.

RESULTS

A total of 1,743 patients received SAVR with an RDV, whereas 14,730 patients were treated with transfemoral TAVR. Patients treated with TAVR were significantly older and had higher surgical risk scores. Following valve replacement, patients treated with an RDV had a significantly higher rate of disabling stroke (1.7% vs. 1.1%; p = 0.03), need for transfusion of >4 red blood cell units (8.5% vs. 1.4%; p < 0.001), and new onset renal replacement therapy (1.9% vs. 1.2%; p = 0.01), whereas the need for a new permanent pacemaker was lower (8.4% vs. 14.9%; p < 0.001). In-hospital mortality was similar (1.6% vs. 1.8%; p = 0.62). These findings persisted after 1:1 propensity score matching, but in-hospital mortality was significantly higher after RDVs (1.7% vs. 0.6%; p = 0.003). Balloon-expandable (BE) RDVs had significantly lower residual gradients compared with BE-THVs, while self-expanding (SE)-RDVs had significantly higher residual gradients compared with SE-THVs.

CONCLUSIONS

In a large all-comers' registry, TAVR with current-generation THVs was associated with improved in-hospital outcomes compared with SAVR with current-generation RDVs. The pacemaker rate is significantly higher with TAVR. Post-procedural hemodynamic function varied between individual RDVs and THVs.

摘要

目的

本研究旨在比较外科主动脉瓣置换术(SAVR)中使用新一代快速部署瓣膜(RDV)与经导管主动脉瓣置换术(TAVR)中使用新一代经导管心脏瓣膜(THV)的患者特征、手术结果和瓣膜血流动力学。

背景

目前接受 RDV 治疗的患者人群可能与当前的 TAVR 人群具有潜在相似性,但在大型患者人群中仍缺乏比较研究。

方法

2011 年至 2017 年间,共有 16473 例接受 SAVR 的患者使用新一代 RDV 或经股动脉 TAVR 联合新一代 THV 入组德国主动脉瓣登记处。对 RDV 和 THV 进行 1:1 倾向评分匹配前后的基线、手术和住院结局参数进行分析。此外,还比较了具有相似设计特征的 RDV 和 THV。

结果

共有 1743 例患者接受了 RDV 行 SAVR,而 14730 例患者接受了经股动脉 TAVR。接受 TAVR 治疗的患者年龄明显较大,且手术风险评分较高。瓣膜置换后,接受 RDV 治疗的患者致残性卒中发生率显著较高(1.7%比 1.1%;p=0.03),需要输注>4 单位红细胞(8.5%比 1.4%;p<0.001)和新发生的肾脏替代治疗(1.9%比 1.2%;p=0.01),而需要新植入永久性起搏器的比例较低(8.4%比 14.9%;p<0.001)。住院死亡率相似(1.6%比 1.8%;p=0.62)。这些发现在 1:1 倾向评分匹配后仍然存在,但 RDV 后住院死亡率显著升高(1.7%比 0.6%;p=0.003)。球囊扩张型(BE)RDV 的残余梯度明显低于 BE-THV,而自膨型(SE)RDV 的残余梯度明显高于 SE-THV。

结论

在一个大型的所有患者登记处中,与使用新一代 RDV 行 SAVR 相比,使用新一代 THV 行 TAVR 与改善的住院结局相关。TAVR 后起搏器植入率明显升高。术后血流动力学功能在不同的 RDV 和 THV 之间存在差异。

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