Valve Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.
Columbia University Medical Center, New York, New York.
JACC Cardiovasc Interv. 2017 Oct 23;10(20):2090-2098. doi: 10.1016/j.jcin.2017.07.027.
The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry.
TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed.
Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined.
Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03).
Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis.
作者旨在比较经导管主动脉瓣置换术（TAVR）中商业化的可重定位 Evolut R 平台与 CoreValve 装置在胸外科医师学会（STS）/美国心脏病学会（ACC）经导管瓣膜治疗（TVT）注册中心的结果。
TAVR 技术不断发展，商业实践中迅速采用迭代变化。需要了解这种采用的结果。
TVT 注册中心中接受 23、26 或 29 毫米自膨式假体进行 TAVR 的患者被纳入研究。检查了手术、住院和 30 天结局的站点报告事件。
2014 年 1 月至 2016 年 4 月，9616 例接受自膨式假体 TAVR 的患者在 TVT 注册中心输入了数据。与接受 CoreValve TAVR 治疗的患者相比，接受 Evolut R TAVR 治疗的患者 STS-PROM 评分较低（8.0±5.4%比 8.7±5.3%；p<0.001），股动脉入路更多（91.6%比 89.2%；p<0.001），并且更常接受镇静（27.4%比 12.7%；p<0.001）。使用 Evolut R TAVR，需要二次假体的情况更少（2.2%比 4.5%；p<0.001），移植物迁移的情况更少（0.2%比 0.6%；p=0.01），中度/重度瓣周漏的发生率较低（术后，4.4%比 6.2%；p<0.001），中位住院时间更短（4.0 比 5.0 天；p<0.001）。接受 Evolut R TAVR 治疗的患者具有更高的器械成功率（96.3%比 94.9%；p=0.001）。在 30 天时，Evolut R 患者的死亡率更低（3.7%比 5.3%；p<0.001），需要起搏器的情况更少（18.3%比 20.1%；p=0.03）。
商业化采用 Evolut R 平台与主动脉瓣狭窄患者接受 TAVR 的急性结局显著改善相关。
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