Holzamer Andreas, Doss Mirko, Schramm Rene, Diegeler Anno, Conradi Lenard, Strauch Justus, Holzhey David, Erlebach Magdalena, Schröfel Holger, Arsalan Mani, Allocco Dominic J, Hilker Michael
Klinikum der Universität Regensburg, Regensburg, Germany.
Kerckhoff Klinik, Bad Nauheim, Germany.
Int J Cardiol Heart Vasc. 2021 Aug 31;36:100862. doi: 10.1016/j.ijcha.2021.100862. eCollection 2021 Oct.
A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE bioprosthetic aortic valve.
This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm, discharge: 1.9 [SD 0.6] cm), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe).
TA-TAVR with the ACURATE valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.
当经股动脉（TF）途径不可行时，可采用经心尖（TA）途径进行经导管主动脉瓣置换术（TAVR）。CHANGE neo TA研究评估了在常规临床实践中通过TA-TAVR使用ACURATE生物人工主动脉瓣治疗的患者。
这项单臂上市后研究计划招募200名受试者；由于参与中心的TA-TAVR手术量下降，招募提前终止。最终招募了107名患者（平均年龄：79.3岁；54.2%为女性；基线时平均STS评分：6.2%）。意向性治疗人群的30天死亡率为11.2%（主要终点），12个月时为25.6%。30天安全性的VARC-2综合终点发生在24.3%的患者中。6名患者（5.6%）在30天内接受了永久性起搏器植入。各中心报告的超声心动图数据显示，平均主动脉瓣压差（基线：38.8[标准差13.1]mmHg，出院时：6.7[标准差3.7]mmHg）和有效瓣口面积（基线：0.7[标准差0.2]cm²，出院时：1.9[标准差0.6]cm²）早期有所改善，瓣周反流的出院发生率较低（74.7%无/微量，24.2%轻度，1.1%重度）。
使用ACURATE瓣膜系统进行TA-TAVR可产生可接受的临床结果，为不适合TF-TAVR的主动脉瓣狭窄患者提供了一种替代方案。
