Duke University Medical Center, Durham, North Carolina.
New York Presbyterian Hospital, Columbia University Medical Center, New York.
JAMA Cardiol. 2017 Nov 1;2(11):1197-1206. doi: 10.1001/jamacardio.2017.3306.
Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. However, to our knowledge, the durability of these prostheses is incompletely defined.
To determine the midterm hemodynamic performance of balloon-expandable transcatheter heart valves.
DESIGN, SETTING, AND PARTICIPANTS: In this study, we analyzed core laboratory-generated data from echocardiograms of all patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1 Trial with successful TAVR or surgical AVR (SAVR) obtained preimplantation and at 7 days, 1 and 6 months, and 1, 2, 3, 4, and 5 years postimplantation. Patients from continued access observational studies were included for comparison.
Successful implantation after randomization to TAVR vs SAVR (PARTNER 1A; TAVR, n = 321; SAVR, n = 313), TAVR vs medical treatment (PARTNER 1B; TAVR, n = 165), and continued access (TAVR, n = 1996). Five-year echocardiogram data were available for 424 patients after TAVR and 49 after SAVR.
Death or reintervention for aortic valve structural indications, measured using aortic valve mean gradient, effective orifice area, Doppler velocity index, and evidence of hemodynamic deterioration by reintervention, adverse hemodynamics, or transvalvular regurgitation.
Of 2795 included patients, the mean (SD) age was 84.5 (7.1) years, and 1313 (47.0%) were female. Population hemodynamic trends derived from nonlinear mixed-effects models showed small early favorable changes in the first few months post-TAVR, with a decrease of -2.9 mm Hg in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index, and an increase of 0.09 cm2 in effective orifice area. There was relative stability at a median follow-up of 3.1 (maximum, 5) years. Moderate/severe transvalvular regurgitation was noted in 89 patients (3.7%) after TAVR and increased over time. Patients with SAVR showed no significant changes. In TAVR, death/reintervention was associated with lower ejection fraction, stroke volume index, and aortic valve mean gradient up to 3 years, with no association with Doppler velocity index or valve area. Reintervention occurred in 20 patients (0.8%) after TAVR and in 1 (0.3%) after SAVR and became less frequent over time. Reintervention was caused by structural deterioration of transcatheter heart valves in only 5 patients. Severely abnormal hemodynamics on echocardiograms were also infrequent and not associated with excess death or reintervention for either TAVR or SAVR.
This large, core laboratory-based study of transcatheter heart valves revealed excellent durability of the transcatheter heart valves and SAVR. Abnormal findings in individual patients, suggestive of valve thrombosis or structural deterioration, were rare in this protocol-driven database and require further investigation.
clinicaltrials.gov Identifier: NCT00530894.
经导管主动脉瓣置换术（TAVR）治疗严重主动脉瓣狭窄的应用正在迅速增加。然而，据我们所知，这些假体的耐久性尚未完全确定。
确定球囊扩张经导管心脏瓣膜的中期血液动力学性能。
设计、地点和参与者：在这项研究中，我们分析了来自所有成功接受 TAVR 或外科主动脉瓣置换术（SAVR）的患者的核心实验室生成的超声心动图数据，这些患者来自于 Placement of Aortic Transcatheter Valves（PARTNER）1 试验，并在植入前、植入后 7 天、1 个月、6 个月以及 1、2、3、4 和 5 年进行了测量。包括继续接受观察性研究的患者进行比较。
随机分组接受 TAVR 与 SAVR（PARTNER 1A；TAVR，n=321；SAVR，n=313）、TAVR 与药物治疗（PARTNER 1B；TAVR，n=165）以及继续接受治疗（TAVR，n=1996）的患者。5 年超声心动图数据可用于 424 例 TAVR 后患者和 49 例 SAVR 后患者。
因主动脉瓣结构性指征死亡或再次干预，通过再次干预、不良血液动力学或跨瓣反流来评估，使用主动脉瓣平均梯度、有效瓣口面积、多普勒速度指数来衡量。
在 2795 例纳入的患者中，平均（标准差）年龄为 84.5（7.1）岁，1313 例（47.0%）为女性。来自非线性混合效应模型的人群血液动力学趋势显示，TAVR 后最初几个月内有较小的早期有利变化，主动脉瓣平均梯度降低 2.9mmHg，多普勒速度指数增加 0.028，有效瓣口面积增加 0.09cm2。中位数随访 3.1（最长 5）年后相对稳定。TAVR 后 89 例（3.7%）患者出现中度/重度跨瓣反流，并随时间增加。SAVR 患者没有明显变化。在 TAVR 中，死亡/再次干预与射血分数、每搏量指数和主动脉瓣平均梯度降低相关，直到 3 年，但与多普勒速度指数或瓣口面积无关。TAVR 后有 20 例（0.8%）患者和 1 例（0.3%）SAVR 后患者需要再次干预，随着时间的推移，再次干预的频率逐渐降低。仅 5 例患者因经导管心脏瓣膜结构性恶化而再次干预。超声心动图上严重异常的血液动力学也很少见，与 TAVR 或 SAVR 的额外死亡或再次干预无关。
这项大型的基于核心实验室的经导管心脏瓣膜研究显示，经导管心脏瓣膜和 SAVR 的耐久性非常好。在这个协议驱动的数据库中，个别患者提示瓣膜血栓形成或结构性恶化的异常发现很少见，需要进一步研究。
clinicaltrials.gov 标识符：NCT00530894。
