Columbia University Irving Medical Center, New York, NY, USA.
Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
EuroIntervention. 2023 Jul 17;19(4):e352-e362. doi: 10.4244/EIJ-D-23-00282.
TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability.
We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS.
This was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety.
Thirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm, and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm, MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm.
Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.
经导管主动脉瓣置换术（TAVI）是治疗严重主动脉瓣狭窄（AS）患者的一种广泛接受的治疗方法。尽管采用了多种治疗方法，但仍有机会开发针对特定患者的技术，以提供最佳的急性和潜在长期获益，特别是在血液动力学、血流和耐久性方面。
我们旨在评估 DurAVR 经导管心脏瓣膜（THV）的安全性和可行性，DurAVR THV 是一种首创的仿生瓣膜，用于治疗有症状的严重 AS 患者。
这是一项首例人体（FIH）前瞻性、非随机、单臂、单中心研究。招募了患有任何手术风险的严重、有症状的 AS 且符合 DurAVR THV 假体植入条件的患者；在术后 30 天、6 个月和 1 年时对植入物成功、血液动力学性能和安全性进行评估。
13 例患者（73.9±6.4 岁，77%为女性）入选。100%的患者成功植入 DurAVR THV，无器械相关并发症。发生 1 例入路并发症、1 例永久性起搏器植入和 1 例中度主动脉瓣反流。在任何随访期间，均未报告死亡、中风、出血、再次介入或心肌梗死。尽管平均瓣环大小为 22.95±1.09mm，但在 30 天时观察到有利的血液动力学结果（有效瓣口面积[EOA]2.00±0.17cm，平均压力梯度[MPG]9.02±2.68mmHg），并在 1 年时保持稳定（EOA 1.96±0.11cm，MPG 8.82±1.38mmHg），从而使零名患者存在任何程度的假体-患者不匹配。此外，源自心血管磁共振的新瓣膜性能测量显示，层流得到恢复，与疾病前状态一致，同时平均联合长度为 8.3±1.7mm。
DurAVR THV 的 FIH 研究初步结果显示，安全性良好，1 年时血液动力学表现有希望且恢复接近正常的血流动力学。需要进一步的临床研究来评估 DurAVR THV 在解决 AS 患者终生管理挑战方面可能发挥的作用。
