Department of Cardiology and Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany.
Department of Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.
J Interv Cardiol. 2022 Jun 25;2022:9138403. doi: 10.1155/2022/9138403. eCollection 2022.
The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE , a supra-annular self-expanding bioprosthetic aortic valve.
While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE valve has a pericardial sealing skirt designed to minimize PVL.
The primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE .
The rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months ( < 0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient ( < 0.001) and effective orifice area (=0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months.
Results from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.
PROGRESS PVL 注册研究评估了经导管主动脉瓣置换术（TAVI）在接受 ACURATE 治疗的患者中的应用，ACURATE 是一种瓣环上自膨式生物瓣主动脉瓣。
尽管 TAVI 的临床结果与手术相当，但仍存在残余主动脉瓣反流（AR）和瓣周漏（PVL）等常见并发症。ACURATE 瓣膜具有心包密封裙边设计，旨在最大限度地减少 PVL。
主要终点是核心超声心动图实验室评估的随时间推移的总 AR 发生率。该研究纳入了来自欧洲和加拿大 22 个中心的 500 名患者（平均年龄：81.8±5.1 岁；61%为女性；平均基线 STS 评分：6.0±4.5%）；498 名患者接受了 ACURATE 治疗。
出院时≥中度 AR 的发生率为 4.6%，12 个月时为 3.1%；出院时≥中度 PVL 的发生率为 4.6%，12 个月时为 2.6%。配对分析显示，出院至 12 个月时整体 PVL 显著改善（<0.001）；64.6%的患者 PVL 分级无变化，24.9%改善，10.5%恶化。患者的跨瓣梯度（<0.001）和有效瓣口面积（=0.01）也显著改善。30 天时的死亡率为 2.2%，12 个月时为 11.3%。30 天时永久起搏器植入（PPI）率为 10.2%，12 个月时为 12.2%。
PROGRESS PVL 的研究结果支持 ACURATE 瓣膜 TAVI 的持续安全性和疗效，该研究显示出出色的瓣膜血流动力学、良好的临床结果，以及从出院到 12 个月随访时 PVL 的显著个体间改善。
