Departments of Cardiology, Cardiac Surgery, and Anaesthesiology, HELIOS Heart Center Siegburg, Ringstrasse 49, Siegburg, Germany.
Circ Cardiovasc Interv. 2008 Dec;1(3):167-75. doi: 10.1161/CIRCINTERVENTIONS.108.819839.
Percutaneous aortic valve replacement is a new emerging technology for interventional treatment of severe aortic valve stenosis in surgical high-risk patients. This study was intended to provide a summary of the development and current safety and efficacy status of the self-expanding CoreValve Revalving prosthesis.
Between 2005 and 2008, we have enrolled 136 consecutive patients with percutaneous aortic valve replacement using the CoreValve prosthesis. In this prospective nonrandomized, single-center trial, we analyzed procedural outcome, complications and clinical status up to 1 year. First, second, and third generation of the CoreValve prosthesis were implanted in 10, 24, and 102 consecutive high-risk patients (logistic EuroScore: 23.1+/-15.0%) with severe symptomatic aortic valve stenosis. Mean transvalvular pressure gradient was 41.5+/-16.7 mm Hg. The procedural success rate increased from generation 1/2 to 3 from 70.0%/70.8% to 91.2% (P=0.003). The 30-day combined rate of death/stroke/myocardial infarction was 40.0%/20.8%/14.7% (P=0.11) for generation 1, 2, and 3, with no procedural death in generation 3. Pressure gradients improved significantly with a final mean gradient of 8.1+/-3.8 mm Hg. Overall functional status assessed by New York Heart Association class improved from 3.3+/-0.5 (pre) to 1.7+/-0.7 (post) (P<0.001) and remained stable in the follow-up.
In experienced hands, percutaneous aortic valve replacement with the CoreValve system for selected patients with severe aortic valve stenosis has a high acute success rate associated with a low periprocedural mortality/stroke rate as well as remarkable clinical and hemodynamic improvements, which persist over time. Additional studies are now required to confirm these findings, particularly head-to-head comparisons with surgical valve replacement in different risk populations.
经皮主动脉瓣置换术是一种新兴的介入治疗技术，适用于外科高危患者的严重主动脉瓣狭窄。本研究旨在总结自膨式 CoreValve Revalving 假体的发展现状和当前的安全性及疗效。
在 2005 年至 2008 年间，我们连续纳入了 136 例使用 CoreValve 假体行经皮主动脉瓣置换术的患者。在这项前瞻性、非随机、单中心试验中，我们分析了 1 年时的手术结果、并发症和临床情况。第一代、第二代和第三代 CoreValve 假体分别植入了 10、24 和 102 例连续的高危患者（Logistic EuroScore：23.1+/-15.0%），这些患者均患有严重症状性主动脉瓣狭窄。平均跨瓣压差为 41.5+/-16.7mmHg。手术成功率从第一代/第二代的 70.0%/70.8%增加到第三代的 91.2%（P=0.003）。第一代、第二代和第三代的 30 天死亡/卒中/心肌梗死联合发生率分别为 40.0%/20.8%/14.7%（P=0.11），第三代无手术死亡。压力梯度明显改善，最终平均梯度为 8.1+/-3.8mmHg。纽约心脏协会（NYHA）功能分级评估的整体功能状态从术前的 3.3+/-0.5 改善到术后的 1.7+/-0.7（P<0.001），且在随访期间保持稳定。
在有经验的医生手中，对于特定的严重主动脉瓣狭窄患者，使用 CoreValve 系统行经皮主动脉瓣置换术具有较高的即刻成功率，围手术期死亡率/卒中率较低，临床和血液动力学改善显著，且随着时间的推移持续存在。现在需要进一步的研究来证实这些发现，特别是在不同风险人群中与外科瓣膜置换术进行头对头比较。
