NEJM：瓣周返流是导管主动脉瓣膜置换术的主要缺陷

《New England Journal of Medicine》3月26日在线发表纽约哥伦比亚大学的Susheel K.Kodali博士的最新研究成果，Susheel K.Kodali博士通过对经导管主动脉瓣膜置换术(TAVR)患者2年随访结果首次确认，哪怕只是轻度瓣周主动脉返流也会严重影响患者生存率。

该项旨在比较TAVR与开放手术治疗患者预后的PARTNER (主动脉瓣膜置换)试验结果显示，TAVR术后2年无或痕量瓣周主动脉返流(瓣周漏)死亡率为26%，而轻度和中至重度瓣周漏患者分别为33%和 51%，后者差异显著。此外，TAVR组 瓣周漏(多出现于术后30 d内) 发生率显著高于开放手术组，术后2年TAVR组和开放手术组无或痕量瓣周漏发生率分别约为48%和90%，中至重度瓣周漏发生率分别为7%和1%。

虽然1年和2年总体预后显示TAVR和开放手术组死亡率相似，但TAVR组和开放手术组痕量或无瓣周漏患者1年死亡率分别为13%和24%，2年死亡率分别为26%和30%，接近统计学显著差异。换言之，TAVR组痕量或无瓣周漏患者预后优于开放手术组，但由于TAVR组轻、 中或重度瓣周漏患者较多，这些患者的不良预后使的TAVR组总体预后与开放手术组相似，表明瓣周漏对总体预后具有重要影响。

法国鲁昂Charles Nicolle医院心脏病学教授G. Alain Cribier博士评论称，临床趋势表明1级和2级瓣周漏对预后影响不大，该研究显示主动脉返流，特别是中至重度返流不可接受。目前已经有针对瓣周漏的应对办法，例如可通过全面评估瓣膜解剖学特点而应用较大瓣膜等。他还指出，瓣周漏发生率呈下降趋势。

Kodali博士指出，导致瓣周主动脉返流的因素包括瓣膜大小和植入位置。最近2项报告表明，既往TAVR植入瓣膜普遍小35-40%，提示需要更好地了解瓣膜解剖学结构。他们的另一项研究表明，瓣膜植入后行球囊扩张可使36例中或重度返流患者瓣周返流量显著减少。他同意瓣周主动脉返流是目前亟待改进的重要方面，植入大小合适的瓣膜便可无需事后扩张。

PARTNER 试验合作者、埃默里大学Robert A. Guyton博士称，通过技术改进可使TAVR术后瓣周漏发生率和严重程度改善50%，但不可能完全消除。他预测中或重度瓣周漏发生率或许可降至25%，但与开放手术相比仍然很高。而目前的问题是不能预测发生瓣周漏的潜在患者，或许将来可通过瓣膜钙量检测预测可能发生瓣周漏的患者并采取开放手术方式替代TAVR。（生物谷 bioon.com）

doi:10.1056/NEJMoa1200384
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Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement

Susheel K. Kodali, M.D., Mathew R. Williams, M.D., Craig R. Smith, M.D., Lars G. Svensson, M.D., Ph.D., John G. Webb, M.D., Raj R. Makkar, M.D., Gregory P. Fontana, M.D., Todd M. Dewey, M.D., Vinod H. Thourani, M.D., Augusto D. Pichard, M.D., Michael Fischbein, M.D., Ph.D., Wilson Y. Szeto, M.D., Scott Lim, M.D., Kevin L. Greason, M.D., Paul S. Teirstein, M.D., S. Chris Malaisrie, M.D., Pamela S. Douglas, M.D., Rebecca T. Hahn, M.D., Brian Whisenant, M.D., Alan Zajarias, M.D., Duolao Wang, Ph.D., Jodi J. Akin, M.S., William N. Anderson, Ph.D., and Martin B. Leon, M.D. for the PARTNER Trial Investigators

Background The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. Methods At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. Results The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan–Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). Conclusions A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality.