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高危重度主动脉瓣狭窄患者经导管与外科瓣膜置换术中人工瓣膜-患者不匹配的发生率及后遗症:一项PARTNER试验队列分析

Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis.

作者信息

Pibarot Philippe, Weissman Neil J, Stewart William J, Hahn Rebecca T, Lindman Brian R, McAndrew Thomas, Kodali Susheel K, Mack Michael J, Thourani Vinod H, Miller D Craig, Svensson Lars G, Herrmann Howard C, Smith Craig R, Rodés-Cabau Josep, Webb John, Lim Scott, Xu Ke, Hueter Irene, Douglas Pamela S, Leon Martin B

机构信息

Québec Heart and Lung Institute/Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Québec, Canada.

Medstar Health Research Institute, Washington, DC.

出版信息

J Am Coll Cardiol. 2014 Sep 30;64(13):1323-34. doi: 10.1016/j.jacc.2014.06.1195.

Abstract

BACKGROUND

Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR).

OBJECTIVES

The objectives of this study were: 1) to compare the incidence of PPM in the TAVR and surgical aortic valve replacement (SAVR) randomized control trial (RCT) arms of the PARTNER (Placement of AoRTic TraNscathetER Valves) I Trial cohort A; and 2) to assess the impact of PPM on regression of left ventricular (LV) hypertrophy and mortality in these 2 arms and in the TAVR nonrandomized continued access (NRCA) registry cohort.

METHODS

The PARTNER Trial cohort A randomized patients 1:1 to TAVR or bioprosthetic SAVR. Postoperative PPM was defined as absent if the indexed effective orifice area (EOA) was >0.85 cm(2)/m(2), moderate if the indexed EOA was ≥0.65 but ≤0.85 cm(2)/m(2), or severe if the indexed EOA was <0.65 cm(2)/m(2). LV mass regression and mortality were analyzed using the SAVR-RCT (n = 270), TAVR-RCT (n = 304), and TAVR-NRCA (n = 1,637) cohorts.

RESULTS

The incidence of PPM was 60.0% (severe: 28.1%) in the SAVR-RCT cohort versus 46.4% (severe: 19.7%) in the TAVR-RCT cohort (p < 0.001) and 43.8% (severe: 13.6%) in the TAVR-NRCA cohort. In patients with an aortic annulus diameter <20 mm, severe PPM developed in 33.7% undergoing SAVR compared with 19.0% undergoing TAVR (p = 0.002). PPM was an independent predictor of less LV mass regression at 1 year in the SAVR-RCT (p = 0.017) and TAVR-NRCA (p = 0.012) cohorts but not in the TAVR-RCT cohort (p = 0.35). Severe PPM was an independent predictor of 2-year mortality in the SAVR-RCT cohort (hazard ratio [HR]: 1.78; p = 0.041) but not in the TAVR-RCT cohort (HR: 0.58; p = 0.11). In the TAVR-NRCA cohort, severe PPM was not a predictor of 1-year mortality in all patients (HR: 1.05; p = 0.60) but did independently predict mortality in the subset of patients with no post-procedural aortic regurgitation (HR: 1.88; p = 0.02).

CONCLUSIONS

In patients with severe aortic stenosis and high surgical risk, PPM is more frequent and more often severe after SAVR than TAVR. Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM. Severe PPM also has a significant impact on survival after TAVR in the subset of patients with no post-procedural aortic regurgitation. TAVR may be preferable to SAVR in patients with a small aortic annulus who are susceptible to PPM to avoid its adverse impact on LV mass regression and survival. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

摘要

背景

关于人工瓣膜-患者不匹配(PPM)的发生率及其对经导管主动脉瓣置换术(TAVR)后结局的影响,目前所知甚少。

目的

本研究的目的是:1)比较PARTNER(主动脉经导管瓣膜置入)I试验队列A的TAVR和外科主动脉瓣置换术(SAVR)随机对照试验(RCT)组中PPM的发生率;2)评估PPM对这两组以及TAVR非随机持续入组(NRCA)登记队列中左心室(LV)肥厚消退和死亡率的影响。

方法

PARTNER试验队列A将患者按1:1随机分为TAVR组或生物瓣SAVR组。如果指数化有效瓣口面积(EOA)>0.85 cm²/m²,则术后PPM定义为不存在;如果指数化EOA≥0.65但≤0.85 cm²/m²,则为中度;如果指数化EOA<0.65 cm²/m²,则为重度。使用SAVR-RCT(n = 270)、TAVR-RCT(n = 304)和TAVR-NRCA(n = 1637)队列分析LV质量消退和死亡率。

结果

SAVR-RCT队列中PPM的发生率为60.0%(重度:28.1%),而TAVR-RCT队列中为46.4%(重度:19.7%)(p<0.001),TAVR-NRCA队列中为43.8%(重度:13.6%)。在主动脉瓣环直径<20 mm的患者中,接受SAVR的患者发生重度PPM的比例为33.7%,而接受TAVR的患者为19.0%(p = 0.002)。在SAVR-RCT(p = 0.017)和TAVR-NRCA(p = 0.012)队列中,PPM是1年时LV质量消退较少的独立预测因素,但在TAVR-RCT队列中不是(p = 0.35)。重度PPM是SAVR-RCT队列中2年死亡率的独立预测因素(风险比[HR]:1.78;p = 0.041),但在TAVR-RCT队列中不是(HR:0.58;p = 0.11)。在TAVR-NRCA队列中,重度PPM在所有患者中不是1年死亡率的预测因素(HR:1.05;p = 0.60),但在术后无主动脉瓣反流的患者亚组中确实独立预测死亡率(HR:1.88;p = 0.02)。

结论

在严重主动脉瓣狭窄且手术风险高的患者中,SAVR后PPM比TAVR更频繁且更常为重度。SAVR后发生PPM的患者比未发生PPM的患者生存率更差,LV质量消退更少。在术后无主动脉瓣反流的患者亚组中,重度PPM对TAVR后的生存也有显著影响。对于易发生PPM的小主动脉瓣环患者,TAVR可能比SAVR更可取,以避免其对LV质量消退和生存的不利影响。(PARTNER试验:主动脉经导管瓣膜置入试验;NCT00530894)

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