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在小主动脉环中经导管植入现代球囊扩张和自扩张瓣膜后,假体-患者不匹配。

Prosthesis-patient mismatch after transcatheter implantation of contemporary balloon-expandable and self-expandable valves in small aortic annuli.

机构信息

Division of Cardiology, Montefiore Medical Center, Bronx, New York, USA.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

出版信息

Catheter Cardiovasc Interv. 2023 Nov;102(5):931-943. doi: 10.1002/ccd.30818. Epub 2023 Sep 5.

Abstract

BACKGROUND

Evidence of clinical impact of PPM after TAVI is conflicting and might vary according to the type of valve implanted.

AIMS

To assess the clinical impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) with balloon-expandable (BEV) and self-expandable valves (SEV) in patients with small annuli.

METHODS

TAVI-SMALL 2 enrolled 628 patients in an international retrospective registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm ) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Analyses were performed comparing patients with less than moderate (n = 452), moderate (n = 138), and severe PPM (n = 38). Primary endpoint was incidence of all-cause mortality. Predictors of all-cause mortality and PPM were investigated.

RESULTS

At a median follow-up of 380 days (interquartile range: 210-709 days), patients with severe PPM, but not moderate PPM, had an increased risk of all-cause mortality when compared with less than moderate PPM (log-rank p = 0.046). Severe PPM predicted all-cause mortality in patients with BEV (hazard ratio [HR]: 5.20, 95% confidence interval [CI]: 1.27-21.2) and intra-annular valves (IAVs, HR: 4.23, 95% CI: 1.28-14.02), and it did so with borderline significance in the overall population (HR: 2.89, 95% CI: 0.95-8.79). Supra-annular valve (SAV) implantation was the only predictor of severe PPM (odds ratio: 0.33, 95% CI: 0.13-0.83).

CONCLUSIONS

Patients with small aortic annuli and severe PPM after TAVI have an increased risk of all-cause mortality at early term follow-up, especially after IAV or BEV implantation. TAVI with SAV protected from severe PPM.

摘要

背景

经导管主动脉瓣置换术(TAVI)后瓣-患者不匹配(PPM)的临床影响证据相互矛盾,并且可能因植入的瓣膜类型而异。

目的

评估经股动脉 TAVI 治疗小瓣环患者中使用球囊扩张瓣膜(BEV)和自膨式瓣膜(SEV)的 PPM 对临床的影响。

方法

TAVI-SMALL 2 是一项国际回顾性注册研究,共纳入 628 例严重主动脉瓣狭窄且瓣环较小(瓣环周长<72mm 或面积<400mm )的患者,于 2011 年至 2020 年在 16 个高容量中心行经股动脉 TAVI 治疗。分析比较了小于中度(n=452)、中度(n=138)和严重 PPM(n=38)的患者。主要终点为全因死亡率。研究了全因死亡率和 PPM 的预测因素。

结果

中位随访 380 天(四分位距:210-709 天)时,与小于中度 PPM 相比,严重 PPM 患者的全因死亡率增加(log-rank p=0.046)。严重 PPM 预测了 BEV(危险比 [HR]:5.20,95%置信区间 [CI]:1.27-21.2)和瓣内瓣膜(IAVs,HR:4.23,95% CI:1.28-14.02)患者的全因死亡率,在总体人群中具有边缘显著性(HR:2.89,95% CI:0.95-8.79)。瓣上瓣膜(SAV)植入是严重 PPM 的唯一预测因素(比值比:0.33,95% CI:0.13-0.83)。

结论

TAVI 后小主动脉瓣环和严重 PPM 的患者在早期随访中有更高的全因死亡率风险,尤其是在植入 IAV 或 BEV 后。SAV 植入可避免严重 PPM。

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