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在所有患者人群中使用自膨式 Portico 瓣膜系统行经导管主动脉瓣植入术:手术和临床结果。

Transcatheter aortic valve implantation with the self-expanding Portico valve system in an all-comers population: procedural and clinical outcomes.

机构信息

Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

出版信息

EuroIntervention. 2018 Aug 20;14(6):621-628. doi: 10.4244/EIJ-D-18-00488.

DOI:10.4244/EIJ-D-18-00488
PMID:29969432
Abstract

AIMS

Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). The aim of this study was to evaluate the newer-generation Portico TAVI system in an all-comers population.

METHODS AND RESULTS

This single-centre study included 216 patients with severe AS (Society of Thoracic Surgeons [STS] score 4.3±3.0%). The Portico valve was implanted using the transfemoral (91.2%), transsubclavian (5.6%) and transcaval (3.2%) access. Device success was achieved in 94.4% of cases. At 30 days, mortality and stroke rates were 2.3% and 0.5%, respectively. Early safety was achieved in 91.7% of cases. More-than-mild paravalvular leak (PVL), as assessed by echocardiogram, was observed in 3.4% of the patients, with rates of 4.9% and 1.9% in the first and second half of the cohort, respectively. A permanent pacemaker was implanted in 15.8% of those without prior pacemaker, with a rate of 11.1% in the second half of the cohort. At one year, incidence rates for all-cause mortality and stroke were 12.3% and 2.3%, respectively. In the low-risk group (STS <4%; n=128), Kaplan-Meier estimates at 30 days and one year were 0% and 7.5% for all-cause mortality and 0.8% and 2.2% for stroke, respectively. Haemodynamic improvements persisted over time with a mean transvalvular gradient of 7.0±3.0 mmHg at one-year follow-up.

CONCLUSIONS

The Portico TAVI system was safe to implant and achieved a high device success rate. With learning curve effects, the device achieves lower rates of PVL and pacemaker implantation and provides adequate clinical and haemodynamic outcomes up to one year.

摘要

目的

经导管主动脉瓣置换术(TAVI)是治疗严重主动脉瓣狭窄(AS)患者的一种成熟疗法。本研究旨在评估新一代Portico TAVI 系统在所有患者人群中的应用。

方法和结果

本单中心研究纳入了 216 例严重 AS 患者(胸外科医师学会评分 [STS] 4.3±3.0%)。采用经股动脉(91.2%)、经锁骨下动脉(5.6%)和经腔静脉(3.2%)入路植入 Portico 瓣膜。94.4%的病例实现了器械成功。30 天死亡率和卒中发生率分别为 2.3%和 0.5%。91.7%的病例早期安全性良好。超声心动图评估发现,3.4%的患者存在中重度瓣周漏(PVL),其中队列前半段和后半段的发生率分别为 4.9%和 1.9%。在没有起搏器的患者中,有 15.8%的患者植入了永久性起搏器,队列后半段的这一比例为 11.1%。1 年时,全因死亡率和卒中发生率分别为 12.3%和 2.3%。在低危组(STS<4%;n=128)中,30 天和 1 年的全因死亡率和卒中发生率的 Kaplan-Meier 估计值分别为 0%和 7.5%、0.8%和 2.2%。随着时间的推移,血流动力学改善得以持续,1 年时跨瓣压差的平均值为 7.0±3.0mmHg。

结论

Portico TAVI 系统植入安全,器械成功率高。随着学习曲线的影响,该器械可降低 PVL 和起搏器植入的发生率,并在 1 年时提供足够的临床和血流动力学结局。

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