Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
EuroIntervention. 2018 Aug 20;14(6):621-628. doi: 10.4244/EIJ-D-18-00488.
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.
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.
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.
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。
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。
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。