From the Technical University Dresden Heart Center, Germany (A.L); Herzzentrum Leipzig, Germany (D.H.); St. Johannes Hospital, Dortmund, Germany (H.M.); Royal Victoria Hospital, Belfast, United Kingdom (G.M.); University Heart Center Hamburg, Germany (U.S.); Asklepios Kliniken, Hamburg, Germany (C.F.); Genesis Care, Adelaide, Australia (S.G.W.); MC Leeuwarden, the Netherlands (A.J.v.B.); St Thomas' Hospital, London, United Kingdom (S.R.); Glenfield Hospital, Leicester, England (J.K.); Heart Center of Bernau, Germany (C.B.); Righospitalet, University of Copenhagen, Denmark (L.S.); Department of Cardiology, Charité-Universitaetsmedizin Berlin, Germany (A.L.); Department of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Germany (G.S.); and Universitat Frankfurt Zentrum der Chirurgie, Germany (T.W.).
Circ Cardiovasc Interv. 2018 Feb;11(2):e005206. doi: 10.1161/CIRCINTERVENTIONS.117.005206.
BACKGROUND: The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS). METHODS AND RESULTS: High-risk patients (n=222) with symptomatic severe AS (mean age, 83.0±4.6 years; 74.3% women) were enrolled across 12 centers in Europe and Australia. The study's primary end point was all-cause mortality at 30 days. A total of 209 patients who received the Portico TAVI system were available for follow-up after the 30-day visit. Data collection included hemodynamic assessment by echocardiography with core laboratory evaluation and assessment of functional status. Valve Academic Research Consortium-defined adverse events were adjudicated by an independent Clinical Events Committee. TAVI using the Portico valve led to a significant and persistent improvement in aortic valve function at 1 year. More than mild paravalvular leak was present in 5.7% and 7.5% of patients at 30 days and 1 year, respectively. Kaplan-Meier estimates at 30 days and 1 year were 3.6% and 13.8% for all-cause mortality, 3.6% and 9.6% for cardiovascular mortality, and 3.2% and 5.8% for major (disabling) stroke. After 30 days and ≤1 year of follow-up, adverse events included stage 3 acute kidney injury (n=3), major vascular complications (n=5), and life-threatening/disabling bleeding (n=3). Overall permanent pacemaker rate was 14.7%. At 1 year, 74.8% improved ≥1 New York Heart Association class compared with baseline (<0.0001). CONCLUSIONS: The Portico TAVI system is safe and effective at 1 year, yielding low mortality and stroke rates in high-risk patients with severe AS. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284.
背景：Portico TAVI（经导管主动脉瓣植入术）系统研究的目的是评估在欧洲和澳大利亚的 12 个中心的高危患者人群中，使用新型可重新护套的自扩张 TAVI 系统植入后 1 年的结果。
方法和结果：共纳入了 222 名患有症状性严重主动脉瓣狭窄（平均年龄 83.0±4.6 岁，74.3%为女性）的高危患者。该研究的主要终点是 30 天的全因死亡率。共有 209 名接受 Portico TAVI 系统治疗的患者在 30 天就诊后可进行随访。数据收集包括核心实验室评估的超声心动图评估的血流动力学评估和功能状态评估。由独立的临床事件委员会裁定 Valve Academic Research Consortium 定义的不良事件。使用 Portico 瓣膜进行 TAVI 可导致主动脉瓣功能在 1 年内显著且持续改善。在 30 天和 1 年时，分别有 5.7%和 7.5%的患者存在超过轻度瓣周漏。30 天和 1 年的 Kaplan-Meier 估计全因死亡率分别为 3.6%和 13.8%，心血管死亡率分别为 3.6%和 9.6%，主要（致残）卒中分别为 3.2%和 5.8%。在 30 天和 1 年的随访期间，不良事件包括 3 例 3 期急性肾损伤，5 例大血管并发症和 3 例危及生命/致残性出血。总体永久起搏器植入率为 14.7%。在 1 年时，与基线相比，74.8%的患者纽约心脏协会（NYHA）心功能分级提高≥1 级（<0.0001）。
结论：Portico TAVI 系统在高危严重主动脉瓣狭窄患者中 1 年时安全有效，死亡率和卒中率较低。
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