ACURATE neo2 的短期疗效

IF 1.4 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Structural Heart Pub Date : 2024-05-01 DOI:10.1016/j.shj.2023.100277
Akihiro Tobe MD , Scot Garg MD, PhD , Helge Möllmann MD, PhD , Andreas Rück MD, PhD , Won-Keun Kim MD , Andrea Buono MD , Andrea Scotti MD , Azeem Latib MD , Stefan Toggweiler MD , Antonio Mangieri MD , Mika Laine MD , Christopher U. Meduri MD , Tobias Rheude MD , Ivan Wong MBBS , Chenniganahosahalli Revaiah Pruthvi MD , Tsung-Ying Tsai MD , Yoshinobu Onuma MD, PhD , Patrick W. Serruys MD, PhD
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引用次数: 0

摘要

ACURATE neo是一种用于治疗重度主动脉瓣狭窄的自扩张经导管心脏瓣膜(THV),其疗效不佳的主要原因是中度/重度瓣膜旁漏(PVL)发生率较高。为了克服这一局限性,新一代 ACURATE neo2 的外部密封裙增加了 60%。有关其长期性能的数据有限,但临床证据表明其短期性能有所改善,可与当代 THV 相媲美。本报告回顾了 ACURATE neo2 的短期临床和超声心动图结果数据。在 PubMed 上搜索到 13 项研究,包括 5 项单臂研究和 8 项与其他 THV 的非随机对比研究,这些研究报告了住院或 30 天的临床和超声心动图结果。院内或30天全因死亡率≤3.3%,与其他当代THV相当。术后≧中度PVL的发生率为0.6%-4.7%。在多中心倾向匹配分析中,与neo相比,neo2显著降低了≧中度PVL的发生率(3.5% vs. 11.3%,p <0.01),而与Evolut Pro/Pro+(Neo2:2.0% vs. Pro/Pro+:3.1%,p = 0.28)和SAPIEN 3 Ultra(Neo2:0.6% vs. Ultra:1.1%,p = 0.72)的发生率相当。除一项研究外,neo2的永久起搏器植入率一直较低(3.3%-8.6%),在倾向匹配分析中显著低于Evolut Pro/Pro+(6.7% vs. 16.7%,p <0.01),与SAPIEN 3 Ultra相当(8.1% vs. 10.3%,p = 0.29)。总之,与前代产品相比,ACURATE neo2 通过显著降低 PVL 显示出更好的短期性能,其短期临床和超声心动图结果与当代 THV 相当。
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Short-Term Outcomes of ACURATE neo2

Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural ≧moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of ≧moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs.

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来源期刊
Structural Heart
Structural Heart Medicine-Cardiology and Cardiovascular Medicine
CiteScore
1.60
自引率
0.00%
发文量
81
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