The Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany; Cardiology Department, The Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
The Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
JACC Cardiovasc Interv. 2018 Dec 24;11(24):2507-2518. doi: 10.1016/j.jcin.2018.07.050. Epub 2018 Nov 28.
OBJECTIVES: The aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli. BACKGROUND: The degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs. METHODS: Patients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (>23 mm) or small (≤23 mm) annuli. RESULTS: THV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR. CONCLUSIONS: Older-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli.
目的：本研究旨在比较大瓣环与小瓣环患者中自膨式和球囊扩张式经导管心脏瓣膜（THV）的疗效。
背景：THV 的过度扩张程度取决于瓣环大小，这会改变自膨式和球囊扩张式 THV 的血流动力学性能。
方法：在随机CHOICE（高风险严重主动脉瓣狭窄患者经导管主动脉瓣置换术的比较：美敦力核心瓣膜与爱德华 SAPIEN XT）试验（核心瓣膜[CV]，n=120；SAPIEN XT[SXT]，n=121）和非随机CHOICE-Extend 注册研究（ Evolut R[ER]，n=100；SAPIEN 3[S3]，n=334）中，通过超声心动图（所有患者）和心脏磁共振成像（MRI）反流分数（RF）（患者亚组）比较 THV 性能。患者根据主动脉瓣环平均直径分为瓣环较大（>23mm）或较小（≤23mm）。
结果：CV 的 THV 平均扩张百分比为 19.1±6.4%，SXT 为 11.4±7.0%，ER 为 18.8±4.8%，S3 为 3.7±5.5%。在大瓣环组和小瓣环组中，CV 和 ER 的跨瓣压差均低于 SXT 和 S3。在随机 CHOICE 试验中，与 SXT 相比，CV 在大瓣环中发生中度至重度人工瓣膜反流（PVR）的比例更高（15.1% vs. 0.0%；p=0.002；MRI RF：10.5±10.2% vs. 4.4±4.5%；p=0.036），但在小瓣环中无差异（0.0% vs. 5.7%；p=0.50；MRI RF：4.0±4.1% vs. 4.0±3.4%；p=0.98）。在 CHOICE-Extend 注册研究中，2 例患者发生中度至重度 PVR，ER 和 S3 在大瓣环（41.7% vs. 32.5%；p=0.24）或小瓣环（47.1% vs. 43.8%；p=0.84）中发生任何程度 PVR 的差异均无统计学意义。MRI RF 在大瓣环中无差异（5.0±3.8% vs. 5.0±6.1%；p=0.99），但在小瓣环中 ER 明显低于 S3（2.9±2.3% vs. 4.8±3.7%；p=0.023）。多因素分析显示，在小瓣环中，与 S3 相比，ER 行经导管主动脉瓣置换术与较低的假体-患者不匹配发生率相关，且 PVR 风险无增加。
结论：与自膨式 THV 相比，在大瓣环患者中，上一代球囊扩张式 THV 与较低的 PVR 相关，而在小瓣环患者中则无差异。新一代自膨式 THV 改善了大瓣环患者的密封性能，在小瓣环患者中可能具有潜在优势。
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