University of California Davis Medical Center, Sacramento, California, USA.
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.
JACC Cardiovasc Interv. 2024 Nov 11;17(21):2530-2540. doi: 10.1016/j.jcin.2024.08.004. Epub 2024 Oct 23.
Reducing mitral regurgitation (MR) during mitral transcatheter edge-to-edge repair (M-TEER) may come at the cost of increased mitral valve gradient (MVG). The combined impact of residual MR and MVG on clinical outcomes after M-TEER is unknown.
This study sought to evaluate the impact of postprocedure MR and MVG on clinical outcomes after M-TEER.
EXPANDed is a pooled, patient-level cohort of the EXPAND (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) and EXPAND G4 studies, which were designed to evaluate real-world safety and effectiveness of the third- and fourth-generation MitraClip TEER Systems. Subjects were categorized by echocardiographic core laboratory (ECL) assessments into 4 groups according to 30-day MR grade and mean MVG: 1) MR ≤1+/MVG <5 mm Hg; 2) MR ≤1+/MVG ≥5 mm Hg; 3) MR ≥2+/MVG <5 mm Hg; and 4) MR ≥2+/MVG ≥5 mm Hg.
A total of 1,723 subjects had evaluable echocardiograms at 30 days: 72% had MR ≤1+/MVG <5 mm Hg, 18% had MR ≤1+/MVG ≥5 mm Hg, 7% had MR ≥2+/MVG <5 mm Hg, and 3% had MR ≥2+/MVG ≥5 mm Hg. MR≤1+ was sustained through 1 year in 93% of patients who achieved 30-day MR≤1+. MVG decreased from 30 days to 1 year in subjects with MVG ≥5 mm Hg (6.7 ± 4.0 to 5.5 ± 2.5 mm Hg MR ≤1+/MVG ≥5 mm Hg and 6.5 ± 1.5 to 5.5 ± 1.7 mm Hg MR ≥2+/MVG ≥5 mm Hg). One-year rates of all-cause mortality and heart failure hospitalization were lower for subjects who achieved MR ≤1+ at 30 days, regardless of MVG.
Reduction of MR to mild or less after M-TEER with the latest-generation MitraClip systems was associated with clinical benefit regardless of MVG.
在二尖瓣经导管缘对缘修复术(M-TEER)期间减轻二尖瓣反流(MR)可能会导致二尖瓣瓣口梯度(MVG)增加。M-TEER 后残余 MR 和 MVG 对临床结局的综合影响尚不清楚。
本研究旨在评估 M-TEER 后 MR 和 MVG 对临床结局的影响。
EXPAND 是 EXPAND(评估下一代 MitraClip 装置在现实世界中的性能和安全性的当代前瞻性研究)和 EXPAND G4 研究的汇总患者水平队列,旨在评估第三代和第四代 MitraClip TEER 系统的真实世界安全性和有效性。根据 30 天的 MR 分级和平均 MVG,通过超声心动图核心实验室(ECL)评估将受试者分为 4 组:1)MR≤1+/MVG<5mmHg;2)MR≤1+/MVG≥5mmHg;3)MR≥2+/MVG<5mmHg;和 4)MR≥2+/MVG≥5mmHg。
共有 1723 名受试者在 30 天时有可评估的超声心动图:72%的受试者 MR≤1+/MVG<5mmHg,18%的受试者 MR≤1+/MVG≥5mmHg,7%的受试者 MR≥2+/MVG<5mmHg,3%的受试者 MR≥2+/MVG≥5mmHg。93%的患者在 30 天达到 MR≤1+的情况下,MR≤1+持续至 1 年。MVG 在 MVG≥5mmHg 的受试者中从 30 天到 1 年下降(MR≤1+/MVG≥5mmHg 从 6.7±4.0mmHg 降至 5.5±2.5mmHg,MR≥2+/MVG≥5mmHg 从 6.5±1.5mmHg 降至 5.5±1.7mmHg)。无论 MVG 如何,在 30 天达到 MR≤1+的患者,1 年全因死亡率和心力衰竭住院率均较低。
在使用最新一代 MitraClip 系统进行 M-TEER 后,将 MR 减少到轻度或更低水平与临床获益相关,而与 MVG 无关。