Kar Saibal, Price Matthew J, Morse M Andrew, Rinaldi Michael J, Mahoney Paul, Denti Paolo, Asch Federico M, Zamorano Jose L, Aiyer Janani, Huang Rong, Maisano Francesco, von Bardeleben Ralph Stephan, Rodriguez Evelio
Los Robles Regional Medical Center, HCA Healthcare, Thousand Oaks, California, USA.
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.
JACC Cardiovasc Interv. 2025 Apr 14;18(7):898-908. doi: 10.1016/j.jcin.2024.12.023. Epub 2025 Mar 5.
Treating anterior and bileaflet mitral valve disease in patients with primary or degenerative mitral regurgitation (DMR) is considered more challenging than posterior leaflet repair.
The aim of this analysis was to evaluate the impact of anterior, posterior, or bileaflet disease on outcomes following mitral transcatheter edge-to-edge repair (M-TEER) in the EXPANDed studies.
EXPANDed is a pooled, patient-level analysis of subjects undergoing M-TEER with the MitraClip G3 or G4 system as part of the contemporary EXPAND and EXPAND G4 studies. Subjects with DMR were categorized according to echocardiography core laboratory-assessed prolapse or flail location into posterior (prolapse or flail at P1, P2, and/or P3), anterior (prolapse or flail at A1, A2, and/or A3) or bileaflet disease (prolapse or flail at any combination of A1, A2, and A3 and P1, P2, and P3). Key outcomes assessed included procedural outcomes, 30-day major adverse events, and 1-year mitral regurgitation (MR) severity.
Of 2,205 subjects in EXPANDed, 556 had echocardiography core laboratory-assessed DMR and prolapse or flail location. A total of 389 had posterior, 106 had anterior, and 61 had bileaflet disease. All groups experienced low device and procedure times with high procedural success rates (defined as discharge MR ≤2+). Thirty-day major adverse events rates were low across all groups (posterior, 4.4% [17 of 388]; anterior, 3.8% [4 of 105]; bileaflet, 6.6% [4 of 61]; P = 0.65). Through 1 year, all groups showed a significant reduction in MR severity from baseline (MR ≤1+ posterior, 82% [179 of 219]; anterior, 93% [53 of 57]; bileaflet, 97% [28 of 29]).
Results from the EXPANDed studies demonstrate that subjects with DMR treated with M-TEER experienced significant improvements in outcomes, regardless of the location of prolapse or flail.
治疗原发性或退行性二尖瓣反流(DMR)患者的前叶和双叶二尖瓣疾病被认为比后叶修复更具挑战性。
本分析的目的是评估在EXPANDed研究中,前叶、后叶或双叶疾病对二尖瓣经导管缘对缘修复术(M-TEER)后结局的影响。
EXPANDed是一项汇总的、患者水平的分析,纳入了接受使用MitraClip G3或G4系统进行M-TEER的受试者,作为当代EXPAND和EXPAND G4研究的一部分。根据超声心动图核心实验室评估的脱垂或连枷部位,将DMR患者分为后叶(P1、P2和/或P3处脱垂或连枷)、前叶(A1、A2和/或A3处脱垂或连枷)或双叶疾病(A1、A2和A3以及P1、P2和P3的任何组合处脱垂或连枷)。评估的主要结局包括手术结局、30天主要不良事件和1年二尖瓣反流(MR)严重程度。
在EXPANDed研究的2205名受试者中,556名有超声心动图核心实验室评估的DMR和脱垂或连枷部位。共有389名后叶疾病患者、106名前叶疾病患者和61名双叶疾病患者。所有组的器械操作和手术时间均较短,手术成功率较高(定义为出院时MR≤2+)。所有组的30天主要不良事件发生率均较低(后叶,4.4%[388例中的17例];前叶,3.8%[105例中的4例];双叶,6.6%[61例中的4例];P = 0.65)。至1年时,所有组的MR严重程度均较基线有显著降低(后叶MR≤1+,82%[219例中的179例];前叶,93%[57例中的53例];双叶,97%[29例中的28例])。
EXPANDed研究结果表明,接受M-TEER治疗的DMR患者,无论脱垂或连枷部位如何,结局均有显著改善。