p.32 抽出テキスト

................. remodelling or survival.333 Indications for isolated mitral valve surgery in SMR are particularly restrictive, owing to significant procedural risk, high rates of recurrent mitral regurgitation, and the absence of proven survival benefit.333335 In patients with atrial functional mitral regurgitation, LVEF is usually normal, LV dilatation less pronounced and mitral annular dilatation represents the main mechanism of mitral regurgitation. This subgroup may be more effectively treated by ring annuloplasty often associated with ablation of AF but evidence is still limited.319 TEER with the MitraClip system is a minimal-invasive treatment option for SMR. Two RCTs (COAPT and MITRA-FR)323,336,337 have evaluated its safety and efficacy in patients with symptomatic heart failure and severe SMR persisting despite medical therapy, who were considered either ineligible or not appropriate for surgery by the Heart Team (Supplementary Table 7). The results indicate that the procedure is safe and effectively reduces SMR up to 3 years.338 However, in the MITRA-FR trial,323,336 MitraClip implantation had no impact on the primary endpoint of all-cause mortality or heart failure hospitalization at 12 months and 2 years compared to GDMT alone. In the COAPT trial,337 MitraClip implantation substantially reduced the primary endpoint of cumulative hospitalizations for heart failure, as well as several pre-specified secondary endpoints, including allcause mortality at 2 years. Subanalyses of the COAPT trial confirm the positive response to TEER in several patient subgroups;339343 conversely, the effect of the interventional treatment was neutral throughout all subgroups in an echocardiographic subanalyses of the MITRA-FR trial.344 The conflicting results of these two trials have generated considerable discussion. These diverging results might be partially explained by effect size of the trials, differences in trial design, patient selection, echocardiographic assessment of SMR severity, use of medical therapy, and technical factors. Patients in COAPT demonstrated greater severity of SMR (EROA 41±15 mm2 vs. 31±10 mm2) and less LV dilatation (mean indexed LV end-diastolic volume 101±34 mL/m2 vs. 135±35 mL/m2) than those enrolled in MITRA-FR. Perhaps reflecting greater severity of SMR in relation to LV dimensions (‘disproportionate’ mitral regurgitation), patients in COAPT were overall more likely to benefit from TEER in terms of reduced mortality and heart failure hospitalization.345 Additional studies are needed to identify patients who will benefit the most from TEER. Therefore, TEER should be considered in selected patients with severe SMR fulfilling the COAPT inclusion criteria,346348 who receive optimal medical therapy supervised by a heart failure specialist and are as close as possible to the patients actually enrolled in the study. Optimization of the procedural result should also be pursued. In addition, TEER may be considered only in selected cases when the COAPT criteria are not fulfilled with the aim of improving symptoms and quality of life.349353 In patients with less severe SMR (EROA <30 mm2) and advanced LV dilatation/dysfunction, the prognostic benefit of MitraClip remains unproven.323,354,355 Patients with end-stage LV and/or RV failure and no option for revascularization may be better served by cardiac transplantation or LV assist device implantation. Valve intervention is generally not an option when LVEF is <15%.247 The management of moderate ischaemic SMR in patients undergoing CABG remains an object of debate.322,330 Surgery is more likely to be considered if myocardial viability is present and if comorbidity is low. Exercise-induced dyspnoea and a large increase in mitral regurgitation severity and SPAP favour combined surgery.

Transcatheter mitral valve repair systems other than TEER, as well as transcatheter mitral valve replacement devices, are currently the subject of intense investigation but clinical data are still limited.

Recommendations on indications for mitral valve intervention in chronic severe secondary mitral regurgitationa

Recommendations Classb Levelc

Valve surgery/intervention is recommended only in patients with severe SMR who remain symptomatic despite GDMT (including CRT if indicated) and has to be decided by a structured collaborative Heart Team.247,323,336,337 I B Patients with concomitant coronary artery or other cardiac disease requiring treatment Valve surgery is recommended in patients undergoing CABG or other cardiac surgery.329,330,333 I B In symptomatic patients, who are judged not appropriate for surgery by the Heart Team on the basis of their individual characteristics,d PCI (and/or TAVI) possibly followed by TEER (in case of persisting severe SMR) should be considered. IIa C Patients without concomitant coronary artery or other cardiac disease requiring treatment TEER should be considered in selected symptomatic patients, not eligible for surgery and fulfilling criteria suggesting an increased chance of responding to the treatment.337,338,356,357 e IIa B Valve surgery may be considered in symptomatic patients judged appropriate for surgery by the Heart Team. IIb C In high-risk symptomatic patients not eligible for surgery and not fulfilling the criteria suggesting an increased chance of responding to TEER, the Heart Team may consider in selected cases a TEER procedure or other transcatheter valve therapy if applicable, after careful evaluation for ventricular assist device or heart transplant.e IIb C

2D = two-dimensional; CABG = coronary artery bypass grafting; CRT = cardiac resynchronization therapy; EROA = effective regurgitation orifice area; GDMT = guideline-directed medical therapy; LVEF = left ventricular ejection fraction; SMR = secondary mitral regurgitation; PCI = percutaneous coronary intervention; SMR = secondary mitral regurgitation; TAVI = transcatheter aortic valve implantation; TEER: transcatheter edge-to-edge repair. aSee Table 7 for SMR quantification (an EROA >_30 mm2 by 2D proximal isovelocity surface area corresponds likely to severe SMR). Quantification of SMR must always be performed under optimal guidelines-directed medical treatment. bClass of recommendation. cLevel of evidence. dLVEF, predicted surgical risk, amount of myocardial viability, coronary anatomy/ target vessels, type of concomitant procedure needed, TEER eligibility, likelihood of durable surgical repair, need of surgical mitral replacement, local expertise. eCOAPT criteria (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation): see Supplementary Table 7. ESC/EACTS 2021

........................................................................................................................................................... Downloaded from academic.oup.com/eurheartj/article/43/7/561/6358470 by guest on 07 October 2026