Abstract

ObjectivesTo assess the value of effective regurgitant orifice (ERO) in predicting outcome after edge-to-edge transcatheter mitral valve repair (TMVR) for secondary mitral regurgitation (SMR) and identify the optimal cut-off for patients’ selection.MethodsUsing the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry, that included patients undergoing edge-to-edge TMVR for SMR between November 2008 and January 2019 in 8 experienced European centres, we assessed the optimal ERO threshold associated with mortality in SMR patients undergoing TMVR, and compared characteristics and outcomes of patients according to baseline ERO.ResultsAmong 1062 patients with severe SMR and ERO quantification by proximal isovelocity surface area method in the registry, ERO was < 0.3 cm2 in 575 patients (54.1%), who were more symptomatic at baseline (NYHA class ≥ III: 91.4% vs. 86.9%, for ERO < vs. ≥ 0.3 cm2; P = 0.004). There was no difference in all-cause mortality at 2-year follow-up according to baseline ERO (28.3% vs. 30.0% for ERO < vs. ≥ 0.3 cm2, P = 0.585). Both patient groups demonstrated significant improvement of at least one NYHA class (61.7% and 73.8%, P = 0.002), resulting in a prevalence of NYHA class ≤ II at 1-year follow-up of 60.0% and 67.4% for ERO < vs. ≥ 0.3 cm2, respectively (P = 0.05).ConclusionAll-cause mortality at 2 years after TMVR does not differ if baseline ERO is < or ≥ 0.3 cm2, and both groups exhibit relevant clinical improvements. Accordingly, TMVR should not be withheld from patients with ERO < 0.3 cm2 who remain symptomatic despite optimal medical treatment, if TMVR appropriateness was determined by experienced teams in dedicated valve centres.

Highlights

  • Chronic secondary mitral regurgitation (SMR) is a frequent finding in the setting of heart failure with reduced ejection fraction (HFrEF), and is associated with adverse prognosis

  • Two prospective randomized trials assessed the benefit of transcatheter mitral valve repair (TMVR) on top of optimal medical treatment (OMT) in patients with severe SMR: the French Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation (MITRA‐FR) trial, which showed no benefit from TMVR on top of OMT [9], and the American Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial, which demonstrated significant reductions in mortality and hospitalisations for heart failure as well as improvements in quality of life [10, 10]

  • One of the potential explanations that were discussed for the observed discrepancies in outcomes is the difference in effective regurgitant orifice (ERO) in each study: mean baseline ERO was 0.31 ­cm2 in MITRA‐FR, vs. 0.41 ­cm2 in COAPT ­cm2, which led to a questioning of the yield of TMVR in the setting of low ERO, even though guidelines advocate for an integrative approach to assess the severity of MR

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Summary

Introduction

Chronic secondary mitral regurgitation (SMR) is a frequent finding in the setting of heart failure with reduced ejection fraction (HFrEF), and is associated with adverse prognosis. Edge-to-edge transcatheter mitral valve repair (TMVR) has been shown to be an effective and safe therapeutic option in patients with primary MR at high surgical risk [3]. Two prospective randomized trials assessed the benefit of TMVR on top of OMT in patients with severe SMR: the French Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation (MITRA‐FR) trial, which showed no benefit from TMVR on top of OMT [9], and the American Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial, which demonstrated significant reductions in mortality and hospitalisations for heart failure as well as improvements in quality of life [10, 10]. One of the potential explanations that were discussed for the observed discrepancies in outcomes is the difference in effective regurgitant orifice (ERO) in each study: mean baseline ERO was 0.31 ­cm in MITRA‐FR, vs. 0.41 ­cm in COAPT ­cm, which led to a questioning of the yield of TMVR in the setting of low ERO (mainly < 0.3 ­cm2), even though guidelines advocate for an integrative approach to assess the severity of MR

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