Original article
Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registryReparación mitral transcatéter según la etiología de la insuficiencia mitral: datos de la vida real procedentes del registro español de MitraClip

https://doi.org/10.1016/j.rec.2019.07.018Get rights and content

Abstract

Introduction and objectives

Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR.

Methods

Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint.

Results

A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8 ± 11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P = .101). Independent predictors were functional class (P = .029), previous surgical revascularization (P = .031), EuroSCORE II (P = .003), diabetes mellitus (P = .037), and left ventricular ejection fraction (P = .015).

Conclusions

This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up.

Resumen

Introducción y objetivos

La reparación de la válvula mitral transcatéter (RVMT) con el sistema MitraClip es un tratamiento para los pacientes con insuficiencia mitral (IM) grave de alto riesgo quirúrgico. El objetivo principal fue analizar los resultados del RVMT en pacientes con IM grave, según la etiología.

Métodos

Estudio observacional, prospectivo y multicéntrico con inclusión de pacientes consecutivos. El objetivo primario fue el combinado de mortalidad por todas las causas y reingresos hospitalarios por insuficiencia cardiaca al año. Se compararon las características clínicas y del procedimiento y los eventos para cada grupo de IM. Se realizó un análisis multivariable para determinar las variables asociadas con el objetivo primario.

Resultados

Se incluyó a 558 pacientes; 364 (65,2%) tenían etiología funcional; 111 (19,9%), degenerativa, y 83 (14,9%), mixta. La media de edad fue 72,8 ± 11,1 años y eran varones el 70,3%. Respecto al objetivo primario, hubo 95 (17%) eventos en toda la serie. No hubo diferencias significativas entre los 3 grupos en el número de eventos del objetivo primario: 11 (11,3%) en la IM degenerativa, 71 (21,3%) en la funcional y 13 (18,1%) en la mixta (p = 0,101). Los predictores independientes fueron la clase funcional (p = 0,029), la revascularización quirúrgica previa (p = 0,031), el EuroSCORE II (p = 0,003), la diabetes mellitus (p = 0,037) y la fracción de eyección del ventrículo izquierdo (p = 0,015).

Conclusiones

Este trabajo confirma con datos de la práctica clínica la seguridad y la eficacia de la RVMT independientemente de la etiología de la IM y se documentan los principales factores asociados con el pronóstico durante el primer año de seguimiento.

Section snippets

INTRODUCTION

Mitral regurgitation (MR) is a valve disease with increasing prevalence. Severe MR is associated with progressive left ventricular dilatation and the development of heart failure (HF). Untreated symptomatic patients have annual mortality rates exceeding 5%.1, 2 MR interventions vary according to the pathophysiological mechanism: in primary or organic MR, some of the components of the mitral apparatus (leaflets, chordae, or papillary muscles) are affected and valve repair/replacement is

Study design and population

In this observational and multicenter study, data were obtained from the Spanish MitraClip registry. This registry is endorsed by the Cardiac Catheterization and Interventional Cardiology (SHCI) Section of the Spanish Society of Cardiology and has prospectively included consecutive patients treated with MitraClip since June 1, 2012. The inclusion of patients treated with the MitraClip in the Spanish registry is open to all members of the SHCI who perform the technique. This study analyzed the

Baseline characteristics of the population

In total, 558 patients were included: 364 had FMR (65.2%), 111 had DMR (19.9%), and 83 had MMR (14.9%). Baseline characteristics are shown in table 1. The mean age was 72.8 ± 11.1 years and men comprised 70.3%. Compared with patients with FMR, patients with DMR were older, were more likely to have had prior cardiac surgery, and had higher surgical risk. Among patients with FMR and MMR, there were higher proportions of men, previous ischemic heart disease, percutaneous revascularization, and

DISCUSSION

This collaborative project of 16 Spanish hospitals was performed in accordance with the recommendations of the Spanish Society of Cardiology regarding TMVR using a registry sponsored by this body and with real-life data from patients with symptomatic severe MR treated by TMVR with MitraClip.

Our series shows the safety and efficacy of TMVR with MitraClip in a high-risk population, with a persistent improvement in functional class and a reduction in MR grade. There were no significant differences

CONCLUSIONS

This is the largest reported series of patients with MR treated by TMVR in Spain and reflects the general use of the technique in our environment. This work confirms, through real-life data from Spain, the safety and efficacy of the treatment and documents the main factors associated with prognosis during the first year of follow-up of these patients.

CONFLICTS OF INTEREST

None declared.

WHAT IS KNOWN ABOUT THE TOPIC?

  • TMVR with the MitraClip device is safe and effective for both degenerative and functional MR. No significant differences have been found in the prognosis of patients treated with TMVR according to MR cause.

WHAT DOES THIS STUDY ADD?

  • This article contributes to a better understanding of the setting of severe and symptomatic MR treated by TMVR according to cause. This work confirms the safety and efficacy of the treatment in Spain and documents the main factors associated with prognosis during the first year

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