Percutaneous Mitral Valve Repair: Outcome Improvement with Operator Experience and a Second-Generation Device

Abstract

Background and aim: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. Methods: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. Results: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; p = 0.032). Conclusions: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.

Procedural and clinical outcomes after repeat edge‐to‐edge transcatheter mitral valve repair

“…9,10 Suboptimal MR reduction might reflect not only the initial learning curve of operators but also the treatment of more challenging mitral anatomies by experienced interventionalists. 11 In some cases, these residual MR are not present after the initial procedure and show up during the follow-up period. Progressive left ventricle remodeling, leaflet perforation or partial detachment have been described as potential mechanisms for MR progression after edge-to-edge repair.…”

“…In fact, the presence of residual MR > 2 has been associated with poor outcomes at long term 9,10 . Suboptimal MR reduction might reflect not only the initial learning curve of operators but also the treatment of more challenging mitral anatomies by experienced interventionalists 11 . In some cases, these residual MR are not present after the initial procedure and show up during the follow‐up period.…”

EMCAPT study: the effect of MitraClip treatment on the mitral annulus and left atrial appendage evaluation by transoesophageal echocardiography

“…MitraClip is a catheter-based technology similar to the surgical Alfieri technique used in MR treatment [ 1 ]. The first clinical use of MitraClip in humans was carried out in 2003 and the number of cases worldwide has approached almost 200,000 [ 1 , 5 ]. MitraClip is performed via the femoral vein access, consisting of a steerable catheter and a clip delivery system under the guidance of 3D TEE.…”

A word to the wise …

“…On the other hand, in the EVEREST-II study (therefore in highly selected patients), rates of reoperation and 3+ or 4+ MR at 5 years in the percutaneous repair group were 43% and 19%, respectively [ 4 ]. Noteworthy, 3+ and 4+ MR do not include moderate MR but only moderate–severe and severe MR and also, the EVEREST-II included both degenerative and functional MR. Another important aspect to consider is that so far over 100,000 patients over a 17-year period have been treated with Mitraclip, demonstrating the perseverance of our interventional cardiology colleagues (and some surgeons) that, despite the poor initial outcomes of this procedure, have worked to transform a suboptimal conventional surgical procedure (edge to edge with no annular stabilization) into a successful microinvasive alternative, optimizing technology, technique and patient selection [ 5 , 6 ]. Meanwhile, NC procedures have been performed only in ∼1000 patients and we are still using the first-generation device.…”