Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System

ObjectivesThe aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system.BackgroundTransseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair.MethodsPatients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria.ResultsFourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%).ConclusionsThis first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.     

Comparison of Clinical and Echocardiographic Outcomes After Surgical Redo Mitral Valve Replacement and Transcatheter Mitral Valve-in-Valve Therapy

Objectives

There are minimal data regarding clinical outcomes and echocardiographic findings after transcatheter mitral valve-in-valve replacement (TMVR) compared with redo surgical mitral valve replacement (SMVR).

Early Experience With New Transcatheter Mitral Valve Replacement

Background

Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.

Contemporary Transcatheter Mitral Valve Replacement for Mitral Annular Calcification or Ring

ObjectivesThe aim of this study was to evaluate outcomes of commercial transcatheter mitral valve replacement (TMVR) for annular rings and calcification using contemporary techniques.BackgroundTMVR is evolving in the absence of other viable treatment options for severe mitral annular calcification and failing ring repairs. The concomitant use of laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction and pre-emptive alcohol septal ablation is not well studied in clinical practice.MethodsA single-center study was conducted of valve–in–mitral annular calcification (ViMAC) and valve-in-ring (ViRing) TMVR from September 2015 to April 2020. In-hospital and 30-day outcomes were assessed.ResultsForty patients underwent TMVR (28 ViMAC and 12 ViRing). Sixteen ViMAC (57%) and 5 ViRing (42%) patients underwent attempted laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction. Three patients underwent pre-emptive alcohol septal ablation. The median index hospitalization was 7 days. Six patients died within 30 days of the procedure, 6 (21%) in the ViMAC group and none in the ViRing group. Five patients (13%) had left ventricular outflow tract obstruction: 4 (14%) in the ViMAC cohort and 1 (8%) in the ViRing cohort. Five patients (13%) had either intraprocedural valve embolization or late migration (4 ViMAC and 1 ViRing). Technical success defined according to Mitral Valve Academic Research Consortium criteria was present in 25 patients (63%): 9 (75%) in the ViRing cohort and 16 (57%) in the ViMAC cohort. At 30 days, the mitral valve gradient was significantly reduced (5.5 ± 2.1 vs. 10.6 ± 4.8; p < 0.01). Three patients (8%) had at least moderate residual mitral regurgitation.ConclusionsTranscatheter ViMAC and ViRing can be successfully performed but frequently require the use of contemporary adjunctive techniques.     

Impact of the Leaflet-to-Annulus Index on Residual Mitral Regurgitation in Patients Undergoing Edge-to-Edge Mitral Repair

ObjectivesThis study sought to investigate the clinical impact of leaflet-to-annulus mismatch on residual mitral regurgitation (MR) after percutaneous edge-to-edge mitral repair.BackgroundAnnular dilation is a common feature of secondary MR, which requires concomitant annuloplasty in surgical mitral valve repair.MethodsConsecutive MR patients undergoing MitraClip (Abbott Vascular, Santa Clara, California) implantation in the Heart Center Bonn were enrolled. Residual MR was defined as a post-procedural MR ≥2+ and patients were stratified into 2 groups according to the residual MR. The study calculated the leaflet-to-annulus index (LAI) using pre-procedural 2- and 3-dimensional transesophageal echocardiography. All-cause death within a 1-year follow-up was examined.ResultsOf 420 consecutive patients, 117 (27.9%) patients had residual MR (≥2+). Patients with residual MR had a significantly lower pre-procedural LAI than did those with MR <2+ (median 1.14 [interquartile range (IQR): 1.07 to 1.20] vs. 1.18 [IQR: 1.12 to 1.29]; p < 0.001). A multivariable analysis revealed that the LAI value was significantly associated with residual MR (odds ratio: 0.95; p < 0.001). After 1-year follow-up, patients with residual MR had a significantly worse prognosis than did patients with MR <2+ (estimated mortality rate 17.4% vs. 7.3%; log-rank p = 0.002), and the presence of residual MR was independently correlated with 1-year mortality (hazard ratio: 2.74; p = 0.004).ConclusionsThe LAI value is associated with residual MR after MitraClip implantation, which is independently correlated with 1-year mortality. This index might be a useful tool to identify patients with the need for concomitant annuloplasty before edge-to-edge repair.     

Cerebral Embolic Risk During Transcatheter Mitral Valve Interventions: An Unaddressed and Unmet Clinical Need?

As new transcatheter mitral valve (MV) interventions continuously evolve, potential procedure-related adverse events demand careful investigation. The risk of cerebral embolic damage is ubiquitous in any left-sided structural heart intervention (and potentially linked to long-term neurocognitive sequelae); therefore, efforts to evaluate these aspects in the field of catheter-based MV procedures are justified. Given the peculiarities of MV anatomy, MV disease, and MV procedures, the lessons learned from other transcatheter heart interventions (i.e., transcatheter aortic valve replacement) cannot be directly translated to MV applications. Through a systematic assessment of available evidence, the authors present and discuss procedure- and patient-related factors potentially associated with cerebral embolic risk during catheter-based MV interventions. Given the paucity of available data in this field, future large, dedicated studies are needed to understand whether cerebral embolic injury represents a real clinical issue during MV procedures.     

Predictors of adverse outcomes after transcatheter mitral valve replacement

Introduction: Transcatheter mitral valve replacement (TMVR) is still a recent technology with numerous unknowns but also great promises. The risk of complications reported in observational studies have limited its adoption by interventional cardiology and surgical communities.

Areas covered: Some of the major setbacks of TMVR are complications related to the devices and those related to the pathway. Device-related complications include left ventricle outflow tract (LVOT) obstruction, transcatheter heart valve (THV) dislocation or embolization, thrombosis, and stroke. The transapical approach currently remains the main pathway for TMVR but is associated with high risk of major bleeding and residual apical myocardial scarring. Complication prediction and prevention seem possible. Device-related complication prediction is based on pre-operative imaging including multi-slice computed tomography with 3-dimensional reconstructions and echocardiography which allow LVOT obstruction prediction and appropriate sizing aiming at avoiding dislocation. Industry should aim at the development of transfemoral delivery systems. Nevertheless, several recent feasibility observational studies suggested acceptable safety and efficacy of transcatheter mitral valve replacement.

Expert opinion: TMVR complications and transapical delivery are some of the main setbacks which need to be addressed for TMVR to be adopted for broad clinical use.     

Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients

Background

Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.

Causes and Clinical Outcomes of Patients Who Are Ineligible for Transcatheter Mitral Valve Replacement

Objectives

The aim of this study was to gain insight into the causes and outcomes of patients who do not qualify for transcatheter mitral valve replacement (TMVR).