Device profile of the AltaValve system for transcatheter mitral valve replacement: overview of its safety and efficacy

ABSTRACT

Introduction

In patients with severe mitral regurgitation (MR), transcatheter mitral valve replacement (TMVR) has recently emerged as an alternative to surgery. However, compared with transcatheter aortic valve replacement, TMVR faces several technical challenges and a high screening failure rate, mainly due to a more complex mitral annulus geometry and the potential interaction with the sub-valvular apparatus and the left ventricular outflow tract (LVOT). The AltaValve system is a device intended for TMVR with unique design features that may overcome most anatomical limitations for this therapy.

Areas covered

A summary of the current evidence regarding TMVR is presented, followed by a review of the main technical challenges. The main features, differential characteristics, and potential advantages of the AltaValve system are discussed. Finally, we describe the first-in-human procedures with AltaValve and the main details of the upcoming feasibility trial.

Expert opinion

A high number of high-risk surgical patients with MR remain undertreated. TMVR is continuously evolving, and AltaValve constitutes another step forward in this field. Its unique design avoiding annular and LVOT engagement represents a clear potential benefit, along with its recently incorporated trans-septal approach system. However, more evidence is warranted regarding its feasibility in different clinical settings and mid-term performance.

KEYWORDS:

• Mitral regurgitation
• transcatheter mitral valve replacement
• altavalve

Article highlights

• Surgical mitral valve replacement is denied to a large number of patients due to comorbidities.

• TMVR has several challenges: LVOT obstruction, fully percutaneous access, and interaction with the complex mitral annular anatomy.

• The AltaValve system may overcome some of TMVR drawbacks: avoids LVOT potential obstruction and preserves native mitral anatomy with its supra-annular position.

• The first in-human case was successful, and clinical status as well as 12-month prosthesis performance of the first patient was optimal.

• The trans-femoral/trans-septal AltaValve system has been developed and it is currently being evaluated in humans.

Declaration of interest

J Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific, and holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. A Alperi was supported by a grant from the Fundacion Alfonso Martin Escudero (Madrid, Spain). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.