Author + information
- Received October 29, 2018
- Revision received October 31, 2018
- Accepted October 31, 2018
- Published online January 21, 2019.
- Alfredo Nunes Ferreira-Neto, MD,
- Francois Dagenais, MD,
- Mathieu Bernier, MD,
- Eric Dumont, MD,
- Afonso B. Freitas-Ferraz, MD and
- Josep Rodés-Cabau, MD∗ ()
- ↵∗Address for correspondence:
Dr. Josep Rodés-Cabau, Quebec Heart and Lung Institute, Laval University, 2725 chemin Ste-Foy, Quebec City QC G1V 4G5, Canada.
Transcatheter mitral valve replacement (TMVR) systems may interact with the subvalvular apparatus, associate with an increased risk for left ventricular outflow tract obstruction, and are limited by mitral annular dimension and calcification (1). The AltaValve (4C Medical Technologies, Minneapolis, Minnesota) is a new TMVR system implanted in a supra-annular position, which may overcome some of the most important limitations of current TMVR systems. The AltaValve consists of a self-expanding nitinol frame of spherical shape (50 to 90 mm) that contains a 27-mm trileaflet bovine pericardium valve (Figure 1A). A fabric skirt is added to the bottom of the frame (annular ring) to prevent paravalvular leaks. The current system is implanted through a transapical approach (a transseptal system will be available in 2019) using a 32-F delivery system and is repositionable and partially retrievable (can be retrieved any time up to ∼80% expansion of the stent frame). We report the first-in-human experience with this innovative TMVR system.
A 77-year-old man with a history of prior coronary artery bypass grafting and surgical aortic valve replacement, chronic atrial fibrillation, and reduced left ventricular ejection fraction (30%) presented with severe symptomatic (New York Heart Association functional class III) mitral regurgitation despite optimal medical therapy. The patient was considered at very high surgical risk, and TMVR with the AltaValve system was proposed. On the basis of computed tomographic measurements, an AltaValve system with a 70-mm frame and a 46-mm annular ring was selected. After puncturing the left ventricular apex, the delivery system was inserted up to the roof of the left atrium and then precisely centered using transesophageal echocardiographic guidance. The progressive retrieval of the delivery system led to the expansion of the valve frame. Transesophageal echocardiography showed the correct positioning of the valve, with no residual mitral regurgitation, and no left ventricular outflow tract obstruction (Figure 1B). Cardiac computed tomography at 6 days post-procedure confirmed correct positioning of the valve and good apposition of the stent frame to the left atrial wall (Figure 1A), and transthoracic echocardiography confirmed prior transesophageal echocardiographic findings. The patient was discharged 9 days post-procedure (on warfarin and aspirin therapy), and there were no adverse events at 30-day follow-up.
The present report shows the feasibility of TMVR with a new and unique supra-annular system, with good early clinical and valve hemodynamic outcomes. The confirmation of these findings in a larger cohort of patients would represent a major step forward in the TMVR field, with a device easy to implant and with few anatomic exclusion criteria, which would allow the treatment of a larger proportion of patients with mitral regurgitation (likely including those with mitral annular calcification). Further studies are warranted.
Dr. Rodés-Cabau holds the Canadian Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 29, 2018.
- Revision received October 31, 2018.
- Accepted October 31, 2018.
- 2019 American College of Cardiology Foundation