Heart failure (HF) symptoms and quality of life can be improved by use of the Sapien 3 aortic balloon-expandable transcatheter heart valve (THV) in patients undergoing transcatheter mitral valve-in-valve (MViV), valve-in-ring (MViR) and valve-in-mitral annular calcifications (ViMAC), particularly MViV, a new investigation shows.
Mayra Guerrero, MD, of the Mayo Clinic, Rochester, Minnesota, presented these results during a late-breaking trial session Wednesday at EuroPCR 2023 in Paris.
Transcatheter mitral valve replacement (TMVR) is an alternative procedure for patients with bioprostheses that are failing, surgical repairs with prosthetic rings and MAC. Few trials have evaluated and compared the outcomes of MViV, MViR and ViMAC procedures. The Mitral Implantation of TRAnscatheter vaLves (MITRAL) trial is the first to evaluate these three procedures and compare 5-year patient outcomes.
This multicenter, prospective study occurred at 13 sites throughout the U.S. The trial enrolled 91 patients classified as extremely high surgical risk who underwent MViV (n=30, at least moderate to severe mitral regurgitation [MR], 100% transseptal, mean age=76.4 years, 63.3% female), MViR (n=30, at least moderate to severe MR, 100% transseptal, mean age=71.7 years, 36.7% female) or ViMAC (n=31; severe MR; 48.4% transseptal, 48.4% transatrial, 3.2% transapical; mean age=74.9 years, 71% female). All patients had severe mitral stenosis, defined as mitral valve area ≤1.5 cm2.
Patients had follow-up visits at 30 days and 1 year post-TMVR and every year after that through 5 years. Echocardiograms, New York Heart Association (NYHA) class and Kansas City Cardiomyopathy Questionnaire (KCCQ) score were obtained and evaluated at each visit. Among the three groups, patients in the MViV group had the lowest rates of all-cause death (21.4% versus 65.5% MViR, 67.9% ViMAC; p<0.001).
The MViV and ViMAC groups also saw sustained reductions in MR, as 84% of MViV patients and 83% of ViMAC patients had none/trace MR at 5 years, while the MViR group did not see this sustained improvement in MR (33% with none/trace MR at 5 years).
Patients in the MViV group also had fewer mitral valve reinterventions (3.6% versus 10.3% MViR, 17.9% ViMAC). All three patient groups experienced sustained NYHA and KCCQ score improvements, as well as THV performance, at 5 years.
Overall, MViV, MViR and ViMAC are sufficient alternatives for patients who are at high risk for surgery and require a different form of management. Patients who underwent MViV did experience higher rates of survival compared with the other two groups, Guerrero concluded.
The MITRAL Trial was partially funded by an unrestricted research grant from Edwards Lifesciences, manufacturer of the Sapien 3 THV.