The balloon-expandable Myval transcatheter heart valve (THV) can be used to safely perform a transcatheter valve-in-valve (ViV) or valve-in-ring (ViR) implantation for failed left side heart bioprosthesis with a high success rate and low early and mid-term morbidity and mortality, according to study findings published in the International Journal of Cardiology.
Investigators sought to assess early- and mid-term clinical outcomes among patients with left side heart bioprosthetic deterioration treated with transcatheter ViV/ViR implantation using the Myval THV. The primary outcome was postprocedural technical success. Secondary outcomes included death, final mean transprosthetic aortic valve gradient of more than 20 mm Hg, mean transprosthetic mitral valve gradient of more than 10 mm Hg, and need for a second THV.
This was a multicenter observational study conducted from April 2019 to January 2022. The investigators included 97 consecutive patients with severe symptomatic aortic BHVs (n=33; aged 71.6±14.9 years; 30.3% women) and mitral BHVs (n=64; aged 67.3±14.5 years; 60.9% women) or annuloplasty ring failure receiving transcatheter aortic ViV and mitral ViV or ViR implantation with balloon-expandable (BE) Myval implantation. The European consensus statement was used to define BHV/ring failure. Potential candidates for transcatheter ViV or ViR implantation were symptomatic patients considered too high-risk for surgical valve replacement.
Patients receiving mitral ViV vs patients receiving aortic ViV had more history of atrial fibrillation (64.1% vs 24.2%), coronary artery disease (35.9% vs 24.2%), and chronic obstructive pulmonary disease (20.3% vs 12.1%). Patients receiving aortic ViV vs patients receiving mitral ViV had more history of stroke (21.2% vs 14.1%), carotid artery disease (33.3% vs 17.2%), and hypertension (75.8% vs 65.6%). Treatment groups were similar for New York Heart Association (NYHA) class III, peripheral vascular disease, and dyslipidemia. Overall, 84.4% of mitral group patients and 72.7% of aortic group patients had stents.
The percutaneous transfemoral arterial route was used for all aortic ViV procedures. Mitral ViV/ViR procedures were performed either through transapical, or transfemoral vein access, and interatrial septal predilatation in 95.3% of patients.
There were 95 patients who achieved technical success. Acute structural transcatheter mitral ViV/ViR dysfunction requiring a second THV implantation occurred in 2 patients. There were no procedural deaths.
Early-term (30 days following mitral and aortic ViV/ViR implantation) there was an increase in valve areas and a significant reduction in prosthetic transvalvular pressure gradients. Overall, there were 5 hospitalizations (2 among aortic patients).
There was 92% survival at 15 (IQR, 8-21) months. Patients receiving aortic ViV implantation experienced 97% survival compared with 89% survival in patients receiving mitral ViV/ViR (hazard ratio, 2.7; 95% CI, 0.33-22.7; P =.34). There were 3 patients in the mitral group who required hospitalization.
Patients with aortic and mitral ViV/ViR implantation had significant improvement in NYHA functional class I (n=2 at baseline) and II (n=20 at baseline) at the longest available follow-up (93.8% and 92.1%, respectively). The mortality rate at the longest available follow-up time was 11%.
Study limitations include the observational design, underpowered sample size, and the limited follow-up duration.
“…transcatheter ViV (or ViR) implantation for failed left side heart surgical bioprosthesis (or ring) can be safely performed with the use of the new BE Myval THV with a high success rate and minimal early mortality and morbidity,” the study authors wrote. “Particularly, a 100% success rate was observed in aortic ViV procedures, which may reflect the substantial procedural refinements that have been achieved in the past years in transcatheter aortic valve replacement (TAVR) interventions.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Moscarella E, Ielasi A, Mussayev A, et al. Transcatheter valve-in-valve or valve-in-ring implantation with a novel balloon-expandable device in patients with bioprosthetic left side heart valves failure: 1-year follow-up from a multicenter experience. Int J Cardiol. Published online January 16, 2023. doi:10.1016/j.ijcard.2023.01.017