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Outcomes After Transseptal MViV Replacement
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- This observational study reports that transseptal MViV with SAPIEN 3/SAPIEN 3 Ultra was associated with excellent procedural outcomes, low complication rates, significant improvement in valve performance with no or mild MR in 99.2%, and an acceptable mortality rate in a high-risk population.
- Transseptal MViV has the potential to become the preferred therapy for the majority of patients with failing bioprostheses, but careful evaluation by a heart team and lifetime management is crucial.
- In younger low-surgical-risk patients who may be candidates for redo surgery, further data are required to compare long-term outcomes between the two strategies because durability data beyond 5 years are lacking for MViV.
Study Questions:
What are the contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra transcatheter mitral valve-in-valve (MViV) replacement?
Methods:
The investigators used the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. The primary efficacy outcome was 1-year all-cause mortality. Secondary endpoints included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. Multivariable analyses were performed to identify independent predictors of 30-day and 1-year mortality.
Results:
A total of 4,243 patients with a mean ± SD STS score of 9.2 ± 7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association (NYHA) class (NYHA class I/II, 18-87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38-78) were noted at 1 year (p < 0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS <4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4-8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital (p = 0.0005), 30-day (p = 0.004), and 1-year mortality rates (p = 0.01).
Conclusions:
The authors report excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era.
Perspective:
This observational study reports that transseptal MViV with SAPIEN 3/SAPIEN 3 Ultra was associated with excellent procedural outcomes, low complication rates, significant improvement in valve performance with no or mild mitral regurgitation (MR) in 99.2%, and an acceptable mortality rate in a high-risk population. Furthermore, the mortality rate was largely influenced by the patients’ risk factors and the presence of other medical conditions, as demonstrated by the fact that the low-risk group had a very low mortality. Transseptal MViV has the potential to become the preferred therapy for the majority of patients with failing bioprostheses, but careful evaluation by a heart team and lifetime management are crucial. Especially, in younger low-surgical-risk patients who may be candidates for redo surgery, further data are required to compare long-term outcomes between the two strategies because durability data beyond 5 years are lacking for MViV.
Clinical Topics: Valvular Heart Disease, Mitral Regurgitation, Invasive Cardiovascular Angiography and Intervention
Keywords: Heart Valve Diseases, Mitral Valve Insufficiency, STS/ACC TVT Registry
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