An analysis from the Valve-in-Valve International Data (VIVID) Registry demonstrates that significant residual mitral regurgitation (MR) and residual mitral stenosis (MS) are common after mitral valve-in-valve (ViV) and valve-in-ring (ViR) procedures and are associated with poorer outcomes at 4 years.
These late-breaking trial results were presented Thursday at the PCR e-Course.
In patients who are deemed too high risk for surgical reoperation for a failing surgical mitral valve repair or replacement, mitral ViV and ViR are percutaneous options. However, there are limited data on the clinical significance of valve hemodynamics after the procedure.
Matheus Simonato, MD, of Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, and fellow investigators sought to examine midterm outcomes after mitral ViV and ViR.
A total of 1,079 patients (857 ViV, 222 ViR; mean age 73.5 years ± 12.5; 40.8% male) from 90 centers between March 2006 and March 2020 were included in the analysis from the VIVID Registry. These patients’ median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 8.6%; median clinical follow-up was 492 days; and the median echocardiographic follow-up for patients who survived 1 year was 772.5 days.
There was no difference in 30-day mortality between ViV (8.6%) vs. ViR (6.5%) (p=0.29). At 4 years, Kaplan-Meier estimate of survival rate was 62.5% in ViV vs. 49.5% for ViR (p<0.001). Mean gradient across the mitral valve (83% SAPIEN 3/SAPIEN XT [Edwards Lifesciences, Irvine, CA]) post-procedure was 5.7 ± 2.8 mmHg (≥5 mmHg, 61.4% of patients).
Significant residual MS (≥10 mmHg) occurred in 8.2% of the ViV and 12.0% of the ViR patients (p=0.09). Significant residual MR (≥ moderate) was more common in ViR patients (16.6% vs. 3.1%; p<0.001) and was associated with lower survival at 4 years (35.1% vs. 61.6%; p=0.02).
The rates of Mitral Valve Academic Research Consortium (MVARC)-defined device success were low for both procedures (43.9% total; 32.0% ViR vs. 47.0% ViV; p<0.001), mostly related to having postprocedural mean gradient ≥5mmHg. Left ventricular outflow tract obstruction was seen in 5.9% of ViR and 1.8% ViV patients (p=0.001).
Correlates for residual MS were smaller true internal diameter, younger age and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subdistribution hazard ratio [SHR], 4.67; 95% confidence interval [CI], 1.74 – 12.56; p=0.002) and significant residual MR (SHR, 7.88; 95% CI, 2.88 – 21.53; p<0.001) were both independently associated with repeat mitral valve replacement.
Despite being a retrospective study, this large registry demonstrates that mitral ViR patients had higher mortality and required more redo MVR at four-year follow-up. Both residual MR and residual MS are relatively common after ViV and ViR. Residual MR was associated with higher mortality and need for repeat MVR. Residual MS was no predictive of patient mortality but was associated with repeat MVR.
The investigators concluded that strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.
PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.