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20 mm vs. ≥23 mm Balloon-Expandable TAVR Outcomes
Quick Takes
- In a post hoc analysis of STS/ACC TVT Registry data, 3-year all-cause mortality was similar for patients who underwent TAVR with a 20 mm compared to a ≥23 mm balloon-expandable valve.
- Severe measured prosthesis-patient mismatch and low (<10 mm Hg) discharge echo/Doppler mean gradient (MG) were associated with increased mortality.
- On multivariable analysis, factors associated with increased 3-year all-cause mortality were moderate/severe paravalvular leak at discharge, mild paravalvular leak, low (<10 mm Hg) discharge MG, high (>30 mm Hg) discharge MG, and new permanent pacemaker insertion.
Study Questions:
Among patients undergoing transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve (BEV), what are the 3-year clinical outcomes associated with a small (20 mm) compared to a larger (≥23 mm) device; and is there a relationship between the discharge echocardiographic (echo) mean gradient (MG) and measured or predicted thresholds for prosthesis-patient mismatch (PPM) with clinical outcomes?
Methods:
Data from the STS/ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) with Centers for Medicare & Medicaid Services linkage were used to perform 1:1 propensity-matched analyses of patients who underwent TAVR with a 20 mm versus a ≥23 mm BEV (Sapien 3, Sapien 3 Ultra, or Sapien 3 Ultra Resilia) between June 2015 and March 2023. Measured PPM was calculated using the discharge echo/Doppler effective orifice area (EOA); predicted PPM was derived using a previously published report (Hahn RT, et al., JACC Cardiovasc Imaging 2019;12:25-34). Spline curves and Kaplan-Meier plots with adjusted hazard ratios were used to determine the relationship between MG and 3-year all-cause mortality.
Results:
A total of 316,091 patients underwent BEV-TAVR during the study interval, including 8,102 with a 20 mm BEV; after propensity matching, 8,100 pairs were compared. A 20 mm BEV was associated with higher MG compared to ≥23 mm BEV (16.2 ± 7.2 mm Hg vs. 11.8 ± 5.7 mm Hg, p < 0.0001), more prevalent MG ≥20 mm Hg (26.4% vs. 6.9%, p < 0.0001), and smaller EOA (1.4 ± 0.4 vs. 1.7 ± 0.5 cm2, p < 0.0001) and EOA index (0.8 ± 0.3 vs. 1.0 ± 0.2 cm2/m2, p < 0.0001).
At 3 years, there was no difference in mortality between patients who underwent 20 vs. ≥23 mm BEV (31.5% vs. 32.5%; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.05; p = 0.46). Compared to discharge echo/Doppler MG 10-30 mm Hg, a low MG (<10 mm Hg) was associated with increased 3-year mortality (HR, 1.25; 95% CI, 1.22-1.27; p < 0.01); a high MG (>30 mm Hg) also was associated with an (quantitatively unreported) increased risk of mortality. Three-year all-cause mortality was higher in association with measured severe PPM (33.5% vs. 32.9% [measured moderate PPM] vs. 32.1% [measured no PPM], p < 0.0001) and predicted no PPM (33.5% vs. 30.3% [predicted moderate PPM] vs. 31.1% [predicted severe PPM], p < 0.0001). Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF).
On multivariable analysis, factors associated with increased 3-year all-cause mortality were moderate/severe paravalvular leak at discharge (HR, 1.5; 95% CI, 1.35-1.67), mild paravalvular leak (HR, 1.11; 95% CI, 1.08-1.14), low discharge MG (HR, 1.25; 95% CI, 1.22-1.27), high discharge MG (HR, 1.16; 95% CI, 1.00-1.35), and new permanent pacemaker insertion (HR, 1.2; 95% CI, 1.16-1.24).
Conclusions:
Patients with a 20 mm BEV had similar 3-year survival compared to patients with a larger (≥23 mm) BEV. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with increased mortality and lower LVEF; which the authors conclude suggests that LVEF is the culprit for worse outcomes.
Perspective:
In this post hoc analysis of data in the STS/ACC TVT Registry, 3-year all-cause mortality was similar for patients who underwent TAVR with a 20 mm compared to a ≥23 mm BEV. Both low MG and high MG were associated with increased mortality; the nonlinear association between MG and mortality likely is attributable to the coexistence of low MG and low LVEF. The study demonstrates a correlation between measured severe PPM and high mortality. ‘Predicted PPM’ (in which published point estimates of EOA are used to try to predict PPM in different patients) is known to be unreliable; this is even more so in this study, in which the source publication only included some of the same BEVs. In the setting of coexistent severe PPM and low LVEF, the authors appear to focus on LVEF; however, with both variables associated with excess mortality, the present study does not allow the reliable differentiation of cause and effect on mortality. As has been demonstrated after surgical aortic valve replacement, the coexistence of severe (measured) PPM and LV systolic dysfunction might be a potent predictor of excess mortality after TAVR.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Heart Valve Diseases, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement
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