TCT CONNECT-150 Real World Outcomes With Small (20-mm) Balloon Expandable Sapien 3 Valves Compared to Larger Valves (23-, 26-, and 29-mm)
Eng M, Abbas A, Hahn R, Wang DD, Eleid M, and O'Neill W. TCT CONNECT-150 Real World Outcomes With Small (20-mm) Balloon Expandable Sapien 3 Valves Compared to Larger Valves (23-, 26-, and 29-mm). Journal of the American College of Cardiology 2020; 76(17):B64.
Journal of the American College of Cardiology
Background: Small bioprosthetic valves have been associated with higher gradients and subsequently, patient prosthesis mismatch (PPM). We sought to compare the outcomes of patients undergoing implantation of Edwards SAPIEN 3 or SAPIEN 3 Ultra (ES3/U) 20-mm valves against those receiving >20-mm ES3/U valve prostheses (23-, 26-, and 29-mm) out to 1 year.
Methods: All patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with ES3 or ES3U in stenotic native valves between June 2015 and Jan 2020 were included in the analysis. Baseline characteristics and outcomes for patients receiving 20-mm valves (n = 3,932) were compared to those receiving >20-mm S3/U valves (n = 128,798) after propensity matching. The 30-day and 1-year outcomes were based on Kaplan-Meier estimates and all comparisons were made using the log-rank test. Multivariable analysis determined independent predictors and association of post-TAVR hemodynamic parameters with 1-year all-cause mortality post-TAVR. All patients in the study cohorts were linked to the CMS claims database.
Results: Patients receiving 20-mm valves were mainly female (96.4%) and had less vascular disease but more multivalvular disease compared to the patients receiving > 20-mm valves. Overall 30-day Society of Thoracic Surgeon score risk was higher in 20-mm patients (7.1% vs. 5.8%). Small valves in the propensity-matching analysis showed significantly higher discharge gradients (15.7 ± 7.09 mm Hg vs. 11.7 ± 5.54 mm Hg, p < 0.0001) and echo-derived severe PPM rates (21.5% vs. 9.7%, p < 0.0001). However, this difference did not impact 1-year all-cause mortality (20-mm: 13.0% vs. >20-mm: 12.7%, p = 0.72) or any of the other major adverse event rates and outcomes (i.e., cardiac death, stroke, major vascular complication, life-threatening bleeding, re-hospitalization, and quality of life) between the 2 cohorts. Based on a multivariable analysis post-TAVR, elevated echo gradient was associated with reduced mortality whereas the presence of severe-PPM was not associated with 1-year all-cause mortality. The presence of moderate/severe paravalvular leak at discharge was an independent predictor of 1-year mortality (hazard ratio: 1.82; 95% confidence interval: 1.41 to 2.34; p < 0.001).
Conclusion: Small balloon expandable (20-mm) valves were associated with higher gradients and severe PPM rates compared to larger (>20-mm) valves, but these factors were not associated with significant differences in 1-year all-cause mortality or rehospitalization.