Unlabelled: (350/350) BACKGROUND: Standardized implant protocols have shown promise in improving outcomes in transcatheter aortic valve replacement (TAVR). However, the impact of implant depth on clinical outcomes remains unclear. Objectives: To evaluate clinical and hemodynamic outcomes across varying TAVR implantation depths using data from the Optimize PRO study. Methods: This prospective, multicenter Optimize PRO study included patients with symptomatic severe aortic stenosis undergoing TAVR with Evolut PRO/PRO+ systems. Patients were stratified by core laboratory-adjudicated non-coronary cusp implant depth. The echocardiographic outcome composite included none/trace paravalvular regurgitation, aortic mean gradient ≤10mmHg and no prosthesis-patient-mismatch at discharge. Results: Patients (N=603) were stratified by implant depth: <1mm (N=88), 1 to ≤3mm (N=196), >3 to ≤5mm (N=170), and >5mm (N=149). Baseline characteristics were similar across implant depth groups, except for a higher proportion of females in higher implant depths. Higher implant depths were associated with less resheathing and recapture (27.3% [24/88], 33.7% [66/196], 48.8% [83/170], 51.7% [77/149]; P<.001), and shorter median [Q1, Q3] hospital stay (days: 1[1,1], 1[1,2], 2 [1,3], 2 [1,4]; P<.001). Rates of valve migration (0% [95% CI:NA], 0.5% [95% CI:0.1-3.6], 0.6% [95% CI:0.1-4.1], 1.3% [95% CI:0.3-5.3]; P=.63) were low across implant depth groups. The 1-year all-cause mortality or all-stroke rate was comparable across implant depth groups (8.1% [95% CI:3.9-16.2], 7.2% [95% CI:4.3-11.8], 10.7% [95% CI:6.9-16.5], 12.5% [95% CI:8.1-19.2]; P=.40). After 1 year, higher implant depths were associated with lower rates of permanent pacemaker implantation (PPI, 2.3% [95% CI:0.6-8.8], 9.2% [95% CI:5.9-14.3], 15.9% [95% CI:11.2-22.4], 20.3% [95% CI:14.6-27.7]; P<.001). Rates of New York Heart Association functional class I were numerically different across implant depth groups but did not reach statistical significance (NYHA, 77.8% [56/72], 71.8% [130/181], 65.2% [101/155], 67.7% [84/124], P=.09 across all classes). In males, echo outcome composite rates were not statistically different across depth groups (58.6%[17/29], 50.6% [39/77], 43.8% [35/80], 36.1% [26/72]; P=.14), although the exploratory trend test reached statistical significance (P=.02). Conclusions: Higher TAVR device implantation was associated with improved clinical outcomes with similar safety events, including valve migration, across depths. The long-term effect of this approach including the ability to perform redo-TAVR safely, will be further studied in the future.
Dvir, D., Jilaihawi, H. A., Fraser, D., Rodes-Cabau, J., Nazif, T., Mittal, S., Grubb, K. J., Gada, H., Teiger, E., Lin, L., Rovin, J. D., Khalil, R. F., Sultan, I., Yudi, M. B., Gardner, B., Lorenz, D., Chetcuti, S., Patel, N. C., Harvey, J., Mahoney, P., Talreja, D., Trani, C., Mylotte, D., Schwartz, B., Jafar, Z., Van Der Heyden, J., Maffeo, D., Yong, G., Valle-Fernández, R. D., Wang, J., Gooley, R., Yeh, Y. J., Yakubov, S. J., First Large Comprehensive Core-Laboratory Evaluation of Implantation Depth and Clinical Outcomes in TAVR: Final Global Results from the Optimize PRO Prospective Study, <<JACC: CARDIOVASCULAR INTERVENTIONS>>, 2026; (May 21): N/A-N/A. [doi:10.1016/j.jcin.2026.05.007] [https://hdl.handle.net/10807/340222]
First Large Comprehensive Core-Laboratory Evaluation of Implantation Depth and Clinical Outcomes in TAVR: Final Global Results from the Optimize PRO Prospective Study
Trani, Carlo;
2026
Abstract
Unlabelled: (350/350) BACKGROUND: Standardized implant protocols have shown promise in improving outcomes in transcatheter aortic valve replacement (TAVR). However, the impact of implant depth on clinical outcomes remains unclear. Objectives: To evaluate clinical and hemodynamic outcomes across varying TAVR implantation depths using data from the Optimize PRO study. Methods: This prospective, multicenter Optimize PRO study included patients with symptomatic severe aortic stenosis undergoing TAVR with Evolut PRO/PRO+ systems. Patients were stratified by core laboratory-adjudicated non-coronary cusp implant depth. The echocardiographic outcome composite included none/trace paravalvular regurgitation, aortic mean gradient ≤10mmHg and no prosthesis-patient-mismatch at discharge. Results: Patients (N=603) were stratified by implant depth: <1mm (N=88), 1 to ≤3mm (N=196), >3 to ≤5mm (N=170), and >5mm (N=149). Baseline characteristics were similar across implant depth groups, except for a higher proportion of females in higher implant depths. Higher implant depths were associated with less resheathing and recapture (27.3% [24/88], 33.7% [66/196], 48.8% [83/170], 51.7% [77/149]; P<.001), and shorter median [Q1, Q3] hospital stay (days: 1[1,1], 1[1,2], 2 [1,3], 2 [1,4]; P<.001). Rates of valve migration (0% [95% CI:NA], 0.5% [95% CI:0.1-3.6], 0.6% [95% CI:0.1-4.1], 1.3% [95% CI:0.3-5.3]; P=.63) were low across implant depth groups. The 1-year all-cause mortality or all-stroke rate was comparable across implant depth groups (8.1% [95% CI:3.9-16.2], 7.2% [95% CI:4.3-11.8], 10.7% [95% CI:6.9-16.5], 12.5% [95% CI:8.1-19.2]; P=.40). After 1 year, higher implant depths were associated with lower rates of permanent pacemaker implantation (PPI, 2.3% [95% CI:0.6-8.8], 9.2% [95% CI:5.9-14.3], 15.9% [95% CI:11.2-22.4], 20.3% [95% CI:14.6-27.7]; P<.001). Rates of New York Heart Association functional class I were numerically different across implant depth groups but did not reach statistical significance (NYHA, 77.8% [56/72], 71.8% [130/181], 65.2% [101/155], 67.7% [84/124], P=.09 across all classes). In males, echo outcome composite rates were not statistically different across depth groups (58.6%[17/29], 50.6% [39/77], 43.8% [35/80], 36.1% [26/72]; P=.14), although the exploratory trend test reached statistical significance (P=.02). Conclusions: Higher TAVR device implantation was associated with improved clinical outcomes with similar safety events, including valve migration, across depths. The long-term effect of this approach including the ability to perform redo-TAVR safely, will be further studied in the future.
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