First Large Comprehensive Core-Laboratory Evaluation of Implantation Depth and Clinical Outcomes in TAVR: Final Global Results from the Optimize PRO Prospective Study.

Authors

Danny Dvir, Hasan A Jilaihawi, Douglas Fraser, Josep Rodes-Cabau, Tamim Nazif, Suneet Mittal, Kendra J Grubb, Hemal Gada, Emmanuel Teiger, Lang Lin, Joshua D Rovin, Ramzi F Khalil, Ibrahim Sultan, Matias B Yudi, Blake Gardner, David Lorenz, Stanley Chetcuti, Nainesh C Patel, James Harvey, Paul Mahoney, Deepak Talreja, Carlo Trani, Darren Mylotte, Brian Schwartz, Zubair Jafar, Jan Van der Heyden, Diego Maffeo, Gerald Yong, Raquel Del Valle-Fernández, John Wang, Robert Gooley, Yu Jung Yeh, Steven J Yakubov

Published in

JACC. Cardiovascular interventions. May 21, 2026. Epub May 21, 2026.

Abstract

(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.
To evaluate clinical and hemodynamic outcomes across varying TAVR implantation depths using data from the Optimize PRO study.
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.
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).
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.

PMID:
42223923
Bibliographic data and abstract were imported from PubMed on 01 Jun 2026.

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