First Large Comprehensive Core-Laboratory Evaluation of Implantation Depth and Clinical Outcomes in TAVR: Final Global Results from the Optimize PRO Prospective Study.
Document Type
Article
Publication Title
JACC. Cardiovascular interventions
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.
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.
DOI
10.1016/j.jcin.2026.05.007
Publication Date
5-21-2026
Recommended Citation
Dvir D, Jilaihawi HA, Fraser D, Rodes-Cabau J, Nazif T, Mittal S, Grubb KJ, Gada H, Teiger E, Lin L, Rovin JD, Khalil RF, Sultan I, Yudi MB, Gardner B, Lorenz D, Chetcuti S, Patel NC, Harvey J, Mahoney P, Talreja D, Trani C, Mylotte D, Schwartz B, Jafar Z, Van der Heyden J, Maffeo D, Yong G, Valle-Fernández RD, Wang J, Gooley R, Yeh YJ, Yakubov SJ. First Large Comprehensive Core-Laboratory Evaluation of Implantation Depth and Clinical Outcomes in TAVR: Final Global Results from the Optimize PRO Prospective Study. JACC Cardiovasc Interv. 2026 May 21:S1936-8798(26)01448-2. doi: 10.1016/j.jcin.2026.05.007. Epub ahead of print. PMID: 42223923.