Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses
Abstract
:1. Introduction
2. Methods
2.1. Multidetector Computed Tomography
2.2. Assessment of PPM and PVL
2.3. Outcomes of Interest
2.4. Statistical Analysis
3. Results
3.1. Baseline Data
3.2. Procedural Data and Outcomes
3.3. Hemodynamics
4. Discussion
Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
BEV | balloon-expanding valve |
iAVA | indexed aortic valve area |
IAV | intra-annular valve |
MDCT | multidetector computed tomography |
PVL | paravalvular leakage |
SAV | supra-annular valve |
SEV | self-expanding valve |
TAVR | transcatheter aortic valve replacement |
THV | transcatheter heart valve |
PPM | prosthesis-patient mismatch |
References
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Variable | Navitor | Ultra | p Value |
---|---|---|---|
n = 104 | n = 75 | ||
Age, years | 83.0 [79.0; 87.0] | 80.0 [72.5; 84.5] | 0.001 |
Female gender, % | 91 (87.5%) | 63 (84.0%) | 0.654 |
BMI, kg/m2 | 26.7 [23.6; 29.7] | 26.2 [23.9; 28.8] | 0.780 |
NYHA IV | 3 (2.9%) | 3 (4.0%) | 0.696 |
EuroSCORE II, % | 3.8 [2.1; 5.0] | 2.7 [2.0; 4.3] | 0.072 |
eGFR, ml/min/1.73 m2 | 52.5 [35.0; 65.2] | 62.0 [46.5; 72.0] | 0.006 |
Peripheral artery disease | 22 (21.2%) | 15 (20.0%) | 0.999 |
Prior stroke | 11 (10.6%) | 8 (10.7%) | 1.000 |
Atrial fibrillation | 38 (36.5%) | 24 (32.0%) | 0.638 |
Coronary artery disease | 74 (71.2%) | 49 (65.3%) | 0.506 |
Prior coronary intervention | 32 (30.8%) | 27 (36.0%) | 0.566 |
Echocardiographic data | |||
Left ventricular ejection fraction, % | 61.0 [55.0; 64.2] | 57.0 [55.0; 64.0] | 0.141 |
Mean aortic valve gradient, mmHg | 40.0 [30.0; 49.0] | 43.0 [38.0; 51.8] | 0.030 |
EOA, cm2 | 0.7 [0.6; 0.8] | 0.7 [0.6; 0.9] | 0.980 |
Electrocardiographic data | |||
Right bundle branch block | 3 (2.9%) | 2 (2.7%) | 1.000 |
Left bundle branch block | 2 (1.9%) | 2 (2.7%) | 1.000 |
Atrioventricular block | 13 (12.5%) | 7 (9.6%) | 0.718 |
MDCT data | |||
Annulus Area (mm2) | 392.5 [372.8; 411.3] | 400.0 [373.0; 416.5] | 0.267 |
Annulus diameter, mm | 22.8 [22.1; 23.2] | 22.9 [22.1; 23.3] | 0.392 |
Aortic valve calcification, AU | 1615.0 [974.0; 2319.0] | 2083.0 [1194.5; 2930.0] | 0.010 |
Calcium density (AU/cm2) | 416.8 [272.4; 586.1] | 513.3 [318.3; 742.0] | 0.013 |
Variable | Navitor | Ultra | p Value |
---|---|---|---|
n = 104 | n = 75 | ||
Procedural parameter | |||
Prosthesis size | <0.001 | ||
23 | 8 (7.7%) | 68 (90.7%) | |
25 | 57 (54.8%) | 0 (0.0%) | |
26 | 0 (0.0%) | 7 (9.3%) | |
27 | 39 (37.5%) | 0 (0.0%) | |
Procedural duration, min | 46.5 [40.0; 60.0] | 43.0 [40.0; 55.0] | 0.073 |
Contrast agent, ml | 130.0 [100.8; 155.2] | 100.0 [90.0; 120.0] | <0.001 |
Pre-dilatation, % | 100 (96.2%) | 5 (6.7%) | <0.001 |
Post-dilatation, % | 31 (29.8%) | 8 (10.7%) | 0.004 |
Echocardiographic outcome | |||
Left ventricular ejection fraction, % | 60.0 [55.0; 64.2] | 60.0 [55.0; 65.0] | 0.980 |
Mean aortic valve gradient, mmHg | 8.0 [6.0; 10.0] | 13.0 [10.0; 16.0] | <0.001 |
EOA, cm2 | 1.9 [1.7; 2.2] | 1.7 [1.4; 2.0] | <0.001 |
iEOA, cm2/m2 | 1.1 [0.9; 1.2] | 1.0 [0.8; 1.1] | <0.001 |
Severe PPM | 0 (0.0%) | 2 (3.2%) | 0.152 |
Moderate-Severe PPM | 12 (12.2%) | 21 (33.3%) | 0.002 |
Relevant PVL (>mild/trace or VinV) | 1 (1.0%) | 1 (1.3%) | 1.000 |
Elevated Gradients (>19 mmHg) | 0 (0.0%) | 6 (8.2%) | 0.005 |
Clinical outcome | |||
Technical success | 102 (98.1%) | 70 (93.3%) | 0.132 |
Device success at 30 days | 98 (94.2%) | 60 (80.0%) | 0.007 |
30 day mortality | 4 (3.8%) | 1 (1.3%) | 0.401 |
Conversion to sternotomy | 0 (0.0%) | 0 (0.0%) | 1.000 |
Multiple valves (VinV) | 1 (1.0%) | 0 (0.0%) | 1.000 |
Device migration/embolization | 2 (1.9%) | 0 (0.0%) | 0.510 |
Major vascular complication | 0 (0.0%) | 5 (6.7%) | 0.012 |
Bleeding (type 3–4) | 6 (5.8%) | 5 (6.7%) | 1.000 |
Major cardiac structural complication | 1 (1.0%) | 2 (2.7%) | 0.573 |
Disabling Stroke | 3 (2.9%) | 1 (1.3%) | 0.641 |
AKI (type 2–4) | 2 (1.9%) | 0 (0.0%) | 0.510 |
New permanent pacemaker 1 | 18 (18.4%) | 6 (8.5%) | 0.110 |
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Eckel, C.; Al-Rashid, F.; Bargon, S.; Schlüter, J.; Sötemann, D.; Elsässer, A.; Blumenstein, J.; Möllmann, H.; Grothusen, C. Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses. J. Clin. Med. 2025, 14, 1824. https://doi.org/10.3390/jcm14061824
Eckel C, Al-Rashid F, Bargon S, Schlüter J, Sötemann D, Elsässer A, Blumenstein J, Möllmann H, Grothusen C. Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses. Journal of Clinical Medicine. 2025; 14(6):1824. https://doi.org/10.3390/jcm14061824
Chicago/Turabian StyleEckel, Clemens, Fadi Al-Rashid, Sophie Bargon, Judith Schlüter, Dagmar Sötemann, Albrecht Elsässer, Johannes Blumenstein, Helge Möllmann, and Christina Grothusen. 2025. "Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses" Journal of Clinical Medicine 14, no. 6: 1824. https://doi.org/10.3390/jcm14061824
APA StyleEckel, C., Al-Rashid, F., Bargon, S., Schlüter, J., Sötemann, D., Elsässer, A., Blumenstein, J., Möllmann, H., & Grothusen, C. (2025). Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses. Journal of Clinical Medicine, 14(6), 1824. https://doi.org/10.3390/jcm14061824