FIGURE 1.
FIGURE 2.
FIGURE 3.
FIGURE 4.
Baseline characteristics and medical history of unmatched and matched cohorts with severe aortic stenosis who underwent TAVI with different THVs_ Data availability is provided in the first row for each variable, n (%)
| BASELINE CHARACTERISTICS | Overall Cohort (n = 1053) | Unmatched cohorts | Matched cohorts | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Myval series (n = 97) | Sapien series (n = 400) | Evolut series (n = 556) | p-value* (Overall) | Myval series (n = 60) | Sapien series (n = 60) | Evolut series (n = 60) | p-value* (Overall) | ||
| Age (Years), mean ± SD | n = 1053 (100) | n = 97 (100) | n = 400 (100) | n = 556 (100) | 0.682 | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.729 |
| 81.3 ± 6.4 | 81.0 ± 6.5 | 80.7 ± 6.4 | 81.5 ± 6.7 | 81.3 ± 6.7 | 80.5 ± 6.6 | 81.5 ± 7.1 | |||
| Sex, n (%) | n = 1053 (100) | n = 97 (100) | n = 400 (100) | n = 556 (100) | 0.009 | n = 60 (100) | n = 60 (100) | n = 60 (100) | |
| Male, n (%) | 542 (51.5) | 52 (53.6) | 209 (46.2) | 311 (55.9) | 29 (48.3) | 24 (40.0) | 31 (51.7) | 0.419 | |
| Female, n (%) | 511 (48.5) | 45 (46.4) | 243 (53.8) | 245 (44.1) | 31 (51.7) | 36 (60.0) | 29 (48.3) | ||
| BMI (kg/m2), mean ± SD | n = 1001 (95) | n = 97 (100) | n = 377 (94) | n = 527 (95) | 0.003 | n=60 (100) | n = 60 (100) | n = 60 (100) | 0.88 5 |
| 27.59 ± 4.87 | 28.56 ± 5.31 | 27.99 ± 5.18 | 27.12 ± 4.49 | 28.06 ± 5.12 | 27.62 ± 5.14 | 27.83 ± 4.66 | |||
| Body surface area (m2), mean ± SD | n = 1001 (95) | n = 97 (100) | n = 377 (94) | n = 527 (95) | 0.041 | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.134 |
| 1.83 ± 0.21 | 1.87 ± 0.22 | 1.81 ± 0.21 | 1.83 ± 0.2 | 1.85 ± 0.22 | 1.78 ± 0.18 | 1.82 ± 0.21 | |||
| Indication, n (%) | n = 1051 (100) | n = 97 (100) | n = 398 (100) | n = 556 (100) | 0.445 | n = 60 (100) | n = 60 (100) | n = 60 (100) | |
| Stenosis | 1038 (98.8) | 96 (99.0) | 391 (98.2) | 551 (99.1) | 60 (100.0) | 59 (98.3) | 60 (100.0) | 1.000 | |
| Regurgitation | 13 (1.2) | 1 (1.0) | 7 (1.8) | 5 (0.9) | 0 (0.0) | 1 (1.7) | 0 (0.0) | ||
| Etiology, n (%) | n = 1050 (100) | n = 97 (100) | n = 399 (100) | n = 554 (100) | 0.414 | n = 60 (100) | n = 60 (100) | n = 60 (100) | |
| Degenerative | 980 (93.3) | 91 (93.8) | 366 (91.7) | 523 (94.4) | 55 (91.7) | 53 (88.3) | 55 (91.7) | 0.024 | |
| Rheumatic | 3 (0.3) | 0 (0.0) | 1 (0.3) | 2 (0.4) | 0 (0.0) | 0 (0.0) | 1 (1.7) | ||
| ViV, n (%) | 67 (6.4) | 6 (6.2) | 32 (8.0) | 29 (5.2) | 0.011 | 5 (8.3) | 5 (8.3) | 0 (0.0) | 0.326 |
| Creatinine (μmol/L), mean ± SD | n = 995 (95) | n = 97 (100) | n = 368 (92) | n = 530 (95) | n = 60 (100) | n = 60 (100) | n = 60 (100) | ||
| 111.95 ± 74.74 | 102.32 ± 68.56 | 105.00 ± 64.36 | 118.55 ± 81.70 | 94.58 ± 36.27 | 100.97 ± 54.30 | 111.13 ± 82.84 | |||
| DVI, mean ± SD | n = 704 (67) | n = 68 (70) | n = 263 (66) | n = 373 (67) | 0.985 | n = 48 (80) | n = 50 (83) | n = 51 (85) | 0.706 |
| 0.20 ± 0.06 | 0.20 ± 0.04 | 0.20 ± 0.08 | 0.20 ± 0.05 | 0.20 ± 0.03 | 0.19 ± 0.05 | 0.19 ± 0.04 | |||
| Systolic pulmonary artery pressure (mm Hg), mean ± SD | n = 675 (64) | n = 60 (62) | n = 247 (62) | n = 368 (66) | 0.158 | n = 42 (70) | n = 51 (85) | n = 53 (88) | 0.355 |
| 42.9 ± 13.3 | 40.6 ± 14.3 | 42.3 ± 13.3 | 43.7 ± 13.1 | 38.8 ± 12.8 | 41.8 ± 12.38 | 42.4 ± 13.3 | |||
| Euroscore 2, mean ± SD | n = 920 (87) | n = 96 (99) | n = 321 (80) | n = 503 (91) | 0.384 | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.307 |
| 6.17 ± 6.74 | 5.41 ± 5.30 | 6.05 ± 6.51 | 6.40 ± 7.11 | 4.74 ± 3.82 | 6.40 ± 8.23 | 5.7 ± 4.72 | |||
| STS score, mean ± SD | n = 830 (79) | n = 97 (100) | n = 284 (71) | n = 449 (81) | 0.219 | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.359 |
| 4.43 ± 4.03 | 3.78 ± 3.09 | 4.28 ± 3.97 | 4.67 ± 4.24 | 3.90 ± 3.65 | 4.64 ± 5.51 | 5.07 ± 4.18 | |||
| Annular perimeter (mm), mean ± SD | n = 949 (90) | n = 91 (94) | n = 359 (90) | n = 499 (90) | 0.871 | n = 56 (93) | n = 59 (98) | n = 60 (100) | 0.407 |
| 80.2 ± 35.5 | 79.5 ± 7.2 | 79.6 ± 31.3 | 80.8 ± 41.0 | 79.1 ± 6.8 | 77.3 ± 10.2 | 79.0 ± 7.2 | |||
| Annular area (mm2), mean ± SD | n = 968 (92) | n = 92 (95) | n = 368 (92) | n = 508 (91) | 0.293 | n = 57 (95) | n = 59 (98) | n = 60 (100) | 0.774 |
| 464.5 ± 97.6 | 476.7 ± 94.7 | 459.6 ± 88.1 | 465.9 ± 104.3 | 473.6 ± 92.3 | 461.5 ± 95.3 | 468.7 ± 85.8 | |||
| NYHA class before, n (%) | n = 994 (94) | n = 97 (100) | n = 367 (92) | n = 530 (95) | 0.471 | n = 60 (100) | n = 60 (100) | n = 60 (100) | |
| 1 | 22 (2.2) | 4 (4.1) | 9 (2.5) | 9 (1.7) | 3 (5.0) | 2 (3.3) | 1 (1.7) | ||
| 2 | 205 (20.6) | 17 (17.5) | 75 (20.4) | 113 (21.3) | 12 (20.0) | 15 (25.0) | 14 (23.3) | 0.963 | |
| 3 | 653 (65.7) | 68 (70.1) | 245 (66.8) | 340 (64.2) | 40 (66.7) | 38 (63.3) | 41 (68.3) | ||
| 4 | 114 (11.5) | 8 (8.2) | 38 (10.4) | 68 (12.8) | 5 (8.3) | 5 (8.3) | 4 (6.7) | ||
| Aortic regurgitation before, n (%) | n = 918 (87) | n = 84 (87) | n = 333 (83) | n = 501 (90) | 0.300 | n = 53 (88) | n = 60 (100) | n = 59 (98) | |
| None/trace | 284 (30.9) | 31 (36.9) | 101 (30.3) | 152 (30.3) | 21 (39.6) | 11 (18.3) | 12 (20.3) | ||
| Mild | 522 (56.9) | 40 (47.6) | 194 (58.3) | 288 (57.5) | 25 (47.2) | 43 (71.7) | 43 (72.9) | 0.032 | |
| Moderate | 90 (9.8) | 12 (14.3) | 27 (8.1) | 51 (10.2) | 7 (13.2) | 5 (8.3) | 4 (6.8) | ||
| Severe | 22 (2.4) | 1 (1.2) | 11 (3.3) | 10 (2.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) | ||
| Mitral regurgitation before, n (%) | n = 882 (84) | n = 82 (85) | n = 327 (82) | n = 473 (85) | 0.090 | n = 52 (87) | n = 59 (98) | n = 58 (97) | |
| None/trace | 111 (1.2) | 17 (20.7) | 35 (10.7) | 59 (12.5) | 12 (23.1) | 4 (6.8) | 2 (3.4) | ||
| Mild | 697 (75.9) | 64 (78.1) | 261 (79.8) | 372 (78.6) | 40 (76.9) | 50 (84.7) | 50 (86.2) | 0.002 | |
| Moderate | 69 (7.5) | 1 (1.2) | 29 (8.9) | 39 (8.2) | 0 (0.0) | 5 (8.5) | 6 (10.3) | ||
| Severe | 5 (0.5) | 0 (0.0) | 2 (0.6) | 3 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| Medical history, n (%) | |||||||||
| Arterial hypertension | 878 (83.4) | 88 (90.7) | 327 (81.8) | 463 (83.3) | - | 56 (93.3) | 56 (93.3) | 54 (90.0) | - |
| Diabetes - oral antidiabetics | 179 (17.0) | 12 (12.4) | 63 (15.8) | 104 (18.7) | - | 5 (8.3) | 8 (13.3) | 10 (16.7) | - |
| Diabetes -insulin dependent | 72 (6.8) | 7 (7.2) | 22 (5.5) | 43 (7.7) | - | 6 (10.0) | 6 (10.0) | 5 (8.3) | - |
| Pulmonary disease | 139 (13.2) | 17 (17.5) | 43 (10.8) | 79 (14.2) | - | 9 (15.0) | 9 (15.0) | 11 (18.3) | - |
| CKD (eGF < 60 mL/min/1.73 m2) | 278 (26.4) | 28 (28.9) | 94 (23.5) | 156 (28.1) | - | 18 (30.0) | 17 (28.3) | 13 (21.7) | - |
| CKD - dialysis | 24 (2.3) | 1 (1.0) | 5 (1.3) | 18 (3.2) | - | 0 (0.0) | 1 (1.7) | 1 (1.7) | - |
| Hyperlipidemia | 300 (28.5) | 31 (32.0) | 107 (26.8) | 162 (29.1) | - | 18 (30.0) | 23 (38.3) | 19 (31.7) | - |
| Cardiac history, n (%) | |||||||||
| IHD (any type of revascularization, proximal significant coronary stenosis) | 254 (24.1) | 26 (26.8) | 79 (19.8) | 149 (26.8) | - | 17 (28.3) | 11 (18.3) | 18 (30.0) | - |
| AV block I | 94 (8.9) | 8 (8.2) | 23 (5.8) | 63 (11.3) | - | 3 (5.0) | 4 (6.7) | 9 (15.0) | - |
| AV block II | 8 (0.8) | 0 (0.0) | 0 (0.0) | 8 (1.4) | - | 0 (0.0) | 0 (0.0) | 1 (1.7) | - |
| RBBB | 72 (6.8) | 8 (8.2) | 26 (6.5) | 38 (6.8) | - | 7 (11.7) | 3 (5.0) | 4 (6.7) | - |
| LBBB | 89 (8.5) | 10 (10.3) | 33 (8.3) | 46 (8.3) | - | 5 (8.3) | 9 (15.0) | 5 (8.3) | - |
| Atrial fibrillation | 15 (1.4) | 1 (1.03) | 4 (1.00) | 10 (1.8) | - | 1 (1.67) | 2 (3.3) | 4 (6.7) | - |
| Atrial fibrillation - slow ventricular response | 242 (23.0) | 22 (22.7) | 91 (22.8) | 129 (23.2) | - | 12 (20) | 14 (23.3) | 9 (15.0) | - |
| Electrosystolic rhythm | 66 (6.3) | 3 (3.1) | 32 (8.0) | 31 (5.6) | - | 1 (1.67) | 4 (6.7) | 4 (6.7) | - |
Comparison of haemodynamic parameters in a matched cohort_ Data availability is provided in the first row for each variable, n (%)
| Hemodynamic Outcomes in Matched Cohort | P value | |||
|---|---|---|---|---|
| Parameters | Cohort | Before procedure | After procedure | |
| Aortic Vmax (m/s), mean ± SD | Myval series | n = 56 (93) 4.3 ± 0.5 | n = 58 (97) 2.1 ± 0.5 | < 0.001 |
| Evolut series | n = 59 (98) 4.3 ± 0.6 | n = 54 (90) 1.8 ± 0.4 | < 0.001 | |
| Sapien series | n = 58 (97) 4.3 ± 0.6 | n = 55 (92) 2.2 ± 0.4 | < 0.001 | |
| p-value (Myval vs. Evolut) | 0.780 | < 0.001 | ||
| p-value (Myval vs. Sapien) | 0.908 | 0.355 | ||
| Aortic mean gradient (mm Hg), mean ± SD | Myval series | n = 60 (100) 47.2 ± 13.1 | n = 58 (97) 11.1 ±5.4 | < 0.001 |
| Evolut series | n = 60 (100) 46.6 ± 15.3 | n = 54 (90) 6.7 ± 2.61 | < 0.001 | |
| Sapien series | n = 60 (100) 47.3 ± 14.8 | n = 54 (90) 10.8 ± 3.9 | < 0.001 | |
| p-value (Myval vs. Evolut) | 0.808 | < 0.001 | ||
| p-value (Myval vs. Sapien) | 0.958 | 0.684 | ||
| AVA and EOA (cm2), mean ± SD | Myval series | n = 60 (100) 0.7 ±0.1 | n = 57 (95) 1.9 ± 0.5 | < 0.001 |
| Evolut series | n = 60 (100) 0.7 ± 0.1 | n = 51 (85) 1.8 ± 0.5 | < 0.001 | |
| Sapien series | n = 60 (100) 0.6 ± 0.2 | n = 56 (93) 1.7 ± 0.5 | < 0.001 | |
| p-value (Myval vs. Evolut) | 0.121 | 0.807 | ||
| p-value (Myval vs. Sapien) | 0.068 | 0.026 | ||
| LVEF (%), mean ± SD | Myval series | n = 59 (98) 59.2 ± 11.1 | n = 52 (87) 61.6 ± 9.9 | 0.061 |
| Evolut series | n = 60 (100) 54.8 ± 14.7 | n = 52 (87) 58.5 ± 12.4 | 0.057 | |
| Sapien series | n = 60 (100) 56.1 ± 15.8 | n = 53 (88) 58.3 ± 14.9 | 0.023 | |
| p-value (Myval vs. Evolut) | 0.063 | 0.170 | ||
| p-value (Myval vs. Sapien) | 0.211 | 0.180 | ||
Summary of differences between Myval series, Sapien series, and Evolut series
| Device | Myval series | Sapien series | Evolut series |
|---|---|---|---|
| Images | |||
| Support structure | Nickel-cobalt alloy | Cobalt-chromium alloy | Nitinol (nickel-titanium) frame |
| Valve structure | 53% open cells on the upper half and 47% closed cells on the lower half form the hexagonal frame for the hybrid honeycomb cell design concept | Heterogeneous frame design that incorporates hexagons and diamonds. Overall, the frame consists of 5 rungs and 12 open cells, where the upper cells are larger and the lower cells are smaller | A radiopaque self-expanding nitinol support frame with a diamond cell configuration |
| Conventional sizes | 20, 23, 26, 29 mm | 20, 23, 26, 29 mm | 23, 26, 29 mm |
| Intermediate sizes | 21.5, 24.5, 27.5 mm | Not available | Not available |
| Extra-large sizes | 30.5, 32 mm | Not available | 34 mm |
| Valve annulus size range | 18.5-32.7 mm (area derived diameter) | 18.6-29.5 mm (area derived diameter) | 17/18–30 mm (CT-derived diameters) |
| Introducer sheath | 14F Python introducer sheath for all diameters (20-32 mm) | 14F eSheath for 20-26mm | Evolut R & Evolut Pro: A 14F delivery system or an 18F sheath for 23–29 mm; a 16F delivery system or a 20F sheath for 34 mm. |
| Deployment technique | The design generates a specific “zebra crossing” like pattern under fluoroscopy. This is used for position and deployment. | The design does not generate any specific pattern. Positioning is at 50% using balloon radiopaque marker. | The design does not generate any specific pattern. Positioning is controlled by radiopaque markers. |
In-hospital cardiac complications in the propensity-score matched cohort_ Data availability is provided in the first row for each variable, n (%)
| In-hospital outcomes, n (%) | Myval series (n = 60) | Sapien series (n = 60) | Evolut series (n = 60) | p-value overall | p-value Myval series vs Evolut series | p-value Myval series vs. Sapien series | p-value Evolut series vs. Sapien series |
|---|---|---|---|---|---|---|---|
| Cardiac complications | 0.390 | 1.000 | 0.491 | 0.272 | |||
| 3 (5.1) | 6 (10.0) | 2 (3.4) | |||||
| New pericardial effusion | 0 (0.0) | 1 (1.7) | 1 (1.7) | 1.000 | 1.000 | 1.000 | 1.000 |
| Tamponade | 0 (0.0) | 4 (6.7) | 1 (1.7) | 0.129 | 1.000 | 0.119 | 0.364 |
| Annular rupture | 1 (1.7) | 1 (1.7) | 0 (0.0) | 1.000 | 1.000 | 1.000 | 1.000 |
| Valve embolization | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1.000 | 1.000 | 1.000 | 1.000 |
| Improper valve position | 0 (0.0) | 1 (1.7) | 0 (0.0) | 1.000 | 1.000 | 1.000 | 1.000 |
| Conversion to heart surgery | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1.000 | 1.000 | 1.000 | 1.000 |
| Periprocedural myocardial infarction (< 72h) | 2 (3.3) | 0 (0.0) | 0 (0.0) | 0.330 | 0.496 | 0.496 | 1.000 |
| Spontaneous myocardial infarction (> 72h) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1.000 | 1.000 | 1.000 | 1.000 |
| Neurological complications | 0.534 | 0.364 | 1.000 | 0.619 | |||
| 3 (5.2) | 2 (3.4) | 1 (1.7) | |||||
| Transient ischemic attack | 1 (1.7) | 0 (0.0) | 1 (1.7) | 1.000 | 1.000 | 1.000 | 1.000 |
| Ischemic cerebrovascular insult | 2 (3.4) | 2 (3.4) | 0 (0.0) | 0.548 | 0.496 | 1.000 | 0.496 |
| Hemorrhagic cerebrovascular insult | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1.000 | 1.000 | 1.000 | 1.000 |
| Bleeding | n = 59 (98) | n = 59 (98) | n = 60 (100) | 0.768 | 0.743 | 0.741 | 1.000 |
| 4 (6.8) | 6 (10.2) | 6 (10.0) | |||||
| Bleeding - minor | 3 (5.0) | 1 (1.7) | 2 (3.3) | 0.872 | 1.000 | 0.619 | 1.000 |
| Bleeding - major | 0 (0.0) | 4 (6.7) | 3 (5.0) | 0.164 | 0.246 | 0.119 | 1.000 |
| Bleeding - life-threatening | 1 (1.7) | 1 (1.7) | 1 (1.7) | 1.000 | 1.000 | 1.000 | 1.000 |
| Other complications | |||||||
| Acute kidney injury | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.350 | 0.364 | 0.207 | 1.000 |
| 1 (1.7) | 5 (8.3) | 4 (6.7) | |||||
| New left bundle branch block | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.495 | 1.000 | 0.439 | 0.439 |
| 5 (8.3) | 2 (3.3) | 5 (8.3) | |||||
| New atrial fibrillation | n = 60 (100) | n = 60 (100) | n = 60 (100) | 1.000 | 1.000 | 1.000 | 1.000 |
| 2 (3.3) | 2 (3.3) | 1 (1.7) | |||||
| Permanent pacemaker implantation after TAVI | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.719 | 0.816 | 1.000 | 0.605 |
| 7 (11.9) | 6 (10.0) | 9 (15.0) | |||||
| 30-day mortality | n = 60 (100) | n = 60 (100) | n = 60 (100) | 1.000 | 1.000 | 1.000 | 1.000 |
| 2 (3.3) | 3 (5.0) | 2 (3.3) | |||||
| 1 -year mortality | 0.934 | 1.000 | 1.000 | 1.000 | |||
| 5 (8.3) | 5 (8.3) | 6 (10.0) | |||||