TABLE 1.
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) Full retrievability of the undeployed Myval THV Series system | 14F eSheath for 20-26mm 16F eSheath for 29mm The Sapien THV system cannot be retrieved once inside the patient | 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. Evolut Pro+: 14F InLine sheath for 23-29 mm and 18 Fr InLine sheath for 34 mm Can be retrieved before full deployment |
| 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. |
FIGURE 1.
Flowchart of patient selection and propensity score matching in transcatheter aortic valve implantation (TAVI) cohorts.
AVA = aortic valve area; BMI = body mass index; BSA = body surface area; LVEF = left ventricular ejection fraction; NYHA = New York Heart Association; RBBB = Right Bundle Branch Block; STS = Society of Thoracic Surgeons
TABLE 2.
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) | - |
1 AV = atrioventricular; BMI = body mass index; CKD = Chronic kidney disease; DVI = Doppler velocity index; eGFR = estimated glomerular filtration rate; IHD = Ischemic heart disease; LBBB = Left bundle branch block; NYHA = New York Heart Association; RBBB = right bundle branch block; SD = standard deviation; STS = Society of Thoracic Surgeons; THV = transcatheter heart valve; TAVI = transcatheter valve implantation; ViV = valve-in-valve.
FIGURE 2.
Sizes of implanted transcatheter heart valves – (A) Myval series, (B) Sapien series, (C) Evolut series.
FIGURE 3.
Paravalvular regurgitation after transcatheter implantation of Myval, Sapien, and Evolut series.
TABLE 3.
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 | n = 59 (98) | n = 60 (100) | n = 59 (98) | 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 | n = 58 (97) | n = 58 (97) | n = 59 (98) | 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 | n = 60 (100) | n = 60 (100) | n = 60 (100) | 0.934 | 1.000 | 1.000 | 1.000 |
| 5 (8.3) | 5 (8.3) | 6 (10.0) | |||||
TABLE 4.
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 | ||
FIGURE 4.
Kaplan-Meier survival curves of matched cohorts for 30 days (A) and 1 year (B) after transcatheter implantation of Myval, Sapien, and Evolut series in patients with severe symptomatic aortic stenosis.