Table 3.
Procedural and 30‐Day Clinical Outcomes
| AltaValve | Caisson | CardiAQ | CardioValve | Fortisa | HighLife | Intrepid | MValve System | Tiara | Sapien M3 | Tendyne | Global Cohortb | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All‐cause 30‐d mortality | 0/1 (0.0) | 2/11 (18.2) | 7/26 (26.9) | 3/5 (60.0) | 5/13 (38.5) | 3/15 (20.0) | 7/50 (14.0) | 1/1 (100) | 6/58 (10.3) | 0/15 (0.0) | 6/100 (6.0) | 40/295 (13.6) |
| Procedure‐related mortality | 0/1 (0.0) | NA | 3/26 (11.5) | 1/5 (20.0) | 4/13 (30.8) | 2/11 (18.2) | 3/50 (6.0) | NA | 0/59 (0.0) | 0/15 (0.0) | 0/100 (0.0) | 13/280 (4.6) |
| Technical success | 1/1 (100) | 18/23 (78.3) | 22/26 (84.6) | 5/5 (100) | 10/13 (76.9) | 8/11 (72.7) | 48/49 (97.9) | 1/1 (100) | 56/59 (94.9) | 13/15 (86.7) | 97/100 (97.0) | 278/303 (91.7) |
| Procedure time, min | NA | 177 ±65 | NA | 43.6±13.1 | 123±27 | NA | 100 (80–124) | NA | 82 (60–155) | 189 ±100 | 136.1±36.3 | 121.4 (43.6–189) |
| Approach | ||||||||||||
| Transfemoral | 23/23 (100) | 14/26 (53.8) | 5/5 (100) | 15/15 (100) | 57/308 (18.5) | |||||||
| Transapical | 1/1 (100) | 12/26 (46.2) | 13/13 (100) | 15/15 (100) | 50/50 (100) | 1/1 (100) | 59/59 (100) | 100/100 (100) | 251/308 (81.5) | |||
| Conversion to open heart surgery | 0/1 (0.0) | 4/23 (17.4) | NA | NA | 2/13 (15.4) | 2/11 (18.2) | 0/50 (0.0) | NA | 3/59 (5.1) | 0/15 (0.0) | 0/100 (0.0) | 11/272 (4.0) |
| LVOT obstruction | 0/1 (0.0) | 0/17 (0.0) | NA | 0/5 (0.0) | 0/13 (0.0) | 1/15 (6.6) | 0/50 (0.0) | NA | 0/58 (0.0) | 0/15 (0.0) | 0/100 (0.0) | 1/274 (0.4) |
| Device embolization or migration | 0/1 (0.0) | 0/17 (0.0) | NA | NA | 0/13 (0.0) | NA | 0/50 (0.0) | NA | 2/58 (3.4) | 0/15 (0.0) | 0/100 (0.0) | 2/254 (0.8) |
| Malposition | 0/1 (0.0) | NA | 1/13 (7.7) | NA | 1/13 (7.7) | NA | 1/50 (2.0) | NA | 3/59 (5.1) | NA | 2/100 (2.0) | 8/236 (3.4) |
| Moderate or severe MR | 0/1 (0.0) | 1/11 (9.1) | 0/26 (0.0) | 0/5 (0.0) | 0/13 (0.0) | 0/15 (0.0) | 0/50 (0.0) | NA | 1/37 (2.7) | 1/15 (6.6) | 1/100 (1.0) | 4/273 (1.5) |
| Valve dysfunction | 0/1 (0.0) | NA | NA | NA | 0/13 (0.0) | 0/11 (0.0) | 0/50 (0.0) | NA | NA | 1/15 (6.6) | 0/100 (0.0) | 1/190 (0.5) |
| Device thrombosis | 0/1 (0.0) | NA | NA | NA | 1/13 (7.7) | 1/15 (6.6) | 0/50 (0.0) | NA | NA | NA | 1/100 (1.0) | 3/179 (1.7) |
| Stroke | 0/1 (0.0) | 0/11 (0.0) | NA | NA | 0/13 (0.0) | 0/15 (0.0) | 2/50 (4.0) | NA | 2/37 (5.4) | 1/15 (6.6) | 2/100 (2.0) | 7/242 (2.9) |
| Bleeding | 0/1 (0.0) | 0/11 (0.0) | 1/13 (7.7) | 1/5 (20.0) | 0/13 (0.0) | NA | 9/50 (18.0) | NA | NA | 0/15 (0.0) | 20/100 (20.0) | 31/208 (14.9) |
| Access site complication | 0/1 (0.0) | 0/11 (0.0) | NA | 1/5 (20.0) | NA | NA | 0/50 (0.0) | NA | 4/58 (6.9) | 0/15 (0.0) | 1/100 (1.0) | 6/240 (2.5) |
| Acute kidney injury | 0/1 (0.0) | NA | NA | NA | 2/13 (15.4) | NA | 5/50 (10.0) | NA | 12/37 (32.4) | 1/15 (6.6) | 8/100 (8.0) | 28/216 (13.0) |
| Mean transmitral gradient, mm Hg | NA | 3.1 | NA | 4.4 | 3±1 | NA | 4.1±1.3 | NA | NA | 5.53±2.2 | 3.0±1.1 | 3.5 (3.0–5.53) |
| Length of stay, d | 9 | NA | NA | NA | 10±6 | NA | NA | NA | NA | 6.3 ±3.2 | 11.1±8.7 | 10.4 (6.3–11.1) |
Values are mean±SD or n/N (%) except as noted. LVOT indicates left ventricular outflow tract; MR, mitral regurgitation; NA, not available.
a
In late 2015, Edwards Lifesciences stopped the Fortis program. The valve is not currently available.
b
Values are weighted mean (range) or n/N (%).