Table 4.
Midterm Clinical Outcomes
| Caisson | CardiAQ | Fortisa | HighLife | Intrepid | Tiara | Tendyne | Global Cohortb | |
|---|---|---|---|---|---|---|---|---|
| Follow‐up, mo | 9.9 | NA | 24a | 12 | 7.04±6.7 | 3 | 13.7 | 10.1 (3–24) |
| Any mortality | 2/11 (18.2) | 9/13 (69.2) | 7/13 (53.8) | 4/15 (26.7) | 11/50 (22.0) | 12/55 (21.8) | 26/100 (26) | 71/257 (27.6) |
| Cardiovascular mortality | NA | NA | 5/13 (38.5) | NA | 11/50 (22.0) | NA | 22/100 (22) | 38/163 (23.3) |
| NYHA class III–IV | 1/9 (11.1) | NA | 1/8 (12.5) | NA | 9/43 (20.9) | 1.9±0.6 | 10/86 (11.6) | 21/146 (14.4) |
| Mean transmitral gradient, mm Hg | NA | NA | 3±1 | NA | 4.1±1.3 | NA | 3.0±1.1 | 3.3 (3–4.1) |
| Moderate or severe MR | 0/9 (0.0) | 0/12 (0.0) | 0/8 (0.0) | 0/12 (0.0) | 0/42 (0) | NA | NA | 0/83 (0.0) |
| Stroke | 2/11 (18.2) | NA | NA | 0/15 (0.0) | 3/50 (6.0) | NA | 3/100 (3) | 8/176 (4.5) |
| Myocardial infarction | 0/11 (0.0) | NA | NA | 0/15 (0.0) | 0/50 (0.0) | NA | 4/100 (4) | 4/176 (2.3) |
| HF hospitalization | 1/11 (9.1) | NA | 2/13 (15.4) | NA | 12/50 (24.0) | NA | 31/100 (31) | 46/174 (26.4) |
| Reintervention for mitral valve | 0/11 (0.0) | NA | 0/13 (0.0) | NA | 0/50 (0.0) | NA | 4/100 (4) | 4/174 (2.3) |
| Bioprosthetic valve dysfunction | NA | NA | 0/13 (0.0) | 0/15 (0.0) | NA | NA | 0/100 (0) | 0/128 (0.0) |
| Device hemolysis | NA | NA | NA | NA | NA | NA | 3/100 (3) | 3/100 (3.0) |
| Device embolization | NA | NA | 0/13 (0.0) | NA | 0/50 (0.0) | NA | 0/100 (0) | 0/163 (0.0) |
| Device thrombosis | NA | NA | NA | NA | 0/50 (0.0) | NA | 6/100 (6) | 6/150 (4.0) |
| Fracture | NA | NA | 0/13 (0.0) | NA | NA | NA | 0/100 (0) | 0/113 (0.0) |
| Endocarditis | NA | NA | NA | NA | 2/50 (4.0) | NA | 2/100 (2) | 4/150 (2.7) |
Values are mean±SD or n/N (%) except as noted. HF indicates heart failure; MR, mitral regurgitation; NA, not available; NYHA, New York Heart Association.
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 (%).