Table 3.
One-year outcomes after MitraClip implantation in different registries and trials
| EVEREST II (n = 184) | ACESS-EU (n = 567) | Transcatheter Valve Treatment Sentinel Pilot Registry European Sentinel Pilot Registry (n = 552/628) | TRAMI (prospective cohort) (n = 749) | |
|---|---|---|---|---|
| Mitral regurgitation at 1 year, n (%) | ||||
| None/mild | NA | NA | 216/368 (58.6%) | NA |
| Moderate | NA | NA | 130/368 (35.4%) | NA |
| Severe | NA | NA | 22/368 (6.0%) | NA |
| 0+/1+ | 84/153 (54.9%) | 100/327 (30.6%) | NA | NA |
| 2+ | 41/153 (26.8%) | 158/327 (48.3%) | NA | NA |
| 3+/4+ | 28/153 (18.3%) | 69/327 (21.1%) | NA | NA |
| NYHA class at 1 year, n (%) | ||||
| I–II | 180/184 (97.8%) | 245/343 (71.4%) | 265/357 (74.2%) | 305/482 (63.3%) |
| III–IV | 4/184 (2.2%) | 98/343 (28.6%) | 92/357 (25.8%) | 177/482 (36.7%) |
| Quality of life | ||||
| EQ-5D-3L (compared with baseline) | NA | NA | NA | |
| Mobility | NA | NA | NA | 0.58 |
| Self-care | NA | NA | NA | <0.001 |
| Usual activities | NA | NA | NA | 0.89 |
| Pain/discomfort | NA | NA | NA | 0.21 |
| Anxiety/depression | NA | NA | NA | <0.0001 |
| EQ VAS (compared with baseline) | NA | NA | NA | 60.0 [50–70] vs. 50.0 [40–60]; P < 0.0001 |
| 36-item short-form Health Survey (compared with baseline) | Improvement (P < 0.001) | NA | NA | NA |
| MLHFQ (compared with baseline) | NA | Improvement of 13.5 ± 20.5 points (P < 0.0001) | NA | NA |
| 6MWT (compared with baseline) | NA | Improvement of 59.5 ± 112.4 m (P < 0.0001) | NA | NA |
| Adverse events | ||||
| MACCE (death, MI, and stroke) | ||||
| Death | 11/181 (6.1%) | 98/567 (17.3%) | 15.3% (Kaplan–Meier curve) | 152/749 (20.3%) |
| Myocardial infarction | 1/184 (0.5%) | 8/567 (1.4%) | NA | 4/425 (0.9%) |
| Stroke | 2/184 (1.1%) | 6/567 (1.1%) | NA | 9/423 (2.1%) |
| Non-MACCE | ||||
| TIA | 1/184 (0.5%) | NA | NA | 16/426 (3.8%) |
| Bleeding complications | 5/184 (2.7%) | 27/567 (4.8%) | NA | 56/443 (12.6%) |
| Need for resuscitation | 2/184 (1.1%) | 12/567 (2.1%) | NA | 9/426 (2.1%) |
| Rehospitalizations, n (%) | NA | NA | NA | 364/566 (64.3%) |
| Cardiac decompensation | NA | NA | 22.8% (Kaplan–Meier curve) | 80/566 (14.1%) |
| Other cardiac reason | NA | NA | NA | 101/566 (17.8%) |
| Non-cardiac reason | NA | NA | NA | 146/566 (25.8%) |
| Additional MV procedure, n (%) | 37/181 (21%) | 55/567 (9.7%) | 17/444 (3.8%) | 37/436 (8.5%) |
| Surgical | 37/181 (21%) | 36/ 567 (6.3%) | 4/444 (0.9%) | 10/436 (2.3%) |
| Percutaneous | 0/181 (0%) | 19/567 (3.4%) | 13/444 (2.9%) | 23/436 (5.2%) |