Table 5.
Baseline Characteristics, Procedural and 30‐Day Results, and Midterm Outcomes Comparing the TMVR Cohort With the COAPT Device Group
| TMVR (N=308) | COAPT Device Group (N=302) | |
|---|---|---|
| Characteristics of the patients at baseline | ||
| Age, y | 75.2±3.5 | 72.2±11.2 |
| STS‐PROM score, % | 7.7±0.75 | 7.8±5.5 |
| Secondary MR | 217/280 (77.5) | 302/302 (100) |
| Grade III or IV MR severity | 211/213 (99.1) | 302/302 (100) |
| Left ventricular ejection fraction | 42.4±4.7 | 31.3±9.3 |
| Hypertension | 102/123 (82.9) | 243/302 (80.5) |
| Diabetes mellitus | 70/190 (36.8) | 106/302 (35.1) |
| Prior myocardial infarction | 89/177 (50.3) | 156/302 (51.7) |
| Prior coronary artery bypass surgery | 111/251 (44.2) | 121/302 (40.1) |
| Chronic obstructive pulmonary disease | 95/249 (38.2) | 71/302 (23.5) |
| Hospitalization for HF within past year | 77/163 (47.2) | 176/302 (58.3) |
| Procedural and 30‐d clinical outcomes | ||
| Procedure time, min | 121.4±41.9 | 162.9±118.1 |
| All‐cause 30‐d mortality | 40/295 (13.6) | 7/302 (2.3) |
| Stroke | 7/242 (2.9) | 2/302 (0.7) |
| Moderate or severe MR | 4/273 (1.5) | 20/273 (7.3) |
| Unplanned mitral valve surgery | 11/272 (4.0) | 0/302 (0.0) |
| Midterm clinical outcomesa | ||
| Any mortality during follow‐up | 71/257 (27.6) | 57/302 (18.9) |
| NYHA class III–IV | 21/146 (14.4) | 48/237 (20.3) |
| Moderate or severe MR | 0/83 (0.0) | 11/210 (5.2) |
| HF hospitalization | 46/174 (26.4) | 92/302 (35.7) |
| Unplanned mitral valve reintervention | 4/174 (2.3) | 10/302 (3.3)b |
| Device embolization or migration | 2/254 (0.8) | 1/293 (0.3) |
| Endocarditis | 4/150 (2.7) | 0/293 (0.0) |
Values are mean±SD or n/N (%). COAPT indicates Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy; HF, heart failure; MR, mitral regurgitation; NYHA, New York Heart Association; STS‐PROM, Society of Thoracic Surgeons Predicted Risk of Mortality; TMVR, transcatheter mitral valve replacement.
a
Midterm follow‐up for TMVR cohort and COAPT device group were 10.1 and 12 mo, respectively.
b
Unplanned mitral valve intervention within 24 mo.