Table 1.
Clinical, procedural, and follow-up characteristics from the main studies using coaptation devices.
| MitraClip/TriClip | PASCAL | FORMA | ||||
|---|---|---|---|---|---|---|
| Mehr et al. (18) (n = 249) | Nickenig et al. (8) (n = 85) | Fam et al. (6) (n = 28) | Perlman et al. (27) (n = 18) | Kodali et al. (28) (n = 29) | ||
| Baseline characteristics | ||||||
| Age, years | 77 ± 9 | 78 ± 8 | 78 ± 6 | 76 ± 10 | 76 ± 8 | |
| Female, n (%) | 128 (51) | 56 (66) | 15 (54) | 13 (72) | 19 (66) | |
| Atrial fibrillation, n (%) | 183 (74) | 78 (92) | 26 (93) | 16 (89) | 24 (83) | |
| NYHA III-IV, n (%) | 238 (96) | 64 (75) | 28 (100) | 17 (94) | 25 (86) | |
| Transtricusid CIED, n (%) | 74 (30) | 12 (14) | 1 (3) | 3 (17) | n/a | |
| EuroSCORE II, % | 6.4 (4-14) | 8.6 ± 11 | 6.2 ± 5.2 | 9 ± 5.7 | 8.4 ± 5.3 | |
| Echocardiography | ||||||
| LVEF, % | 49 ± 14 | 59 ± 8 | 59 ± 6 | 59 ± 9 | 57 ± 12 | |
| TAPSE, mm | 16 ± 4 | 14 ± 0.3 | 16 ± 3 | 15 ± 5 | 14 ± 0.4 | |
| TR grade | TR 5+ (%) | n/a | 31/84 (37) | 12 (43) | 11 (61) | n/a |
| TR 4+ (%) | 129 (52) | 24/84 (29) | 9 (32) | 6 (33) | n/a | |
| TR 3+ (%) | 112 (45) | 24/84 (29) | 7 (25) | 1 (6) | n/a | |
| Maximum gap width, mm | 5.3 ± 3.3 | n/a | 6.9 ± 3 | n/a | n/a | |
| Vena contracta width, mm | 9.9 ± 4.1 | 17 ± 0.6 | 11.4 ± 5 | 12,1 ± 3.3 | 16 ± 0.5 | |
| EROA, cm2 | 0.70 ± 0.5 | 0.65 ± 0.3 | 1.3 ± 2.4 | 1 ± 0.6 | 2,2 ± 1.5 | |
| Mitral regurgitation ≥ moderate, n (%) | 108 (43) | 0 (0) | n/a | 4 (22) | n/a | |
| Procedural and 30-day outcomes | ||||||
| Procedural success, n (%) | 192 (77) | 76/84 (91) | 24 (86) | 16 (89) | 27 (93) | |
| Number of implants, n | 2 ± 1 | 2,2 ± 0.8 | 1,4 ± 0.6 | n/a | n/a | |
| Post-procedural tricuspid gradient, mmHg | 2.4 ± 1.5 | 2.12 ± 1.2* | 1.6 ± 1 | n/a | n/a | |
| Procedural Procedural-related Death, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (7) | |
| Need for cardiac Surgery, n (%) | 1 (0.4) | 0 (0) | 0 (0) | 1 (6) | 3 (10) | |
| 30-day TR grade > moderate, n (%) | n/a | 36/83 (43) | 4/26 (15) | 7/16 (44) | n/a | |
| 30-day mortality, n (%) | n/a | 0 (0) | 2 (7) | 0 (0) | 2 (7) | |
| Follow-up | ||||||
| Follow-up time | 290 days | 6 months | 30 days | 12 months | 30 days | |
| Mortality, n (%) | 44 (19) | 4/84 (5) | 2 (7) | 0 (0) | N/A | |
| TR grade > moderate, n (%) | 46 (28) | 30/70 (43) | 4/26 (15) | 12/13 /92) | 2 (7) | |
| NYHA I-II, n (%) | 121 (69) | 63/73 (86) | 23/26 (88) | 11/14 (79) | 18/25 (72) | |
Values are mean SD or n/N (%).
*
At 30 days. CIED, Cardiac implantable electronic device; EROA, effective regurgitant orifice area; EuroSCORE, European System for Cardiac Operative Risk Evaluation; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; TAPSE, Tricuspid annular plane systolic excursion; TR, Tricuspid regurgitation.