Table 2.
Summary of available clinical data in transcatheter tricuspid repair.
| TriClip (n = 85) | PASCAL (n = 34) | Cardioband (n = 30) | Trialign (n = 15) | FORMA (n = 19) | Mistral (n = 7) | |
|---|---|---|---|---|---|---|
| Baseline | ||||||
| Age, years | 77.8 ± 7.9 | 76.3 ± 10.4 | 75.2 ± 6.6 | 73.6 ± 6.6 | 76 ± 9 | 76.0 |
| Female | 66% | 52.9% | 73.3% | 86.7% | 73.7% | 57% |
| EuroSCORE II | 8.7 ± 10.7 | 5.3 ± 5.2 | 4.1 ± 2.8 | - | 9.2 ± 5.6 | 4.0 |
| NYHA III/IV | 75% | 79.4% | 83.3% | 66.7% | 94.7% | 100% |
| TR etiology | ||||||
| Functional | 84% | 87.9% | 100% | 100% | 100% | 100% |
| CIED RV lead | 14% | 11.8% | 13.3% | 0% | 15.8% | 14% |
|
8% | 3% | 24% | - | 5% | 0% |
| Procedural outcomes | ||||||
| Procedural time (mins) | 75a | 167.7 ± 152a | 254.5 ± 92.8 | 124 ± 62a | - | 58–125 |
| Technical success | 100% | 85.3% | 100% | 100% | 89.5% | 100% |
| In-hospital mortality | 0 | 0 | 3% | 0 | 0 | 0 |
| Conversion to surgery | 0 | 0 | 0 | 0 | 5.3% | 0 |
| Device embolization | 0 | 0 | 0 | 0 | 5.3% | 0 |
| Conduction disturbance | 0 | 0 | 3% | 0 | 0 | 0 |
| Coronary complication | 0 | 0 | 10% | 6.7% | 0 | 0 |
| Follow-up outcomes | ||||||
| Follow-up | 1 year | 30 days | 6 months | 30 days | 32 months | 30 days |
| Mortality | 7.1% | 0% | 10% | 0% | 23.5% | 0 |
| Stroke | 1.2% | 0% | 3%b | 0% | 0%b | 0 |
| Major bleeding | 11.9% | 5.9% | 13% | 0% | 10.5%b | 0 |
| Malposition | 6%c | 2.9%c | 0 | 20%d | 5.3% | 0 |
| TR severity outcomes | ||||||
| <Severe | 71% | 52% | 73% | - | 67% | - |
| ≥1 grade reduction | 87% | 85% | - | - | - | 100% |
| PISA EROA, cm2 (mean) | 0.65 to 0.32; p < 0.0001 | 0.77 to 0.48; p = 0.007 | 0.76 to 0.39; p = 0.0004 | 0.51 to 0.32; p = 0.020 | 0.92 to 0.77; p = 0.52 | 0.52 to 0.15e; p < 0.01 |
| Regurgitant Volume (ml/beat) | 52.20 to 27.68; p < 0.0001 | 51.52 to 38.80; p = 0.060 | 87.4 to 49.5; p = 0.036 | 79.6 to 57; p = 0.065 | - | 49.4 to 19.7e; p < 0.01 |
| Vena contracta (cm) | 1.73 to 0.78; p < 0.0001 | 1.50 to 0.78; p < 0.001 | 1.20 to 0.88; p < 0.0001 | 1.3 to 1.0; p = 0.022 | 1.18 to 0.84; p = 0.005 | 0.95 to 0.62e; p < 0.05 |
| Right heart remodeling | ||||||
| RV base end diastolic dimension (cm) | 5.28 to 4.79; p < 0.0001 | 3.86 to 3.60f; p < 0.05 | 3.76 to 3.72f; p = 0.71 | - | 5.54 to 5.2; p = 0.19 | - |
| Tricuspid annular diameter septal-lateral (cm) | 4.34 to 4.03; p < 0.0001 | 4.51 to 4.27; p = 0.015 | 4.16 to 3.78; p = 0.0014 | 4.0 to 3.8; p = 0.038 | 4.6 to 4.3; p = 0.090 | - |
| TAPSE (cm) | 1.44 to 1.59; p = 0.0002 | 1.45 to 1.70; p = 0.39 | - | 1.7 to 1.6; p = 0.31 | 1.53 to 1.48; p = 0.80 | 1.6 to 2 (median); p < 0.05 |
| Clinical outcomes | ||||||
| NYHA I/II | 83% | 83% | 88% | 100% | 66.7% | 100% |
| 6MWD | +31 m p = 0.002 | +70 m p < 0.001 | +60 m p = 0.004 | +53 m p = 0.008 | +54 m p = 0.016 | +102 m p < 0.05 |
| KCCQ | +20 p < 0.0001 | +15 p < 0.001 | +24 p < 0.0001 | −26.5g p < 0.001 | +16.2 p = 0.016 | +20.2 p < 0.05 |
a
Implant time.
b
30-day follow-up.
c
Single Leaflet Device Attachment (SLDA).
d
Single pledget detachment, no reintervention.
e
Medial.
f
RV mid end diastolic dimension.
g
MLHFQ, Minnesota Living with Heart Failure Questionnaire.
NYHA, New York Heart Association; CIED, Cardiac implantable electronic device; RV, Right ventricle; TR, Tricuspid regurgitation; PISA, Proximal isovelocity surface area; EROA, Effective regurgitant orifice area; TAPSE, Tricuspid annular plane systolic excursion; 6MWD, 6 min walk distance; KCCQ, Kansas City Cardiomyopathy Questionnaire.