Table 1.
Trials regarding transcatheter edge-to-edge repair (TEER) of the tricuspid valve.
| Author | Device | Participants (Age) | Follow-Up Time | Outcomes | |||
|---|---|---|---|---|---|---|---|
| TR Reduction | NYHA Class | 6MWT/KCCQ Score | Safety Endpoints | ||||
| Nickenig et al. [33] | MitraClip | 64 (76.6) | 30 days | A total of 91% of patients had at least 1 TR grade reduction, and 13% of patients remained in severe/massive TR; however, there was a significant decrease compared to baseline (88%) (p = 0.01). | No patients were NYHA IV; however, 63% remained NYHA III. | A 6 min walking test was significantly improved after the procedure (16.1 m increase; p = 0.007). | The device was implanted successfully in 97% of patients. There were no intraprocedural deaths. In-hospital mortality rate was 5%. |
| Orban et al. [34] | MitraClip | 50 (77) | 6 months | A total of 90% of patients had a reduction of at least 1 TR grade and 77% had a TR grade lower than 2. | NYHA class was improved by at least 1 class in 79% of patients. | A 6MWT distance was found to be increased by 44% (84 m, p = 0.056) and KCCQ score was improved by 21 points (p < 0.0001). | The event free survival rate was 78%. There was a total of 28% of patients hospitalized for worsening heart failure during the follow-up period. |
| Braun et al. [35] | MitraClip | 31 (77) | 30 days | A total of 69% of patients had a TR grade lower or equal to 2. | A total of 69% of patients were NYHA class I/II (p < 0.001). | Not mentioned. | A total of 1 patient died due to insufficient TR reduction. |
| Mehr et al. (TriValve registry) [36] | TriClip | 249 (77) | 1 year | TR reduction was sustained in 84% of patients, and 72% of patients had a TR grade lower or equal to 2 at the time of the follow-up. | A total of 69% of patients were NYHA I/II at the follow-up (p < 0.001). | Not mentioned. | Implantations success rate was 96%. The combined endpoint of death or unplanned hospitalization for heart failure occurred in 31% of patients. One year mortality rate was 20.3%. |
| Lurz et al. (TRILUMINATE) [37] | TriClip | 85 (77.8) | 1 year | At 1 year, 87% of subjects had a sustained TR reduction of at least 1 TR severity grade, and 70% of subjects had moderate or less TR at the time of the follow-up. | A total of 83% of patients were NYHA I/II at 1 year. | A 6MWT distance increased from by 31 m at 1 year. | Hospitalization rate decreased from 1.30 to 0.78 events/patient–year. |
| Lurz et al. (bRIGHT study) [38] | TriClip | 300 (78.5) | 30 days | A total of 71% of patients had moderate or less TR (p < 0.0001). | A total of 78% of patients were NYHA class I/II (p < 0.0001). | There was a significant improvement in KCCQ score by 18 points (p < 0.0001). | Implantation success was 98%. Major adverse event rate was 1%. |
| Lurz et al. (bRIGHT study) [39] | TriClip | 200 (78) | 1 year | A total of 86% of patients had moderate or less TR at 1 year follow-up. | A total of 77% of patients were NYHA class I/II. | KCCQ score was significantly improved by 21 points (p < 0.0001). | The major adverse event rate was 11.5%. All-cause mortality was 11.0%. There was a 44% reduction in heart failure hospitalizations during the follow-up, compared to the year before the intervention. |
| Adams et al. (TRILUMINATE-Pivotal study) [40] | TriClip | 97 (79) | 30 days | A total of 74% of patients had less than moderate TR, and 67% of patients had a reduction in TR class of at least 2 grades. | A total of 76% of patients were NYHA I/II. | KCCQ score was significantly improved by 16.64 points. | The implantation success was 99%. Mortality rate was 1% 7.2% had a major bleeding during the follow-up. |
| Sorajja et al. (TRILUMINATE-Pivotal 1 year follow-up) [41] | TriClip | 350, 175 in each arm (TriClip vs. medical therapy) (78) | 30 days 1 year |
TEER arm: 87.0% of the TR of no greater than moderate at 30 days. Medical therapy arm: 4.8% of the TR of no greater than moderate at 30 days. |
TEER arm: 83.9% of patients were NYHA I/II at 1 year follow-up. Medical therapy arm: 59.5% of patients were NYHA I/II at 1 year follow-up. |
TEER arm: KCCQ score was improved by a mean of 12.3 ± 1.8 points. Medical therapy arm: KCCQ score was improved by a mean of 0.6 ± 1.8 point. |
A total of 98.3% of the patients who underwent the procedure were free from major adverse events at the 30 day follow-up. |
| Fam et al. [42] | PASCAL | 28 (78) | 30 days | A total of 85% of patients had a TR grade lower or equal to 2. | A total of 88% of patients were NYHA class I/II at the follow-up. | A 6MWT distance was increased by 95 m (p < 0.001). | Mortality rate was 7.1%. |
| Kitamura et al. [43] | PASCAL | 30 (77) | 1 year | TR reduction of at least 1 grade was sustained in 89% of patients at 1 year, and 82% and 86% of patients had moderate or less TR at the 30 day and 1 year, respectively. |
A total of 90% of patients were NYHA class I/II. | A 6MWT distance was increased by72 m at 1 year (p < 0.01). | A 1 year survival rate was 93%. A total of 20% of patients required a rehospitalization due to acute heart failure during the 1 year follow-up period. Cardiovascular mortality rate was 6.7%. |
| Kodali et al. [44] | PASCAL | 34 (76) | 30 days | A total of 85% of patients had a TR severity reduction of at least 1 grade at 30 days, and 52% had moderate or less TR severity (p < 0.001). | A total of 89% of the patients followed up were NYHA class I/II (p < 0.001). | A 6MWT distance was improved by 71 m (p < 0.001) and KCCQ score improved by 15 points (p < 0.001). | The major adverse events rate was 5.9%. |
| Baldus et al. (TriClasp study) [45] | PASCAL | 74(with 72 undergoing the procedure) (80) | 30 days | A total of 88% of patients achieved at least 1 TR grade reduction, and 90% had moderate or lower TR severity. | A total of 56% of patients were NYHA class I/II. | A 6MWT distance was significantly improved by 38 m (p < 0.001) and KCCQ scire was significantly improved by 13 points (p < 0.001). | Successful implantation rate was 97%. All-cause mortality rate was 2.9%. Composite major adverse event rate was 3.0%. Cardiovascular mortality rate was 1.5%. Heart failure rehospitalization rate was 4.5%. |
| Schofer et al. (TriClasp study) [46] | Pascal | 177 (80) | 6 months | A total of 88% of patients had moderate or lower TR, and 83% of patients achieved equal or greater than 1 TR grade reduction at 6 months. | A total of 61% of patients were NYHA class I/II. | A 6MWT distance was improved by 32 m (p = 0.01) and KCCQ score was improved by 9 points (p < 0.001). | Implantation success was 99%. The composite major adverse events rate was 4%. All-cause mortality rate was 5.1%. Cardiovascular mortality rate was 2.3%. The rate of heart failure hospitalization was 7.9% at 6 months. |
| Davidson et al. (CLASP II TR roll in) [47] | PASCAL | 73 (79.8) | 30 days | A total of 83.0% of patients improved by 1 or more TR grade, 62.3% improved by 2 or more grades, and 73.6% of patients had moderate or less TR severity. | A total of 86% of patients were NYHA class I/II. | KCCQ score was significantly improved by 17.9 points (p < 0.001). | The rate of successful implantation was 84.4%. The composite major adverse events rate was 8.7%. Cardiovascular mortality rate was 0%. All-cause mortality and heart failure hospitalization rate were both 0%. |
| Hahn et al. (CLASP TR) [48] | PASCAL | 65 (46 had 1 year follow-up) (77) | 1 year | A total of 100% of patients improved by at least 1 TR grade, while 75% improved by at least 2 TR grades, and 86% of patients had moderate or less TR severity at 1 year. | A total of 92% of patients were NYHA class I/II. | A 6MWT distance was significantly increased by 94 m (p < 0.014). KCCQ score was significantly improved by 18 points (p < 0.001). |
The implantation success rate was 91%. The composite major adverse events rate was 16.9%. All-cause mortality rate was 10.8%. Cardiovascular mortality rate was 7.7%. Heart failure rehospitalization rate was 18.5%. |