Table 4.
Trials regarding heterotopic caval valve implantation.
| Author | Device | Participants (Age) | Follow-Up Time | Outcomes | ||
|---|---|---|---|---|---|---|
| NYHA Class | 6MWT Distance/KCCQ Score | Safety Endpoints | ||||
| Dreger et al. [66] | Sapien | 28 (14 intervention vs. 14 medical therapy) (77) | 1 year | The trial was stopped due to safety concerns (valve dislocations) at 3 months. However, a significant (p = 0.025) improvement in NYHA class was reported. | ||
| Lauten et al. (TRICUS) [67] | TricValve and others | 25 (73.9) (TtricValve = 6) | 1 year | A total of 52.7% were NYHA class I/II. | Not mentioned. |
The 30-day mortality was 8%. In-hospital mortality was 16%. |
| Estévez-Loureiro (TRICUS EURO study) [68] | TricValve | 35 (76) | 30 days and 6 months | A total of 79.4% of patients were NYHA class I/II at 6 months (p = 0.0006). | KCCQ score was improved by 17.7 points at 6 months (p = 0.004). | All-cause mortality rate was 8.5%. Heart failure hospitalization rate was 20%. |
| Wild et al. [69] | Tricento | 21 (76) | 1 year | A total of 65% of patients were NYHA class I/II. | Not mentioned. | Technical success was 100%. In-hospital mortality was 0%. The 1-year survival rate was 76%. Heart failure rehospitalization rate was 19% at 1 year. |