Table 3.
Summary characteristics of TAVI studies and trials concerning valve durability.
| Study | Study Design | Patients, n TAVI vs. SAVR |
Age TAVI vs. SAVR |
STS TAVI vs. SAVR |
Prosthes | Follow-Up, Years | Results/Interpretation |
|---|---|---|---|---|---|---|---|
| PARTNER 1A | Randomized trial | 348 vs. 351 | 83.6 ± 6.8; 84.5 ± 6.4 | 11.8 ± 3.3; 11.7 ± 3.5 | BE vs. SAVR | 5 | No cases of SVD. Rate of moderate/severe AR was higher in TAVI cohort |
| PARTNER 2A | Randomized trial | 1011 vs. 1021 | 81.5 ± 6.7; 81.7 ± 6.7 |
5.8 ± 2.1; 5.8 ± 1.9 |
BE vs. SAVR | 5 | Freedom from SVD resulted higher in the SAVR group. Rate of mild PVR was higher in TAVI cohort |
| CoreValve U.S. | Randomized trial | 390 vs. 357 | 83.2 ± 7.1; 83.5 ± 6.3 | 7.3 ± 3; 7.5 ± 3.2 |
SE vs. SAVR | 5 | Higher rate of moderate SVD in surgery cohort. Rate of moderate/severe AR was higher in TAVI cohort |
| SURTAVI | Randomized trial | 864 vs. 796 | 79.9 ± 6.2; 79.7 ± 6.1 |
4.4 ± 1.5; 4.5 ± 1.6 |
SE vs. SAVR | 5 | No difference between the groups in terms of SVD |
| PARTNER 3 | Randomized trial | 503 vs. 497 | 73.3 ± 5.8; 73.6 ± 6.1 |
1.9 ± 0.7; 1.9 ± 0.6 |
BE vs. SAVR | 5 | BVF of 1.4% in the TAVR group and of 2.0% in the SAVR group |
| Evolut Low Risk | Randomized trial | 734 vs. 734 | 74.1 ± 5.8; 73.6 ± 5.9 |
1.9 ± 0.7; 1.9 ± 0.7 |
SE vs. SAVR | 3 | No difference in terms of reintervention. Rate of PPM superior in surgery cohort |
| CHOICE | Randomized trial | 121 vs 120 (BE vs. SE) |
81.9 ± 6.7; 79.6 ± 15.8 (BE vs. SE) |
5.6 ± 2.9 6.2 ± 3.9 (BE vs. SE) |
SE vs. BE | 5 | Moderate or severe SVD occurred more frequently with BE prosthesis |
| NOTION-2 * | Randomized trial | 187 vs. 183 | 71.1 ± 3.1; 71.0 ± 3.2 |
1.1 (0.9 − 1.5) 1.1 (0.8 − 1.5) |
SE vs. SAVR | 3 | No difference between the groups in terms of SVD |
| NOTION | Randomized trial | 145 vs. 135 | 79.2 ± 4.9 79.0 ± 4.7 |
2.9 ± 1.6 3.1 ± 1.7 |
SE vs. SAVR | 10 | SVD was lower in patients who underwent TAVI |
| Testa et al. [63] | Registry | 990 | 82 ± 6 | 9 ± 10 | SE | 8 | Low cumulative incidence of BVF and SVD |
BE: balloon-expanding; BVF: bioprosthesis valve failure; PVR: perivalvular regurgitation; SAVR: surgical aortic valve replacement; SE: self-expanding; STS: Society of Thoracic Surgeons Score; SVD: structural valve deterioration; TAVI: transcatheter aortic valve implantation. *: It was the first trial that randomized patients with a bicuspid anatomy.