Table A11:
Study Results—Quality of Life (KCCQ Overall Score)
Author, Year N (TAVI/SAVR) | KCCQ Overall Score, Mean Change from Baseline (95% CI) AMD (95% CI), TAVI vs. SAVR | KCCQ Overall Score % With ≥ 10 Pointsa Improvement Over Time | |||||
---|---|---|---|---|---|---|---|
30 Days | 6 Months | 1 Year | 2 Years | 30 Days | 1 Year | 2 Years | |
Reardon et al, 201719 SURTAVI, mITT 1,660 (864/796) mITT |
TAVI: 18.4 (SD 22.8) SAVR: 5.9 (SD 27.0) 95% CrI for difference: 10.0–15.1 |
TAVI: 21.8 (SD 22.3) SAVR: 21.3 (SD 22.3) 95% Crl for difference: −1.9 to 2.8 |
TAVI: 20.9 (SD 22.2) SAVR: 20.6 (SD 22.2) 95% CrI for difference: −2.2 to 2.9 |
Not reported | Not reported | Not reported | Not reported |
Leon et al, 2016b10 PARTNER 2, transfemoral cohort 1,550 (775/775) |
TAVI: 17.5 (15.8–19.3) SAVR: 3.2 (1.3–5.5) AMD: 14.1 (11.7–16.4) P < .001 |
Not reported | TAVI: 22.1 (20.4–23.9) SAVR: 22.1 (20.1–24.1) AMD: −0.1 (−2.2 to 2.1) P = .94 |
TAVI: 20.2 (18.2–22.2) SAVR: 18.4 (16.3–20.6) AMD: 1.0 (−1.5 to 3.5) P = .42 |
TAVI: 64.0 SAVR: 41.2 P < .001 |
TAVI: 71.1 SAVR: 68.9 P = .36 |
TAVI: 67.2 SAVR: 66.2 P = .98 |
Leon et al, 2016b10 PARTNER 2, transthoracic cohort 482 (236/246) |
TAVI: 6.4 (2.5–10.3) SAVR: 5.6 (1.5–9.6) AMD: 3.5 (−1.4 to 8.4) P = .17 |
Not reported | TAVI: 16.7 (13.0–20.4) SAVR: 18.6 (15.2–21.9) AMD: −0.5 (−5.1 to 4.0) P = .82 |
TAVI: 15.8 (12.0–19.7) SAVR: 17.7 (13.6–21.7) AMD: −1.2 (−6.5 to 4.1) P = .66 |
TAVI: 46.4 SAVR: 42.2 P = .17 |
TAVI: 57.8 SAVR: 65.8 P = .099 |
TAVI: 62.3 SAVR: 68.2 P = .31 |
Abbreviations: AMD, adjusted mean difference; CI, confidence interval; CrI, credible interval; KCCQ, Kansas City Cardiomyopathy Questionnaire; mITT, modified intention to treat; SAVR, surgical aortic valve replacement; SD, standard deviation; TAVI, transcatheter aortic valve implantation.
Considered a substantial or moderate improvement.
Results for the full cohort were not provided because there was a significant interaction between access site and treatment group for several key health status measurements at 1 month.