Table 1.
Study | N | Device | Incidence of moderate PPM (%) | Incidence of severe PPM (%) | Impact of moderate PPM on mortality | Impact of severe PPM on mortality |
---|---|---|---|---|---|---|
Intra-annular BEV | ||||||
PARTNER IA trial (67)** | 304 | Sapien | 27 | 20 | HR (95% CI) = 1.10 (0.67–1.80) | HR (95% CI) = 0.58 (0.30–1.13) |
PARTNER IA NRCA registry (67)* | 1,637 | Sapien | 30 | 14 | HR (95% CI) = 0.94 (0.69–1.29) | HR (95% CI) = 1.20 (0.81–1.78) |
PARTNER II S3i cohort (68)* | 765 | Sapien 3 | 36 18 (CT) | 96 (CT) | Any PPM vs. no PPM HR (95% CI) = 0.68 (0.39–1.17) Any PPM vs. no PPM HR (95% CI) = 0.60 (0.30–1.24) | |
PARTNER III trial (69)* | 496 | Sapien 3 | 29 | 5 | HR (95% CI) = 0.95 (0.60–1.50) | HR (95% CI) = 1.31 (0.60–2.86) |
Supra-annular SEV | ||||||
CoreValve US High Risk trial (70)* | 390 | CoreValve | 19 | 7 | - | Severe PPM vs. no severe PPM log-rank p = 0.24 |
Evolut Low Risk trial (71)* | 722 | Evolut R (74%), Evolut PRO (22%), CoreValve (4%) | 10 | 1 | - | - |
BEV + SEV | ||||||
STS/TVT ACC registry (72)* | 62,125 | - | 25 | 12 | HR (95% CI) = 1.00 (0.93–1.07) | HR (95% CI) = 1.19 (1.09–1.31) |
Swiss TAVI registry (73)* | 448 | Sapien, Sapien XT and Sapien 3 (50%)CoreValve and Evolut R (50%) | 31 (BEV)27 (SEV) | 16 (BEV)7 (SEV) | HR (95% CI) = 0.96 (0.42–2.23) for CV mortality | HR (95% CI) = 1.6 (0.59–4.34) for CV mortality |
OCEAN TAVI registry (74)* | 1,546 | Sapien XT (82%), Sapien 3 (9%), CoreValve (9%) | 9 | 1 | Any PPM vs. no PPM log-rank p = 0.41 | |
Registry by Schofer et al. (38)*** | 1,309 | 23 | 13 | Severe PPM vs. moderate PPM vs. no PPM log-rank p = 0.59 | ||
Intra-annular BEV (49%) | 25 | 11 | HR (95% CI) = 1.89 (1.13–3.16) if LVEF <40% | |||
Supra-annular SEV (21%) | 14 | 4 | ||||
Intra-annular SEV (12%) | 13 | 24 | ||||
Cusp-fixating SEV (12%) | 42 | 25 | ||||
Infra-annular mechanically-expandable THV (5%) | 19 | 13 | ||||
Non-metallic THV (0.2%) | 33 | 0 | ||||
Registry by Ternacle et al. (27)* | 1,088 | Sapien (17%), Sapien XT (39%) and Sapien 3 (27%), CoreValve (4%), Evolut R (13%) | 27 | 17 | HR (95% CI) = 1.38 (0.92–2.06) | HR (95% CI) = 1.02 (0.60–1.72) |
10 (predicted) | 1 (predicted) | Any PPM vs. no PPM HR (95% CI) = 1.22 (0.67–2.23) |
BEV, ballon-expandable valve; CI, confidence interval; CT, computed tomography; CV, cardiovascular; HR, hazard ratio; LVEF, left ventricular ejection fraction; PPM, prosthesis-patient mismatch; SEV, self-expandable valve.
If not otherwise stated, the reported results are for the following comparisons: moderate PPM vs. no PPM, severe PPM vs. no PPM.
1-year follow-up.
2-year follow-up.
3-year follow-up.