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. 2021 Jun 4;8:670457. doi: 10.3389/fcvm.2021.670457

Table 1.

Selected studies assessing incidence and impact of PPM after TAVI.

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.