Table 4.
Short‐Term Clinical Outcomes as Defined by Valve Academic Research Consortium‐2 Criteria and Predischarge Echocardiographic Parameters
| Variable | Total cohort | Small THV cohort | PSM small THV cohort | ||||||
| Evolut PRO/PRO+/Evolut R 34 mm (N=917) | S3/Ultra (N=756) | P value | Evolut PRO/PRO (N=284) | S3/Ultra (N=260) | P value | Evolut PRO/PRO+ (N=139) | S3/Ultra (N=139) | P value | |
| Predischarge echocardiographic parameters* | |||||||||
| Peak AV gradient, mm Hg | 16.3±8.0 [772] | 21.9±8.0 [581] | <0.001 | 18.0±10.0 [240] | 26.0±10.4 [203] | <0.001 | 18±8.3 | 25.2±8.8 | <0.001 |
| Peak AV gradient ≥20 mm Hg | 207 (26.8) | 343 (59) | <0.001 | 82 (34.2) | 151 (74.4) | <0.001 | 42 (36.8) | 77 (73.3) | <0.001 |
| Mean AV gradient, mm Hg | 8.8±5.0 [756] | 11.5±5 [513] | <0.001 | 9.7±5.5 [236] | 14.0±5.9 [181] | <0.001 | 9.7±4.6 | 13.5±5.3 | <0.001 |
| Residual PVR (moderate/severe), n (%) | 49 (5.6) | 5 (0.7) | <0.001 | 11 (4) | 3 (1.2) | <0.001 | 6 (4.4) | 3 (2.2) | <0.001 |
| Procedural complications, n (%) | |||||||||
| Valve malposition | 0.429 | ||||||||
| Valve migration | 10 (1.2) | 2 (0.3) | 0.381 | 2 (0.7) | 0 | 0.4 | 0 | 0 | |
| Valve embolization | 1 (0.1) | 1 (0.2) | 1 (0.4) | 0 | 0 | 0 | |||
| Ectopic valve deployment | 3 (0.4) | 2 (0.3) | 0 | 1 (0.5) | 0 | 1 (1) | |||
| Bail out valve in valve | 9 (1) | 5 (0.7) | 0.482 | 2 (0.7) | 3 (1.2) | 0.673 | 0 | 2 (1.5) | 0.242 |
| Tamponade | 13 (1.5) | 13 (1.8) | 0.520 | 8 (2.9) | 3 (1.2) | 0.166 | 4 (2.9) | 2 (1.5) | 0.684 |
| Conversion to full sternotomy | 6 (0.7) | 3 (0.5) | 0.619 | 4 (1.5) | 2 (1.0) | 0.710 | 2 (2) | 2 (1.5) | 1.000 |
| Periprocedural complications (during in‐hospital stay) | |||||||||
| New PPM implantation† | 114 (14.4) | 81 (13.4) | 0.58 | 29 (11.3) | 19 (9.4) | 0.503 | 10 (7.9) | 7 (6.6) | 0.698 |
| Periprocedural MI | 4 (0.4) | 4 (0.5) | 0.784 | 2 (0.7) | 1 (0.4) | 1.000 | 2 (1.4) | 1 (0.7) | 1.0 |
| Bailout PCI | 6 (0.7) | 8 (1.1) | 0.367 | 2 (0.7) | 2 (0.8) | 1.000 | 2 (1.5) | 2 (2) | 0.771 |
| CVA | 28 (3.2) | 18 (2.5) | 0.405 | 15 (5.6) | 6 (2.4) | 0.068 | 8 (6.1) | 4 (3.0) | 0.255 |
| Postprocedural renal replacement | 12 (1.4) | 6 (1.0) | 0.528 | 4 (1.5) | 2 (1.1) | 1.000 | 1 (0.7) | 2 (2.1) | 0.574 |
| Acute kidney injury (stage 3) | 27 (3.3) | 8 (2) | 0.422 | 10 (3.8) | 3 (2.3) | 0.438 | 3 (2.2) | 2 (2.4) | 0.683 |
| Periprocedural bleeding complications (life threatening+major) | 26 (3) | 9 (1.8) | 0.065 | 12 (4.4) | 3 (1.7) | 0.344 | 5 (3.7) | 3 (2.7) | 0.775 |
| Vascular major complications | 34 (3.9) | 18 (2.5) | 0.012 | 17 (6.2) | 8 (3.2) | 0.26 | 5 (3.6) | 3 (2.2) | 0.871 |
| Death at discharge | 15 (1.7) | 15 (2.1) | 0.553 | 4 (1.5) | 4 (1.6) | 1.000 | 2 (1.5) | 2 (1.5) | 1.000 |
Data are given as mean±SD unless otherwise indicated. Data in brackets are number of patients with available data. AV indicates aortic valve; CVA, cerebrovascular accident; MI, myocardial infarction; PCI, percutaneous coronary intervention; PPM, permanent pacemaker; PSM, propensity score matched; PVR, paravalvular regurgitation; and THV, transcatheter heart valve.
*
N=878 Evolut group and N=726 Edwards SAPIEN group in all patients, and N=234 Evolut PRO and N=190 Edwards SAPIEN group in patients with small THVs.
†
Excluding patients with previous PPM.