Clinical and procedural characteristics in patients with or without PPM in the S3, XT and entire cohorts
| S3 cohort | XT cohort | Entire cohort | |||||||
| PPM | non-PPM | P value | PPM | non-PPM | P value | PPM | non-PPM | P value | |
| n=120 | n=700 | n=115 | n=1199 | n=235 | n=1899 | ||||
| Clinical characteristics | |||||||||
| Age, years | 83.0 (80.0–86.0) | 84.0 (81.0–88.0) | 0.007 | 83.0 (80.0–87.0) | 85.0 (82.0–88.0) | 0.006 | 83.0 (80.0–87.0) | 85.0 (81.0–88.0) | 0.00007 |
| Female | 86 (71.7) | 467 (66.7) | 0.34 | 86 (74.8) | 834.0 (69.6) | 0.29 | 172 (73.2) | 1301.0 (68.5) | 0.16 |
| Height, cm | 152.0 (146.8–159.3) | 150.0 (144.0–158.0) | 0.04 | 148.8 (145.0–155.4) | 149.0 (143.5–156.0) | 0.62 | 150.0 (145.0–158.0) | 149.5 (143.8–156.5) | 0.04 |
| Weight, kg | 53.62 (45.77–60.0) | 49.8 (43.0–57.8) | 0.01 | 49.2 (43.9–57.8) | 49.0 (42.3–56.0) | 0.14 | 51.8 (45.1–58.8) | 49.25 (42.55–56.68) | 0.002 |
| Body mass index, kg/m2 | 22.8 (20.3–25.4) | 22.21 (19.7–24.5) | 0.12 | 22.4 (19.9–25.2) | 22.0 (19.6–24.3) | 0.17 | 22.58 (20.25–25.3) | 22.06 (19.63–24.34) | 0.03 |
| Body surface area, m2 | 1.5 (1.4–1.6) | 1.4 (1.3–1.6) | 0.006 | 1.45 (1.33–1.52) | 1.41 (1.3–1.53) | 0.28 | 1.46 (1.34–1.59) | 1.4 (1.3–1.54) | 0.003 |
| NYHA class, III or IV | 66 (55.0) | 350 (50.0) | 0.32 | 57 (49.6) | 601 (50.1) | 0.92 | 123 (52.3) | 951 (50.1) | 0.53 |
| Dyslipidaemia | 62 (51.7) | 302 (43.1) | 0.09 | 55 (47.8) | 492 (41.0) | 0.17 | 117 (49.8) | 794 (41.8) | 0.02 |
| Diabetes mellitus | 33 (27.5) | 161 (23.0) | 0.30 | 22 (19.1) | 257 (21.4) | 0.63 | 55 (23.4) | 418 (22.0) | 0.62 |
| Hypertension | 91 (75.8) | 515 (73.6) | 0.65 | 97 (84.3) | 933 (77.8) | 0.12 | 188 (80.0) | 1448 (76.3) | 0.22 |
| COPD | 13 (10.8) | 71 (10.1) | 0.87 | 18 (15.7) | 207 (17.3) | 0.80 | 31 (13.2) | 278 (14.6) | 0.62 |
| eGFR, mL/min/1.73 m² | 49.4 (40.0–60.0) | 51.4 (38.0–64.0) | 0.29 | 48.0 (37.5–60.3) | 50.6 (37.6–64.4) | 0.26 | 48.98 (38.5–60.0) | 51.0 (37.83–64.1) | 0.13 |
| Logistic EuroSCORE, % | 11.5 (8.1–19.6) | 12.1 (8.0–19.0) | 0.70 | 13.1 (9.0–23.3) | 12.8 (8.4–21.4) | 0.51 | 12.3 (8.6–20.8) | 12.8 (8.0–20.5) | 0.91 |
| STS score, % | 5.0 (3.6–7.5) | 6.1 (4.3–9.1) | 0.001 | 6.3 (4.8–9.3) | 6.8 (4.7–9.4) | 0.74 | 5.7 (4.1–8.5) | 6.6 (4.5–9.3) | 0.006 |
| Echocardiographic data | |||||||||
| AVA, cm2 | 0.56 (0.47–0.71) | 0.65 (0.53–0.76) | 0.0001 | 0.56 (0.49–0.69) | 0.63 (0.51–0.75) | 0.0009 | 0.56 (0.48–0.7) | 0.64 (0.52–0.75) | <0.0001 |
| Indexed AVA, cm2/m2 | 0.4 (0.3–0.5) | 0.46 (0.4–0.5) | <0.0001 | 0.4 (0.32–0.48) | 0.44 (0.37–0.52) | 0.0002 | 0.4 (0.3–0.49) | 0.44 (0.38–0.52) | <0.0001 |
| Peak velocity, m/s | 4.56 (4.02–5.2) | 4.5 (4.06–5.02) | 0.33 | 4.47 (4.0–4.9) | 4.5 (4.05–5.07) | 0.23 | 4.5 (4.0–5.0) | 4.5 (4.1–5.1) | 0.890 |
| Mean gradient, mm Hg | 49.5 (38.8–65.3) | 47.0 (38.0–61.0) | 0.43 | 47.2 (36.5–57.5) | 47.9 (38.0–60.15) | 0.44 | 47.8 (37.0–63.0) | 47.5 (38.0–60.5) | 0.940 |
| LVEF modified simpson, % | 61.0 (53.8–66.6) | 63.1 (54.3–69.2) | 0.26 | 62.0 (55.0–68.0) | 61.56 (51.74–67.3) | 0.39 | 61.2 (54.6–67.51) | 62.0 (52.0–68.0) | 0.005 |
| AR ≧ moderate | 16 (13.3) | 86 (12.3) | 0.76 | 17 (14.8) | 106 (8.8) | 0.04 | 33 (14.0) | 192.0 (10.1) | 0.07 |
| MR ≧ moderate | 19 (15.8) | 88 (12.6) | 0.31 | 16 (13.9) | 108 (9.0) | 0.09 | 35 (14.9) | 196.0 (10.3) | 0.04 |
| CT data | |||||||||
| Annular area, mm2 | 377.1 (339.1–427.5) | 399.2 (357.0–458.7) | 0.002 | 352.0 (320.1–394.0) | 387.0 (346.2–437.7) | <0.0001 | 365.4 (328.7–415.7) | 391.9 (350.4–444.5) | <0.0001 |
| Mean annulus diameter, mm | 22.3 (20.9–23.7) | 22.6 (21.4–24.4) | 0.01 | 21.5 (20.2–22.7) | 22.3 (21.1–23.6) | <0.0003 | 21.8 (20.7–23.2) | 22.4 (21.2–23.9) | <0.0001 |
| Procedural Characteristics | |||||||||
| Size of prosthesis | <0.0001 | <0.0001 | <0.0001 | ||||||
| 20 mm | 22 (18.3) | 39 (5.6) | 9 (7.8) | 22 (1.8) | 31 (13.2) | 61 (3.2) | |||
| 23 mm | 73 (60.8) | 399 (57.0) | 80 (69.6) | 695 (58.0) | 153 (65.1) | 1094 (57.6) | |||
| 26 mm | 22 (18.3) | 220 (31.4) | 24 (20.9) | 430 (35.9) | 46 (19.6) | 650 (34.2) | |||
| 29 mm | 3 (2.5) | 42 (6.0) | 2 (1.7) | 52 (4.3) | 5 (2.1) | 94 (5.0) | |||
| Size of prosthesis ≦ 23 mm | 95 (17.8) | 25 (8.7) | 0.0004 | 89 (11.0) | 26 (5.1) | 0.0002 | 51 (6.4) | 184 (13.7) | <0.0001 |
| Transfemoral approach | 119 (99.2) | 697.0 (99.6) | 0.47 | 74 (64.3) | 924.0 (77.1) | 0.004 | 193 (82.1) | 1621.0 (85.4) | 0.21 |
| Area oversizing | 110.6 (100.4–118.6) | 110.2 (102.8–117.6) | 0.66 | 121.7 (111.5–129.1) | 117.9 (109.8–126.2) | 0.04 | 115.9 (105.8–123.4) | 115.0 (107.1–123.3) | 0.93 |
| Balloon predilatation | 50 (41.7) | 226 (32.3) | 0.05 | 101 (87.8) | 983 (82.0) | 0.12 | 151 (64.3) | 1209 (63.7) | 0.89 |
| Balloon postdilatation | 10 (8.3) | 149 (21.3) | 0.0006 | 15 (13.0) | 284 (23.7) | 0.01 | 25 (10.6) | 433 (22.8) | <0.0001 |
| Contrast volume, ml | 80.0 (50.0–123.5) | 99.5 (65.0–131.8) | 0.001 | 108.0 (77.5–138.0) | 117.0 (83.0–153.0) | 0.07 | 96.0 (60.0–128.0) | 109.0 (79.0–146.0) | <0.0001 |
| Fluoroscopy time, min | 16.2 (13.4–20.7) | 17.7 (14.0–22.9) | 0.049 | 19.4 (12.7–27.0) | 19.0 (14.0–25.0) | 0.62 | 17.4 (13.1–24.0) | 18.6 (14.0–24.0) | 0.19 |
Values are presented as the median (IQR), mean±SD, or n (%).
AR, aortic valve regurgitation; AVA, aortic valve area; BSA, body surface area; eGFR, estimated glomerular filtration rate; EuroSCORE, European System for Cardiac Operative Risk Evaluation; LVEF, left ventricular ejection fraction; MR, mitral valve regurgitation; NYHA, New York Heart Association; PPM, prosthesis–patient mismatch; S3, SAPIEN; STS, Society of Thoracic Surgeons; TAVI, transcatheter aortic valve implantation; XT, SAPIEN XT.