Table 2.
Procedural characteristics.
| Characteristic | Portico™ DS 1 % (n) of Subjects (n = 501) |
FlexNav™ DS % (n) of Subjects (n = 500) |
p-Value | Total % (n) of Subjects (n = 1001) |
|---|---|---|---|---|
| Portico™ valve implant success | 97.4% (488) | 97.6% (488) | 0.8434 | 97.5% (976) |
| Procedural mortality | 0.2% (1) | 0.0% (0) | 1.0000 | 0.1% (1) |
| Conversion to SAVR | 0.4% (2) | 0.0% (0) | 0.4995 | 0.2% (2) |
| More than 1 valve implanted 2 | 1.8% (9) | 2.0% (10) | 0.8134 | 1.9% (19) |
| No Portico™ valve implanted | 0.2% (1) | 0.4% (2) | 0.6242 | 0.3% (3) |
| Anesthesia | <0.0001 | |||
| General anesthesia | 30.1% (151) | 16.4% (82) | 23.3% (233) | |
| Conscious sedation | 69.9% (350) | 82.6% (413) | 76.2% (763) | |
| Access method | 0.1639 | |||
| Transfemoral | 98.2% (492) | 99.2% (496) | 98.7% (988) | |
| Subclavian/axillary | 1.8% (9) | 0.8% (4) | 1.3% (13) | |
| Vessel diameter (mm) | 7.42 ± 1.44 | 7.09 ± 1.36 | 0.0002 | 7.25 ± 1.41 |
| Valve utilized | ||||
| 23 mm | 5.6% (28) | 9.0% (45) | 0.0380 | 7.3% (73) |
| 25 mm | 25.7% (129) | 31.4% (157) | 0.0478 | 28.6% (286) |
| 27 mm | 39.1% (196) | 32.2% (161) | 0.0223 | 35.7% (357) |
| 29 mm | 29.5% (148) | 27.4% (137) | 0.4530 | 28.5% (285) |
| Valve resheathed | 34.3% (172) | 41.2% (206) | 0.0250 | 37.8% (378) |
| Implant too high | 55.8% (96) | 77.7% (160) | 67.7% (256) | |
| Implant too low | 35.5% (61) | 18.0% (37) | 25.9% (98) | |
| Coronary occlusion | 0.0% (0) | 0.0% (0) | 0.0% (0) | |
| Other | 8.7% (15) | 4.4% (9) | 6.3% (24) | |
| Introducer sheath used | 93.6% (469) | 24.0% (120) | <0.0001 | 58.8% (589) |
| 18F | 32.8% (154) | 25.8% (31) | 31.4% (185) | |
| 19F | 65.7% (308) | 65.0% (78) | 65.5% (386) | |
| 20F | 0.2% (1) | 4.2% (5) | 1.0% (6) | |
| Other | 1.3% (6) | 5.0% (6) | 2.0% (12) | |
| Pre-balloon valvuloplasty | 85.4% (428) | 88.4% (442) | 0.1635 | 86.9% (870) |
| Post-balloon valvuloplasty | 37.7% (189) | 37.4% (187) | 0.9156 | 37.6% (376) |
| Concomitant procedures | 8.4% (42) | 4.8% (24) | 0.0224 | 6.6% (66) |
| Non-coronary cusp (NCC) depth (mm) | 5.1 ± 3.0 | 4.5 ± 3.0 | 0.0043 | 4.8 ± 3.0 |
| Left coronary cusp (LCC) depth (mm) | 5.8 ± 2.9 | 5.5 ± 2.9 | 0.0610 | 5.6 ± 2.9 |
| Total procedure time (first incision to closure, min) | 64.6 ± 38.0 | 73.4 ± 39.8 | 0.0004 | 69.0 ± 39.1 |
1 First-generation Portico™ delivery system; 2 includes more than one Portico™ THV or Portico™ THV and other commercial valve implanted.