Table 2.
Procedural characteristics.
| Global FlexNav DS cohort (n = 193) | CAV group (n = 362) | |
|---|---|---|
| Anesthesia: conscious sedation | 59.1 (114/193) | 32.0 (116/362) |
| Transfemoral access | 100.0 (193/193) | 95.0 (343/361) |
| Total fluoroscopy time, min | 21.21 ± 8.18 (191) | 19.51 ± 63.91 (359) |
| Pre-BAV performed | 94.8 (183/193) | 55.4 (200/361) |
| Final deployed stent depth, mm | 4.21 ± 2.75 (176) | 4.48 ± 2.34 (266) |
| Postimplant balloon valvuloplasty | 29.5 (57/193) | 20.4 (74/362) |
| Resheathing attempted | 43.0 (83/193) | NA |
| Implanted valve sizea, mm | ||
| 20.0 | NA | 1.9 (7/361) |
| 23.0 | 2.6 (5/191) | 26.9 (97/361) |
| 25.0 | 28.8 (55/191) | NA |
| 26.0 | NA | 41.6 (150/361) |
| 27.0 | 32.5 (62/191) | NA |
| 29.0 | 36.1 (69/191) | 24.1 (87/361) |
| 31.0 | NA | 1.9 (7/361) |
| 34.0 | NA | 3.3 (12/361) |
| Length of hospital stay, d | 3.0 ± 2.3 (193) | 2.9 ± 2.2 (362) |
| Procedural successb | 96.9 (187/193) | 98.3 (356/362) |
| Procedural mortalityc | 0.0 (0/193) | 0.0 (0/362) |
| Conversion to SAVR | 0.0 (0/193) | 0.3 (1/362) |
| Need for a second TAVR valve | 3.1 (6/193) | 1.4 (5/362) |
| No valve implanted | 0.0 (0/193) | 0.0 (0/362) |
| Successful vascular access | 100.0 (193/193) | 100.0 (362/362) |
BAV, balloon aortic valvuloplasty; CAV, commercially available valve; TAVR, transcatheter aortic valve replacement; SAVR, surgical aortic valve replacement.
Continuous parameters: values are represented as mean ± SD (n). Categorical parameters: rate per subject (%) is calculated n/N, where n is the number of subjects with an event and N is the total number of subjects at risk. NA refers to data not available.
Device size based on the final valve implanted. Two subjects who required a second valve were implanted with a non–Portico valve and not included in this summary.
Procedural success is defined as the absence of procedural mortality and correct positioning of a single transcatheter prosthetic heart valve in the proper anatomical location.
Procedural mortality is defined as deaths that occurred during the index procedure.