Table 4.
Operation process and treatment outcome.
Characteristics (n, %) | Total N = 37 |
Type 1 N = 17 |
Type 2 N = 3 |
Type 3 N = 13 |
Type 4 N = 4 |
p |
---|---|---|---|---|---|---|
Retrospective cases | 7 (18.9) | 0 | 0 | 3 (23.1) | 4 (100.0) | 0.000 |
Prospective cases | 30 (81.1) | 17 (100.0) | 3 (100.0) | 10 (76.9) | 0 | |
General anesthesia | 21 (56.8) | 10 (58.8) | 3 (100.0) | 7 (53.8) | 1 (25.0) | 0.261 |
Local anesthesia * | 16 (43.2) | 7 (41.2) | 0 | 6 (46.2) | 3 (75.0) | |
First-generation THV | 28 (75.7) | 12 (70.6) | 3 (100.0) | 9 (69.2) | 4 (100.0) | 0.426 |
Second-generation THV # | 9 (24.3) | 5 (29.4) | 0 | 4 (30.8) | 0 | |
Oversize (%) | ||||||
Annulus | 17.4 ± 7.9 | 20.4 ± 8.7 | 10.6 ± 1.7 a | 18.0 ± 4.8 | 8.0 ± 5.2 a | 0.009 |
Narrowest super-annulus | 14.7 ± 7.4 | 16.7 ± 6.7 | 7.7 ± 4.5 | 13.7 ± 7.1 | 13.9 ± 11.0 | 0.240 |
LVOT | 13.9 ± 11.3 | 17.9 ± 10.8 | 4.3 ± 5.0 a | 15.2 ± 9.6 | −0.4 ± 7.5 ac | 0.007 |
2 mm below the annulus | 17.1 ± 9.9 | 20.3 ± 9.6 | 9.3 ± 3.3 a | 19.0 ± 6.8 | 2.6 ± 8.2 a | 0.002 |
Ascending aorta | 8.3 ± 15.2 | 17.5 ± 9.9 | 19.8 ± 13.3 | −5.1 ± 11.2 ab | 4.0 ± 14.3 ab | 0.000 |
Narrowest AA | 14.7 ± 16.6 | 25.8 ± 20.7 | 25.0 ± 18.4 | −0.0 ± 11.5 ab | 7.8 ± 10.9 a | 0.000 |
Outcome | ||||||
THV downward | 6 (16.2) | 1 (5.9) | 2 (66.7) | 2 (15.4) | 1 (25.0) | 0.066 |
THV upward | 8 (21.6) | 1 (5.9) | 0 | 5 (38.5) | 2 (50.0) | 0.060 |
THV release into the artery | 5 (13.5) | 1 (2.7) | 0 | 3 (23.1) | 1 (25.0) | 0.426 |
THV pulled out of the body | 1 (2.7) | 0 | 0 | 1 (7.7) | 0 | 0.594 |
THV-in-THV implantation | 8 (21.6) | 1 (5.9) | 2 (66.7) | 3 (23.1) | 2 (50.0) | 0.046 |
PPI | 9 (24.3) | 7 (41.2) | 0 | 2 (15.4) | 0 | 0.142 |
Annular rupture | 0 | 0 | 0 | 0 | 0 | - |
Descending aortic dissection | 2 (5.4) | 0 | 0 | 2 (15.4) | 0 | 0.272 |
Death | 0 | 0 | 0 | 0 | 0 | - |
Moderate-to-severe PVL | 5 (13.5) | 0 | 0 | 4 (30.8) | 1 (25.0) | 0.076 |
Device success | 25 (67.6) | 16 (94.1) | 1 (33.3) | 6 (46.2) | 2 (50.0) | 0.016 |
Operation success | 32 (86.5) | 17 (100.0) | 3 (100.0) | 9 (69.2) | 3 (75.0) | 0.076 |
Note: THV = transcatheter heart valve; Oversize = 100 × (THV diameter/MDCT measurement diameter − 1); PPI = permanent pacemaker implantation; PVL = perivalvular leakage; * 21 patients before May 2021 are TAVR under general anesthesia and after May 2021, and 16 patients will receive TAVR under local anesthesia; # 28 patients before Aug 2021 are TAVR with first-generation non-recyclable THV systems and After Aug 2021, and 9 patients will receive TAVR second-generation recyclable THV systems because the second-generation recyclable THV systems were used in the China market on Aug 2021; a: comparison between types 2–4 and type 1; b: comparison between types 3–4 and type 2; c: comparison between types 4 and 3, p < 0.05.