Table 3.
Procedural details and outcomes post-Benchmark implementation by country
| Characteristic, n (%) or mean ± SD or median (IQR) | France (568 pts, 9 sites) |
Spain (248 pts, 5 sites) |
Germany (235 pts, 6 sites) |
Italy (202 pts, 4 sites) |
Austria (109 pts, 2 sites) |
p value |
|---|---|---|---|---|---|---|
| Local anaesthesia (LA) ± conscious sedation | 544 (96.8) | 224 (90.3) | 231 (98.3) | 177 (96.7) | 104 (95.4) | < 0.001 |
| LA w/o sedation/anxiolytic | 76 (13.6) | 2 (0.8) | 41 (17.4) | 18 (9.9) | 0 (0.0) | |
| LA + minimal sedation/anxiolytic | 292 (52.1) | 98 (39.7) | 94 (40.0) | 87 (47.8) | 1 (0.9) | |
| LA + moderate sedation | 173 (30.9) | 25 (10.1) | 84 (35.7) | 67 (36.8) | 103 (94.5) | |
| Deep sedation | 1 (0.2) | 98 (39.7) | 12 (5.1) | 4 (2.2) | 0 (0.0) | |
| Procedural information | ||||||
| Total procedure time |
46.2 ± 23.2 40.0 (30.0, 55.0) |
73.0 ± 31.1 70.0 (50.0, 85.0) |
46.4 ± 22.1 40.0 (32.0, 55.0) |
87.4 ± 38.1 77.5 (60.0, 100.0) |
41.5 ± 23.7 37.0 (24.0, 48.8) |
< 0.001 |
| Intervention time |
63.9 ± 31.5 55.0 (45.0, 70.5) |
106.3 ± 40.6 100.0 (80.0, 125.0) |
88.7 ± 30.0 90.0 (65.0, 106.0) |
111.6 ± 36.3 105.0 (90.0, 130.0) |
80.4 ± 35.7 80.0 (46.0, 110.0) |
< 0.001 |
| Procedural success | 546 (98.6) | 247 (100.0) | 229 (97.4) | 180 (100.0) | 109 (100.0) | 0.017 |
| Complications | ||||||
| Second valve needed | 4 (0.7) | 0 (0.0) | 2 (0.9) | 0 (0.0) | 0 (0.0) | 0.528 |
| Permanent pacemaker implantation | 47 (8.4) | 14 (5.6) | 7 (3.0) | 7 (3.8) | 1 (0.9) | 0.002 |
| Conversion to conventional surgery | 3 (0.5) | 0 (0.0) | 2 (0.9) | 0 (0.0) | 0 (0.0) | 0.657 |
| Bleedinga | 9 (1.6) | 15 (6.1) | 1 (0.4) | 3 (1.8) | 1 (0.9) | 0.002 |
IQR interquartile range, LA local anaesthesia, SD standard deviation, pts patients
aMajor bleeding (BARC type 3a) defined as overt bleeding either associated with a drop in the haemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding