Table 3.
Procedural characteristics of lesion treatment in the overall population and patient subgroups.
| Overall | Primary IVL | Secondary IVL | Bailout IVL | ISR IVL | |
|---|---|---|---|---|---|
| No. of IVL treated lesions | 110 | 25 | 51 | 11 | 23 |
| IVL | |||||
| No. of IVL catheters delivered, n | 113 | 25 | 53 | 12 | 23 |
| Lesions treated with 1 IVL catheter, n (%) | 107 (97.3) | 25 (100) | 49 (96.1) | 10 (90.9) | 23 (100) |
| Lesions treated with 2 IVL catheters, n (%) | 3 (2.7) | 0 (0) | 2 (3.9) | 1 (9.1) | 0 (0) |
| Number of pulses (mean ± SD), n | 64 ± 21 | 65 ± 20 | 61 ± 23 | 68 ± 11 | 67 ± 22 |
| Diameter of IVL balloon, mm | 3.0 ± 0.4 | 3.1 ± 0.5 | 2.9 ± 0.4 | 2.9 ± 0.3 | 3.2 ± 0.4 |
| Predilatation | |||||
| Pre-IVL high-pressure dilatation, n (%) | 70 (63.6) | 0 (0) | 51 (100) | 6 (54.6) | 13 (56.5) |
| Largest balloon diameter (mean ± SD), mm | 2.9 ± 0.4 | – | 2.8 ± 0.4 | 2.8 ± 0.3 | 3.0 ± 0.4 |
| Mean pressure (mean ± SD), atm | 19 ± 4 | – | 19 ± 4 | 19 ± 5 | 19 ± 5 |
| Pre-IVL cutting balloon, n (%) | 7 (6.4) | 0 (0) | 1 (2) | 0 (0) | 6 (26.1) |
| Largest balloon diameter (mean ± SD), mm | 2.9 ± 0.4 | – | 3.0 | – | 2.9 ± 0.4 |
| Post-IVL high-pressure dilatation, n (%) | 65 (59.1) | 9 (36) | 36 (70.6) | – | 20 (87) |
| Largest balloon diameter (mean ± SD), mm | 3.1 ± 0.5 | 3.2 ± 0.4 | 2.9 ± 0.3 | – | 3.4 ± 0.5 |
| Mean pressure (mean ± SD), atm | 20 ± 8 | 16 ± 3 | 19 ± 6 | – | 25 ± 10 |
| Median of balloons/lesion (IQR), n | 3 (2–4) | 1 (1–2) | 3 (3–4) | 2 (1–4) | 3 (2–5) |
| Lesion treatment | |||||
| DES implantation, n (%) | 91 (82.7) | 25 (100) | 49 (96.1) | 11 (100) | 6 (26.1) |
| Median of DES/lesion | 1 (1;2) | 1 (1;2) | 2 (1;3) | 1 (1;3) | 0 (0;1) |
| 0 DES, n (%) | 19 (17.3) | 0 (0) | 2 (3.9) | 0 (0) | 17 (73.9) |
| 1 DES, n (%) | 46 (41.8) | 14 (56) | 23 (45.1) | 6 (54.5) | 3 (13) |
| 2 DES, n (%) | 23 (20.9) | 5 (20) | 13 (25.5) | 2 (18.2) | 3 (13) |
| 3 DES, n (%) | 20 (18.2) | 6 (24) | 11 (21.6) | 3 (27.3) | 0 (0) |
| 4 DES, n (%) | 2 (3.9) | 0 (0) | 2 (3.9) | 0 (0) | 0 (0) |
| Stented length (mean ± SD), mm | 35.5 ± 20.5 | 40.8 ± 25.9 | 34.6 ± 18.6 | 34.9 ± 17.2 | 22.3 ± 7.7 |
| DCB used, n (%) | 12 (10.9) | 0 (0) | 0 (0) | 0 (0) | 12 (52.2) |
| Median of DCB/lesion | 0 (0;0) | – | – | – | 1 (0;1) |
| 0 DCB, n (%) | 98 (89.1) | – | – | – | 11 (47.8) |
| 1 DCB, n (%) | 9 (8.2) | – | – | – | 9 (39.1) |
| 2 DCB, n (%) | 3 (2.7) | – | – | – | 3 (13) |
| Postdilatation | |||||
| High-pressure dilatation before IVL, n (%) | 11 (10) | – | – | 11 (100) | – |
| Largest balloon diameter (mean ± SD), mm | 3.1 ± 0.4 | – | – | 3.1 ± 0.4 | – |
| Mean pressure (mean ± SD), atm | 22 ± 7 | – | – | 22 ± 7 | – |
| Final high-pressure dilatation, n (%) | 84 (76.4) | 23 (92) | 42 (82.4) | 10 (90.9) | 9 (39.1) |
| Largest balloon diameter (mean ± SD), mm | 3.6 ± 0.6 | 3.8 ± 0.7 | 3.6 ± 0.6 | 3.3 ± 0.2 | 3.5 ± 0.6 |
| Mean pressure (mean ± SD), atm | 19 ± 5 | 17 ± 3 | 19 ± 4 | 21 ± 5 | 24 ± 9 |
Values are n (%), mean ± SD, or median (IQR).
DCB, drug-coated balloon; DES, drug-eluting stent; ISR, in-stent restenosis; IVL, intravascular lithotripsy; IQR, interquartile range.