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Page 6 of 12 Sciahbasi et al. Vessel Plus 2023;7:19 https://dx.doi.org/10.20517/2574-1209.2023.22

Table 2. Clinical characteristics of patients enrolled in multicentre studies
Author Aksoy Aziz Iwanczyk Cubero-Gallego Rola El Jattari Basavar-Ajaiah Honton Tian
Year 2019 2020 2021 2021 2021 2022 2022 2022 2023
Study type Pros Retr Retr Pros Retr Pros Retr Pros Pros
Sites 3 6 3 5 2 5 8 11 3
Patients 71 190 46 109 52 134 273 202 20
Lesions 78 200 46 109 54 134 273 202 20
Age (years) 76 ± 10 72 ± 10 71.1 ± 7.4 79 ± 1 71 ± 3 74 ± 9 72 ± 9 74 ± 9 65 ± 8
Male sex 72 (51) 72 (137) 65 (30) 83 (90) 67 (35) 76 (102) 79 (216) 77 (155) 80 (16)
Hyperlipidaemia 63 (45) NA 94 (43) 79.82 (87) 96 (52) NA NA 64 (129) 45 (9)
Hypertension 93 (66) 92 (172) 96 (44) 88.99 (97) 90 (47) NA 78 (214) 81 (163) 70 (14)
Diabetes 34 (24) 50 (95) 54 (25) 58 (63) 56 (29) 34 (45) 40 (110) 35 (71) 50 (10)
CKD 35 (25) 16 (30) 24 (11) 32.11 (35) 19 (10) NA 17 (45) 25 (50) 0
Lesion length 21 ± 16 NA NA 26 ± 9 NA NA 32 ± 11 22 ± 14 27 ± 7
% Stenosis 72 ± 13 NA 80 (70-90)* 60 83 ± 10 NA NA 81 ± 11 73 ± 12
LM 16.7 (13) 15 (28) 12 (25) 11.72 (15) 35 (18) 6.7 (9) 17 (47) 11 (25) 0
CTO 3 (2) 7 (14) 7 (3) 3 (4) 10 (5) NA 4 (12) NA 0
ISR 22 (17) 23 (46) 17 (6) NA NA 30 (40) 21 (58) 23 (50) 0
ACS 31 (22) 48 (91) 82.6 (38) 60.56 (66) 83 (43) 33.7 (45) 48 (132) 21 (42) 0
STEMI 1 (1) NA 0 11 (12) 6 (3) 4 (5) 11 (39) NA 0
UA/NSTEMI 29.6 (21) NA 78 (36) 50 (54) 77 (40) 29.9 (40) 37 (103) NA 0
Success 78 (61) 99 (189) 89 (45) 99 (108) 98 (51) 88 (118) 99 (270) 96 (194) 95 (19)
MACE 1 (1) 3 (5) 2 (1) 6 (7) 6 (3) 3 (4) 11 (30) 15 (31) 5 (1)
Complications 5 (4) 3 (6) 4 (2) 2 (3) 4 (2) 2 (2) 3 (8) 6 (12) 0
FU (days) 30 222 30 600 30 30 687 365 180
Results are expressed as mean ± standard deviation or percentage with absolute numbers in brackets. *Median with interquartile range; ACS:
Acute coronary syndrome; CKD: chronic Kidney Disease; CTO: chronic total occlusion;; FU: follow up; ISR: intra-stent restenosis; LM: left main;
MACE: major adverse cardiac event; NA: not available; NSTEMI: non-ST elevation myocardial infarction; Pros: prospective; Retr: retrospective;
STEMI: ST elevation myocardial infarction; UA: unstable angina.

procedural success is higher and long-term clinical results are improved. Specific analyses are needed to
[37]
confirm this hypothesis .

SPECIAL POPULATIONS
The feasibility and safety of IVL has also been tested in different specific conditions as:

- Left main stenosis. A potential advantage of the IVL over other plaque modification techniques is the
treatment of large vessels as left main. Only few studies have specifically been conducted on IVL use on left
main calcified lesions [38-40] , but in almost all the studies, the PCI success rate was 100% with no or very few
complications rate despite the complexity of the lesions treated. A possible concern for the use of IVL on
LM lesions is the prolonged vessel occlusion needed to deliver the required energy that could lead to severe
ischaemia. In this case, the application of abbreviated IVL cycles could be used to avoid significant ischemia.

- Acute myocardial infarction. Although acute coronary syndrome presentation was an exclusion criterion in
the approval studies, the use of IVL balloons in these kinds of lesions reserves promising potential. In the
real-world multicentre registries, the percentage of acute coronary syndromes was around 50%, but the
percentage of ST-elevation myocardial infarction was significantly lower. One of the larger multicentre
retrospective analyses was performed in the UK on 72 STEMI patients in whom IVL was used for CAC
[41]