Safety and efficacy of Lithoplasty in treating calcified iliac arterial disease: A Single Center Experience

Background
Severe calcified iliac arteries may be difficult to dilate and may result in stent under expansion, thrombosis and restenosis. Lithoplasty (Shockwave Medical) provides circumferential pulsatile energy to disrupt calcified plaque and improve acute gain while minimizing vessel injury. There is currently no data on the use of lithoplasty in the iliac arteries.

Methods
Symptomatic patients with moderate to severe calcified iliac arteries treated with lithoplasty followed by adjunctive final treatment were retrospectively reviewed. A total of 7 patients were treated with lithoplasty by a single operator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or amputation. Primary effectiveness endpoint is acute procedural success (≤30% residual) at end of procedure.

Results
7 patients (mean age 67.28± 6.67; 3 left iliac arteries and 4 right iliac arteries) were included. Mean lesion length was 86.6± 56.09 mm,vessel diameter 6.25 ± 0.99,total occlusions 57%, mean baseline stenosis 95%± 6.45%, calcium 100% (severe 85.8%, moderate 14.2%). Mean shockwave balloon diameter was 6.41 ± 0.92. Mean number of pulses delivered 72.14± 23.07.There were 2 cases treated with atherectomy (1 Jetstream [Boston Sci] and 1 Orbital [CSI]) prior to shockwave. There were 3 dissections (12.5%), all NHLBI type C. Embolic filter was used in 1 case. Stent was done on 100% of lesions.Residual stenosis was 0%. There were no perforations, distal embolization, amputation. Procedural success was 100%.

Conclusions
Shockwave is safe in treating severe calcified iliac arteries with high procedural success and low adverse events. Larger data is needed to validate these findings.