Mid-term outcomes of Shockwave intravascular lithotripsy in the IVLIAC Registry for the treatment of calcified iliac occlusive disease.

OBJECTIVE

The aim of this study was to evaluate safety and efficacy of intravascular lithotripsy (IVL) treatment in calcified iliac arteries and explore a new approach to determining whether to stent or not to stent calcific iliac vessels.

METHODS

All consecutive patients who underwent IVL (Shockwave Medical) for calcified iliac arteries from February 2021 to May 2024 at four centers were included. Indication for IVL was Rutherford category ≥3 in iliac lesions with moderate-to-severe calcification and was based on a new algorithm: IVL as stand-alone therapy ± provisional stenting in case of stenosis, or IVL as vessel preparation for planned stenting in cases of chronic total occlusion. The primary endpoint was primary patency; assisted primary patency, secondary patency, and freedom from iliac complications were also analyzed. Clinical and procedural data were compared between two groups: IVL stand-alone therapy (IVL ONLY) vs IVL with adjunctive stenting (IVL + STENT). Indication for IVL ONLY was based on adjunctive completion assessments (extravascular ultrasound and translesional gradient pressure). A Cox regression univariate analysis between cases with or without target lesion revascularization was performed.

RESULTS

In total, 100 iliac arteries were treated in 86 patients (52 male; mean age, 74 ± 9 years). Median follow-up was 20 months (range, 1-45 months). Critical limb ischemia was present in 55% of the patients, the majority of whom (75%) had severe calcifications (180°-360°). The mean target lesion length was 40.95 ± 29.25 mm with a mean stenosis of 84% ± 10% (12 chronic total occlusions). Technical success was 99%. The target lesions were treated with IVL ONLY in 77% of cases, whereas IVL + STENT was employed in the remaining 23% of the cases (provisional stenting, 11%; planned stenting, 12%). Mean residual stenosis was 14.95% ± 14% at final angiogram. Extravascular ultrasound with improved imaging (bi-triphasic in place of monophasic/blunted ipsilateral common femoral artery waveform), and/or decreased translesional gradient pressure (mean, -71%) were detected in all IVL ONLY cases. Primary patency and assisted primary patency at 24 months were 95% (95% confidence interval, 85.1%-98.1%) and 98% (95% confidence interval, 92%-99.5%), respectively, whereas secondary patency was 100%. Primary patency showed no statistically significant difference (P = 24) between the IVL ONLY and IVL + STENT groups. There was one iliac rupture and no distal embolization. Longer target lesions (P = 24) were significantly related to target lesion revascularization.

CONCLUSIONS

IVL is a safe and effective treatment option for calcific iliac occlusive disease. This multicenter experience shows promising mid-term results in terms of primary patency despite the very low stenting rate, preserving future treatment options. Further studies are needed to confirm these findings.