IFT01 - MID-TERM CLINICAL OUTCOMES FROM IVLIAC STUDY: LEAVING NOTHING BEHIND AS MAIN STRATEGY BY USING INTRAVASCULAR LITHOTRIPSY IN CALCIFIED ILIAC ARTERIES

Objectives: To evaluate safety and efficacy of intravascular lithotripsy (IVL) for calcified iliac arteries and explore a new approach to determin when to stent or not to stent iliac vessels.

Methods: All consecutive patients treated with IVL in calcified iliac arteries between February 2021 and May 2024 at 4 centers have been included in this study. Indication for IVL treatment was clinically relevant iliac occlusive disease (Rutherford category ≥ 3) in patients with calcified iliac lesions. The primary endpoint of this study was primary patency; assisted primary patency, secondary patency and freedom from iliac complications (rupture, embolization, and flow-limiting dissection) were also analyzed. Clinical outcomes together with pre/intraprocedural characteristics were evaluated in two groups (IVL ONLY, IVL stand-alone therapy; IVL+STENT, IVL with adjunctive stenting). Indication for IVL stand-alone therapy was based on adjunctive completion assessment (EVUS, extravascular ultrasound and/or translesional gradient pressure)(Fig.1). A Cox regression univariate analysis between cases with or without target lesion revascularization (TLR) was performed.

Results: In total, 100 iliac axes were treated in 86 patients (52 male, mean age 73.5 ± 9 years). Mean follow-up was 21 ± 11.23 (1-45) months. Critical limb ischemia was present in 55% of the patients and majority of them (75%) had severe calcifications (180-360°). Target lesion length was 40.95 ± 29.25mm with a mean stenosis of 83.6% ± 10% (12 chronic total occlusions). The target lesions were treated by IVL ONLY in 77% of the cases while IVL+STENT in the remaining 23% of the cases (bare metal stents 13%, covered stents 10%). Technical success was 99%. Mean residual stenosis was 14.95% ± 14% at final angiogram. Completion functional control was assessed by an improved EVUS (bi-thriphasic waveform at the level of ipsilateral common femoral artery) and/or decreased (-71%) translesion gradient pressure in all IVL ONLY cases.
Primary patency and assisted primary patency at 24 months were 94.6% (95%CI: 85.1%-98.1%) and 98% (95%CI: 92%-99.5%), respectively, while secondary patency was 100%(Fig.2). There was no statistically significative difference between IVL ONLY and IVL + STENT groups in terms of primary patency (p:0.24) or any other clinical outcome (postprocedural, early and/or during follow-up).
There was one iliac rupture, five flow-limiting dissection treated with stenting and no distal embolization.

Conclusions: Intravascular lithotripsy is a safe and effective treatment option for calcific iliac occlusive disease. This multicentric experience shows promising mid-term results in terms of primary patency despite the very low stenting rate, maintaining open options for future treatments.