Intravascular Lithotripsy-Assisted Femoropopliteal Revascularization for Heavily Calcified Chronic Limb-Threatening Ischemia: Midterm Outcomes from a Single-Center Retrospective Study

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BACKGROUND: To evaluate early and midterm outcomes of intravascular lithotripsy (IVL)-assisted endovascular treatment for severely calcified femoropopliteal disease in patients with chronic limb-threatening ischemia (CLTI). METHODS: This retrospective, single-center, single-arm study included 43 consecutive Rutherford class 4-6 CLTI patients treated between June 2023 and April 2025. Severe calcification was defined as Peripheral Arterial Calcium Scoring System grade 3 or 4. IVL was used for vessel preparation before drug-coated balloon angioplasty; adjunctive stenting was reserved for residual stenosis, recoil, or flow-limiting dissection. Overall survival, primary patency, and freedom from target-lesion reintervention were estimated using Kaplan-Meier analysis. RESULTS: The mean age was 73.2 ± 9.3 years; 34 patients (79.1%) had diabetes and 21 (48.8%) had chronic kidney disease. The mean lesion length was 25.5 ± 6.0 cm. Chronic total occlusions were present in 27 patients (62.8%), popliteal involvement in 18 (41.9%), and TransAtlantic Inter-Society Consensus C/D disease in 38 (88.4%). Peripheral Arterial Calcium Scoring System grade 3 and 4 calcification were present in 19 (44.2%) and 24 (55.8%) patients, respectively. Technical success was achieved in all cases, with final residual stenosis <30%. Bailout stenting was required in 9 patients (20.9%). At 24 months, Kaplan-Meier estimates were 93.0% for overall survival and 90.6% for both primary patency and freedom from target-lesion reintervention. CONCLUSION: In this exploratory CLTI cohort, IVL-assisted femoropopliteal revascularization was feasible despite severe calcification and complex anatomy, with selective stenting and encouraging midterm patency and freedom from reintervention.

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