Abstract
Background Intravascular lithotripsy (IVL) is increasingly used to treat heavily calcified lower-limb arterial disease. We audited outcomes from a UK vascular center to assess the safety and effectiveness of this modality. Methods This was a single-center prospective audit of consecutive patients undergoing IVL at a UK vascular center between March 2023 and September 2025. Demographic data, lesion characteristics (including peripheral artery calcification scoring system {PACSS} grade), procedural details, and outcomes were recorded. Primary outcomes assessed safety, measured by 30-day survival, 30-day amputation-free survival (AFS), and procedure-related complications (perforation, dissection, and distal embolization), and effectiveness, defined as target vessel recanalization. Secondary outcomes included 30-day hospital readmission and one-year AFS. Statistical analyses included Fisher's exact test and t-tests, as appropriate, with Kaplan-Meier survival analysis. Follow-up duration ranged from two to 24 months. Results Forty-five patients were included, of whom 37 (82.2%) were men, with a median age of 76.0 years. Twenty-four patients (53.3%) were elective admissions. Most procedures involved the superficial femoral artery (SFA), above-knee popliteal, and tibial segments, with Rutherford classes predominantly 4-5. Technical success was achieved in 91% (n = 41) of cases, and immediate procedural complications were infrequent. The 30-day readmission rate was 24.2% (n = 11). Severe calcification (PACSS grades 4-5) was not associated with major amputation (p = 0.67) or peri-procedural complications (p = 1.00). Thirty-day AFS was 75.6% (n = 37; 95% CI: 69.4%-91.7%), and 30-day overall survival was 88.9% (n = 40). Thirty-day mortality was significantly higher following emergency admission compared to elective admission (p = 0.03). At one year, major amputation occurred in 21.4% (n = 9) and all-cause mortality in 9.5%. Thirty-day readmission strongly predicted subsequent major amputation (66.7% versus 15.6%; p = 0.006). Conclusions In a predominantly critical limb-threatening ischemia (CLTI) cohort with heavy arterial calcification, adjunctive IVL achieved high technical success with low peri-procedural complication rates. Early limb and survival outcomes were largely driven by baseline disease severity and the urgency of presentation, with emergency admission and early readmission serving as adverse prognostic markers. IVL appears to be a safe and effective vessel preparation strategy in complex calcified disease, supporting the need for larger prospective studies to refine patient selection and long-term outcomes.