Purpose <p>To evaluate the feasibility and safety of an ultra-low-dose iodinated contrast media (CM) protocol during peripheral endovascular procedures in patients with chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI).</p> Materials and methods <p>This prospective, two-center, observational study included consecutive patients with CLTI and renal dysfunction (eGFR &lt; 60&#xa0;mL/min/1.73m<sup>2</sup>, stages 2–4) undergoing infrainguinal revascularization over a 1-year period. The protocol utilized 1:9 or 2:8 CM-to-saline dilutions to minimize iodine exposure. Primary endpoints were technical success (revascularization using ≤ 15&#xa0;mL CM) and the incidence of Contrast-Associated Acute Kidney Injury (CI-AKI), defined as a 25% increase from baseline or a 0.5&#xa0;mg/dL increase in absolute sCr value, within 72&#xa0;h. Secondary endpoints included procedural success, limb salvage, and freedom from clinically driven target lesion revascularization (TLR) at 6&#xa0;months.</p> Results <p>Eighteen patients were enrolled, presenting advanced (Rutherford 6: 38.9%; occlusions: 38.8%) and complex infrainguinal disease (both femoropopliteal and infrapopliteal disease 27.7%; occlusions 38.8%). Technical success was 94.5%, with a mean CM volume of 10.3 ± 3.5&#xa0;mL (range: 5–17&#xa0;mL). Procedural success was 100%. No cases of CI-AKI occurred; one patient (5.5%) required dialysis 3 months post-procedure due to disease progression. Mean sCr and eGFR significantly improved at 72&#xa0;h compared to baseline (p &lt; 0.0001). At 6&#xa0;months, limb salvage was 94.4%, TLR-free rate was 81.3% and survival was 83.3%.</p> Conclusion <p>Ultra-low-dose iodinated CM protocol in complex CLTI endovascular treatment of CKD patients is safe and effective, achieving high technical success without evidence of renal function deterioration.</p> Level of evidence <p>Level 4, Case Series.</p>

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Feasibility pilot study of the use of ultra-low dose iodinated contrast agent for endovascular procedures in patients with chronic limb-threatening ischemia and renal impairment: the ULTRA-LOW study

  • Stavros Spiliopoulos,
  • Stavros Grigoriadis,
  • Nikolaos Galanakis,
  • Elias Kehagias,
  • Konstantinos Palialexis,
  • Ornella Moschovaki-Zeiger,
  • Athanasios Giannakis,
  • Ioannis Giannikouris,
  • Petros Nikolopoulos,
  • Constantine N. Antonopoulos,
  • George Sfyroeras,
  • Konstantinos Moulakakis,
  • Andreas Lazaris,
  • John Kakisis

摘要

Purpose

To evaluate the feasibility and safety of an ultra-low-dose iodinated contrast media (CM) protocol during peripheral endovascular procedures in patients with chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI).

Materials and methods

This prospective, two-center, observational study included consecutive patients with CLTI and renal dysfunction (eGFR < 60 mL/min/1.73m2, stages 2–4) undergoing infrainguinal revascularization over a 1-year period. The protocol utilized 1:9 or 2:8 CM-to-saline dilutions to minimize iodine exposure. Primary endpoints were technical success (revascularization using ≤ 15 mL CM) and the incidence of Contrast-Associated Acute Kidney Injury (CI-AKI), defined as a 25% increase from baseline or a 0.5 mg/dL increase in absolute sCr value, within 72 h. Secondary endpoints included procedural success, limb salvage, and freedom from clinically driven target lesion revascularization (TLR) at 6 months.

Results

Eighteen patients were enrolled, presenting advanced (Rutherford 6: 38.9%; occlusions: 38.8%) and complex infrainguinal disease (both femoropopliteal and infrapopliteal disease 27.7%; occlusions 38.8%). Technical success was 94.5%, with a mean CM volume of 10.3 ± 3.5 mL (range: 5–17 mL). Procedural success was 100%. No cases of CI-AKI occurred; one patient (5.5%) required dialysis 3 months post-procedure due to disease progression. Mean sCr and eGFR significantly improved at 72 h compared to baseline (p < 0.0001). At 6 months, limb salvage was 94.4%, TLR-free rate was 81.3% and survival was 83.3%.

Conclusion

Ultra-low-dose iodinated CM protocol in complex CLTI endovascular treatment of CKD patients is safe and effective, achieving high technical success without evidence of renal function deterioration.

Level of evidence

Level 4, Case Series.