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Outcomes of Intravascular Lithotripsy in the Treatment of Chronic Limb-Threatening Ischemia: A Single-Center Retrospective Study

  • Clinical Investigation
  • Arterial Interventions
  • Published:
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Abstract

Purpose

Vascular calcification is an important risk factor for endovascular treatment failure and complications in patients with chronic limb-threatening ischemia (CLTI). Intravascular lithotripsy (IVL) is a pulsatile balloon-based device that has emerged as a tool in the treatment of calcified vessels. The purpose of this study is to evaluate the efficacy and safety of IVL in the treatment of peripheral calcified lesions in CLTI patients.

Materials and methods

A retrospective study was performed within a single institution. Thirty-six CLTI patients treated with IVL for peripheral calcified lesions from 2018 to 2022 were identified. Data on pre- and post-IVL luminal stenosis measured by digital subtraction angiography, lesion location, adjunctive therapies, ankle-brachial index (ABI), and intra-procedural complications were obtained. A total of 41 target lesions in twenty-eight patients were included, with ABI data available in 20 treated lower extremities.

Results

Across all 41 target lesions, IVL produced clinically significant luminal gain of 75.5% ± 23.0. Luminal gain by vessel location was 87.3% ± 15.8, 57% ± 25.7, and 78.5% ± 20.6 in the aortoiliac (n = 8), common femoral (n = 9), and femoropopliteal (n = 24) segments, respectively. Lesions treated with IVL alone yielded a luminal gain of 71.4% ± 25.6 (n = 10), while IVL alongside adjunctive therapy produced a luminal gain of 76.8% ± 22.4. In 20 treated lower extremities, ABI improvement of 0.20 ± 0.26 (p = 0.002) was recorded. Intra-procedural complications occurred in 1/36 patients, which was one instance of thrombus occurring prior to IVL.

Conclusion

IVL may be an effective option for creating safe luminal gain and vessel preparation in patients with CLTI.

Level of Evidence 2: Retrospective Cohort Study.

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Acknowledgements

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Funding

This study was not supported by any funding.

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Authors and Affiliations

  1. Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA

    Samuel A. Salazar

  2. Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA

    Yasaswi Vengalasetti

  3. Department of Interventional Radiology, Medical University of South Carolina, Charleston, SC, USA

    Varshana Gurusamy

  4. Department of Interventional Radiology, Miami Cardiac and Vascular Institute, Baptist Health South Florida, Miami, FL, USA

    Matthew Kilbridge, Alex Powell, Brian J. Schiro, Constantino S. Peña, Ripal T. Gandhi & Andrew S. Niekamp

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  1. Samuel A. Salazar
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  2. Yasaswi Vengalasetti
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  4. Varshana Gurusamy
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Corresponding author

Correspondence to Andrew S. Niekamp.

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Conflicts of interest

Authors Varshana Gurusamy MD and Constantino S. Peña MD have received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Shockwave Medical.

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For this type of study, consent for publication is not required.

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This retrospective chart review study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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This study has obtained IRB approval from the Baptist Health South Florida IRB (approval protocol number: 1678481) and the need for informed consent was waived.

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Salazar, S.A., Vengalasetti, Y., Kilbridge, M. et al. Outcomes of Intravascular Lithotripsy in the Treatment of Chronic Limb-Threatening Ischemia: A Single-Center Retrospective Study. Cardiovasc Intervent Radiol 46, 1214–1220 (2023). https://doi.org/10.1007/s00270-023-03510-1

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  • DOI: https://doi.org/10.1007/s00270-023-03510-1

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