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Clinical outcomes after balloon angioplasty with Crosser device for heavily calcified common femoral and popliteal artery disease

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Abstract

Data on the mid-term clinical outcomes after endovascular treatment (EVT) using a Crosser catheter (C. R. Bard, Inc.) as a crossing or flossing device for a heavily calcified lesion in the common femoral artery (CFA) or popliteal artery (PA) are lacking. The aim of this study was to investigate the safety and efficacy of EVT using a Crosser catheter for isolated and heavily calcified CFA or PA disease. We retrospectively analyzed 64 consecutive patients (72 lesions; CFA 30, PA 42) who underwent EVT for heavily calcified CFA or PA lesions with Crosser catheters between April 2015 and April 2019. The primary endpoint was clinically driven target lesion revascularization (CD-TLR). The median follow-up was 18.5 months. The mean age of the study population was 70 ± 9.5 years, with a male prevalence of 73.6%. The mean Proposed Peripheral Artery Calcification Scoring System grade was 2.9 ± 0.9. Procedure success, defined as 50% or less residual stenosis without suboptimal results, was achieved in 94.4% of lesions. There were no cases of bailout stenting or target lesion-related complications. After EVT, the 1-year CD-TLR-free rate for CFA and PA lesions was 87.4 and 76.8%, respectively. The corresponding rates at 2 years were 82.2 and 62.8%, respectively. In the multivariate analysis used to define CD-TLR predictors for CFA and PA lesions, hemodialysis was the only independent predictor (HR 3.35, 95% CI 1.02–13.95, P = 0.045). EVT with a Crosser device for heavily calcified CFA and PA lesions seems to be safe and feasible.

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The data of our study are unavailable to access because it is confidential.

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Acknowledgements

We thank Editage (www.editage.jp) for the English language editing.

Funding

This research received no grant from any funding agency in public, commercial or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Cardiology, The Heart Institute of Japan, Tokyo Women’s Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan

    Ahmed Elsayed Hassan, Masashi Nakao, Haruka Katsumata, Yusuke Inagaki, Kazuki Tanaka, Hisao Otsuki, Hiroyuki Arashi, Junichi Yamaguchi & Nobuhisa Hagiwara

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  1. Ahmed Elsayed Hassan
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  2. Masashi Nakao
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  3. Haruka Katsumata
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  4. Yusuke Inagaki
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  5. Kazuki Tanaka
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  6. Hisao Otsuki
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  7. Hiroyuki Arashi
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  8. Junichi Yamaguchi
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  9. Nobuhisa Hagiwara
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Contributions

All authors contributed to the study conception and design. AEH and MN performed material preparation, data collection, and analysis. The first draft of the manuscript was written by AEH, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Masashi Nakao.

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Conflicts of interest

Junichi Yamaguchi and Hisao Otsuki belong to the division (Clinical Research division for Cardiovascular Catheter Intervention) financially maintained by the donation from Abbott Vascular, Boston Scientific, Medtronic Terumo. The other authors declare that they have no conflict of interest.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the institutional ethics committee of Tokyo Women’s Medical University Hospital (No 3502-R).

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Informed consent was obtained from all individual participants included in the study.

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Hassan, A.E., Nakao, M., Katsumata, H. et al. Clinical outcomes after balloon angioplasty with Crosser device for heavily calcified common femoral and popliteal artery disease. Heart Vessels 36, 1359–1365 (2021). https://doi.org/10.1007/s00380-021-01816-z

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  • DOI: https://doi.org/10.1007/s00380-021-01816-z

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