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Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: cuttIng ballooN angioplaSTy combined wITh paclitaxel drUg-coaTed balloon angioplasty, an observatIONal study (INSTITUTION Study)

  • Clinical Investigation
  • Venous Interventions
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

A Correction to this article was published on 15 February 2022

This article has been updated

Abstract

Purpose

To study the safety and efficacy of cutting balloon angioplasty (CBA) followed by paclitaxel drug-coated balloon (PCB) angioplasty for recurrent venous lesions in arteriovenous fistulas (AVFs).

Materials and Methods

We conducted a prospective single-arm cohort study of CBA followed by PCB angioplasty for recurrent AVF stenoses between September 2017 and April 2019. In total, 44 participants were recruited. Target lesions were included if they had recurred within 12 months post-angioplasty, were >  = 0.5 cm upstream from the arteriovenous anastomosis, and did not involve the central veins. Up to two non-target lesions per circuit/participant with the same definition were allowed. Lesions were considered separate when there was an intervening 2-cm segment of normal vessel. Technical success was defined as complete lesion effacement on angioplasty. End-points of target and circuit patency were evaluated clinically at 3, 6, and 12 months post-procedure.

Result

Technical success was 96% (42/44): Two participants were excluded from analysis due to the need for high-pressure balloon angioplasty as the target lesions did not efface with CBA. The median follow-up duration was 337.5 days. Mean stenosis pre- and post-angioplasty was 69.0% (51.6–84.8) and 20.8% (0–44.8), respectively. The target lesion primary, primary assisted and circuit patency for the entire study population (n = 42) were 61.6 ± 7.8%, 92.7 ± 4.0%, and 54.7 ± 7.9%, respectively, at 12 months. For participants without non-target lesions (n = 22), the rates were 77.3 ± 8.9%, 90.9 ± 6.1%, and 60.7 ± 11.0%, respectively, at 12 months.

Conclusion

CBA followed by PCB angioplasty appears safe and feasible for treatment of recurrent venous lesions in dysfunctional AVFs.

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Funding

Cutting balloons and drug-coated balloons are sponsored by a research grant from Boston Scientific Corporation.

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Authors and Affiliations

  1. Department of Vascular and Interventional Radiology, Singapore General Hospital, Singapore, Singapore

    Zehao Tan, Shaun Xavier Ju Min Chan, Kun Da Zhuang, Sum Leong, Jasmine Ming Er Chua, Ankur Patel, Farah Gillan Irani, Sivanathan Chandramohan, Kiang Hiong Tay, Richard Hoau Gong Lo, Nanda Venkatanarasimha, Chow Wei Too, Bien Soo Tan, Hlaing Hlaing Win, Abdul Syafiq Bin Abdul Rahman, Muhammad Syadad Bin Sulaiman & Apoorva Gogna

  2. Department of Radiology, Haaglanden Medical Center, The Hague, Netherlands

    Thijs Urlings

  3. Department of Vascular and Interventional Radiology, Madras Institute of Orthopedics and Traumatology (MIOT) Hospitals, Chennai, India

    Karthikeyan Damodharan

  4. Department of Renal Medicine, Singapore General Hospital, Singapore, Singapore

    Chieh Suai Tan

  5. Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore

    Tze Tec Chong

Authors
  1. Zehao Tan
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  2. Shaun Xavier Ju Min Chan
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  18. Hlaing Hlaing Win
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  19. Abdul Syafiq Bin Abdul Rahman
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  20. Muhammad Syadad Bin Sulaiman
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  21. Apoorva Gogna
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Corresponding author

Correspondence to Zehao Tan.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Singhealth Centralized Institutional Review Board (CIRB reference number: 2017/2026) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

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

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The original online version of this article was revised: The affiliations for two of the authors were mistakenly switched in the initial publication prior to revision on 15 February 2022. The affiliation for the author “Chieh Suai Tan” should be “Department of Renal Medicine” and “Tze Tec Chong” should be “Department of Vascular Surgery”.

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Tan, Z., Chan, S.X.J.M., Da Zhuang, K. et al. Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: cuttIng ballooN angioplaSTy combined wITh paclitaxel drUg-coaTed balloon angioplasty, an observatIONal study (INSTITUTION Study). Cardiovasc Intervent Radiol 45, 646–653 (2022). https://doi.org/10.1007/s00270-021-03030-w

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  • DOI: https://doi.org/10.1007/s00270-021-03030-w

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