Abstract
Introduction
Endovascular therapies have not yet had an ideal effect on thromboangiitis obliterans (TAO) and no data have been published about laser-assisted angioplasty (LA) combined with radiofrequency ablation (RFA) for TAO. This study aimed to investigate the outcome of LA combined with RFA for TAO.
Methods
Sixteen consecutive patients underwent LA and RFA procedures between June 2018 and March 2019 in this prospective pilot study. The clinical outcomes and complications were assessed at 6, 12, and 18 months after the procedure. The primary endpoint was defined as the limb salvage rate and freedom of target-lesion revascularization (f-TLR) of the limb, and the effect on the outcome was assessed by the ankle brachial index (ABI), numerical rating scores (NRSs), and the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D).
Results
Men accounted for 87.5% of the patients. All patients underwent LA, and following the RFA procedure, two patients received bailout stenting (12.50%). The technique success rate was 100%, and no severe complications occurred. The ABI was significantly higher at the 18-month follow-up than at baseline (P < 0.001). The primary and secondary patency rates were 71.82% and 79.80%, respectively, and the f-TLR and limb salvage rates were 90% and 92.86% based on Kaplan–Meier analysis. The EQ-5D value was higher after the procedure than at baseline (P < 0.001), and the NRS value was lower after the procedure than at baseline (P < 0.001).
Conclusions
Our results confirmed that LA combined with RFA was a feasible procedure that resulted in acceptable limb salvage and f-TLR rates.
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Funding
No funding or sponsorship was received for this study or publication of this article. The Rapid Service Fee was funded by the authors.
Medical Writing and Editorial Assistance
The language of this article was edited by American Journal Experts (AJE).
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Author Contributions
LY, JDT, YT, and MY contributed to the study design, data analysis and article writing. LY, JDT, JLL, CL, and YH contributed to data collection. All authors contributed to the article and approved the submitted version.
Disclosures
The authors, Lin Yang, Jingdong Tang, Ye Tian, Miao Yang, Jianlin Liu, Chao Liu, and Yang Han, have nothing to disclose.
Compliance with Ethics Guidelines
The study was approved by the institutional review board (IRB), the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University. It fully complied with the ethical standards of the hospital and followed the Helsinki Declaration of 1964 and its later amendments. Written informed consent was obtained from each patient before enrollment in the trial.
Data Availability
The data generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Yang, L., Tang, J., Tian, Y. et al. The Preliminary Outcome of Laser-Assisted Angioplasty Combined with Endovascular Radiofrequency Ablation for Thromboangiitis Obliterans. Adv Ther 38, 5700–5709 (2021). https://doi.org/10.1007/s12325-021-01945-x
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DOI: https://doi.org/10.1007/s12325-021-01945-x