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Endovenous laser ablation (EVLA) for vein insufficiency: two-year results of a multicenter experience with 1940-nm laser diode and a novel optical fiber

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Abstract

Thermoablative techniques currently represent, in accordance with international guidelines, the most used methods in the treatment of varicose veins. From some years, lasers with a wavelength greater than 1900 nm have been introduced for EndoVenous Laser Ablation (EVLA) treatment. However, currently, few clinical studies regarding this new technology are reported in the medical literature. The aim of this study is to evaluate outcomes at a 2-year follow-up (mid-term) of EVLA of varicose veins of the lower limbs using a 1940-nm laser and a new cylindric monoring fiber. This clinical trial was conducted as a multicenter, retrospective, non-randomized, non-blind clinical study. Ninety-three patients were enrolled for a total of one hundred consecutive procedures performed in the period between January 2021 and May 2021 in two Italian facilities. The primary efficacy endpoint was the occlusion rate of the treated vein immediately after surgery and at the follow-up (24 months). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power and linear energy density or LEED). The primary safety endpoints were the incidence of pain (1 day and 7 days after surgery) and the rate of intraoperative and postoperative complications. The precepted pain was evaluated with the visual analog scale (VAS). The secondary safety endpoint was the evaluation of the improvement of the patient’s symptoms related to venous disease. This evaluation was conducted by recording the changes in clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification. All procedures were carried out regularly on an outpatient basis, and no intraoperative complications occurred. The occlusion rate of the target veins was 100% at 7- and 30-day controls. At follow-up controls, performed at 6 months, 1 and 2 years carried out showed an occlusion rate respectively of 99% (97 to 100), 96.9% (93.6 to 100), and 95.9% (92.1 to 99.9). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power watt and linear energy density): As regards the power parameters, we report an average of watts of 4.5 ± 0.8 [2.5 to 6] and linear energy density delivered (LEED) of 41.2 ± 8.6 [(21.1 to 66.7)]. The pain reported (with VAS scale) on 1 day of the procedure was 2 [1; 3] and 1 [0 to 4] at 7 days. All patients showed improved symptoms related to venous disease, with reduction of the individual CEAP class to which they belong. This study demonstrates that EndoVascular Laser Ablation (EVLA) treatment of varicose veins with a wavelength > 1900 nm is safe and effective. The overall occlusion rate was high. The reported results suggest that using lower parameters, such as output power (watts) and LEED (linear energy density), do not reduce the success rate of the treatment when used over 35 J/cm.

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Funding

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

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Authors and Affiliations

  1. Fondazione Villa Salus, Ospedale Villa Salus, Venezia Mestre (VE), Servizio di Flebochirurgia Avanzata, Venice, Italy

    Luca Palombi, Fabio Martinelli & Pier Giovanni Bianchi

  2. Unione Sanitaria Internazionale, Villa del Lido Medical House, Rome, Italy

    Monica Morelli

  3. Medical Statistics, Department of Public Health, University of Naples Federico II, Naples, Italy

    Dario Bruzzese

  4. Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy

    Gennaro Quarto

  5. Rome, Italy

    Luca Palombi

Authors
  1. Luca Palombi
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  2. Monica Morelli
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  4. Fabio Martinelli
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  5. Gennaro Quarto
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  6. Pier Giovanni Bianchi
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Contributions

Conception and design: LP; analysis and interpretation: DB, LP, and GQ; data collection: LP, MM, FM, and PGB; writing the article: LP and MM; critical revision of the article: GQ; final approval of the article: all authors; overall responsibility: LP.

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Correspondence to Luca Palombi.

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Competing interests

L. Palombi provides consultive advice to NeoLaser L.t.d., Caesarea, Israel. All other authors state “no conflict of interest.”

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Palombi, L., Morelli, M., Bruzzese, D. et al. Endovenous laser ablation (EVLA) for vein insufficiency: two-year results of a multicenter experience with 1940-nm laser diode and a novel optical fiber. Lasers Med Sci 39, 61 (2024). https://doi.org/10.1007/s10103-024-04000-7

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