Abstract
BackgroundThe BLUE 400 filter system (Carl Zeiss Meditec, Oberkochen, Germany) has provided visualization of 5-ALA-induced fluorescence-guided surgery for more than 20 years. Nevertheless, constraints, e.g., limited background discrimination during hemostasis, obstruct fluency of surgery. A novel filter with improved background visualization was developed, requiring validation regarding fluorescence discrimination. The aim of this article is to determine diagnostic accuracy and perception of protoporphyrin IX (PpIX) discrimination of a novel filter system with higher background illumination (BLUE 400 AR) compared with the gold standard, BLUE 400.MethodsA surgical microscope equipped with both BLUE 400 and BLUE 400 AR was used. Comparisons were performed on a biological basis and on the visual perception of margins. High-resolution images were compared during and after surgery by senior neurosurgeons. In a predefined biopsy algorithm, four biopsies per patient at tumor margins of PpIX fluorescence and adjacent brain were acquired using BLUE 400 AR only from regions intended for resection and assessed for cell count and density.ResultsThirty-two patients with malignant gliomas were included in this study. BLUE 400 AR markedly enhanced the brightness of the surgical field, allowing superior discrimination of brain anatomy. A total of 128 biopsies from fluorescence margins were collected. Positive predictive value (PPV) was 98.44% (95% CI, 90.06–99.77%) for malignant glioma. Residual median cell density in non-fluorescent tissue was 13% (IQR 13 to 31). Perception of the location of fluorescent margins on HD images was equivalent for both filter combinations.ConclusionsBLUE 400 AR demonstrated superior background compared with conventional BLUE 400 in malignant glioma surgery but comparable fluorescence margins and PPV. Therefore, BLUE 400 AR can be considered safe and effective in supporting malignant glioma surgery.
Highlights
IntroductionFirst introduced in 1998 [10,11,12], and corroborated for efficacy and safety by a randomized phase III trial in 2006 [9], 5-aminolevulinic acid (5-ALA) was approved by the European Medicines Agency and, more recently, by the FDA in the USA
Eric Suero Molina and Louise Stögbauer contributed to this work.This article is part of the Topical Collection on Tumor—GliomaElectronic supplementary material The online version of this article contains supplementary material, which is available to authorized users.Fluorescence-guided surgery (FGS) with 5-aminolevulinic acid (5-ALA) is well established in malignant glioma surgery
The primary aim of this study was to estimate the positive predictive value of 5-ALA induced-fluorescence using the new method in samples taken from the border of the fluorescent regions
Summary
First introduced in 1998 [10,11,12], and corroborated for efficacy and safety by a randomized phase III trial in 2006 [9], 5-ALA was approved by the European Medicines Agency and, more recently, by the FDA in the USA With this method, fluorescence is assessed visually using special optical filters, which have remained literally unchanged since their inception in 1998 [10]. The aim of this article is to determine diagnostic accuracy and perception of protoporphyrin IX (PpIX) discrimination of a novel filter system with higher background illumination (BLUE 400 AR) compared with the gold standard, BLUE 400. Conclusions BLUE 400 AR demonstrated superior background compared with conventional BLUE 400 in malignant glioma surgery but comparable fluorescence margins and PPV. BLUE 400 AR can be considered safe and effective in supporting malignant glioma surgery
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