Artikel
Development and validation of a Triple-LED surgical loupe device for fluorescence-guided resections with 5-ALA
Entwicklung und Validierung einer chirurgischen Lupenbrille mit Dreifach-LED für fluoreszenzgestützte Resektionen mit 5-ALA
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Autoren
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Eric Suero-Molina
- Universitätsklinikum Münster, Klinik für Neurochirurgie, Münster, Deutschland
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Sönke Hellwig
- Universitätsklinikum Münster, Klinik für Neurochirurgie, Münster, Deutschland
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Anna Walke
- Universitätsklinikum Münster, Klinik für Neurochirurgie, Münster, Deutschland; Core Unit Proteomics, Interdisciplinary Center for Clinical Research, Münster, Deutschland
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Astrid Jeibmann
- Universitätsklinikum Münster, Institut für Neuropathologie, Münster, Deutschland
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Herbert Stepp
- Klinikum der Ludwig-Maximilians-Universität München, Laser-Forschungslabor, LIFE Center, München, Deutschland
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Walter Stummer
- Universitätsklinikum Münster, Klinik für Neurochirurgie, Münster, Deutschland
| Veröffentlicht: | 25. Mai 2022 |
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Gliederung
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Objective: Fluorescence-guided resections using 5-aminolevulinic acid (5-ALA) have been studied extensively using the BLUE400 system (Carl Zeiss Meditec). We now introduce a triple-LED headlight/loupe device for visualizing fluorescence, and compare this to the BLUE400 gold-standard in order to assure similar and not more or less sensitive protoporphyrin-IX (PPIX) visualization.
Methods: We defined the spectral requirements for a triple-LED headlight/loupe device for reproducing the xenon-based BLUE400 module. The system consisted of a white light LED (normal surgery), a 409nm LED for excitation, a 450nm LED for background illumination and appropriate observation filters. We determined prototype’s excitation and emission spectra, illumination and detection intensities, and spot homogeneity. We further performed a prospectively-randomized and blinded study for fluorescence assessments of fresh, marginal, fluorescing and non-fluorescing tumor samples comparing the LED/loupe device with BLUE400 in malignant glioma patients treated with 20mg/kg b.w. 5-ALA. Tumor samples were immediately assessed in turn both with a Kinevo® and a novel triple-LED/loupe device by different surgeons.
Results: Seven triple-diode/loupe devices were analyzed. Illumination intensities in the 409 and 450nm range were comparable to BLUE400, with high spot homogeneity. Fluorescence intensities measured distally to oculars/telescope were 9.9 fold higher with the loupe device. spectrography. For validation 26 malignant gliomas patients with 240 biopsies were analyzed. With BLUE400 results as reference, sensitivity for reproducing fluorescence findings was 100%, specificity 95%, PPV 98%, NPV 100% and accuracy 95%. This study reached its primary study aim with agreement in 226 of 240 (0.942; lower 95% CI: 0.904, upper 95% CI: 0.968).
Conclusion: We observed only minor differences regarding spectra and illumination intensities during evaluation. Fluorescence intensities available to surgeons were 9.9-fold higher with the loupe device. Importantly, the independent perception of fluorescence using the new system and BLUE400 was statistically equivalent. We believe the triple-LED loupe device to be a useful and safe option for surgeons who prefer loupes to the microscope for surgical resections in appropriate patients.
