Month: March 2023

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Intraoperative confocal laser endomicroscopy: prospective in vivo feasibility study of a clinical-grade system for brain tumors

J Neurosurg 138:587–597, 2023

The authors evaluated the feasibility of using the first clinical-grade confocal laser endomicroscopy (CLE) system using fluorescein sodium for intraoperative in vivo imaging of brain tumors.

METHODS A CLE system cleared by the FDA was used in 30 prospectively enrolled patients with 31 brain tumors (13 gliomas, 5 meningiomas, 6 other primary tumors, 3 metastases, and 4 reactive brain tissue). A neuropathologist classified CLE images as interpretable or noninterpretable. Images were compared with corresponding frozen and permanent histology sections, with image correlation to biopsy location using neuronavigation. The specificities and sensitivities of CLE images and frozen sections were calculated using permanent histological sections as the standard for comparison. A recently developed surgical telepathology software platform was used in 11 cases to provide real-time intraoperative consultation with a neuropathologist.

RESULTS Overall, 10,713 CLE images from 335 regions of interest were acquired. The mean duration of the use of the CLE system was 7 minutes (range 3–18 minutes). Interpretable CLE images were obtained in all cases. The first interpretable image was acquired within a mean of 6 (SD 10) images and within the first 5 (SD 13) seconds of imaging; 4896 images (46%) were interpretable. Interpretable image acquisition was positively correlated with study progression, number of cases per surgeon, cumulative length of CLE time, and CLE time per case (p ≤ 0.01). The diagnostic accuracy, sensitivity, and specificity of CLE compared with frozen sections were 94%, 94%, and 100%, respectively, and the diagnostic accuracy, sensitivity, and specificity of CLE compared with permanent histological sections were 92%, 90%, and 94%, respectively. No difference was observed between lesion types for the time to first interpretable image (p = 0.35). Deeply located lesions were associated with a higher percentage of interpretable images than superficial lesions (p = 0.02). The study met the primary end points, confirming the safety and feasibility and acquisition of noninvasive digital biopsies in all cases. The study met the secondary end points for the duration of CLE use necessary to obtain interpretable images. A neuropathologist could interpret the CLE images in 29 (97%) of 30 cases.

CONCLUSIONS The clinical-grade CLE system allows in vivo, intraoperative, high-resolution cellular visualization of tissue microstructure and identification of lesional tissue patterns in real time, without the need for tissue preparation.

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Long-term results of the NECK trial—implanting a disc prosthesis after cervical anterior discectomy cannot prevent adjacent segment disease

The Spine Journal 23 (2023) 350−360

Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment disease as compared to anterior cervical discectomy and fusion (ACDF).

PURPOSE: To evaluate the long-term outcome in patients with cervical radiculopathy due to a herniated disc undergoing ACDA, ACDF or ACD (no cage, no plate) in terms of clinical outcome measured by the Neck Disability Index (NDI). Likewise, clinically relevant adjacent segment disease is assessed as a long-term result.

STUDY DESIGN: Double-blinded randomized controlled trial.

PATIENT SAMPLE: A total of 109 patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without cage.

OUTCOME MEASURES: Clinical outcome was measured by patients’ self-reported NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, perceived recovery and reoperation rate. Radiological outcome was assessed by radiographic cervical curvature and adjacent segment degeneration (ASD) parameters at baseline and up until five years after surgery.

METHODS: To account for the correlation between repeated measurements of the same individual Generalized Estimated Equations (GEE) were used to calculate treatment effects, expressed in difference in marginal mean values for NDI per treatment group.

RESULTS: Clinical outcome parameters were comparable in the ACDA and ACDF group, but significantly worse in the ACD group, though not reaching clinical relevance. Annual reoperation rate was 3.6% in the first two years after surgery, declined to 1.9% in the years thereafter. The number of reoperations for ASD was not lower in the ACDA group, while the number of reoperations at the index level was higher after ACD, when compared to ACDF and ACDA.

CONCLUSIONS: A persisting absence of clinical superiority was demonstrated for the cervical disc prosthesis five years after surgery. Specifically, clinically relevant adjacent level disease was not prevented by implanting a prosthesis. Single level ACD without implanting an intervertebral device provided worse clinical outcome, which was hypothesized to be caused by delayed fusion. This stresses the need for focusing on timely fusion in future research.

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Fiber-Optic Intracranial Pressure Monitoring System Using Wi-Fi—An In Vivo Study

Neurosurgery 92:647–656, 2023

Continuous invasive monitoring of intracranial pressure (ICP) is essential in neurocritical care for surveillance and management of raised ICP. Fluid-based systems and strain gauge microsensors remain the current standard. In the past few decades, several studies with wireless monitoring were developed aiming to reduce invasiveness and complications.

OBJECTIVE: To describe a novel Wi-Fi fiber-optic device for continuous ICP monitoring using smartphone in a swine model.

METHODS: Two ICP sensors (wireless prototype and wire-based reference) were implanted in the cerebral parenchyma of a swine model for a total of 120 minutes of continuous monitoring. Every 5 minutes, jugular veins compression was performed to evaluate ICP changes. The experimentation was divided in 3 phases for comparison and analysis.

RESULTS: Phase 1 showed agreement in ICP changes for both sensors during jugular compression and releasing, with a positive and strong Spearman correlation (r = 0.829, P < .001). Phase 2 started after inversion of the sensors in the burr holes; there was a positive and moderately weak Spearman correlation (r = 0.262, P < .001). For phase 3, the sensors were returned to the first burr holes; the prototype behaved similarly to the reference sensor, presenting a positive and moderately strong Spearman correlation (r = 0.669, P < .001).

CONCLUSION: A Wi-Fi ICP monitoring system was demonstrated in a comprehensive and feasible way. It was possible to observe, using smartphone, an adequate correlation regarding ICP variations. Further adaptations are already being developed.

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