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Simon H. Bayerl, Adnan Ghori, Melina Nieminen-Kelhä, Tiziana Adage, Jörg Breitenbach, Peter Vajkoczy and Vincent Prinz

OBJECTIVE

The management of patients with aneurysmal subarachnoid hemorrhage (aSAH) remains a highly demanding challenge in critical care medicine. Despite all efforts, the calcium channel antagonist nimodipine remains the only drug approved for improving outcomes after aSAH. However, in its current form of application, it provides less than optimal efficacy and causes dose-limiting hypotension in a substantial number of patients. Here, the authors tested in vitro the release dynamics of a novel formulation of the calcium channel blocker nicardipine and in vivo local tolerance and tissue reaction using a chronic cranial window model in mice.

METHODS

To characterize the release kinetics in vitro, dissolution experiments were performed using artificial cerebrospinal fluid over a time period of 21 days. The excipients used in this formulation (NicaPlant) for sustained nicardipine release are a mixture of two completely degradable polymers. A chronic cranial window in C57BL/6 mice was prepared, and NicaPlant slices were placed in proximity to the exposed cerebral vasculature. Epifluorescence video microscopy was performed right after implantation and on days 3 and 7 after surgery. Vessel diameter of the arteries and veins, vessel permeability, vessel configuration, and leukocyte–endothelial cell interaction were quantified by computer-assisted analysis. Immunofluorescence staining was performed to analyze inflammatory reactions and neuronal alterations.

RESULTS

In vitro the nicardipine release profile showed an almost linear curve with about 80% release at day 15 and full release at day 21. In vivo epifluorescence video microscopy showed a significantly higher arterial vessel diameter in the NicaPlant group due to vessel dilatation (21.6 ± 2.6 µm vs 17.8 ± 1.5 µm in controls, p < 0.01) confirming vasoactivity of the implant, whereas the venous diameter was not affected. Vessel dilatation did not have any influence on the vessel permeability measured by contrast extravasation of the fluorescent dye in epifluorescence microscopy. Further, an increased leukocyte–endothelial cell interaction due to the implant could not be detected. Histological analysis did not show any microglial activation or accumulation. No structural neuronal changes were observed.

CONCLUSIONS

NicaPlant provides continuous in vitro release of nicardipine over a 3-week observation period. In vivo testing confirmed vasoactivity and lack of toxicity. The local application of this novel nicardipine delivery system to the subarachnoid space is a promising tool to improve patient outcomes while avoiding systemic side effects.

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Vincent Prinz, Simon Bayerl, Nora Renz, Andrej Trampuz, Marcus Czabanka, Johannes Woitzik, Peter Vajkoczy and Tobias Finger

OBJECTIVE

Loosening of pedicle screws is a frequent complication after spinal surgery. Implant colonization with low-virulent microorganisms forming biofilms may cause implant loosening. However, the clinical evidence of this mechanism is lacking. Here, the authors evaluated the potential role of microbial colonization using sonication in patients with clinical pedicle screw loosening but without signs of infection.

METHODS

All consecutive patients undergoing hardware removal between January 2015 and December 2017, including patients with screw loosening but without clinical signs of infection, were evaluated. The removed hardware was investigated using sonication.

RESULTS

A total of 82 patients with a mean (± SD) patient age of 65 ± 13 years were eligible for evaluation. Of the 54 patients with screw loosening, 22 patients (40.7%) had a positive sonication result. None of the 28 patients without screw loosening who served as a control cohort showed a positive sonication result (p < 0.01). In total, 24 microorganisms were detected in those 22 patients. The most common isolated microorganisms were coagulase-negative staphylococci (62.5%) and Cutibacterium acnes (formerly known as Propionibacterium acnes) (25%). When comparing only the patients with screw loosening, the duration of the previous spine surgery was significantly longer in patients with a positive microbiological result (288 ± 147 minutes) than in those with a negative result (201 ± 103 minutes) (p = 0.02).

CONCLUSIONS

The low-virulent microorganisms frequently detected on pedicle screws by using sonication may be an important cause of implant loosening and failure. Longer surgical duration increases the likelihood of implant colonization with subsequent screw loosening. Sonication is a highly sensitive approach to detect biofilm-producing bacteria, and it needs to be integrated into the clinical routine for optimized treatment strategies.