Leukocyte- and platelet-rich fibrin in cranial surgery: a single-blinded, prospective, randomized controlled noninferiority trial.

OBJECTIVE: CSF leakage is a major complication after cranial surgery, and although fibrin sealants are widely used for reinforcing dural closure, concerns exist regarding their safety, efficacy, and cost. Leukocyte- and platelet-rich fibrin (L-PRF), an autologous platelet concentrate, is readily available and inexpensive, making it a cost-effective alternative for commercially available fibrin sealants. This study aimed to demonstrate the noninferiority of L-PRF compared with commercially available fibrin sealants in preventing postoperative CSF leakage in supra- and infratentorial cranial surgery, with secondary outcomes focused on CSF leakage risk factors and adverse events. METHODS: In a single-blinded, prospective, randomized controlled interventional trial conducted at a neurosurgery department of a tertiary care center (UZ Leuven, Belgium), patients undergoing elective cranial neurosurgery were randomly assigned to receive either L-PRF (active treatment) or commercially available fibrin sealants (control) for dural closure in a 1:1 ratio. RESULTS: Among 350 included patients, 328 were analyzed for the primary endpoint (44.5% male, mean age 52.3 ± 15.1 years). Six patients (5 in the control group, 1 in the L-PRF group) presented with CSF leakage requiring any intervention (relative risk [RR] 0.20, one-sided 95% CI -∞ to 1.02, p = 0.11), confirming noninferiority. Of these 6 patients, 1 (in the control group) presented with CSF leakage requiring revision surgery. No risk factors for reconstruction failure in combination with L-PRF were identified. RRs for adverse events such as infection (0.72, 95% CI -∞ to 1.96) and meningitis (0.36, 95% CI -∞ to 1.25) favored L-PRF treatment, although L-PRF treatment showed slightly more bleeding events (1.44, 95% CI -∞ to 4.66). CONCLUSIONS: Dural reinforcement with L-PRF proved noninferior to commercially available fibrin sealants, with no safety issues. Introducing L-PRF to standard clinical practice could result in important cost savings due to accessibility and lower cost. Clinical trial registration no.: NCT03812120 (ClinicalTrials.gov).

Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial {1}.

BACKGROUND: CSF leakage is a major complication after cranial surgery, thus, adequate dural closure must be performed. Commercially available fibrin sealants are currently considered the gold standard for dural closure, but problems have been reported regarding safety, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) as an alternative to commercially available fibrin sealants. METHODS/DESIGN: This single-blinded, prospective randomized controlled interventional trial aims to demonstrate the non-inferiority of L-PRF compared to commercially available fibrin sealants for dural closure. This trial will include patients undergoing cranial neurosurgery (supratentorial and infratentorial) with intentional opening of the dura. Patients are randomized in a 1:1 fashion comparing L-PRF to commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage within 12 weeks after surgery. Secondary endpoints are complications such as bleeding or wound infections. Additionally, a cost-effectiveness analysis is performed. DISCUSSION: With this trial, we will evaluate the safety and efficiency of L-PRF compared to commercially available fibrin sealants. TRIAL REGISTRATION: ClinicalTrials.gov NCT03812120. Registered on 22 January 2019.

NID1-related autosomal dominant Dandy-Walker malformation with occipital cephalocele in three generations.

The combination of Dandy-Walker malformation and occipital cephalocele is a rare autosomal dominant condition, known as ADDWOC, and caused by mutations in NID1 or LAMC1. We present a three-generation family with variable manifestations of Dandy-Walker malformation and occipital cephalocele. They all have normal psychomotor development and lack neurological manifestations. Mutation analysis revealed a likely pathogenic missense variant in NID1 (c.3336T > G, p.Asn1112Lys), affecting an amino acid residue crucial in the nidogen/laminin interaction.

Randomized Trial Comparing Burr Hole Craniostomy, Minicraniotomy, and Twist Drill Craniostomy for Treatment of Chronic Subdural Hematoma.

BACKGROUND: The mainstay of treatment for symptomatic or large chronic subdural hematoma (CSDH) is surgery, but controversy still exists regarding the best surgical technique. Three different techniques are commonly used: burr hole craniostomy (BHC), minicraniotomy (MC), and twist drill craniostomy (TDC). OBJECTIVE: To determine which surgical technique for drainage of CSDH offers best results. METHODS: We set up a multicenter prospective randomized trial (Comparison of Chronic Subdural Hematoma Treatment [COMPACT] trial) comparing BHC, MC, and TDC for the surgical treatment of CSDH. The primary end point was reoperation rate, and secondary end points included complication rates and clinical outcome. Patients were considered to have good outcome when they did not undergo reoperation, suffered no surgical or medical complication, and had no related mortality. Clinical outcome was also evaluated by evolution of the Markwalder score and the modified Rankin score. RESULTS: Two-hundred forty-five patients were included in the final analysis: 79 BHC, 84 MC, and 82 TDC. Mean duration of surgery was shorter for TDC than for BHC and MC ( P < .001). Reoperation rate was 7.6% for BHC, 13.1% for MC, and 19.5% for TDC ( P = .07). This trend toward better results for BHC was not statistically significant in logistic regression analysis. The proportion of patients with good outcome was 78.5% for BHC group, 76.2% for MC, and 69.5% for TDC ( P = .4). Evolution of the Markwalder score and modified Rankin score were not significantly different between treatment groups. CONCLUSION: All 3 techniques are effective at treating patients with CSDH with eventual 6-month outcome being similar. Although not reaching statistical significance in our study, BHC offers the lowest recurrence rate combined with manageable complication rate.

Fetoscopic insufflation of heated-humidified carbon dioxide during simulated spina bifida repair is safe under controlled anesthesia in the fetal lamb.

OBJECTIVE: To assess the safety of Partial-Amniotic-Insufflation-of-heated-humidified-CO2 (hPACI) during fetoscopic spina bifida repair (fSB-repair). METHOD: A simulated fSB-repair through an exteriorized uterus under hPACI was performed in 100-day fetal lambs (term = 145 days) under a laboratory anesthesia protocol (n = 5; group 1) which is known to induce maternal-fetal acidosis and hypercapnia. Since these may not occur clinically, we applied a clinical anesthesia protocol (n = 5; group 2), keeping maternal parameters within physiological conditions, that is, controlled maternal arterial carbon dioxide (CO2) pressure (pCO2  = 30 mmHg), blood pressure (≥67 mmHg), and temperature (37.1-39.8°C). Our superiority study used fetal pH as the primary outcome. RESULTS: Compared to group 1, controlled anesthesia normalized fetal pH (7.23 ± 0.02 vs. 7.36 ± 0.02, p < 0.001), pCO2 (70.0 ± 9.1 vs. 43.0 ± 1.0 mmHg, p = 0.011) and bicarbonate (27.8 ± 1.1 vs. 24.0 ± 0.9 mmol/L, p = 0.071) at baseline. It kept them within clinically acceptable limits (pH ≥ 7.23, pCO2  ≤ 70 mmHg, bicarbonate ≤ 30 mm/L) for ≥120 min of hPACI as opposed to ≤30 min in group one. Fetal pO2 and lactate were comparable between groups and generally within normal range. Fetal brain histology demonstrated fewer apoptotic cells and higher neuronal density in the prefrontal cortex in group two. There was no difference in fetal membrane inflammation, which was mild. CONCLUSION: Fetoscopic insufflation of heated-humidified CO2 during simulated fSB-repair through an exteriorized uterus can be done safely under controlled anesthesia.

The incidence of postoperative cerebrospinal fluid leakage after elective cranial surgery: a systematic review.

Cerebrospinal fluid (CSF) leakage is a major complication after elective neurosurgical procedures. The aim of this systematic literature review is to summarize the incidence rates of postoperative cerebrospinal fluid leakage for neurosurgical procedures, classified by surgical approach. The Pubmed, Cochrane, Embase, and Web of Science databases were searched for studies reporting the outcome of patients undergoing elective neurosurgical procedures. The number of patients, surgical approach, and indication for surgery were recorded for each study. Outcomes related to CSF leakage such as clinical manifestation and treatment were reported as well. One hundred and thirteen studies were included, reporting 94,695 cases. Overall, CSF leaks were present in 3.8% of cases. Skull base surgery had the highest rate of CSF leakage with 6.2%. CSF leakage occurred in 5.9% of anterior skull base procedures, 6.4% of middle fossa, and 5.2% of transpetrosal surgeries. 5.8% of reported infratentorial procedures were complicated by CSF leakage versus 2.9% of supratentorial surgeries. CSF leakage remains a common serious adverse event after cranial surgery. There exists a need for standardized procedures to reduce the incidence of postoperative CSF leakage, as this serious adverse event may lead to increased health care costs.

Long-Term Outcomes of Patients with Hydrocephalus Secondary to Tectal Plate Glioma versus Idiopathic Aqueductal Stenosis: Results from a Single Center.

INTRODUCTION: Tectal plate gliomas (TPG) constitute a distinct entity of benign tumors of the brain stem which show an indolent clinical course. Adequate treatment of secondary hydrocephalus is undoubtedly a major factor in the outcome. However, little is known about to what degree the tumor itself determines the long-term outcome of these patients. METHODS: We retrospectively analyzed and compared the clinical and radiological data of 16 pediatric TPG patients with data of 12 pediatric idiopathic aqueductal stenosis (IAS) patients treated in our center from 1988 to 2018. For both groups, we assessed the long-term outcome in terms of hydrocephalus management, and for the TPG group, we assessed tumor growth during follow-up. In a separate prospective part of the study, we performed a neuropsychological evaluation in a subgroup of patients using a standardized testing battery, covering intelligence, learning, memory, executive functions, and an inventory on depression. RESULTS: In the TPG group, the mean clinical and radiological follow-up was 84 and 70 months, respectively. On average, the maximum diameter of the tumor increased by 11% (p = 0.031) and the estimated tumor volume with 35% (p = 0.026) on radiological follow-up. The fronto-occipital horn ratio (FOHR) decreased by 23% on average after treatment. In the IAS group, the mean clinical and radiological follow-up was 117 and 85 months, respectively. In this group, the FOHR decreased by 21% on average. Neurocognitive testing revealed significant higher scores in the TPG group on global intelligence (TPG = 109, IAS = 85.5, U = 3, p < 0.01, z = -2.71), performance (TPG= 100, IAS = 85, U = 7, p = 0.03, z = -2.2), and verbal intelligence (TPG = 122, IAS = 91.5, U = 2, p < 0.00, z = -2.87) as well as working memory (TPG = 109.5, IAS = 77, U = 0.5, p = 0.01, z = -2.46). CONCLUSION: Our results suggest that the long-term outcome in TPG patients is acceptable and that cognition is substantially better preserved than in patients with IAS. This puts the idea of a significant contribution of the tumoral mass to disease outcome on the long term in question. Adequate and prompt management of hydrocephalus is the most important factor in long-term cognitive outcome.

Validation of a high-fidelity training model for fetoscopic spina bifida surgery.

Open fetal surgery for spina bifida (SB) is safe and effective yet invasive. The growing interest in fetoscopic SB repair (fSB-repair) prompts the need for appropriate training. We aimed to develop and validate a high-fidelity training model for fSB-repair. fSB-repair was simulated in the abdominal cavity and on the stomach of adult rabbits. Laparoscopic fetal surgeons served either as novices (n = 2) or experts (n = 3) based on their experience. Technical performance was evaluated using competency Cumulative Sum (CUSUM) analysis and the group splitting method. Main outcome measure for CUSUM competency was a composite binary outcome for surgical success, i.e. watertight repair, operation time ≤ 180 min and Objective-Structured-Assessment-of-Technical-Skills (OSATS) score ≥ 18/25. Construct validity was first confirmed since competency levels of novices and experts during their six first cases using both methods were significantly different. Criterion validity was also established as 33 consecutive procedures were needed for novices to reach competency using learning curve CUSUM, which is a number comparable to that of clinical fSB-repair. Finally, we surveyed expert fetal surgeons worldwide to assess face and content validity. Respondents (26/49; 53%) confirmed it with ≥ 71% of scores for overall realism ≥ 4/7 and usefulness ≥ 3/5. We propose to use our high-fidelity model to determine and shorten the learning curve of laparoscopic fetal surgeons and retain operative skills.

Stroke rate after external fractionated radiotherapy for benign meningioma.

PURPOSE: Patients with a benign meningioma often have a long survival following the treatment of their meningioma. Since radiotherapy is frequently part of the treatment, long-term side effects are of considerable concern. A controversial long-term side effect of radiotherapy is stroke. Due to its severity, it is important to know the frequency of this side effect. The aim of this study was to assess the stroke incidence and risk factors among patients receiving radiotherapy for their benign meningioma. METHODS: We performed a retrospective database study of patients who underwent primary or adjuvant radiotherapy for their benign meningioma at University Hospitals Leuven from January 2003 to December 2017. RESULTS: We included 169 patients with a median age of 51 years (range 22-84). Every patient received fractionated radiotherapy using photons with a median dose of 56 Gy (range 54-56) in fractions of 2 Gy (range 1.8-2). The median follow-up was 5.3 years (range 0.1-14). The cumulative stroke incidence function showed an incidence of 11.6% after 9 years of follow-up, translating to a stroke incidence per year of 1.29%. We found two significant risk factors for stroke: medically treated arterial hypertension (p = 0.005) and history of previous stroke or transient ischemic attack (p < 0.001). 5-year local control and overall survival rates were respectively 97.4% and 91.2%. Other late grade III/IV toxicities occurred in 16.0% (27/169) of patients. CONCLUSION: Our study shows a higher incidence of stroke in patients who received radiotherapy for their benign meningioma compared to the general population.

Computed tomography based assessment of programmable shunt valve settings.

Introduction: Programmable shunt valve settings can sometimes be difficult to assess using classic read-out tools, warranting a skull X-ray. Research question: Can we use available head computed tomography (CT) scans to determine the valve settings, in order to obviate the need for additional skull X-rays? Material and methods: The valve setting of two different programmable shunts (Codman Certas Plus® and Sophysa Polaris®) were assessed by two blinded observers in 24 patients using 65 head CT scans (slice thickness ≤2 â€‹mm). Using multi-planar reconstruction (MPR) tools, images were resliced according to the direction of the valve, allowing a direct readout of the valve settings. We validated our CT based method against 32 available skull X-rays. Results: For all CT scans it was possible to assess the valve setting. No interobserver variability was found and there was a 100 â€‹% concordance between the CT based method and skull X-rays. Discussion: CT based assessment of programmable shunt valve settings is feasible and reliable. It may obviate the need for additional skull x-rays when a head CT scan is available. Conclusions: This technique can reduce radiation exposure and can be applied to historical CT imaging with unknown valve settings.

Validation of the Fetal Lamb Model of Spina Bifida.

A randomized trial demonstrated that fetal spina bifida (SB) repair is safe and effective yet invasive. New less invasive techniques are proposed but are not supported by adequate experimental studies. A validated animal model is needed to bridge the translational gap to the clinic and should mimic the human condition. Introducing a standardized method, we comprehensively and reliably characterize the SB phenotype in two lamb surgical models with and without myelotomy as compared to normal lambs. Hindbrain herniation measured on brain magnetic resonance imaging (MRI) was the primary outcome. Secondary outcomes included gross examination with cerebrospinal fluid (CSF) leakage test, neurological examination with locomotor assessment, whole-body MRI, motor and somatosensory evoked potentials; brain, spinal cord, hindlimb muscles, bladder and rectum histology and/or immunohistochemistry. We show that the myelotomy model best phenocopies the anatomy, etiopathophysiology and symptomatology of non-cystic SB. This encompasses hindbrain herniation, ventriculomegaly, posterior fossa anomalies, loss of brain neurons; lumbar CSF leakage, hindlimb somatosensory-motor deficit with absence of motor and somatosensory evoked potentials due to loss of spinal cord neurons, astroglial cells and myelin; urinary incontinence. This model obtains the highest validity score for SB animal models and is adequate to assess the efficacy of novel fetal therapies.

Outcome after surgery in supratentorial and infratentorial solitary brain metastasis.

BACKGROUND: The aim of this retrospective study was to investigate and compare the outcome after surgery in patients with a supratentorial solitary metastasis (SSM) and an infratentorial solitary metastasis (ISM). A worse prognosis has been reported in ISM. METHODS: Fifty-two patients with a newly diagnosed solitary brain metastasis on MRI were included to identify risk factors affecting the outcome. Key variables included tumor size, staging of the primary tumor, time span of presurgical work-up, and surgical technique. Outcome variables included postoperative complications, tumor recurrence, and mortality. Kaplan-Meier survival analysis was applied. RESULTS: Thirty patients with a SSM and 22 patients with an ISM underwent gross total resection. The tumor size did not have a statistical significant effect on survival. Presurgical work-up time was similar in SSM and ISM. Postoperative complications were more frequently encountered in ISM. Recurrence rate was comparable in SSM and ISM. Carcinomatous meningitis (CM) was more frequently seen in ISM, and CM was seen more often with the piecemeal resection technique. There was no statistical difference in overall survival between SSM and ISM. CONCLUSIONS: This study identified factors that play a role in the outcome after surgery in patients with ISM and SSM on MRI. Postoperative complications seemed to be higher in ISM and CM was more often seen in ISM, but the worse prognosis in patients with ISM compared with SSM could not be confirmed.

Multidimensional, patient-reported outcome after posterior fossa decompression in 79 patients with Chiari malformation type I.

BACKGROUND: We studied patient-reported outcome among patients who underwent posterior fossa decompression (PFD) for Chiari malformation type I (CM-I). METHODS: We interviewed patients who underwent PFD for CM-I from 1995 to 2016. RESULTS: A total of 79 patients were interviewed. The median age at surgery was 30 years (range 5-72 years) with 27 pediatric patients. Forty-six patients had syringomyelia (36 adults and 10 pediatric patients). Fifty-four patients (68%) reported at least some improvement, 46 (58%) important improvement, 13 (16%) worsening, and 12 stabilization (15%). Any improvement as well as important improvement were significantly more often reported in the nonsyringomyelia group (85% vs. 57%, P = 0.01 and 76% vs. 46%, P = 0.01, respectively). Of the 47 patients reporting preoperative neck pain, 31 (66%) reported at least some improvement after surgery and 9 (19%) worsening after surgery. Of the 59 patients experiencing headaches before surgery, 45 (76%) reported at least some improvement after surgery and 4 (7%) worsening. Quality of life was mostly affected by pain and discomfort in all groups. Sixty-two patients (78%) were satisfied or very satisfied with the results of surgery and 8 (11%) were unsatisfied or very unsatisfied. Up to 71 patients (90%) would consent to surgery again. CONCLUSION: In CM-I patients, PFD offers symptom improvement in about two-thirds of patients with high patient satisfaction. Symptom improvement is significantly higher in patients without associated syringomyelia, but patient satisfaction is similar. Symptom worsening is more frequent in the adult than in the pediatric population, with similar rates of postoperative improvement and patient satisfaction.

The Value of the Middle Meningeal Artery in Cerebrovascular Bypass Surgery: An Anatomic Feasibility Study.

BACKGROUND: Over the past decade, there has been a revival and a renewed interest for cerebrovascular bypass procedures. The superficial temporal artery (STA) has its value as a reliable donor vessel; however, a possible role for the middle meningeal artery (MMA) as a donor artery is still unclear. OBJECTIVE: To assess the feasibility of using the MMA as a donor vessel in cerebrovascular surgery. METHODS: We performed cadaveric dissections on 12 fresh specimens (23 sides) after bilateral silicone injection into the internal and external carotid arteries. We compared the size, diameter, and possibility to perform a bypass to the middle cerebral artery for both the MMA and the STA. Measurements were done using an electrical caliper. Additional measurements of the MMA and STA were performed on 20 random angiograms. RESULTS: There was no statistically significant difference in diameter of the MMA at its ostium being 2.4 mm, compared to 2.7 mm for the STA ostium (t-test; P = .21). The MMA could be mobilized over 4.1 cm, whereas the STA over 8.3 cm. Finally, the mean diameter of the donor vessel at the site of the anastomosis was 1.6 mm versus 1.9 mm for MMA and STA, respectively (P = .0026). We were able to perform an MMA and middle cerebral artery anastomosis on 17 sides. CONCLUSION: These results suggest that the MMA is a potentially valuable donor vessel to be used in selected cases. The availability of a suitable MMA branch should be assessed preoperatively on the angiogram.

Quick foot placement adjustments during gait are less accurate in individuals with focal cerebellar lesions.

Online gait corrections are frequently used to restore gait stability and prevent falling. They require shorter response times than voluntary movements which suggests that subcortical pathways contribute to the execution of online gait corrections. To evaluate the potential role of the cerebellum in these pathways we tested the hypotheses that online gait corrections would be less accurate in individuals with focal cerebellar damage than in neurologically intact controls and that this difference would be more pronounced for shorter available response times and for short step gait corrections. We projected virtual stepping stones on an instrumented treadmill while some of the approaching stepping stones were shifted forward or backward, requiring participants to adjust their foot placement. Varying the timing of those shifts allowed us to address the effect of available response time on foot placement error. In agreement with our hypothesis, individuals with focal cerebellar lesions were less accurate in adjusting their foot placement in reaction to suddenly shifted stepping stones than neurologically intact controls. However, the cerebellar lesion group's foot placement error did not increase more with decreasing available response distance or for short step versus long step adjustments compared to the control group. Furthermore, foot placement error for the non-shifting stepping stones was also larger in the cerebellar lesion group as compared to the control group. Consequently, the reduced ability to accurately adjust foot placement during walking in individuals with focal cerebellar lesions appears to be a general movement control deficit, which could contribute to increased fall risk.

Craniocerebral birth injuries in term newborn infants: a retrospective series.

OBJECTIVE: In an attempt to further define the spectrum of cranial birth injuries, we analyzed 21 consecutive cranial birth injuries in term neonates presenting to the neurosurgical department of our institution over the period 1994-2015. METHODS: We performed a retrospective chart review from the medical records of the University Hospitals of the KU Leuven, from 1994 to 2015. We included 21 infants of 36-week gestational age or older with a diagnosis of cranial birth injury. The types and locations of injuries, the presenting signs, symptoms and their timing, and the required treatment(s) were recorded. Various maternal and neonatal factors and the mode of delivery were recorded. We recorded the different modes of delivery rates at our institution in the year 2013 and the rates in the Flemish community between 1995 and 2013, in order to compare the mode of delivery rates in the study group with current practice at our institution and with general practice over the years in the Flemish community. RESULTS: The most common clinical presentations were swelling (43% of cases) and seizures (19% of cases). Average Apgar scores were 6.57 at 1 min and 8.43 at 5 min; 48% of children had abnormally low Apgar scores at 1 min and 9.5% had abnormally low scores at 5 min. The most common intracranial lesion was skull fractures (33%). Operative treatment was required in 11 infants (52%). One infant died. Assisted mechanical delivery by either forceps and/or vacuum extraction occurred in 43% of infants. In comparison, in the year 2013, only 13.97% of deliveries at our institution were mechanically assisted. Over the period 1995-2013, the highest mechanically assisted delivery rates in the Flemish community were 14.1% in 1996. CONCLUSION: Although our series is too small to make firm conclusions, it is remarkable that the rates of assisted mechanical deliveries in our series far exceeded the assisted mechanical delivery rates at our institution in the year 2013 and even the highest vacuum and forceps delivery rates in the Flemish community over the period 1995-2013.

Maternal-fetal surgery for myelomeningocele: some thoughts on ethical, legal, and psychological issues in a Western European situation.

BACKGROUND: The results of the Management of Myelomeningocele Study (MOMS) randomized controlled trial have demonstrated that maternal-fetal surgery (MFS) for myelomeningocele (MMC) compared to postnatal MMC repair has clear neurological benefits for the child at 12 and 30 months of age. Level I evidence nevertheless does not provide answers to many questions in this delicate field. Since the beginning of 2012, our fetal center has been offering MFS for spina bifida aperta (SBA) to patients from different European and non-European countries, in a societal context where termination of pregnancy is the option chosen by most patients when being informed of this diagnosis. METHODS: We aim to explore in this text some of the ethical, legal, and psychological issues that we have encountered. RESULTS: For many of these questions, we do not have definite answers. A pregnant patient when diagnosed with a MMC fetus is a vulnerable subject. She needs to be referred to a highly specialized center with sufficient expertise in diagnosis and in all therapeutic options. Objective but compassionate counseling is of paramount importance. It is required that a multidisciplinary professional team obtains full voluntary consent from the mother after providing an appropriate information including diagnosis, short-, medium-, and long-term prognosis as well as benefits and harms of the fetal surgery. CONCLUSION: The latter should be offered with full respect for maternal choice and individual assessment and perception of potential risks taking into consideration legislation in the fetal center and the parents' country legislation.

10-year follow-up after implantation of the Bryan Cervical Disc Prosthesis.

PURPOSE: Cervical arthroplasty is being used as an alternative for cervical fusion, but long-term follow-up results have rarely been reported. In this paper, we present 10-year follow-up results after implantation of the Bryan Cervical Disc Prosthesis in a single center. METHODS: 89 patients underwent implantation of a single-level Bryan Cervical Disc Prosthesis to treat radiculopathy and/or myelopathy. Clinical (Neurological Success, Neck Disability Index (NDI), Neck- and Arm-Pain, and SF-36) and radiological follow-up was prospectively organized up to 10 years after surgery. Adverse events and second surgeries were recorded and evaluated. RESULTS: Ten-year follow-up data were available for 72 (81%) patients. Maintenance or improvement of the neurological state was seen in 89% of patients after 10-year follow-up. SF-36 PCS scores improved significantly at all follow-up points. SF-36 MCS improvement was significant at 4 and 6 year, but not at 8- and 10-year follow-up. Significant improvement for NDI, and Neck- and Arm-Pain scores was found for the subgroup of patients in whom these data were available. Mean angular motion of the prosthesis at 10-year follow-up was 8.6°. Mobility of the device, defined as >2° of angular motion, was reached in 81% of patients. During the study period, 21 patients (24%) developed new or recurrent radiculopathy or myelopathy, the majority of these being treated conservatively. Seven patients (8%) required 8 additional spine surgeries to treat persistent or recurrent symptoms. Of these, 2 patients (2%) were reoperated at the index level and at 5 (6%) an adjacent level. CONCLUSION: In this study, favorable long-term clinical outcome after implantation of the Bryan Cervical Disc Prosthesis was seen, with the majority of prostheses remaining mobile after 10-year follow-up. However, still 6% of patients required adjacent level surgery.