Risk Factors and Management of Incisional Cerebrospinal Fluid Leakage After Craniotomy: A Retrospective International Multicenter Study.

BACKGROUND: Incisional cerebrospinal fluid (iCSF) leakage is a serious complication after intradural cranial surgery. OBJECTIVE: To determine the incidence and risk factors of iCSF leakage after craniotomy. Secondarily, the complications after iCSF leakage and the success rate of iCSF leakage treatment was studied. METHODS: All patients who underwent an intradural cranial surgery from 2017 to 2018 at 5 neurosurgical centers were retrospectively included. Data were retrieved from medical records with 2 months of follow-up. First, univariate regression analyses were performed. Subsequently, identified risk factors were evaluated in a multivariate regression analysis. RESULTS: In total 2310 consecutive patients were included. Total iCSF leakage rate was 7.1% (n = 165). Younger age, male, higher body mass index, smoking, infratentorial surgery, and use of a dural substitute were associated with increased iCSF leakage risk, and use of a sealant reduced that risk. The odds for developing a wound infection and/or meningitis were 15 times higher in patients with iCSF leakage compared with patients without leakage. Initial conservative iCSF leakage treatment failed in 48% of patients. In 80% of cases, external cerebrospinal fluid drainage ceased the iCSF leakage. A total of 32% of patients with iCSF leakage required wound revision surgery. CONCLUSION: iCSF leakage risk increases by younger age, higher body mass index, smoking, infratentorial craniotomy, and dural substitute use, whereas sealant use reduced the risk for iCSF leakage. The leak increases the risk of postoperative infections. When iCSF leakage occurs, immediate external cerebrospinal fluid drainage or wound revision should be considered.

Surgeons Learning Curve of Transforaminal Endoscopic Discectomy for Sciatica.

OBJECTIVE: Full-endoscopic spine surgery is gaining interest as a less-invasive alternative to treat sciatica caused by a lumbar disc herniation. Concerns, however, exist with the learning curve as percutaneous transforaminal endoscopic discectomy (PTED) appears to be more difficult to be performed compared to other techniques. In this study, the clinical outcomes during and after the learning curve are presented of 3 surgeons naïve to PTED. METHODS: In the first phase of a randomized controlled, noninferiority trial comparing PTED with microdiscectomy, 3 surgeons were trained in the PTED-procedure by a senior surgeon. After performing up to 20 cases under supervision, they started performing PTED on their own. Results of the early cases were compared to the later cases (>20). Furthermore, complications and reoperations were compared. Finally, differences in clinical outcomes between surgeons were compared. RESULTS: At 12 months of follow-up, 87% of the patients had follow-up data available. In general, there were no significant differences in patient-reported outcomes between the early and later PTED cases. Furthermore, outcomes of the early PTED cases were comparable to the outcomes of microdiscectomy, while the later PTED cases had small, but more favorable outcomes compared to microdiscectomy. Two learning curve surgeons had substantially higher rates of reoperations within 1 year, compared to the senior surgeon or the microdiscectomy group. Duration of surgery was also longer for all learning curve surgeons. Finally, when comparing clinical outcomes of patients undergoing PTED versus microdiscectomy, there appears to be some statistically significant differences in outcomes compared between the senior and 3 learning curve surgeons. CONCLUSION: PTED appears to be safe to be adopted by surgeons naïve to the procedure when they are initially supervised by an experienced senior surgeon. Duration of surgery and risk of repeated surgery are increased during the learning curve, but patient-reported outcomes of the early PTED cases are similar to the outcomes of later PTED cases, and similar to the outcomes of microdiscectomy cases. This study underlines the need for an experienced mentor for surgeons to safely adopt PTED.

Body Image and Cosmesis after Percutaneous Transforaminal Endoscopic Discectomy versus Conventional Open Microdiscectomy for Sciatica.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: Percutaneous transforaminal endoscopic discectomy (PTED) was introduced as a less invasive procedure to treat sciatica. Even though the PTED has a small scar size, it is unknown if PTED also leads to better scar-related patient-reported outcomes. Therefore, we aimed to compare scar-related outcomes between patients undergoing PTED vs open microdiscectomy. METHODS: Patients with at least 6 weeks of radiating leg pain were randomized in a 1:1 ratio to PTED or open microdiscectomy. Scar-related patient-reported outcomes were measured using the Body Image Score (BIS), Cosmesis Scale (CS) and a 0-10 numeric rating scale (NRS) on scar esthetic. RESULTS: Of the 530 included patients, 286 patients underwent PTED and 244 underwent open microdiscectomy as allocated. At 12 months of follow-up, 95% of the patients had data available. At 12 months, the BIS was 6.2 ± 1.7 in the PTED-group and 6.6 ± 1.9 in the open microdiscectomy group (between-group difference .4, 95% CI .2 to .7). CS was 21.3 ± 3.0 in the PTED-group and 18.6 ± 3.4 in the open microdiscectomy group (between-group difference -2.7, 95% CI -3.1 to -2.3). Average NRS for scar esthetic was 9.2 ± 1.3 and 7.8 ± 1.6 in the PTED and open microdiscectomy groups, respectively (between-group difference -1.4, 95% CI -1.6 to -1.2). CONCLUSIONS: PTED leads to a higher self-rated scar esthetic as compared to open microdiscectomy, while self-reported body image seems to be comparable between both groups. Therefore, from an esthetic point, PTED seems to be the preferred technique to treat sciatica.

Cost-effectiveness of full endoscopic versus open discectomy for sciatica.

OBJECTIVE: To assess the costs and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy among patients with sciatica. METHODS: This economic evaluation was conducted alongside a 12-month multicentre randomised controlled trial with a non-inferiority design, in which patients were randomised to PTED or open microdiscectomy. Patients were aged from 18 to 70 years and had at least 6 weeks of radiating leg pain caused by lumbar disc herniation. Effect measures included leg pain and quality-adjusted life years (QALYs), as derived using the EQ-5D-5L. Costs were measured from a societal perspective. Missing data were multiply imputed, bootstrapping was used to estimate statistical uncertainty, and various sensitivity analyses were conducted to determine the robustness. RESULTS: Of the 613 patients enrolled, 304 were randomised to PTED and 309 to open microdiscectomy. Statistically significant differences in leg pain and QALYs were found in favour of PTED at 12 months follow-up (leg pain: 6.9; 95% CI 1.3 to 12.6; QALYs: 0.040; 95% CI 0.007 to 0.074). Surgery costs were higher for PTED than for open microdiscectomy (ie, €4500/patient vs €4095/patient). All other disaggregate costs as well as total societal costs were lower for PTED than for open microdiscectomy. Cost-effectiveness acceptability curves indicated that the probability of PTED being less costly and more effective (ie, dominant) compared with open microdiscectomy was 99.4% for leg pain and 99.2% for QALYs. CONCLUSIONS: Our results suggest that PTED is more cost-effective from the societal perspective compared with open microdiscectomy for patients with sciatica. TRIAL REGISTRATION NUMBER: NCT02602093.

Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial.

OBJECTIVE: To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. DESIGN: Multicentre randomised controlled trial with non-inferiority design. SETTING: Four hospitals in the Netherlands. PARTICIPANTS: 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial. INTERVENTIONS: PTED (n=179) compared with open microdiscectomy (n=309). MAIN OUTCOME MEASURES: The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses. RESULTS: At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis. CONCLUSIONS: PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica. TRIAL REGISTRATION: NCT02602093ClinicalTrials.gov NCT02602093.

Patient preferences for treatment of lumbar disc herniation: a discrete choice experiment.

OBJECTIVE: Lumbar discectomy is a frequently performed procedure to treat sciatica caused by lumbar disc herniation. Multiple surgical techniques are available, and the popularity of minimally invasive surgical techniques is increasing worldwide. Clinical outcomes between these techniques may not show any substantial differences. As lumbar discectomy is an elective procedure, patients' own preferences play an important role in determining the procedure they will undergo. The aims of the current study were to determine the relative preference weights patients apply to various attributes of lumbar discectomy, determine if patient preferences change after surgery, identify preference heterogeneity for choosing surgery for sciatica, and calculate patient willingness to pay for other attributes. METHODS: A discrete choice experiment (DCE) was conducted among patients with sciatica caused by lumbar disc herniation. A questionnaire was administered to patients before they underwent surgery and to an independent sample of patients who had already undergone surgery. The DCE required patients to choose between two surgical techniques or to opt out from 12 choice sets with alternating characteristic levels: waiting time for surgery, out-of-pocket costs, size of the scar, need of general anesthesia, need for hospitalization, effect on leg pain, and duration of the recovery period. RESULTS: A total of 287 patients were included in the DCE analysis. All attributes, except scar size, had a significant influence on the overall preferences of patients. The effect on leg pain was the most important characteristic in the decision for a surgical procedure (by 44.8%). The potential out-of-pocket costs for the procedure (28.8%), the wait time (12.8%), need for general anesthesia (7.5%), need for hospitalization (4.3%), and the recovery period (1.8%) followed. Preferences were independent of the scores on patient-reported outcome measures and baseline characteristics. Three latent classes could be identified with specific preference patterns. Willingness-to-pay was the highest for effectiveness on leg pain, with patients willing to pay €3133 for a treatment that has a 90% effectiveness instead of 70%. CONCLUSIONS: Effect on leg pain is the most important factor for patients in deciding to undergo surgery for sciatica. Not all proposed advantages of minimally invasive spine surgery (e.g., size of the scar, no need of general anesthesia) are necessarily perceived as advantages by patients. Spine surgeons should propose surgical techniques for sciatica, not only based on own ability and proposed eligibility, but also based on patient preferences as is part of shared decision making.

Ceramic 3D-Printed Titanium Cranioplasty.

STUDY DESIGN: Inlay cranioplasties following partial craniectomy in tumor or trauma cases and onlay cranioplasties for reconstructions of residual developmental skull anomalies are frequently performed using CAD-CAM techniques. OBJECTIVE: In this case series, we present a novel cranial implant design, being a combination of 3D-printed titanium grade 23 and calcium phosphate paste (CeTi). METHODS: The titanium patient-specific implant, manufactured using selective laser melting, has a latticed border with interconnected micropores. The cranioplasty is miniscrew fixed and its border zone subsequently partially filled with calcium phosphate paste to promote osteoinduction and osteoconduction. From April 2017 to April 2019, 8 patients have been treated with such a CeTi implant. The inlay cranioplasties were each time revision surgeries of complicated cases. RESULTS: All implants were successful after a limited follow-up time (range 18-42 months). There were no dehiscences and no infections, and no complaints of thermal conduction. CONCLUSIONS: The proposed CeTi cranial implant combines the strength of titanium implants with the biological integration potential of ceramic implants and seems particularly resistant to infection, probably due to the biofunctionalized titanium surface and the antimicrobial activity of elevated intracellular free calcium levels.

Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol.

BACKGROUND: Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery. OBJECTIVE: To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. METHODS: We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP. EXPECTED OUTCOMES: Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy. DISCUSSION: As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.

Cognitive functioning in patients with nonfunctioning pituitary adenoma before and after endoscopic endonasal transsphenoidal surgery.

OBJECTIVE: Patients with nonfunctioning pituitary adenomas (NFPAs) can suffer from cognitive dysfunction. However, the literature on longitudinal cognitive follow-up of patients undergoing endoscopic endonasal transsphenoidal surgery (EETS) is limited. This study was performed to investigate perioperative cognitive status and course in patients with NFPAs. METHODS: Patients underwent computerized neuropsychological assessment 1 day before (n = 45) and 3 months after (n = 36) EETS. Performance in 7 domains was measured with a computerized test battery (CNS Vital Signs) and standardized using data from a healthy control group. The authors conducted analyses of cognitive performance at both time points and changes pre- to post-ETSS on a group and an individual level. Linear multiple regression analyses were employed to investigate predictors of cognitive performance. RESULTS: On average, patients scored significantly lower in 6 of 7 cognitive domains before and after surgery than controls. Impairment proportions were significantly higher among patients (56% before surgery, 63% after surgery) than among controls. Patients showed no change over time in group-level (mean) performance, but 28% of individual patients exhibited cognitive improvement and 28% exhibited cognitive decline after surgery. Hormonal deficiency showed a positive correlation with verbal memory before surgery. Postoperative performances in all cognitive domains were predicted by preoperative performances. CONCLUSIONS: Cognitive impairment was present before and after EETS in over half of NFPA patients. Individual patients showed diverse postoperative cognitive courses. Monitoring of cognitive functioning in clinical trajectories and further identification of disease-related and psychological predictors of cognition are warranted.

The significance of intra-abdominal pressure in neurosurgery and neurological diseases: a narrative review and a conceptual proposal.

Intra-abdominal pressure (IAP) is a physiological parameter that has gained considerable attention during the last few decades. The incidence of complications arising from increased IAP, known as intra-abdominal hypertension (IAH) or abdominal compartment syndrome in critically ill patients, is high and its impact is significant. The effects of IAP in neurological conditions and during surgical procedures are largely unexplored. IAP also appears to be relevant during neurosurgical procedures (spine and brain) in the prone position, and in selected cases, IAH may affect cerebrospinal fluid drainage after a ventriculoperitoneal shunt operation. Furthermore, raised IAP is one of the contributors to intracranial hypertension in patients with morbid obesity. In traumatic brain injury, case reports described how abdominal decompression lowers intracerebral pressure. The anatomical substrate for transmission of the IAP to the brain and venous system of the spine is the extradural neural axis compartment; the first reports of this phenomenon can be found in anatomical studies of the sixteenth century. In this review, we summarize the available knowledge on how IAP impacts the cerebrospinal venous system and the jugular venous system via two pathways, and we discuss the implications for neurosurgical procedures as well as the relevance of IAH in neurological disorders.

How I do it: percutaneous transforaminal endoscopic discectomy for lumbar disk herniation.

BACKGROUND: Percutaneous transforaminal endoscopic discectomy (PTED) has emerged as a less invasive technique to treat symptomatic lumbar disk herniation (LDH). PTED is performed under local anesthesia with the advantage of immediate intraoperative feedback of the patient. In this paper, the technique is described as conducted in our hospital. METHODS: PTED is performed under local anesthesia in prone position on thoracopelvic supports. The procedure is explained stepwise: e.g. marking, incision, introduction of the 18-gauge needle and guidewire to the superior articular process, introduction of the TomShidi needle and foraminotomy up to 9 mm, with subsequently removal of disk material through the endoscope. Scar size is around 8 mm. CONCLUSION: PTED seems a promising alternative to conventional discectomy in patients with LDH and can be performed safely.

Simulating Internal Carotid Artery Injury during Transsphenoidal Transclival Endoscopic Surgery in a Perfused Cadaver Model.

Introduction Managing internal carotid artery (ICA) injury during extended endoscopic transsphenoidal surgery is an extreme challenge. We aimed to find a possible surgical treatment strategy. Methods We operated seven fresh, perfused cadaver heads with a transsphenoidal endoscopic approach of the ICA using a three-dimensional-high definition (3D-HD) endoscope. We made a paraclival ICA leak, which we tried to manage with clips and microsutures. Results Accurate transsphenoidal clip application on the ICA was impossible with standard aneurysm clips and applier. It was only feasible with a 9 mm slightly bended clip that could be opened from the inside and be applied with a dedicated flexible thin applier. Transsphenoidal suturing of an ICA leak was impossible from the ipsilateral nostril or with standard microinstruments. Suturing was only feasible from the contralateral nostril using flexible microinstruments with a thin 90-mm shaft. This was technically very challenging and involved a steep learning curve. Conclusion Tamponade with muscle or fat and a quick transfer to the angiography suite for endovascular control remains the preferable option in case of an ICA leak during endoscopic transsphenoidal surgery. If tamponade gives insufficient initial control, ICA clipping could be possible with dedicated instruments, with risk of increasing the defect, stenosis, or occlusion of the vessel. Transsphenoidal ICA suturing remains extremely difficult, and laboratory practice seems essential.