Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.

Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.

A prospective multi-center study comparing the complication profile of modest systemic hypothermia versus normothermia for acute cervical spinal cord injury.

STUDY DESIGN: Prospective multi-center trial. OBJECTIVES: To characterize the complication profile associated with modest systemic hypothermia after acute cervical SCI in a prospective multi-center study. SETTING: Five trauma centers in the United States. METHODS: We analyzed data from a prospective, multi-center trial on the use of modest systemic hypothermia for acute cervical SCI. Patients with acute cervical SCI were assigned to receive modest systemic hypothermia (33 C) or standard of care medical treatment. Patients in the hypothermia group were cooled to 33 C and maintained at the target temperature for 48 h. Complication profile and the rate of complications within the first 6 weeks after injury were compared between the two groups. Multiple regression analysis was performed to determine risk factors for complications after injury. RESULTS: Fifty patients (hypothermia: 27, control: 23) were analyzed for this study. Median age was significantly lower in the hypothermia arm (39 vs 59 years, p = 0.02). Respiratory complications were the most common (hypothermia: 55.6% vs control: 52.2%, p = 0.81). The rate of deep vein thrombosis was not significantly different between the two groups (hypothermia: 14.8% vs control 17.4%, p = 0.71). The rate of complications was not statistically different between the two groups. CONCLUSION: In this prospective multi-center controlled trial, preliminary data show that modest systemic hypothermia was not associated with increased risk of complications within the first 6 weeks after acute cervical SCI. TRIAL INFORMATION: The study is registered on clinicaltrials.gov NCT02991690. University of Miami IRB (Central IRB) approval No.: 20160758. Emory University IRB #IRB00093786.

Complication Rates in Early Versus Late Cranioplasty-A 14-Year Single-Center Case Series.

BACKGROUND: Cranioplasty (CP) following decompressive craniectomy (DC) is a common neurosurgical procedure for cranial cosmesis and protection. There is uncertainty regarding the complication rates and potential benefits related to the timing of CP. OBJECTIVE: To investigate the impact of the timing of CP on complication rates for different etiologies of DC. METHODS: A retrospective chart review was performed of all CP cases between 2004 and 2018 for traumatic and nontraumatic indications of DC. Demographics, clinical characteristics, and complications were collected. Early and late CP were defined as replacement of the bone flap at ≤90 and >90 d following DC, respectively. RESULTS: A total of 278 patients were included, receiving 81 early and 197 late CPs. When analyzing all patients, early CP was associated with a statistically significant higher odds of any complication (odds ratio [OR]: 3.25, P < .001), reoperation (OR: 2.57, P = .019), hydrocephalus (OR: 6.03, P = .003), and symptomatic extra-axial collections (OR: 9.22, P = .003). Subgroup analysis demonstrated statistically significant higher odds of these complications only for the CP trauma subgroup, but not the nontrauma subgroup. The odds of complications postCP demonstrated a statistically significant decrease of 4.4% for each week after DC (Unit Odds Ratio [U-OR]: 0.956, P = .0363). CONCLUSION: In our retrospective series, early CP was associated with higher odds of postoperative complications compared to late CP in the trauma subgroup. Greater care should be taken in preoperative planning and increased vigilance postoperatively for complications with this potentially more vulnerable subpopulation. Future prospective controlled trials are needed to elucidate optimal timing for CP.

Very early Charcot spinal arthropathy associated with forward bending after spinal cord injury: a case report.

Introduction: Charcot spinal arthropathy (CSA) is an uncommon clinical entity following spinal cord injury (SCI). It is characterized by progressive cartilaginous and bony destruction and is felt to be due to loss of proprioceptive and nociceptive feedback from the spine. CSA is typically diagnosed many years following SCI and has the potential to lead to progressive neurologic decline if left untreated. Case presentation: We describe the case of a 49-year-old male who fell approximately thirty feet from a ladder and sustained a fracture/dislocation at T3-4 and T8-9 resulting in a T4 ASIA A SCI. He underwent T2-T12 posterior spinal stabilization and, within 1 year and 2 months of initial injury, developed an unusual back protuberance, decreased spasticity, and change in bladder function. The patient's imaging and physical exam were consistent with CSA. Discussion: This case is notable in two respects. First, this is one of the earliest cases of CSA identified in the literature. Although CSA is generally considered a late complication of SCI, CSA should be placed in the differential for all individuals with spinal cord presenting with clinical findings typical of CSA. Second, this case was associated with unsupervised attempts to improve range of motion (ROM) in a SCI patient with a fused spine. The association of unsupervised stretching and CSA has not been previously described.

Autologous Cranioplasty is Associated with Increased Reoperation Rate: A Systematic Review and Meta-Analysis.

OBJECTIVE: Consensus regarding selection of synthetic versus autologous flap reimplantation for cranioplasty after decompressive craniectomy has not been reached and the multiple factors considered for each patient make comparative analysis challenging. This study examines the association between choice of material and related complications. METHODS: A systematic literature review and meta-analysis were performed using PubMed for articles reporting delayed cranioplasty after decompressive craniectomy using a cohort design comparing autologous bone and synthetic implants. Extracted data included implant material and incidence of infection, reoperations related to implant, wound complications, and resorption. RESULTS: One randomized controlled trial and 11 cohort studies were included for a total of 1586 implants (950 bone, 636 synthetic). Autologous implants had significantly more reoperations than did synthetic implants (n = 1586 implants; odds ratio [OR], 1.91; 95% confidence interval [CI], 1.40-2.61). Reoperations were most often because of resorption (54%, n = 159/295) followed by infection (41%, n = 121/295). The pooled incidence of resorption in autologous implants was 20% (n = 159/791). Among the other outcomes, there was no significant difference for infections (n = 1586; OR, 1.24; CI, 0.82-1.88) or wound complications (n = 678; OR, 0.56; CI, 0.22-1.45). For the trauma subpopulation, there was no significant difference in infection rate with either material (n = 197; OR, 1.89; CI; 0.59-6.09). CONCLUSIONS: Autologous implants had significantly more reoperations primarily because if the intrinsic risk of resorption (level of evidence 3b).

Comparing Cortical Trajectory Transforaminal Lumbar Interbody Fusions Against Pedicle Trajectory Transforaminal Lumbar Interbody Fusions and Posterolateral Fusions: A Retrospective Cohort Study of 90-day Outcomes.

BACKGROUND: The cortical screw (CS) trajectory for pedicle screw placement is believed to require a smaller incision and less tissue dissection resulting in lower blood loss and faster healing; however, this has not yet been confirmed in clinical studies. OBJECTIVE: To compare CS transforaminal lumbar interbody fusions (TLIF), traditional pedicle screw (TPS) trajectory TLIFs, and posterolateral fusion (PLF) without interbody for differences in operative characteristics and complications. METHODS: We performed a retrospective cohort study (CS, TPS, and PLF) looking at patients who underwent lumbar fusion with 1 or 2 levels. Extracted data included demographics, comorbidities, estimated blood loss, transfusions, operative time, length of stay, discharge disposition (home vs rehabilitation), and complications within the perioperative, 30- and 90-d periods. RESULTS: A total of 118 patients (45 CS, 35 TPS, and 38 PLF) were included with average age 62 and 90-d follow-up for 106 (90%) patients. CS had less average blood loss (231 ml) than either TPS (424, P = .0023) or PLF (400, P = .0070). CS had far fewer transfusions than either TPS or PLF (P < .0001). TPS had longer average operating room (OR) time (262 min) than either CS (214, P = .0075) or PLF (211, P = .0060). CS had the shortest length of postoperative stay (4.3 days) which was significantly shorter than PLF (6.2, P = .0138) but not different than TPS (4.8). There were no differences in discharge disposition, complications, perioperative, 30-d, 90-d, durotomy, or wound healing issues. CONCLUSION: The CS trajectory is associated with less blood loss, fewer transfusions, reduced OR time, and shorter length of stay, with no difference in complications.

Isolated Transverse Process Spinal Fractures Increase the Likelihood of Incurring Visceral and Pelvic Injuries: A Retrospective Review at a Level-1 Trauma Center.

BACKGROUND: Although isolated transverse process fractures (ITPF) do not confer any inherent risk of compromised spinal stability, there is increasing interest in their overall prognostic significance. As a proxy for localized or directional forces in high-energy traumatic mechanisms, ITPF may serve as an indicator for the presence of other coexisting traumatic injuries. Specific injuries may be predicted by the presence of ITPF at specific spinal levels, but few studies have examined this in depth and may not account for confounding variables. METHODS: We retrospectively analyzed data from 306 patients presenting with acute traumatic ITPF. ITPF number and location by spinal segment were determined from initial computed tomography. Mechanism of trauma, Injury Severity Score, and extent of non-spinal-associated injuries were recorded. Correlation analysis compared ITPF location with injury severity, non-spinal-associated injury location, type, and patterns. Significant injury associations were further explored with logistic regression analysis controlling for age, mechanism of injury, and Injury Severity Score. RESULTS: The adjusted odds of pulmonary visceral injury was 4.69 (95% confidence interval, 2.33-9.44) times higher among patients with thoracic-level ITPF compared with other ITPF levels. Lumbar ITPFs had increased odds of abdominal visceral injury (odds ratio, 4.85; P = 0.0002), pelvic fractures (odds ratio, 4.2; P < 0.0001). The number needed to scan to observe a pelvic injury among patients with lumbar ITPF was 3. Other significant associations were also observed. CONCLUSIONS: Spinal level of ITPF is associated with increased likelihood of specific patterns of injury, and additional investigation is warranted.

Early Cranioplasty is Associated with Greater Neurological Improvement: A Systematic Review and Meta-Analysis.

BACKGROUND: Cranioplasty after decompressive craniectomy is a common neurosurgical procedure, yet the optimal timing of cranioplasty has not been well established. OBJECTIVE: To investigate whether the timing of cranioplasty is associated with differences in neurological outcome. METHODS: A systematic literature review and meta-analysis was performed using MEDLINE, Scopus, and the Cochrane databases for studies reporting timing and neurological assessment for cranioplasty after decompressive craniectomy. Pre- and postcranioplasty neurological assessments for cranioplasty performed within (early) and beyond (late) 90 d were extracted. The standard mean difference (SMD) was used to normalize all neurological measures. Available data were pooled to compare pre-cranioplasty, postcranioplasty, and change in neurological status between early and late cranioplasty cohorts, and in the overall population. RESULTS: Eight retrospective observational studies were included for a total of 528 patients. Studies reported various outcome measures (eg, Barthel Index, Karnofsky Performance Scale, Functional Independence Measure, Glasgow Coma Scale, and Glasgow Outcome Score). Cranioplasty, regardless of timing, was associated with significant neurological improvement (SMD .56, P = .01). Comparing early and late cohorts, there was no difference in precranioplasty neurological baseline; however, postcranioplasty neurological outcome was significantly improved in the early cohort (SMD .58, P = .04) and showed greater magnitude of change (SMD 2.90, P = .02). CONCLUSION: Cranioplasty may improve neurological function, and earlier cranioplasty may enhance this effect. Future prospective studies evaluating long-term, comprehensive neurological outcomes will be required to establish the true effect of cranioplasty on neurological outcome.

Unusual cause of encephalopathy after brain surgery.

For patients who have had a recent neurosurgical procedure, a visit to the emergency department for encephalopathy may automatically prompt a neurosurgical consult. We present a case of a patient with a history of Chiari malformation decompressed 6 months prior who presented with a 2-week history of slowly progressive altered mental status, headache and imbalance-symptoms consistent with her initial Chiari symptoms, so neurosurgery was consulted. Imaging showed no acute abnormality, but laboratory results revealed metabolic acidosis with high salicylate levels. When reporting medication use, this patient initially left out that she had been taking Goody's powder (845 mg aspirin) for headaches, and long-term use led to metabolic encephalopathy. Despite a recent history of surgery, it is important to keep the differential diagnosis broad especially when there are signs of metabolic derangement.

The role of diffusion tensor imaging in spinal pathology: A review.

Diffusion tensor imaging (DTI) allows for noninvasive, in vivo visualization of white matter fiber tracts in the central nervous system by measuring the diffusion of water molecules. It provides both quantitative and qualitative (i.e., tractography) means to describe a region-of-interest. While protocols for the use of DTI are better established in the brain, the efficacy and potential applications of DTI in spinal cord pathology are less understood. In this review, we examine the current literature regarding the use of DTI in the spinal cord pathology, and in particular its diagnostic and prognostic value in traumatic injury, spinal tumors, cervical myelopathies, amyotrophic lateral sclerosis, and multiple sclerosis. Although structural magnetic resonance imaging (MRI) has long been the gold standard for noninvasive imaging of soft tissues, DTI provides additional tissue characteristics not found in the conventional MRI. We place emphasis on the unique characteristics of DTI, its potential value as an adjunct imaging modality, and its impact on clinical practice.

Cranioplasty Infection and Resorption Are Associated with the Presence of a Ventriculoperitoneal Shunt: A Systematic Review and Meta-Analysis.

BACKGROUND: Following decompressive craniectomy, hydrocephalus is a common complication often necessitating placement of a ventriculoperitoneal shunt (VPS). Complications in the presence of a VPS have been reported, but a clear association has not been established. METHODS: PRISMA guidelines were used to perform a literature search using PubMed to identify articles that published the complication rates associated with staged or simultaneous cranioplasty and VPS placement. From these event rates, odds ratios (ORs) with 95% confidence intervals (CIs) of complications were calculated. Data were pooled using the Mantel-Haenszel method. The Oxford Center for Evidence-Based Medicine guidelines were used to assess the quality of individual articles and studies. The Newcastle-Ottawa Scale was used to assess the risk of bias in studies. RESULTS: Of the 30 papers reviewed for complications in the presence and absence of a VPS, 7 studies, with a total of 1635 patients, were eligible for meta-analysis. Overall rates of complications (n = 1635; OR, 9.75; 95% CI, 4.8-20.1), infection (OR, 4.9; 95% CI, 2.2-10.7), and bone resorption (OR, 10.6; 95% CI, 4.9-23.0) were increased when a VPS was placed at the time of cranioplasty. Simultaneous procedures were associated with increased complication rates (n = 283; OR, 4.3; 95% CI, 2.3-8.2) compared with staged procedures. CONCLUSIONS: Cranioplasty in the presence of a VPS is associated with a higher rate of overall complications, including infection and bone resorption. Performing cranioplasty and VPS placement in the same operation is associated with an increased rate of complications compared with staged procedures. Surgeons should consider staging these procedures when possible and counsel patients about these risks.

Effect of perioperative steroids on dysphagia after anterior cervical spine surgery: A systematic review.

BACKGROUND: Dysphagia following anterior cervical spine surgery is common. Steroids potentially reduce post-operative inflammation that leads to dysphagia; however, the efficacy, optimal dose and route of steroid administration have not been fully elucidated. OBJECTIVE: The purpose of this systematic review is to evaluate the effect of peri-operative steroids on the incidence and severity of dysphagia following anterior cervical spine surgery. METHODS: A PubMed search adherent to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed to include clinical studies reporting use of steroids in adult patients following anterior cervical spine surgery. Data regarding steroid dose, route and timing of administration were abstracted. Incidence and severity of post-operative dysphagia were pooled across studies. RESULTS: Seven of 72 screened articles met inclusion criteria for a total of 246,298 patients that received steroids. Patients that received systemic and local steroids had significant reductions in rate and severity of dysphagia postoperatively. Reduction of dysphagia severity was more pronounced in patients undergoing multilevel procedures in both groups. There was no difference in infectious complications among patients that received steroids compared with controls. There was no difference in fusion rates at long-term follow-up. CONCLUSIONS AND CLINICAL RELEVANCE: Steroids may reduce dysphagia after anterior cervical spinal procedures in the early post-operative period without increasing complications. This may be especially beneficial in patients undergoing multilevel procedures. Future studies should further define the optimal dose and route of steroid administration, and the specific contraindications for use.

Effects of Cranioplasty on Cerebral Blood Flow Following Decompressive Craniectomy: A Systematic Review of the Literature.

BACKGROUND: Cranioplasty after decompressive craniectomy (DC) is routinely performed for reconstructive purposes and has been recently linked to improved cerebral blood flow (CBF) and neurological function. OBJECTIVE: To systematically review all available literature to evaluate the effect of cranioplasty on CBF and neurocognitive recovery. METHODS: A PubMed, Google Scholar, and MEDLINE search adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines included studies reporting patients who underwent DC and subsequent cranioplasty in whom cerebral hemodynamics were measured before and after cranioplasty. RESULTS: The search yielded 21 articles with a total of 205 patients (range 3-76 years) who underwent DC and subsequent cranioplasty. Two studies enrolled 29 control subjects for a total of 234 subjects. Studies used different imaging modalities, including CT perfusion (n = 10), Xenon-CT (n = 3), single-photon emission CT (n = 2), transcranial Doppler (n = 6), MR perfusion (n = 1), and positron emission tomography (n = 2). Precranioplasty CBF evaluation ranged from 2 days to 6 months; postcranioplasty CBF evaluation ranged from 7 days to 6 months. All studies demonstrated an increase in CBF ipsilateral to the side of the cranioplasty. Nine of 21 studies also reported an increase in CBF on the contralateral side. Neurological function improved in an overwhelming majority of patients after cranioplasty. CONCLUSION: This systematic review suggests that cranioplasty improves CBF following DC with a concurrent improvement in neurological function. The causative impact of CBF on neurological function, however, requires further study.

Percutaneous Instrumentation Without Arthrodesis for Thoracolumbar Flexion-Distraction Injuries: A Review of the Literature.

Background: Flexion-distraction injuries (FDI) represent 5% to 15% of traumatic thoracolumbar fractures. Treatment depends on the extent of ligamentous involvement: osseous/Magerl type B2 injuries can be managed conservatively, while ligamentous/Magerl type B1 injuries undergo stabilization with arthrodesis. Minimally invasive surgery without arthrodesis can achieve similar outcomes to open procedures. This has been studied for burst fractures; however, its role in FDI is unclear. Objective: To conduct a systematic review of the literature that examined minimally invasive surgery instrumentation without arthrodesis for traumatic FDI of the thoracolumbar spine. Methods: Four electronic databases were searched, and articles were screened using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines for patients with traumatic FDI of the thoracolumbar spine treated with percutaneous techniques without arthrodesis and had postoperative follow-up. Results: Seven studies with 44 patients met inclusion criteria. There were 19 patients with osseous FDI and 25 with ligamentous FDI. When reported, patients (n = 39) were neurologically intact preoperatively and at follow-up. Osseous FDI patients underwent instrumentation at 2 levels, while ligamentous injuries at approximately 4 levels. Complication rate was 2.3%. All patients had at least 6 mo of follow-up and demonstrated healing on follow-up imaging. Conclusion: Percutaneous instrumentation without arthrodesis represents a low-risk intermediate between conservative management and open instrumented fusion. This "internal bracing" can be used in osseous and ligamentous FDIs. Neurologically intact patients who do not require decompression and those that may not tolerate or fail conservative management may be candidates. The current level of evidence cannot provide official recommendations and future studies are required to investigate long-term safety and efficacy.

Spinal stability after resection of nerve sheath tumors.

BACKGROUND: The aim of this paper was to present a generalizable group of patients who have undergone resection of spinal nerve sheath tumors and attempt to identify factors that may be predictive of the need for intraoperative fusion. METHODS: We conducted a retrospective review of patients who underwent excision of spinal nerve sheath tumors performed by the senior author at the University of Miami/Jackson Memorial Medical Center. RESULTS: Out of the 48 cases reviewed in this study, a total of 7 (14.6%) underwent fusion at the same time as decompression and tumor excision. Fusion was deemed necessary in these cases for a number of different reasons, including preexisting scoliosis, cervical instability, preexisting listhesis, and tumor size and/or aggressiveness warranting more extensive bony exposure. Cervical tumors in patients with NF-1 and total facetectomy being performed were both factors found to be predictive of the decision to perform intraoperative fusion with instrumentation (P values of 0.009 and <0.001, respectively). There were seven cases in which partial facetectomies were performed without fusion, none of which later developed instability. Finally, excision of malignant peripheral nerve sheath tumors was also associated with the decision to perform fusion (P=0.008). The average length of follow­up was 2 years, 11 months (SEM 8 months). CONCLUSIONS: Most patients can undergo resection of spinal nerve sheath tumors without fusion. Patients with pre­existing deformity or instability, a history of NF-1 together with the tumor in the cervical region, malignant nerve sheath tumors, or those who undergo a total facet resection may require instrumented spinal fusion during tumor excision. We also observed that removal of one third or even half of a facet joint complex appears to be well tolerated with no instability seen on follow­up.

Carotid cavernous fistula after Pipeline placement: a single-center experience and review of the literature.

OBJECTIVE: Carotid cavernous fistula (CCF) development after Pipeline Embolization Device (PED) treatment of cavernous carotid aneurysms (CCA) can be a challenging pathology to treat for the neurointerventionalist. METHODS: A database of all patients whose aneurysms were treated with the PED since its approval by the Food and Drug Administration in 2011 was retrospectively reviewed. Demographic information, aneurysm characteristics, treatment technique, antiplatelet regimen, and follow-up data were collected. A literature review of all papers that describe PED treatment of CCA was then completed. RESULTS: A total of 44 patients with 45 CCAs were identified (38 women, 6 men). The mean age was 59.9±9.0 years. The mean maximal aneurysm diameter was 15.9±6.9 mm (mean neck 7.1±3.6 mm). A single PED was deployed in 32 patients, with two PEDs deployed in 10 patients and three PEDs in 3 patients. Adjunctive coiling was performed in 3 patients. Mean follow-up duration based on final imaging (MR angiography or digital subtraction angiography) was 14.1±12.2 months. Five patients (11.4%) developed CCFs in the post-procedural period after PED treatment, all within 2 weeks of device placement. These CCFs were treated with a balloon test occlusion followed by parent artery sacrifice. Our literature review yielded only three reports of CCFs after PED placement, with the largest series having a CCF rate of 2.3%. CONCLUSIONS: CCF formation is a known risk of PED treatment of CCA. Although transvenous embolization can be used for treating CCFs, parent artery sacrifice remains a viable option on the basis of these data. Studies support the view that adjunctive coiling may have a protective effect against post-PED CCF formation. None of the coiled aneurysms in our database or in the literature have ruptured. Follow-up data will lead to a better understanding of the safety profile of the PED for CCA.