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Hyun-Seung Kang, Moon Hee Han, Bae Ju Kwon, Byung-Woo Yoon and Kee-Hyun Chang

✓ The concept of a cerebrofacial arteriovenous metameric syndrome (CAMS) recently has been posited. A 22-year-old woman presented with gait ataxia. She had unilateral angiomatous lesions involving the lower face, the auricle, and the retromastoid area, as well as the tongue on the right side. Angiography revealed the presence of extensive arteriovenous malformations (AVMs) in the ipsilateral cerebellum and pons, in addition to those located in the facial region. The authors report a case of multiple AVMs of the face, cerebellum, and pons, corresponding to CAMS Type 3, and include a review of the literature.

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Reginald Davis, Joshua D. Auerbach, Hyun Bae and Thomas J. Errico

Object

Posterolateral spinal fusion (PSF) has long been the standard of care for degenerative spondylolisthesis, but less invasive, motion-preserving alternatives have been proposed to reduce the complications associated with fusion while still providing neural decompression and stabilization. The object of the current study is to evaluate the safety and efficacy of coflex Interlaminar Stabilization compared with PSF to treat low-grade spondylolisthesis with spinal stenosis.

Methods

This is a prospective, randomized, multicenter FDA investigational device exemption (IDE) trial comparing coflex Interlaminar Stabilization with laminectomy and PSF. A total of 322 patients from 21 sites in the US were enrolled between 2006 and 2008 for the IDE trial. The current study evaluated only the subset of patients from this overall cohort with Grade 1 spondylolisthesis (99 in the coflex group and 51 in the fusion group). Subjects were randomized 2:1 to receive decompression and coflex interlaminar stabilization or decompression and posterolateral spinal fusion with spinal instrumentation. Data collected included perioperative outcomes, Oswestry Disability Index (ODI), back and worse leg visual analog scale (VAS) scores, 12-Item Short Form Health Survey, Zurich Claudication Questionnaire (ZCQ), and radiographic outcomes at a minimum of 2 years. The FDA criteria for overall device success required the following to be met: 15-point reduction in ODI, no reoperations, no major device-related complications, and no postoperative epidural injections.

Results

At a minimum of 2 years, patient follow-up was 94.9% and 94.1% in the coflex and fusion control groups, respectively. There were no group differences at baseline for any demographic, clinical, or radiographic parameter. The average age was 63 years in the coflex cohort and 65 years in the fusion cohort. Coflex subjects experienced significantly shorter operative times (p < 0.0001), less estimated blood loss (p < 0.0001), and shorter length of stay (p < 0.0001) than fusion controls. Both groups experienced significant improvements from baseline at 2 years in ODI, VAS back, VAS leg, and ZCQ, with no significant group differences, with the exception of significantly greater ZCQ satisfaction with coflex at 2 years. FDA overall success was achieved in 62.8% of coflex subjects (59 of 94) and 62.5% of fusion controls (30 of 48) (p = 1.000). The reoperation rate was higher in the coflex cohort (14 [14.1%] of 99) compared with fusion (3 [5.9%] of 51, p = 0.18), although this difference was not statistically significant. Fusion was associated with significantly greater angulation and translation at the superior and inferior adjacent levels compared with baseline, while coflex showed no significant radiographic changes at the operative or index levels.

Conclusions

Low-grade spondylolisthesis was effectively stabilized by coflex and led to similar clinical outcomes, with improved perioperative outcomes, compared with PSF at 2 years. Reoperation rates, however, were higher in the coflex cohort. Patients in the fusion cohort experienced significantly increased superior and inferior level angulation and translation, while those in the coflex cohort experienced no significant adjacent or index level radiographic changes from baseline. Coflex Interlaminar Stabilization is a less invasive, safe, and equally efficacious clinical solution to PSF to treat low-grade spondylolisthesis, and it appears to reduce stresses at the adjacent levels. Clinical trial registration no.: NCT00534235 (ClinicalTrials.gov).

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Chang-Hyun Lee, Tae-Ahn Jahng, Seung-Jae Hyun, Chi Heon Kim, Sung-Bae Park, Ki-Jeong Kim, Chun Kee Chung, Hyun-Jib Kim and Soo-Eon Lee

OBJECTIVE

The Dynesys, a pedicle-based dynamic stabilization (PDS) system, was introduced to overcome the drawbacks of fusion procedures. Nevertheless, the theoretical advantages of PDS over fusion have not been clearly confirmed. The aim of this study was to compare clinical and radiological outcomes of patients who underwent PDS using the Dynesys system with those who underwent posterior lumbar interbody fusion (PLIF).

METHODS

The authors searched PubMed, Embase, Web of Science, and the Cochrane Database. Studies that reported outcomes of patients who underwent PDS or PLIF for the treatment of degenerative lumbar spinal disease were included. The primary efficacy end points were perioperative outcomes. The secondary efficacy end points were changes in the Oswestry Disability Index (ODI) and back and leg pain visual analog scale (VAS) scores and in range of motion (ROM) at the treated and adjacent segments. A meta-analysis was performed to calculate weighted mean differences (WMDs), 95% confidence intervals, Q statistics, and I2 values. Forest plots were constructed for each analysis group.

RESULTS

Of the 274 retrieved articles, 7 (which involved 506 participants [Dynesys, 250; PLIF, 256]) met the inclusion criteria. The Dynesys group showed a competitive advantage in mean surgery duration (20.73 minutes, 95% CI 8.76–32.70 minutes), blood loss (81.87 ml, 95% CI 45.11–118.63 ml), and length of hospital stay (1.32 days, 95% CI 0.23–2.41 days). Both the Dynesys and PLIF groups experienced improved ODI and VAS scores after 2 years of follow-up. Regarding the ODI and VAS scores, no statistically significant difference was noted according to surgical procedure (ODI: WMD 0.12, 95% CI −3.48 to 3.72; back pain VAS score: WMD −0.15; 95% CI −0.56 to 0.26; leg pain VAS score: WMD −0.07; 95% CI −0.47 to 0.32). The mean ROM at the adjacent segment increased in both groups, and there was no substantial difference between them (WMD 1.13; 95% CI −0.33 to 2.59). Although the United States is the biggest market for Dynesys, no eligible study from the United States was found, and 4 of 8 enrolled studies were performed in China. The results must be interpreted with caution because of publication bias. During Dynesys implantation, surgeons have to decide the length of the spacer and cord pretension. These values are debatable and can vary according to the surgeon's experience and the patient's condition. Differences between the surgical procedures were not considered in this study.

CONCLUSIONS

Fusion still remains the method of choice for advanced degeneration and gross instability. However, spinal degenerative disease with or without Grade I spondylolisthesis, particularly in patients who require a quicker recovery, will likely constitute the main indication for PDS using the Dynesys system.

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Robert J. Jackson, Reginald J. Davis, Gregory A. Hoffman, Hyun W. Bae, Michael S. Hisey, Kee D. Kim, Steven E. Gaede and Pierce Dalton Nunley

OBJECTIVE

Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7.

METHODS

This was a prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients).

RESULTS

At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts.

CONCLUSIONS

Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment.

Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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Rudolph J. Schrot, Jesna S. Mathew, Yueju Li, Laurel Beckett, Hyun W. Bae and Kee D. Kim

Object

The authors analyzed headache relief after anterior cervical discectomy. Headache may be relieved after anterior cervical discectomy, but the mechanism is unknown. If headaches were directly referred from upper cervical pathology, more headache relief would be expected from surgery performed at higher cervical levels. If spinal kinesthetics were the mechanism, then headache relief may differ between arthroplasty and fusion. Headache relief after anterior cervical discectomy was quantified by the operated disc level and by the method of operation (arthroplasty vs arthrodesis).

Methods

The authors performed a post hoc analysis of an artificial disc trial. Data on headache pain were extracted from the Neck Disability Index (NDI) questionnaire.

Results

A total of 260 patients underwent single-level arthroplasty or arthodesis. Preoperatively, 52% reported NDI headache scores of 3 or greater, compared with only 13%–17% postoperatively. The model-based mean NDI headache score at baseline was 2.5 (95% CI 2.3–2.7) and was reduced by 1.3 points after surgery (95% CI 1.2–1.4, p < 0.001). Higher cervical levels were associated with a greater degree of preoperative headache, but there was no association with headache relief. There was no significant difference in headache relief between arthroplasty and arthrodesis.

Conclusions

Most patients with symptomatic cervical spondylosis have headache as a preoperative symptom (88%). Anterior cervical discectomy with both arthroplasty and arthrodesis is associated with a durable decrease in headache. Headache relief is not related to the level of operation. The mechanism for headache reduction remains unclear.

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Ben B. Pradhan, Alexander W. L. Turner, Michael A. Zatushevsky, G. Bryan Cornwall, Sean S. Rajaee and Hyun W. Bae

Object

Traditional posterior pedicle screw fixation is well established as the standard for spinal stabilization following posterior or posterolateral lumbar fusion. In patients with lumbar spinal stenosis requiring segmental posterior instrumented fusion and decompression, interlaminar lumbar instrumented fusion (ILIF) is a potentially less invasive alternative with reduced morbidity and includes direct decompression assisted by an interlaminar allograft spacer stabilized by a spinous process plate. To date, there has been no biomechanical study on this technique. In the present study the biomechanical properties of the ILIF construct were evaluated using an in vitro cadaveric biomechanical analysis, and the results are presented in comparison with other posterior fixation techniques.

Methods

Eight L1–5 cadaveric specimens were subjected to nondestructive multidirectional testing. After testing the intact spine, the following conditions were evaluated at L3–4: bilateral pedicle screws, bilateral laminotomy, ILIF, partial laminectomy, partial laminectomy plus unilateral pedicle screws, and partial laminectomy plus bilateral screws. Intervertebral motions were measured at the index and adjacent levels.

Results

Bilateral pedicle screws without any destabilization provided the most rigid construct. In flexion and extension, ILIF resulted in significantly less motion than the intact spine (p < 0.05) and no significant difference from the laminectomy with bilateral pedicle screws (p = 0.76). In lateral bending, there was no statistical difference between ILIF and laminectomy with unilateral pedicle screws (p = 0.11); however, the bilateral screw constructs were more rigid (p < 0.05). Under axial rotation, ILIF was not statistically different from laminectomy with unilateral or bilateral pedicle screws or from the intact spine (p > 0.05). Intervertebral motions adjacent to ILIF were typically lower than those adjacent to laminectomy with bilateral pedicle screws.

Conclusions

Stability of the ILIF construct was not statistically different from bilateral pedicle screw fixation following laminectomy in the flexion and extension and axial rotation directions, while adjacent segment motions were decreased. The ILIF construct may allow surgeons to perform a minimally invasive, single-approach posterior decompression and instrumented fusion without the added morbidity of traditional pedicle screw fixation and posterolateral fusion.

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Joonho Chung, Sang Hyun Suh, Chang-Ki Hong, Jin-Yang Joo, Yong Cheol Lim, Yong Sam Shin and Yong Bae Kim

OBJECT

The purpose of this study was to report the authors' preliminary experience using self-expanding closed-cell stents deployed in small arteries (< 2 mm in diameter) to treat intracranial aneurysms.

METHODS

A total of 31 patients were studied. All subjects met the following criteria: 1) they received an Enterprise stent for treatment of a wide-necked aneurysm or a dissecting aneurysm or as part of a stent-salvage procedure; and 2) they had an Enterprise stent deployed in a small parent artery (< 2 mm in diameter) that had no atherosclerotic stenosis. Procedure-related complications and follow-up sizes of the parent arteries were evaluated for safety and patency.

RESULTS

There were 16 ruptured aneurysms and 15 unruptured aneurysms. Three (9.7%) of the 31 patients experienced procedure-related complications, and they all were asymptomatic. Follow-up angiography was performed in 27 patients (87.1%) (at a mean 15.5 months after surgery). Parent arteries with 2 acute angles (n = 4) were occluded in 3 cases (75.0%), and those with no acute angles (n = 13) or 1 acute angle (n = 6) showed 100% patency on follow-up angiography. There was a significant difference between the follow-up sizes (mean 1.72 ± 0.30 mm) of parent arteries and their sizes (mean 1.59 ± 0.26 mm) before treatment (95% CI − 0.254 to − 0.009 mm; p = 0.037, paired-samples t-test).

CONCLUSIONS

In the current series the deployment of self-expanding closed-cell stents in small arteries was safe and resulted in good patency, especially when the stents were deployed in segments of the parent artery with no acute angles or only 1 acute angle.

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Reginald J. Davis, Kee D. Kim, Michael S. Hisey, Gregory A. Hoffman, Hyun W. Bae, Steven E. Gaede, Ralph F. Rashbaum, Pierce Dalton Nunley, Daniel L. Peterson and John K. Stokes

Object

Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine.

Methods

This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients).

Results

A total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates.

Conclusions

The results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov).

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Reginald J. Davis, Pierce Dalton Nunley, Kee D. Kim, Michael S. Hisey, Robert J. Jackson, Hyun W. Bae, Gregory A. Hoffman, Steven E. Gaede, Guy O. Danielson III, Charles Gordon and Marcus B. Stone

OBJECT

The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.

METHODS

A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the US. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.

RESULTS

At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.

CONCLUSIONS

Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels.

Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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Joonho Chung, Yong Cheol Lim, Sang Hyun Suh, Yu Shik Shim, Yong Bae Kim, Jin-Yang Joo, Bum-soo Kim and Yong Sam Shin

Object

The purpose of this study was to report the authors' experiences in stent-assisted coil embolization (SAC) of ruptured wide-necked aneurysms in the acute period and to evaluate the incidence of and risk factors for periprocedural complications.

Methods

A total of 72 patients were recruited for this study between March 2007 and June 2012. All patients met the following criteria: 1) the presence of ruptured intracranial wide-necked saccular aneurysms, and 2) the patient underwent SAC for treatment of those aneurysms within 72 hours of rupture. All of the patients with clinically poor grades or acute hydrocephalus underwent external ventricular drainage (EVD) before SAC. The incidence of and risk factors for periprocedural complications were retrospectively evaluated.

Results

Of the 72 patients included in this study, periprocedural complications occurred in 14 (19.4%), including asymptomatic complications in 4 (5.6%) and symptomatic complications in 10 (13.9%); there were symptomatic thromboembolic complications in 5 patients (6.9%), and symptomatic hemorrhagic complications in 5 (6.9%). The authors observed no subacute or delayed thromboembolic complications during the follow-up period of 18.8 months. Use of EVD (OR 1.413, 95% CI 0.088–2.173; p = 0.046) was the only independent risk factor for periprocedural complications on multivariate logistic regression analysis.

Conclusions

The periprocedural complication rate during SAC was 19.4% among 72 patients. Because of the high complication rate, microsurgical clipping or endovascular treatment with another technique (multiple-microcatheter or balloon-assisted technique) may be a more appropriate option for first-line treatment than SAC, especially in patients requiring EVD.