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A Retrospective Analysis of Complications Associated With Bone Morphogenetic Protein 2 in Anterior Lumbar Interbody Fusion
Hindoyan, Kevork; Tilan, Justin; Buser, Zorica; Cohen, Jeremiah R; Brodke, Darrel S; Youssef, Jim A; Park, Jong-Beom; Yoon, S Tim; Meisel, Hans-Joerg; Wang, Jeffrey C
STUDY DESIGN/METHODS:Retrospective review. OBJECTIVE:The aim of our study was to quantify the frequency of complications associated with recombinant human bone morphogenetic protein 2 (rhBMP-2) use in anterior lumbar interbody fusion (ALIF). METHODS:The orthopedic subset of the Medicare database (PearlDiver) was queried for this retrospective cohort study using International Statistical Classification of Diseases 9 (ICD-9) and Current Procedure Terminology (CPT) codes for ALIF procedures with and without rhBMP-2 between 2005 and 2010. Frequencies of complications and reoperations were then identified within 1 year from the index procedure. Complications included reoperations, pulmonary embolus, deep vein thrombosis, myocardial infarction, nerve-related complications, incision and drainage procedures, wound, sepsis, pneumonia, urinary tract infections, respiratory, heterotopic ossification, retrograde ejaculation, radiculopathy, and other medical complications. Odds ratios (ORs) and 95% confidence intervals (CIs) were used to assess the statistical significance. RESULTS:We identified a total of 41 865 patients who had an ALIF procedure. A total of 14 384 patients received rhBMP-2 while 27 481 did not. Overall, 6016 (41.8%) complications within 1 year from surgery were noted within the group who received rhBMP-2 and 12 950 (47.1%) complications within 1 year from surgery were recorded in those who did not receive rhBMP-2 (OR = 0.81, CI = 0.77-0.84). Overall, exposure to rhBMP-2 was associated with significantly decreased odds of complications with exception to reoperation rates (0.9% rhBMP-2 vs 1.0% no rhBMP-2; OR = 0.88, CI = 0.71-1.09) and radiculopathy (4.4% rhBMP-2 vs 4.3% no rhBMP-2; OR = 1.02, CI = 0.93-1.13). CONCLUSIONS:The use of rhBMP-2 in patients undergoing ALIF procedure was associated with a significantly decreased rate of complications. Further studies are needed to elucidate a true incidence of complication.
PMCID:5415156
PMID: 28507884
ISSN: 2192-5682
CID: 5185982
Iatrogenic Spinal Cord Injury Resulting From Cervical Spine Surgery
Daniels, Alan H; Hart, Robert A; Hilibrand, Alan S; Fish, David E; Wang, Jeffrey C; Lord, Elizabeth L; Buser, Zorica; Tortolani, P Justin; Stroh, D Alex; Nassr, Ahmad; Currier, Bradford L; Sebastian, Arjun S; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel
STUDY DESIGN/METHODS:Retrospective cohort study of prospectively collected data. OBJECTIVE:To examine the incidence of iatrogenic spinal cord injury following elective cervical spine surgery. METHODS:A retrospective multicenter case series study involving 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was conducted. Medical records for 17 625 patients who received cervical spine surgery (levels from C2 to C7) between January 1, 2005, and December 31, 2011, were reviewed to identify occurrence of iatrogenic spinal cord injury. RESULTS:In total, 3 cases of iatrogenic spinal cord injury following cervical spine surgery were identified. Institutional incidence rates ranged from 0.0% to 0.24%. Of the 3 patients with quadriplegia, one underwent anterior-only surgery with 2-level cervical corpectomy, one underwent anterior surgery with corpectomy in addition to posterior surgery, and one underwent posterior decompression and fusion surgery alone. One patient had complete neurologic recovery, one partially recovered, and one did not recover motor function. CONCLUSION/CONCLUSIONS:Iatrogenic spinal cord injury following cervical spine surgery is a rare and devastating adverse event. No standard protocol exists that can guarantee prevention of this complication, and there is a lack of consensus regarding evaluation and treatment when it does occur. Emergent imaging with magnetic resonance imaging or computed tomography myelography to evaluate for compressive etiology or malpositioned instrumentation and avoidance of hypotension should be performed in cases of intraoperative and postoperative spinal cord injury.
PMCID:5400194
PMID: 28451499
ISSN: 2192-5682
CID: 5185942
Risk and Cost of Reoperation After Single-Level Posterior Cervical Foraminotomy: A Large Database Study
Sayari, Arash J; Tuchman, Alexander; Cohen, Jeremiah R; Hsieh, Patrick C; Buser, Zorica; Wang, Jeffrey C
STUDY DESIGN/METHODS:Retrospective cohort study. OBJECTIVE:To examine the risk of undergoing another cervical spine surgery after single-level posterior cervical foraminotomy (PCF) and analyze the costs of such reoperations. METHODS:Using the PearlDiver database, we created database algorithms to identify cohorts of patients who underwent single-level PCF and also had various reoperations of interest, within 1, 2, and 4 years of follow-up. We also identified the per-patient average charge (PPAC) for each reoperation cohort. RESULTS:In the Medicare cohort, the incidence of any reoperation was 8.3%, 9.8%, and 10.5% within 1, 2, and 4 years of follow-up, respectively. The PPAC was $8520 for the initial PCF procedure. When a second cervical surgery was performed, the PPAC was $70 349 for anterior fusion, $15 760 for posterior decompression alone, and $77 976 for posterior decompression and fusion. In the UnitedHealth cohort, the incidence of any reoperation was 13.6%, 16.7%, and 17.0% within 1, 2, and 4 years of follow-up, respectively. CONCLUSIONS:The overall incidence of another cervical spine operation was slightly higher in the Medicare population to that in previous literature, but much higher in the UnitedHealth population. The most common reoperation after PCF varied between the Medicare and UnitedHealth datasets, and costs varied widely based on the procedure performed. This study provides pertinent information that surgeons can use to discuss the risk of reoperation with their patients.
PMCID:5415152
PMID: 28507880
ISSN: 2192-5682
CID: 5185972
Routine Use of Intraoperative Neuromonitoring During ACDFs for the Treatment of Spondylotic Myelopathy and Radiculopathy Is Questionable: A Review of 15,395 Cases
Ajiboye, Remi M; D'Oro, Anthony; Ashana, Adedayo O; Buerba, Rafael A; Lord, Elizabeth L; Buser, Zorica; Wang, Jeffrey C; Pourtaheri, Sina
STUDY DESIGN/METHODS:A retrospective database study. OBJECTIVE:The goal of this study was to (1) evaluate the trends in the use of intraoperative neuromonitoring (ION) for anterior cervical discectomy and fusion (ACDF) surgery in the United States and (2) assess the incidence of neurological injuries after ACDFs with and without ION. SUMMARY OF BACKGROUND DATA/BACKGROUND:Somatosensory-evoked potentials (SSEPs) and motor-evoked potentials (MEPs) are the commonly used ION modalities for ACDFs. Controversy exists on the routine use of ION for ACDFs and there is limited literature on national practice patterns of its use. METHODS:A retrospective review was performed using the PearlDiver Patient Record Database to identify cases of spondylotic myelopathy and radiculopathy that underwent ACDF from 2007 to 2014. The type of ION modality used and the rates of neurological injury after surgery were assessed. RESULTS:During the study period, 15,395 patients underwent an ACDF. Overall, ION was used in 2627 (17.1%) of these cases. There was a decrease in the use of ION for ACDFs from 22.8% in 2007 to 4.3% use in 2014 (P < 0.0001). The ION modalities used for these ACDFs were quite variable: SSEPs only (48.7%), MMEPs only (5.3%), and combined SSEPs and MMEPs (46.1%). Neurological injuries occurred in 0.23% and 0.27% of patients with and without ION, respectively (P = 0.84). Younger age was associated with a higher utility of ION (<45: 20.3%, 45-54: 19.3%, 55-64: 16.6%, 65-74: 14.3%, and >75: 13.6%, P < 0.0001). Significant regional variability was observed in the utility of ION for ACDFs across the country (West; 21.9%, Midwest; 12.9% (P < 0.0001). CONCLUSION/CONCLUSIONS:There has been a significant decrease in the use of ION for ACDFs. Furthermore, there was significant age and regional variability in the use of ION for ACDFs. Use of ION does not further prevent the rate of postoperative neurological complications for ACDFs as compared with the cases without ION. The utility of routine ION for ACDFs is questionable. LEVEL OF EVIDENCE/METHODS:3.
PMID: 27120059
ISSN: 1528-1159
CID: 5185752
Treatment for early postoperative esophageal fistula complicated with anterior cervical surgery
Yuan, Haifeng; Ding, Huiqiang; Hu, Lihong; Buser, Zorica; Zhao, Haoning; Li, Xusheng
OBJECT:To investigate the efficacy of debridement, open drainage, and early feeding to treat early esophageal fistula complicated with anterior cervical surgery. METHODS:Retrospective analysis was conducted on data from 3154 patients who had undergone anterior cervical surgeries for cervical vertebra diseases between January 2006 and January 2013, in which eight patients had esophageal fistula with five males and three females. Four patients had cervical spinal injuries and four patients had cervical spondylosis. All of whom had postoperative esophageal fistulas and underwent debridement and drainage. The wounds were left open for natural drainage. No drainage devices were placed in surgical sites, and no gastric tubes were placed after surgeries. Such normal food as rice balls but not liquid or semiliquid diet was recommended. Local pressurization was conducted with fists during feeding to prevent food overflowing from orificium fistulae. RESULTS:Healed esophageal fistulas were achieved in all of the patients after 1-2 weeks treatment. There weren't recurrent esophageal fistulas and delayed infection found during 2-5 years follow-up. Good swallowing functions and stable cervical vertebrae were achieved in all of the patients. The satisfactory therapeutic effects were achieved in patients with previous neck diseases. Frankel classifications were increased by 1-2 grades in patients with cervical spinal injuries. JOA scores were increased from 9.5 before surgery to 15.5 after surgery in patients with cervical vertebra diseases. CONCLUSIONS:Early postoperative esophageal fistula complication after anterior cervical surgery can successfully be treated by debridement, drainage without gastric tube, and with early oral postoperative feeding but without fluids.
PMID: 28117633
ISSN: 2309-4990
CID: 5185872
A response to a commentary by Dr. Daniel J. Cher [Comment]
Schoell, Kyle; Buser, Zorica; Jakoi, Andre; Pham, Martin; Patel, Neil N; Hsieh, Patrick C; Liu, John C; Wang, Jeffrey C
PMID: 27986244
ISSN: 1878-1632
CID: 5185832
Demographic Trends in the Use of Intraoperative Neuromonitoring for Scoliosis Surgery in the United States
Ajiboye, Remi M; Park, Howard Y; Cohen, Jeremiah R; Vellios, Evan E; Lord, Elizabeth L; Ashana, Adedayo O; Buser, Zorica; Wang, Jeffrey C
BACKGROUND:Intraoperative neuromonitoring (ION) such as motor-evoked potential (MEP), somatosensory evoked potentials (SSEP) and electromyography (EMG) are used to detect impending neurological injuries during spinal surgery. To date, little is known on the trends in the use of ION for scoliosis surgery in the United States. METHODS:A retrospective review was performed using the PearlDiver Database to identify patients that had scoliosis surgery with and without ION from years 2005 to 2011. Demographic information (such as age, gender, region within the United States) and clinical information (such as type of ION and rates of neurological injury) were assessed. RESULTS:There were 3618 patients who had scoliosis surgery during the study period. ION was used in 1361 (37.6%) of these cases. The number of cases in which ION was used increased from 27% in 2005 to 46.9% in 2011 (p < 0.0001). Multimodal ION was used more commonly than unimodal ION (64.6% vs. 35.4%). The most commonly used modality was combined SSEP and EMG while the least used modality was MEP only. Neurological injuries occurred in 1.8% and 2.0% of patients that had surgery with and without ION, respectively (p = 0.561). ION was used most commonly in patients < 65 years of age and in the Northeastern part of the United States (age; p = 0.006, region; p < 0.0001). CONCLUSIONS:The use of ION for scoliosis surgery gradually increased annually from 2005 to 2011. Age and regional differences were noted with neuromonitoring being most commonly used for scoliosis surgery in non-elderly patients and in the Northeastern part of the United States. No differences were noted in the risk of neurological injury in patients that had surgery with and without ION. Although the findings from this study may seem to suggest that ION may not influence the risk of neurologic injury, this result must be interpreted with caution as inherently riskier surgeries may utilize ION more, leading to an actual reduction in injuries more dramatic than observed in this study.
PMCID:5779268
PMID: 29372137
ISSN: 2211-4599
CID: 5186192
Analysis of Recombinant Human Bone Morphogenetic Protein-2 Use in the Treatment of Lumbar Degenerative Spondylolisthesis
Yao, Qingqiang; Cohen, Jeremiah R; Buser, Zorica; Park, Jong-Beom; Brodke, Darrel S; Meisel, Hans-Joerg; Youssef, Jim A; Wang, Jeffrey C; Yoon, S Tim
PMCID:5110337
PMID: 27853658
ISSN: 2192-5682
CID: 5185822
Postoperative complications in patients undergoing minimally invasive sacroiliac fusion
Schoell, Kyle; Buser, Zorica; Jakoi, Andre; Pham, Martin; Patel, Neil N; Hsieh, Patrick C; Liu, John C; Wang, Jeffrey C
BACKGROUND CONTEXT:Minimally invasive sacroiliac (SI) joint fusion has become increasingly relevant in recent years as a treatment for SI joint pathology. Previous studies have found minimally invasive SI fusion to be an effective and safe treatment option for chronic SI joint pain. However, these studies have been primarily single-center, case-based, or manufacturer-sponsored investigations, and as such their findings are limited to their sample populations. PURPOSE:The aim of this study was to investigate the safety of minimally invasive SI fusion using a large nationwide sample group to more accurately identify complication rates of this increasingly popular procedure. STUDY DESIGN/SETTING:This is a retrospective database study. PATIENT SAMPLE:The sample includes patients within the orthopedic subset of Humana database who underwent minimally invasive SI fusion between 2007 and 2014. OUTCOME MEASURES:Complications and novel lumbar and nerve pathology were the outcome measures. METHODS:Patients undergoing minimally invasive SI fusion from 2007 to 2014 were identified using the Pearl Diver patient record database (Pearl Diver Technologies, West Conshohocken, PA, USA) from the nationwide private insurance provider Humana Inc. This approach provided access to records of over 18 million patients in every major geographic region of the country. Using the ICD-9 diagnosis codes (International Classification of Diseases 9th edition), data from patient records were analyzed to reveal incidence of postoperative infection, pain, osteomyelitis, joint derangement, urinary tract infection, and novel lumbar and nervous system pathology. RESULTS:Four hundred sixty-nine patients (305 female; 164 male) within the Humana insurance database received minimally invasive SI fusion between 2007 and 2014. Data from these patients showed a substantial increase in the use of the procedure over this 7-year period. Among these patients, an overall complication rate of 13.2% (n=62) was seen at 90 days postoperatively and 16.4% (n=77) at 6 months. The number of patients receiving a first time diagnosis of lumbar pathology following minimally invasive SI fusion in the sample population was also analyzed. The incidence of novel lumbar pathology in this population was 3.6% (n=17) at 90 days postoperatively and 5.3% (n=25) at 6 months. Men experienced diagnoses of novel lumbar pathology at higher rates than women within both 90 days (men=6.7%; women≤3.3%) and 6 months (men=9.1%; women≤3.3%) of the procedure (p<.01). CONCLUSIONS:The results of this study show that minimally invasive SI joint fusion could possibly carry higher risks of complications than previously stated. These findings are useful for physicians and patients when considering treatment for chronic SI joint pain.
PMID: 27349627
ISSN: 1878-1632
CID: 5185772
Synthetic bone graft versus autograft or allograft for spinal fusion: a systematic review
Buser, Zorica; Brodke, Darrel S; Youssef, Jim A; Meisel, Hans-Joerg; Myhre, Sue Lynn; Hashimoto, Robin; Park, Jong-Beom; Tim Yoon, S; Wang, Jeffrey C
The purpose of this review was to compare the efficacy and safety of synthetic bone graft substitutes versus autograft or allograft for the treatment of lumbar and cervical spinal degenerative diseases. Multiple major medical reference databases were searched for studies that evaluated spinal fusion using synthetic bone graft substitutes (either alone or with an autograft or allograft) compared with autograft and allograft. Randomized controlled trials (RCT) and cohort studies with more than 10 patients were included. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest. The search yielded 214 citations with 27 studies that met the inclusion criteria. For the patients with lumbar spinal degenerative disease, data from 19 comparative studies were included: 3 RCTs, 12 prospective, and 4 retrospective studies. Hydroxyapatite (HA), HA+collagen, β-tricalcium phosphate (β-TCP), calcium sulfate, or polymethylmethacrylate (PMMA) were used. Overall, there were no differences between the treatment groups in terms of fusion, functional outcomes, or complications, except in 1 study that found higher rates of HA graft absorption. For the patients with cervical degenerative conditions, data from 8 comparative studies were included: 4 RCTs and 4 cohort studies (1 prospective and 3 retrospective studies). Synthetic grafts included HA, β-TCP/HA, PMMA, and biocompatible osteoconductive polymer (BOP). The PMMA and BOP grafts led to lower fusion rates, and PMMA, HA, and BOP had greater risks of graft fragmentation, settling, and instrumentation problems compared with iliac crest bone graft. The overall quality of evidence evaluating the potential use and superiority of the synthetic biological materials for lumbar and cervical fusion in this systematic review was low or insufficient, largely due to the high potential for bias and small sample sizes. Thus, definitive conclusions or recommendations regarding the use of these synthetic materials should be made cautiously and within the context of the limitations of the evidence.
PMID: 27231812
ISSN: 1547-5646
CID: 5185762