In 2011, Epstein and Hood documented that 17.2% of 274 patients with cervical/lumbar complaints seen in first or second opinion over one year were told they needed “unnecessary” spine surgery (e.g., defined as for pain alone, without neurological deficits, or significant radiographic abnormalities). Subsequently, in 2012 Gamache found that 69 (44.5%) of the 155 second opinion patients seen over a 14-month period were told by outside spine surgeons that they needed surgery; the second opinion surgeon (Gamache) found those operations to be unnecessary. Increasingly, patients, spine surgeons, hospitals, and insurance carriers should not only be questioning whether spinal operations are “unnecessary”, but also whether they are “wrong” (e.g., overly extensive, anterior vs. posterior operations), or “right” (appropriate).
Prospectively, 437 patients with cervical or lumbar complaints were seen in spinal consultation over a 20-month period. Of the 254 (58.1%) patients coming in for first opinions those with surgical vs. non-surgical lesions were identified. Of the 183 (41.9%) patients coming in for second opinions, who were previously told by outside surgeons that they needed spine operations, the second opinion surgeon documented the number of “unnecessary”, “wrong”, or “right” operations previously recommended.
Surgical pathology was identified in 138 (54.3%) patients presenting for first opinions. For patients seen in second opinion, 111 (60.7%) were told by outside surgeons that they required “unnecessary”, 61 (33.3%) the “wrong”, or 11 (6%) the “right” operations.
Of 183 second opinions seen over 20 months, the second opinion surgeon documented that previous spine surgeons recommended “unnecessary” (60.7%), the “wrong” (33.3%), or the “right” (6%) operations.
First opinions; right; spine surgery; second opinions; unnecessary; wrong
Intraoperative neural monitoring (IONM), utilizing somatosensory evoked potentials (SEP) and electromyography (EMG), was introduced to cervical spine surgery in the late 1980's. However, as SEP only provided physiological data regarding the posterior cord, new motor deficits were observed utilizing SEP alone. This prompted the development of motor evoked potential monitoring (MEP) which facilitated real-time assessment of the anterior/anterolateral spinal cord. Although all three modalities, SEP, EMG, and MEP, are routinely available for IONM of cervical spine procedures, MEP are not yet routinely employed. The purpose of this review is to emphasize that MEP should now routinely accompany SEP and EMG when performing IONM of cervical spine surgery. Interestingly, one of the most common reasons for malpractice suits involving the cervical spine, is quadriparesis/quadriplegia following a single level anterior cervical diskectomy and fusion (ACDF). Previously, typical allegations in these suits included; negligent surgery, lack of informed consent, failure to diagnose/treat, and failure to brace. Added to this list, perhaps, as the 5th most reason for a suit will be failure to monitor with MEP. This review documents the value of MEP monitoring in addition to SEP and EMG monitoring in cervical spine surgery. The addition of MEP0 should minimize major motor injuries, and more accurately and reliably detect impending anterior cord deterioration that may be missed with SEP monitoring alone.
Cervical surgery; electromyography; intraoperative monitoring; motor evoked potentials; neurological; somatosensory evoked potentials; spine surgery
Increasingly, adverse events (AE) attributed to utilizing BMP/INFUSE (Bone Morphogenetic Protein, Medtronic, Memphis, TN, USA) “off-label” in spine surgery are being reported. In 2008, the Food and Drug Administration (FDA) issued a warning that in anterior cervical spine surgery, the “off-label” use of BMP/INFUSE contributed to marked dysphagia, hematoma, seroma, swelling, and/or the need for intubation/tracheostomy. Subsequent studies have cited the following AE; heterotopic ossification (HO), osteolysis, infection, arachnoiditis, increased neurological deficits, retrograde ejaculation, and cancer. Furthermore, in 2011, Carragee et al. noted that 13 of the original industry-sponsored BMP/INFUSE spinal surgery studies failed to acknowledge multiple AE. Additionally, in 2012, Comer et al. observed that the frequency of retrograde ejaculation reported for BMP/INFUSE used “on-label” to perform Anterior Lumbar Interbody Fusion/Lumbar Tapered Fusion-Cage Device (ALIF/LT-Cage) was also largely “under-reported.” To summarize, there is mounting evidence in the spinal literature that utilizing BMP/INFUSE in spinal fusions contributes to major perioperative and postoperative morbidity.
Adverse events; BMP/INFUSE; fusions; morbidity; “off-label”; spinal surgery
A 45 year old male with multiple comorbidities presented to his internist with a 2 week history of right sided neck pain and tenderness, accompanied by tingling in the hand. The internists’ neurological examination was normal, except for decreased range of motion of the right arm. He referred the patient to a chiropractor; he performed plain X rays which revealed mild spasm, but never ordered a magnetic resonance imaging study. The chiropractor manipulated the patient's neck on two successive days. By the morning of the third visit, the patient reported extreme pain and difficulty walking. Without performing a new neurological examination or obtaining an MR scan, the chiropractor again manipulated the patient's neck. He immediately became quadriplegic. Despite undergoing an emergency C5 C6 anterior cervical diskectomy/fusion to address a massive disc found on the MR scan (CT was negative), the patient remained quadriplegic (e.g., C4 sensory, C6 motor levels). A major point of negligence in this case was the failure of both the referring internist and chiropractor to order an MR of the cervical spine prior to the chiropractic manipulation. The internist claimed that there was no known report of permanent quadriplegia resulting from neck manipulation in any medical journal, article or book, or in any literature of any kind or on the internet and that the risk of this injury must be vanishingly small given the large numbers of manipulations performed annually. The total amount of the verdict was $14,596,000.00 the internist's liability was 5% ($759,181.65).
Cervical manipulation; cervical disc; chiropractic treatment; quadriplegia
In spinal surgery, cerebrospinal fluid (CSF) fistulas attributed to deliberate dural opening (e.g., for tumors, shunts, marsupialization of cysts) or inadvertent/traumatic dural tears (DTs) need to be readily recognized, and appropriately treated.
During spinal surgery, the dura may be deliberately opened to resect intradural lesions/tumors, to perform shunts, or to open/marsupialize cysts. DTs, however, may inadvertently occur during primary, but are seen more frequently during revision spinal surgery often attributed to epidural scarring. Other etiologies of CSF fistulas/DTs include; epidural steroid injections, and resection of ossification of the posterior longitudinal ligament (OPLL) or ossification of the yellow ligament (OYL). Whatever the etiology of CSF fistulas or DTs, they must be diagnosed utilizing radioisotope cisternography (RIC), magnetic resonance imaging (MRI), computed axial tomography (CT) studies, and expeditiously repaired.
DTs should be repaired utilizing interrupted 7-0 Gore-Tex (W.L. Gore and Associates Inc., Elkton, MD, USA) sutures, as the suture itself is larger than the needle; the larger suture occludes the dural puncture site. Closure may also include muscle patch grafts, dural patches/substitutes (bovine pericardium), microfibrillar collagen (Duragen: Integra Life Sciences Holdings Corporation, Plainsboro, NJ), and fibrin glues or dural sealants (Tisseel: Baxter Healthcare Corporation, Deerfield, IL, USA). Only rarely are lumbar drains and wound-peritoneal and/or lumboperitoneal shunts warranted.
DTs or CSF fistulas attributed to primary/secondary spinal surgery, trauma, epidural injections, OPLL, OYL, and other factors, require timely diagnosis (MRI/CT/Cisternography), and appropriate reconstruction.
Cerebrospinal fluid; dural sealants; fibrin sealants; fistulas; muscle grafts; reconstruction methods; spinal surgery; suture techniques
Although we routinely utilize medical consultants for preoperative clearance and postoperative patient follow-up, we as spine surgeons need to know more medicine to better select and care for our patients.
This study provides additional medical knowledge to facilitate surgeons’ “cross-talk” with medical colleagues who are concerned about how multiple comorbid risk factors affect their preoperative clearance, and impact patients’ postoperative outcomes.
Within 6 months of an acute myocardial infarction (MI), patients undergoing urological surgery encountered a 40% mortality rate: similar rates may likely apply to patients undergoing spinal surgery. Within 6 weeks to 2 months of placing uncoated cardiac, carotid, or other stents, endothelialization is typically complete; as anti-platelet therapy may often be discontinued, spinal surgery can then be more safely performed. Coated stents, however, usually require 6 months to 1 year for endothelialization to occur; thus spinal surgery is often delayed as anti-platelet therapy must typically be continued to avoid thrombotic complications (e.g., stroke/MI). Diabetes and morbid obesity both increase the risk of postoperative infection, and poor wound healing, while the latter increases the risk of phlebitis/pulmonary embolism. Both hypercoagluation and hypocoagulation syndromes may require special preoperative testing/medications and/or transfusions of specific hematological factors. Pulmonary disease, neurological disorders, and major psychiatric pathology may also require further evaluations/therapy, and may even preclude successful surgical intervention.
Although we as spinal surgeons utilize medical consultants for preoperative clearance and postoperative care, we need to know more medicine to better select and care for our patients.
Hematology; medical comorbidities; neurological/psychiatric -disorders; obesity; pulmonary; spinal surgery: cardiac disease; stroke
This article examines the value of morbidity and mortality (M&M) conferences, and the multiple factors that contribute to their efficacy. Physicians’ morbidity and mortality conferences (M&MCs) focus on education by reviewing individual adverse events (AE), M&M. Alternatively, Quality Assurance (QA) conferences better examine system-wide issues (e.g., the role institutions play) in attaining or maintaining acceptable levels of patient care. Other issues examined in this review include: whether prospective vs. retrospective M&M data collection are more accurate, and how most states offer ‘nondiscovery’ of M&M proceedings.
Most studies emphasize the educational role of M&MCs, and differentiate their role from QA. Studies comparing the accuracy of prospective vs. retrospective collection of M&M data were reviewed along with the medicolegal issues surrounding the protection of M&M data (‘nondiscovery’).
Multiple review articles emphasized that QA conferences typically identify system-wide failures (e.g., hospital policies) while M&MCs focus on physicians’ AE/morbidity/mortality. Additionally, the prospective collection of M&M data proved to be more accurate than retrospective analysis. Finally, most states protect M&M confidentiality (‘nondisclosure’); a glaring exception is Florida, ‘The Sunshine State,’ that allows ‘full disclosure.’
This study reviews how M&MCs, differentiated from QA meetings, and educate physicians. It also documents how prospective collection of M&M data is more accurate than retrospective analysis. Additionally, it documents how in most states, medicolegal protections against discovery are in place, with Florida, the ‘Sunshine State’ remaining a glaring exception.
Attendance revival; conferences; medicolegal requirements; morbidity; mortality; spinal surgery
In 2008, the incidence of hospital acquired pressure ulcers (HAPUs) continued to increase on a neuroscience unit that included both neurosurgical and neurological patients in a 14-bed intensive care unit, and in a 18-bed floor unit.
To reduce HAPUs, several changes were instituted in 2008; (1) turning patients every 1–2 h/repositioning, (2) specialty beds, and (3) a “skin and wound assessment team (SWAT)” that included one (or two) “expert” nurses/nursing assistants who made rounds on all the patients in the unit at least once a week. They would examine patients from “head to toe”, document/measure all pressure ulcers, and educate primary nurses/nurse assistants on the plan/products needed for the patients wound care based on their assessments. In 2010, further measures included: (1) adding eight Stryker beds, (2) adding pressure relieving heel protector boots, and (3) requiring that all new hospital orientees work one shift (7.5 h) shadowing the SWAT team.
The SWAT team initially decreased HAPUs by 48% in 2009; this reduction was further increased in 2010 (57%), and 2011 (61%). Additionally, in 2010, the SWAT team was required to educate nurses in all other units. By 2011, all nurses had to complete the hospital acquired pressure ulcer prevention tutorial.
Since instituting a specialized SWAT team for our neuroscience unit, the incidence of HAPUs (cost estimated for grade IV, US $129,248) was decreased by 48% in 2009, by 57% in 2010, and by 61% in 2011. The SWAT program is now hospital-wide.
Hospital-acquired pressure ulcers; Neuroscience unit; Skin and wound assessment teams
The surgical management of lumbar synovial cysts that have extruded into the spinal canal remains controversial (e.g. decompression with/without fusion).
The neurological presentation, anatomy, pathophysiology, and surgical challenges posed by synovial cysts in the lumbar spine are well known. Neurological complaints typically include unilateral or, more rarely, bilateral radicular complaints, and/or cauda equina syndromes. Anatomically, synovial cysts constitute cystic dilatations of synovial sheaths that directly extrude from facet joints into the spinal canal. Pathophysiologically, these cysts reflect disruption of the facet joints often with accompanying instability, and potentially compromise both the cephalad and caudad nerve roots.
Aspiration of lumbar synovial cysts, which are typically gelatinous and non-aspirable, and typically performed by “pain specialists” (e.g. pain management, rehabilitation, radiologists, others) utilizing fluoroscopy or CT-guided aspiration, is associated with 50–100% failure rates. Surgical decompression with/without fusion (as the issue regarding fusion remains unsettled) results in the resolution of back and radicular pain in 91.6–92.5% and 91.1–91.9% of cases, respectively.
After a thorough review of the literature, it appears that the treatment with the best outcome for patients with synovial cysts is cyst removal utilizing surgical decompression; the need for attendant fusion remains unsettled. The use of an alternative treatment, percutaneous aspiration of cysts, appears to have a much higher recurrence and failure rate, but may be followed by surgery if warranted.
Decompression; extruded lumbar synovial cysts; failed aspiration; failed techniques; fusion
Grafting choices available for performing anterior cervical diskectomy/fusion (ACDF) procedures have become a major concern for spinal surgeons, and their institutions. The “gold standard”, iliac crest autograft, may still be the best and least expensive grafting option; it deserves to be reassessed along with the pros, cons, and costs for alternative grafts/spacers.
Although single or multilevel ACDF have utilized iliac crest autograft for decades, the implant industry now offers multiple alternative grafting and spacer devices; (allografts, cages, polyether-etherketone (PEEK) amongst others). While most studies have focused on fusion rates and clinical outcomes following ACDF, few have analyzed the “value-added” of these various constructs (e.g. safety/efficacy, risks/complications, costs).
The majority of studies document 95%-100% fusion rates when iliac crest autograft is utilized to perform single level ACDF (X-ray or CT confirmed at 6-12 postoperative months). Although many allograft studies similarly quote 90%-100% fusion rates (X-ray alone confirmed at 6-12 postoperative months), a recent “post hoc analysis of data from a prospective multicenter trial” (Riew KD et. al., CSRS Abstract Dec. 2011; unpublished) revealed a much higher delayed fusion rate using allografts at one year 55.7%, 2 years 87%, and four years 92%.
Iliac crest autograft utilized for single or multilevel ACDF is associated with the highest fusion, lowest complication rates, and significantly lower costs compared with allograft, cages, PEEK, or other grafts. As spinal surgeons and institutions become more cost conscious, we will have to account for the “value added” of these increasingly expensive graft constructs.
Allograft; cages; anterior cervical spine surgery; costs; efficacy; explantation; iliac crest autograft; polyether-etherketone; single-level diskectomy/fusion (1-level ACDF)
Interspinous fusion devices (IFDs) are increasingly offered to patients over the age of 50 with lumbar spinal stenosis and intermittent neurogenic claudication. Here, we review the literature on complication rates, reoperation rates, and outcomes for implanting IFD, and offer an assessment of IFD charges at a single institution in 2010.
The literature concerning IFD implants was reviewed with particular attention focused on complications, reoperation rates, and outcomes. Additionally, the costs of implanting 31 IFD devices in 16 patients at one to three levels at a single institution in 2010 are presented.
Reviewing the spinal literature concerning the postoperative status of IFD followed over an average of 23–42.9 postoperative months revealed that IFD resulted in 11.6–38% complication rate, 4.6–85% reoperation rate, and 66.7–77% frequency of poor outcomes. Additionally, the 31 devices implanted in 16 patients at a single university hospital in 2010 cost a total of $576,407.
With high maximal complication rates (38%), reoperation rates (85%), poor outcomes (77%), and high costs ($576,407 for 31 devices in 16 patients), the utilization and implantation of IFD remains extremely controversial and should be investigated further.
Complications; high costs; interspinous fusion devices; lumbar stenosis; poor outcomes; reoperations
Although the frequency of spinal surgical procedures has been increasing, particularly in patients of age 65 and over (geriatric), multiple overlapping comorbidities increase their risk/complication rates. Nevertheless, sometimes these high-risk geriatric patients are considered for “unnecessary”, too much (instrumented fusions), or too little [minimally invasive surgery (MIS)] spine surgery.
In a review of the literature and reanalysis of data from prior studies, attention was focused on the increasing number of operations offered to geriatric patients, their increased comorbidities, and the offers for “unnecessary” spine fusions, including both major open and MIS procedures.
In the literature, the frequency of spine operations, particularly instrumented fusions, has markedly increased in patients of age 65 and older. Specifically, in a 2010 report, a 28-fold increase in anterior discectomy and fusion was observed for geriatric patients. Geriatric patients with more comorbid factors, including diabetes, hypertension, coronary artery disease (prior procedures), depression, and obesity, experience higher postoperative complication rates and costs. Sometimes “unnecessary”, too much (instrumented fusions), and too little (MIS spine) surgeries were offered to geriatric patients, which increased the morbidity. One study observed a 10% complication rate for decompression alone (average age 76.4), a 40% complication rate for decompression/limited fusion (average age 70.4), and a 56% complication rate for full curve fusions (average age 62.5).
Increasingly, spine operations in geriatric patients with multiple comorbidities are sometimes “unnecessary”, offer too much surgery (instrumentation), or too little surgery (MIS).
Geriatric patients; instrumentation; minimally invasive; spinal surgery; unnecessary
INFUSE, bone morphogenetic protein-2 combined with bovine Type I collagen in the lumbar tapered fusion device (LT Cage), is used to promote anterior lumbar interbody fusion (ALIF). In spinal surgery, INFUSE is only Federal Drug Administration (FDA) approved for this “on-label” use. While the efficacy and possible complications due to INFUSE have been debated, we know less about the costs and frequency of “on-label” versus “off-label” use of INFUSE to perform spinal fusions.
At one institution, we determined the costs (with overhead) and frequency of utilizing INFUSE “on-label” and “off-label” in performing spinal fusions during 2010.
During 2010, 177 spinal fusions utilized INFUSE. Ninety-six percent, or 170 of 177 spinal fusions, utilized INFUSE in an “off-label” capacity at a cost of $4,547,822. Only 4%, or seven of 177 cases, utilized INFUSE in an “on-label” capacity (ALIF); the total cost was $296,419.
In 2010, at one institution, 96% of the spinal fusions utilized INFUSE in an off-label capacity (cost $4,547,822), while only 4% were performed on-label (cost $296,4194).
INFUSE; spinal fusion; lumbar; cervical; thoracic; surgery; off-label
There are marked disparities in the frequency of spinal surgery performed within the United States over time, as well as across different geographic areas. One possible source of these disparities is the criteria for surgery.
During a one-year period [November 2009-October 2010], the senior author, a neurosurgeon, saw 274 patients for cervical and lumbar spinal, office consultations. A patient was assigned to the “unnecessary surgery” group if they were told they needed spinal surgery by another surgeon, but exhibited pain alone without neurological deficits and without significant abnormal radiographic findings [dynamic X-rays, MR scans, and/or CT scans].
Of the 274 consults, 45 patients were told they needed surgery by outside surgeons, although their neurological and radiographic findings were not abnormal. An additional 2 patients were told they needed lumbar operations, when in fact the findings indicated a cervical operation was necessary. These 47 patients included 21 [23.1%] of 91 patients with cervical complaints, and 26 [14.2%] of 183 patients with lumbar complaints. The 21 planned cervical operations included 1-4 level anterior diskectomy/fusion [18 patients], laminectomies/fusions [2 patients], and a posterior cervical diskectomy [1 patient]. The 26 planned lumbar operations involved single/multilevel posterior lumbar interbody fusions: 1-level [13 patients], 2-levels [7 patients], 3-levels [3 patients], 4-levels [2 patients], and 5-levels [1 patient]. In 29 patients there were one or more overlapping comorbidities.
During a one-year period, 47 [17.2%] of 274 spinal consultations seen by a single neurosurgeon were scheduled for “unnecessary surgery”.
Cervical; frequency; lumbar; unnecessary spinal surgery
Little is known about the costs of devices explanted during anterior cervical diskectomy and fusion surgery. This retrospective study analyzes the costs to a single hospital of plates, screws and spacers used in all single-level anterior diskectomy and fusion (single-ADF) operations performed during a 1-year period.
Materials and Methods:
Our objective was to determine the costs of instrumentation explanted (i.e. implanted during surgery but removed prior to closure) during 87 single-ADF procedures performed at a single institution within a single year, 2009. All 87 single-ADF procedures were analyzed to determine the frequency and costs (without overhead) to the hospital for both permanently implanted and explanted anterior cervical screws, plates, and spacers (allograft, artificial plastics, and cages). All patients undergoing single-ADF were included in this study irrespective of the diagnosis related group (DRG) category.
The costs, without overhead to the hospital, for the permanently implanted instrumentation were: screws ($103,572: 84 patients); plates ($120,694: 85 patients); allograft spacers ($92,776: 64 patients); cages ($38,821: 9 patients); and autografts (no charge; 14 patients), for a total of $355,863. The additional costs to the hospital for explanted instrumentation were: 37 screws ($11,014: 17 patients); 7 plates ($12,743: 5 patients); and 8 allograft spacers ($9093: 7 patients); there were no explanted cages. The total cost of the explanted devices was $32,850.
During 87 single-ADF procedures, a total of 37 screws, 7 plates, and 8 spacers were explanted in 24 (27.6%) patients, resulting in an additional $32,850, 9.2%, to the cost of the implanted devices.
Anterior diskectomy/fusion; costs; explanted devices; instrumentation; single-level
The rate of postoperative spinal infections varies from 0.4% to 3.5%. Although the introduction of additional preoperative, intraoperative, and postoperative methods of prophylaxis should further reduce spinal infection rates, these measures will not succeed unless surgeons are well informed of their availability, utility, and efficacy. This study provides a review of several preoperative, intraoperative, and postoperative methods of prophylaxis that could minimize the risk of postoperative spinal infections. Various preoperative, intraoperative, and postoperative measures could further reduce the risk of spinal infections. Preoperative prophylaxis against methicillin-resistant Staphylococcus aureus could utilize (1) nasal cultures and Bactroban ointment (mupirocin), and (2) multiple prophylactic preoperative applications of chlorhexidine gluconate (CHG) 4% to the skin. Intraoperative prophylactic measures should not only include the routine use of an antibiotic administered within 60 min of the incision, but should also include copious intraoperative irrigation [normal saline (NS) and/or NS with an antibiotic]. Intraoperatively, instrumentation coated with antibiotics, and/or the topical application of antibiotics may further reduce the infection risk. Whether postoperative infections are reduced with the continued use of antibiotic prophylaxis remains controversial. Other postoperative measures may include utilization of a silver (AgNO3)-impregnated dressing (Silverlon dressing) and the continued use of bed baths with CHG 4%. The introduction of multiple preoperative, intraoperative, and postoperative modalities in addition to standardized prophylaxis may further contribute to reducing postoperative spinal infections.
Antibiotic prophylaxis; infection; intraoperative prophylaxis; postoperative prophylaxis; preoperative prophylaxis; spinal surgery
Several cervical laminectomies and instrumented posterior cervical fusions utilize iliac autograft supplemented with demineralized bone matrix, or bone morphogenetic protein, but few utilize artificial bone graft expanders. Here we analyzed whether posterior cervical fusions could effectively utilize iliac autograft supplemented with an artificial bone graft expander, Beta Tricalcium Phosphate [B-TCP]
Materials and Methods:
Fifty-three severely myelopathic patients [average Nurick Score 4.1], averaging 65.3 years of age, underwent posterior cervical laminectomies [average 2.3 levels] and multilevel instrumented fusions [average 7.5 levels] utilizing iliac crest autograft and B-TCP. Pathology addressed included multilevel spondylosis accompanied by ossification of the posterior longitudinal ligament [24 patients], ossification of the yellow ligament [27 patients], and instability [53 patients]. Fusion rates [dynamic X-ray, two-dimensional computerized axial tomography (2D-CT) and outcomes [Nurick Grades, Odom's Criteria, SF-36] were assessed at 3, 6, and 12 months postoperatively.
Fusion was confirmed by two independent neuroradiologists utilizing dynamic X-ray studies [100% of patients] and 2D-CT studies [86.8% of patients] an average of 5.4 months postoperatively. Although there were no symptomatic pseudarthroses, three smokers exhibited delayed fusions [8 postoperative months]. Within 1 postoperative year, patients improved an average of 2.7 Nurick Grades [Nurick Score 1.4], Odom's criteria revealed 48 good/excellent, and 5 fair/poor outcomes, and improvement on all 8 SF-36 Health Scales [maximal on Bodily Pain [+21.96].
High fusion rates and improved neurological outcomes were achieved within one year for 53 patients undergoing multilevel level cervical laminectomies with posterior instrumented fusions utilizing iliac autograft supplemented with B-TCP.
Artificial Bone Graft Expander; Beta TriCalcium Phosphate; Cervical Laminectomy; Iliac Autograft; Multilevel Instrumented Fusion
Few studies focus on the fusion rates and outcomes for single-level anterior cervical diskectomy/fusion (1-ACDF) utilizing iliac autograft and dynamic plates.
Fusion rates and outcomes were prospectively evaluated in 60 consecutive patients undergoing 1-ACDF utilizing iliac autograft and dynamic plates (ABC; Aesculap, Tuttlingen, Germany). Eighteen patients had radiculopathy, while 42 were myelopathic (average Nurick Score 3.3). Pathology included single-level disc disease/spondylosis (38 patients) and/or ossification of the posterior longitudinal ligament (OPLL, 22 patients). Fusion was assessed at 3, 6, and up to 12 months postoperatively utilizing dynamic X-rays and 2D-CT scans. Outcomes were evaluated up to 24 months postoperatively utilizing Odom's Criteria, Nurick Grades, and Short-Form 36 (SF-36) outcome questionnaires. Patients were followed for an average of 4.8 postoperative years (minimum 2 years).
Although dynamic X-rays/2D-CT studies documented 100% fusion an average of 3.8 months (range 2.5-8 months] postoperatively, 5 heavy smokers exhibited delayed fusions [6-8 months postoperatively]. Two years postoperatively, the average Nurick Score was 0.3 (mild radiculopathy), while Odom's Criteria revealed 52 excellent, 6 good, and 2 fair outcomes [the latter 8 patients were heavy smokers]). Utilizing SF-36 outcome questionnaires, patients markedly improved (>10.0 point gain) on 5 of 8 Health Scales within 6 months, 7 of 8 within 1 year, and all 8 within 2 postoperative years.
For 60 patients undergoing 1-ACDF utilizing dynamic plates, ultimately a 100% fusion rate was achieved (5 heavy smokers exhibited delayed fusions). Two years postoperatively, Nurick Grades, Odom's Criteria, and SF-36 questionnaires revealed adequate outcomes.
Single-level; Anterior Cervical Diskectomy/Fusion; SF-36 Outcomes; Fusion Rates; Autograft; Dynamic Plates
INFUSE (recombinant human bone morphogenetic protein-2 [rh-BMP-2]; Medtronic, Memphis, TN, USA) is approved by the Federal Drug Administration (FDA) only for use with the lumbar tapered fusion device (LT Cage; Medtronic) to perform single-level anterior lumbar interbody fusions (ALIF: L2-S1 levels). INFUSE, however, is widely utilized in an “off-label” capacity for anterior and/or posterior cervical, thoracic, and lumbar surgery. Nevertheless, Medicare and other insurance companies, are now increasingly denying reimbursement (average cost of a “large” INFUSE to the hospital without overhead $5000-6000) to hospitals for INFUSE when utilized “off-label”.
This commentary looks at several representative studies citing the cons associated with utilizing INFUSE in spinal surgery, contraindications, complications, and cost factors.
There are multiple cons of utilizing INFUSE in an “off-label” capacity for spinal surgery. Direct contraindications include pregnancy, allergy to titanium, allergy to bovine type I collagen or rhBMP-2, infection, tumor, liver or kidney disease, immunosuppression (e.g., lupus, HIV/AIDS); contraindications are also seen in those receiving radiation, chemotherapy, or steroids. Reported complications include exuberant/ectopic bone formation, paralysis (cord, nerve damage), dural tears, bowel–bladder and sexual dysfunction, respiratory failure, inflammation of adjacent tissues, fetal developmental complications, scar, excessive bleeding, and even death. Complications are so prevalent in the anterior cervical spine, that many surgeons no longer use it in this region. Similarly, INFUSE complications and indications for posterior lumbar interbody fusions (PLIFs) and transforaminal interbody lumbar fusions (TLIFs) should also be reexamined.
More surgeons need to question the safety, efficacy, and appropriate “off-label” use of INFUSE in all spine surgeries.
INFUSE (rhBMP-2); bone morphogenetic protein; spinal surgery; off-label use
To determine whether patients who become quadriplegic following cervical spine surgery are adequately compensated by our present medico-legal system. The outcomes of malpractice suits obtained from Verdict Search (East Islip, NY, USA), a medico-legal journal, were evaluated over a 20-year period. Although the present malpractice system generously rewards many quadriplegic patients with substantial settlements/ Plaintiffs' verdicts, a subset receive lesser reimbursements (verdicts/settlements], while others with defense verdicts receive no compensatory damages.
Utilizing Verdict Search, 54 cases involving quadriplegia following cervical spine surgery were reviewed for a 20-year interval (1988–2008). The reason(s) for the suit, the defendants, the legal outcome, and the time to outcome were identified. Operations included 25 anterior cervical procedures, 22 posterior cervical operations, 1 circumferential cervical procedure, and 6 cases in which the cervical operations were not defined.
The four most prominent legal allegations for suits included negligent surgery (47 cases), lack of informed consent (23 cases), failure to diagnose/treat (33 cases), and failure to brace (15 cases). Forty-four of the 54 suits included spine surgeons. There were 19 Plaintiffs' verdicts (average US $5.9 million, range US $540,000-US $18.4 million), and 20 settlements (average US $2.8 million, range US $66,500-US $12.0 million). Fifteen quadriplegic patients with defense verdicts received no compensatory damages. The average time to verdicts/settlements was 4.3 years.
For 54 patients who were quadriplegic following cervical spine surgery, 15 (28%) with defense verdicts received no compensatory damages. Under a No-Fault system, quadriplegic patients would qualify for a “reasonable” level of compensation over a “shorter” time frame.
Cervical spine surgery; Quadriplegia; Medico-legal liability suits; No-fault system