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1.
Int J Mol Sci ; 21(6)2020 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-32197418

RESUMO

Healthy and degenerating intervertebral discs (IVDs) are innervated by sympathetic nerves, however, adrenoceptor (AR) expression and functionality have never been investigated systematically. Therefore, AR gene expression was analyzed in both tissue and isolated cells from degenerated human IVDs. Furthermore, human IVD samples and spine sections of wildtype mice (WT) and of a mouse line that develops spontaneous IVD degeneration (IVDD, in SM/J mice) were stained for ARs and extracellular matrix (ECM) components. In IVD homogenates and cells α1a-, α1b-, α2a-, α2b-, α2c-, ß1-, and ß2-AR genes were expressed. In human sections, ß2-AR was detectable, and its localization parallels with ECM alterations. Similarly, in IVDs of WT mice, only ß2-AR was expressed, and in IVDs of SM/J mice, ß2AR expression was stronger accompanied by increased collagen II, collagen XII, decorin as well as decreased cartilage oligomeric matrix protein expression. In addition, norepinephrine stimulation of isolated human IVD cells induced intracellular signaling via ERK1/2 and PKA. For the first time, the existence and functionality of ARs were demonstrated in IVD tissue samples, suggesting that the sympathicus might play a role in IVDD. Further studies will address relevant cellular mechanisms and thereby help to develop novel therapeutic options for IVDD.

2.
J Neurosurg ; : 1-11, 2020 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-31923894

RESUMO

OBJECTIVE: Aneurysm wall enhancement (AWE) on 3D vessel wall MRI (VWMRI) has been suggested as an imaging biomarker for intracranial aneurysms (IAs) at higher risk of rupture. While computational fluid dynamics (CFD) studies have been used to investigate the association between hemodynamic forces and rupture status of IAs, the role of hemodynamic forces in unruptured IAs with AWE is poorly understood. The authors investigated the role and implications of abnormal hemodynamics related to aneurysm pathophysiology in patients with AWE in unruptured IAs. METHODS: Twenty-five patients who had undergone digital subtraction angiography (DSA) and VWMRI studies from September 2016 to September 2017 were included, resulting in 22 patients with 25 IAs, 9 with and 16 without AWE. High-resolution CFD models of hemodynamics were created from DSA images. Univariate and multivariate analyses were performed to investigate the association between AWE and conventional morphological and hemodynamic parameters. Normalized MRI signal intensity was quantified and quantitatively associated with wall shear stresses (WSSs) for the entire aneurysm sac, and in regions of low, intermediate, and high WSS. RESULTS: The AWE group had lower WSS (p < 0.01) and sac-averaged velocity (p < 0.01) and larger aneurysm size (p < 0.001) and size ratio (p = 0.0251) than the non-AWE group. From multivariate analysis of both hemodynamic and morphological factors, only low WSS was found to be independently associated with AWE. Sac-averaged normalized MRI signal intensity correlated with WSS and was significantly different in regions of low WSS compared to regions of intermediate (p = 0.018) and high (p < 0.001) WSS. CONCLUSIONS: The presence of AWE was associated with morphological and hemodynamic factors related to rupture risk. Low WSS was found to be an independent predictor of AWE. Our findings support the hypothesis that low WSS in IAs with AWE may indicate a growth and remodeling process that may predispose such aneurysms to rupture; however, a causality between the two cannot be established.

3.
World Neurosurg ; 133: e498-e502, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31562975

RESUMO

OBJECTIVE: Symptomatic spine metastases are found in about 10% of patients with cancer. As the long-term survival of patients with carcinoma rises, the number of patients with symptomatic spine metastases is also increasing. In our tertiary referral center, patients usually present rapidly progressive neurologic disorders, which require an urgent treatment decision. Treatment options include extensive 360° stabilizations. These complex interventions are not always readily available. We examined the extent to which the patient population benefited from decompressive surgery without stabilization. We hypothesize that patients benefit from merely dorsal decompression, which preserves stability when they experience symptomatic spine metastases. METHODS: We performed a retrospective analysis of electronic patient data from 19 patients, who were treated for symptomatic spine metastases by hemilaminectomy between 2009 and 2017. We evaluated the preoperative and postoperative neurologic functions using the American Spinal Injury Association (ASIA) Impairment Scale. A comparative literature analysis was carried out to assess the Spinal Neoplastic Instability Score, Tokuhashi score, and Tomita score. RESULTS: Nine participants had prostate cancer, 4 had mammary carcinoma, 3 had bronchial carcinoma, and 3 had other cancers. The median preoperative ASIA score was C, postoperatively, the score significantly improved to D (sign test P = 0.002). None of the patients needed stabilization within the follow-up period of up to 56 months. CONCLUSIONS: In our patient population, minimal intervention could significantly improve neurologic disorders. This outcome was seen over the whole study period. Even though different scoring systems suggest stabilization, our results show that spinal decompression alone might be indicated as well.


Assuntos
Descompressão Cirúrgica/métodos , Laminectomia/métodos , Neoplasias da Coluna Vertebral/secundário , Neoplasias da Coluna Vertebral/cirurgia , Adulto , Idoso , Feminino , Humanos , Masculino , Microcirurgia/métodos , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
4.
Orthopade ; 49(1): 32-38, 2020 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-31089777

RESUMO

Further developments in disease diagnosis and treatment are of immense relevance for advancements in medical care of the population. A detailed cost-benefit analysis of direct and indirect costs is usually unavailable. In the current article, these aspects are investigated using prospectively collected randomized data over two years. Specifically, the surgical treatment of a herniated lumbar disc is addressed, and whether a newly introduced technique (e.g., annular closure device) can lead to a better quality of care and increased patient satisfaction when performed during the standard operation, while also being economically viable.


Assuntos
Degeneração do Disco Intervertebral , Deslocamento do Disco Intervertebral , Vértebras Lombares , Análise Custo-Benefício , Economia Médica , Humanos , Região Lombossacral
5.
Medicine (Baltimore) ; 98(44): e17760, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689835

RESUMO

BACKGROUND: The risk of recurrent herniation after lumbar discectomy is highest during the first postoperative year. The purpose of this study was to determine whether implantation of a bone-anchored annular closure device (ACD) following limited lumbar discectomy reduced the risk of recurrent herniation and complications during the first year of follow-up compared to limited lumbar discectomy alone (Controls) and whether this risk was influenced by patient characteristics. METHODS: In this randomized multicenter trial, patients with symptomatic lumbar disc herniation and with a large annular defect following limited lumbar discectomy were randomized to bone-anchored ACD or Control groups. The risks of symptomatic reherniation, reoperation, and device- or procedure-related serious adverse events were reported over 1 year of follow-up. RESULTS: Among 554 patients (ACD 276; Control 278), 94% returned for 1-year follow-up. Bone-anchored ACD resulted in lower risks of symptomatic reherniation (8.4% vs. 17.3%, P = .002) and reoperation (6.7% vs. 12.9%, P = .015) versus Controls. Device- or procedure-related serious adverse events through 1 year were reported in 7.1% of ACD patients and 13.9% of Controls (P = .009). No baseline patient characteristic significantly influenced these risks. CONCLUSIONS: Among patients with large annular defects following limited lumbar discectomy, additional implantation with a bone-anchored ACD lowered the risk of symptomatic reherniation and reoperation over 1 year follow-up. Device- or procedure-related serious adverse events occurred less frequently in the ACD group. These conclusions were not influenced by patient characteristics. ClinicalTrials.gov (NCT01283438).


Assuntos
Prótese Ancorada no Osso , Discotomia/instrumentação , Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Prevenção Secundária/métodos , Adulto , Discotomia/métodos , Feminino , Humanos , Masculino , Recidiva , Reoperação/estatística & dados numéricos , Resultado do Tratamento
6.
Cureus ; 11(7): e5169, 2019 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-31528519

RESUMO

Lumbar discectomy is a mainstay surgical treatment for herniation of the lumbar discs and is effective at treating radicular symptomology. Despite the overall success of the procedure; the potential for reherniation and reoperation is significant. To avoid this potential recurrence, surgeons often perform discectomy more aggressively, removing a larger volume of nuclear material in the hopes of minimizing the likelihood of reherniation. This approach, while beneficial in minimizing the chance of reherniation, is associated with a volumetric reduction of the nucleus within the disc space, making the disc more prone to collapse and thus inducing a significant post-operative loss of disc height. While potentially minor in isolation, the loss of disc height, in fact, impacts several aspects of overall patient well-being. We hypothesize that the loss of disc height following discectomy causes an increase in pain and subsequent disability, the combination of which ultimately impacts socioeconomic factors affecting both the patient and the healthcare system as a whole. In this report, we outline the evidence in support of this disability cascade and provide recommendations on methods for limiting its impact. Given the current focus on cost-effectiveness in healthcare decision-making, methods for limiting this potentially damaging sequence of events must be investigated.

7.
Clin Interv Aging ; 14: 1085-1094, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31354252

RESUMO

Background: Lumbar discectomy is a common surgical procedure in middle-aged adults. However, outcomes of lumbar discectomy among older adults are unclear. Methods: Lumbar discectomy patients with an annular defect ≥6 mm width were randomized to receive additional implantation with a bone-anchored annular closure device (ACD, n=272) or no additional implantation (controls, n=278). Over 3 years follow-up, main outcomes were symptomatic reherniation, reoperation, and the percentage of patients who achieved the minimum clinically important difference (MCID) without a reoperation for leg pain, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) score, and SF-36 Mental Component Summary (MCS) score. Results were compared between older (≥60 years) and younger (<60 years) patients. We additionally analyzed data from two postmarket ACD registries to determine consistency of outcomes between the randomized trial and postmarket, real-world results. Results: Among all patients, older patients suffered from crippling or bed-bound preoperative disability more frequently than younger patients (57.9% vs 39.1%, p=0.03). Among controls, female sex, higher preoperative ODI, and current smoking status, but not age, were associated with greater risk of reherniation and reoperation. Compared to controls, the ACD group had lower risk of symptomatic reherniation (HR=0.45, p<0.001) and reoperation (HR=0.54, p=0.008), with risk reductions comparable in older vs younger patients. The percentage of patients achieving the MCID without a reoperation was higher in the ACD group for leg pain (81% vs 72%, p=0.04), ODI (82% vs 73%, p=0.03), PCS (85% vs 75%, p=0.01), and MCS (59% vs 46%, p=0.007), and this benefit was comparable in older versus younger patients. Comparable benefits in older patients were observed in the postmarket ACD registries. Conclusion: Outcomes with lumbar discectomy and additional bone-anchored ACD are superior to lumbar discectomy alone. Older patients derived similar benefits with additional bone-anchored ACD implantation as younger patients.


Assuntos
Prótese Ancorada no Osso , Discotomia/métodos , Vértebras Lombares/cirurgia , Adulto , Fatores Etários , Idoso , Avaliação da Deficiência , Discotomia/psicologia , Feminino , Humanos , Masculino , Saúde Mental , Pessoa de Meia-Idade , Dor/etiologia , Sistema de Registros , Reoperação , Fatores Sexuais , Resultado do Tratamento
8.
Eur Spine J ; 28(11): 2551-2561, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31055663

RESUMO

PURPOSE: Few retrospective studies have addressed Modic changes (MC) following lumbar spine surgery, though it is usually assumed that MC increase in grade and incidence. To test this conventional wisdom, we investigated the natural course of MC following primary lumbar limited discectomy with two-year follow-up. In addition, a possible clinical relevance to those changes was assessed. METHODS: The data of the control group (278 subjects) of a prospective randomized, controlled trial (RCT) were evaluated retrospectively. RESULTS: We did not observe a simple increase in MC with regard to grade. There is variable activity observed in Type 2 (at 12 months) and in Type 1 (at 24 months). Conversion from one grade to another may occur and may be upward or downward. The incidence of MC increased slightly over time, as after surgery a decreasing percentage of the study group remained without MC over two years (1 year: 34% (85/250); 2 years: 30% (72/237)). Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes. Lastly, we found that neither the different MC types nor their changes were correlated with clinical parameters (VAS back, VAS leg, ODI score) preoperatively or during follow-up. CONCLUSION: The pattern of Modic changes following lumbar limited discectomy is complex, not simply increasing. There is variable activity in MC Types 1 and 2 at the different time points of follow-up, and conversion from a higher grader to a lower one or vice versa is possible. These slides can be retrieved under Electronic Supplementary Material.

9.
Pain Res Treat ; 2019: 3498603, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30854236

RESUMO

Purpose. To analyze leg pain severity data from a randomized controlled trial (RCT) of lumbar disc surgery using integrated approaches that adjust pain scores collected at scheduled follow-up visits for confounding clinical events occurring between visits. Methods. Data were derived from an RCT of a bone-anchored annular closure device (ACD) following lumbar discectomy versus lumbar discectomy alone (Control) in patients with large postsurgical annular defects. Leg pain was recorded on a 0 to 100 scale at 6 weeks, 3 months, 6 months, 1 year, and 2 years of follow-up. Patients with pain reduction ≥20 points relative to baseline were considered responders. Unadjusted analyses utilized pain scores reported at follow-up visits. Since symptomatic reherniation signifies clinical failure of lumbar discectomy, integrated analyses adjusted pain scores following a symptomatic reherniation by baseline observation carried forward for continuous data or classification as nonresponders for categorical data. Results. Among 550 patients (272 ACD, 278 Control), symptomatic reherniation occurred in 10.3% of ACD patients and in 21.9% of controls (p < 0.001) through 2 years. There was no difference in leg pain scores at the 2-year visit between ACD and controls (12 versus 14; p = 0.33) in unadjusted analyses, but statistically significant differences favoring ACD (19 versus 29; p < 0.001) in integrated analyses. Unadjusted nonresponder rates were 6.0% with ACD and 6.7% with controls (p = 0.89), but 15.7% and 27.8% (p = 0.001) in integrated analyses. The probability of nonresponse was 16.4% with ACD and 18.3% with controls (p = 0.51) in unadjusted analysis, and 23.7% and 31.2% (p = 0.04) in integrated analyses. Conclusion. In an RCT of lumbar disc surgery, an integrated analysis of pain severity that adjusted for the confounding effects of clinical failures occurring between follow-up visits resulted in different conclusions compared to an unadjusted analysis of pain scores reported at follow-up visits only.

10.
Spine J ; 19(7): 1170-1179, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30776485

RESUMO

BACKGROUND CONTEXT: Lumbar discectomy is largely successful surgical procedure; however, reherniation rates in patients with large annular defects are as high as 27%. The expense associated with a revision surgery places significant burden on the healthcare system. PURPOSE: To compare the direct health care costs through 5 years follow-up of conventional discectomy (Control) with those of discectomy supplemented by an adjunctive annular closure device (ACD) in high-risk patients with large annular defects. STUDY DESIGN: This was a cost-effectiveness study. METHODS: All-cause index level reoperations were reviewed from a multicenter, randomized controlled superiority trial that allocated 554 high-risk discectomy patients with large annular defects to either control or ACD. Medicare and private insurer (Humana) direct costs were derived from a commercially available payer database to estimate costs in the US healthcare system, including those associated with facility, surgeon, imaging, follow-up visits, physical therapy, and injections. A 50:50 split between Medicare and commercial insurers was assumed for the base case analysis. The analysis was also performed on a 80:20 commercial:Medicare payer basis. For the base case scenario, a 2-year time horizon and outpatient cost setting was established for the index procedure. Repeat discectomy was assumed to be performed on a 60:40 outpatient-to-inpatient basis. Complications requiring surgery, revisions, and/or fusion were assumed to be managed in the inpatient setting. Total costs of reoperation and per-patient costs of reoperation were compared between groups for both forms of insurers. One author received consulting fees of <$50,000 for the completion of this study, and the other eight authors did not have any financial associations with the current work. Funding for this study was provided by Intrinsic Therapeutics, but all analyses, interpretation, and writing were performed independently by the authors. RESULTS: At two years follow-up, use of the ACD reduced the rate of symptomatic reherniations in a large defect population to 13% compared with 25% in the control group (p<.001). This reduction in symptomatic reherniations in the ACD group translated to a savings of $2,802 per patient in direct health care costs compared with Control at 2 years and $5,315 per patient by 5 years based on 50% private and 50% public (Medicare) payer split. Under the scenario of 80:20 private:public insurance reimbursement, the estimated direct cost savings were $3,215 and $6,099 per patient at 2- and 5-years postoperatively, respectively, with the use of the ACD. CONCLUSIONS: Symptomatic reherniation and reoperation rates were nearly double among control patients compared with ACD-treated patients, which translated to markedly greater per-patient healthcare costs in the control group, where the ACD was not used.

11.
World Neurosurg ; 2019 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-30639492

RESUMO

BACKGROUND: Patients with aneurysmal subarachnoid hemorrhage (aSAH) are at risk of the development of chronic shunt-dependent hydrocephalus. However, identification of shunt-dependent patients remains challenging. We sought to develop a prognostic model to identify patients with aSAH at risk of chronic shunt-dependent hydrocephalus. In addition to the well-known prognostic variables, blood clearance in the cerebrospinal fluid (CSF) spaces was considered. METHODS: We retrospectively analyzed the data from 227 patients treated at our institution from January 2012 to January 2016. The outcome was ventriculoperitoneal shunt placement within 30 days after aSAH. The candidate prognostic variables were patient age, World Federation of Neurological Surgeons grade and Fisher grade, external ventricular drainage, ventricular and intracerebral hemorrhage, and interval to blood clearance in the peripheral/basal CSF spaces. Adjustment for multiple testing was performed. Multivariable logistic regression analysis was used for model development. Bootstrapping was applied for internal validation. The model performance measures included indexes for explained variance (R2), calibration (graphic plot, Hosmer-Lemeshow test), and discrimination (c-statistic). RESULTS: Of the 227 patients, 90 (39.6%) required a ventriculoperitoneal shunt. The constructed prognostic model combined external ventricular drainage placement, the presence of ventricular blood, and the duration of blood clearance in the basal cisterns. The model performance was promising, with an R2 of 33% (20% after bootstrapping), the calibration plot was adequate, the Hosmer-Lemeshow test result was not significant, and the c-statistic was 0.85 (0.84 as assessed after bootstrapping) indicating a good discriminating prognostic model. CONCLUSIONS: Our prognostic model could help identify patients requiring permanent CSF diversion after aSAH, although additional modification and external validation are needed. Interventions aimed at accelerating the clearance of blood in the basal cisterns might have the potential to prevent the development of chronic hydrocephalus after aSAH.

12.
Neurosurg Rev ; 42(2): 539-547, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29959638

RESUMO

In patients with aneurysmal subarachnoid hemorrhage (aSAH) and multiple aneurysms, there is a need to objectively identify the ruptured aneurysm. Additionally, studying the intra-individual rupture risk of multiple aneurysms eliminates extrinsic risk factors and allows a focus on anatomical factors, which could be extrapolated to patients with single aneurysms too. Retrospective bi-center study (Department of Neurosurgery of the University Hospital Duesseldorf and Bern) on patients with multiple aneurysms and subarachnoid hemorrhage caused by the rupture of one of them. Parameters investigated were height, width, neck, shape, inflow angle, diameter of the proximal and distal arteries, width/neck ratio, height/width ratio, height/neck ratio, and localization. Statistical analysis and logistic regressions were performed by the R program, version 3.4.3. N = 186 patients with aSAH and multiple aneurysms were treated in either department from 2008 to 2016 (Bern: 2008-2016, 725 patients and 100 multiple aneurysms, Duesseldorf: 2012-2016, 355 patients, 86 multiple aneurysms). The mean age was 57 years. N = 119 patients had 2 aneurysms, N = 52 patients had 3 aneurysms, N = 14 had 4 aneurysms and N = 1 had 5 aneurysms. Eighty-four percent of ruptured aneurysms were significantly larger than the largest unruptured. Multilobularity of ruptured aneurysms was significantly higher than in unruptured. Metric variables describing the geometry (height, width, etc.) and shape are the most predictive for rupture. One or two of them alone are already reliable predictors. Ratios are completely redundant in saccular aneurysms.


Assuntos
Aneurisma Roto/etiologia , Aneurisma Intracraniano/complicações , Aneurisma Intracraniano/patologia , Hemorragia Subaracnóidea/etiologia , Adulto , Idoso , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos , Estudos Retrospectivos , Fatores de Risco
13.
World Neurosurg ; 122: e291-e295, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30321678

RESUMO

BACKGROUND: De novo aneurysm formation after completely occluded aneurysms via clipping or coiling has not been well studied. Although known to occur several years after initial aneurysm management, the natural history of de novo aneurysms is obscure. We investigated the formation of new aneurysms in patients who had previously undergone treatment of intracranial aneurysms. METHODS: In a retrospective, single-institutional series, eligible patients who had undergone treatment of ruptured cerebral aneurysms from 2000 to 2011 were included. The primary outcome measure was the development of de novo aneurysms during long-term follow-up. RESULTS: Overall, 130 patients (63% women) who had undergone microsurgical clipping (n = 63; 48.5%) or endovascular coiling (n = 67%; 51.5%) for ruptured aneurysms were included. The average follow-up time for our cohort was 10 ± 2.7 years. De novo aneurysms occurred in 10 of 130 patients (7.7%), with a mean time of 7.9 years for aneurysm detection. No association between the formation of de novo aneurysms and the location of the treated aneurysms, smoking status, hypertension, age, or gender was found. Follow-up imaging studies were performed every 2 years. De novo aneurysms had formed in 2 patients within 2-5 years, 7 patients after 5-10 years, and 1 patient after 10 years of follow-up. In 2 of 10 patients, the de novo aneurysm had ruptured and led to subarachnoid haemorrhage. CONCLUSION: The rate of de novo aneurysm occurrence was 7.6%, with a mean time to development of 7.9 years. This underscores the significance of long-term monitoring of patients with intracranial aneurysms. In our series, most new aneurysms had occurred after 5 years of follow-up.


Assuntos
Aneurisma Roto/cirurgia , Aneurisma Intracraniano/cirurgia , Hemorragia Subaracnóidea/cirurgia , Adolescente , Adulto , Idoso , Criança , Procedimentos Endovasculares , Feminino , Seguimentos , Humanos , Masculino , Microcirurgia , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
14.
Clin Pract ; 8(3): 1089, 2018 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-30101005

RESUMO

The increasing number of incidental intracranial aneurysms creates a dilemma of which aneurysms to treat and which to observe. Clinical scoring systems consider risk factors for aneurysm rupture however objective parameters for assessment of aneurysms stability are needed. We retrospectively analysed contrast enhancing behaviour of un-ruptured aneurysms in the black blood magnetic resonance imaging (MRI) in N=71 patients with 90 aneurysms and assessed correlation between aneurysm wall contrast enhancement (AWCE) and aneurysm anatomy and clinical scoring systems. AWCE is associated with aneurysm height and height to width ratio in ICA aneurysms. AWCE is correlated to larger aneurysms in every anatomical location evaluated. However the mean size of the contrast enhancing aneurysms is significantly different between anatomical localizations indicating separate analyses for every artery. Clinical scoring systems like PHASES and UIATS correlate positively with AWCE in black blood MRI. MRI aneurysm wall contrast enhancement is a positive predictor for aneurysm instability and should be routinely assessed in follow up of incidental aneurysms. Aneurysms smaller than 7 mm with AWCE should be followed closely with focus on growth, as they may be prone to growth and rupture.

16.
Spine J ; 18(12): 2278-2287, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29730458

RESUMO

BACKGROUND CONTEXT: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. PURPOSE: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. DESIGN: This is a multicenter, randomized superiority study. PATIENT SAMPLE: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study. OUTCOME MEASURES: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. METHODS: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. RESULTS: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. CONCLUSIONS: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted.


Assuntos
Discotomia/métodos , Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Microcirurgia/métodos , Adulto , Idoso , Dor nas Costas/cirurgia , Prótese Ancorada no Osso , Discotomia/instrumentação , Feminino , Humanos , Deslocamento do Disco Intervertebral/prevenção & controle , Masculino , Pessoa de Meia-Idade , Medição da Dor , Qualidade de Vida , Reoperação/estatística & dados numéricos , Ciática/cirurgia , Adulto Jovem
17.
Spine (Phila Pa 1976) ; 43(20): 1386-1394, 2018 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-29538243

RESUMO

STUDY DESIGN: Post hoc analysis of a randomized controlled trial. OBJECTIVE: To characterize the morphology and clinical relevance of vertebral endplate changes (VEPC) following limited lumbar discectomy with or without implantation of a bone-anchored annular closure device (ACD). SUMMARY OF BACKGROUND DATA: Implantation of an ACD following limited lumbar discectomy has shown promise in reducing the risk of recurrent herniation in patients with large annular defects. However, the interaction between the ACD and the lumbar endplate over time is not well understood. METHODS: Patients undergoing limited lumbar discectomy with large postsurgical annular defects were randomized intraoperatively to receive additional ACD implantation or limited lumbar discectomy only (Controls). VEPC morphology, area, and volume were assessed with low-dose computed tomography preoperatively and at 1 and 2 years follow-up. RESULTS: Of 554 randomized patients, the as-treated population consisted of 550 patients (267 ACD, 283 Controls). VEPC were preoperatively identified in 18% of patients in the ACD group and in 15% of Controls. At 2 years, VEPC frequency increased to 85% with ACD and 33% in Controls. Device- or procedure-related serious adverse event (8% vs. 17%, P = 0.001) and secondary surgical intervention (5% vs. 13%, P < 0.001) favored the ACD group over Controls. In the ACD group, clinical outcomes were comparable in patients with and without VEPC at 2 years follow-up. In the Control group, patients with VEPC at 2 years had higher risk of symptomatic reherniation versus patients without VEPC (35% vs. 19%, P < 0.01) CONCLUSION.: In patients with large annular defects following limited lumbar discectomy, additional implantation with a bone-anchored ACD reduces risk of postoperative complications despite a greater frequency of VEPC. VEPC were associated with higher risk of symptomatic reherniation in patients treated with limited lumbar discectomy, but not in those who received additional ACD implantation. LEVEL OF EVIDENCE: 2.


Assuntos
Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Região Lombossacral/cirurgia , Complicações Pós-Operatórias/cirurgia , Adulto , Idoso , Discotomia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Tomografia Computadorizada por Raios X/métodos , Adulto Jovem
18.
Acta Neurochir (Wien) ; 160(4): 855-862, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29396603

RESUMO

BACKGROUND: The implantation of a bone-anchored annular closure device (ACD) might be associated with the developed new endplate changes (EPC) after surgery. METHODS: A post hoc analysis has been done in patients from a prospective randomized multicenter study. All patients underwent limited lumbar discectomy with intraoperative randomization into the groups limited lumbar discectomy alone or additional ACD implantation. Low-dose lumbar computed tomography (CT) and clinical investigations were performed preoperatively and 12 months after the operation. RESULTS: A total of 554 patients were randomized. After exclusion of dropouts, the per-protocol population included 493 patients (251 in the control group and 242 in the ACD group); the follow-up rate was ≥ 90%. The number of patients showing EPC at baseline was similar in both groups. The number of patients showing EPC and the total EPC lesion area significantly increased in both groups over time, but significantly increased more in the EPC group for the superior and inferior endplate (all P < 0.0001). There was no association of pre-existing number and size of EPC with sex, age, or smoking habits. Correlation of clinical variables showed no relation with number, size, and increase of EPC area after surgery. CONCLUSIONS: Patients with primary lumbar disc herniation show EPC in the corresponding segments. There is a significant increase of lesion number and size within 12 months after discectomy. This increase is significantly more pronounced in the ACD group. Presence and growth of EPC is not correlated with low-back pain or ODI.


Assuntos
Prótese Ancorada no Osso/efeitos adversos , Discotomia/métodos , Degeneração do Disco Intervertebral/cirurgia , Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Complicações Pós-Operatórias/epidemiologia , Adulto , Discotomia/efeitos adversos , Discotomia/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Tomografia Computadorizada por Raios X
19.
Eur Spine J ; 26(1): 181-188, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-25813011

RESUMO

PURPOSE: Augmentation of pedicle screws is recommended in selected indications (for instance: osteoporosis). Generally, there are two techniques for pedicle screw augmentation: inserting the screw in the non cured cement and in situ-augmentation with cannulated fenestrated screws, which can be applied percutaneously. Most of the published studies used an axial pull out test for evaluation of the pedicle screw anchorage. However, the loading and the failure mode of pullout tests do not simulate the cranio-caudal in vivo loading and failure mechanism of pedicle screws. The purpose of the present study was to assess the fixation effects of different augmentation techniques (including percutaneous cement application) and to investigate pedicle screw loosening under physiological cyclic cranio-caudal loading. METHODS: Each of the two test groups consisted of 15 vertebral bodies (L1-L5, three of each level per group). Mean age was 84.3 years (SD 7.8) for group 1 and 77.0 years (SD 7.00) for group 2. Mean bone mineral density was 53.3 mg/cm3 (SD 14.1) for group 1 and 53.2 mg/cm3 (SD 4.3) for group 2. 1.5 ml high viscosity PMMA bone cement was used for all augmentation techniques. For test group 1, pedicles on the right side of the vertebrae were instrumented with solid pedicle screws in standard fashion without augmentation and served as control group. Left pedicles were instrumented with cannulated screws (Viper cannulated, DePuy Spine) and augmented. For test group 2 pedicles on the left side of the vertebrae were instrumented with cannulated fenestrated screws and in situ augmented. On the right side solid pedicle screws were augmented with cement first technique. Each screw was subjected to a cranio-caudal cyclic load starting at 20-50 N with increasing upper load magnitude of 0.1 N per cycle (1 Hz) for a maximum of 5000 cycles or until total failure. Stress X-rays were taken after cyclic loading to evaluate screw loosening. RESULTS: Test group 1 showed a significant higher number of load cycles until failure for augmented screws compared to the control (4030 cycles, SD 827.8 vs. 1893.3 cycles, SD 1032.1; p < 0.001). Stress X-rays revealed significant less screw toggling for the augmented screws (5.2°, SD 5.4 vs. 16.1°, SD 5.9; p < 0.001). Test group 2 showed 3653.3 (SD 934) and 3723.3 (SD 560.6) load cycles until failure for in situ and cement first augmentation. Stress X-rays revealed a screw toggling of 5.1 (SD 1.9) and 6.6 (SD 4.6) degrees for in situ and cement first augmentation techniques (p > 0.05). CONCLUSION: Augmentation of pedicle screws in general significantly increased the number of load cycles and failure load comparing to the nonaugmented control group. For the augmentation technique (cement first, in situ augmented, percutaneously application) no effect could be exhibited on the failure of the pedicle screws. By the cranio-caudal cyclic loading failure of the pedicle screws occurred by screw cut through the superior endplate and the characteristic "windshield-wiper effect", typically observed in clinical practice, could be reproduced.


Assuntos
Fixação de Fratura/métodos , Teste de Materiais , Fraturas por Osteoporose/cirurgia , Parafusos Pediculares , Fraturas da Coluna Vertebral/cirurgia , Suporte de Carga , Idoso , Idoso de 80 Anos ou mais , Feminino , Fixação de Fratura/efeitos adversos , Humanos , Vértebras Lombares/lesões , Vértebras Lombares/cirurgia , Masculino , Falha de Prótese
20.
J Neurol Surg A Cent Eur Neurosurg ; 78(1): 46-52, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27123747

RESUMO

Background Integrity of intervertebral disks may influence, and be influenced by, the maintenance of hydrostatic pressures inside the nucleus pulposus. Disk degeneration causes decreased pressures, leading to overload and injury of the annulus fibrosus, increasing the risk of disk herniation. Diskectomies to treat disk herniation can cause further loss of hydrostatic pressures resulting in worsening degeneration. This study investigated the impact of opening the annulus on intradiscal pressure and whether implantation of an annular closure device (ACD) can restore physiologic pressures. Methods The pressure responses under unconstrained moments in concert with axial compressive loads of nine human cadaver lumbar disks were biomechanically tested at baseline, immediately following posterior annulotomy, and immediately following implantation of the ACD. Results The analysis of variance indicated a significant difference in the pressure response (p = 0.0001) among the three rounds of testing. Specifically, the post hoc Bonferroni test revealed that the pressure response after diskectomy was significantly different when compared with baseline (p < 0.001) and after ACD implantation (p = 0.001). However, baseline and ACD pressure responses were insignificantly different (p = 1.000). Conclusion Our findings suggest that restoration of annular integrity during diskectomy with implantation of the tested ACD may restore pressures closer to preoperative levels. Whether or not restoring pressures to preoperative levels has any clinical benefit or effect on the rate of degeneration is an area for further clinical research.


Assuntos
Discotomia , Deslocamento do Disco Intervertebral/fisiopatologia , Disco Intervertebral/fisiopatologia , Vértebras Lombares/fisiopatologia , Fenômenos Biomecânicos/fisiologia , Humanos , Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia
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