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1.
PLoS Med ; 21(8): e1004447, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39173109

RESUMEN

BACKGROUND: Degenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)-a list of key outcomes-and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further "how" these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research. METHODS AND FINDINGS: A minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery. CONCLUSIONS: The AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS.


Asunto(s)
Vértebras Cervicales , Consenso , Técnica Delphi , Enfermedades de la Médula Espinal , Humanos , Vértebras Cervicales/cirugía , Enfermedades de la Médula Espinal/cirugía , Evaluación de Resultado en la Atención de Salud/métodos , Resultado del Tratamiento , Proyectos de Investigación
2.
Ann Neurol ; 2023 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-37606612

RESUMEN

OBJECTIVE: A motor complete spinal cord injury (SCI) results in the loss of voluntary motor control below the point of injury. Some of these patients can regain partial motor function through inpatient rehabilitation; however, there is currently no biomarker to easily identify which patients have this potential. Evidence indicates that spasticity could be that marker. Patients with motor complete SCI who exhibit spasticity show preservation of descending motor pathways, the pathways necessary for motor signals to be carried from the brain to the target muscle. We hypothesized that the presence of spasticity predicts motor recovery after subacute motor complete SCI. METHODS: Spasticity (Modified Ashworth Scale and pendulum test) and descending connectivity (motor evoked potentials) were tested in the rectus femoris muscle in patients with subacute motor complete (n = 36) and motor incomplete (n = 30) SCI. Motor recovery was assessed by using the International Standards for Neurological Classification of Spinal Cord Injury and the American Spinal Injury Association Impairment Scale (AIS). All measurements were taken at admission and discharge from inpatient rehabilitation. RESULTS: We found that motor complete SCI patients with spasticity improved in motor scores and showed AIS conversion to either motor or sensory incomplete. Conversely, patients without spasticity showed no changes in motor scores and AIS conversion. In incomplete SCI patients, motor scores improved and AIS conversion occurred regardless of spasticity. INTERPRETATION: These findings suggest that spasticity represents an easy-to-use clinical outcome that might help to predict motor recovery after severe SCI. This knowledge can improve inpatient rehabilitation effectiveness for motor complete SCI patients. ANN NEUROL 2023.

3.
J Intensive Care Med ; 39(7): 683-692, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38282376

RESUMEN

Background: Published evidence indicates that mean arterial pressure (MAP) below a goal range (hypotension) is associated with worse outcomes, though MAP management failures are common. We sought to characterize hypotension occurrences in ICUs and consider the implications for MAP management. Methods: Retrospective analysis of 3 hospitals' cohorts of adult ICU patients during continuous vasopressor infusion. Two cohorts were general, mixed ICU patients and one was exclusively acute spinal cord injury patients. "Hypotension-clusters" were defined where there were ≥10 min of cumulative hypotension over a 60-min period and "constant hypotension" was ≥10 continuous minutes. Trend analysis was performed (predicting future MAP using 14 min of preceding MAP data) to understand which hypotension-clusters could likely have been predicted by clinician awareness of MAP trends. Results: In cohorts of 155, 66, and 16 ICU stays, respectively, the majority of hypotension occurred within the hypotension-clusters. Failures to keep MAP above the hypotension threshold were notable in the bottom quartiles of each cohort, with hypotension durations of 436, 167, and 468 min, respectively, occurring within hypotension-clusters per day. Mean arterial pressure trend analysis identified most hypotension-clusters before any constant hypotension occurred (81.2%-93.6% sensitivity, range). The positive predictive value of hypotension predictions ranged from 51.4% to 72.9%. Conclusions: Across 3 cohorts, most hypotension occurred in temporal clusters of hypotension that were usually predictable from extrapolation of MAP trends.


Asunto(s)
Presión Arterial , Hipotensión , Unidades de Cuidados Intensivos , Vasoconstrictores , Humanos , Vasoconstrictores/administración & dosificación , Vasoconstrictores/efectos adversos , Vasoconstrictores/uso terapéutico , Estudios Retrospectivos , Femenino , Persona de Mediana Edad , Masculino , Anciano , Presión Arterial/efectos de los fármacos , Adulto , Infusiones Intravenosas
4.
Eur Spine J ; 33(7): 2594-2603, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38802596

RESUMEN

PURPOSE: FDA investigational device exemption (IDE) studies are considered a gold standard of assessing safety and efficacy of novel devices through RCTs. The fragility index (FI) has emerged as a means to assess robustness of statistically significant study results and inversely, the reverse fragility index (RFI) for non-significant differences. Previous authors have defined results as fragile if loss to follow up is greater than the FI or RFI. The aim of this study was to assess the FI, RFI, and robustness of data supplied by IDE studies in spinal surgery. METHODS: This was a systematic review of the literature. Inclusion criteria included randomized controlled trials with dichotomous outcome measures conducted under IDE guidelines between 2000 and 2023. FI and RFI were calculated through successively changing events to non-events until the outcome changed to non-significance or significance, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ) were calculated by dividing the FI and RFI, respectively, by the sample size. RESULTS: Thirty-two studies met inclusion criteria with a total of 40 unique outcome measures; 240 outcomes were analyzed. Twenty-six studies reported 96 statistically significant results. The median FI was 6 (IQR: 3-9.25), and patients lost to follow up was greater than the FI in 99.0% (95/96) of results. The average FQ was 0.027. Thirty studies reported 144 statistically insignificant results and a median RFI of 6 (IQR: 4-8). The average RFQ extrapolated was 0.021, and loss to follow up was greater than the RFI in 98.6% (142/144) of results. CONCLUSIONS: IDE studies in spine surgery are surprisingly fragile given their reputations, large sample sizes, and intent to establish safety in investigational devices. This study found a median FI and RFI of 6. The number of patients lost to follow-up was greater than FIand RFI in 98.8% (237/240) of reported outcomes. FQ and RFQ tell us that changes of two to three patients per hundred can flip the significance of reported outcomes. This is an important reminder of the limitations of RCTs. Analysis of fragility in future studies may help clarify the strength of the relationship between reported data and their conclusions.


Asunto(s)
Fusión Vertebral , United States Food and Drug Administration , Humanos , Fusión Vertebral/métodos , Estados Unidos , Ensayos Clínicos Controlados Aleatorios como Asunto , Aprobación de Recursos/legislación & jurisprudencia
5.
BMC Med Res Methodol ; 23(1): 100, 2023 04 22.
Artículo en Inglés | MEDLINE | ID: mdl-37087419

RESUMEN

INTRODUCTION: AO Spine RECODE-DCM was a multi-stakeholder priority setting partnership (PSP) to define the top ten research priorities for degenerative cervical myelopathy (DCM). Priorities were generated and iteratively refined using a series of surveys administered to surgeons, other healthcare professionals (oHCP) and people with DCM (PwDCM). The aim of this work was to utilise word clouds to enable the perspectives of people with the condition to be heard earlier in the PSP process than is traditionally the case. The objective was to evaluate the added value of word clouds in the process of defining research uncertainties in National Institute for Health Research (NIHR) James Lind Alliance (JLA) Priority Setting Partnerships. METHODS: Patient-generated word clouds were created for the four survey subsections of the AO Spine RECODE-DCM PSP: diagnosis, treatment, long-term management and other issues. These were then evaluated as a nested methodological study. Word-clouds were created and iteratively refined by an online support group of people with DCM, before being curated by the RECODE-DCM management committee and expert healthcare professional representatives. The final word clouds were embedded within the surveys administered at random to 50% of participants. DCM research uncertainties suggested by participants were compared pre- and post-word cloud presentation. RESULTS: A total of 215 (50.9%) participants were randomised to the word cloud stream, including 118 (55%) spinal surgeons, 52 (24%) PwDCM and 45 (21%) oHCP. Participants submitted 434 additional uncertainties after word cloud review: word count was lower and more uniform across each survey subsections compared to pre-word cloud uncertainties. Twenty-three (32%) of the final 74 PSP summary questions did not have a post-word cloud contribution and no summary question was formed exclusively on post-word cloud uncertainties. There were differences in mapping of pre- and post-word cloud uncertainties to summary questions, with greater mapping of post-word cloud uncertainties to the number 1 research question priority: raising awareness. Five of the final summary questions were more likely to map to the research uncertainties suggested by participants after having reviewed the word clouds. CONCLUSIONS: Word clouds may increase the perspective of underrepresented stakeholders in the research question gathering stage of priority setting partnerships. This may help steer the process towards research questions that are of highest priority for people with the condition.


Asunto(s)
Investigación Biomédica , Prioridades en Salud , Humanos , Incertidumbre , Personal de Salud , Encuestas y Cuestionarios
6.
Mol Cell Proteomics ; 20: 100096, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34129941

RESUMEN

Despite the emergence of promising therapeutic approaches in preclinical studies, the failure of large-scale clinical trials leaves clinicians without effective treatments for acute spinal cord injury (SCI). These trials are hindered by their reliance on detailed neurological examinations to establish outcomes, which inflate the time and resources required for completion. Moreover, therapeutic development takes place in animal models whose relevance to human injury remains unclear. Here, we address these challenges through targeted proteomic analyses of cerebrospinal fluid and serum samples from 111 patients with acute SCI and, in parallel, a large animal (porcine) model of SCI. We develop protein biomarkers of injury severity and recovery, including a prognostic model of neurological improvement at 6 months with an area under the receiver operating characteristic curve of 0.91, and validate these in an independent cohort. Through cross-species proteomic analyses, we dissect evolutionarily conserved and divergent aspects of the SCI response and establish the cerebrospinal fluid abundance of glial fibrillary acidic protein as a biochemical outcome measure in both humans and pigs. Our work opens up new avenues to catalyze translation by facilitating the evaluation of novel SCI therapies, while also providing a resource from which to direct future preclinical efforts.


Asunto(s)
Proteína Ácida Fibrilar de la Glía/sangre , Proteína Ácida Fibrilar de la Glía/líquido cefalorraquídeo , Traumatismos de la Médula Espinal/sangre , Traumatismos de la Médula Espinal/líquido cefalorraquídeo , Animales , Femenino , Humanos , Proteómica , Médula Espinal/patología , Traumatismos de la Médula Espinal/patología , Porcinos
7.
Eur Spine J ; 32(3): 824-830, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36708396

RESUMEN

BACKGROUND: Longer hospital length of stay (LOS) has been associated with worse outcomes and increased resource utilization. However, diagnostic and patient-level factors associated with LOS have not been well studied on a large scale. The goal was to identify patient, surgical and organizational factors associated with longer patient LOS for adult patients at a high-volume quaternary spinal care center. METHODS: We performed a retrospective analysis of 13,493 admissions from January 2006 to December 2019. Factors analyzed included age, sex, admission status (emergent vs scheduled), ASIA grade, operative vs non-operative management, mean blood loss, operative time, and adverse events. Specific adverse events included surgical site infection (SSI), other infection (systemic or UTI), neuropathic pain, delirium, dural tear, pneumonia, and dysphagia. Diagnostic categories included trauma, oncology, deformity, degenerative, and "other". A multivariable linear regression model was fit to log-transformed LOS to determine independent factors associated with patient LOS, with effects expressed as multipliers on mean LOS. RESULTS: Mean LOS for the population (SD) was 15.8 (34.0) days. Factors significantly (p < 0.05) associated with longer LOS were advanced patient age [multiplier on mean LOS 1.011/year (95% CI: 1.007-1.015)], emergency admission [multiplier on mean LOS 1.615 (95% CI: 1.337-1.951)], ASIA grade [multiplier on mean LOS 1.125/grade (95% CI: 1.051-1.205)], operative management [multiplier on mean LOS 1.211 (95% CI: 1.006-1.459)], and the occurrence of one or more AEs [multiplier on mean LOS 2.613 (95% CI: 2.188-3.121)]. Significant AEs included postoperative SSI [multiplier on mean LOS 1.749 (95% CI: 1.250-2.449)], other infections (systemic infections and UTI combined) [multiplier on mean LOS 1.650 (95% CI: 1.359-2.004)], delirium [multiplier on mean LOS 1.404 (95% CI: 1.103-1.787)], and pneumonia [multiplier on mean LOS 1.883 (95% CI: 1.447-2.451)]. Among the diagnostic categories explored, degenerative patients experienced significantly shorter LOS [multiplier on mean LOS 0.672 (95%CI: 0.535-0.844), p < 0.001] compared to non-degenerative categories. CONCLUSION: This large-scale study taking into account diagnostic categories identified several factors associated with patient LOS. Future interventions should target modifiable factors to minimize LOS and guide hospital resource allocation thereby improving patient outcomes and quality of care and decreasing healthcare-associated costs.


Asunto(s)
Delirio , Columna Vertebral , Humanos , Adulto , Tiempo de Internación , Estudios Retrospectivos , Columna Vertebral/cirugía , Infección de la Herida Quirúrgica
8.
Eur Spine J ; 32(8): 2637-2646, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37079079

RESUMEN

PURPOSE: Current literature suggests that biportal spinal endoscopy is safe and effective in treating lumbar spine pathology such as lumbar disc herniation, lumbar stenosis, and degenerative spondylolisthesis. No prior study has investigated the postoperative outcomes or complication profile of the technique as a whole. This study serves as the first comprehensive systematic review and meta-analysis of biportal spinal endoscopy in the lumbar spine. METHODS: A PubMed literature search provided over 100 studies. 42 papers were reviewed and 3673 cases were identified with average follow-up time of 12.5 months. Preoperative diagnoses consisted of acute disc herniation (1098), lumbar stenosis (2432), and degenerative spondylolisthesis (229). Demographics, operative details, complications, and perioperative outcome and satisfaction scores were analyzed. RESULTS: Average age was 61.32 years, 48% male. 2402 decompressions, 1056 discectomies, and 261 transforaminal lumbar Interbody fusions (TLIFs) were performed. Surgery was performed on 4376 lumbar levels, with L4-5 being most common(61.3%). 290 total complications occurred, 2.23% durotomies, 1.29% inadequate decompressions, 3.79% epidural hematomas, and < 1% transient nerve root injuries, infections, and iatrogenic instability. Significant improvement in VAS-Back, VAS-Leg, ODI, and Macnab Scores were seen across the cohort. CONCLUSION: Biportal spinal endoscopy is a novel method to address pathology in the lumbar spine with direct visualization through an endoscopic approach. Complications are comparable to previously published rates. Clinical outcomes demonstrate effectiveness. Prospective studies are required to assess the efficacy of the technique as compared to traditional techniques. This study demonstrates that the technique can be successful in the lumbar spine.


Asunto(s)
Desplazamiento del Disco Intervertebral , Fusión Vertebral , Estenosis Espinal , Espondilolistesis , Humanos , Masculino , Persona de Mediana Edad , Femenino , Desplazamiento del Disco Intervertebral/cirugía , Espondilolistesis/cirugía , Constricción Patológica , Estenosis Espinal/cirugía , Endoscopía/efectos adversos , Endoscopía/métodos , Vértebras Lumbares/cirugía , Fusión Vertebral/efectos adversos , Fusión Vertebral/métodos , Resultado del Tratamiento , Estudios Retrospectivos
9.
Can J Surg ; 66(6): E550-E560, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37967971

RESUMEN

BACKGROUND: Current measures to prevent spinal surgical site infection (SSI) lack compliance and lead to antimicrobial resistance. We aimed to examine the effectiveness of bundled preoperative intranasal photodynamic disinfection therapy (nPDT) and chlorhexidine gluconate (CHG) body wipes in the prophylaxis of spine SSIs in adults, as well as determine our institutional savings attributable to the use of this strategy and identify adverse events reported with nPDT-CHG. METHODS: We performed a 14-year prospective observational interrupted time-series study in adult (age > 18 yr) patients undergoing emergent or elective spine surgery with 3 time-specific cohorts: before rollout of our institution's nPDT-CHG program (2006-2010), during rollout (2011-2014) and after rollout (2015-2019). We used unadjusted bivariate analysis to test for temporal changes across patient and surgical variables, and segmented regression to estimate the effect of nPDT-CHG on the annual SSI incidence rates per period. We used 2 models to estimate the cost of nPDT-CHG to prevent 1 additional SSI per year and the annual cumulative cost savings through SSI prevention. RESULTS: Over the study period, 13 493 patients (mean 964 per year) underwent elective or emergent spine surgery. From 2006 to 2019, the mean age, mean Charlson Comorbidity Index (CCI) score and mean Spine Surgical Invasiveness Index (SSII) score increased from 48.4 to 58.1 years, from 1.7 to 2.6, and from 15.4 to 20.5, respectively (p < 0.001). Unadjusted analysis confirmed a significant decrease in the annual number (74.6 to 26.8) and incidence (7.98% to 2.67%) of SSIs with nPDT-CHG (p < 0.001). After adjustment for mean age, mean CCI score and mean SSII score, segmented regression showed an absolute reduction in the annual SSI incidence rate of 3.36% per year (p < 0.001). The estimated annual cost to prevent 1 additional SSI per year was about $1350-$1650, and the estimated annual cumulative cost savings were $2 484 856-$2 495 016. No adverse events were reported with nPDT-CHG. CONCLUSION: Preoperative nPDT-CHG administration is an effective prophylactic strategy for spinal SSIs, with significant cost savings. Given its rapid action, minimal risk of antimicrobial resistance, broad-spectrum activity and high compliance rate, preoperative nPDT-CHG decolonization should be the standard of care for all patients undergoing emergent or elective spine surgery.


Asunto(s)
Antiinfecciosos , Desinfección , Humanos , Adulto , Persona de Mediana Edad , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/prevención & control , Infección de la Herida Quirúrgica/etiología , Clorhexidina/uso terapéutico
10.
Can J Surg ; 66(3): E274-E281, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37169386

RESUMEN

BACKGROUND: Surgery for degenerative spine pathologies is typically performed on a scheduled basis; however, worsening symptoms may warrant emergency surgery. An increasing number of patients requiring emergency surgery has been observed (22.6% in 2006 to 34.8% in 2019). We sought to compare the outcomes of patients who received scheduled surgery and those who required emergency surgery. METHODS: All patients treated between Jan. 1, 2006, and Dec. 31, 2019, were included. Retrospective comparisons were made between patients who were scheduled (elective) for surgery and those requiring emergency surgery, patients who were scheduled for surgery and those who decompensated while on the surgical waitlist and patients who presented as de novo emergencies and those who decompensated while on the surgical waitlist. RESULTS: Among the 6217 patients with degenerative pathologies, 4654 (74.9%) patients were scheduled (elective) for surgery and 1563 (25.1%) were patients requiring emergency surgery. Compared with patients who were scheduled, patients requiring emergency surgery had a longer length of stay (LOS) in hospital (5.1 d, interquartile range [IQR] 2.7-11.2 v. 3.6 d, IQR 1.3-6.4, p < 0.001) and lower rate of home discharge (78.6% v. 94.2%, p < 0.001). Patients requiring emergency surgery were 1.34 times more likely to have any adverse events (95% confidence interval [CI] 1.06-1.68, p = 0.01). When compared with patients who were scheduled for surgery, those who decompensated while on the surgical waitlist had longer LOS (7.0 d, IQR 3.3-15.0 v. 3.6 d, IQR 1.3-6.4, p < 0.001), less home discharge (77.6% v. 94.2%, p < 0.001) and were 2.5 times more likely to have any adverse events (95% CI 1.5-4.1, p < 0.001). Patients who decompensated had a 2.1 times higher risk of having any adverse events than patients who presented as de novo emergencies (95% CI 1.2-3.6, p < 0.001). CONCLUSION: We observed worse perioperative outcomes for patients requiring emergency surgery for degenerative spinal conditions than for patients who were scheduled for surgery. Patients who decompensated while on the surgical waitlist had the worst outcomes.


Asunto(s)
Urgencias Médicas , Enfermedades de la Columna Vertebral , Humanos , Estudios Retrospectivos , Procedimientos Quirúrgicos Electivos , Atención a la Salud , Tiempo de Internación , Complicaciones Posoperatorias
11.
J Physiol ; 600(22): 4779-4806, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36121759

RESUMEN

The assessment of left ventricular (LV) contractility in animal models is useful in various experimental paradigms, yet obtaining such measures is inherently challenging and surgically invasive. In a cross-species study using small and large animals, we comprehensively tested the agreement and validity of multiple single-beat surrogate metrics of LV contractility against the field-standard metrics derived from inferior vena cava occlusion (IVCO). Fifty-six rats, 27 minipigs and 11 conscious dogs underwent LV and arterial catheterization and were assessed for a range of single-beat metrics of LV contractility. All single-beat metrics were tested for the various underlying assumptions required to be considered a valid metric of cardiac contractility, including load-independency, sensitivity to inotropic stimulation, and ability to diagnose contractile dysfunction in cardiac disease. Of all examined single-beat metrics, only LV maximal pressure normalized to end-diastolic volume (EDV), end-systolic pressure normalized to EDV, and the maximal rate of rise of the LV pressure normalized to EDV showed a moderate-to-excellent agreement with their IVCO-derived reference measure and met all the underlying assumptions required to be considered as a valid cardiac contractile metric in both rodents and large-animal models. Our findings demonstrate that single-beat metrics can be used as a valid, reliable method to quantify cardiac contractile function in basic/preclinical experiments utilizing small- and large-animal models KEY POINTS: Validating and comparing indices of cardiac contractility that avoid caval occlusion would offer considerable advantages for the field of cardiovascular physiology. We comprehensively test the underlying assumptions of multiple single-beat indices of cardiac contractility in rodents and translate these findings to pigs and conscious dogs. We show that when performing caval occlusion is unfeasible, single-beat metrics can be utilized to accurately quantify cardiac inotropic function in basic and preclinical research employing various small and large animal species. We report that maximal left-ventricular (LV)-pressure normalized to end-diastolic volume (EDV), LV end-systolic pressure normalized to EDV and the maximal rate of rise of the LV pressure waveform normalized to EDV are the best three single-beat metrics to measure cardiac inotropic function in both small- and large-animal models.


Asunto(s)
Benchmarking , Función Ventricular Izquierda , Animales , Perros , Ratas , Porcinos , Función Ventricular Izquierda/fisiología , Porcinos Enanos , Contracción Miocárdica/fisiología , Ventrículos Cardíacos , Volumen Sistólico/fisiología
12.
Eur Spine J ; 31(9): 2188-2195, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35552530

RESUMEN

PURPOSE: Single position surgery has demonstrated to reduce hospital length of stay, operative times, blood loss, postoperative pain, ileus, and complications. ALIF and LLIF surgeries offer advantages of placing large interbody devices under direct compression and can be performed by a minimally invasive approach in the lateral position. Furthermore, simultaneous access to the anterior and posterior column is possible in the lateral position without the need for patient repositioning. The purpose of this study is to outline the anatomical and technical considerations for performing anterior lumbar interbody fusion (ALIF) in the lateral decubitus position. METHODS: Surgical technique and technical considerations for reconstruction of the anterior column in the lateral position by ALIF at the L4-5 and L5-S1 levels. RESULTS: Topics outlined in this review include: Operating room layout and patient positioning; surgical anatomy and approach; vessel mobilization and retractor placement for L4-5 and L5-S1 lateral ALIF exposure, in addition to comparative technique of disc space preparation, trialing and implant placement compared to the supine ALIF procedure. CONCLUSIONS: Anterior exposure performed in the lateral decubitus position allows safe-, minimally invasive access and implant placement in ALIF. The approach requires less peritoneal and vessel retraction than in a supine position, in addition to allowing simultaneous access to the anterior and posterior columns when performing 360° Anterior-Posterior fusion.


Asunto(s)
Vértebras Lumbares , Fusión Vertebral , Humanos , Vértebras Lumbares/cirugía , Región Lumbosacra , Dolor Postoperatorio , Fusión Vertebral/métodos
13.
Eur Spine J ; 31(9): 2175-2187, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35235051

RESUMEN

PURPOSE: Circumferential (AP) lumbar fusion surgery is an effective treatment for degenerative and deformity conditions of the spine. The lateral decubitus position allows for simultaneous access to the anterior and posterior aspects of the spine, enabling instrumentation of both columns without the need for patient repositioning. This paper seeks to outline the anatomical and patient-related considerations in anterior column reconstruction of the lumbar spine from L1-S1 in the lateral decubitus position. METHODS: We detail the anatomic considerations of the lateral ALIF, transpsoas, and anterior-to-psoas surgical approaches from surgeon experience and comprehensive literature review. RESULTS: Single-position AP surgery allows simultaneous access to the anterior and posterior column and may combine ALIF, LLIF, and minimally invasive posterior instrumentation techniques from L1-S1 without patient repositioning. Careful history, physical examination, and imaging review optimize safety and efficacy of lateral ALIF or LLIF surgery. An excellent understanding of patient spinal and abdominal anatomy is necessary. Each approach has relative advantages and disadvantages according to the disc level, skeletal, vascular, and psoas anatomy. CONCLUSIONS: A development of a framework to analyze these factors will result in improved patient outcomes and a reduction in complications for lateral ALIF, transpsoas, and anterior-to-psoas surgeries.


Asunto(s)
Procedimientos de Cirugía Plástica , Fusión Vertebral , Humanos , Vértebras Lumbares/anatomía & histología , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Región Lumbosacra/cirugía , Fusión Vertebral/métodos , Resultado del Tratamiento
14.
Eur Spine J ; 31(9): 2167-2174, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35913621

RESUMEN

PURPOSE: To provide definitions and a conceptual framework for single position surgery (SPS) applied to circumferential fusion of the lumbar spine. METHODS: Narrative literature review and experts' opinion. RESULTS: Two major limitations of lateral lumbar interbody fusion (LLIF) have been (a) a perceived need to reposition the patient to the prone position for posterior fixation, and (b) the lack of a robust solution for fusion at the L5/S1 level. Recently, two strategies for performing single-position circumferential lumbar spinal fusion have been described. The combination of anterior lumbar interbody fusion (ALIF) in the lateral decubitus position (LALIF), LLIF and percutaneous pedicle screw fixation (pPSF) in the lateral decubitus position is known as lateral single-position surgery (LSPS). Prone LLIF (PLLIF) involves transpsoas LLIF done in the prone position that is more familiar for surgeons to then implant pedicle screw fixation. This can be referred to as prone single-position surgery (PSPS). In this review, we describe the evolution of and rationale for single-position spinal surgery. Pertinent studies validating LSPS and PSPS are reviewed and future questions regarding the future of these techniques are posed. Lastly, we present an algorithm for single-position surgery that describes the utility of LALIF, LLIF and PLLIF in the treatment of patients requiring AP lumbar fusions. CONCLUSIONS: Single position surgery in circumferential fusion of the lumbar spine includes posterior fixation in association with any of the following: lateral position LLIF, prone position LLIF, lateral position ALIF, and their combination (lateral position LLIF+ALIF). Preliminary studies have validated these methods.


Asunto(s)
Tornillos Pediculares , Fusión Vertebral , Humanos , Vértebras Lumbares/cirugía , Región Lumbosacra/cirugía , Posicionamiento del Paciente , Fusión Vertebral/métodos
15.
Eur Spine J ; 31(9): 2227-2238, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35551483

RESUMEN

PURPOSE: This study compares perioperative and 1-year outcomes of lateral decubitus single position circumferential fusion (L-SPS) versus minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) for degenerative pathologies. METHODS: Multicenter retrospective chart review of patients undergoing AP fusion with L-SPS or MIS TLIF. Demographics and clinical and radiographic outcomes were compared using independent samples t tests and chi-squared analyses with significance set at p < 0.05. RESULTS: A total of 445 patients were included: 353 L-SPS, 92 MIS TLIF. The L-SPS cohort was significantly older with fewer diabetics and more levels fused. The L-SPS cohort had significantly shorter operative time, blood loss, radiation dosage, and length of stay compared to MIS TLIF. 1-year follow-up showed that the L-SPS cohort had higher rates of fusion (97.87% vs. 81.11%; p = 0.006) and lower rates of subsidence (6.38% vs. 38.46%; p < 0.001) compared with MIS TLIF. There were significantly fewer returns to the OR within 1 year for early mechanical failures with L-SPS (0.0% vs. 5.4%; p < 0.001). 1-year radiographic outcomes revealed that the L-SPS cohort had a greater LL (56.6 ± 12.5 vs. 51.1 ± 15.9; p = 0.004), smaller PI-LL mismatch (0.2 ± 13.0 vs. 5.5 ± 10.5; p = 0.004). There were no significant differences in amount of change in VAS scores between cohorts. Similar results were seen after propensity-matched analysis and sub-analysis of cases including L5-S1. CONCLUSIONS: L-SPS improves perioperative outcomes and does not compromise clinical or radiographic results at 1-year follow-up compared with MIS TLIF. There may be decreased rates of early mechanical failure with L-SPS.


Asunto(s)
Fusión Vertebral , Estudios de Seguimiento , Humanos , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Estudios Retrospectivos , Fusión Vertebral/métodos , Resultado del Tratamiento
16.
Spinal Cord ; 60(5): 470-475, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35418625

RESUMEN

STUDY DESIGN: Observational study. OBJECTIVES: To examine the feasibility of meeting the current clinical guidelines for the hemodynamic management of acute spinal cord injury (SCI) which recommend maintaining mean arterial pressure (MAP) at 85-90 mmHg in the days following injury. METHODS: This study examined data collected minute-by-minute to describe the pressure profile in the first 5 days following SCI in 16 patients admitted to the Intensive Care Unit at Vancouver General Hospital (40 ± 19 years, 13 M/3 F, C4-T11). MAP and intrathecal pressure (ITP) were monitored at 100 Hz by arterial and lumbar intrathecal catheters, respectively, and reported as the average of each minute. Spinal cord perfusion pressure was calculated as the difference between MAP and ITP. The minute-to-minute difference (MMdiff) of each pressure variable was calculated as the absolute difference between consecutive minutes. RESULTS: Only 24 ± 7% of MAP recordings were between 85 and 90 mmHg. Average MAP MMdiff was ~3 mmHg. The percentage of MAP recordings within target range was negatively correlated with the degree of variability (i.e. MMdiff; r = -0.64, p < 0.008) whereas higher mean MAP was correlated with greater variability (r = 0.57, p = 0.021). CONCLUSIONS: Our findings point to the 'real life' challenges in maintaining MAP in acute SCI patients. Given MAP fluctuated ~3 mmHg minute-to-minute, maintaining MAP within a 5 mmHg range with conventional volume replacement and vasopressors presents an almost impossible task for clinicians and warrants reconsideration of current management guidelines.


Asunto(s)
Traumatismos de la Médula Espinal , Presión Arterial , Hemodinámica , Humanos , Médula Espinal , Traumatismos de la Médula Espinal/tratamiento farmacológico , Vasoconstrictores/uso terapéutico
17.
BMC Genomics ; 22(1): 775, 2021 Oct 30.
Artículo en Inglés | MEDLINE | ID: mdl-34717545

RESUMEN

BACKGROUND: The gut microbiome is a diverse network of bacteria which inhabit our digestive tract and is crucial for efficient cellular metabolism, nutrient absorption, and immune system development. Spinal cord injury (SCI) disrupts autonomic function below the level of injury and can alter the composition of the gut microbiome. Studies in rodent models have shown that SCI-induced bacterial imbalances in the gut can exacerbate the spinal cord damage and impair recovery. In this study we, for the first time, characterized the composition of the gut microbiome in a Yucatan minipig SCI model. We compared the relative abundance of the most dominant bacterial phyla in control samples to those collected from animals who underwent a contusion-compression SCI at the 2nd or 10th Thoracic level. RESULTS: We identify specific bacterial fluctuations that are unique to SCI animals, which were not found in uninjured animals given the same dietary regimen or antibiotic administration. Further, we identified a specific time-frame, "SCI-acute stage", during which many of these bacterial fluctuations occur before returning to "baseline" levels. CONCLUSION: This work presents a dynamic view of the microbiome changes that accompany SCI, establishes a resource for future studies and to understand the changes that occur to gut microbiota after spinal cord injury and may point to a potential therapeutic target for future treatment.


Asunto(s)
Microbioma Gastrointestinal , Traumatismos de la Médula Espinal , Animales , Bacterias , Médula Espinal , Porcinos , Porcinos Enanos
18.
Spinal Cord ; 59(8): 865-873, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34083745

RESUMEN

STUDY DESIGN: Qualitative study. OBJECTIVES: The purpose of this study is to understand the patient perspective after diagnosis of an acute traumatic spinal cord injury (tSCI). Discussing the diagnosis and prognosis of a tSCI with a patient can be a challenging experience for both the patient and the physician. As such, this paper attempts to better understand the patient experience to improve communication when discussing this life-altering injury. SETTING: Vancouver General Hospital, Vancouver, British Columbia, Canada. METHODS: This study is a qualitative study utilizing grounded theory and semi-structured interviews. The interview transcripts were manually coded using manifest and latent content analysis. Major and minor codes were identified and discussed. RESULTS: In total, 17 interviews were conducted, fifteen individuals with tSCI who received acute care at Vancouver General Hospital (VGH) and eleven family members were interviewed. Patient participants were interviewed individually or in a paired interview with a participating family member. Patient participants had varying spinal cord injuries from AIS A-D. Two major themes were identified from the interviews. The first major theme was physician demeanor (general approach and attitude towards patients) and the second major theme was delivery of information (content, timing, and source). CONCLUSIONS: This study summarizes the preferences of patients who sustained a tSCI discussions regarding their diagnosis and prognosis in the acute care setting. The goal of this study is to help guide physician interactions at this difficult and vulnerable time for patients with hopes to improve patient care through effective communication.


Asunto(s)
Traumatismos de la Médula Espinal , Canadá , Comunicación , Humanos , Pronóstico , Investigación Cualitativa , Traumatismos de la Médula Espinal/diagnóstico
19.
J Physiol ; 598(5): 929-942, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31876952

RESUMEN

KEY POINTS: We have developed a novel porcine model of high-thoracic midline contusion spinal cord injury (SCI) at the T2 spinal level. We describe this model and the ensuing cardiovascular and neurohormonal responses, and demonstrate the model is efficacious for studying clinically relevant cardiovascular dysfunction post-SCI. We demonstrate that the high-thoracic SCI model, but not a low-thoracic SCI model, induces persistent hypotension along with a gradual reduction in plasma noradrenaline and increases in plasma aldosterone and angiotensin II. We additionally conducted a proof-of-concept long-term (12 weeks) survival study in animals with T2 contusion SCI demonstrating the potential utility of this model for not only acute experimentation but also long-term drug studies prior to translation to the clinic. ABSTRACT: Cardiovascular disease is a leading cause of morbidity and mortality in the spinal cord injury (SCI) population, especially in those with high-thoracic or cervical SCI. With this in mind, we aimed to develop a large animal (porcine) model of high-thoracic (T2 level) contusion SCI and compare the haemodynamic and neurohormonal responses of this injury against a low-thoracic (T10 level) model. Ten Yorkshire pigs were randomly subjected to 20 cm weight drop contusion SCI at either the T2 or the T10 spinal level. Systolic blood pressure (SBP), mean arterial pressure (MAP) and heart rate (HR) were continuously monitored until 4 h post-SCI. Plasma noradrenaline (NA), aldosterone and angiotensin II (ANGII) were measured pre-SCI and at 30, 60, 120 and 240 min post-SCI. Additionally, two Yucatan pigs were subjected to T2-SCI and survived up to 12 weeks post-injury to demonstrate the efficacy of this model for long-term survival studies. Immediately after T2-SCI, SBP, MAP and HR increased (P < 0.0001). Between decompression (5 min post-SCI) and 30 min post-decompression in T2-SCI, SBP and MAP were lower than pre-SCI (P < 0.038). At 3 and 4 h after T2-SCI, SBP remained lower than pre-SCI (P = 0.048). After T10-SCI, haemodynamic indices remained largely unaffected. Plasma NA was lower in T2- vs. T10-SCI post-SCI, whilst aldosterone and ANGII were higher. Both chronically injured pigs demonstrated a vast reduction in SBP at 12 weeks post-SCI. Our model of T2-SCI causes a rapid and sustained alteration in neurohormonal control and cardiovascular function, which does not occur in the T10 model.


Asunto(s)
Sistema Cardiovascular , Traumatismos de la Médula Espinal , Animales , Presión Sanguínea , Modelos Animales de Enfermedad , Hemodinámica , Médula Espinal , Porcinos
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