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1.
Obes Surg ; 34(6): 2237-2247, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38703242

RESUMO

Sleeve gastrectomy (SG) is the most frequently performed bariatric procedure worldwide. The incidence and consequences of sleeve migration (SM) are not clearly understood. There is no clear consensus on appropriate measures to reduce the risk of SM. This study systematically reviewed the literature and identified 405 cases of SM from 21 studies. Age ranged from 18 to 68 years. Thirty-two percent and 11% of patients were females and males respectively, while sex was not reported in 57%. Time to diagnosis ranged from 1 day to 5 years postoperatively. A total of 9.6% and 58.8% of patients had or had no previous hiatal hernia respectively. SM incidence, risk factors, proposed mechanisms, clinical presentation, diagnosis, management, and potential preventive strategies are described in this review.


Assuntos
Gastrectomia , Obesidade Mórbida , Humanos , Gastrectomia/efeitos adversos , Obesidade Mórbida/cirurgia , Feminino , Masculino , Adulto , Fatores de Risco , Pessoa de Meia-Idade , Incidência , Migração de Corpo Estranho/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Cirurgia Bariátrica/efeitos adversos , Idoso , Hérnia Hiatal/cirurgia , Adolescente
3.
Adv Radiat Oncol ; 9(5): 101452, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38590715

RESUMO

Purpose: An effective didactic curriculum is a cornerstone for a successful residency program, as it is the basis upon which residents acquire the necessary knowledge and perspective to provide high-quality, evidence-based care. Here we describe our success in creating a standardized curriculum in clinical radiation oncology - one that was well-received and led to significantly improved performance on the national in-service examination. Methods and Materials: One-hundred and fifty topics were outlined in accordance with the American Board of Radiology; to accommodate this breadth of material, didactic frequency was increased from biweekly to daily. As a clinical correlate to these sessions, a teaching library of over 100 real-world cases was compiled for individual learning. Finally, comprehensive dosimetric constraints were compiled to aid residents in radiation therapy plan evaluation. To evaluate these curricular changes, anonymous questionnaires were provided to all residents and faculty, and de-identified resident clinical performance from the annual in-service examination was analyzed. Results: Before the introduction of the standardized curriculum, the mean clinical percentage on the in-service examination was 46%, equivalent to the 17th percentile. Within 2 years of implementation of the new curriculum, both the mean percentage and percentile were significantly improved, with the mean percentage correct at 69.3% and the mean percentile at the 59th percentile (P < .001 and P = .034, respectively). Feedback showed the curriculum to be well-received and used frequently outside of standard didactic hours. Conclusions: This is the first report of the creation of a standardized curriculum and outcomes in radiation oncology. Although there are certainly developmental challenges, addressing these barriers creates an education model that effectively imparts knowledge, fosters multidisciplinary thinking, and prepares residents for the diverse challenges of clinical practice. We present our institutional experience with the intent of publishing this curriculum on a national platform in the coming years.

4.
Neurosurgery ; 2024 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-38456683

RESUMO

BACKGROUND AND OBJECTIVES: Recent evidence suggests earlier tracheostomy is associated with fewer complications in patients with complete cervical spinal cord injury (SCI). This study aims to evaluate the influence of spine surgical approach on the association between tracheostomy timing and in-hospital adverse events treating patients with complete cervical SCI. METHODS: This retrospective cohort study was performed using Trauma Quality Improvement Program data from 2017 to 2020. All patients with acute complete (American Spinal Injury Association-A) cervical SCI who underwent tracheostomy and spine surgery were included. Tracheostomy timing was dichotomized to early (within 1 week after surgery) and delayed (more than 1 week after surgery). Primary outcome was the occurrence of major in-hospital complications. Secondary outcomes included occurrences of immobility-related complications, surgical-site infection, hospital and intensive care unit length of stay, and time on mechanical ventilation. RESULTS: The study included 1592 patients across 358 trauma centers. Mean time to tracheostomy from surgery was 8.6 days. A total of 495 patients underwent anterior approach, 670 underwent posterior approach, and 427 underwent combined anterior and posterior approach. Patients who underwent anterior approach were significantly more likely to have delayed tracheostomy compared with posterior approach (53% vs 40%, P < .001). Early tracheotomy significantly reduced major in-hospital complications (odds ratio 0.67, 95% CI 0.53-0.84) and immobility complications (odds ratio = 0.78, 95% CI 0.6-1.0). Those undergoing early tracheostomy spent 6.0 (95% CI -8.47 to -3.43) fewer days in hospital, 5.7 (95% CI -7.8 to -3.7) fewer days in the intensive care unit, and 5.9 (95% CI -8.2 to -3.7) fewer days ventilated. Surgical approach had no significant negative effect on the association between tracheostomy timing and the outcomes of interest. CONCLUSION: Earlier tracheostomy for patients with cervical SCI is associated with reduced complications, length of stay, and ventilation time. This relationship appears independent of the surgical approach. These findings emphasize that tracheostomy need not be delayed because of the SCI treatment approach.

6.
JAMA Surg ; 159(5): 493-499, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38446451

RESUMO

Importance: Although robotic surgery has become an established approach for a wide range of elective operations, data on its utility and outcomes are limited in the setting of emergency general surgery. Objectives: To describe temporal trends in the use of laparoscopic and robotic approaches and compare outcomes between robotic and laparoscopic surgery for 4 common emergent surgical procedures. Design, Setting, and Participants: A retrospective cohort study of an all-payer discharge database of 829 US facilities was conducted from calendar years 2013 to 2021. Data analysis was performed from July 2022 to November 2023. A total of 1 067 263 emergent or urgent cholecystectomies (n = 793 800), colectomies (n = 89 098), inguinal hernia repairs (n = 65 039), and ventral hernia repairs (n = 119 326) in patients aged 18 years or older were included. Exposure: Surgical approach (robotic, laparoscopic, or open) to emergent or urgent cholecystectomy, colectomy, inguinal hernia repair, or ventral hernia repair. Main Outcomes and Measures: The primary outcome was the temporal trend in use of each operative approach (laparoscopic, robotic, or open). Secondary outcomes included conversion to open surgery and length of stay (both total and postoperative). Temporal trends were measured using linear regression. Propensity score matching was used to compare secondary outcomes between robotic and laparoscopic surgery groups. Results: During the study period, the use of robotic surgery increased significantly year-over-year for all procedures: 0.7% for cholecystectomy, 0.9% for colectomy, 1.9% for inguinal hernia repair, and 1.1% for ventral hernia repair. There was a corresponding decrease in the open surgical approach for all cases. Compared with laparoscopy, robotic surgery was associated with a significantly lower risk of conversion to open surgery: cholecystectomy, 1.7% vs 3.0% (odds ratio [OR], 0.55 [95% CI, 0.49-0.62]); colectomy, 11.2% vs 25.5% (OR, 0.37 [95% CI, 0.32-0.42]); inguinal hernia repair, 2.4% vs 10.7% (OR, 0.21 [95% CI, 0.16-0.26]); and ventral hernia repair, 3.5% vs 10.9% (OR, 0.30 [95% CI, 0.25-0.36]). Robotic surgery was associated with shorter postoperative lengths of stay for colectomy (-0.48 [95% CI, -0.60 to -0.35] days), inguinal hernia repair (-0.20 [95% CI, -0.30 to -0.10] days), and ventral hernia repair (-0.16 [95% CI, -0.26 to -0.06] days). Conclusions and Relevance: While robotic surgery is still not broadly used for emergency general surgery, the findings of this study suggest it is becoming more prevalent and may be associated with better outcomes as measured by reduced conversion to open surgery and decreased length of stay.


Assuntos
Herniorrafia , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Humanos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Feminino , Masculino , Estudos Retrospectivos , Pessoa de Meia-Idade , Herniorrafia/métodos , Adulto , Emergências , Idoso , Colectomia/métodos , Hérnia Inguinal/cirurgia , Tempo de Internação/estatística & dados numéricos , Colecistectomia/métodos , Colecistectomia/estatística & dados numéricos , Hérnia Ventral/cirurgia , Estados Unidos , Conversão para Cirurgia Aberta/estatística & dados numéricos , Procedimentos Cirúrgicos Minimamente Invasivos , Cirurgia de Cuidados Críticos
7.
Trauma Surg Acute Care Open ; 9(1): e001320, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38390469

RESUMO

Clinical research has evolved significantly over the last few decades to include many advanced and alternative study designs to answer unique questions. Recognizing a potential knowledge gap, the AAST Associate Member Council and Educational Development Committee created a research course at the 2022 Annual Meeting in Chicago to introduce junior researchers to these methodologies. This manuscript presents a summary of this AAST Annual Meeting session, and reviews topics including hierarchical modeling, geospatial analysis, patient-centered outcomes research, mixed methods designs, and negotiating complex issues in multicenter trials.

8.
J Biomed Mater Res A ; 112(6): 931-940, 2024 06.
Artigo em Inglês | MEDLINE | ID: mdl-38230545

RESUMO

Tumor hypoxia, resulting from rapid tumor growth and aberrant vascular proliferation, exacerbates tumor aggressiveness and resistance to treatments like radiation and chemotherapy. To increase tumor oxygenation, we developed solid oxygen gas-entrapping materials (O2-GeMs), which were modeled after clinical brachytherapy implants, for direct tumor implantation. The objective of this study was to investigate the impact different formulations of solid O2-GeMs have on the entrapment and delivery of oxygen. Using a Parr reactor, we fabricated solid O2-GeMs using carbohydrate-based formulations used in the confectionary industry. In evaluating solid O2-GeMs manufactured from different sugars, the sucrose-containing formulation exhibited the highest oxygen concentration at 1 mg/g, as well as the fastest dissolution rate. The addition of a surface coating to the solid O2-GeMs, especially polycaprolactone, effectively prolonged the dissolution of the solid O2-GeMs. In vivo evaluation confirmed robust insertion and positioning of O2-GeMs in a malignant peripheral nerve sheath tumor, highlighting potential clinical applications.


Assuntos
Neoplasias , Oxigênio , Humanos , Hipóxia Tumoral/fisiologia , Neoplasias/tratamento farmacológico
9.
Neurosurgery ; 2024 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-38197654

RESUMO

BACKGROUND AND OBJECTIVES: Growing evidence supports prompt surgical decompression for patients with traumatic spinal cord injury (tSCI). Rates of concomitant tSCI and traumatic brain injury (TBI) range from 10% to 30%. Concomitant TBI may delay tSCI diagnosis and surgical intervention. Little is known about real-world management of this common injury constellation that carries significant clinical consequences. This study aimed to quantify the impact of concomitant TBI on surgical timing in a national cohort of patients with tSCI. METHODS: Patient data were obtained from the National Trauma Data Bank (2007-2016). Patients admitted for tSCI and who received surgical intervention were included. Delayed surgical intervention was defined as surgery after 24 hours of admission. Multivariable hierarchical regression models were constructed to measure the risk-adjusted association between concomitant TBI and delayed surgical intervention. Secondary outcome included favorable discharge status. RESULTS: We identified 14 964 patients with surgically managed tSCI across 377 North American trauma centers, of whom 2444 (16.3%) had concomitant TBI and 4610 (30.8%) had central cord syndrome (CCS). The median time to surgery was 20.0 hours for patients without concomitant TBI and 24.8 hours for patients with concomitant TBI. Hierarchical regression modeling revealed that concomitant TBI was independently associated with delayed surgery in patients with tSCI (odds ratio [OR], 1.3; 95% CI, 1.1-1.6). Although CCS was associated with delayed surgery (OR, 1.5; 95% CI, 1.4-1.7), we did not observe a significant interaction between concomitant TBI and CCS. In the subset of patients with concomitant tSCI and TBI, patients with severe TBI were significantly more likely to experience a surgical delay than patients with mild TBI (OR, 1.4; 95% CI, 1.0-1.9). CONCLUSION: Concomitant TBI delays surgical management for patients with tSCI. This effect is largest for patients with tSCI with severe TBI. These findings should serve to increase awareness of concomitant TBI and tSCI and the likelihood that this may delay time-sensitive surgery.

10.
Adv Radiat Oncol ; 9(1): 101336, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38260219

RESUMO

Purpose: The purpose of this work was to investigate the use of a segmentation approach that could potentially improve the speed and reproducibility of contouring during magnetic resonance-guided adaptive radiation therapy. Methods and Materials: The segmentation algorithm was based on a hybrid deep neural network and graph optimization approach that also allows rapid user intervention (Deep layered optimal graph image segmentation of multiple objects and surfaces [LOGISMOS] + just enough interaction [JEI]). A total of 115 magnetic resonance-data sets were used for training and quantitative assessment. Expert segmentations were used as the independent standard for the prostate, seminal vesicles, bladder, rectum, and femoral heads for all 115 data sets. In addition, 3 independent radiation oncologists contoured the prostate, seminal vesicles, and rectum for a subset of patients such that the interobserver variability could be quantified. Consensus contours were then generated from these independent contours using a simultaneous truth and performance level estimation approach, and the deviation of Deep LOGISMOS + JEI contours to the consensus contours was evaluated and compared with the interobserver variability. Results: The absolute accuracy of Deep LOGISMOS + JEI generated contours was evaluated using median absolute surface-to-surface distance which ranged from a minimum of 0.20 mm for the bladder to a maximum of 0.93 mm for the prostate compared with the independent standard across all data sets. The median relative surface-to-surface distance was less than 0.17 mm for all organs, indicating that the Deep LOGISMOS + JEI algorithm did not exhibit a systematic under- or oversegmentation. Interobserver variability testing yielded a mean absolute surface-to-surface distance of 0.93, 1.04, and 0.81 mm for the prostate, seminal vesicles, and rectum, respectively. In comparison, the deviation of Deep LOGISMOS + JEI from consensus simultaneous truth and performance level estimation contours was 0.57, 0.64, and 0.55 mm for the same organs. On average, the Deep LOGISMOS algorithm took less than 26 seconds for contour segmentation. Conclusions: Deep LOGISMOS + JEI segmentation efficiently generated clinically acceptable prostate and normal tissue contours, potentially limiting the need for time intensive manual contouring with each fraction.

11.
Adv Sci (Weinh) ; 11(9): e2308346, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38084435

RESUMO

Modulation of autophagy, specifically its inhibition, stands to transform the capacity to effectively treat a broad range of cancers. However, the clinical efficacy of autophagy inhibitors has been inconsistent. To delineate clinical and epidemiological features associated with autophagy inhibition and a positive oncological clinical response, a retrospective analysis of patients is conducted treated with hydroxychloroquine, a known autophagy inhibitor. A direct correlation between smoking status and inhibition of autophagy with hydroxychloroquine is identified. Recognizing that smoking is associated with elevated circulating levels of carbon monoxide (CO), it is hypothesized that supplemental CO can amplify autophagy inhibition. A novel, gas-entrapping material containing CO in a pre-clinical model is applied and demonstrated that CO can dramatically increase the cytotoxicity of autophagy inhibitors and significantly inhibit the growth of tumors when used in combination. These data support the notion that safe, therapeutic levels of CO can markedly enhance the efficacy of autophagy inhibitors, opening a promising new frontier in the quest to improve cancer therapies.


Assuntos
Hidroxicloroquina , Neoplasias Pulmonares , Masculino , Humanos , Hidroxicloroquina/efeitos adversos , Neoplasias Pulmonares/tratamento farmacológico , Monóxido de Carbono/farmacologia , Próstata , Estudos Retrospectivos , Autofagia
12.
JAMA Surg ; 159(2): 223-225, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38019482

RESUMO

This cross-sectional study examines the surgical workforce in all counties across the US from 2010 to 2020.


Assuntos
Vulnerabilidade Social , Cirurgiões , Humanos , Estados Unidos , Recursos Humanos , População Rural
13.
Artigo em Inglês | MEDLINE | ID: mdl-38053239

RESUMO

BACKGROUND: Motor vehicle crashes (MVCs) are a leading cause of preventable trauma death in the United States (US). Access to trauma center care is highly variable nationwide. The objective of this study was to measure the association between geospatial access to trauma center care and MVC mortality. METHODS: This was a population-based study of MVC-related deaths that occurred in 3,141 US counties (2017-2020). ACS and state-verified level I-III trauma centers were mapped. Geospatial network analysis estimated the ground transport time to the nearest trauma center from the population-weighted centroid for each county. In this way, the exposure was the predicted access time to trauma center care for each county population. Hierarchical negative binomial regression measured the risk-adjusted association between predicted access time and MVC mortality, adjusting for population demographics, rurality, access to trauma resources, and state traffic safety laws. RESULTS: We identified 92,398 crash fatalities over the four-year study period. Trauma centers mapped included 217 level I, 343 level II, and 495 level III trauma centers. The median county predicted access time was 47 min (IQR 26-71 min). Median county MVC mortality was 12.5 deaths/100,000 person-years (IQR 7.4-20.3 deaths/100,000 person-years). After risk-adjustment, longer predicted access times were significantly associated with higher rates of MVC mortality (>60 min vs. <15 min; MRR 1.36; 95%CI 1.31-1.40). This relationship was significantly more pronounced in urban/suburban vs. rural/wilderness counties (p for interaction, <0.001). County access to trauma center care explained 16% of observed state-level variation in MVC mortality. CONCLUSIONS: Geospatial access to trauma center care is significantly associated with MVC mortality and contributes meaningfully to between-state differences in road traffic deaths. Efforts to improve trauma system organization should prioritize access to trauma center care to minimize crash fatalities. LEVEL OF EVIDENCE: Level III, Epidemiological.

14.
J Neurointerv Surg ; 2023 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-37914392

RESUMO

BACKGROUND: Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. METHODS: The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months. RESULTS: A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed. CONCLUSION: Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. TRIAL REGISTRATION NUMBER: NCT03844334.

16.
Surgery ; 174(4): 1063-1070, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37500410

RESUMO

BACKGROUND: Traumatic hemothorax is common, and management failure leads to worse outcomes. We sought to determine predictive factors and understand the role of trauma center performance in hemothorax management failure. METHODS: We prospectively examined initial hemothorax management (observation, pleural drainage, surgery) and failure requiring secondary intervention in 17 trauma centers. We defined hemothorax management failure requiring secondary intervention as thrombolytic administration, tube thoracostomy, image-guided drainage, or surgery after failure of the initial management strategy at the discretion of the treating trauma surgeon. Patient-level predictors of hemothorax management failure requiring secondary intervention were identified for 2 subgroups: initial observation and immediate pleural drainage. Trauma centers were divided into quartiles by hemothorax management failure requiring secondary intervention rate and hierarchical logistic regression quantified variation. RESULTS: Of 995 hemothoraces in 967 patients, 186 (19%) developed hemothorax management failure requiring secondary intervention. The frequency of hemothorax management failure requiring secondary intervention increased from observation to pleural drainage to surgical intervention (12%, 22%, and 35%, respectively). The number of ribs fractured (odds ratio 1.12 per fracture; 95% confidence interval 1.00-1.26) and pulmonary contusion (odds ratio 2.25, 95% confidence interval 1.03-4.91) predicted hemothorax management failure requiring secondary intervention in the observation subgroup, whereas chest injury severity (odds ratio 1.58; 95% confidence interval 1.17-2.12) and initial hemothorax volume evacuated (odds ratio 1.10 per 100 mL; 95% confidence interval 1.05-1.16) predicted hemothorax management failure requiring secondary intervention after pleural drainage. After adjusting for patient characteristics in the logistic regression model for hemothorax management failure requiring secondary intervention, patients treated at high hemothorax management failure requiring secondary intervention trauma centers were 6 times more likely to undergo an intervention after initial hemothorax management failure than patients treated in low hemothorax management failure requiring secondary intervention trauma centers (odds ratio 6.18, 95% confidence interval 3.41-11.21). CONCLUSION: Failure of initial management of traumatic hemothorax is common and highly variable across trauma centers. Assessing patient selection for a given management strategy and center-level practices represent opportunities to improve outcomes from traumatic hemothorax.


Assuntos
Fraturas Ósseas , Traumatismos Torácicos , Humanos , Hemotórax/diagnóstico , Hemotórax/etiologia , Hemotórax/cirurgia , Estudos Prospectivos , Estudos de Coortes , Traumatismos Torácicos/terapia , Traumatismos Torácicos/cirurgia , Tubos Torácicos , Fraturas Ósseas/complicações
17.
Neurosurgery ; 93(6): 1305-1312, 2023 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-37341486

RESUMO

BACKGROUND AND OBJECTIVES: It is believed that early tracheostomy in patients with traumatic cervical spinal cord injury (SCI) may lessen the risk of developing complications and reduce the duration of mechanical ventilation and critical care stay. This study aims to assess whether early tracheostomy is beneficial in patients with traumatic cervical SCI. METHODS: We conducted a retrospective cohort study using data from the American College of Surgeons Trauma Quality Improvement Program database from 2010 to 2018. Adult patients with a diagnosis of acute complete (ASIA A) traumatic cervical SCI who underwent surgery and tracheostomy were included. Patients were stratified into those receiving early (at or before 7 days) and delayed tracheostomy. Propensity score matching was used to assess the association between delayed tracheostomy and the risk of in-hospital adverse events. Risk-adjusted variability in tracheostomy timing across trauma centers was investigated using mixed-effects regression. RESULTS: The study included 2001 patients from 374 North American trauma centers. The median time to tracheostomy was 9.2 days (IQR: 6.1-13.1 days), with 654 patients (32.7%) undergoing early tracheostomy. After matching, the odds of a major complication were significantly lower for early tracheostomy patients (OR: .90; 95% CI: .88-.98). Patients were also significantly less likely to experience an immobility-related complication (OR: .90; 95% CI: .88-.98). Patients in the early group spent 8.2 fewer days in the critical care unit (95% CI: -10.2 to -6.61) and 6.7 fewer days ventilated (95% CI: -9.44 to -5.23). There was significant variability in tracheostomy timeliness between trauma centers with a median odds ratio of 12.2 (95% CI: 9.7-13.7), which was not explained by case-mix and hospital-level characteristics. CONCLUSION: A 7-day threshold to implement tracheostomy seems to be associated with reduced in-hospital complications, time in the critical care unit, and time on mechanical ventilation.


Assuntos
Medula Cervical , Lesões do Pescoço , Traumatismos da Medula Espinal , Adulto , Humanos , Estudos Retrospectivos , Traqueostomia/efeitos adversos , Respiração Artificial , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/epidemiologia , Traumatismos da Medula Espinal/cirurgia , Lesões do Pescoço/cirurgia
19.
J Neurointerv Surg ; 15(12): 1175-1180, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37355252

RESUMO

INTRODUCTION: The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients. METHODS: 150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator. RESULTS: 83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade. CONCLUSIONS: Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time.


Assuntos
Embolização Terapêutica , Procedimentos Endovasculares , Aneurisma Intracraniano , Humanos , Resultado do Tratamento , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Estudos Prospectivos , Embolização Terapêutica/métodos , Procedimentos Endovasculares/métodos , Estudos Retrospectivos
20.
Trauma Surg Acute Care Open ; 8(1): e001050, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36967862

RESUMO

Objective: To quantify and assess the relative performance parameters of thoracic lavage and percutaneous thoracostomy (PT) using a novel, basic science 2×2 randomized controlled simulation trial. Summary background data: Treatment of traumatic hemothorax (HTX) with open tube thoracostomy (TT) is painful and retained HTX is common. PT is potentially less painful whereas thoracic lavage may reduce retained HTX. Yet, procedural time and the feasibility of combining PT with lavage remain undefined. Methods: A simulated partially clotted HTX (2%-gelatin-saline mixture) was loaded into a TT trainer and then evacuated after randomization to one of four protocols: TT+/-lavage or PT+/-lavage. Standardized inserts with fixed 28-Fr TT or 14-Fr PT positioning were used to minimize tube positioning variability. Lavage consisted of two 500 mL aliquots of warm saline after initial HTX evacuation. The primary outcome was HTX volume evacuated. The secondary outcome was additional procedural time required for the addition of the lavage. Results: A total of 40 simulated HTX trials were randomized. TT alone evacuated a median of 1236 mL (IQR 1168, 1294) leaving a residual volume of 265 mL (IQR 206, 333). PT alone resulted in a significantly greater median residual volume of 588 mL (IQR 497, 646) (p=0.002). Adding lavage resulted in similar residual volumes for TT compared with TT alone but significantly less for PT compared with PT alone (p=0.002). Lavage increased procedural time for TT by a median of 7.0 min (IQR 6.5, 8.0) vs 11.7 min (IQR 10.2, 12.0) for PT (p<0.001). Conclusion: This simulation trial characterized HTX evacuation in a standardized fashion. Adding lavage to thoracostomy placement may improve evacuation, particularly for small-diameter tubes, with little added procedural time. Further prospective clinical study is warranted. Level of evidence: NA.

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