RESUMEN
Importance: There is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections. Objective: To assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections. Design, Setting, and Participants: This parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed. Interventions: Intrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication. Main Outcomes and Measures: Primary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data. Results: Twenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups (P = .21). Median hospital stay tended to be longer in the IPFT (11 [IQR, 4-18] days) vs surgery (5 [IQR, 4-6] days) groups, although the difference as not significantly different (P = .08). There were no 30-day readmissions or 30- or 90-day deaths. Conclusions and Relevance: In this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial. Trial Registration: ClinicalTrials.gov Identifier: NCT03873766.
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Enfermedades Transmisibles , Activador de Tejido Plasminógeno , Masculino , Humanos , Persona de Mediana Edad , Anciano , Femenino , Activador de Tejido Plasminógeno/uso terapéutico , Fibrinolíticos/uso terapéutico , Estudios Prospectivos , Terapia Trombolítica , Desoxirribonucleasas/uso terapéuticoRESUMEN
OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.
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Trastornos de Deglución , Reflujo Gastroesofágico , Laparoscopía , Humanos , Estudios de Casos y Controles , Trastornos de Deglución/etiología , Trastornos de Deglución/cirugía , Esfínter Esofágico Inferior/cirugía , Reflujo Gastroesofágico/cirugía , Fenómenos Magnéticos , Calidad de Vida , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Rationale: When drainage of complicated pleural space infections alone fails, there exists two strategies in surgery and dual agent-intrapleural fibrinolytic therapy; however, studies comparing these two management strategies are limited. Objectives: To determine the outcomes of surgery versus fibrinolytic therapy as the primary management for complicated pleural space infections (CPSI). Methods: A retrospective review of adults with a CPSI managed with surgery or fibrinolytics between 1/2015 and 3/2018 within a multicenter, multistate hospital system was performed. Fibrinolytics was defined as any dose of dual-agent fibrinolytic therapy and standard fibrinolytics as 5-6 doses twice daily. Treatment failure was defined as persistent infection with a pleural collection requiring intervention. Crossover was defined by any fibrinolytics after surgery or surgery after fibrinolytics. Logistic regression with inverse probability of treatment weighting (IPTW) were employed to account for selection bias effect of management strategies in treatment failure and crossover. Results: We identified 566 patients. Surgery was the initial strategy in 55% (311/566). The surgery group had less additional treatments (surgery: 10% [32/311] versus fibrinolytics: 39% [100/255], P < 0.001), treatment failures (surgery: 7% [22/311] versus fibrinolytics: 29% [74/255], P < 0.001), and crossovers (surgery: 6% [20/311] versus fibrinolytics: 19% [49/255], P < 0.001). Logistic regression analysis with IPTW demonstrated a lower odds of treatment failure with surgery compared with any fibrinolytics (odds ratio [OR], 0.20; 95% confidence interval [CI], 0.10-0.30; P < 0.001); and compared with standard fibrinolytics (OR, 0.20; 95% CI, 0.11-0.35; P < 0.001). Conclusions: Although there is a lack of consensus as to the optimal management strategy for patients with a CPSI, in surgical candidates, operative management may offer more benefits and could be considered early in the management course. However, our study is retrospective and nonrandomized; thus, prospective trials are needed to explore this further.
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Empiema Pleural , Derrame Pleural , Adulto , Humanos , Estudios de Cohortes , Empiema Pleural/tratamiento farmacológico , Fibrinolíticos , Derrame Pleural/tratamiento farmacológico , Estudios Prospectivos , Estudios Retrospectivos , Terapia TrombolíticaRESUMEN
BACKGROUND: Complex pleural space infections are commonly managed with antibiotics, pleural drainage, intrapleural fibrinolytic therapy, and surgery. These strategies often utilize radiographic imaging during management, however little data is available on cumulative radiation exposure received during inpatient management. We aimed to identify the type and quantity of radiographic studies along with the resultant radiation exposure during the management of complex pleural space infections. METHODS: Retrospective review of community network healthcare system from January 2015 to July 2018. Patients were identified through billing databases as receiving intrapleural fibrinolytic therapy and/or surgical intervention. Patient demographics, clinical outcomes, and inpatient radiographic imaging was collected to calculate cumulative effective dose. RESULTS: A total of 566 patients were identified with 7275 total radiographic studies performed and a median cumulative effective dose of 16.9 (IQR 9.9-26.3) mSv. Multivariable linear regression analysis revealed computed tomography use was associated with increased cumulative dose, whereas increased age was associated with lower cumulative dose. Over 74% of patients received more than 10 mSv, with 7.4% receiving more than 40 mSv. CONCLUSIONS: The number of radiographic studies and overall cumulative effective dose in patients hospitalized for complex pleural space infection was high with the median cumulative effective dose > 5 times normal yearly exposure. Ionizing radiation and modern radiology techniques have revolutionized medical care, but are likely not without risk. Additional study is warranted to identify the frequency and imaging type needed during complex pleural space infection management, attempting to keep ionizing radiation exposure as low as reasonably possible.
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Infecciones Bacterianas/diagnóstico por imagen , Enfermedades Pleurales/diagnóstico por imagen , Enfermedades Pleurales/microbiología , Dosis de Radiación , Exposición a la Radiación/estadística & datos numéricos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cavidad Pleural , Estudios RetrospectivosRESUMEN
INTRODUCTION: Ideally, all patients with isolated orbit fracture would undergo ophthalmologic evaluation before surgical intervention to rule out concomitant globe injury and possible vision loss. Unfortunately, not all institutions are capable of providing the evaluation before surgery. The authors hypothesize that the anatomic location of a single-wall orbit isolated orbit fracture can help predict the likelihood of ocular injury and thus identify high-risk patients who mandate ophthalmologic evaluation before surgical repair. METHODS: A retrospective chart review was performed at a tertiary academic medical center using the institutional trauma registry for maxillofacial trauma. All subjects with an isolated single-wall orbit fracture were included in this study. Statistical analysis was performed using a Fisher exact test. RESULTS: Two hundred seventy-nine subjects with orbit fractures were identified for inclusion in this study. Forty-one of the 279 (14.7%) subjects had isolated single-wall orbit fractures. Isolated single-wall fractures included orbit floor = 19 of 41 (46.3%), medial wall = 15 of 41 (36.6%), lateral wall = 4 of 41 (9.8%), and orbit roof = 3 of 41 (7.3%). Concomitant ocular injury (13 of 41, 31.8%) was associated with isolated orbit wall fractures as follows: orbit floor = 4 of 19 (21.1%), medial wall = 6 of 15 (40%), lateral wall = 2 of 4 (50%), and orbit roof = 1 of 3 (33.3%). A Fisher exact test demonstrated that there was no statistically significant association between individual isolated wall fractures and ocular injury (P = 0.5000). CONCLUSIONS: Isolated orbit wall fractures are common in maxillofacial trauma and often require surgical repair. Concomitant ocular injury is common (31.8%) with this highest incidence occurring with lateral wall fractures (50%); however, statistical analysis did not demonstrate a significant relationship between the anatomic location of an isolated single-wall fracture and eye injuries.