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1.
Heart Rhythm ; 18(12): 2072-2079, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34214647

RESUMO

BACKGROUND: To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT-) have been reported. OBJECTIVE: The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT- patients. METHODS: Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT- patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes. RESULTS: Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT-) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT-; P = .404) as well as for ineffective shocks (5 DT- vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339-11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752-76.203; P = .003). CONCLUSION: In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts.


Assuntos
Desfibriladores Implantáveis , Cardioversão Elétrica/estatística & dados numéricos , Análise de Falha de Equipamento , Falha de Equipamento/estatística & dados numéricos , Taquicardia Ventricular , Pesquisa Comparativa da Efetividade , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Desfibriladores Implantáveis/estatística & dados numéricos , Análise de Falha de Equipamento/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Teste de Materiais/métodos , Teste de Materiais/estatística & dados numéricos , Pessoa de Meia-Idade , Pontuação de Propensão , Medição de Risco/métodos , Taquicardia Ventricular/mortalidade , Taquicardia Ventricular/terapia
2.
J Occup Environ Hyg ; 18(6): 265-275, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33989113

RESUMO

The COVID-19 pandemic has caused a high demand for respiratory protection among health care workers in hospitals, especially surgical N95 filtering facepiece respirators (FFRs). To aid in alleviating that demand, a survey of commercially available filter media was conducted to determine whether any could serve as a substitute for an N95 FFR while held in a 3D-printed mask (Stopgap Surgical Face Mask from the NIH 3D Print Exchange). Fourteen filter media types and eight combinations were evaluated for filtration efficiency, breathing resistance (pressure drop), and liquid penetration. Additional testing was conducted to evaluate two filter media disinfection methods in the event that the filters were reused in a hospital setting. Efficiency testing was conducted in accordance with the procedures established for approving an N95 FFR. One apparatus used a filter-holding device and another apparatus employed a manikin head to which the 3D-printed mask could be sealed. The filter media and combinations exhibited collection efficiencies varied between 3.9% and 98.8% when tested with a face velocity comparable to that of a standard N95 FFR at the 85 L min-1 used in the approval procedure. Breathing resistance varied between 10.8 to >637 Pa (1.1 to > 65 mm H2O). When applied to the 3D-printed mask efficiency decreased by an average of 13% and breathing resistance increased 4-fold as a result of the smaller surface area of the filter media when held in that mask compared to that of an N95 FFR. Disinfection by dry heat, even after 25 cycles, did not significantly affect filter efficiency and reduced viral infectivity by > 99.9%. However, 10 cycles of 59% vaporized H2O2 significantly (p < 0.001) reduced filter efficiency of the media tested. Several commercially available filter media were found to be potential replacements for the media used to construct the typical cup-like N95 FFR. However, their use in the 3D-printed mask demonstrated reduced efficiency and increased breathing resistance at 85 L min-1.


Assuntos
COVID-19/prevenção & controle , Desinfecção/normas , Contaminação de Equipamentos/prevenção & controle , Teste de Materiais/normas , Respiradores N95/virologia , Exposição Ocupacional/prevenção & controle , Pandemias/prevenção & controle , Poluentes Ocupacionais do Ar/análise , Análise de Falha de Equipamento/estatística & dados numéricos , Guias como Assunto , Humanos , Exposição por Inalação/análise , SARS-CoV-2
3.
J Am Heart Assoc ; 10(7): e018063, 2021 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-33787324

RESUMO

Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.


Assuntos
Morte Súbita Cardíaca , Desfibriladores Implantáveis , Cardioversão Elétrica , Complicações Pós-Operatórias , Implantação de Prótese/efeitos adversos , Idoso , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/efeitos adversos , Desfibriladores Implantáveis/classificação , Desfibriladores Implantáveis/estatística & dados numéricos , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/métodos , Análise de Falha de Equipamento/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Feminino , Humanos , Masculino , Avaliação das Necessidades , Países Baixos/epidemiologia , Seleção de Pacientes , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros/estatística & dados numéricos , Reoperação/estatística & dados numéricos , Medição de Risco , Fatores de Risco
4.
PLoS One ; 15(10): e0238746, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33002015

RESUMO

The paper investigates a new scheme for generating lifetime probability distributions. The scheme is called Exponential- H family of distribution. The paper presents an application of this family by using the Weibull distribution, the new distribution is then called New Flexible Exponential distribution or in short NFE. Various statistical properties are derived, such as quantile function, order statistics, moments, etc. Two real-life data sets and a simulation study have been performed so that to assure the flexibility of the proposed model. It has been declared that the proposed distribution offers nice results than Exponential, Weibull Exponential, and Exponentiated Exponential distribution.


Assuntos
Teoria da Probabilidade , Distribuições Estatísticas , Acidentes de Trânsito/estatística & dados numéricos , Aeronaves , Simulação por Computador , Análise de Falha de Equipamento/estatística & dados numéricos , Humanos , Tábuas de Vida , Funções Verossimilhança , Modelos Estatísticos , Modelos de Riscos Proporcionais
5.
PLoS One ; 15(10): e0239070, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33091004

RESUMO

The running of high-speed electrically driven feed pump has a direct impact on the safety of personnel equipment and economic benefits of power plant, as the result, intelligent condition monitoring and fault diagnosis of electrically driven feed pump becomes an urgent need. In the practical process of electrically driven feed pump fault diagnosis, the running of the equipment is in normal state for a long time, occasionally, with faults, which makes the fault data very rare in a large number of monitoring data, and makes it difficult to extract the internal fault features behind the original time series data, When the deep learning theory is used in practice, the imbalance between the fault data and the normal data occurs in the operation data set. In order to solve the problem of data imbalance, this paper proposes a fault diagnosis method of GAN-SAE. This method first makes compensation for the imbalance of sample data based on the Generative Adversarial Network (GAN), and then uses the Stacked Auto Encoder (SAE) method to extract the signal features. By designing the fault diagnosis program, compared with only using SAE, back propagation neural networks (BP) and multi-hidden layer neural networks(MNN) method, the GAN-SAE method can offer better capability of extracting features, and the accuracy of fault diagnosis of electrically driven feed pump could be improved to 98.89%.


Assuntos
Análise de Falha de Equipamento/métodos , Centrais Elétricas , China , Aprendizado Profundo , Eletricidade , Desenho de Equipamento , Análise de Falha de Equipamento/estatística & dados numéricos , Humanos , Redes Neurais de Computação , Centrais Elétricas/estatística & dados numéricos
6.
Clin Orthop Relat Res ; 478(9): 2105-2116, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32530896

RESUMO

BACKGROUND: Several kinds of cutting guides, including patient-specific instrumentation, navigation, standard cutting guides, accelerometer-based navigation, and robotic guidance, are available to restore a planned alignment during TKA. No previous study has simultaneously compared all of these devices; a network meta-analysis is an especially appealing method because it allows comparisons across approaches that were not compared head-to-head in individual randomized controlled trials. QUESTIONS/PURPOSES: We performed a network meta-analysis to determine whether novel approaches to achieving implant alignment, such as patient-specific instrumentation, navigation, accelerometer-based navigation, and robotic guidance, provide any advantage over standard cutting guides in terms of: (1) hip-knee-ankle (HKA) alignment outliers greater than ± 3°, (2) outcome scores (1989 - Knee Society Score and WOMAC score) measured 6 months after surgery, or (3) femoral and tibial implant malalignment (greater than ± 3°), taken separately, in the frontal and sagittal plane, as well as other secondary outcomes including validated outcome scores 1 and 2 years after surgery. METHODS: In our network meta-analysis, we included randomized controlled trials comparing the different cutting guides by using at least one of the previously specified criteria, without limitation on language or date of publication. We searched electronic databases, major orthopaedic journals, proceedings of major orthopaedic meetings, ClinicalTrials.gov, and the World Health Organization's International Clinical Trials Registry Platform until October 1, 2018. This led to the inclusion of 90 randomized controlled trials involving 9389 patients (mean age 68.8 years) with 10,336 TKAs. Two reviewers independently selected trials and extracted data. The primary outcomes were the proportion patients with malalignment of the HKA angle (defined as HKA > 3° from neutral) and the Knee Society Score and WOMAC scores at 6 months postoperatively. We combined direct and indirect comparisons using a Bayesian network meta-analysis framework to assess and compare the effect of different cutting guides on outcomes. Bayesian estimates are based on the posterior distribution of an endpoint and are called credible intervals. Usually the 95% credible interval, corresponding to a posterior probability of 0.95 that the endpoint lies in the interval, is computed. Unlike the frequentist approach, the Bayesian approach does not allow the calculation of the p value. RESULTS: The proportion of HKA outliers was lower with navigation than with patient-specific instrumentation (risk ratio 0.46 [95% credible interval (CI) 0.34 to 0.63]) and standard cutting guides (risk ratio 0.45 [95% CI 0.37 to 0.53]); however, this corresponded to an actual difference of only 12% of patients for navigation versus 21% of patients for patient-specific instrumentation, and 12% of patients for navigation versus 25% for standard cutting guides. We found no differences for other comparisons between different cutting guides, including robotics and the accelerometer. We found no differences in the Knee Society Score or WOMAC score between the different cutting guides at 6 months. Regarding secondary outcomes, navigation reduced the risk of frontal and sagittal malalignments for femoral and tibial components compared with the standard cutting guides, but none of the other cutting guides showed superiority for the other secondary outcomes. CONCLUSIONS: Navigation resulted in approximately 10% fewer patients having HKA outliers of more than 3°, without any corresponding improvement in validated outcomes scores. It is unknown whether this incremental reduction in the proportion of patients who have alignment outside a window that itself has been called into question will justify the increased costs and surgical time associated with the approach. We believe that until or unless these new approaches either (1) convincingly demonstrate superior survivorship, or (2) convincingly demonstrate superior outcomes, surgeons and hospitals should not use these approaches since they add cost, have a learning curve (during which some patients may be harmed), and have the risks associated with uncertainty of novel surgical approaches. LEVEL OF EVIDENCE: Level I, therapeutic study.


Assuntos
Artroplastia do Joelho/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Prótese do Joelho/estatística & dados numéricos , Neuronavegação/estatística & dados numéricos , Modelagem Computacional Específica para o Paciente/estatística & dados numéricos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Artroplastia do Joelho/efeitos adversos , Teorema de Bayes , Fêmur/cirurgia , Humanos , Articulação do Joelho/cirurgia , Prótese do Joelho/efeitos adversos , Cadeias de Markov , Metanálise em Rede , Neuronavegação/efeitos adversos , Duração da Cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Tíbia/cirurgia , Resultado do Tratamento
7.
J Mater Sci Mater Med ; 31(7): 56, 2020 Jun 27.
Artigo em Inglês | MEDLINE | ID: mdl-32594253

RESUMO

INTRODUCTION: Ceramic-on-ceramic couplings demonstrated to be reliable bearings in primary total hip arthroplasty (THA), with long-term remarkable results. Like-on-like configurations were widely described. On the contrary, mixed material combinations from the same manufacturer, Delta-on-Forte or Forte-on-Delta, were poorly studied. In particular, it is unknown whether mixed ceramic combinations are more at risk of ceramic fractures. Thus, a registry study was conducted to investigate the long-term survival rates and reasons for revision of mixed ceramic combinations. A comparison with Delta-on-Delta couplings was also performed. MATERIALS AND METHODS: The regional arthroplasty registry RIPO was enquired about three cohorts of ceramic bearings (head-on-liner: Delta-on-Forte, Forte-on-Delta, Delta-on-Delta). Demographics, survival rates and reasons for revision were evaluated and compared. RESULTS: In total, 346 (1.5%) implants had a Delta-on-Forte coupling (mean follow-up: 6.4 years). In total, 1163 (5%) THAs had a Forte-on-Delta articulation (mean follow-up: 8.2 years). Delta-on-Delta surfaces were implanted in 21,874 (93.5%) hips (mean follow-up: 3.9 years). Mixed material combinations were implanted between 2003 and 2007. The survival rates of the three cohorts were similar and were higher than 95% at 10 years. In Forte-on-Delta group, four liners failed (0.3% of the implants), whereas ceramic fractures occurred in 15 cases (0.1%) in Delta-on-Delta couplings (3 heads and 12 liners). Considering ceramic fracture as endpoint, there was no significant difference between the three survival rates. CONCLUSIONS: Mixed ceramic bearing configurations from the same manufacturer in primary THA showed mid-to-longterm dependable outcomes, not inferior to the most recent like-on-like ceramic bearings. No additional risks of ceramic fractures were evident. Thus, closer follow-ups are not required.


Assuntos
Artroplastia de Quadril/instrumentação , Artroplastia de Quadril/métodos , Cerâmica/química , Prótese de Quadril , Idoso , Artroplastia de Quadril/estatística & dados numéricos , Cerâmica/uso terapêutico , Estudos de Coortes , Análise de Falha de Equipamento/estatística & dados numéricos , Feminino , Seguimentos , Articulação do Quadril/fisiopatologia , Articulação do Quadril/cirurgia , Prótese de Quadril/efeitos adversos , Prótese de Quadril/estatística & dados numéricos , Humanos , Masculino , Próteses Articulares Metal-Metal/efeitos adversos , Pessoa de Meia-Idade , Desenho de Prótese , Falha de Prótese , Reoperação , Resultado do Tratamento
8.
Urology ; 141: 39-44, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32277991

RESUMO

OBJECTIVE: To assess the timing and variables associated with damage to flexible ureteroscopes (fURS) at our institution. Flexible ureteroscopy is an important modality in the treatment of benign and malignant conditions of the upper urinary tract. While the durability and versatility of fURS have improved considerably, repair costs remain high and time out of commission diminishes workflow. After purchasing new digital fURS, we studied how and when these instruments were being damaged. MATERIALS AND METHODS: Between September 1, 2017 and June 30, 2018, we performed leak testing on fURS both before and after use. We gathered intraoperative data related to the user, the surgical indication, and the associated tools used in all cases that employed a digital or fiber optic fURS. Categorical and continuous variables were analyzed to identify risk factors for intraoperative fURS damage. RESULTS: During the study period, complete data was gathered for 281 cases. Twenty-two fURS failed leak testing indicating an overall leak failure rate of 7.8%. Of these, 15 failed leak testing preoperatively indicating nonoperative damage occurring sometime during transport, handling, or sterile processing. The other 7 failures occurred during the procedures. No intraoperative variables were significantly associated with failures. CONCLUSION: Our institutional leak failure rate is 8% (22/281). The majority of these failures did not occur during surgery. Of the 7 that occurred during surgery, larger stone burden and higher wattage showed mild association. Ongoing evaluation will target minimizing fURS damage outside of the operating room.


Assuntos
Análise de Falha de Equipamento/métodos , Ureteroscópios , Análise de Falha de Equipamento/estatística & dados numéricos , Tecnologia de Fibra Óptica , Maleabilidade , Fatores de Risco , Fatores de Tempo
9.
Dig Dis Sci ; 65(12): 3710-3718, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32107675

RESUMO

BACKGROUND: In patients with unresectable hilar malignant biliary obstruction (MBO), bilateral metal stent placement is recommended. However, treatment selection between partially stent-in-stent (SIS) and side-by-side (SBS) methods is still controversial. STUDY: Clinical outcomes of bilateral metal stent placement by SBS and SIS methods for hilar MBO were retrospectively studied in four Japanese centers. While large-cell-type uncovered metal stents were placed above the papilla in SIS, braided-type uncovered metal stents were placed across the papilla in SBS. RESULTS: A total of 64 patients with hilar MBO (40 SIS and 24 SBS) were included in the analysis. Technical success rate was 100% in SIS and 96% in SBS. Functional success rate was 93% in SIS and 96% in SBS. Early adverse event rates were higher in SBS (46%) than in SIS (23%), though not statistically significant (P = 0.09). Post-procedure pancreatitis was exclusively observed in SBS group (29%). Recurrent biliary obstruction rates were 48% and 43%, and the median time to recurrent biliary obstruction was 169 and 205 days in SIS and SBS, respectively. CONCLUSIONS: Other than a trend to higher adverse event rates including post-procedure pancreatitis in SBS, clinical outcomes of SIS and SBS methods were comparable in patients with unresectable hilar MBO.


Assuntos
Colestase/cirurgia , Descompressão Cirúrgica , Tumor de Klatskin , Pancreatite , Complicações Pós-Operatórias , Stents , Idoso , Colangiografia/métodos , Colestase/diagnóstico , Colestase/etiologia , Descompressão Cirúrgica/efeitos adversos , Descompressão Cirúrgica/instrumentação , Descompressão Cirúrgica/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Feminino , Humanos , Japão/epidemiologia , Tumor de Klatskin/complicações , Tumor de Klatskin/patologia , Masculino , Estadiamento de Neoplasias , Avaliação de Processos e Resultados em Cuidados de Saúde , Pancreatite/diagnóstico , Pancreatite/etiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Recidiva , Estudos Retrospectivos , Stents/efeitos adversos , Stents/classificação , Stents/estatística & dados numéricos
10.
Dig Dis Sci ; 65(12): 3702-3709, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32036515

RESUMO

BACKGROUND: Self-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable. AIMS: The aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS. METHODS: We enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers. RESULTS: We included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days. CONCLUSIONS: We confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.


Assuntos
Neoplasias dos Ductos Biliares , Colangite , Colestase , Descompressão Cirúrgica , Pancreatite , Complicações Pós-Operatórias , Stents Metálicos Autoexpansíveis/estatística & dados numéricos , Idoso , Neoplasias dos Ductos Biliares/complicações , Neoplasias dos Ductos Biliares/epidemiologia , Colangite/diagnóstico , Colangite/etiologia , Colestase/diagnóstico , Colestase/etiologia , Colestase/cirurgia , Descompressão Cirúrgica/efeitos adversos , Descompressão Cirúrgica/instrumentação , Descompressão Cirúrgica/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Feminino , Humanos , Japão/epidemiologia , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Pancreatite/diagnóstico , Pancreatite/etiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Falha de Prótese , Recidiva
11.
Female Pelvic Med Reconstr Surg ; 26(2): 128-136, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31990801

RESUMO

OBJECTIVES: Prolene polypropylene ("Prolene") meshes demonstrate no in vivo degradation, yet some claim degradation continues until no more Prolene polypropylene can be oxidized. We studied whether implantation time affects the morphology/extent of previously reported as cracking/degradation of completely cleaned Prolene explants. METHODS: Urogynecological explants (248 patients) were collected. After excluding non-Prolene/unknown meshes and those without known implantation times, completely cleaned explants (n = 205; 0.2-14.4 years implantation) were analyzed with light microscopy, scanning electron microscopy, and Fourier transform infrared spectroscopy. Based on implant times and storage (fixative or dry), representative specimens were randomly selected for comparison. Controls were unused ("exemplar") TVT specimens with and without intentional oxidation via ultraviolet light exposure. RESULTS: Prolene explants included 31 dry (18 TVT; 7 Prolift; 4 Gynemesh; 2 others) and 174 wet (87 TVT; 47 Prolift; 10 Gynemesh; 30 others) specimens. Specimens had similar morphologies before cleaning. Progressive cleaning removed tissue and cracked tissue-related material exposing smooth, unoxidized, and nondegraded fibers, with no visible gradient-type/ductile damage. Fourier transform infrared spectroscopy of the explants confirmed progressive loss of proteins. Cleaning intentionally oxidized exemplars did not remove oxidized carbonyl frequencies and showed deep cracks and gross fiber rupture/embrittlement, unlike the explants and nonoxidized exemplars. CONCLUSIONS: If in vivo Prolene degradation exists, there should be wide-ranging crack morphology and nonuniform crack penetration, as well as more cracking, degradation, and physical breakage for implants of longer implantation times, but this was not the case. There is no morphologic or spectral/chemical evidence of Prolene mesh degradation after up to 14.4 years in vivo.


Assuntos
Remoção de Dispositivo , Procedimentos Cirúrgicos em Ginecologia/instrumentação , Pelve/cirurgia , Procedimentos de Cirurgia Plástica/instrumentação , Polipropilenos , Análise de Falha de Equipamento/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Segurança de Equipamentos/métodos , Feminino , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Efeitos Adversos de Longa Duração/diagnóstico , Efeitos Adversos de Longa Duração/prevenção & controle , Teste de Materiais/métodos , Polipropilenos/efeitos adversos , Polipropilenos/uso terapêutico , Procedimentos de Cirurgia Plástica/métodos , Telas Cirúrgicas/normas
12.
Int J Artif Organs ; 43(2): 109-118, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31530254

RESUMO

In selected patients with left ventricular assist device-associated infection or malfunction, pump exchange may become necessary after conservative treatment options fail and heart transplantation is not readily available. We examined the survival and complication rate in patients (⩾19 years of age) who underwent HeartMate II to HeartMate II exchange at our institution from 1 January 2010 to 28 February 2018. Clinical outcomes were analyzed and compared for patients who underwent exchange for pump thrombosis (14 patients), breach of driveline integrity (5 patients), and device-associated infection (2 patients). There were no differences in 30-day mortality (p = 0.58), need for temporary renal replacement therapy (p = 0.58), right ventricular mechanical support (p = 0.11), and postoperative stroke (p = 0.80) among groups. Survival at 1 year was 90% ± 7% for the whole cohort and 85% ± 10% for those who underwent exchange for pump thrombosis. In patients exchanged for device thrombosis, freedom from re-thrombosis and survival free from pump re-thrombosis at 1 year were 49% ± 16% and 42% ± 15%, respectively. No association of demographic and clinical variables with the risk of recurrent pump thrombosis after the first exchange was identified. Survival after left ventricular assist device exchange compares well with published results after primary left ventricular assist device implantation. However, recurrence of thrombosis was common among patients who required a left ventricular assist device exchange due to pump thrombosis. In this sub-group, consideration should be given to alternative strategies to improve the outcomes.


Assuntos
Insuficiência Cardíaca , Coração Auxiliar , Infecções Relacionadas à Prótese , Reoperação/estatística & dados numéricos , Trombose , Análise de Falha de Equipamento/estatística & dados numéricos , Feminino , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Coração Auxiliar/efeitos adversos , Coração Auxiliar/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Nebraska/epidemiologia , Avaliação de Processos e Resultados em Cuidados de Saúde , Implantação de Prótese/efeitos adversos , Implantação de Prótese/métodos , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/etiologia , Recidiva , Estudos Retrospectivos , Trombose/diagnóstico , Trombose/epidemiologia , Trombose/etiologia
13.
Sex Health ; 17(1): 91-95, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31610140

RESUMO

Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex.


Assuntos
Preservativos/normas , Análise de Falha de Equipamento/estatística & dados numéricos , Guias como Assunto , Rotulagem de Produtos/normas , Comportamento Sexual , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
14.
Int J Cardiol ; 299: 81-86, 2020 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-31279662

RESUMO

BACKGROUND: Optical coherence tomography (OCT) was used to assess serial changes in severe acute stent malapposition (ASM) after drug-eluting stent (DES) implantation. METHODS: The maximal depth and axial lengths of ASM after DES implantation were serially quantified at percutaneous coronary intervention (PCI), and at 3 and 12-month follow-up, for 100 lesions in 96 patients. Severe ASM was defined as a maximal malapposed depth ≥400 µm or maximal malapposed axial length ≥1 mm. RESULTS: Of the 100 lesions, 23 lesions (23%) had a severe ASM depth at PCI. At 3 months, the maximal depth decreased to <400 µm in 12 of 23 lesions (52%). At 12 months, the maximal depth further decreased to <400 µm in 8 of the remaining 11 lesions (73%). Similarly, of 53 lesions (53%) with a severe ASM length at PCI, the maximal length decreased to 0 mm in 26 (49%) but remained severe in 17 lesions (32%) at 3 months. At 12 months, 9 of the 17 remaining lesions (53%) further decreased to 0 mm. The cut-off values for the maximal malapposed depth and length to predict the absence of stent malapposition at 12 months were 565 µm at PCI and 165 µm at 3 months, and were 2.7 mm at PCI and 0.1 mm at 3 months, respectively. CONCLUSION: Half of the severe ASM cases resolved within 3 months, and another half resolved during 3-12 months of follow-up. Our findings provide a better understanding of the time-dependent natural course of severe ASM using OCT.


Assuntos
Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos/efeitos adversos , Everolimo/uso terapêutico , Intervenção Coronária Percutânea/instrumentação , Ajuste de Prótese/efeitos adversos , Sirolimo/uso terapêutico , Tomografia de Coerência Óptica/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Análise de Falha de Equipamento/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Imunossupressores/uso terapêutico , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Fatores de Tempo
15.
Drug Discov Ther ; 13(5): 280-287, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31723100

RESUMO

Few studies have investigated the molecular mechanisms of catheter failure (CF). Herein, we performed histological and molecular biological analyses of the catheter tip to demonstrate its potential as a resource for biological investigation. Additionally, we searched for risk factors for the development of inflammation and coagulation, which are pathological conditions clarified by biological analysis. The CF group included 30 failed catheters involving thrombus and subcutaneous edema identified by ultrasonography. The No-CF group included 26 catheters with no complications. The removed catheter tips were fixed for hematoxylin-eosin (HE) staining with the application of a real-time reverse transcriptase polymerase chain reaction for eukaryotic 18S ribosomal RNA (rRNA), interleukin 1ß, tumor necrosis factor α, tissue plasminogen activator, and plasminogen activator inhibitor 1 (SERPINE1). HE staining identified attached nuclear cells on the inner surfaces of both CF and No-CF catheters. The 18S rRNA was amplified in all samples. The expression level of SERPINE1 was significantly higher in the CF group than in the No-CF group (p = 0.01), whereas the expression levels of other genes did not differ between the groups. Symptoms of CF associated with the expression of SERPINE1 were analyzed. The catheter being in contact with blood vessels during placement was a suggested factor related to the high expression of SERPINE1 (p = 0.04). Catheter tips are a potential resource for biological investigation, and expression analysis of the attached cells can reflect the pathological condition of the catheterized tissue. Further studies using catheter tips are required to elucidate the molecular mechanisms of CF.


Assuntos
Catéteres/efeitos adversos , Análise de Falha de Equipamento/estatística & dados numéricos , Idoso , Estudos de Casos e Controles , Feminino , Expressão Gênica , Humanos , Leucócitos/metabolismo , Masculino , Inibidor 1 de Ativador de Plasminogênio/biossíntese
16.
Artigo em Inglês | MEDLINE | ID: mdl-31454944

RESUMO

This article explores the performance optimizations of an embedded database memory management system to ensure high responsiveness of real-time healthcare data frameworks. SQLite is a popular embedded database engine extensively used in medical and healthcare data storage systems. However, SQLite is essentially built around lightweight applications in mobile devices, and it significantly deteriorates when a large transaction is issued such as high resolution medical images or massive health dataset, which is unlikely to occur in embedded systems but is quite common in other systems. Such transactions do not fit in the in-memory buffer of SQLite, and SQLite enforces memory reclamation as they are processed. The problem is that the current SQLite buffer management scheme does not effectively manage these cases, and the naïve reclamation scheme used significantly increases the user-perceived latency. Motivated by this limitation, this paper identifies the causes of high latency during processing of a large transaction, and overcomes the limitation via proactive and coarse-grained memory cleaning in SQLite.The proposed memory reclamation scheme was implemented in SQLite 3.29, and measurement studies with a prototype implementation demonstrated that the SQLite operation latency decreases by 13% on an average and up to 17.3% with our memory reclamation scheme as compared to that of the original version.


Assuntos
Dispositivos de Armazenamento em Computador/normas , Bases de Dados Factuais/normas , Registros Eletrônicos de Saúde/normas , Análise de Falha de Equipamento/estatística & dados numéricos , Guias como Assunto , Armazenamento e Recuperação da Informação/normas , Dispositivos de Armazenamento em Computador/estatística & dados numéricos , Bases de Dados Factuais/estatística & dados numéricos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Humanos , Armazenamento e Recuperação da Informação/estatística & dados numéricos
17.
Strahlenther Onkol ; 195(12): 1086-1093, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31399799

RESUMO

PURPOSE: Ionizing radiation is able to cause severe damage to cardiac implantable electronic devices (CIED). In Germany, the DEGRO/DGK guideline recommends close monitoring of patients with CIEDs undergoing radiotherapy (RT). Nevertheless, especially in the era of intensity-modulated techniques and predominant use of 6 MV photons, errors of CIEDs are rare events. Therefore, we performed daily CIED controls and hypothesized that no relevant device interaction would occur in our cohort. METHODS: From 2014 to 2018, we collected data of 51 patients (62 courses) with daily interrogation (n = 1046) of CIED. The dose to the skin above the CIED was measured by semiconductor or ion chamber dosimetry at least once per RT course. In many cases the dose was also calculated. RESULTS: The prescribed dose to the planning target volume (PTV) ranged from 7.5 to 78.0 Gy (IQR 27.8-61.0 Gy). The median measured cumulative dose to the skin above the CIED was 0.17 Gy, whereas the median calculated dose was 1.03 Gy. No error occurred in the group with maximum beam energy >10 MeV. Three events without clinical relevance could be recognized in the group with an intensity-modulated technique at 6 MV. None of the three concerned devices were located directly within the PTV. CONCLUSION: Errors of CIEDs during RT are rare events. The approach according to the DEGRO/DGK guideline is safe, but also consumes resources. In our cohort it was not compulsory to relocate any CIED. Clinically relevant events are uncommon, so it remains debatable which procedure is necessary. Daily controls could be avoided in some selected cases without compromising patient safety.


Assuntos
Contraindicações de Procedimentos , Desfibriladores Implantáveis , Fidelidade a Diretrizes , Marca-Passo Artificial , Radioterapia/efeitos adversos , Medição de Risco , Estudos de Coortes , Correlação de Dados , Relação Dose-Resposta à Radiação , Análise de Falha de Equipamento/estatística & dados numéricos , Neoplasias de Cabeça e Pescoço/radioterapia , Humanos , Incidência , Neoplasias Pulmonares/radioterapia , Análise de Ativação de Nêutrons , Radioterapia/estatística & dados numéricos , Estudos Retrospectivos , Medição de Risco/estatística & dados numéricos , Estatística como Assunto
18.
Radiat Prot Dosimetry ; 187(1): 17-20, 2019 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-31204777

RESUMO

While it is known that temperatures above 100°C have an effect on the reported dose of a TLD, it is less widely known what the susceptibility is to temperatures below 100°C, temperatures humans could reasonably expect to be exposed to. With the expanding nuclear industry in climates with more extreme temperatures, (e.g. United Arab Emirates and Saudi Arabia) the effect on a TLD if left on a dashboard of a car need to be evaluated. This research experimentally determined the extent of this thermal susceptibility by testing a range of high temperatures, 40°C - 90°C. The experimental results found that there is a statistically significant reduction in TLD-100H (natLiF:Mg,Cu,P) light output for TLDs there were exposed to temperatures as low as 40°C for 8 hour durations and 50°C for 2 hour durations. There is statistical difference in TLD-100H light output for elevated temperature durations of 8 hours compared to 24 hours.


Assuntos
Exposição Ambiental/análise , Análise de Falha de Equipamento/estatística & dados numéricos , Temperatura Alta , Monitoramento de Radiação/métodos , Dosimetria Termoluminescente/instrumentação , Humanos , Doses de Radiação , Dosimetria Termoluminescente/métodos
20.
ISA Trans ; 83: 261-275, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30268438

RESUMO

In the bearing health assessment issues, using the adaptive nonstationary vibration signal processing methods in the time-frequency domain, lead to improving of early fault detection. On the other hand, the noise and random impulses which contaminates the input data, are a major challenge in extracting fault-related features. The main goal of this paper is to improve the Ensemble Empirical mode decomposition (EEMD) algorithm and combine it with a new proposed denoising process and the higher order spectra to increase the accuracy and speed of the fault severity and type detection. The main approach is to use statistical features without using any dimension reduction and data training. To eliminate unrelated components from faulty condition, the best combination of denoising parameters based on the wavelet transform, is determined by a proposed performance index. In order to enhance the efficiency of the EEMD algorithm, a systematic method is presented to determine the proper amplitude of the additive noise and the Intrinsic Mode Functions (IMFs) selection scheme. The fault occurrence detection and the fault severity level identification are performed by the Fault Severity Index (FSI) definition based on the energy level of the Combined Fault-Sensitive IMF (CFSIMF) envelope using the central limit theorem. Also, taking the advantages of a bispectrum analysis of CFSIMF envelope, fault type recognition can be achieved by Fault Type Index (FTI) quantification. Finally, the proposed method is validated using experimental data set from two different test rigs. Also, the role of the optimum denoising process and the algorithm of systematic selection of the EEMD parameters are described regardless of its type and estimating the consistent degradation pattern.


Assuntos
Algoritmos , Análise de Falha de Equipamento/métodos , Análise de Falha de Equipamento/estatística & dados numéricos , Reprodutibilidade dos Testes , Processamento de Sinais Assistido por Computador , Razão Sinal-Ruído , Vibração , Análise de Ondaletas
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