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1.
Circ J ; 87(12): 1809-1816, 2023 11 24.
Artigo em Inglês | MEDLINE | ID: mdl-37532552

RESUMO

BACKGROUND: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61-6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria. CONCLUSIONS: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.


Assuntos
Arritmias Cardíacas , Marca-Passo Artificial , Feminino , Humanos , População do Leste Asiático , Desenho de Equipamento , Marca-Passo Artificial/efeitos adversos , Derrame Pericárdico/etiologia , Resultado do Tratamento , Masculino , Arritmias Cardíacas/terapia
2.
J Cardiovasc Electrophysiol ; 34(2): 438-444, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36579406

RESUMO

INTRODUCTION: A current limitation of single chamber implantable cardioverter defibrillators (ICDs) is the lack of an atrial lead to reliably detect atrial fibrillation (AF) episodes. A novel ventricular based atrial fibrillation (VBAF) detection algorithm was created for single chamber ICDs to assess R-R variability for detection of AF. METHODS: Patients implanted with Visia AF™ ICDs were prospectively enrolled in the Medtronic Product Surveillance Registry from December 15, 2015 to January 23, 2019 and followed with at least 30 days of monitoring with the algorithm. Time to device-detected daily burden of AF ≥ 6 min, ≥6 h, and ≥23 h were reported. Clinical actions after device-detected AF were recorded. RESULTS: A total of 291 patients were enrolled with a mean follow-up of 22.5 ± 7.9 months. Of these, 212 (73%) had no prior history of AF at device implant. However, 38% of these individuals had AF detected with the VBAF algorithm with daily burden of ≥6 min within two years of implant. In these 80 patients with newly detected AF by their ICD, 23 (29%) had a confirmed clinical diagnosis of AF by their provider. Of patients with a clinical diagnosis of AF, nine (39%) were newly placed on anticoagulation, including five of five (100%) patients having a burden >23 h. CONCLUSIONS: Continuous AF monitoring with the new VBAF algorithm permits early identification and actionable treatment for patients with undiagnosed AF that may improve patient outcomes.


Assuntos
Fibrilação Atrial , Desfibriladores Implantáveis , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Fibrilação Atrial/etiologia , Desfibriladores Implantáveis/efeitos adversos , Fibrilação Ventricular/etiologia
3.
Circ Arrhythm Electrophysiol ; 15(8): e011029, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35925831

RESUMO

BACKGROUND: Lead dislodgement (LD) has been one of the most common early complications after cardiovascular implantable electronic device implant. However, limited data are available on the clinical characteristics and long-term outcomes of LD events. The aim of this study was to examine the risk factors, clinical significance, and management strategies of LD events after cardiovascular implantable electronic device implant. METHODS: This study was a retrospective cohort analysis of 20 683 patients who underwent cardiovascular implantable electronic device implant between January 1, 2010 and January 31, 2020 in Medtronic's Product Surveillance Registry, with a mean follow-up time of 3.3±2.5 SD years. The study population was divided into 2 groups: group A with LD events (N=350) and group B without LD events (N=20 333). RESULTS: During this period, 350 patients (1.69%) had LD events involving 371 leads (0.95%), among a total of 39 060 leads implanted. Passive fixation type (right atrium pacing lead, P=0.041), lower sensing amplitude (right ventricle defibrillating lead, P=0.020), and lower lead impedance at implant (right atrium pacing lead, P=0.009) were associated with increased LD risk. Multivariate analysis showed female sex (hazard ratio, 1.520, P=0.008) and higher body mass index (hazard ratio, 1.012, P=0.001) were independently associated with increased risk of LD events. LD events were not associated with significant changes in the long-term risks of cardiac and overall mortality. In group A, repositioning the dislodged leads increased the risk of a second LD event compared with implanting new leads (P=0.012). CONCLUSIONS: Female sex and higher body mass index were associated with higher risk of LD events in the Product Surveillance Registry. Among patients with dislodged leads, implanting new leads was associated with lower risk of future LD events. Further studies on how to reduce LD risk and to improve management of these events are needed. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01524276.


Assuntos
Desfibriladores Implantáveis , Desfibriladores Implantáveis/efeitos adversos , Feminino , Ventrículos do Coração , Humanos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco
4.
Pulm Circ ; 9(4): 2045894019878615, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31723407

RESUMO

BACKGROUND: The DelIVery for Pulmonary Arterial Hypertension clinical trial was a multi-center, prospective, single arm, Investigational Device Exemption study utilizing a fully implantable, programmable intravascular delivery system consisting of a pump and a catheter for intravenous treprostinil. The study met its primary endpoint and demonstrated that the intravascular delivery system significantly reduced catheter related complications at 22,000 subject-days of follow-up compared with a predefined objective performance criterion. Here we summarize the results obtained during a 6.4-year follow-up period. METHODS: Throughout study follow-up, participants had clinic visits and medication refills at least every 12 weeks (dependent on the subjects' dose). All adverse events and intravascular delivery system complications were evaluated and recorded. RESULTS: Sixty pulmonary arterial hypertension subjects were followed post device implantation for approximately 282 patient-years (range 87 days to 6.4 years). Of the 60 subjects, 14 died (1 related to intravascular delivery system pump failure), 2 withdrew after lung transplants, and 2 withdrew due to pump pocket infection. No catheter-related bloodstream infections, catheter thrombosis or occlusions, or catheter kinks occurred through 282 patient-years. Two participants had adverse events of abdominal pain, rash, due to subcutaneous treprostinil "leaks" after one catheter puncture and one catheter laceration during pump refill and replacement, respectively. Eight pump failure events occurred: seven pump motor stalls and one early replacement (faulty battery). CONCLUSION: Delivery of treprostinil with an intravascular delivery system is a safe alternative to an external delivery system, while providing enhanced life experiences. To preserve the risk-benefit ratio, treatment at specialized pulmonary arterial hypertension centers is recommended until training is disseminated at other sites.

5.
J Arthroplasty ; 34(6): 1139-1142, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30885407

RESUMO

BACKGROUND: Interest in direct anterior approach (DAA) has increased over the last decade. In our previously published study comparing DAA to posterolateral approach (PA), early 3-month benefits were noted in terms of pain and function. There was no difference noted at 6 or 12 months. This study reports average 5-year follow-up of our original study. METHODS: Originally there were 43 DAA patients and 44 PA patients. At an average 5-year follow-up, patients were evaluated clinically with a University of California at Los Angeles activity score, Harris hip score, and Hip Disability and Osteoarthritis Outcome Score Jr Survivorship analysis was calculated. Radiographs were evaluated for loosening and evidence of radiolucent lines. RESULTS: There were 2 deaths 1 in each group, neither was related to the implant or procedure. Four patients were lost to follow-up: 2 in the DAA group and 2 in the PA group. There was no statistical difference between surgical approaches in terms of Harris hip score, University of California at Los Angeles activity score, and Hip Disability and Osteoarthritis Outcome Score Jr. The 7-year survivorship was not significantly different. There were no loose implants at average 5-year follow-up. CONCLUSION: Both DAA and PA yield good results at an average 5-year follow-up in terms of survivorship, function, rate of complications, and radiographic analysis.


Assuntos
Artroplastia de Quadril/métodos , Prótese de Quadril , Desenho de Prótese , Adulto , Idoso , Artroplastia de Quadril/instrumentação , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Estudos Prospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
6.
Langmuir ; 33(51): 14592-14598, 2017 12 26.
Artigo em Inglês | MEDLINE | ID: mdl-29207247

RESUMO

A new procedure is presented for direct generation of surface micropatterns on uniaxially oriented polyethylene (PE) films using interference holography with a nanosecond pulsed laser. An ultraviolet absorber, 2-(2H-benzotriazol-2-yl)-4,6-di-tert-pentylphenol (BZT) is incorporated into PE prior to stretching to generate absorption at the wavelength of the laser. Illumination with an interference pattern in the absorption band of BZT leads to an obvious height variation in the exposed regions and consequently relief gratings are generated. The height in the exposed regions is strongly dependent on the angle between the grating direction and the film orientation direction. This phenomenon is attributed to a combination of events such as melting, entropic contraction, recrystallization, thermal evaporation of BZT, and anisotropic thermal conductivity. It is shown that the relief height increases with increasing BZT concentration and exhibits a linear dependence on the energy dose above a certain threshold. Additionally, the oriented PE films with the surface micropatterns are explored for strain sensors. The results demonstrate that small strains below 10% are monitored accurately in tensile deformation of the micropatterned, oriented PE films which makes these films potentially useful as strain sensors.

7.
ACS Appl Mater Interfaces ; 9(37): 32161-32167, 2017 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-28840717

RESUMO

A photonic shape memory polymer film that shows large color response (∼155 nm) in a wide temperature range has been fabricated from a semi-interpenetrating network of a cholesteric polymer and poly(benzyl acrylate). The large color response is achieved by mechanical embossing of the photonic film above its broad glass transition temperature. The embossed film, as it recovers to its original shape on heating through the broad thermal transition, exhibits multiple structural colors ranging from blue to orange. The relaxation behavior of the embossed film can be fully described using a Kelvin-Voigt model, which reveals that the influence of temperature on the generation of colors is much stronger than that of time, thereby producing stable multiple colors.

8.
Small ; 13(33)2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28736935

RESUMO

While self-assembled molecular building blocks could lead to many next-generation functional organic nanomaterials, control over the thin-film morphologies to yield monolithic sub-5 nm patterns with 3D orientational control at macroscopic length scales remains a grand challenge. A series of photoresponsive hybrid oligo(dimethylsiloxane) liquid crystals that form periodic cylindrical nanostructures with periodicities between 3.8 and 5.1 nm is studied. The liquid crystals can be aligned in-plane by exposure to actinic linearly polarized light and out-of-plane by exposure to actinic unpolarized light. The photoalignment is most efficient when performed just under the clearing point of the liquid crystal, at which the cylindrical nanostructures are reoriented within minutes. These results allow the generation of highly ordered sub-5 nm patterns in thin films at macroscopic length scales, with control over the orientation in a noncontact fashion.

9.
Adv Mater ; 28(45): 10068-10072, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27689779

RESUMO

Highly ordered nanopatterns are obtained at sub-5 nm periodicities by the graphoepitaxial directed self-assembly of monodisperse, oligo(dimethylsiloxane) liquid crystals. These hybrid organic/inorganic liquid crystals are of high interest for nanopatterning applications due to the combination of their ultrasmall feature sizes and their ability to be directed into highly ordered domains without additional annealing.

10.
PLoS One ; 10(7): e0133088, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26207990

RESUMO

Line patterns produced by lamellae- and cylinder-forming block copolymer (BCP) thin films are of widespread interest for their potential to enable nanoscale patterning over large areas. In order for such patterning methods to effectively integrate with current technologies, the resulting patterns need to have low defect densities, and be produced in a short timescale. To understand whether a given polymer or annealing method might potentially meet such challenges, it is necessary to examine the evolution of defects. Unfortunately, few tools are readily available to researchers, particularly those engaged in the synthesis and design of new polymeric systems with the potential for patterning, to measure defects in such line patterns. To this end, we present an image analysis tool, which we have developed and made available, to measure the characteristics of such patterns in an automated fashion. Additionally we apply the tool to six cylinder-forming polystyrene-block-poly(2-vinylpyridine) polymers thermally annealed to explore the relationship between the size of each polymer and measured characteristics including line period, line-width, defect density, line-edge roughness (LER), line-width roughness (LWR), and correlation length. Finally, we explore the line-edge roughness, line-width roughness, defect density, and correlation length as a function of the image area sampled to determine each in a more rigorous fashion.


Assuntos
Membranas Artificiais , Nanoestruturas , Reconhecimento Automatizado de Padrão , Polímeros , Poliestirenos , Polivinil , Piridinas , Teste de Materiais , Propriedades de Superfície
11.
J Neurosurg ; 122(2): 443-8, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25415066

RESUMO

OBJECT: The real-world effectiveness of antibiotic-impregnated shunt catheters to reduce the incidence of shunt infections is still debated. The literature to date consists mostly of small, single-institution studies. The aim of this study was to assess the incidence of infection for antibiotic-impregnated catheters (AICs) versus standard shunt catheters in a large nationwide administrative database. METHODS: The authors retrospectively reviewed hospital discharge and billing records from the Premier Perspective Database from April 2003 to July 2009 to identify all adult and pediatric patients undergoing de novo ventricular shunt placement. The primary end point was the incidence of shunt infection within 1 year of implantation. Multivariate logistical regression was performed to determine factors associated with increased incidence of infection. RESULTS: A total of 10,819 adult (AIC, 963; standard catheter, 9856) and 1770 pediatric (AIC, 229; standard catheter, 1541) patients underwent ventricular shunt placement in 287 US hospitals. Overall, the incidence of infection was 3.5% in adults (n=380) and 6.6% in pediatric patients (n=116). AICs were associated with significant reduction in infection for both adult (2.2% vs 3.6%, p=0.02) and pediatric (2.6% vs 7.1%, p<0.01) patients. AIC use was associated with reduced infection regardless of hospital size, annual shunt volume, hospital location, or patient risk factors and remained associated with a reduced infection in multivariate analysis for both adult (p=0.02) and pediatric (p=0.02) patients. CONCLUSIONS: The use of antibiotic-impregnated shunt catheters was associated with a reduction in shunt infections for both adult and pediatric patients. This provides further support that AICs may represent a reliable means of reducing shunt infections for both adult and pediatric patients.


Assuntos
Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Infecções Bacterianas/prevenção & controle , Catéteres/microbiologia , Derivações do Líquido Cefalorraquidiano/efeitos adversos , Hidrocefalia/terapia , Adolescente , Idoso , Idoso de 80 Anos ou mais , Infecções Bacterianas/epidemiologia , Derivações do Líquido Cefalorraquidiano/instrumentação , Criança , Pré-Escolar , Feminino , Humanos , Incidência , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
12.
World Neurosurg ; 83(3): 382-6, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24933241

RESUMO

BACKGROUND: Cerebrospinal fluid (CSF) shunt infection is a major cause of morbidity and mortality in the treatment of hydrocephalus and is associated with significant medical cost. Several studies have demonstrated the efficacy of antibiotic-impregnated (AI) shunt catheters in reducing CSF shunt infection; however, providers remain reluctant to adopt AI catheters into practice because of the increased upfront cost. The objective of this study was to determine if the use of AI catheters provided cost savings in a large nationwide database. METHODS: Hospital discharge and billing records from the Premier Perspective Database from 2003-2009 were retrospectively reviewed to identify all adult and pediatric patients undergoing de novo ventricular shunt placement. The incidence of shunt infection within 1 year of implantation was determined. Shunt infection-related cost was defined as all inpatient billing costs incurred during hospitalization for treatment of shunt infection. RESULTS: In 287 U.S. hospitals, 10,819 adult (AI catheters, 963; standard catheters, 9856) and 1770 pediatric (AI catheters, 229; standard catheters, 1541) patients underwent ventricular shunt placement. AI catheters were associated with significant reduction in infection for both adult (2.2% vs. 3.6%, P = 0.02) and pediatric (2.6% vs. 7.1%, P < 0.01) patients. Total infection-related costs were $17,371,320 ($45,714 ± $49,745 per shunt infection) for adult patients and $6,508,064 ($56,104 ± $65,746 per shunt infection) for pediatric patients. Infection-related cost per 100 de novo shunts placed was $120,534 for AI catheters and $162,659 for standard catheters in adult patients and $165,087 for AI catheters and $395,477 for standard catheters in pediatric patients. CONCLUSIONS: In analysis of this large, nationwide database, AI catheters were found to be associated with a significant reduction in infection incidence, resulting in tremendous cost savings. AI catheters were associated with a cost savings of $42,125 and $230,390 per 100 de novo shunts placed in adult and pediatric patients, respectively.


Assuntos
Antibacterianos/economia , Antibacterianos/uso terapêutico , Infecções Relacionadas a Cateter/economia , Infecções Relacionadas a Cateter/prevenção & controle , Derivações do Líquido Cefalorraquidiano/economia , Hidrocefalia/economia , Hidrocefalia/cirurgia , Adolescente , Adulto , Idoso , Antibacterianos/administração & dosagem , Catéteres , Criança , Pré-Escolar , Redução de Custos , Bases de Dados Factuais , Feminino , Humanos , Lactente , Recém-Nascido , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
13.
ACS Nano ; 8(4): 3979-91, 2014 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-24655292

RESUMO

The self-assembly of block copolymer (BCP) thin films is a versatile method for producing periodic nanoscale patterns with a variety of shapes. The key to attaining a desired pattern or structure is the annealing step undertaken to facilitate the reorganization of nanoscale phase-segregated domains of the BCP on a surface. Annealing BCPs on silicon substrates using a microwave oven has been shown to be very fast (seconds to minutes), both with and without contributions from solvent vapor. The mechanism of the microwave annealing process remains, however, unclear. This work endeavors to uncover the key steps that take place during microwave annealing, which enable the self-assembly process to proceed. Through the use of in situ temperature monitoring with a fiber optic temperature probe in direct contact with the sample, we have demonstrated that the silicon substrate on which the BCP film is cast is the dominant source of heating if the doping of the silicon wafer is sufficiently low. Surface temperatures as high as 240 °C are reached in under 1 min for lightly doped, high resistivity silicon wafers (n- or p-type). The influence of doping, sample size, and BCP composition was analyzed to rule out other possible mechanisms. In situ temperature monitoring of various polymer samples (PS, P2VP, PMMA, and the BCPs used here) showed that the polymers do not heat to any significant extent on their own with microwave irradiation of this frequency (2.45 GHz) and power (∼600 W). It was demonstrated that BCP annealing can be effectively carried out in 60 s on non-microwave-responsive substrates, such as highly doped silicon, indium tin oxide (ITO)-coated glass, glass, and Kapton, by placing a piece of high resistivity silicon wafer in contact with the sample-in this configuration, the silicon wafer is termed the heating element. Annealing and self-assembly of polystyrene-block-poly(2-vinylpyridine) (PS-b-P2VP) and polystyrene-block-poly(methyl methacrylate) (PS-b-PMMA) BCPs into horizontal cylinder structures were shown to take place in under 1 min, using a silicon wafer heating element, in a household microwave oven. Defect densities were calculated and were shown to decrease with higher maximum obtained temperatures. Conflicting results in the literature regarding BCP annealing with microwave are explained in light of the results obtained in this study.

14.
Aust Crit Care ; 26(4): 180-8, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23583261

RESUMO

BACKGROUND: Ventilator associated pneumonia (VAP) in the intensive care unit (ICU) has been shown to be associated with significant morbidity and mortality.(1-3) It has been reported to affect between 9 and 27% of intubated patients receiving mechanical ventilation.(4-6) OBJECTIVE: A meta-analysis was undertaken to combine information from published studies of the effect of subglottic drainage of secretions on the incidence of ventilated associated pneumonia in adult ICU patients. DATA SOURCES: Studies were identified by searching MEDLINE (1966 to January 2011), EMBASE (1980-2011), and CINAHL (1982 to January 2011). REVIEW METHODS: Randomized trials of subglottic drainage of secretions compared to usual care in adult mechanically ventilated ICU patients were included in the meta-analysis. RESULTS: Subglottic drainage of secretions was estimated to reduced the risk of VAP by 48% (fixed-effect relative risk (RR)=0.52, 95% confidence interval (CI), 0.42-0.65). When comparing subglottic drainage and control groups, the summary relative risk for ICU mortality was 1.05 (95% CI, 0.86-1.28) and for hospital mortality was 0.96 (95% CI, 0.81-1.12). Overall subglottic drainage effect on days of mechanical ventilation was -1.04 days (95% CI, -2.79-0.71). CONCLUSION: This meta-analysis of published randomized control trials shows that almost one-half of cases of VAP may be prevented with the use of specialized endotracheal tubes designed to drain subglottic secretions. Time on mechanical ventilation may be reduced and time to development of VAP may be increased, but no reduction in ICU or hospital mortality has been observed in published trials.


Assuntos
Cuidados Críticos/métodos , Drenagem/instrumentação , Intubação Intratraqueal/instrumentação , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Desenho de Equipamento , Glote , Humanos , Unidades de Terapia Intensiva , Respiração Artificial/efeitos adversos
15.
J Arthroplasty ; 28(4): 624-30, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23142442

RESUMO

Early post-operative clinical outcomes were analyzed for subjects having a rotating platform (RP) posterior stabilized (PS) total knee arthroplasty (TKA); a subset of which underwent in vivo kinematics and produced kinematic results that compare well with subjects in previous fluoroscopic studies that were deemed excellent in nature. In total, 153 subjects (180 knees) were enrolled in the prospective clinical study. TKAs were performed by three surgeons at three North American centers. Ten subjects were randomly chosen and evaluated under fluoroscopic surveillance. Average active flexion increased from 113.3 (SD=16.6) degrees before surgery to 118.3 (SD=9.9) degrees 12-months post-operatively. American Knee Society (AKS) function score increased from an average of 57.6 (SD=18.8) points pre-operatively to 85.3 (SD=16.6) points 12-months post-operatively. For the kinematic subset, post-operative weight-bearing flexion was 115.9 (SD=8.4),while subjects achieved an average posterior femoral rollback of their lateral condyle of -5.4mm. The average femorotibial axial rotation from full extension to maximum weight-bearing flexion was 3.9 degrees (SD=3.9). Certain kinematic parameters were deemed statistically significant when determining early post-operative clinical success.


Assuntos
Artroplastia do Joelho , Prótese do Joelho , Adulto , Idoso , Idoso de 80 Anos ou mais , Fenômenos Biomecânicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Amplitude de Movimento Articular , Resultado do Tratamento
16.
J Arthroplasty ; 28(3): 429-38, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23219622

RESUMO

From March 2006 to August 2008, 93 subjects (186 knees) underwent simultaneous bilateral total knee arthroplasty performed by eight surgeons at North American centers. This randomized study was conducted to determine whether non-weight-bearing passive flexion was superior for knees receiving a posterior stabilized high flexion device compared to a posterior stabilized standard device in the contra-lateral knee. Weight-bearing single leg active flexion was one secondary endpoint. Follow-up compliance was 92.5%. Results show small, but significant superiority in the motion metrics for the high flexion device compared to the standard device 12 months after surgery, especially for a subgroup of patients with pre-operative flexion less than 120° in both knees. Thus, the ideal candidate for the high flexion device may be one with lesser pre-operative flexion.


Assuntos
Artroplastia do Joelho , Articulação do Joelho/fisiopatologia , Prótese do Joelho , Osteoartrite do Joelho/fisiopatologia , Desenho de Prótese , Adulto , Idoso , Feminino , Humanos , Articulação do Joelho/cirurgia , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/cirurgia , Amplitude de Movimento Articular
17.
Neurosurgery ; 71(1): 6-13, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22418581

RESUMO

BACKGROUND: External ventricular drainage (EVD) catheters provide reliable and accurate means of monitoring intracranial pressure and alleviating elevated pressures via drainage of cerebrospinal fluid (CSF). CSF infections occur in approximately 9% of patients. Antibiotic-impregnated (AI) EVD catheters were developed with the goal of reducing the occurrence of EVD catheter-related CSF infections and their associated complications. OBJECTIVE: To present an international, prospective, randomized, open-label trial to evaluate infection incidence of AI vs standard EVD catheters. METHODS: Infection was defined as (1) proven infection, positive CSF culture and positive Gram stain or (2) suspected infection: (A) positive CSF culture with no organisms identified on initial Gram stain; (B) negative CSF culture with a gram-positive or -negative stain; (C) CSF leukocytosis with a white blood cell/red blood cell count >0.02. RESULTS: Four hundred thirty-four patients underwent implantation of an EVD catheter. One hundred seventy-six patients in the AI-EVD cohort and 181 in the standard EVD catheter cohort were eligible for evaluation of infection. The 2 groups were similar in all clinical characteristics. Proven infection was documented in 9 (2.5%) patients (AI: 4 [2.3%] vs standard: 5 [2.8%], P = 1.0). Suspected infection was documented in 31 (17.6%) patients receiving AI and 37 (20.4%) patients receiving standard EVD catheters, P = .504. Duration of time to suspected infection was prolonged in the AI cohort (8.8 ± 6.1 days) compared with the standard EVD cohort (4.6 ± 4.2 days), P = .002. CONCLUSION: AI-EVD catheters were associated with an extremely low rate of catheter-related infections. AI catheters were not associated with risk reduction in EVD infection compared to standard catheters. Use of AI-EVD catheters is a safe option for a wide variety of patients requiring CSF drainage and monitoring, but the efficacy of AI-EVD catheters was not supported in this trial.


Assuntos
Antibacterianos/uso terapêutico , Infecções Bacterianas/etiologia , Infecções Relacionadas a Cateter/etiologia , Derivações do Líquido Cefalorraquidiano/efeitos adversos , Adulto , Idoso , Infecções Bacterianas/tratamento farmacológico , Infecções Relacionadas a Cateter/tratamento farmacológico , Estudos de Coortes , Feminino , Humanos , Cooperação Internacional , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Fatores de Tempo , Adulto Jovem
18.
Nano Lett ; 12(1): 264-8, 2012 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-22168820

RESUMO

Block copolymers can be used to template large arrays of nanopatterns with periodicities equal to the characteristic spacing of the polymer. Here we demonstrate a technique capitalizing on the multilayered arrangement of cylindrical domains to effectively double the pattern density templated by a given polymer. By controlling the initial thickness of the film and the solvent annealing conditions, it was possible to reproducibly create density doubled lines by swelling the film with solvent until bilayers of horizontal cylinders were obtained. This process was also demonstrated to be compatible with graphoepitaxy.


Assuntos
Cristalização/métodos , Impressão Molecular/métodos , Nanoestruturas/química , Nanoestruturas/ultraestrutura , Polímeros/química , Substâncias Macromoleculares/química , Teste de Materiais , Conformação Molecular , Tamanho da Partícula , Gravidade Específica , Propriedades de Superfície
19.
Orthopedics ; 34(1): 16, 2011 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-21210627

RESUMO

Interest in mobile-bearing knee prostheses is increasing in the US market. We studied results at 2 to 5 years with a mobile-bearing system that includes a cobalt-chrome tibial tray and femoral component with a polyethylene cruciate-retaining tibial component insert that allows rotation around a central axis and can be used with cruciate-retaining or posterior-stabilized femoral components. The inserts used in this study were cruciate retaining and did not include the posterior-stabilized design. The goal of this study was to demonstrate the function and safety of this prosthesis along with the lack of spinout, which is a major concern in the mobile-bearing knee. Four hundred thirty-five knees constituted the study cohort and underwent survivorship analysis and complication reporting. Routine clinic evaluations included pre- and postoperative radiographs and Knee Society knee and function scores at 6 and 12 weeks and every 2 years. The most recent follow-up data within 2 to 5 years was included for the study along with survey data. Flexion at most recent follow-up averaged 125°. Knee Society score at most recent visit averaged 88 of 100. Knee Society function score averaged 83 of 100. Radiographic results were available for 226 knees, with 97.3% assessed as normal and 6 with these issues: patella stress fracture (3), aseptic tibial loosening (1), patellar osteolysis (1), and patella aseptic loosening (1). In comparison with the fixed-bearing knee equivalent, this mobile-bearing knee demonstrated at least equivalent results in terms of survivorship, function, and patient satisfaction in the short- and mid-term.


Assuntos
Artroplastia do Joelho/instrumentação , Articulação do Joelho/cirurgia , Prótese do Joelho , Desenho de Prótese , Falha de Prótese , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/métodos , Materiais Biocompatíveis , Cimentação , Ligas de Cromo , Feminino , Indicadores Básicos de Saúde , Humanos , Articulação do Joelho/diagnóstico por imagem , Articulação do Joelho/fisiopatologia , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Complicações Pós-Operatórias , Radiografia , Amplitude de Movimento Articular , Resultado do Tratamento
20.
ACS Nano ; 4(11): 7021-9, 2010 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-20964379

RESUMO

Block copolymer self-assembly is an innovative technology capable of patterning technologically relevant substrates with nanoscale precision for a range of applications from integrated circuit fabrication to tissue interfacing, for example. In this article, we demonstrate a microwave-based method of rapidly inducing order in block copolymer structures. The technique involves the usage of a commercial microwave reactor to anneal block copolymer films in the presence of appropriate solvents, and we explore the effect of various parameters over the polymer assembly speed and defect density. The approach is applied to the commonly used poly(styrene)-b-poly(methyl methacrylate) (PS-b-PMMA) and poly(styrene)-b-poly(2-vinylpyridine) (PS-b-P2VP) families of block copolymers, and it is found that the substrate resistivity, solvent environment, and anneal temperature all critically influence the self-assembly process. For selected systems, highly ordered patterns were achieved in less than 3 min. In addition, we establish the compatibility of the technique with directed assembly by graphoepitaxy.

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