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1.
Am J Cardiol ; 162: 31-40, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34903344

RESUMO

Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).


Assuntos
Implantes Absorvíveis/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/cirurgia , Oclusão de Enxerto Vascular/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Stents/efeitos adversos , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/diagnóstico , Reestenose Coronária/epidemiologia , Feminino , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Reoperação , Fatores de Tempo , Resultado do Tratamento
2.
Plast Reconstr Surg ; 148(4): 838-848, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34398868

RESUMO

BACKGROUND: Resorbable hardware allows adequate strength for maintaining the relative position of the craniofacial skeleton during osseous healing, and allowing subsequent growth in pediatric patients. The purpose of this study was to determine the complication profile of the latest copolymer of resorbable plates for craniofacial reconstruction in pediatric patients. METHODS: Retrospective query of the operative billing record was performed for use of the DePuy Synthes Rapidsorb Fixation System at the authors' tertiary children's hospital from 2015 to 2019. Three hundred twenty-five patients were randomly selected for analysis of complications within the first postoperative year. RESULTS: Median age at craniofacial reconstruction was 3.0 years, with 127 procedures (39.9 percent) performed for an intracranial mass and 141 procedures (44.3 percent) performed for craniosynostosis. Overall, 7.9 percent patients had a postoperative wound complication. The most common complications were dehiscence (3.8 percent), hematoma/seroma (3.5 percent), and infection (2.5 percent). There were no instances of extrusion, plate fracture, or screw loosening. Hardware complications in the temporoparietal region were more likely to occur at incision sites (p = 0.001), whereas wound complications at the frontal region were more likely to occur away from incision sites (p < 0.001). There were no differences in complications between plates secured with resorbable screws or with the resorbable injectable polymer system (p ≥ 0.161 for all). Radiotherapy was significantly implicated in development of clinical infection (p = 0.001), culture-positive infection (p < 0.001), readmission (p = 0.007), reoperation (p = 0.003), and plate removal (p = 0.007). CONCLUSION: Resorbable cranial hardware has an overall favorable complication profile for craniofacial reconstruction in pediatric patients undergoing surgical intervention for craniosynostosis or intracranial mass resection.


Assuntos
Implantes Absorvíveis/efeitos adversos , Procedimentos de Cirurgia Plástica/efeitos adversos , Copolímero de Ácido Poliláctico e Ácido Poliglicólico/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Crânio/cirurgia , Placas Ósseas/efeitos adversos , Parafusos Ósseos/efeitos adversos , Pré-Escolar , Craniossinostoses/cirurgia , Feminino , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Procedimentos de Cirurgia Plástica/instrumentação , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Crânio/anormalidades , Crânio/lesões , Fraturas Cranianas/cirurgia , Neoplasias Cranianas/cirurgia , Resultado do Tratamento
3.
J Laryngol Otol ; 135(10): 858-863, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34423758

RESUMO

OBJECTIVE: This study evaluated the post-operative indications for sinonasal topical steroid treatment using a corticosteroid (steroid)-eluting, sinus-bioabsorbable device and its effects in patients with eosinophilic chronic rhinosinusitis. METHOD: Post-operative courses were investigated in two groups: group A with patients who underwent sinonasal topical steroid treatment, and group B with control patients who did not. RESULTS: Group A was significantly younger than group B (p < 0.01), and the pre-operative computed tomography score was significantly higher in group A than in group B (p < 0.05). In the post-operative stage, the nasal symptoms questionnaire component of olfactory loss and the post-operative endoscopic appearance score were significantly worse in group A than in group B (p < 0.01). CONCLUSION: These data suggest that younger age, more severe rhinosinusitis and post-operative olfactory loss led to the need for sinonasal topical steroid treatment to prevent relapsing inflammation after functional endoscopic sinus surgery in patients with eosinophilic chronic rhinosinusitis.


Assuntos
Endoscopia/métodos , Seios Paranasais/cirurgia , Rinite/cirurgia , Sinusite/cirurgia , Esteroides/administração & dosagem , Implantes Absorvíveis/efeitos adversos , Administração Tópica , Adulto , Idoso , Estudos de Casos e Controles , Doença Crônica , Eosinofilia/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos do Olfato/epidemiologia , Seios Paranasais/efeitos dos fármacos , Período Pós-Operatório , Recidiva , Estudos Retrospectivos , Rinite/tratamento farmacológico , Índice de Gravidade de Doença , Sinusite/tratamento farmacológico , Esteroides/uso terapêutico , Tomografia Computadorizada por Raios X/estatística & dados numéricos
4.
Adv Mater ; 33(36): e2101447, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34302396

RESUMO

Existing temporary epicardial pacing wires (TPWs) are rigid and non-absorbable, such that they can cause severe complications after cardiac surgery. Here, a soft and absorbable temporary epicardial pacing wire (saTPW) for effectively correcting abnormal heart rates in a rabbit model, such as bradycardia and ventricular premature beat, is developed. The saTPW exhibits excellent conductivity, flexibility, cycling stability (>100 000 cycles), and less inflammatory response during two-month subcutaneous implantation in a rat model. The saTPW which consists of poly(l-lactide-co-ε-caprolactone) and liquid metal, can degrade about 13% (mass loss) in the rats over a two-month subcutaneous implantation. It can be absorbed over time in the body. The cytocompatibility and absorbability avoid secondary injuries caused by remaining wires which are permanently left in the body. The saTPW will provide a great platform for diagnosis and treatments in cardiovascular diseases by delivering the physiological signal and applying electrical stimulation for therapy.


Assuntos
Implantes Absorvíveis/efeitos adversos , Materiais Biocompatíveis/química , Procedimentos Cirúrgicos Cardíacos/métodos , Metais/química , Poliésteres/química , Animais , Estimulação Cardíaca Artificial , Eletrodos Implantados/efeitos adversos , Gálio/química , Humanos , Índio/química , Masculino , Polietilenotereftalatos , Coelhos , Ratos , Fatores de Risco
5.
Pharm Res ; 38(5): 885-900, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33970399

RESUMO

PURPOSE: This study aimed to develop personalized biodegradable stent (BDS) for the treatment of coronary heart disease. Three-dimensional (3D) printing technique has offered easy and fast fabrication of BDS with enhanced reproducibility and efficacy. METHODS: A variety of BDS were printed with 3 types of hydrogel (~5 ml) resources (10%w/v sodium alginate (SA), 10%w/v cysteine-sodium alginate (SA-CYS), and 10%w/v cysteine-sodium alginate with 0.4%w/v PLA-nanofibers (SA-CYS-NF)) dispersed from an 22G print head nozzle attached to the BD-syringe. The printability of hydrogels into 3D structures was examined based on such variables as hydrogel's viscosity, printing distance, printing speed and the nozzle size. RESULTS: It was demonstrated that alginate composition (10%w/v) offered BDS with sufficient viscosity that defined the thickness and swelling ratio of the stent struts. The thickness of the strut was found to be 338.7 ± 29.3 µm, 262.5 ± 14.7 µm and 237.1 ± 14.7 µm for stents made of SA, SA-CYS and SA-CYS-NF, respectively. SA-CYS-NF stent displayed the highest swelling ratio of 38.8 ± 2.9% at the initial 30 min, whereas stents made of SA and SA-CYS had 23.1 ± 2.4% and 22.0 ± 2.4%, respectively. CONCLUSION: The printed stents had sufficient mechanical strength and were stable against pseudo-physiological wall shear stress. An addition of nanofibers to alginate hydrogel significantly enhanced the biodegradation rates of the stents. In vitro cell culture studies revealed that stents had no cytotoxic effects on human umbilical vein endothelial cells (HUVECs) and Raw 264.7 cells (i.e., Monocyte/macrophage-like cells), supporting that stents are biocompatible and can be explored for future clinical applications.


Assuntos
Implantes Absorvíveis/efeitos adversos , Hidrogéis/química , Impressão Tridimensional , Stents/efeitos adversos , Alginatos/química , Angioplastia/instrumentação , Animais , Aterosclerose/cirurgia , Cisteína/química , Células Endoteliais da Veia Umbilical Humana , Humanos , Teste de Materiais , Camundongos , Nanofibras/química , Poliésteres/química , Células RAW 264.7 , Reprodutibilidade dos Testes
6.
J Biomed Mater Res A ; 109(8): 1521-1529, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33590952

RESUMO

The local response of tissue triggered by implantation of degradable magnesium-based implant materials was investigated in vivo in a murine model. Pins (5.0 mm length by 0.5 mm diameter) made of Mg, Mg-10Gd, and Ti were implanted in the leg muscle tissue of C57Bl/6N mice (n = 6). Implantation was generally well tolerated as documented by only a mild short term increase in a multidimensional scoring index. Lack of difference between the groups indicated that the response was systemic and surgery related rather than material dependent. Longitudinal in vivo monitoring utilizing micro-computed tomography over 42 days demonstrated the highest and most heterogeneous degradation for Mg-10Gd. Elemental imaging of the explants by micro X-ray fluorescence spectrometry showed a dense calcium-phosphate-containing degradation layer. In order to monitor resulting surgery induced and/or implant material associated local cell stress, sphingomyelin based liposomes containing indocyanine green were administered. An initial increase in fluorescent signals (3-7 days after implantation) indicating cell stress at the site of the implantation was measured by in vivo fluorescent molecular tomography. The signal decreased until the 42nd day for all materials. These findings demonstrate that Mg based implants are well tolerated causing only mild and short term adverse reactions.


Assuntos
Implantes Absorvíveis , Ligas/análise , Magnésio/análise , Implantes Absorvíveis/efeitos adversos , Ligas/efeitos adversos , Ligas/metabolismo , Animais , Imageamento Tridimensional , Implantes Experimentais/efeitos adversos , Magnésio/efeitos adversos , Magnésio/metabolismo , Teste de Materiais , Camundongos Endogâmicos C57BL , Imagem Óptica , Espectrometria por Raios X
7.
J Vasc Surg Venous Lymphat Disord ; 9(2): 510-524.e4, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33227458

RESUMO

OBJECTIVE: Absorbable inferior vena cava filters (IVCFs) could be more effective and safer than standard IVCFs in theory, as they will self-resorb over time, thus rendering the need for filter retrieval and the risks associated with it unnecessary. This scoping review aims to evaluate the design of current absorbable IVCFs, review the development phase of the absorbable IVCFs, assess the efficacy of the absorbable IVCFs and their complications, and discuss the limitations and areas for future research. METHODS: MEDLINE, PubMed, and Embase databases were electronically searched and citations of relevant studies manually searched. Study selection and data extraction were performed by two independent reviewers using predetermined criteria and stored on premade proforma, respectively. The risk of bias (RoB) for both in vitro and in vivo studies were performed using established RoB tools. RESULTS: Eight studies were suitable for inclusion in this scoping review; five were in vivo and three were in vitro studies. No clinical trials were found. The RoB varied from moderate to high for in vivo studies and from low to moderate for in vitro studies. Overall, there was evidence from both in vivo and in vitro studies that absorbable IVCFs were effective in clot capturing and self-resorption and could decrease complications associated with standard IVCFs. However, there was a broad lack of statistical analyses and control groups to determine the significance of these findings. CONCLUSIONS: Absorbable IVCFs have shown promising features and results in preclinical models. However, significant research needs to be further performed to achieve the ideal characteristics of an absorbable IVCF before the first human trial can be conducted safely.


Assuntos
Implantes Absorvíveis , Implantação de Prótese/instrumentação , Filtros de Veia Cava , Tromboembolia Venosa/prevenção & controle , Implantes Absorvíveis/efeitos adversos , Animais , Humanos , Desenho de Prótese , Implantação de Prótese/efeitos adversos , Fatores de Risco , Fatores de Tempo , Filtros de Veia Cava/efeitos adversos
8.
J Craniofac Surg ; 31(7): e741-e744, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32649558

RESUMO

Resorbable surgical materials are often used in the pediatric population to provide fixation in the growing skeleton. Although foreign body reactions to poly-D-L-lactic acid (PDLLA) plates and screws have been previously reported in other fields, to date PDLLA polymers have been well-tolerated in the setting of craniofacial surgery. The authors report a case of a previously healthy 4-month-old patient with Crouzon syndrome who underwent a frontal-orbital advancement with resorbable PDLLA plates and screws and subsequently experienced extensive foreign body reactions and wound healing complications.


Assuntos
Implantes Absorvíveis/efeitos adversos , Placas Ósseas/efeitos adversos , Reação a Corpo Estranho/etiologia , Poliésteres/efeitos adversos , Crânio/cirurgia , Humanos , Lactente , Masculino
10.
J Biomed Mater Res A ; 108(10): 2005-2014, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32323458

RESUMO

Because acellular vascular xenografts induce an immunological reaction through macrophage infiltration, they are conventionally crosslinked with glutaraldehyde (GA). However, the GA crosslinking reaction inhibits not only the host immune reaction around the graft but also the graft's enzymatic degradability, which is one of the key characteristics of acellular grafts that allow them to be replaced by host tissue. In this study, we used an 8-arm polyethylene glycol (PEG) to successfully suppress macrophage infiltration, without eliminating graft degradation. Decellularized ostrich carotid arteries were modified with GA or N-hydroxysuccinimide-activated 8-arm PEG (8-arm PEG-NHS), which has a molecular weight of 17 kDa. To evaluate the enzymatic degradation in vitro, the graft was immersed in a collagenase solution for 12 hr. The 8-arm PEG-modified graft was degraded to the same extent as the unmodified graft, but the GA-modified graft was not degraded. The graft was transplanted into rat subcutaneous tissue for up to 8 weeks. Although CD68-positive cells accumulated in the unmodified graft, they did not infiltrate into either modified graft. However, the GA-modified grafts calcified, but the 8-arm PEG-modified graft did not calcify after transplantation. These data suggested that 8-arm PEG-NHS is a promising modification agent for biodegradable vascular xenografts, to suppress acute macrophage infiltration only.


Assuntos
Implantes Absorvíveis , Prótese Vascular , Glutaral/química , Macrófagos/citologia , Polietilenoglicóis/química , Implantes Absorvíveis/efeitos adversos , Animais , Prótese Vascular/efeitos adversos , Artérias Carótidas/química , Reagentes de Ligações Cruzadas/química , Macrófagos/imunologia , Masculino , Ratos Sprague-Dawley , Struthioniformes
11.
Minerva Med ; 111(6): 529-535, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32323934

RESUMO

BACKGROUND: The FLEX-LONG study assessed the safety and clinical outcomes of ultra-long (44 mm/48 mm) biodegradable polymer-coated Supraflex (Sahajanand Medical Technology Pvt. Ltd., Surat, India) sirolimus-eluting stents (SES) in real-world patients with complex, long coronary artery lesions. METHODS: It was an investigator-initiated, retrospective, non-randomized, observational and single-center study, which evaluated one-year results of 141 patients who had undergone implantation of at least one ultra-long (44 mm/48 mm) Supraflex SES. The incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one-year follow-up was considered as primary outcome. Stent thrombosis was analyzed as a safety outcome. RESULTS: The mean age of the study population was 56.2±9.6 years and 78.0% (110/141) patients were male. The study analyzed high risk patients, including 62 (44.0%) hypertensive and 60 (42.6%) diabetic patients. Total 147 target lesions were treated, including 25 (17.0%) total occlusions. Total 51 (34.7%) and 96 (65.3%) Supraflex SES of 44 mm and 48 mm were implanted, respectively. Average stent length and diameter were 46.6±1.9 mm and 3.4±0.2 mm, respectively. One-year follow-up was obtained in 100% of patients. There was one probable stent thrombosis after three weeks. At one-year follow-up, 99.3% of patients remained event free. CONCLUSIONS: The results of the FLEX-LONG study support the use of ultra-long (44 mm/48 mm) Supraflex SES, in the treatment of high-risk real-world patients. The stent appeared to be safe and effective at one-year with low clinical events in complex, long coronary artery lesions.


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Imunossupressores/administração & dosagem , Desenho de Prótese , Sirolimo/administração & dosagem , Implantes Absorvíveis/efeitos adversos , Implantes Absorvíveis/estatística & dados numéricos , Doença da Artéria Coronariana/patologia , Diabetes Mellitus/epidemiologia , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/estatística & dados numéricos , Feminino , Humanos , Hipercolesterolemia/epidemiologia , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fumantes/estatística & dados numéricos , Trombose/epidemiologia , Resultado do Tratamento
12.
Hernia ; 24(3): 669-676, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31925599

RESUMO

INTRODUCTION: Synthetic non-resorbable mesh is almost standard in hernia surgery. However, several studies have showed negative effects of permanent implants such as chronic inflammation and complications involving different organs bordering the mesh. Such complications can raise the risk of chronic post-operative pain (CPP). Recently promising results regarding CPP have been published in patients with Lateral Inguinal Hernia (LIH) using a slowly resorbable mesh in Lichtenstein technique. For this reason the aim of the present study was to find the effect of a slowly resorbable implant on the long-term rate of hernia recurrence and chronic post-operative pain in patients with LIH repaired with TEP procedure. METHODS: Prospective pilot study of TEP repair using TIGR® Matrix Surgical Mesh in 35 primary LIH. At 3-year follow-up the Visual Analogue Scale (VAS) and the Inguinal Pain Questionnaire were employed to assess pain. Recurrence was determined by ultrasound and clinical examination. RESULTS: All patients completed the pain questionnaires but one patient did not attend the planned clinical examination for the 3-year follow-up. No patients had CPP, as defined in the World Guidelines for Groin Hernia Management. Almost all patients had lower VAS score in any activity 3 years following surgery in comparison to the preoperative period. Three patients (8.8%) suffered symptomatic recurrence during the 3-year follow-up. CONCLUSION: TEP repair in patients with LIH using a synthetic long-term resorbable mesh was found to be encouraging respecting chronic post-operative pain at 3-year follow-up but at the cost of an increased risk of recurrence.


Assuntos
Implantes Absorvíveis , Herniorrafia/métodos , Telas Cirúrgicas , Implantes Absorvíveis/efeitos adversos , Adulto , Idoso , Dor Crônica/diagnóstico , Dor Crônica/etiologia , Seguimentos , Hérnia Inguinal/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/efeitos adversos , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/etiologia , Projetos Piloto , Estudos Prospectivos , Recidiva , Telas Cirúrgicas/efeitos adversos , Inquéritos e Questionários , Resultado do Tratamento , Escala Visual Analógica
13.
Skeletal Radiol ; 49(1): 65-73, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31214727

RESUMO

PURPOSE: To use magnetic resonance imaging (MRI) to investigate the knee joint of children following arthroscopic fixation of osteochondral lesions using bioabsorbable nails and to correlate these imaging findings with time from arthroscopic treatment and with risk factors at the time of imaging. MATERIALS AND METHODS: Our study included postarthroscopic MRI studies from 58 children (mean age at arthroscopy, 13.8 + 2.1 years) who have undergone bioabsorbable nail fixation of unstable osteochondral lesions between February 1, 2011 and September 30, 2017. All studies were retrospectively reviewed for broken nails, intra-articular debris, and internal knee derangement. Demographic information and information pertaining to active symptoms was obtained from both MRI questionnaire that was completed at the time of the study and clinical note that preceded the study. Marginal logistic regression models estimated using generalized estimating equations (GEE) were used to identify factors associated with a broken nail and joint effusion. RESULTS: A total of 104 postoperative studies were reviewed, which included 60 with symptoms and 44 without symptoms. Nail breakage was present in 38 (36.6%) studies and associated with presence of symptoms (OR 2.43, p = 0.036) and effusion (OR 2.76, p = 0.025). An effusion was present in 40 (38.5%) studies which decreased with increasing time from treatment (OR 0.89, p = 0.007) and increased with symptoms (OR 10.87, p < 0.001). Meniscal tear was present on 8 (7.7%) and chondral irregularity on 14 (13.5%) studies. CONCLUSION: Broken nail, effusion, and less commonly, meniscal tears and chondral irregularity, are all complications that can arise following fixation of osteochondral lesions with bioabsorbable nails. MRI can serve as a valuable tool in assessing these complications.


Assuntos
Artroscopia/efeitos adversos , Cartilagem Articular/diagnóstico por imagem , Fraturas Ósseas/diagnóstico por imagem , Articulação do Joelho/diagnóstico por imagem , Imageamento por Ressonância Magnética , Osteocondrite Dissecante/diagnóstico por imagem , Implantes Absorvíveis/efeitos adversos , Artroscopia/métodos , Pinos Ortopédicos/efeitos adversos , Cartilagem Articular/lesões , Cartilagem Articular/cirurgia , Criança , Fraturas Ósseas/cirurgia , Humanos , Artropatias/diagnóstico por imagem , Artropatias/cirurgia , Articulação do Joelho/cirurgia , Osteocondrite Dissecante/cirurgia , Fatores de Risco , Fatores de Tempo
14.
Hernia ; 24(3): 587-590, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31776875

RESUMO

PURPOSE: Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices. METHODS: Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types. RESULTS: Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results. CONCLUSIONS: High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.


Assuntos
Hérnia Ventral/cirurgia , Herniorrafia/efeitos adversos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Infecções Relacionadas à Prótese/epidemiologia , Sistema de Registros/estatística & dados numéricos , Telas Cirúrgicas/efeitos adversos , Implantes Absorvíveis/efeitos adversos , Implantes Absorvíveis/estatística & dados numéricos , Adulto , Idoso , Feminino , Hérnia Ventral/epidemiologia , Herniorrafia/métodos , Herniorrafia/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados/métodos , Infecções Relacionadas à Prótese/etiologia , Telas Cirúrgicas/estatística & dados numéricos , Estados Unidos/epidemiologia
15.
Eur J Vasc Endovasc Surg ; 59(4): 643-652, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31874809

RESUMO

OBJECTIVE: Biodegradable materials for in situ vascular tissue engineering could meet the increasing clinical demand for sufficient synthetic small diameter vascular substitutes in aortocoronary bypass and peripheral vascular surgery. The aim of this study was to design a new degradable thermoplastic polycarbonate urethane (dPCU) with improved biocompatibility and optimal biomechanical properties. Electrospun conduits made from dPCU were evaluated in short and long term follow up and compared with expanded polytetrafluoroethylene (ePTFE) controls. METHODS: Both conduits were investigated prior to implantation to assess their biocompatibility and inflammatory potential via real time polymerase chain reaction using a macrophage culture. dPCU grafts (n = 28) and ePTFE controls (n = 28) were then implanted into the infrarenal abdominal aorta of Sprague-Dawley rats. After seven days, one, six, and 12 months, grafts were analysed by histology and immunohistochemistry (IHC) and assessed biomechanically. RESULTS: Anti-inflammatory signalling was upregulated in dPCU conduits and increased significantly over time in vitro. dPCU and ePTFE grafts offered excellent long and short term patency rates (92.9% in both groups at 12 months) in the rat model without dilatation or aneurysm formation. In comparison to ePTFE, dPCU grafts showed transmural ingrowth of vascular specific cells resulting in a structured neovessel formation around the graft. The graft material was slowly reduced, while the compliance of the neovessel increased over time. CONCLUSION: The newly designed dPCU grafts have the potential to be safely applied for in situ vascular tissue engineering applications. The degradable substitutes showed good in vivo performance and revealed desirable characteristics such as biomechanical stability, non-thrombogenicity, and minimal inflammatory response after long term implantation.


Assuntos
Implantes Absorvíveis , Nanofibras/uso terapêutico , Cimento de Policarboxilato/farmacologia , Tempo , Implantes Absorvíveis/efeitos adversos , Animais , Materiais Biocompatíveis/metabolismo , Implante de Prótese Vascular , Politetrafluoretileno/farmacologia , Ratos Sprague-Dawley , Reimplante/métodos , Uretana/farmacologia , Grau de Desobstrução Vascular/efeitos dos fármacos
16.
Pol Przegl Chir ; 91(5): 12-20, 2019 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-31702571

RESUMO

The aim of our study was to evaluate of short-term outcomes of 4210 patients who underwent open abdominal surgery with used either single-layer, absorbable, or continuous sutures. Seromuscular anastomosis were presented (without mucosa). Fluid therapy: GDT and zero-balance GDT were also discussed. Anastomosis leakage developed in 6 patients. They were treated by creating a stoma. Simultaneously, septic shock was treated. Re-anastomoses were performed after some time and after sepsis was suppressed. Results of treatment with use of double-layer sutures, which was is use before 1978, were presented. Analysis of 536 patients treated at the same time was conducted and 53 patients with anastomosis leakage was identified. Out of this group, 2 patients survived. Based on the literature review, the methods for performing anastomosis. Attention was paid to the advantages of single layer over multi-layer sutures: effectiveness, simplicity and lower cost of treatment. The occurrence of mechanical ileus was less frequently observed since ceasing to employ peritoneoplasty, and preoperational preparation of gastrointestinal tract in patients had a beneficial influence on their postoperative course. Postoperative complications were discussed mainly based on additional examinations such as TC and MRI. The attention was focused on the importance of medical observation and clinical examination by an experienced surgeon in order to identify postoperative complications. Antibiotic treatment in cases of postoperative complications was presented, as well as fluid therapy: GDT, zero-balance GDT and the procedures employed in cases of complications such as: anastomosis leakage, mechanical ileus, inter-peritoneal abscess. Anastomotic stenosis was not observed in this group of patients.


Assuntos
Implantes Absorvíveis/efeitos adversos , Anastomose Cirúrgica/efeitos adversos , Fístula Anastomótica/etiologia , Procedimentos Cirúrgicos do Sistema Digestório/métodos , Complicações Pós-Operatórias/etiologia , Anastomose Cirúrgica/métodos , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Técnicas de Sutura/instrumentação
17.
Int. braz. j. urol ; 45(6): 1180-1185, Nov.-Dec. 2019. tab
Artigo em Inglês | LILACS | ID: biblio-1056331

RESUMO

ABSTRACT Objective: To evaluate long-term (5-10 years) outcomes of Minimally Invasive Surgical (MIS) kit insertion with Prolift® (non-absorbable) mesh compared to the use of Prolift M® (partially absorbable), for anterior vaginal wall prolapse repair. Study design: In this retrospective study we compared women undergoing MIS kit Prolift® insertion (n=90) vs. Prolift M® insertion (n=79) for anterior vaginal wall prolapse repair between 2006 and 2012 at our Institution. A number of 169 women fulfilled the inclusion criteria and were included in the study. Results: During the study period 128 women (76%) completed full follow-up; of them 58 (73%) following MIS kit Prolift® insertion, and 70 (88%) following MIS kit ProliftM® insertion. There was no significant difference between the Prolift® and Prolift M® regarding parity (3.04 vs. 2.88, p=0.506), presence of hypertension (24.1% vs. 39.1%, p=0.088), diabetes mellitus (3.4% vs. 11.6%, p=0.109), or urinary stress incontinence (39.7% vs. 47.1%, p=0.475). All participants had been diagnosed with POP grade 3 or 4 before the procedure. No significant complications during the procedure or postoperative period were identified in the study groups. The follow-up period was at least five years in duration for both groups. Both groups were comparable according to questionnaires focused on function and satisfaction. Conclusion: Patients undergoing MIS kit Prolift® and Prolift M® insertion for anterior vaginal wall prolapse repair had comparable early and late postoperative outcomes. No differences in patient's function and satisfaction between the two groups were identified. According to our findings, there is no superiority to either of the two studied mesh devices.


Assuntos
Humanos , Feminino , Idoso , Telas Cirúrgicas/efeitos adversos , Prolapso Uterino/cirurgia , Implantes Absorvíveis/efeitos adversos , Complicações Pós-Operatórias , Inquéritos e Questionários , Estudos Retrospectivos , Seguimentos , Prolapso Uterino/complicações , Prolapso Uterino/fisiopatologia , Resultado do Tratamento , Satisfação do Paciente , Diafragma da Pelve , Estatísticas não Paramétricas , Pessoa de Meia-Idade
18.
Acta Orthop Traumatol Turc ; 53(6): 414-419, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31563430

RESUMO

OBJECTIVES: The objective of this study was to evaluate the incidence of osteolysis around the bioabsorbable and nonabsorbable anchors using serial magnetic resonance imaging (MRI) and to determine the relationship between osteolysis and the retear rate after arthroscopic rotator cuff repair. METHODS: From July 2012 to July 2014, 50 patients [28 men and 22 women; mean age, 56.4 (range: 45-56) years] underwent arthroscopic rotator cuff repair for a medium-to large-size tear with double-row suture-bridge technique. The bioabsorbable anchors used in the medial row comprised hydroxyapatite-polylactic acid enantiomer, and the nonabsorbable anchors in the lateral row were polyetheretherketone (PEEK)-type anchors. All patients underwent MRI evaluation at 3, 6, and 12 months postoperatively to determine osteolysis and identify any retear. RESULTS: The incidences of osteolysis at 3, 6, and 12 months postoperatively were 1%, 4%, and 6% with nonabsorbable anchors and 13%, 29%, and 39% with bioabsorbable anchors, respectively. The incidences of osteolysis were significantly higher with the bioabsorbable anchors than with the nonabsorbable anchors (P < 0.005 for all three follow-ups). There was no significant difference between osteolysis and non-osteolysis groups regarding the retear rate or retear size (P = 0.189 and 0.069, respectively). CONCLUSIONS: Osteolysis was common around bioabsorbable anchors used for arthroscopic rotator cuff repair, and it also occurred around the PEEK-type nonabsorbable anchors. The incidence of osteolysis of nonabsorbable anchors was significantly lower than that of bioabsorbable anchors. Osteolysis did not significantly affect rotator cuff retear after arthroscopic repair with either bioabsorbable or nonabsorbable anchors. LEVEL OF EVIDENCE: Level III, Therapeutic Study.


Assuntos
Implantes Absorvíveis/efeitos adversos , Artroscopia/efeitos adversos , Imageamento por Ressonância Magnética/métodos , Osteólise/diagnóstico , Lesões do Manguito Rotador/cirurgia , Manguito Rotador/cirurgia , Técnicas de Sutura/efeitos adversos , Suturas/efeitos adversos , Adulto , Idoso , Artroscopia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteólise/etiologia , Estudos Retrospectivos , Manguito Rotador/diagnóstico por imagem , Lesões do Manguito Rotador/diagnóstico , Ruptura , Técnicas de Sutura/instrumentação
19.
BMJ Case Rep ; 12(9)2019 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-31537588

RESUMO

Postoperative reaction and infection after anterior cruciate ligament (ACL) reconstruction is a rare complication. We report two cases of bioabsorbable screw extrusion and Pseudomonas aeruginosa tibial tunnel infection in 17/18-year-old men, 2 and 4 years after ACL reconstruction, respectively. They underwent tibial tunnel debridement, removal of the still intact poly-L-D-lactic acid bioabsorbable screw and subsequent wound closure. Physical examination findings confirmed patency of the hamstring graft. Culture guided antibiotics were completed, and wounds healed unremarkably. Both returned to previous level of activity. Successful treatment is achieved through a logical sequence of management, as well as a multidisciplinary approach to prevent unnecessary secondary procedures and morbidity.


Assuntos
Reconstrução do Ligamento Cruzado Anterior/métodos , Parafusos Ósseos/microbiologia , Tíbia/microbiologia , Implantes Absorvíveis/efeitos adversos , Administração Intravenosa , Adolescente , Reconstrução do Ligamento Cruzado Anterior/efeitos adversos , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Artroscopia/métodos , Parafusos Ósseos/efeitos adversos , Desbridamento/métodos , Diagnóstico Diferencial , Músculos Isquiossurais/transplante , Humanos , Masculino , Osteomielite/tratamento farmacológico , Osteomielite/cirurgia , Pseudomonas aeruginosa/isolamento & purificação , Líquido Sinovial/microbiologia , Tíbia/patologia , Tíbia/cirurgia , Resultado do Tratamento
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