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[PMID]:28470445
[Au] Autor:Leroy A; Ribeiro S; Grossiord C; Alves A; Vestberg RH; Salles V; Brunon C; Gritsch K; Grosgogeat B; Bayon Y
[Ad] Endereço:Laboratoire des Multimatériaux et Interfaces, UMR 5615 CNRS-Université Lyon 1, Université de Lyon, 43 bd du 11 Novembre 1918, Villeurbanne, Cedex 69622, France.
[Ti] Título:FTIR microscopy contribution for comprehension of degradation mechanisms in PLA-based implantable medical devices.
[So] Source:J Mater Sci Mater Med;28(6):87, 2017 Jun.
[Is] ISSN:1573-4838
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The integration and evolution of implantable medical devices made of bioresorbable polymers and used for temporary biomedical applications are crucial criteria in the success of a therapy and means of follow-up after implantation are needed. The objective of this work is to develop and evaluate a method based on microscopic Fourier Transform InfraRed spectroscopy (FTIR) mappings to monitor the degradation of such polymers on tissue explant sections, after implantation. This technique provided information on their location and on both their composition and crystallinity, which is directly linked to their state of degradation induced predominantly by chain scissions. An in vitro study was first performed on poly(L-lactic acid) (PLLA) meshes to validate the procedure and the assumption that changes observed on FTIR spectra are indeed a consequence of degradation. Then, mappings of in vivo degraded PLLA meshes were realized to follow up their degradation and to better visualize their degradation mechanisms. This work further warrants its translation to medical implants made of copolymers of lactic acid and to other polyesters.
[Mh] Termos MeSH primário: Implantes Absorvíveis
Poliésteres/química
Espectroscopia de Infravermelho com Transformada de Fourier
[Mh] Termos MeSH secundário: Animais
Materiais Biocompatíveis
Equipamentos e Provisões
Masculino
Coelhos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biocompatible Materials); 0 (Polyesters); 459TN2L5F5 (poly(lactide))
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1007/s10856-017-5894-7


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[PMID]:28452709
[Au] Autor:Al-Asousi F; Okpaleke C; Dadgostar A; Javer A
[Ad] Endereço:Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, St. Paul's Sinus Centre, University of British Columbia, Vancouver, British Columbia, Canada.
[Ti] Título:The use of polydioxanone plates for endoscopic skull base repair.
[So] Source:Am J Rhinol Allergy;31(2):122-126, 2017 Mar 01.
[Is] ISSN:1945-8932
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Many reconstructive techniques and materials have been reported for repair of skull base defects after sinonasal tumor excision, cerebrospinal fluid (CSF) leaks, and coverage of denuded bone. Synthetic materials have been developed for endoscopic skull base repair to avoid donor-site morbidity. Polydioxanone plate is a bioabsorbable implant designed for nasal septal reconstruction and has the ability to retain strength for at least 10 weeks and absorbs in 6 months. OBJECTIVES: This study aimed to describe the use of polydioxanone plates in endoscopic skull base defect and CSF leak repair, and to describe our experience with the surgical technique and postoperative management. METHODS: This was a retrospective case series of patients who, between May 2013 and December 2015, underwent endoscopic sinus surgery and skull base repair for CSF leak or after excision of a skull base tumor by using polydioxanone plates. Patients who presented with sinonasal inflammatory disease or skull base tumors underwent endoscopic skull base repair by using polydioxanone plates in an underlay fashion and mucosal membrane grafts with or without adjuvant materials in an overlay fashion. The patients were reviewed at 6 days, 6 weeks, and 3 months after surgery. Postoperative adverse events, including CSF leak, infection, bleeding, headache, and graft failure, were recorded. RESULTS: The cases of seven patients (five women, two men; mean age, 53.9 years) were reviewed. Five patients underwent sinonasal tumor resection and two underwent repair for CSF leak. The mean (standard deviation) defect size was 16.4 ± 11.4 mm. There was no evidence of postoperative CSF leak, and lumbar drains were not used. One patient reported transient headache and facial pressure at the 6-week follow-up visit. The surgeons' experience with polydioxanone plate placement, postoperative healing, and follow-up was satisfactory. CONCLUSION: Polydioxanone could be used to achieve rigid repair of endoscopic skull base defects. These early results, although promising, require validation in clinical trials.
[Mh] Termos MeSH primário: Implantes Absorvíveis/utilização
Vazamento de Líquido Cefalorraquidiano/cirurgia
Endoscopia
Seios Paranasais/cirurgia
Procedimentos Cirúrgicos Reconstrutivos
Neoplasias da Base do Crânio/cirurgia
Base do Crânio/cirurgia
[Mh] Termos MeSH secundário: Materiais Biocompatíveis/química
Feminino
Seguimentos
Seres Humanos
Masculino
Meia-Idade
Seios Paranasais/patologia
Polidioxanona/química
Complicações Pós-Operatórias
Estudos Retrospectivos
Base do Crânio/anormalidades
Base do Crânio/patologia
Neoplasias da Base do Crânio/patologia
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biocompatible Materials); 31621-87-1 (Polydioxanone)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.2500/ajra.2017.31.4411


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[PMID]:29370208
[Au] Autor:von Zur Mühlen C; Reiss S; Krafft AJ; Besch L; Menza M; Zehender M; Heidt T; Maier A; Pfannebecker T; Zirlik A; Reinöhl J; Stachon P; Hilgendorf I; Wolf D; Diehl P; Wengenmayer T; Ahrens I; Bode C; Bock M
[Ad] Endereço:Department of Cardiology and Angiology I, Heart Center Freiburg University, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
[Ti] Título:Coronary magnetic resonance imaging after routine implantation of bioresorbable vascular scaffolds allows non-invasive evaluation of vascular patency.
[So] Source:PLoS One;13(1):e0191413, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Evaluation of recurrent angina after percutaneous coronary interventions is challenging. Since bioresorbable vascular scaffolds (BVS) cause no artefacts in magnetic resonance imaging (MRI) due to their polylactate-based backbone, evaluation of vascular patency by MRI might allow for non-invasive assessment and triage of patients with suspected BVS failure. METHODS: Patients with polylactate-based ABSORB-BVS in proximal coronary segments were examined with 3 Tesla MRI directly (baseline) and one year after implantation. For assessment of coronary patency, a high-resolution 3D spoiled gradient echo pulse sequence with fat-saturation, T2-preparation (TE: 40 ms), respiratory and end-diastolic cardiac gating, and a spatial resolution of (1.08 mm)3 was positioned parallel to the course of the vessel for bright blood imaging. In addition, a 3D navigator-gated T2-weighted variable flip angle turbo spin echo (TSE) sequence with dual-inversion recovery black-blood preparation and elliptical k-space coverage was applied with a voxel size of (1.14 mm)3. For quantitative evaluation lumen diameters of the scaffolded areas were measured in reformatted bright and black blood MR angiography data. RESULTS: 11 patients with implantation of 16 BVS in the proximal coronary segments were included, of which none suffered from major adverse cardiac events during the one year follow up. Vascular patency in all segments implanted with BVS could be reliably assessed by MRI at baseline and after one year, whereas segments with metal stents could not be evaluated due to artefacts. Luminal diameter within the BVS remained constant during the one year period. One patient with atypical angina after BVS implantation was noninvasively evaluated showing a patent vessel, also confirmed by coronary angiography. CONCLUSIONS: Coronary MRI allows contrast-agent free and non-invasive assessment of vascular patency after ABSORB-BVS implantation. This approach might be supportive in the triage and improvement of diagnostic workflows in patients with postinterventional angina and scaffold implantation. TRIAL REGISTRATION: German Register of Clinical Studies DRKS00007456.
[Mh] Termos MeSH primário: Implantes Absorvíveis
Angina Pectoris/diagnóstico por imagem
Angina Pectoris/etiologia
Angiografia por Ressonância Magnética/métodos
Intervenção Coronária Percutânea/efeitos adversos
Grau de Desobstrução Vascular
[Mh] Termos MeSH secundário: Implantes Absorvíveis/efeitos adversos
Idoso
Seres Humanos
Imagem Tridimensional/métodos
Meia-Idade
Poliésteres
Tecidos Suporte/efeitos adversos
Tecidos Suporte/química
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Polyesters); 459TN2L5F5 (poly(lactide))
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180302
[Lr] Data última revisão:
180302
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180126
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0191413


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[PMID]:28453413
[Au] Autor:Bruns NE; Glenn IC; Craner DR; McNinch NL; Schomisch SJ; Ponsky TA
[Ad] Endereço:1 Division of Pediatric Surgery, Akron Children's Hospital , Akron, Ohio.
[Ti] Título:Assessing the Adequacy of Absorbable Braided Suture for Laparoscopic High Ligation in Rabbits.
[So] Source:J Laparoendosc Adv Surg Tech A;27(7):733-736, 2017 Jul.
[Is] ISSN:1557-9034
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Our previous work demonstrated that intentional peritoneal injury reduces the incidence of recurrence of a patent processus vaginalis even after removal of the suture. Therefore, the necessity of permanent suture has been brought into question because of the risk of suture granuloma formation. The purpose of this study was to evaluate the efficacy of absorbable, braided versus permanent, braided suture in a rabbit survival model of laparoscopic percutaneous ligation of the processus vaginalis with intentional peritoneal injury. MATERIALS AND METHODS: Eighteen New Zealand White rabbits underwent bilateral subcutaneous endoscopically assisted ligation (SEAL) of the internal ring. Before SEAL, peritoneal injury was caused with endoscopic shears. Each animal was randomized to receive absorbable braided suture on one side and permanent braided suture on the contralateral side. The rabbits were survived for 8 weeks to allow for complete hydrolysis of the absorbable suture. Necropsy was performed during which the integrity of the repair was assessed with insufflation of carbon dioxide up to 30 mm Hg. McNemar's test for paired data was performed for statistical analysis. RESULTS: Seventeen rabbits survived 8 weeks. One rabbit died in the early postoperative period because of urinary tract obstruction. After insufflation, four (24%) recurrences were present in the absorbable group and two (12%) recurrences were present in the permanent group. This difference was not statistically significant (P = .50). Both rabbits with a recurrence on the side with permanent suture also had a recurrence with absorbable suture on the contralateral side. In all rabbits, the permanent suture was identified, whereas there was no visual evidence of absorbable suture. CONCLUSIONS: A trend toward a higher recurrence rate with the use of absorbable braided suture was present, although, in this study, the finding was not statistically significant. Caution should be used when considering implementation of absorbable suture for laparoscopic inguinal hernia repair.
[Mh] Termos MeSH primário: Hérnia Inguinal/cirurgia
Laparoscopia/instrumentação
Suturas
[Mh] Termos MeSH secundário: Implantes Absorvíveis
Animais
Insuflação
Laparoscopia/métodos
Ligadura/instrumentação
Ligadura/métodos
Modelos Animais
Peritônio/lesões
Coelhos
Distribuição Aleatória
Recidiva
Técnicas de Sutura
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1089/lap.2016.0231


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[PMID]:28468954
[Au] Autor:Mahmoud AN; Barakat AF; Elgendy AY; Schneibel E; Mentias A; Abuzaid A; Elgendy IY
[Ad] Endereço:From the Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville (A.N.M., A.Y.E., E.S., I.Y.E.); Department of Medicine, Cleveland Clinic Foundation, OH (A.F.B.); Division of Cardiovascular Medicine, Department of Medicine, University of Iowa Carver College of
[Ti] Título:Long-Term Efficacy and Safety of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Metallic Stents: A Meta-Analysis of Randomized Trials.
[So] Source:Circ Cardiovasc Interv;10(5), 2017 May.
[Is] ISSN:1941-7632
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Data regarding the long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents are limited. This meta-analysis aimed to compare the long-term outcomes with both devices. METHODS AND RESULTS: Randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with everolimus-eluting stents were included. Summary estimates risk ratios (RRs) were constructed. The primary efficacy outcome was target lesion failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, and the primary safety outcome was definite or probable stent/scaffold thrombosis. Six trials with 5392 patients were included (mean follow-up, 25 months). BVS had a higher rate of target lesion failure (RR, 1.33; 95% confidence interval [CI], 1.11-1.58) driven by the higher rates of target vessel myocardial infarction (RR, 1.65; 95% CI, 1.26-2.17) and target lesion revascularization (RR, 1.39; 95% CI, 1.08-1.78). The risk of definite or probable stent/scaffold thrombosis (RR, 3.22; 95% CI, 1.89-5.49) and very late stent/scaffold thrombosis (>1 year; RR, 4.78; 95% CI, 1.66-13.8) was higher with BVS. The risk of cardiac and all-cause mortality was similar in both groups. CONCLUSIONS: Compared with everolimus-eluting stents, BVS is associated with increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization in these studies (mean follow-up, 25 months). The risk of definite or probable stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS. Further information from randomized trials is critical to evaluate clinical outcomes with BVS on complete resolution of the scaffold.
[Mh] Termos MeSH primário: Implantes Absorvíveis
Fármacos Cardiovasculares/administração & dosagem
Materiais Revestidos Biocompatíveis
Doença da Artéria Coronariana/terapia
Stents Farmacológicos
Everolimo/administração & dosagem
Metais
Intervenção Coronária Percutânea/instrumentação
[Mh] Termos MeSH secundário: Idoso
Fármacos Cardiovasculares/efeitos adversos
Doença da Artéria Coronariana/diagnóstico por imagem
Doença da Artéria Coronariana/mortalidade
Trombose Coronária/etiologia
Everolimo/efeitos adversos
Feminino
Seres Humanos
Masculino
Meia-Idade
Infarto do Miocárdio/etiologia
Razão de Chances
Intervenção Coronária Percutânea/efeitos adversos
Intervenção Coronária Percutânea/mortalidade
Desenho de Prótese
Ensaios Clínicos Controlados Aleatórios como Assunto
Medição de Risco
Fatores de Risco
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS
[Nm] Nome de substância:
0 (Cardiovascular Agents); 0 (Coated Materials, Biocompatible); 0 (Metals); 9HW64Q8G6G (Everolimus)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180227
[Lr] Data última revisão:
180227
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE


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[PMID]:27774758
[Au] Autor:Ielasi A; Varricchio A; Campo G; Leoncini M; Cortese B; Vicinelli P; Brugaletta S; di Uccio FS; Latib A; Tespili M
[Ad] Endereço:Cardiology Division, Bolognini Hospital Seriate, Seriate, BG, Italy.
[Ti] Título:A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study.
[So] Source:Catheter Cardiovasc Interv;89(7):1129-1138, 2017 Jun 01.
[Is] ISSN:1522-726X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. BACKGROUNDS: Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events. METHODS: This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781. RESULTS: The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up. CONCLUSIONS: This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc.
[Mh] Termos MeSH primário: Implantes Absorvíveis
Fármacos Cardiovasculares/administração & dosagem
Materiais Revestidos Biocompatíveis
Trombose Coronária/terapia
Everolimo/administração & dosagem
Intervenção Coronária Percutânea/instrumentação
Polímeros/química
Infarto do Miocárdio com Supradesnível do Segmento ST/terapia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Fármacos Cardiovasculares/efeitos adversos
Angiografia Coronária
Trombose Coronária/diagnóstico por imagem
Trombose Coronária/mortalidade
Everolimo/efeitos adversos
Estudos de Viabilidade
Feminino
Seres Humanos
Itália
Masculino
Meia-Idade
Intervenção Coronária Percutânea/efeitos adversos
Intervenção Coronária Percutânea/mortalidade
Estudos Prospectivos
Desenho de Prótese
Recidiva
Sistema de Registros
Projetos de Pesquisa
Fatores de Risco
Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem
Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade
Fatores de Tempo
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Cardiovascular Agents); 0 (Coated Materials, Biocompatible); 0 (Polymers); 9HW64Q8G6G (Everolimus)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1002/ccd.26801


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[PMID]:29384619
[Au] Autor:Zhao H; Wang YL; Peng JR; Zhang L; Qu Y; Chu BY; Dong ML; Tan LW; Qian ZY
[Ti] Título:Biodegradable Self-Assembled Micelles Based on MPEG-PTMC Copolymers: An Ideal Drug Delivery System for Vincristine.
[So] Source:J Biomed Nanotechnol;13(4):427-36, 2017 Apr.
[Is] ISSN:1550-7033
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Despite advantageous properties, micelles using methoxy poly(ethylene glycol)-poly(trimethylene carbonate) (MPEGPTMC) have not been widely studied. In this work, we aim to develop a novel vehicle for vincristine (VCR) based on a MPEG-PTMC micelle system. MPEG-PTMC with a series of molecular weights were synthesized and screened for the appropriate range for forming stable VCR micelles. The prepared micelles were then characterized in vitro and in vivo . VCR micelles presented high stability and ideal sustained release profile. The passive targeting effect was also enhanced compared with liposomal VCR. These results provide critical data to give the first clues regarding novel VCR micelles which exhibit potential for clinical application.
[Mh] Termos MeSH primário: Implantes Absorvíveis
Dioxanos/química
Implantes de Medicamento/química
Nanocápsulas/química
Polietilenoglicóis/química
Vincristina/administração & dosagem
Vincristina/química
[Mh] Termos MeSH secundário: Cristalização/métodos
Difusão
Composição de Medicamentos/métodos
Implantes de Medicamento/administração & dosagem
Micelas
Nanocápsulas/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Dioxanes); 0 (Drug Implants); 0 (Micelles); 0 (Nanocapsules); 0 (monomethoxy poly(ethylene glycol)-block-poly(trimethylene carbonate)); 30IQX730WE (Polyethylene Glycols); 5J49Q6B70F (Vincristine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180223
[Lr] Data última revisão:
180223
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180201
[St] Status:MEDLINE


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[PMID]:29382011
[Au] Autor:Bundhun PK; Pursun M; Huang F
[Ad] Endereço:Institute of Cardiovascular Diseases, the First Affiliated Hospital of Guangxi Medical University.
[Ti] Título:Biodegradable polymer drug-eluting stents versus first-generation durable polymer drug-eluting stents: A systematic review and meta-analysis of 12 randomized controlled trials.
[So] Source:Medicine (Baltimore);96(47):e8878, 2017 Nov.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Even if drug-eluting stents (DES) showed beneficial effects in patients with coronary artery diseases (CADs), limitations have been observed with the first-generation durable polymer DES (DP-DES). Recently, biodegradable polymer DES (BP-DES) have been approved to be used as an alternative to DP-DES, with potential benefits. We aimed to systematically compare BP-DES with the first-generation DP-DES using a large number of randomized patients. METHODS: Electronic databases were searched for randomized controlled trials (RCTs) comparing BP-DES with first-generation DP-DES. The main endpoints were the long-term (≥2 years) adverse clinical outcomes that were reported with these 2 types of DES. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and the analysis was carried out by RevMan 5.3 software. RESULTS: Twelve trials with a total number of 13,480 patients (7730 and 5750 patients were treated by BP-DES and first-generation DP-DES, respectively) were included. During a long-term follow-up period of ≥2 years, mortality, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACEs) were not significantly different between these 2 groups with OR: 0.84, 95% CI: 0.66-1.07; P = .16, I = 0%, OR: 1.01, 95% CI: 0.45-2.27; P = .98, I = 0%, OR: 0.91, 95% CI: 0.75-1.11; P = .37, I = 0% and OR: 0.86, 95% CI: 0.44-1.67; P = .65, I = 0%, respectively. Long-term total stent thrombosis (ST), definite ST, and probable ST were also not significantly different between BP-DES and the first-generation DP-DES with OR: 0.77, 95% CI: 0.50-1.18; P = .22, I = 0%, OR: 0.71, 95% CI: 0.43-1.18; P = .19, I = 0% and OR: 1.31, 95% CI: 0.56-3.08; P = .53, I = 6%, respectively. CONCLUSION: Long-term mortality, MI, TLR, MACEs, and ST were not significantly different between BP-DES and the first-generation DP-DES. However, the follow-up period was restricted to only 3 years in this analysis.
[Mh] Termos MeSH primário: Implantes Absorvíveis/efeitos adversos
Doença da Artéria Coronariana/cirurgia
Stents Farmacológicos/efeitos adversos
Complicações Pós-Operatórias/etiologia
Desenho de Prótese/efeitos adversos
[Mh] Termos MeSH secundário: Seres Humanos
Polímeros
Complicações Pós-Operatórias/mortalidade
Ensaios Clínicos Controlados Aleatórios como Assunto
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Polymers)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180207
[Lr] Data última revisão:
180207
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180201
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000008878


  9 / 7364 MEDLINE  
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[PMID]:28468138
[Au] Autor:Wong FK; Adams S; Hudson DA; Ozaki W
[Ad] Endereço:*David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA †Division of Plastic and Reconstructive Surgery, Red Cross War Memorial Children's Hospital, Rondebosch ‡Department of Plastic and Reconstructive Surgery, University of Cape Town, Groote Schuur Hospital, Observatory, Cape Town, South Africa §Division of Plastic and Reconstructive Surgery, UCLA Medical Center, Los Angeles, CA.
[Ti] Título:Use of Resorbable Fixation System in Pediatric Facial Fractures.
[So] Source:J Craniofac Surg;28(3):635-637, 2017 May.
[Is] ISSN:1536-3732
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Resorbable fixation system (RFS) is an alternative to titanium in open reduction and internal fixation of pediatric facial fractures. METHODS: This study retrospectively reviewed all medical records in a major metropolitan pediatric hospital in Cape Town, South Africa from September 2010 through May 2014. Inclusion criteria were children under the age of 13 with facial fractures who have undergone open reduction and internal fixation using RFS. Intraoperative and postoperative complications were reviewed. RESULTS: A total of 21 patients were included in this study. Twelve were males and 9 were females. Good dental occlusion was achieved in all patients and there were no complications intraoperatively. Three patients developed postoperative implanted-related complications: all 3 patients developed malocclusions and 1 developed an additional sterile abscess over the right zygomatic bone. For the latter, incision and drainage was performed and the problem resolved without additional operations. DISCUSSION: Resorbable fixation system is an alternative to titanium products in the setting of pediatric facial fractures without complications involving delayed union or malunion. The combination of intermaxillary fixation and RFS is not needed postoperatively for adequate fixation of mandible fractures. Resorbable fixation system is able to provide adequate internal fixation when both low-stress and high-stress craniofacial fractures occur simultaneously.
[Mh] Termos MeSH primário: Implantes Absorvíveis
Ossos Faciais/lesões
Fixação Interna de Fraturas/métodos
Redução Aberta
Fraturas Cranianas/cirurgia
[Mh] Termos MeSH secundário: Criança
Pré-Escolar
Ossos Faciais/cirurgia
Feminino
Seguimentos
Fixação Interna de Fraturas/instrumentação
Seres Humanos
Lactente
Masculino
Estudos Retrospectivos
África do Sul
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180202
[Lr] Data última revisão:
180202
[Sb] Subgrupo de revista:D
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1097/SCS.0000000000003413


  10 / 7364 MEDLINE  
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[PMID]:29320138
[Au] Autor:Food and Drug Administration, HHS.
[Ti] Título:Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer. Final order.
[So] Source:Fed Regist;83(4):600-2, 2018 Jan 05.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the absorbable perirectal spacer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
[Mh] Termos MeSH primário: Implantes Absorvíveis/classificação
Segurança de Equipamentos/classificação
Radiologia/classificação
Radiologia/instrumentação
Reto
[Mh] Termos MeSH secundário: Seres Humanos
Masculino
Neoplasias da Próstata/radioterapia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE



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