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1.
Zhongguo Gu Shang ; 33(12): 1111-5, 2020 Dec 25.
Artigo em Chinês | MEDLINE | ID: mdl-33369317

RESUMO

OBJECTIVE: To evaluate early clinical effects of bioabsorbable suture anchors for the treatment of Bankart lesion. METHODS: Total 23 patients with the Bankart lesion were treated with arthroscopic repair using bioabsorbable suture anchors from January 2010 to June 2017. There were 20 males and 3 females, with an average age of (23.4±3.9) years old (ranged, 19 to 34 years old). Fourteen patients had injuries on the right shoulder joint and 9 patients had the injuries on the left side. The mechanism of primary dislocation included 17 cases of training, 5 cases of sports injury and 1 case of falling down. The mean interval time from injury to surgery was(10.9±5.8) months (ranged, 3 to 36 months). The Bankart lesion was repaired by bio-cortical suture anchors. The Rowes rating system for Bankart repair was used to evaluate therapeutic effects. RESULTS: All 23 patients were followed up, with a mean duration of(24.5±3.7) months(ranged, 18 to 39 months). At the latest follow up, there was no recurrent dislocation occurred, and all patients had returned to sports and work. The Rowes rating system for Bankart repair was 53.91±11.67 pre-operationally and 91.74±12.30 post operationally, respectively (P<0.01). According to the Rowes rating system, there were 0 case of excellent, 0 case of fine, 9 cases of good and 14 cases of bad pre-operationally;16 cases of excellent, 4 case of fine, 3 cases of good and 0 cases of bad post operationally;the difference was statistically significant (P<0.01). CONCLUSION: Applying bio-cortical bone suture anchors for the Bankart lesion is a reliable, efficient and cost effective treatment, which is also suitable for the revision of the Bankart lesion.


Assuntos
Lesões de Bankart , Instabilidade Articular , Luxação do Ombro , Articulação do Ombro , Implantes Absorvíveis , Adulto , Artroscopia , Feminino , Humanos , Masculino , Amplitude de Movimento Articular , Recidiva , Luxação do Ombro/cirurgia , Âncoras de Sutura , Resultado do Tratamento , Adulto Jovem
2.
Medicine (Baltimore) ; 99(52): e23810, 2020 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-33350767

RESUMO

BACKGROUND: Percutaneous coronary intervention with the new generation drug eluting stents (DES) is 1 among the revascularization procedures required to treat patients with coronary artery disease (CAD). Since late stent thrombosis and silent myocardial infarction are highly associated with type 2 diabetes mellitus (T2DM), an analysis comparing the newer generation DES in this specific subgroup of patients would be scientifically relevant.In this analysis, we aimed to systematically compare the cardiovascular outcomes observed with the ultrathin bioresorbable polymer sirolimus eluting stents (SES) versus thin, durable polymer everolimus eluting stents (EES) following percutaneous coronary intervention in patients with T2DM. METHODS: Through online databases, relevant studies comparing ultrathin bioresorbable polymer SES versus the durable polymer EES were carefully searched. The cardiovascular outcomes were assessed during a follow-up time period of 1 year and more than 1 year (1-5 years) respectively. This meta-analysis was carried out by the latest version of the RevMan software. Following analysis, the results were represented by odds ratios (OR) with 95% confidence intervals (CI). RESULTS: A total number of 1967 patients with T2DM were included in this analysis. During a 1 year follow-up time period, target lesion failure (TLF) (OR: 0.59, 95% CI: 0.34-1.02; P = .06, target vessel revascularization (TVR) (OR: 0.97, 95% CI: 0.55-1.70; P = .91) and target lesion revascularization (TLR) (OR: 0.91, 95% CI: 0.44-1.87; P = .79) were similarly observed with ultrathin bioresorbable polymer SES versus the thin, durable polymer EES in these patients with T2DM. Other cardiovascular outcomes including myocardial infarction (MI), major adverse cardiac events, all-cause mortality (OR: 0.72, 95% CI: 0.37-1.40; P = .34), cardiac death and stent thrombosis (OR: 0.85, 95% CI: 0.45-1.62; P = .63) were also similarly observed with these 2 types of new stents. During a follow-up time period above 1 year (1-5 years), still no significant difference was observed in TLF, TVR, TLR, major adverse cardiac events, MI, all-cause mortality, cardiac death and stent thrombosis (OR: 0.62, 95% CI: 0.33-1.16; P = .14). CONCLUSIONS: The ultrathin bioresorbable polymer SES were similar to the durable polymer EES in these patients with T2DM. These 2 types of new generation stents were comparable in terms of cardiovascular outcomes. Hence, they might be recommended in patients with T2DM. Upcoming trials should be able to confirm this hypothesis.


Assuntos
Implantes Absorvíveis/efeitos adversos , Doenças Cardiovasculares/epidemiologia , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus Tipo 2/complicações , Stents Farmacológicos/efeitos adversos , Everolimo/farmacologia , Intervenção Coronária Percutânea/instrumentação , Sirolimo/farmacologia , Doença da Artéria Coronariana/complicações , Humanos , Imunossupressores/farmacologia , Avaliação de Resultados em Cuidados de Saúde
3.
J Vasc Interv Radiol ; 31(11): 1817-1824, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33008719

RESUMO

PURPOSE: To prospectively evaluate the initial human experience with an absorbable vena cava filter designed for transient protection from pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective, single-arm, first-in-human study of 8 patients with elevated risk of venous thromboembolism (VTE). Seven absorbable IVC filters (made of polydioxanone that breaks down into H2O and CO2 in 6 mo) were placed prophylactically before orthopedic (n = 5) and gynecologic (n = 2) surgeries, and 1 was placed in a case of deep vein thrombosis. Subjects underwent CT cavography and abdominal radiography before and 5, 11, and 36 weeks after filter placement to assess filter migration, embolization, perforation, and caval thrombosis and/or stenosis. Potential PE was assessed immediately before and 5 weeks after filter placement by pulmonary CT angiography. RESULTS: No symptomatic PE was reported throughout the study or detected at the planned 5-week follow-up. No filter migration was detected based on the fixed location of the radiopaque markers (attached to the stent section of the filter) relative to the vertebral bodies. No filter embolization or caval perforation was detected, and no caval stenosis was observed. Throughout the study, no filter-related adverse events were reported. CONCLUSIONS: Implantation of an absorbable vena cava filter in a limited number of human subjects resulted in 100% clinical success. One planned deployment was aborted as a result of stenotic pelvic veins, resulting in 89% technical success. No PE or filter-related adverse events were observed.


Assuntos
Implantes Absorvíveis , Polidioxanona/química , Implantação de Prótese/instrumentação , Embolia Pulmonar/terapia , Filtros de Veia Cava , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Implantação de Prótese/efeitos adversos , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/etiologia , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
4.
Shanghai Kou Qiang Yi Xue ; 29(3): 237-241, 2020 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-33043338

RESUMO

PURPOSE: The aim of this study was to compare the stress distribution of microtitanium plate and bioresorbable plates in fixation of mandibulotomy. METHODS: Three dimensional models of different internal fixation systems in mandibular resection were established, and three dimensional finite element analysis was carried out to compare the displacement changes of fracture segments and stress distribution of titanium plates under the same stress conditions. RESULTS: The maximum stress value of titanium plate was 49.8 MPa, and that of absorbable plate was 4.42 MPa. The maximum stress value of titanium plate was far greater than that of absorbable plate. However, all the stresses were less than their yield limits. It can be seen from the relative displacement comparison that when the mini-titanium plate was fixed on the mandible, the maximum displacement value was 0.1 mm; when absorbable plate was used for fixation, the maximum displacement value was 0.2 mm, and the relative displacement of both plates was small. CONCLUSIONS: These results suggest that the stiffness and internal strength of bioabsorbable fixation system are sufficient to support bone healing at the mandible site.


Assuntos
Implantes Absorvíveis , Osteotomia Mandibular , Placas Ósseas , Análise de Elementos Finitos , Fixação Interna de Fraturas
5.
Minerva Med ; 111(4): 315-323, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33032393

RESUMO

BACKGROUND: The registry investigated clinical outcomes after 12 months of implantation of ultra-thin strut (60 µm) biodegradable polymer-coated Tetrilimus everolimus-eluting stents (EES; Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in patients with atherosclerotic coronary lesions. Additionally, sub-group analysis was performed to evaluate outcomes of ultra-long (44/48 mm) Tetrilimus EES in patients with long lesions. METHODS: This was an observational, single-center, single-arm and investigator-initiated retrospective registry. In this all-comers registry, patients who underwent implantation of Tetrilimus EES for treatment of coronary artery disease during routine clinical practice between February-2016 and August-2016 at tertiary care center of India were included. Primary endpoint was occurrence of any major adverse cardiac event (MACE) up to 12 months' follow-up. MACE was a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Similar endpoints were observed in sub-group patients. RESULTS: Total 766 stents were implanted to treat 695 lesions in 558 patients. Of treated lesions, 11.4% lesions were type B2 and 78.3% were type C lesions. In sub-group analysis of 143 patients, a total of 155 long coronary lesions were intervened successfully with only one stent been implanted per lesion. At 12 months' follow-up, four (0.7%) cases of cardiac death, eight (1.4%) of MI, and two (0.4%) of TLR were reported, resulting in a 2.5% rate of MACE. The MACE rate was 2.8% in sub-group patients. CONCLUSIONS: Twelve months' clinical data demonstrated favorable safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice and also in patients with ultra-long lesions.


Assuntos
Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Implantes Absorvíveis , Idoso , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polímeros , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Stents , Resultado do Tratamento
6.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 2675-2678, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-33018557

RESUMO

In the recent years, Bioresorbable Vascular Scaffolds (BVS) for the treatment of atherosclerosis have been introduced. InSilc is a cloud based in silico clinical trial (ISCT) platform for drug-eluting BVS. The platform integrates multidisciplinary and multiscale models predicting the BVS performance. In this study, we present a use case scenario and demonstrate the functioning of the individual modules and of the whole pipeline and the ability to predict BVS short, medium, long-term outcomes.


Assuntos
Implantes Absorvíveis , Stents Farmacológicos , Ensaios Clínicos como Assunto , Simulação por Computador , Tecidos Suporte , Resultado do Tratamento
7.
Plast Reconstr Surg ; 146(4): 409e-413e, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32969997

RESUMO

Breast reconstruction remains an important field in plastic surgery, with most procedures using implants and/or autologous tissue. Few series report on experience with fat grafting as the primary form of breast reconstruction. The present article describes a new method of breast reconstruction using a three-dimensional absorbable mesh construct-or Lotus scaffold-and autologous fat grafting. A retrospective review was performed for all patients who underwent breast reconstruction using the Lotus scaffold and autologous fat grafting. Postoperative mammograms and magnetic resonance imaging scans were analyzed. Tissue specimens collected at subsequent procedures were harvested and stained with hematoxylin and eosin for histologic evaluation. Lastly, compression testing of the scaffold was performed using a tensiometer and digital tracking technology. Twenty-two patients underwent reconstruction of 28 breasts using the Lotus scaffold and autologous fat grafting between February of 2015 and February of 2018. Average follow-up was 19 months. All patients were satisfied with final breast shape and size. Mean patient age was 60.5 years and the average body mass index was 28 kg/m. Patients required on average two fat grafting sessions to achieve a successful result (range, zero to four). Postoperative mammography and magnetic resonance imaging showed robust adipose tissue in the breast with a slowly resorbing mesh and no oil cysts or calcifications. Histologic evaluation showed the presence of fat tissue around the scaffold and no evidence of capsule formation. Compression testing revealed the Lotus scaffold to be compliant with a high-resilience profile. The Lotus scaffold with autologous fat grafting is a viable method for breast reconstruction, giving the patient an autologous reconstruction with less morbidity compared to free tissue transfer. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, IV.


Assuntos
Implantes Absorvíveis , Tecido Adiposo/transplante , Mamoplastia/métodos , Telas Cirúrgicas , Engenharia Tecidual/métodos , Tecidos Suporte , Idoso , Feminino , Humanos , Mamoplastia/instrumentação , Pessoa de Meia-Idade , Estudos Retrospectivos , Transplante Autólogo
8.
Medicine (Baltimore) ; 99(35): e22001, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871954

RESUMO

In adolescent patients, cannulated lag screw (CLS) is a widely accepted choice for fixation of the medial epicondylar fracture of the humerus (MEFH). Absorbable implants, including rod, screw, and mini-plate, have been reported in children. However, to the best of our understanding, this study is the first head-to-head comparative study of CLS versus bioabsorbable screw (BS) in the treatment of MEFH.Patients of MEFH operated at our institute, from January 2010 to January 2016, were reviewed retrospectively. The patients were divided into 2 groups, the CLS group and the BS group, as per the type of implant the patient received. The CLS group consisted of 35 patients, whereas the BS group consisted of 30 patients. Demographic data, including sex, age at the time of surgery, operated side, and implant material, were collected from the hospital database. Elbow range of motion (ROM), radiographic manifestation was recorded during the out-patient visit. The elbow joint function was evaluated according to the Broberg and Morrey elbow scale and Mayo elbow performance index score.Thirty patients, including 18 males and 12 females, were included in the CLS group, whereas 35 patients, including 21 males and 14 females, were included in the BS group. At 6-month follow-up, elbow range of motion, Broberg and Morrey elbow scale and Mayo elbow performance index scale showed no significant difference between the 2 groups. The carrying angle was within the normal range in both groups. There was no nonunion or malunion in either group. The rate of hypoplasia or hyperplasia was low in both groups, 3.3% in CLS and 2.9% in BS. The rate of implant prominence was significantly higher in the CLS group (33.3%) than BS (0%).Both CLS and BS are safe and effective choices for displaced MEFH in adolescents. The BS can produce a satisfactory clinical outcome and is comparable to the CLS. Besides, the BS has the advantage of not needing second surgery for implant removal.


Assuntos
Implantes Absorvíveis , Parafusos Ósseos , Articulação do Cotovelo/lesões , Fixação de Fratura/instrumentação , Fraturas do Úmero/cirurgia , Adolescente , Criança , Feminino , Humanos , Masculino , Estudos Retrospectivos
9.
Medicine (Baltimore) ; 99(33): e21696, 2020 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-32872043

RESUMO

INTRODUCTION: Lateral condylar fracture (LCF) of the humerus in children is one of the commonest elbow injuries in children. Early recognition of the problem and appropriate management usually yields satisfactory outcomes. Closed or open reduction with Kirschner-wire (KW) is a cost-effective choice of fixation method for displaced fracture. However, various other methods, including partially threaded cannulated cancellous screw and biodegradable pin (BP), have also been used. This study aimed to investigate the efficacy of BP and compare its clinical outcomes with KW. MATERIAL AND METHODS: Patients with LCF admitted from January 2008 to January 2016 at our institute were reviewed retrospectively. Baseline information and clinical data were collected from Hospital Database. Patients were divided into the KW group and BP group. RESULTS: In all, 85 patients (male 50, female 35) in the KW group and 76 patients (male 47, female 29) in the BP group were included in this study. The average age of patients in the KW group was 5.2 years, and that of BP was 5.9 years. No nonunion or malunion was observed in either group. At the last follow-up visit, there was no statistically significant difference between the 2 groups with regard to elbow function and appearance. The incidence of long-term complications, including avascular necrosis, fishtail deformity, and lateral prominence, showed no significant difference between both the groups. The incidence of hardware prominence was higher in the KW (13/85, 15.6%) than BP (2/76, 2.6%) group (P < .001). CONCLUSIONS: Both KW and BP are safe and effective choices for LCF of the humerus in children. Both the implant designs produce satisfactory and comparable clinical outcomes. However, BP has the advantage of less hardware prominence, no need for hardware removal, and fewer long-term complications.


Assuntos
Implantes Absorvíveis , Fios Ortopédicos , Fixação Interna de Fraturas/métodos , Fraturas do Úmero/cirurgia , Criança , Pré-Escolar , Articulação do Cotovelo/diagnóstico por imagem , Articulação do Cotovelo/cirurgia , Feminino , Humanos , Fraturas do Úmero/diagnóstico por imagem , Masculino , Estudos Retrospectivos
10.
Artigo em Chinês | MEDLINE | ID: mdl-32791775

RESUMO

Objective: In combination with 3D printing technology and degradable composite materials, to discuss the preparation method of tissue engineering ossicles for middle ear hearing reconstruction. Methods: Domestic polymer (polylactic acid-glycolic acid copolymer, PLGA) and degradable ceramic material (ß-tricalcium phosphate, ß-TCP) were selected and prepared by low temperature deposition method according to the design ratio to Program according to the outline design code of the required scaffold to generate appropriate print files, and then the self-developed low-temperature deposition printing device was used to prepare tissue-engineered osseous scaffolds in accordance with the print files in a low-temperature environment. The scaffolds was freeze-dried and sterilized for later use after printing. Light microscopy and scanning electron microscopy were used to observe the apparent characteristics and internal structure of the scaffolds and to check its pore size, porosity and mechanical properties. Results: After printing, a degradable scaffold was obtained. Under the optical microscope, it was a small cylindrical shape with a diameter of 1.5 mm and a length of 6.0 mm, and its surface had micropores. The degradable scaffold had a horizontal and vertical interlaced warp and weft structure, the wire spacing was 1.2 mm, and the pores were connected to each other. The surface could see circular or quadrangular pores with a pore size of about 100-400 µm. The diameter of the inter-pore cross-linked channels was about 50 µm and the diameter of the surrounding circular micropores was about 10-40 µm. ß-TCP particles with a size of about 700 nm were attached to the surface of the PLGA material. The average porosity of the whole scaffolds was (83.43±0.01)%, and the content of BMP-2 loaded was about 0.7 µg/mm(3). After freeze-drying, the mechanical strength of the scaffold was moderate, and there was no obvious deformation during stretching and compression, which met the mechanical requirements of tissue engineering ossicles. Conclusions: Using the low-temperature deposition printing method and strictly controlled processes and conditions, a polymer-degradable ceramic ossicle tissue engineering scaffold can be prepared for implantation experiments. The scaffold has suitable porosity and mechanical properties, and can be loaded with osteoinductive factors.


Assuntos
Materiais Biocompatíveis , Ossículos da Orelha , Impressão Tridimensional , Engenharia Tecidual , Tecidos Suporte , Implantes Absorvíveis , Fosfatos de Cálcio , Orelha Média/cirurgia , Liofilização , Humanos , Microscopia , Copolímero de Ácido Poliláctico e Ácido Poliglicólico , Desenho de Prótese
11.
Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi ; 34(6): 481-485;491, 2020 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-32842174

RESUMO

Objective:To evaluate the effect of use of balloon catheter dilation (BCD) with bioabsorbable steroid-releasing sinus implants in pediatric chronic rhinosinusitis(PCRS). Method:A retrospective study was performed of 49 children with failed medical therapy, who underwent surgery, and children all accepted adenoidectomy.77 sides of sinus were performed with balloon catheter dilation sinuplasty. They were divided into two groups:the balloon group and the balloon with implant group. The balloon group included 26 cases, 16 cases of which accepted balloon catheter dilation sinuplasty of both maxillary sinuses, and 10 cases of which accepted one side. The balloon with implant group included 23 cases,12 cases of which accepted balloon catheter dilation sinuplasty of both maxillary sinuses plus positioning of bioabsorbable steroid-releasing sinus implants, and 11 cases of which accepted one side. VAS and SN-5 scales were completed by children and their parents to evaluate subjective symptoms. Children all accepted CT of sinus and CT score (Lund-Mackey) was completed by a doctor. We use the SPSS 23.0 with the way of Repeated measures ANOVA to analyze the data between two groups, aiming to identify the effect of the operation manners. Result:The procedures were successful in all patients in the balloon with implant group. No complications happened. No sinus implants moving and no detachment. In the balloon with implant group, VAS score declined from 6.9 before operation to 2.0 of six months after operation and SN-5 score declined from 2.397 to 1.376 and CT score of one side of operation declined from 9.628 to 1.314. VAS score, SN-5 score and CT score of the balloon with implant group all declined significantly after operation. The remission rate of the VAS and SN-5 score in the balloon with implant group were 100% and 95% respectively. The SN-5 score data of patients in two groups with SN-5 score <2.5 before operation was analyzed. There was no statistical significance between the data of two groups before operation(P=0.199), and there was no statistical significance between the data decline of SN-5 score of two groups after operation (F=2.336,P=0.14). The data of patients in two groups with SN-5 score ≥2.5 before operation was analyzed. There was no statistical significance between the data of two groups before operation(P=0.628), and, after operation, there was statistical significance between the data decline of SN-5 score of two groups (F=13.861,P=0.001).It meant the balloon with implant group declined more. The CT score data of patients in two groups with CT score (3-8) before operation was analyzed. There was no statistical significance between the data of two groups before operation(P=0.411),and there was no statistical significance between the data decline of CT score of two groups after operation(F=1.108,P=0.300).The data of patients in two groups with CT score (9-12) before operation was analyzed. There was no statistical significance between the data of two groups before operation(P=0.792), and, after operation, there was statistical significance between the data decline of CT score of two groups (F=13.059,P=0.001). It meant the balloon with implant group declined more. Conclusion:In our study, the use of balloon catheter dilation (BCD) with bioabsorbable steroid-releasing sinus implants made a clinical curative effect in the treatment of PCRS with failed medical therapy, and it was safety. In severe PCRS patients, balloon catheter dilation (BCD) with bioabsorbable steroid-releasing sinus implants was more effective than the use of balloon catheter sinuplasty (BCS) alone.


Assuntos
Rinite , Implantes Absorvíveis , Criança , Doença Crônica , Dilatação , Endoscopia , Humanos , Estudos Retrospectivos , Resultado do Tratamento
12.
Medicine (Baltimore) ; 99(31): e21554, 2020 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-32756213

RESUMO

BACKGROUND: Bioresorbable vascular scaffolds (BVS) completely resorb within 3 years after placement into the coronary artery. The safety and effectiveness of bioabsorbable scaffolds are of critical importance during this 3-year period. OBJECTIVE: We performed a meta-analysis to compare the safety and efficacy of BVS and second-generation drug-eluting stents (DES) at 3 years after implantation. METHODS: Published randomized trials comparing BVS to second-generation DES for the treatment of coronary artery disease were identified within PubMed, EMBASE, Cochrane Library, Web of Science, and relevant Web sites with publication dates through June 2019. The primary efficacy endpoint was target lesion failure. The primary safety endpoint was definite/probable stent/scaffold thrombosis. Secondary outcomes were cardiac death, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and a patient-oriented composite end point. RESULTS: Six randomized controlled trials, with a total of 5,412 patients (BVS n = 3,177; DES n = 2,235), were included. At 3 years, BVS was associated with higher rates of target lesion failure (OR = 1.33, 95%CI: 1.10-1.60, P = 0.003) and definite/probable stent/scaffold thrombosis (OR = 3.75, 95% CI: 2.22-6.35, P < .00001)compared with DES. The incidence of target vessel myocardial infarction (OR = 1.68, 95% CI: 1.30-2.17, P < .0001), ischemia-driven target lesion revascularization (OR = 1.46, 95% CI: 1.14-1.86, P = .003), and the patient-oriented composite end point(OR = 1.20, 95% CI: 1.04-1.39, P = .01) were higher for those treated with BVS compared with DES. However, there was no significant difference in risk of cardiac death (OR = 0.94, 95%CI: 0.61-1.45, P = .79) between treatment groups. CONCLUSIONS: At the 3-year follow-up, BVS was inferior to second-generation DES in both safety and efficacy.


Assuntos
Implantes Absorvíveis/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Morte , Humanos , Infarto do Miocárdio/etiologia , Revascularização Miocárdica/estatística & dados numéricos , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose/etiologia
13.
Am Heart J ; 227: 111-117, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32739537

RESUMO

BACKGROUND: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued. METHODS: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure. CONCLUSIONS: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Sirolimo/administração & dosagem , Implantes Absorvíveis , Estudos de Equivalência como Asunto , Humanos , Estudos Multicêntricos como Assunto , Polímeros , Estudos Prospectivos , Desenho de Prótese
15.
PLoS One ; 15(7): e0235842, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32639989

RESUMO

Biodegradable stents are promising treatments for many diseases, e.g., coronary artery disease, urethral diseases, tracheal diseases, and esophageal strictures. The mechanical properties of biodegradable stent materials play a key role in the safety and efficacy of treatment. In particular, insufficient creep resistance of the stent material could result in premature stent collapse or narrowing. Commercially available biodegradable self-expandable SX-ELLA stents made of polydioxanone monofilament were tested. A new, simple, and affordable method to measure the shear modulus of tiny viscoelastic wires is presented. The important mechanical parameters of the polydioxanone filament were obtained: the median Young's modulus was [Formula: see text] = 958 (922, 974) MPa and the shear modulus was [Formula: see text] = 357 (185, 387) MPa, resulting in a Poisson's ratio of ν = 0.34. The SX-ELLA stents exhibited significant force relaxation due to the stress relaxation of the polydioxanone monofilament, approximately 19% and 36% 10 min and 48 h after stent application, respectively. However, these results were expected, and the manufacturer and implanting clinician should be aware of the known behavior of these biodegradable materials. If possible, a biodegradable stent should be designed considering therapeutic force rather than initial force. Additionally, new and more advanced biodegradable shape-memory polymers should be considered for future study and use.


Assuntos
Implantes Absorvíveis , Materiais Biocompatíveis/química , Polidioxanona/química , Stents , Módulo de Elasticidade , Humanos , Teste de Materiais , Fenômenos Mecânicos , Desenho de Prótese
16.
PLoS One ; 15(7): e0235673, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32645029

RESUMO

BACKGROUND AND OBJECTIVES: This study sought to compare clinical outcomes between bioresorbable scaffolds (BRS) and durable polymer everolimus-eluting metallic stents (DP-EES) in patients with acute myocardial infarction (AMI) undergoing successful percutaneous coronary intervention (PCI). METHODS: From March 2016 to October 2017, 952 patients with AMI without cardiogenic shock undergoing successful PCI with BRS (n = 136) or DP-EES (n = 816) were enrolled from a multicenter, observational Korea Acute Myocardial Infarction Registry. RESULTS: In the crude population, there was no significant difference in the 1-year rate of device-oriented composite endpoint (DOCE) and device thrombosis between the BRS and DP-EES groups (2.2% vs. 4.8%, hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.13-1.41, p = 0.163; 0.7% vs. 0.5%, HR 1.49, 95% CI 0.16-13.4, p = 0.719, respectively). BRS implantation was opted in younger patients (53.7 vs. 62.6 years, p < 0.001) with low-risk profiles, and intravascular image-guided PCI was more preferred in the BRS group (60.3% vs. 27.2%, p < 0.001). CONCLUSIONS: At 1-year follow-up, no differences in the rate of DOCE and device thrombosis were observed between patients with AMI treated with BRS and those treated with DP-EES. Our data suggest that imaging-guided BRS implantation in young patients with low risk profiles could be a reasonable strategy in the setting of AMI.


Assuntos
Implantes Absorvíveis/efeitos adversos , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Doença Aguda/terapia , Adulto , Idoso , Fármacos Cardiovasculares/uso terapêutico , Determinação de Ponto Final , Everolimo/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Modelos de Riscos Proporcionais , República da Coreia , Trombose/etiologia , Tecidos Suporte/efeitos adversos , Resultado do Tratamento
17.
Int Heart J ; 61(4): 665-672, 2020 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-32684594

RESUMO

Clinical outcomes after percutaneous coronary intervention (PCI) for severely calcified lesions remain poor. The purpose of this study was to investigate the neointimal response after everolimus-eluting stents (EES) for severely calcified lesions treated with rotational atherectomy (RA) using optical coherence tomography (OCT).We retrospectively analyzed 34 lesions in which PCI was performed with EES deployment following RA and OCT was performed immediately after PCI and at follow-up (nine months). The EES was either durable-polymer (DP) EES (22 lesions) or bioabsorbable polymer (BP) -EES (12 lesions). Strut coverage and malapposition were evaluated at 1-mm intervals of cross-section (CS) by serial OCT analysis. Malapposed strut was defined as having the distance from luminal border > 100 µm.A total of 11,823 struts immediately after PCI and 11,720 struts at follow-up were analyzed. Immediately after PCI, the strut-level analysis showed no significant differences in the percentage of malapposed struts between the DP-EES group and the BP-EES group. At follow-up, the BP-EES group showed a more prevalent covered strut compared with the DP-EES group (strut-level analysis: 95% versus 97%, P = 0.045; CS-level analysis: 97% versus 100%, P < 0.01; lesion-level analysis: 27% versus 83%, P < 0.01, respectively).In severely calcified lesions requiring RA, the BP-EES group achieved better neointimal coverage than the DP-EES group at nine months. Additional prospective studies are needed.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Aterectomia Coronária/instrumentação , Stents Farmacológicos/estatística & dados numéricos , Neointima/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/administração & dosagem , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polímeros , Estudos Retrospectivos , Tomografia de Coerência Óptica
18.
Int Heart J ; 61(4): 673-684, 2020 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-32684595

RESUMO

Hyperglycemia is an important risk factor for poor clinical outcomes in patients with acute myocardial infarction (AMI). The relative superiority of the long-term clinical outcomes of durable-polymer (DP) -based and biodegradable-polymer (BP) -based newer-generation drug-eluting stents (DESs) after successful percutaneous coronary intervention (PCI) in patients with AMI and prediabetes is not well established. We compared the clinical outcomes in such patients between DP-based and BP-based newer-generation DESs.A total of 4,377 patients with AMI and prediabetes were divided into the following two groups: the DP-DES group (n = 3,775; zotarolimus-eluting stents [ZES; n = 1,546] and everolimus-eluting stents [EES; n = 2,229]) and the BP-DES group (n = 602; biolimus-eluting stents [BES]). The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization. The secondary endpoint was the occurrence of stent thrombosis (ST).The 2-year adjusted hazard ratio (aHR) of MACEs for ZES versus EES, ZES versus BES, EES versus BES, and ZES/EES versus BES (aHR: 1.125; 95% confidence interval [CI], 0.834-1.518; P = 0.440) were similar. The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Stents Farmacológicos/estatística & dados numéricos , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/instrumentação , Estado Pré-Diabético/complicações , Idoso , Antineoplásicos/administração & dosagem , Everolimo/administração & dosagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Sirolimo/administração & dosagem , Sirolimo/análogos & derivados
19.
Ann Surg ; 272(2): 241-247, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32675536

RESUMO

OBJECTIVE: To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair. SUMMARY OF BACKGROUND DATA: Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair. METHODS: Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years. RESULTS: 126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh. CONCLUSIONS: No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.


Assuntos
Hérnia Hiatal/cirurgia , Herniorrafia/métodos , Laparoscopia/métodos , Telas Cirúrgicas/efeitos adversos , Técnicas de Sutura , Implantes Absorvíveis , Adulto , Análise de Variância , Austrália , Distribuição de Qui-Quadrado , Método Duplo-Cego , Feminino , Seguimentos , Hérnia Hiatal/diagnóstico por imagem , Herniorrafia/efeitos adversos , Humanos , Laparoscopia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Reoperação/métodos , Medição de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Cicatrização/fisiologia
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