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1.
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
2.
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
5.
Rev Esp Cardiol (Engl Ed) ; 72(4): 298-304, 2019 Apr.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29954720

RESUMO

INTRODUCTION AND OBJECTIVES: There is little evidence on rates of stent thrombosis (ST) in patients receiving dual antiplatelet therapy (DAPT) with ticagrelor or prasugrel. The aim of this study was to analyze the incidence and predictors of ST after an acute coronary syndrome among patients receiving DAPT with ticagrelor vs prasugrel. METHODS: We used data from the RENAMI registry (REgistry of New Antiplatelet therapy in patients with acute Myocardial Infarction), analyzing a total of 4123 acute coronary syndrome patients discharged with DAPT with ticagrelor or prasugrel in 11 centers in 6 European countries. The endpoint was definite ST within the first year. A competitive risk analysis was carried out using a Fine and Gray regression model, with death being the competitive event. RESULTS: A total of 2604 patients received DAPT with ticagrelor and 1519 with prasugrel; ST occurred in 41 patients (1.10%), with a similar cumulative incidence between ticagrelor (1.21%) and prasugrel (0.90%). The independent predictors of ST were age (sHR, 1.03; 95%CI, 1.01-1.06), ST segment elevation (sHR, 2.24; 95%CI, 1.22-4.14), previous myocardial infarction (sHR, 2.56; 95%CI, 1.19-5.49), and serum creatinine (sHR, 1.29; 95%CI, 1.08-1.54). CONCLUSIONS: Stent thrombosis is infrequent in patients receiving DAPT with ticagrelor or prasugrel. The variables associated with an increased risk of ST were advanced age, ST segment elevation, previous myocardial infarction, and serum creatinine.


Assuntos
Síndrome Coronariana Aguda/terapia , Oclusão de Enxerto Vascular/etiologia , Inibidores da Agregação de Plaquetas/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Stents , Trombose/etiologia , Ticagrelor/uso terapêutico , Implantes Absorvíveis/estatística & dados numéricos , Stents Farmacológicos , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/estatística & dados numéricos , Falha de Prótese/efeitos adversos , Estudos Retrospectivos
6.
J. coloproctol. (Rio J., Impr.) ; 38(4): 314-319, Oct.-Dec. 2018. tab
Artigo em Inglês | LILACS | ID: biblio-975980

RESUMO

ABSTRACT Background: The surgical treatment of anal fistula is complex due to the possibility of fecal incontinence. Fistulotomy and cutting Setons have the same incidence of fecal incontinence depending on the complexity of the fistula. Sphincter-preserving procedures such as anal fistula plug and ligation of intersphincteric fistula tract procedure may result in more recurrence requiring repeated operations. The aim of this study was to evaluate and compare the outcomes of treating fistula in Ano utilizing two methods: Fistula plug (Gore Bio-A) and ligation of intersphincteric tract (LIFT). Methods: Fifty four patients (33 males; 21 female, median ages 42 [range 32-47] years) with high anal inter-transphenteric fistula were treated with LIFT and fistula plug procedures from September 2011 until August 2016 by a single surgeon and were retrospectively evaluated. All were followed for a median of 23.9 (range 4-54) months with clinical examination. Twenty one patients underwent fistula plug and 33 patients underwent LIFT procedure (4 patients of the LIFT group underwent LIFT and rectal mucosa advancement flap). The healing rate and complications were evaluated clinically and through telephone calls. Results: The mean operative time for the Plug was 25 ± 17 min and for the LIFT was 40 ± 20 min (p = 0.017) and the mean hospital stay was 2.4 ± 1.1 and 1.9 ± 0.3 (p = 0.01) respectively. The early complications of the plug and LIFT procedures included; anal pain (33.3%, 66.6%, p = 0.13), perianal discharge (77.8%, 91%, p = 0.62), anal pruritus (38.9%, 50.0%, p = 0.71) and bleeding per rectum (16.7%, 33.3%, p = 0.39) respectively. The overall mean follow-up was 20.9 ± 16.8 months, p = 0.68. There was no statistically significant difference between the two groups (21.9 ± 7.5 months, 19.9 ± 16.1 months, p = 0.682). The healing rate was 76.2% (16/21 patients) in the fistula plug group and 81.1% (27/33 patients) in the LIFT group (p = 0.73). Patients who had LIFT procedure and a mucosal advancement flap had 100% healing rate (4 out of 4 patients). No incontinence of stool or feces and no fistula plug expulsion were seen in our patients. The healing time ranged from 1 to 6 months after surgery. There was no post-operative perianal abscess, cellulitis or pain. Conclusions: LIFT and anal plug are safe procedures for patients with primary and recurrent anal fistula. Both techniques showed excellent results in terms of healing and complication rate. None of our patients had incontinence after 5 years follow-up. The best success rate in our patients was seen after LIFT procedure with mucosal advancement flap. Larger and controlled randomized trials are needed for better assessment of treatment options.


RESUMO Introdução: O tratamento cirúrgico da fístula anal é complexo devido à possibilidade de incontinência fecal. A fistulotomia e o seton de corte têm a mesma incidência da incontinência fecal, dependendo da complexidade da fístula. Procedimentos de preservação do esfíncter, como o tampão da fístula anal e o procedimento LIFT (ligadura do trato da fístula interesfincteriana), podem resultar em mais recorrência, exigindo cirurgias repetidas. O objetivo deste estudo foi avaliar e comparar os desfechos do tratamento da fístula anal utilizando dois métodos: Tampão de fístula (Gore Bio-A) e Ligadura do Trato Interesfincteriano (LIFT). Métodos: Cinquenta e quatro pacientes (33 homens; 21 mulheres, com mediana de idade de 42 [variação 32-47] anos) foram tratados com LIFT e procedimentos com tampão de fístula de setembro de 2011 até agosto de 2016 por um único cirurgião e foram avaliados retrospectivamente. Todos foram acompanhados por uma mediana de 23,9 (variação de 4 a 54) meses com exame clínico. Vinte e um pacientes foram submetidos a tampão de fístula e 33 pacientes foram submetidos ao procedimento LIFT (4 pacientes do grupo LIFT foram submetidos a LIFT e retalho de avanço da mucosa retal). A taxa de cicatrização e as complicações foram avaliadas clinicamente e por meio de ligações telefônicas. Resultados: O tempo cirúrgico médio para o Tampão foi de 25 ± 17 minutos e para o LIFT foi de 40 ± 20 minutos (p = 0,017) e o tempo médio de internação foi de 2,4 ± 1,1 e 1,9 ± 0,3 (p = 0,01), respectivamente. As primeiras complicações dos procedimentos de tampão e LIFT incluíram: dor anal (33,3%, 66,6%, p = 0,13), secreção perianal (77,8%, 91%, p = 0,62), prurido anal (38,9%, 50,0%, p = 0,71) e sangramento pelo reto (16,7%, 33,3 %, p = 0,39) respectivamente. A média geral de acompanhamento foi de 20,9 ± 16,8 meses, p = 0,68. Não houve diferença estatisticamente significativa entre os dois grupos (21,9 ± 7,5 meses, 19,9 ± 16,1 meses, p = 0,682). A taxa de cicatrização foi de 76,2% (16/21 pacientes) no grupo com tampão de fístula e 81,1% (27/33 pacientes) no grupo LIFT (p = 0,73). Pacientes submetidos ao procedimento LIFT e um retalho de avanço da mucosa tiveram 100% de taxa de cura (4 de 4 pacientes). Nenhuma incontinência fecal e nenhuma expulsão do tampão da fístula foram observadas em nossos pacientes. O tempo de cicatrização variou de 1 a 6 meses após a cirurgia. Não houve abscesso perianal, celulite ou dor no pós-operatório. Conclusões: LIFT e tampão anal são procedimentos seguros para pacientes com fístula anal primária e recorrente. Ambas as técnicas apresentaram excelentes resultados em termos de cicatrização e taxa de complicações. Nenhum de nossos pacientes teve incontinência após 5 anos de acompanhamento. A melhor taxa de sucesso em nossos pacientes foi observada após o procedimento LIFT com retalho de avanço da mucosa. Ensaios clínicos randomizados de maior porte e controlados são necessários para melhor avaliação das opções de tratamento.


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Instrumentos Cirúrgicos/estatística & dados numéricos , Fístula Retal/cirurgia , Implantes Absorvíveis/estatística & dados numéricos , Resultado do Tratamento , Esfincterotomia/métodos
7.
Int Heart J ; 59(5): 1134-1141, 2018 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-30101856

RESUMO

For the suppression of inflammation in the aneurysm development, we focused on inhibition of an important transcription factor, nuclear factor-kappa B (NF-κB), using a decoy strategy. We newly developed a novel bioabsorbable sheet that delivers NF-κB decoy oligodeoxynucleotide (ODN).We treated 5-week-old SD rats that were induced with abdominal aortic aneurysm (AAA) using 0.5 M CaCl2 with an NF-κB decoy sheet. Four weeks after AAA induction, aortic tissue was excised for further examinations. We showed that this bioabsorbable sheet could deliver the decoy ODN into the target tissues and dissolve within a week. Treatment with the NF-κB decoy sheet reduced the aneurysm size compared with the controls. It also suppressed inflammation due to the effect of NF-κB decoy ODN. Immunohistochemistry revealed that the expression of CD31, CD4, and CD11b in the NF-κB decoy sheet group was significantly lower than in the control sheet group. The NF-κB decoy sheet was absorbed on the target tissue.We have revealed that the bioabsorbable sheet mediated decoy ODN is effective for transfection into target organs. We have also indicated that NF-κB decoy ODN transfection using this sheet has the potential to suppress the dilatation of aneurysm. The bioabsorbable sheet mediated transfection of the decoy ODN can be beneficial for the clinical treatment of AAA and other NF-κB-related cardiovascular diseases.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Aorta/anatomia & histologia , Aneurisma da Aorta Abdominal/tratamento farmacológico , NF-kappa B/metabolismo , Oligodesoxirribonucleotídeos/metabolismo , Oligonucleotídeos/metabolismo , Animais , Aorta/efeitos dos fármacos , Aorta/patologia , Aorta/ultraestrutura , Aneurisma da Aorta Abdominal/metabolismo , Aneurisma da Aorta Abdominal/patologia , Antígeno CD11b/metabolismo , Antígenos CD4/metabolismo , Regulação da Expressão Gênica , Inflamação/tratamento farmacológico , Inflamação/metabolismo , Inflamação/patologia , Masculino , NF-kappa B/efeitos dos fármacos , Oligodesoxirribonucleotídeos/farmacologia , Molécula-1 de Adesão Celular Endotelial a Plaquetas/metabolismo , Ratos , Ratos Sprague-Dawley , Transfecção/métodos
8.
J Drugs Dermatol ; 17(7): 786-793, 2018 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30005090

RESUMO

BACKGROUND: Absorbable suspension sutures for tissue repositioning represent a minimally invasive approach to facial rejuvenation. With 2015 FDA 510(k) approval of Silhouette InstaLift™ (Sinclair Pharma, Irvine, CA), a completely absorbable device comprised of 82% PLLA/18% PLGA sutures and bi-directional cones, came the challenge of developing optimal technique for achieving effective, precise, and durable tissue repositioning. Here, the authors discuss the importance of straight-line vector planning (SLVP) and positioning of the suture perpendicular to the plane to be elevated in obtaining optimal results for tissue repositioning. Both the scientific underpinnings of SLVP are presented, along with detailed discussion of technique for suture placement in the mid-face, jawline/jowls, and neck. METHODS: The authors are some of the earliest adopters of absorbable suspension sutures in the United States and have both used InstaLift™ sutures for tissue repositioning and facial recontouring in treatment of more than 500 patients and developed the principles of SLVP as a method to ensure optimal outcomes. RESULTS: Patient case studies illustrating the importance of SLVP are presented. In over 500 patients treated within the authors' practices since InstaLift approval there have been no serious adverse events and noticeable bruising has occurred in less than 5% of patients. Results of repositioning and recontouring are evident for up to 24 months. CONCLUSIONS: Absorbable suspension sutures are a highly adaptable, non-invasive device for lifting and repositioning of descended facial tissue. Outcomes are dependent upon proper technique, including SLVP. J Drugs Dermatol. 2018;17(7):786-793.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Rejuvenescimento , Ritidoplastia/métodos , Envelhecimento da Pele , Suturas , Face , Feminino , Humanos , Pessoa de Meia-Idade , Pescoço , Satisfação do Paciente , Técnicas de Sutura , Resultado do Tratamento
9.
Clin Hemorheol Microcirc ; 69(1-2): 3-8, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29630530

RESUMO

AIM: To investigate three-year outcomes of patients presenting with nonSTelevation acute coronary syndrome (NSTE-ACS) treated with bioresorbable everolimus-eluting vascular scaffolds (BRS). METHODS AND RESULTS: The study included a total of 488 consecutive patients, enrolled between May 2012 and December 2013 (median age 65 [56-74], 392 men. 269 patients presented with either NSTEMI or unstable angina at the time of enrolling, 219 patients with stable or silent angina. The primary device-oriented endpoint (Target Lesion Failure, TLF) was defined as a combination of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization.Among the cardiac risk factors, NSTE-ACS patients were more frequently smokers (P = 0.028), had less frequently dyslipidemia (P = 0.003) and a history of prior PCI (P < 0.01).The median follow-up was 1070[763-1197] days. The three-years incidence of TLF was slightly higher but did not differ significantly between groups (NSTE-ACS: 16.3% vs. 15.9%, p = 0.163). Accordingly, there was no difference in any of the other endpoints. CONCLUSION: Treatment of NSTE-ACS with BRS appears to be safe and effective. In this group, risk factors for events during follow up did not differ as compared to the general population.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Síndrome Coronariana Aguda/tratamento farmacológico , Stents Farmacológicos/estatística & dados numéricos , Everolimo/uso terapêutico , Intervenção Coronária Percutânea/métodos , Síndrome Coronariana Aguda/patologia , Idoso , Everolimo/farmacologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Resultado do Tratamento
10.
Arch Orthop Trauma Surg ; 137(11): 1539-1546, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28780703

RESUMO

PURPOSE: Various researchers have observed small areas of osteolysis after using bioabsorbable anchors in shoulder surgeries. The purpose of this study is to determine whether radiographic perianchor radiolucent rings after rotator cuff repair are associated with the failure of repair and also assess their clinical implications. Further, the most frequent location of the radiolucent rings in the double-row suture bridge configuration was also assessed. METHODS: One hundred and twenty-nine consecutive patients who underwent arthroscopic rotator cuff repair by suture bridge technique were retrospectively evaluated radiographically and clinically. The number and size of the rings that appeared at each follow-up were recorded. Also, the locations of each ring were recorded as anterior, middle or posterior, and medial or lateral according to the construct of the anchors used for suture bridge technique. The size of the tear, the number of anchors used and age of the patients were compared. Re-tear rates according to ultrasound examinations were also analyzed. RESULTS: After rotator cuff repair, the mean American Shoulder and Elbow Surgeons (ASES) score increased from 46.7 to 88.0 and the overall re-tear rate was 8.5% (11 cases). Seventy-three patients (56.6%) showed RR (total number of 99 rings) at least once during the course of their follow-up and the rings appeared at a mean period of 18.2 months after surgery. Mean size of the rings initially was 5.6 mm and the rings increased or decreased in mean size of 0.4 mm during mean follow-up of 37 months. No correlation was seen with the number of RRs and the rate of re-tears, number of anchors, size of tears, and clinical outcome as determined by the ASES score. Radiolucent ring measurement reproducibility was confirmed by independent, repeated measurements. The rings appeared mostly at anteromedial anchors (75 rings, 75.8%) and the authors suggest that mechanical factors may play a role for the cause of radiolucent rings. CONCLUSIONS: The number and the size of RRs around bioabsorbable anchors after rotator cuff repair do not appear to adversely affect the healing and clinical outcome of ARCR. Most radiolucent rings appeared at anteromedial anchors, indicating that mechanical factors may play a role for the radiolucencies. LEVEL OF EVIDENCE: Case series, level IV.


Assuntos
Implantes Absorvíveis , Artroscopia , Osteólise , Lesões do Manguito Rotador/cirurgia , Manguito Rotador , Implantes Absorvíveis/efeitos adversos , Implantes Absorvíveis/estatística & dados numéricos , Artroscopia/efeitos adversos , Artroscopia/estatística & dados numéricos , Humanos , Osteólise/diagnóstico por imagem , Osteólise/etiologia , Radiografia , Estudos Retrospectivos , Manguito Rotador/diagnóstico por imagem , Manguito Rotador/cirurgia
12.
Am J Rhinol Allergy ; 31(2): 122-126, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-28452709

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.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Vazamento de Líquido Cefalorraquidiano/cirurgia , Endoscopia , Seios Paranasais/cirurgia , Procedimentos Cirúrgicos Reconstrutivos , Neoplasias da Base do Crânio/cirurgia , Base do Crânio/cirurgia , Materiais Biocompatíveis/química , Feminino , Seguimentos , Humanos , Masculino , Pessoa de 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
13.
J Cardiol ; 69(1): 149-155, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-26972344

RESUMO

BACKGROUND: Long-term outcome of drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) versus non-ST-elevation acute coronary syndrome (NSTE-ACS) remains unclear. This study sought to compare the long-term outcomes of biodegradable polymer-coated DES in patients with STEMI versus NSTE-ACS. METHODS: We explored a post hoc analysis of the 5-year outcome of the CREATE trial in the subgroup of patients with STEMI (n=318) versus NSTE-ACS (n=1223) who were implanted with biodegradable polymer-coated DES. The primary outcome was the rate of major adverse cardiac events (MACE) at 5 years. Clopidogrel and aspirin for 6 months followed by chronic aspirin therapy were recommended. RESULTS: STEMI patients showed a trend of increase in MACE (8.7% vs. 6.8%, log rank p=0.289) compared to NSTE-ACS patients at 5 years, and a greater risk of cardiac death (5.4% vs. 2.1%, log rank p=0.003), mainly driven by the higher cardiac death rate within the first month after stent placement (log rank p=0.003) and the last year of follow-up (log rank p=0.001). No significant difference in stent thrombosis was found between them (3.1% vs. 2.5%, log rank p=0.653). Prolonged clopidogrel therapy (>6 months) showed no effect on risk of MACE or stent thrombosis between the two groups (both p for interaction >0.1). CONCLUSIONS: STEMI patients have a higher risk of cardiac mortality compared with NSTE-ACS patients after biodegradable polymer-coated DES placement, primarily attribute to more cardiac deaths that happened within the first month after the event and the last year of follow-up.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Antibacterianos/administração & dosagem , Stents Farmacológicos/estatística & dados numéricos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Sirolimo/administração & dosagem , Implantes Absorvíveis/estatística & dados numéricos , Síndrome Coronariana Aguda/tratamento farmacológico , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polímeros , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Fatores de Tempo , Resultado do Tratamento
14.
Int J Cardiol ; 227: 127-133, 2017 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-27863289

RESUMO

The DESolve® scaffold (Elixir Medical Corporation, Sunnyvale, California, USA) is manufactured from a poly-l-lactide based polymer and elutes an anti-proliferative, anti-inflammatory drug, Novolimus from a poly-l-lactide based topcoat mixture. The strut thickness is 150µm and the scaffold has platinum-iridium radiopaque markers at both ends. Radial support is available during the early time period to prevent recoil. The scaffold biodegrades within 1year (>90% reduction in molecular weight) and then completely bioresorbs within 2years. The DESolve® scaffold permits a wide range of expansion with a consequently reduced risk for strut fracture. Lumen and scaffold enlargement is observed within 3-6months in both preclinical and clinical studies potentially allowing for the scaffolded region to respond to vasoactive stimuli. The device has a unique property of self-correction observed in bench top studies, which in clinical practice has the potential to eliminate minor malapposition following deployment.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Estenose Coronária/terapia , Stents Farmacológicos/normas , Macrolídeos/farmacologia , Intervenção Coronária Percutânea/instrumentação , Angiografia Coronária/métodos , Estenose Coronária/diagnóstico por imagem , Stents Farmacológicos/tendências , Feminino , Seguimentos , Previsões , Humanos , Masculino , Intervenção Coronária Percutânea/métodos , Medição de Risco , Tecidos Suporte , Resultado do Tratamento , Grau de Desobstrução Vascular/fisiologia
15.
Int J Cardiol ; 222: 832-840, 2016 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-27522385

RESUMO

BACKGROUND & AIMS: Although Absorb Bioresorbable Vascular Scaffolds (A-BVS) are routinely used in the Asia-Pacific, there is little information on patient selection or deployment technique here. This document investigates the experiences of leading interventional cardiologists from the Asia-Pacific region with a focus on patient characteristics, deployment techniques and management. METHODS AND RESULTS: A detailed questionnaire was distributed to 28 highly-experienced interventional cardiologists ('Authors') from 13 Asia-Pacific countries. The results were discussed at a meeting on patient selection, technical consideration, deployment practices and patient management. Potential patient benefits of Absorb compared to metallic DES, the learning curve for patient selection and preparation, device deployment, and subsequent patient management approaches are presented. CONCLUSIONS: Current practices are derived from guidelines optimized for European patients. Differences in approach exist in the Asia-Pacific context, including limited access to imaging and frequency of occurrence of complex lesions. Nevertheless, the use of the Absorb BVS ('Absorb') in certain Asia-Pacific countries has flourished and practices here are continuing to mature.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Prótese Vascular/estatística & dados numéricos , Cardiologistas/estatística & dados numéricos , Cardiologia , Doença da Artéria Coronariana/cirurgia , Tecidos Suporte/estatística & dados numéricos , Ásia , Humanos , Desenho de Prótese
16.
J Interv Cardiol ; 29(4): 341-7, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27329969

RESUMO

AIM: We aimed to investigate the safety and efficacy of bioresorbable vascular scaffolds (BVS) in daily use in a real-world patient population. METHODS AND RESULTS: Between March 2013 and September 2014, 224 patients (233 lesions) were treated with BVS at a tertiary care center. Patients underwent follow-up coronary angiography 3-6 months after implantation. Clinical presentations were stable angina in 101 patients (45.1%), unstable angina in 47 (21.0%), NSTEMI in 38 (17.0%), and STEMI in 38 (17.0%) patients. Twenty-two patients (27 lesions) had chronic total occlusion (CTO). Procedural success was achieved in all patients. Two patients died in the follow-up period due to BVS thrombosis (0.9%). In-hospital death occurred in further 3 patients (1.3%) due to other causes not related to the BVS implantation. Total BVS thrombosis was 3.1% (7 patients) and there was only 1 case of relevant restenosis on angiographic follow-up. The overall incidence of major adverse cardiac events was 11 (4.9%). CONCLUSIONS: Mid-term follow-up after implantation of BVS suggests a satisfactory safety profile and low restenosis rate in routine daily practice involving a large range of complex lesions.


Assuntos
Implantes Absorvíveis , Angiografia Coronária/métodos , Intervenção Coronária Percutânea , Complicações Pós-Operatórias , Implantes Absorvíveis/efeitos adversos , Implantes Absorvíveis/estatística & dados numéricos , Idoso , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Suécia/epidemiologia , Resultado do Tratamento
17.
Curr Cardiol Rep ; 18(8): 74, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27312934

RESUMO

The evolution of percutaneous coronary intervention has been considerable. Coronary stents were introduced to avoid vessel recoil and reduce acute and late vessel complications. Later, drug-eluting stents were developed to decrease the neointimal hyperplasia associated with bare metal stents in order to reduce restenosis. However, very late stent thrombosis remains problematic, and the permanent presence of a metal stent could be associated with local inflammation and impaired vascular physiology. Thus, bioresorbable stents have been developed, to prevent recoil initially when this risk is the highest, with subsequent degradation over time, to avoid long-term complications of the presence of stents in the coronary vasculature. Here, we review the current status of bioresorbable stents in percutaneous coronary intervention (PCI), with focus on the platforms that have been studied the most: ABSORB, DESolve, and DREAMS. In terms of clinical outcomes, bioresorbable stents have not yet shown superiority compared with current generation drug-eluting stents, but rather a signal of increased stent thrombosis. Further development and longer-term studies are needed before the routine implementation of bioresorbable stents in clinical practice.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/prevenção & controle , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Implantes Absorvíveis/efeitos adversos , Ensaios Clínicos como Assunto , Humanos , Desenho de Prótese , Resultado do Tratamento
19.
Surg Technol Int ; 28: 125-30, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27042785

RESUMO

INTRODUCTION: The Ultrapro® Advanced™ mesh (Ethicon, Sommerville, NJ) is a new mesh design, using the best characteristics from the previous platform, while adding new, advanced features. Our centre, Imelda Hospital, Bonheiden, Belgium, was chosen as one of the first clinical testing sites. The aim of this study was to present our preliminary data on complication rate and patient satisfaction. MATERIALS AND METHODS: From October 1, 2015 until January 31, 2016, we treated 57 patients, implementing 67 Ultrapro® Advanced™ meshes. One patient was excluded due to postoperative cerebral haemorrhage with aphasia. Only patients with more than one-month follow-up were included for further analysis, resulting in a population of 41 patients with 51 meshes. Of them, 35 were male and only 6 were female, with an average age of 61.4 years and an average BMI of 25.9. The indications were uni- and bilateral laparoscopic inguinal hernia repair (n = 23 and 10 respectively), open inguinal hernia repair (n = 3), and open incisional hernia repair (n = 5). Quality of life was measured preoperatively and at four weeks postoperatively, using the hernia specific Carolina Comfort Scale (CCS) questionnaire. RESULTS: The primary endpoint was complication rate. Only two patients (4.8%) mentioned a mild scrotal hematoma and two patients (4.8%) demonstrated a seroma. There were no superficial wound infections nor early recurrent hernias. Our secondary endpoint was quality of life, measured by the CCS questionnaire, which differentiates between a symptomatic and an asymptomatic group. A total of 13 patients were asymptomatic, whilst 28 patients reported some sort of discomfort, ranging from mild (n = 25) to moderate and/or daily symptoms (n = 3). No patients were disabled by their symptoms. CONCLUSION: The Ultrapro® Advanced™ is a sequel of the classic Ultrapro® mesh with similar characteristics: it is a "lightweight", macroporous, partially absorbable mesh built out of thin filaments, while maintaining sufficient strength. Its improvement is due to incorporation of evidence-based characteristics such as an increased mesh elasticity. Furthermore, the surgical manipulation is improved thanks to the increased mesh memory. Our prospective cohort study shows good initial and short-term results after implementation of the Ultrapro® Advanced™. However, further prospective research is mandatory on the long-term outcomes.


Assuntos
Hérnia/epidemiologia , Herniorrafia/instrumentação , Herniorrafia/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Qualidade de Vida/psicologia , Telas Cirúrgicas/estatística & dados numéricos , Implantes Absorvíveis/estatística & dados numéricos , Bélgica/epidemiologia , Desenho de Equipamento , Análise de Falha de Equipamento , Feminino , Hérnia/diagnóstico , Herniorrafia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Prevalência , Resultado do Tratamento
20.
Int J Cardiol ; 212: 214-22, 2016 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-27045877

RESUMO

BACKGROUND: Bioresorbable vascular scaffolds (BVS) have been shown to be non-inferior to second generation drug eluting stents in recent clinical trials. However, the trials were not powered for individual endpoints and there is concern for increased device thrombosis with BVS. METHODS: We performed a systematic search for randomized clinical trials of BVS versus EES. Efficacy outcomes were target lesion revascularization (TLR) and target vessel revascularization (TVR). Safety outcomes were death, myocardial infarction (MI), and device thrombosis. Meta-regression analyses were performed to evaluate the association of device thrombosis with clinical characteristics (percent patients with acute coronary syndrome) and device deployment characteristics (percent with post stent balloon dilation). RESULTS: We identified six RCTs that enrolled 3738 patients. When compared with EES, BVS was associated with similar risk of TLR (RR=1.06; 95% CI 0.73-1.54), TVR (RR=1.00; 95% CI 0.74-1.35), death (RR=1.11; 95% CI 0.53-2.33) and cardiovascular death (RR=1.39; 95% CI 0.43-4.43) but numerically higher MI (RR=1.35; 95% CI 0.98-1.86) and definite or probable device thrombosis (RR=2.11; 95% CI 0.99-4.47). In a sensitivity analysis using the Peto odds ratio method, the risk of definite or probable device thrombosis was significantly increased (OR=2.08; 95% CI 1.06-4.08; P=0.03), although this did not reach statistical significance in four other models. The risk of definite or probable device thrombosis with BVS was reduced in trials where more post stent balloon dilation was used and in patients without acute coronary syndrome. Moreover, trial sequential analysis showed that the cumulative z-curve crossed the conventional boundary and not the trial sequential boundary, indicating lack of robust data to support increased definite or probable device thrombosis with BVS. CONCLUSIONS: In patients with noncomplex obstructive coronary disease, BVS are comparable to EES for most efficacy and safety outcomes except for a numerical increase in device thrombosis and MI. The risk of the latter outcomes was mitigated in trials where more post stent balloon dilation was used and in patients without acute coronary syndrome. Moreover, with only 3738 patients, the trials are underpowered to detect a difference in rare events such as device thrombosis.


Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Stents Farmacológicos/estatística & dados numéricos , Everolimo/administração & dosagem , Infarto do Miocárdio/epidemiologia , Trombose/epidemiologia , Implantes Absorvíveis/efeitos adversos , Idoso , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Infarto do Miocárdio/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Regressão , Trombose/etiologia , Resultado do Tratamento
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