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1.
Medicine (Baltimore) ; 99(9): e19307, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32118752

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an essential alternate option for people suffering from aortic stenosis. However, the efficacy and safety of TAVR for elderly population (aged over 80 years) is still unclear. METHODS: We plan to perform a systematic review and meta-analysis of clinical controlled trials and propensity-match cohort studies to evaluate the short- and long-term outcomes in elderly aortic stenosis patients who undergo a transcatheter or surgical aortic valve replacement. We will search PubMed, EMBASE, and Cochrane Library using a comprehensive strategy. The related conference proceedings and reference lists of the included studies will also be checked to identify additional studies. Two reviewers will screen retrieved records, extract information, and assess the risk of bias independently. STATA software will be used to conduct data synthesis. There is no requirement of ethical approval and informed consent. RESULTS: This study will be submitted to a peer-reviewed journal for publication. CONCLUSION: This is the first systematic assessment of TAVR for elderly patients with aortic stenosis. We hope it will provide a relatively comprehensive reference for clinical practice and future relevant clinical trials. ETHICS AND DISSEMINATION: Ethics approval and patient consent are not required as this study is a systematic review and meta-analysis. PROSPERO REGISTRATION NUMBER: CRD42019140857. STUDY PROTOCOL REGISTRY: The protocol has been registered in PROSPERO, which is an International Prospective Register of Systematic Reviews. The registration number is CRD42019140857.


Assuntos
Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/normas , Substituição da Valva Aórtica Transcateter/normas , Resultado do Tratamento , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Feminino , Humanos , Masculino , Pontuação de Propensão , Revisão Sistemática como Assunto , Fatores de Tempo
2.
Braz J Cardiovasc Surg ; 34(5): 618-623, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31719014

RESUMO

In aortic valve disease cases, prosthetic valves have been used for valve replacement, however, these prostheses have inherent problems, and their quality in some countries is lower comparing to new-generation models, causing shorter durability. Aortic valve neocuspidization (AVNeo) has emerged as an option, which can be applied to a wide spectrum of these diseases. Despite the promising results, this procedure is not widely spread among cardiac surgeons yet. We developed a surgical technique combining Bentall and Ozaki procedures to treat patients with concomitant ascending aorta replacement and AVNeo and we describe it in this paper.


Assuntos
Aorta/cirurgia , Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas/normas , Desenho de Prótese/normas , Humanos , Ilustração Médica , Reprodutibilidade dos Testes
4.
Ann Thorac Surg ; 108(1): 292-303, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31084919

RESUMO

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary.


Assuntos
Regulamentação Governamental , Próteses Valvulares Cardíacas , Rotulagem de Produtos/legislação & jurisprudência , Comitês Consultivos , União Europeia , Próteses Valvulares Cardíacas/normas , Humanos , Desenho de Prótese , Sociedades Médicas , Cirurgia Torácica , Estados Unidos
5.
J Invasive Cardiol ; 31(5): E76-E82, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31034438

RESUMO

BACKGROUND: In transcatheter aortic valve implantation (TAVI), prosthesis over-sizing prevents paravalvular leak (PVL). Strategies of over-sizing for self-expanding bioprostheses are not well established at present. METHODS: Patients with aortic valve stenosis scheduled for TAVI underwent preprocedural multislice computed tomography. Based on the degree of over-sizing, a ROC curve was drawn to define the optimal value of valve sizing for reducing PVL after TAVI. RESULTS: A total of 152 consecutive patients were included in the study (mean age, 79.95 ± 7.71 years; log EuroScore: 23.87 ± 8.93%). Based on the ROC curve, sizing of 14% was the optimal that would lead to less moderate/severe PVL (P<.01). Group 1 was defined as sizing <14% (n = 49 patients) and group 2 was defined as sizing ≥14% (n = 103 patients). During a follow-up period of 36 ± 14 months, a total of 9 patients died from group 1 vs 4 patients from group 2 (P<.01). Two of the patients who died had moderate/severe PVL and 11 had no/mild PVL (P=.27). From the population, a total of 49 patients (32%) were found to be in the "borderline" zone. Patients who received the smaller valve had lower mean left ventricular outflow tract diameter (P=.048), higher rate of calcium load (mild: 10 [32%] vs 13 [72%]; moderate: 16 [52%] vs 3 [17%]; severe: 5 [16%] vs 2 [11%]; P=.02) and lower mean of sinus of Valsalva diameter (P=.046) compared with patients who received the bigger valve. CONCLUSIONS: In patients undergoing TAVI, over-sizing the prosthesis at least 14% reduces PVL. In borderline cases, taking into consideration additional anatomical parameters may result in low rates of PVL.


Assuntos
Insuficiência da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Tomografia Computadorizada Multidetectores , Complicações Pós-Operatórias , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/prevenção & controle , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Feminino , Grécia , Próteses Valvulares Cardíacas/efeitos adversos , Próteses Valvulares Cardíacas/normas , Humanos , Masculino , Tomografia Computadorizada Multidetectores/métodos , Tomografia Computadorizada Multidetectores/estatística & dados numéricos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios/métodos , Falha de Prótese/etiologia , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos
6.
J Thorac Cardiovasc Surg ; 158(5): 1332-1340, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31005306

RESUMO

OBJECTIVE: We sought to develop an instrument that would enable the delivery of artificial chordae tendineae (ACT) using optical visualization of the leaflet inside the beating heart. METHODS: A delivery instrument was developed together with an ACT anchor system. The instrument incorporates an optically clear silicone grasping surface in which are embedded a camera and LED for direct leaflet visualization during localization, grasping, and chordal delivery. ACTs, comprised of T-shaped anchors and an expanded polytetrafluoroethylene chordae, were fabricated to enable testing in a porcine model. Ex vivo experiments were used to measure the anchor tear-out force from the mitral leaflets. In vivo experiments were performed in which the mitral leaflets were accessed transapically using only optical guidance and ACTs were deployed in the posterior and anterior leaflets (P2 and A2 segments). RESULTS: In 5 porcine ex vivo experiments, the mean force required to tear the anchors from the leaflets was 3.8 ± 1.2 N. In 5 porcine in vivo nonsurvival procedures, 14 ACTs were successfully placed in the leaflets (9 in P2 and 5 in A2). ACT implantation took an average of 3.22 ± 0.83 minutes from entry to exit through the apex. CONCLUSIONS: Optical visualization of the mitral leaflet during chordal placement is feasible and provides direct feedback to the operator throughout the deployment sequence. This enables visual confirmation of the targeted leaflet location, distance from the free edge, and successful deployment of the chordal anchor. Further studies are needed to refine and assess the device for clinical use.


Assuntos
Cordas Tendinosas/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas/normas , Imagem Óptica/métodos , Animais , Desenho de Equipamento , Implante de Prótese de Valva Cardíaca/métodos , Teste de Materiais/métodos , Valva Mitral/cirurgia , Prolapso da Valva Mitral/cirurgia , Modelos Anatômicos , Cirurgia Assistida por Computador/instrumentação , Cirurgia Assistida por Computador/métodos , Suínos
7.
Arq Bras Cardiol ; 112(3): 292-301, 2019 03.
Artigo em Inglês, Português | MEDLINE | ID: mdl-30916201

RESUMO

BACKGROUND: The choice of a mechanical (MP) or biological prosthesis (BP) for patients with valvular heart disease undergoing replacement is still not a consensus. OBJECTIVE: We aimed to determine the clinical outcomes of MP or BP placement in those patients. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared biological prostheses and mechanical prostheses in patients with valvular heart diseases and assessed the outcomes. RCTs were searched in the MEDLINE, EMBASE, LILACS, CENTRAL, SCOPUS and Web of Science (from inception to November 2014) databases. Meta-analyses were performed using inverse variance with random effects models. The GRADE system was used to rate the quality of the evidence. A P-value lower than 0.05 was considered significant. RESULTS: A total of four RCTs were included in the meta-analyses (1,528 patients) with follow up ranging from 2 to 20 years. Three used old generation mechanical and biological prostheses, and one used contemporary prostheses. No significant difference in mortality was found between BP and MP patients (risk ratio (RR = 1.07; 95% CI 0.99-1.15). The risk of bleeding was significantly lower in BP patients than MP patients (RR = 0.64; 95% CI 0.52-0.78); however, reoperations were significantly more frequent in BP patients (RR = 3.60; 95% CI 2.44-5.32). There were no statistically significant differences between BP and MP patients with respect to systemic arterial embolisms and infective endocarditis (RR = 0.93; 95% CI 0.66-1.31, RR = 1.21; CI95% 0.78-1.88, respectively). Results in the trials with modern and old prostheses were similar. CONCLUSIONS: The mortality rate and the risk of thromboembolic events and endocarditis were similar between BP and MP patients. The risk of bleeding was approximately one third lower for BP patients than for MP patients, while the risk of reoperations was more than three times higher for BP patients.


Assuntos
Doenças das Valvas Cardíacas/cirurgia , Próteses Valvulares Cardíacas/normas , Bioprótese , Medicina Baseada em Evidências , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação , Resultado do Tratamento
8.
Hellenic J Cardiol ; 60(2): 101-107, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30853608

RESUMO

BACKGROUND: MitraClip device is a novel therapeutic option for patients with degenerative mitral valve regurgitation. Nevertheless, several studies have also focused on the safety and efficacy of this method in functional mitral valve regurgitation (FMR). AIM: To systematically review all original studies that provided mortality data among FMR patients treated with MitraClip. MATERIALS AND METHODS: We conducted an in-depth literature search of 3 electronic databases (Medline, Scopus and Cochrane Library) in order to identify studies investigating the efficacy of MitraClip in FMR. Thirty-day and 12-month mortality after MitraClip implantation were the measured outcomes. RESULTS: Twenty-eight studies, involving 2383 patients, were included. The phenotype of the studied population was characterized by clinical and echocardiographic parameters suggesting severe FMR (NYHA III-IV: 91%, MR≥3+: 98%) with high surgical risk (mean Euroscore: 24.6%). The Mitraclip device was successfully implanted in 95.8% of patients, resulting in a reduction of two or more degrees of MR. Thirty day and 12-month mortality rates were estimated to be 2.3% and 18.9%, respectively. CONCLUSIONS: MitraClip appears to be a safe therapeutic option for patients with FMR who are considered to be at high surgical risk.


Assuntos
Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/epidemiologia , Cateterismo Cardíaco/métodos , Doença da Artéria Coronariana/epidemiologia , Feminino , Próteses Valvulares Cardíacas/normas , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/mortalidade , Mortalidade , Estudos Observacionais como Assunto , Prevalência , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
9.
Int J Cardiol ; 281: 113-118, 2019 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-30732866

RESUMO

OBJECTIVES: Bioprosthetic pulmonary valve conduits have been reported with an increased risk of endocarditis. Thrombus formation is considered as source of these serious and life-threatening infections. We reviewed a series of explanted valved pulmonary conduits for histological evidence for thrombus formation. MATERIALS AND METHODS: Explanted bioprosthetic pulmonary valves were fixed in formalin and embedded in paraffin or in methylmethacrylate. Standard staining as well as immunohistochemical staining techniques were applied. Native pulmonary valves of German domestic pigs served as controls. RESULTS: 47 valved pulmonary conduits (Hancock n = 23, Homograft n = 7, Contegra n = 7, Melody n = 7, other n = 3) were analyzed histologically. Average time of implantation had been 63 months (6 to 342 months). Indications for explantation included significant obstruction (n = 45), regurgitation (n = 7), and/or endocarditis (n = 6). In 44/47 (93%) specimen, we found accumulation of thrombotic material at the basis of the semilunar valve sinus to a variable degree. 11 patients had been treated with antiplatelet agents, 2 had received anticoagulants at the time of explantation. There was no suspicion of thrombus formation clinically or echocardiographically prior to explantation in any of the patients. Control porcine pulmonary valves (n = 5) did not show any evidence of accumulation of thrombotic material. CONCLUSIONS: In a large series of explanted valved pulmonary conduits, formation of subclinical, mostly non-infectious thrombotic material was an almost ubiquitous finding. We speculate that high incidence of endocarditis in bioprosthetic valves may in part be explained by thrombus apposition at the basis of conduit valve sinus.


Assuntos
Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Estenose da Valva Pulmonar/cirurgia , Valva Pulmonar/cirurgia , Trombose/patologia , Adolescente , Adulto , Animais , Bioprótese/normas , Criança , Pré-Escolar , Feminino , Próteses Valvulares Cardíacas/normas , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Valva Pulmonar/patologia , Estenose da Valva Pulmonar/patologia , Suínos , Trombose/etiologia , Adulto Jovem
10.
J Cardiothorac Vasc Anesth ; 33(3): 796-807, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30064851

RESUMO

The development of transcatheter interventions to provide a minimally invasive alternative to open surgical repair has revolutionized the care of patients with valvular heart disease. Recently, this technology has been expanded to allow for the treatment of pathology of the mitral valve. This review discusses the anesthetic considerations for patients presenting for transcatheter management of mitral valve disease, including transcatheter mitral valve replacement (TMVR) and transcatheter mitral valve repair (TMVRep). The initial focus is on the current literature on transcatheter interventions for mitral valve pathologies as well as current and developing technology for TMVR and TMVRep. The authors' institutional experience with anesthetic management for the TMVR and TMVRep procedures is described, including potential pitfalls and complications, concluding with a discussion of the role of transesophageal echocardiography in the care of this patient population.


Assuntos
Anestesia/métodos , Anestésicos/administração & dosagem , Estenose da Valva Aórtica/diagnóstico por imagem , Cateterismo Cardíaco/métodos , Insuficiência da Valva Mitral/diagnóstico por imagem , Anestesia/normas , Anestésicos/normas , Estenose da Valva Aórtica/tratamento farmacológico , Estenose da Valva Aórtica/cirurgia , Cateterismo Cardíaco/normas , Próteses Valvulares Cardíacas/normas , Humanos , Insuficiência da Valva Mitral/tratamento farmacológico , Insuficiência da Valva Mitral/cirurgia
11.
Int J Cardiol ; 278: 40-45, 2019 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-30545619

RESUMO

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has a substantial impact on daily cardiovascular care delivery based on issues such as cost effectiveness and economic value within a restricted health care budget. Until now, potential financial benefits of third generation valve models have not been evaluated in a real-world setting. METHODS AND RESULTS: We identified 204 eligible patients (Jan 2014-Sep 2016) who either received the balloon-expandable Edwards Sapien 3 (ES3) or the self-expandable Medtronic Evolut R (MER). Baseline information, procedural characteristics, 30-day outcome as well as in-hospital costs and reimbursement were collected and analyzed. The major cost driver was initial valve-kit costs with a significantly higher amount in the ES3 group, which was set at 0 with the lower price (ES3/MER: +4390.0€â€¯±â€¯3.807.0 vs. 0.0€â€¯±â€¯734.1; p < 0.01). However, initial valve-kit costs were balanced by additional material costs in the MER cohort. Overall costs did not differ significantly between valve models (ES3/MER: x + 13.808.0€â€¯±â€¯5.595.0 vs. x + 10.681.0€â€¯±â€¯4.518.0; p = 0.6885) and reimbursement was moderate (ES3/MER: 1.649.7€ vs. 4776.7€). CONCLUSION: Quality, success rate, and costs were comparable between third generation devices. Initial valve-kit costs were significantly higher in the ES3 group, whereas overall costs did not significantly differ between the two valve types.


Assuntos
Custos e Análise de Custo/economia , Assistência à Saúde/economia , Próteses Valvulares Cardíacas/economia , Desenho de Prótese/economia , Substituição da Valva Aórtica Transcateter/economia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Custos e Análise de Custo/normas , Assistência à Saúde/normas , Feminino , Alemanha/epidemiologia , Próteses Valvulares Cardíacas/normas , Humanos , Masculino , Desenho de Prótese/normas , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/normas , Resultado do Tratamento
12.
Circ J ; 83(2): 485-487, 2019 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-30568049

RESUMO

BACKGROUND: Rapid deployment aortic valve replacement has been developed to shorten procedural times and to facilitate minimally invasive cardiovascular surgery. Methods and Results: As a representative rapid-deployment valve, the balloon-expanding INTUITY Elite (the 2nd-generation Edwards INTUITY Valve System) was uneventfully implanted via a right lateral mini-thoracotomy in 2 patients with severe aortic valve stenosis. Both of them recovered quickly and were discharged from hospital without significant adverse events. CONCLUSIONS: Implantation of the INTUITY Elite valve via right mini-thoracotomy is feasible and safe.


Assuntos
Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Toracotomia/métodos , Idoso , Estenose da Valva Aórtica/cirurgia , Feminino , Próteses Valvulares Cardíacas/normas , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Japão , Procedimentos Cirúrgicos Minimamente Invasivos , Fatores de Tempo , Resultado do Tratamento
13.
Mymensingh Med J ; 27(4): 764-770, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30487492

RESUMO

The present experimental study was carried out as an experimental study in the department of Cardiac Surgery at Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh from July 2011 to May 2013 to see which preservation techniques give us morphologically and histologically suitable xenograft heart valve for clinical use. We reviewed 20 bovine aortic valves in 2 years. Each of 10 samples was grouped as glutaraldehyde (1.5%) preservation and cryopreservation (-180°C). After collecting each specimen, sterilization of valve was done in low concentration of sterile antibiotic solution (CLPVA). Then 10 dissected valves were immersed each in 250ml of 1.5% glutaraldehyde solution at 4°C. Another 10 dissected valves were placed in a solution of 100ml 10% DMSO and suspended in vapor phase of liquid nitrogen at -180°C. Then after 4 weeks, the valves were examined for naked eye (color change, shrinkage, swelling, pliability, stiffness of leaflet) and histological (endothelial cells, leaflet extracellular matrix preservation, fibroblast preservation, inflammation, necrosis and other pathological conditions on valve leaflet) examination. Statistical analysis showed that morphological changes were not significant in both groups but in histological examination, cryopreservation showed effective preservation of fibroblast and extracellular matrix than glutaraldehyde preservation.


Assuntos
Valva Aórtica , Bioprótese , Criopreservação/métodos , Glutaral/farmacologia , Próteses Valvulares Cardíacas/normas , Animais , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Bangladesh , Bovinos , Fixadores/farmacologia , Xenoenxertos/normas , Humanos
14.
Interv Cardiol Clin ; 7(4): 425-433, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30274609

RESUMO

Treatment of severe symptomatic aortic stenosis has undergone significant changes with the advent of transcatheter aortic valve replacement (TAVR). Initially reserved for inoperable patients, these devices have improved; outcomes now rival or outperform surgical treatment. TAVR is recommended for high-risk and certain intermediate-risk patients. As transcatheter aortic valve replacement becomes an option for younger, healthier patients, long-term planning and thoughtful considerations of potential subsequent interventions are paramount. A robust understanding of risks, benefits and expected outcomes with TAVR is critical to provide patients with the best treatment option.


Assuntos
Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/normas , Substituição da Valva Aórtica Transcateter/instrumentação , Comorbidade , Fragilidade , Próteses Valvulares Cardíacas/efeitos adversos , Humanos , Guias de Prática Clínica como Assunto , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Análise de Sobrevida , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
15.
Interv Cardiol Clin ; 7(4): 435-443, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30274610

RESUMO

Minimalist transcatheter aortic valve replacement (TAVR) can be implemented with no apparent compromise in patient outcomes. Although this approach is applicable for many patients undergoing TAVR, patient selection by the heart team is critical; one must be cognizant of factors whereby a minimalist approach is unsuitable. In the current era of TAVR, a minimalist approach should encompass the entire process of care and not just the procedure. Streamlining and homogenizing preprocedural workup has potential benefits for patients and health services. Minimalist TAVR is likely the right pathway forward for most patients, but the focus should be patient centered with no compromise to safety.


Assuntos
Estenose da Valva Aórtica/cirurgia , Procedimentos Clínicos/normas , Próteses Valvulares Cardíacas/normas , Substituição da Valva Aórtica Transcateter/instrumentação , Humanos , Tempo de Internação , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Alta do Paciente/tendências , Seleção de Pacientes , Cuidados Pós-Operatórios , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/economia , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
16.
Braz J Cardiovasc Surg ; 33(4): 391-397, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30184037

RESUMO

INTRODUCTION: The interest in Expert systems has increased in the medical area. Some of them are employed even for diagnosis. With the variability of transcatheter prostheses, the most appropriate choice can be complex. This scenario reveals an enabling environment for the use of an Expert system. The goal of the study was to develop an Expert system based on artificial intelligence for supporting the transcatheter aortic prosthesis selection. METHODS: The system was developed on Expert SINTA. The rules were created according to anatomical parameters indicated by the manufacturing company. Annular aortic diameter, aortic area, aortic perimeter, ascending aorta diameter and Valsalva sinus diameter were considered. After performing system accuracy tests, it was applied in a retrospective cohort of 22 patients with submitted to the CoreValve prosthesis implantation. Then, the system indications were compared to the real heart team decisions. RESULTS: For 10 (45.4%) of the 22 patients there was no concordance between the Expert system and the heart team. In all cases with discordance, the software was right in the indication. Then, the patients were stratified in two groups (same indication vs. divergent indication). The baseline characteristics did not show any significant difference. Mortality, stroke, acute myocardial infarction, atrial fibrillation, atrioventricular block, aortic regurgitation and prosthesis leak did not present differences. Therefore, the maximum aortic gradient in the post-procedure period was higher in the Divergent Indication group (23.9 mmHg vs. 11.9 mmHg, P=0.03), and the mean aortic gradient showed a similar trend. CONCLUSION: The utilization of the Expert system was accurate, showing good potential in the support of medical decision. Patients with divergent indication presented high post-procedure aortic gradients and, even without clinical repercussion, these parameters, when elevated, can lead to early prosthesis dysfunction and the necessity of reoperation.


Assuntos
Inteligência Artificial , Próteses Valvulares Cardíacas/normas , Substituição da Valva Aórtica Transcateter/normas , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisão Clínica , Feminino , Humanos , Masculino , Padrões de Referência , Reprodutibilidade dos Testes , Estudos Retrospectivos , Desenho de Programas de Computador , Estatísticas não Paramétricas
18.
Int J Cardiol ; 268: 170-175, 2018 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-30041783

RESUMO

BACKGROUND: The durability of TAVR prostheses has come under major scrutiny since the move towards lower risk patients. We sought to compare the rate of structural valve deterioration (SVD) over time between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). METHODS: We included all TAVR and SAVR patients (age ≥ 75 years) that were performed in our centre from 2005 until 2015. Applying the internationally "agreed on" definitions of SVD, we surveyed all available serial echocardiographic follow-ups. RESULTS: We included 269 TAVR and 174 SAVR cases. Post-intervention, TAVR patients had lower mean and peak gradients but higher rate of mild aortic regurgitation. SAVR patients had longer follow-up (in months, SAVR: 53 (30, 85) Vs TAVR: 33.4 (23, 52)). SVD as per Valve Academic Research Consortium-2 (VARC-2) was similar between the two groups (TAVR 28% Vs SAVR 31%; P = 0.593) but moderate haemodynamic SVD (European Association of Percutaneous Cardiovascular Intervention (EAPCI) criteria) was more common among SAVR cases (TAVR 11.5% Vs SAVR 20.7%; P = 0.007). Using Kaplan-Meier estimates, the rate of SVD over time was not different between the two groups as per VARC-2 criteria but different when moderate haemodynamic SVD criteria were applied (Log Rank P = 0.022) in favour of TAVR. The mean gradient rose steadily over time but more so post-SAVR (ß = 0.52 ±â€¯0.24 in comparison to TAVR at every given time point; P = 0.032). CONCLUSION: Structural valve deterioration is common on long-term follow-up post-TAVR. The rate is similar to post-SAVR cases according to VARC-2 criteria but less according to the moderate haemodynamic SVD criteria.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Bioprótese/normas , Implante de Prótese de Valva Cardíaca/normas , Próteses Valvulares Cardíacas/normas , Desenho de Prótese/normas , Substituição da Valva Aórtica Transcateter/normas , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/diagnóstico , Bioprótese/tendências , Feminino , Seguimentos , Próteses Valvulares Cardíacas/tendências , Implante de Prótese de Valva Cardíaca/tendências , Humanos , Masculino , Desenho de Prótese/tendências , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/tendências , Resultado do Tratamento
20.
Cardiovasc Eng Technol ; 9(3): 301-338, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29951830

RESUMO

Transcatheter Mitral Valve Replacement (TMVR) is currently under clinical investigation as a viable treatment option for mitral regurgitation (MR). Therefore, it is important to outline the key functional requirements of a TMVR prosthesis in order to provide an overall approach to assessing mitral valve replacement devices utilizing a combination of in vitro and preclinical methods. This article provides a review of the mitral valve disease as well as general considerations and guidance for developing a TMVR device based on International Industry Standards. Specific details pertaining to the mitral valve apparatus, morphology of mitral valve disease, assessment of specific patient population as well as hazard analysis to evaluate and develop a TMVR device to treat a specific patient population have been included. The details contained within this report are not all inclusive or explicate for every technology being developed but rather thought of as a general guide on how a TMVR technology could be developed in alignment with International Industry Standards. Key learnings from the Transcatheter Aortic Valve Replacement (TAVR) experience has also been considered and taken into account when outlining this general guidance for TMVR. Key learning points from the TAVR development experience included the following: quantification of acceptable levels of paravalvular leak, valve migration potential using various anchoring methods and overall implant frame failure modes when treating the native aortic valve. It should be noted that TAVR is over a decade further along in development and clinical experience compared to TMVR. These key learnings from the early experience with TAVR should be considered with all transcatheter development projects.


Assuntos
Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Teste de Materiais/métodos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Animais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/normas , Próteses Valvulares Cardíacas/normas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/normas , Humanos , Teste de Materiais/normas , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/fisiopatologia , Modelos Anatômicos , Modelos Animais , Modelos Cardiovasculares , Desenho de Prótese
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