RESUMO
BACKGROUND: Mitral regurgitation (MR) is the most common valvular disease in the United States and increases the risk of death and hospitalization. The economic burden of MR in the United States is not known. METHODS AND RESULTS: We analyzed inpatient hospitalization data from the 1 221 173 Maryland residents who had any in-state admissions from October 1, 2015, to September 30, 2019. We assessed the total charges for patients without MR and for patients with MR who underwent medical management, transcatheter mitral valve repair or replacement, or surgical mitral valve repair or replacement. During the study period, 26 076 inpatients had a diagnosis of MR. Compared with patients without MR, these patients had more comorbidities and higher inpatient mortality. Patients with medically managed MR incurred average total charges of $23 575 per year; MR was associated with $10 559 more in charges per year and an incremental 3.1 more inpatient days per year as compared with patients without MR. Both surgical mitral valve repair or replacement and transcatheter mitral valve repair or replacement were associated with higher charges as compared with medical management during the year of intervention ($47 943 for surgical mitral valve repair or replacement and $63 108 for transcatheter mitral valve repair or replacement). Annual charges for both groups were significantly lower as compared with medical management in the second and third years postintervention. CONCLUSIONS: MR is associated with higher mortality and inpatient charges. Patients who undergo surgical or transcatheter intervention incur lower charges compared with medically managed MR patients in the years after the procedure.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Estados Unidos/epidemiologia , Insuficiência da Valva Mitral/epidemiologia , Insuficiência da Valva Mitral/terapia , Insuficiência da Valva Mitral/complicações , Pacientes Internados , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Maryland/epidemiologia , Estresse Financeiro , Implante de Prótese de Valva Cardíaca/métodos , Resultado do Tratamento , Hospitalização , Cateterismo CardíacoRESUMO
Background Although US recent data suggest that mitral regurgitation (MR) is severely undertreated and carries a poor outcome, population-based views on outcome and management are limited. We aimed to define the current treatment standards, clinical outcomes, and costs related to MR at the nationwide level. Methods and Results In total, 107 412 patients with MR were admitted in France in 2014 to 2015. Within 1 year, 8% were operated and 92% were conservatively managed and constituted our study population (68% primary MR and 32% secondary MR). The mean age was 77±15 years; most patients presented with comorbidities. In-hospital and 1-year mortality rates were 4.1% and 14.3%, respectively. Readmissions were common (63% at least once and 37% readmitted ≥2 times). Rates of 1-year mortality or all-cause readmission and 1-year mortality or heart failure readmission were 67% and 34%, respectively, and increased with age, Charlson index, heart failure at admission, and secondary MR etiology; however, the event rate remained notably high in the primary MR subset (64% and 28%, respectively). The mean costs of hospital admissions and of readmissions were 5345±6432 and 10 080±10 847 euros, respectively. Conclusions At the nationwide level, MR was a common reason for admission and affected an elderly population with frequent comorbidities. Less than 10% of patients underwent a valve intervention. All subsets of patients who were conservatively managed incurred high mortality and readmissions rates, and MR represented a major societal burden with an extrapolated annual cost of 350 to 550 million euros (390-615 million US dollars). New strategies to improve the management and outcomes of patients with both primary and secondary MR are critical and warranted.
Assuntos
Insuficiência da Valva Mitral/mortalidade , Idoso , Idoso de 80 Anos ou mais , Efeitos Psicossociais da Doença , Conjuntos de Dados como Assunto , Feminino , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/economia , Insuficiência da Valva Mitral/terapia , Readmissão do Paciente/estatística & dados numéricosRESUMO
BACKGROUND: There are still many pendent issues about the effective evaluation of cardiac resynchronization therapy impact on functional mitral regurgitation. In order to reduce the intrinsic difficulties of quantification of functional mitral regurgitation itself, an automatic quantification of real-time three-dimensional full-volume color Doppler transthoracic echocardiography was proposed as a new, rapid, and accurate method for the assessment of functional mitral regurgitation severity. Recent studies suggested that images of left ventricle flow by echo-particle imaging velocimetry could be a useful marker of synchrony. Echo-particle imaging velocimetry has shown that regional anomalies of synchrony/synergy of the left ventricle are related to the alteration, reduction, or suppression of the physiological intracavitary pressure gradients. We describe a case in which the two technologies are used in combination during acute echocardiographic optimization of left pacing vector in a 63-year-old man, Caucasian, who showed worsening heart failure symptoms a few days after an implant, and the effect of the device's optimization at 6-month follow-up. DISCUSSION: The degree of realignment of hemodynamic forces, with quantitative analysis of the orientation of blood flow momentum (φ), can represent improvement of fluid dynamics synchrony of the left ventricle, and explain, with a new deterministic parameter, the effects of cardiac resynchronization therapy on functional mitral regurgitation. Real-time three-dimensional color flow Doppler quantification is feasible and accurate for measurement of mitral inflow, left ventricular outflow stroke volumes, and functional mitral regurgitation severity. CONCLUSION: This clinical case offers an innovative and accurate approach for acute echocardiographic optimization of left pacing vector. It shows clinical utility of combined three-dimensional full-volume color Doppler transthoracic echocardiography/echo-particle imaging velocimetry assessment to increase response to cardiac resynchronization therapy, in terms of reduction of functional mitral regurgitation, improving fluid dynamics synchrony of the left ventricle.
Assuntos
Terapia de Ressincronização Cardíaca/métodos , Desfibriladores Implantáveis/efeitos adversos , Insuficiência Cardíaca/terapia , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/terapia , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/terapia , Ecocardiografia Doppler em Cores , Ecocardiografia Tridimensional , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Disfunção Ventricular Esquerda/fisiopatologia , População BrancaRESUMO
BACKGROUND: Echocardiographic quantitation of degenerative mitral regurgitation (DMR) is recommended whenever possible in clinical guidelines but is criticized and its scalability to routine clinical practice doubted. We hypothesized that echocardiographic DMR quantitation, performed in routine clinical practice by multiple practitioners, predicts independently long-term survival and thus is essential to DMR management. METHODS: We included patients diagnosed with isolated mitral valve prolapse from 2003 to 2011 and any degree of mitral regurgitation quantified by any physician/sonographer in routine clinical practice. Clinical/echocardiographic data acquired at diagnosis were retrieved electronically. The end point was mortality under medical treatment analyzed by Kaplan-Meier method and proportional hazard models. RESULTS: The cohort included 3914 patients (55% male) mean age (±standard deviation) 62±17 years with left ventricular ejection fraction 63±8% and median after routinely-measured effective regurgitant orifice area (EROA) [interquartile range], 19 [0-40] mm2. During follow-up (6.7±3.1 years), 696 patients died under medical management, and 1263 underwent mitral surgery. In multivariate analysis, routinely-measured EROA was associated with mortality (adjusted hazard ratio, 1.19; 95% confidence interval, 1.13-1.24; P<0.0001 per 10 mm2) independently of left ventricular ejection fraction and end-systolic diameter, symptoms, and age/comorbidities. The association between routinely-measured EROA and mortality persisted with competitive risk modeling (adjusted hazard ratio, 1.15; 95% confidence interval, 1.10-1.20; P<0.0001 per 10 mm2), or in patients without guideline-based class I/II surgical triggers (adjusted hazard ratio, 1.19; 95% confidence interval, 1.10-1.28; P<0.0001 per 10 mm2) and in all subgroups examined (all P<0.01). Spline curve analysis showed that, compared with general population mortality, excess mortality appears for moderate DMR (EROA ≥20 mm2), becomes notable at EROA ≥30 mm2, and steadily increases with higher EROA levels (eg, higher EROA levels beyond the 40 mm2 threshold). CONCLUSIONS: Echocardiographic DMR quantitation is scalable to routine practice and is independently associated with clinical outcome. Routinely-measured EROA is strongly associated with long-term survival under medical treatment. Excess mortality versus the general population appears in the moderate DMR range and steadily increases with higher EROA. Hence, individual EROA values should be integrated into therapeutic considerations, in addition to categorical DMR grading.
Assuntos
Ecocardiografia Doppler , Insuficiência da Valva Mitral/diagnóstico por imagem , Prolapso da Valva Mitral/diagnóstico por imagem , Valva Mitral/diagnóstico por imagem , Adulto , Idoso , Procedimentos Cirúrgicos Cardíacos , Fármacos Cardiovasculares/uso terapêutico , Feminino , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/terapia , Prolapso da Valva Mitral/mortalidade , Prolapso da Valva Mitral/fisiopatologia , Prolapso da Valva Mitral/terapia , Valor Preditivo dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
DESCRIÇÃO DA TECNOLOGIA: O dispositivo Mitraclip®, através do acesso femoral, chega ao átrio esquerdo por meio de uma punção transeptal. As extremidades livres dos folhetos da valva mitral são clipadas, criando um duplo orifício e reduzindo o volume regurgitante. O procedimento é guiado através da ecocardiografia transesofágica (ETE), e se a insuficiência mitral não for controlada de maneira satisfatória, um segundo clipe pode ser utilizado, ou o clipe pode ser removido sem aparente dano do folheto. REGISTRO DA TECNOLOGIA NO MUNDO: Trata-se de uma tecnologia nova em fase de adoção, pois já possui registro na Agência Nacional de Vigilância Sanitária (Anvisa). Aprovado para utilização no Brasil sob o número 25351.099555/2013-99, publicado no diário oficial em 24 de março de 2014. Também aprovado pelo CE Mark em 2008 e pelo FDA em 2013, o Mitraclip® foi aprovado para uso restrito nos casos de regurgitação mitral degenerativa moderada à grave ou grave, em pacientes sintomáticos e com risco cirúrgico considerado proibitivo. PESQUISA CLÍNICA: Para coletar informações sobre eficácia e segurança do dispositivo, foram selecionados ensaios clínicos randomizados, concluídos e em andamento. Estudos concluídos: Embora muitas intervenções percutâneas estejam em desenvolvimento, apenas duas encontram-se atualmente disponíveis no mercado internacional: MitraClip® e Carillon®. A MitraClip®, única aprovada pelo FDA e pela Anvisa, possui uma base de evidências mais desenvolvida, embora ainda limitada, com apenas um ensaio clínico randomizado, o EVEREST II. ESTUDOS EM ANDAMENTO: Foram identificados dois estudos em andamento. O estudo COAPT (NCT01626079), ainda recrutando, está selecionando pacientes com IM funcional moderada à grave ou grave, sintomáticos, considerados inaptos à cirurgia. Os pacientes, estimativa de 610, serão randomizados para Mitraclip® ou tratamento padrão. Estudo com término programado para 201416. O segundo estudo, RESHAPE-HF (NCT02444338) também randomizou pacientes com IM funcional e tem como comparador o tratamento padrão. Os resultados, inicialmente programados para 2015, foram adiados devido ao lento recrutamento, expectativa de término em 2017. Os resultados destes dois estudos podem impactar significativamente a indicação do Mitraclip® nos pacientes com IM funcional.
Assuntos
Humanos , Instrumentos Cirúrgicos/provisão & distribuição , Ecocardiografia Transesofagiana/instrumentação , Equipamentos e Provisões/provisão & distribuição , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Insuficiência da Valva Mitral/terapia , Brasil , Eficácia , Análise Custo-Benefício , Projetos de Desenvolvimento Tecnológico e InovaçãoRESUMO
BACKGROUND AND AIM OF THE STUDY: Acute severe mitral regurgitation (MR) is a serious medical condition. Whilst clear guidelines exist regarding the management of chronic MR, acute severe MR is usually treated on an individual basis. Currently, few data exist regarding acute MR in the era of primary coronary interventions (PCI). The present study included patients admitted to the Department of Cardiology during recent years with acute severe MR of different etiologies, and an analysis of these data in the light of previous investigations. METHODS: The digital database of the present authors' hospital was searched for patients diagnosed with severe MR between 2008 and 2015. From a total of 228 patients identified, 19 with primary MR and 17 with secondary (functional) MR were admitted to the Department of Cardiology. The clinical data and outcome of these patients were analyzed. RESULTS: Among patients with MR due to acute myocardial infarction (MI), 13 had functional MR and six had MR due to mechanical complications, namely rupture of the papillary muscle or chordae tendineae. Among patients with MR not in the setting of MI, 13 had primary MR and four had functional MR. Patients with MR due to acute MI were more often in cardiogenic shock or had pulmonary edema and had a higher mortality. The strongest predictor of mortality was the presence of shock, followed by female gender, hypertension, age ≥68 years; previous MI and pulmonary edema were also predictors of mortality. In patients with acute MI and secondary MR, PCI to the culprit coronary artery was associated with a lesser degree of MR on follow up. CONCLUSIONS: Patients with severe MR are at high risk of in-hospital death. Patients with functional MR are likely to benefit from prompt PCI to the culprit artery, and for those with primary MR urgent surgery is life-saving.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Unidades de Terapia Intensiva , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/terapia , Valva Mitral/cirurgia , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Doença Aguda , Idoso , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/mortalidade , Tomada de Decisão Clínica , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/mortalidade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
Mitral stenosis (MS) and mitral insufficiency (MI) have different pre-operative hemodynamic characteristics. However, it is unclear if there are differences in long-term echocardiographic characteristics of MS and MI patients after mechanical mitral valve replacement. This study is to compare long-term echocardiographic results of mechanical mitral valve prostheses between MS and MI patients. From January 2003 to January 2009, a total of 199 consecutive patients were recruited in this study. Patients were classified as group MS (n = 123) and MI (n = 76) according to the manifestation of mitral valvular disease. The mean age for patients was 50.1 ± 10.5 years and follow-up time was 7.2 ± 2.0 years. The MS after operation were more likely to experience atrial fibrillation (p = 0.002). The New York Heart Association (NYHA) class in MI showed a greater improvement (p = 0.006) than in MS. The left ventricular end-diastolic dimension (LVEDD) (p = 0.010) and stroke volume (SV) (p = 0.000) in MI were still larger than that in MS patients. These differences did not disappear with time after operation. The long-term echocardiographic results of mechanical mitral valve prostheses between MS and MI patients are significantly different. Over a long-term follow up, MI patients still have a larger LVEDD and SV than MS, and associated with a greater improvement of NYHA class.
Assuntos
Prótese Vascular , Ecocardiografia , Hemodinâmica , Insuficiência da Valva Mitral/terapia , Estenose da Valva Mitral/terapia , Valva Mitral/patologia , Valva Mitral/fisiopatologia , Fibrilação Atrial/complicações , Fibrilação Atrial/fisiopatologia , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/fisiopatologia , Estenose da Valva Mitral/complicações , Estenose da Valva Mitral/fisiopatologia , Cuidados Pós-Operatórios , Cuidados Pré-OperatóriosRESUMO
The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient from the policy perspective and methodologically questionable.We explain how real-world studies could provide relevant evidence to decision makers. Matching techniques are discussed as a viable solution for bias reduction.We describe a case study concerning a cost-effectiveness analysis based on real-world data of a technology already in use: Mitraclip combined with medical therapy versus medical therapy alone in patients with moderate-to-severe mitral regurgitation. The CEA has encountered the scepticism of most reviewers, due not to the statistical methodology but to the fact that the study was observational and not experimental. Editors and reviewers converged in considering real-world economic evaluations premature in the absence of a RCT, even if in the meantime the technology had been implanted >30â000 times. We believe there is a need to acknowledge the importance of real-world studies, and engage the scientific community in the promotion and use of clinical evidence produced through observational studies.
Assuntos
Cateterismo Cardíaco/instrumentação , Aprovação de Equipamentos , Equipamentos e Provisões , Medicina Baseada em Evidências , Insuficiência da Valva Mitral/terapia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/economia , Análise Custo-Benefício , Aprovação de Equipamentos/legislação & jurisprudência , Difusão de Inovações , Desenho de Equipamento , Falha de Equipamento , Segurança de Equipamentos , Equipamentos e Provisões/efeitos adversos , Equipamentos e Provisões/economia , Medicina Baseada em Evidências/economia , Medicina Baseada em Evidências/legislação & jurisprudência , Custos de Cuidados de Saúde , Humanos , Legislação de Dispositivos Médicos , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/economia , Insuficiência da Valva Mitral/fisiopatologia , Formulação de Políticas , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
INTRODUCTION: Intraprocedural assessment of mitral regurgitation (MR) is a challenging issue during the MitraClip procedure, which might influence not only the position but also the number of MitraClips implanted. Though transesophageal echocardiography (TEE) is the predominant tool used during the MitraClip procedure, MR assessment might be facilitated by a multimodality approach including continuous and simultaneous determination of left atrial and left ventricular (LV) pressure. METHODS: 86 consecutive patients (76.5 ± 8 years) who qualified for the MitraClip procedure were included into the study. In all patients, the multimodal assessment of MR (TEE, LV angiogram, TEE bubble evaluation, left atrial (LA) pressure => MitraScore) was performed after introducing the MitraClip guide catheter. In the first 42 patients (group A, no CAP), left atrial (LA) pressure (peak pressure of V-wave) was determined only before and after MitraClip implantation, whereas, in the subsequent 44 patients (group B, with CAP), continuous left atrial pressure monitoring (CAP) was performed. RESULTS: Patients with CAP (group B) had similar total procedural durations and no increase in the complication rate. MitraScore decreased from 10.5 to 3.5 in group A compared to 10.7 to *2.8 in group B (*P = 0.021 vs. group B). Whether the significant improvement of intraprocedural MR in group B translated into superior MR reduction in the conscious patient, was analyzed by transthoracic echocardiography (TTE) in a blinded fashion. Again MR reduction was significantly greater (P = 0.03) in group B (MR grade 2.8 to 0.9) as compared to group A (MR grade 2.8 to 1.3) and 2D vena contracta decreased from 0.54 ± 0.15 cm to 0.17 ± 0.10 in group B compared to group A (0.56 ± 0.19 cm to *0.23 ± 0.12; *P = 0.01 vs. group B). CONCLUSIONS: Multimodality assessment of intraprocedural MR supported by continuous left atrial pressure monitoring was associated with superior intraprocedural results translating into improved MR reduction also at the end of the hospital stay. © 2016 Wiley Periodicals, Inc.
Assuntos
Função do Átrio Esquerdo , Pressão Atrial , Cateterismo Cardíaco/instrumentação , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/terapia , Valva Mitral/fisiopatologia , Monitorização Fisiológica/métodos , Idoso , Idoso de 80 Anos ou mais , Angiografia , Cateterismo Cardíaco/efeitos adversos , Ecocardiografia Doppler , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Feminino , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Imagem Multimodal/métodos , Valor Preditivo dos Testes , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
BACKGROUND: We evaluated the real-world cost-effectiveness of the MitraClip system (Abbott Vascular Inc., Menlo Park, CA) plus medical therapy for patients with moderate/severe mitral regurgitation, as compared with medical therapy (MT) alone. METHODS: Clinical records of patients with moderate to severe functional mitral regurgitation treated with MitraClip (N=232) or with MT (N=151) were collected and outcome analyzed with propensity score adjustment to reduce selection bias. Twelve-month outcomes were modeled over a lifetime horizon to conduct a cost-effectiveness analysis, in the payer's perspective. Costs and benefits were discounted at an annual rate of 3.5%. RESULTS: After propensity score adjustment, the average treatment effect was -9.5% probability of dying at 12months and, following lifetime modeling, 3.35±0.75 incremental life years and 3.01±0.57 incremental quality-adjusted life years. MitraClip contributed to a higher decrease in re-hospitalizations at 12months (difference=-0.54±0.08) and generated a more likely improvement in the New York Heart Association (NYHA) class at 12months versus NYHA at enrollment. Incremental costs, adapted to five possible scenarios, ranged from 14,493 to 29,795 contributing to an incremental cost-effectiveness ratio ranging from 4796 to 7908 . CONCLUSIONS: Compared to MT alone and given conventional threshold values, MitraClip can be considered a cost-effective procedure. The cost-effectiveness of MitraClip is in line or superior to the one of other non-pharmaceutical strategies for heart failure.
Assuntos
Cardiotônicos/economia , Análise Custo-Benefício , Implante de Prótese de Valva Cardíaca/economia , Insuficiência da Valva Mitral/economia , Insuficiência da Valva Mitral/terapia , Índice de Gravidade de Doença , Idoso , Idoso de 80 Anos ou mais , Cardiotônicos/uso terapêutico , Estudos de Coortes , Feminino , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/mortalidade , Estudos Retrospectivos , Taxa de Sobrevida/tendênciasRESUMO
Both organic and functional mitral regurgitation are dynamic. Alterations in left ventricular and annular geometry, together with changing loading conditions on exertion, may lead to changes in the severity of mitral regurgitation. Exercise echocardiography is able to identify exercise-induced increases in the severity of mitral regurgitation and pulmonary artery systolic pressure which are responsible for symptoms in patients with mild or moderate dysfunction at rest. Prognostic parameters (exercise induced changes in effective orifice area, ejection fraction, and global longitudinal strain) may help risk-stratify patients with moderate or severe mitral regurgitation who are asymptomatic. This review examines the evidence base for dynamic mitral regurgitation, methods of assessment, clinical implications as well as possible therapies.
Assuntos
Gerenciamento Clínico , Medicina Baseada em Evidências/métodos , Insuficiência da Valva Mitral/terapia , Guias de Prática Clínica como Assunto , HumanosRESUMO
INTRODUÇÃO: A insuficiência mitral (IM) é caracterizada pela regurgitação sanguínea para o átrio esquerdo durante a sístole ventricular. Pode ser decorrente de anormalidades em diferentes locais do aparato valvar, tais como folhetos, ânulo, cordas tendíneas e músculos papilares. Etiologicamente, a insuficiência mitral é classificada em primária ou degenerativa quando existem anormalidades estruturais da valva e como funcional ou secundária quando a regurgitação não ocorre por problemas na valva, mas como resultado de outros problemas. Dentre as causas primárias, destacam-se a febre reumática, o prolapso valvar mitral, a endocardite infecciosa, traumas e as deformidades congênitas. As etiologias secundárias estão relacionadas à isquemia miocárdica, cardiomiopatia hipertrófica e dilatação ventricular esquerda. A IM secundária tem pior prognóstico por associar-se a outras doenças. TECNOLOGIA: O dispositivo percutâneo MitraClip® (Abbott Vascular, Menlo Park, CA) surgiu como uma possível alternativa à cirurgia convencional de plastia ou troca valvar mitral. Publicado no diário oficial em 24 de março de 2014, o dispositivo foi aprovado para utilização no Brasil pela ANVISA sob o número 25351.099555/2013-99. Nome comercial: clip delivery system MitraClip system. CURVA DE APRENDIZADO: A curva de aprendizado do sistema MitraClip® foi avaliada através de um estudo observacional (3). Selecionados 75 pacientes consecutivos encaminhados para o procedimento, divididos em três grupos, um com os 25 casos iniciais, o segundo com 25 casos seguintes e o terceiro com os últimos 25 procedimentos. Os resultados demonstraram haver uma curva de aprendizado nesta amostra. O tempo médio do procedimento reduziu de 180 para 95 minutos entre o primeiro e o último grupo (p < 0,005). Ocorreram 16 eventos de segurança no primeiro período, 6 no segundo e 3 no terceiro (p = 0,0003). O sucesso de redução da IM para 2+ ou menos foi obtido em 80% nos 2 primeiros grupos e 92% no terceiro (P = 0.46). Em 30 dias, não foi notificado nenhum caso de infarto do miocárdio ou AVC e a mortalidade foi de 2,7% para todos os pacientes, sem diferença entre os períodos. PERGUNTA CLÍNICA: O uso do MitraClip® deve ser considerado em dois grupos distintos: 1. substituto da cirurgia aberta, 2. opção para pacientes cujo alto risco cirúrgico contraindique a cirurgia aberta. DISCUSSÃO: O MitraClip® tem demonstrado boa segurança e eficácia em pacientes selecionados adequadamente através da ecocardiografia transesofágica. Porém, é necessário refinar a seleção dos pacientes, em relação a etiologia da IM, se funcional ou degenerativa, presença de hipertensão pulmonar, disfunção ventricular direita e presença de arritmias como a fibrilação atrial. Apesar dos resultados clínicos promissores, os custos e a custo-efetividade da MitraClip® limitam sua utilização. O benefício clínico é inferior ao obtido com o tratamento cirúrgico, e com um custo muito superior, sendo assim contraindicada a utilização do MitraClip® em substituição à cirurgia aberta. O custo/benefício de um procedimento como MitraClip® pode ser menos significativo em pacientes com IM funcional devido a comorbidades que limitam significativamente sua expectativa de vida. PARECER FINAL: Recomendação forte contrária à incorporação na rotina hospitalar. Frente a eficácia e segurança, a tecnologia pode ser utilizada em contexto de pesquisa ou ensino.
Assuntos
Humanos , Equipamentos e Provisões/provisão & distribuição , Insuficiência da Valva Mitral/terapia , Resultado do Tratamento , Análise Custo-BenefícioRESUMO
BACKGROUND: Structural heart disease, including valvular disease as well as congenital defects, causes important alterations in heart anatomy. As a result, individualised planning for both surgical and percutaneous procedures is crucial for procedural optimisation. Three dimensional (3D) rapid prototyping techniques are being utilised to aid operators in planning structural heart procedures. AIM: We intend to provide a description of 3D printing as a clinically applicable heart modelling technology for the planning of percutaneous structural heart procedures as well as to report our first clinical use of a 3D printed patient-specific heart model in preparation for a percutaneous mitral annuloplasty using the Mitralign percutaneous annuloplasty system. METHODS: Retrospectively gated, contrast enhanced, multi-slice computed tomography (MSCT) scans were obtained. MSCT DICOM data was analysed using software that creates 3D surface files of the blood volume of specific regions of interest in the heart. The surface files are rendered using a software package that creates a solid model that can be printed using commercially available stereolithography machines. RESULTS: The technique of direct percutaneous mitral annuloplasty requires advancement of a guiding catheter through the aorta, into the left ventricle, and requires the positioning of the tip of the catheter between the papillary muscles in close proximity to the mitral annulus. The 3D heart model was used to create a procedural plan to optimise potential device implantation. The size of the deflectable guiding catheter was selected on the basis of the patient's heart model. Target locations for annulus crossing wires were evaluated pre-procedurally using the individual patient's 3D heart model. In addition, the ability to position the Bident Catheter at the appropriate locations under the mitral annulus as well as the manoeuvrability between the papillary muscles were analysed on the heart model, enabling safe completion of the procedure, which resulted in a significant reduction in mitral regurgitation. CONCLUSIONS: 3D printing is a helpful tool in individualised planning for percutaneous structural interventions. Future studies are warranted to assess its role in preparing for percutaneous and surgical heart procedures.
Assuntos
Simulação por Computador , Implante de Prótese de Valva Cardíaca/instrumentação , Insuficiência da Valva Mitral/terapia , Modelos Cardiovasculares , Desenho de Prótese , Humanos , Avaliação da Tecnologia BiomédicaRESUMO
AIMS: Single leaflet clip attachment (SLA) is a prevalent complication in percutaneous edge-to-edge repair of the mitral valve, leading to the recurrence of significant mitral regurgitation. The objective of this retrospective analysis was to evaluate a novel 3-D transoesophageal echocardiographic method for the assessment of clip attachment to the mitral leaflets. METHODS AND RESULTS: We analysed a total of 87 patients treated for symptomatic mitral regurgitation. In 47 patients, clip attachment to the leaflets was assessed by conventional 2-D transoesophageal echocardiography supported by biplane TEE images (biplane TEE group). In 40 patients, clip attachment to the leaflets was assessed by the intraprocedural 3-D volume method in addition to the conventional method (volumetric TEE group). The primary endpoint was defined as clip complications consisting of SLA and clip displacement at any time after clip implantation. Clip complications occurred in nine patients (19.1%) in the biplane TEE group and in two patients (5%) in the volumetric TEE group (p=0.06). Regarding the grade of mitral regurgitation, in the follow-up period we observed a more pronounced deterioration in the biplane TEE group than in the volumetric TEE group. CONCLUSIONS: These findings suggest that the additional use of 3-D volumetric transoesophageal echocardiography for the assessment of clip attachment to the mitral leaflets may contribute to a reduced rate of subsequent clip complications.
Assuntos
Cateterismo Cardíaco/instrumentação , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/terapia , Valva Mitral/diagnóstico por imagem , Instrumentos Cirúrgicos , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Desenho de Equipamento , Feminino , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/fisiopatologia , Valor Preditivo dos Testes , Recidiva , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Cardiogenic shock remains a major cause of morbidity and mortality in patients hospitalized with myocardial infarction, severe valvular disease, and other causes of cardiomyopathy. Emergency physicians play a pivotal role in the initial management of these patients, as they are most often the point of first contact with the medical system. This review discusses the initial assessment and management of cardiogenic shock, emphasizing the importance and role of the emergency physician.
Assuntos
Serviços Médicos de Emergência/métodos , Choque Cardiogênico , Circulação Assistida/métodos , Cardiotônicos/uso terapêutico , Ecocardiografia , Eletrocardiografia , Coração Auxiliar , Humanos , Balão Intra-Aórtico , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/terapia , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/terapia , Reperfusão Miocárdica/métodos , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Disfunção Ventricular Esquerda/complicações , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/terapiaRESUMO
This study determined the incidence of cardiac diagnoses demonstrably related to chest pain in young patients and determined whether those with exertional chest pain were more likely to have a cardiac diagnosis. It evaluated the course of patients with chest pain after pediatric cardiology evaluation regarding interventions, outcomes, and additional test burden. This was a retrospective study of 203 patients with an office pediatric cardiology assessment of chest pain from January 2000 through December 2004. Fifteen patients (7.4%) had cardiac diagnoses, 5 (2.5%) had cardiac diagnoses demonstrably related to their chest pain complaints (arrhythmias, mitral valve prolapse), and none had ischemia. Exertional chest pain, in this study, did not increase the risk of having a cardiac diagnosis. Following evaluation, 80% of patients did not return for complaints of chest pain. Ten percent had 2 or more additional visits to any medical site for chest pain but no additional cardiac diagnoses were found.
Assuntos
Arritmias Cardíacas/diagnóstico , Dor no Peito/etiologia , Insuficiência da Valva Mitral/diagnóstico , Adolescente , Arritmias Cardíacas/complicações , Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/terapia , Dor no Peito/fisiopatologia , Criança , Pré-Escolar , Efeitos Psicossociais da Doença , Feminino , Seguimentos , Humanos , Incidência , Masculino , Insuficiência da Valva Mitral/complicações , Insuficiência da Valva Mitral/epidemiologia , Insuficiência da Valva Mitral/terapia , Esforço Físico , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Functional mitral regurgitation (MR) due to dilated cardiomyopathy or coronary artery disease remains a significant clinical problem. These clinical entities lead to left ventricular enlargement, which results in annular dilation and MR. Surgical valvuloplasty is associated with a high perioperative risk. This is the reason why percutaneous techniques for mitral valve repair are under development. One of the most advanced devices for mitral annuloplasty is the Carillon™ system. AIM: Functional assessment of patients who have undergone mitral annuloplasty using the Carillon™ device. METHODS: Fourteen consecutive patients with functional MR who had undergone successful implantation of the Carillon™ device were enrolled. The device was implanted into the venous system of the heart and applied tension to the mitral annulus in order to improve coaptation of the cusps and reduce MR. In implanted patients echocardiographic MR parameters (vena contracta, effective regurgitant orifice area) were assessed before, immediately after the procedure and during 1-month follow-up. Furthermore, the 6-minute walk test (6MWT), Naughton stress test and the NYHA functional class assessment were performed before the procedure and at 1 month. Quality of life was evaluated by the Kansas City Cardiomyopathy Questionnaire. One month after the procedure patients were also asked to compare their health status with their baseline condition. RESULTS: In implanted patients improvement of echocardiographic MR parameters was observed, both immediately after the procedure and during 1 month follow-up. These parameters included vena contracta (0.36 ± 0.03 and 0.31 ± 0.03 vs 0.65 ± ± 0.04 cm, both p < 0.001) as well as effective regurgitant orifice area (0.18 ± 0.02 and 0.20 ± 0.02 vs 0.28 ± 0.04 cm², p < 0.05 and p < 0.005, respectively). One month after the procedure the 6MWT (390 ± 26.25 vs 311.9 ± 15.71 m, p < 0.001), Naughton treadmill exercise test (5.06 ± 0.47 vs 3.49 ± 0.27 min, p < 0.005) and NYHA classification (1.93 ± ± 0.20 vs 2.93 ± 0.07, p < 0.005) were significantly improved. Quality of life improved from 67.93 ± 3.30 at baseline to 88.31 ± 4.02 at 1 month (p < 0.001). All the patients reported some degree of improvement at 1 month compared to baseline. CONCLUSIONS: Implantation of the Carillon™ device in patients with functional MR leads to increased exercise capacity and improvement of selected echocardiographic MR parameters. Randomised trials are needed to assess the clinical value of the technique. Kardiol Pol 2011; 69, 3: 228-233.
Assuntos
Cateterismo , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/terapia , Idoso , Cardiomiopatia Dilatada/complicações , Equipamentos e Provisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/complicações , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to describe and compare a novel fluoroscopic method and a 2-dimensional transesophageal echocardiographic (TEE) method to localize mitral periprosthetic leaks (PPLs) for transcatheter reduction. BACKGROUND: Transcatheter reduction of significant regurgitation represents a modern and attractive alternative to surgery for the treatment of mitral PPL in high-risk patients. Accurate localization and precise communication between the echocardiographer and the interventional cardiologist are essential for procedural success. METHODS: We analyzed TEE and fluoroscopic studies of patients with mitral PPL who underwent multiplane 2-dimensional TEE-guided transcatheter reduction in our institution. Periprosthetic leaks were routinely localized using the "surgeon's-view" time-clock method during periprocedural TEE assessments. The 2-dimensional TEE examinations were later retrospectively reviewed by an echocardiographer blinded to procedural TEE findings. A corresponding surgeon's-view time-clock method was plotted for fluoroscopic PPL localization. Using this fluoroscopic method, offline fluoroscopic images were reviewed by an independent interventional cardiologist blinded to TEE results. Agreement between methods was evaluated. RESULTS: Complete imaging data were available for analysis in 20 patients who, between 2002 and 2009, underwent transcatheter reduction in which the defect was successfully crossed. There was excellent agreement between procedural TEE and retrospective TEE review for PPL localization (100%; p < 0.0001) and between fluoroscopic and procedural TEE localization (90%; 95% confidence interval [CI]: 77% to 100%; p = 0.0003). In the 2 cases where there was disagreement, fluoroscopic PPL localization was adjacent to TEE localization. CONCLUSIONS: The surgeon's-view time-clock method of localizing PPL using 2-dimensional TEE is highly reproducible and allows fluoroscopic localization using the same reference system with very good agreement.