RESUMEN
Introducción El deterioro cognitivo secundario a eventos cerebrovasculares es una complicación frecuente en las intervenciones de reemplazo de válvula aórtica. Nuestro objetivo es el estudio del perfil de deterioro de los pacientes sometidos a reemplazo valvular quirúrgico o implantación de prótesis transcatéter (TAVI) y si éste resulta diferente según la intervención a la que son sometidos y los factores de riesgo basales. Pacientes y métodos Estudio observacional prospectivo, con dos grupos no equivalentes de pacientes (grupo TAVI y grupo quirúrgico). Se realizaron comparaciones intergrupo en varios dominios cognitivos, con una evaluación basal y mediciones de seguimiento seis y 12 meses después la intervención. Resultados El grupo TAVI presentó resultados inferiores al grupo quirúrgico en funciones ejecutivas y visuoespaciales, puntuaciones parcialmente determinadas por la edad (p < 0,01) y el nivel intelectual previo (Pearson cociente intelectual previo-medias escalares en los test: 0,665; p < 0,001). La media de puntuaciones en los tres momentos de medición indica una disminución del rendimiento en funciones ejecutivas a los seis meses, que se recupera a los 12 meses. En memoria se registraron incrementos sostenidos en ambos momentos, en tanto que la función visuoespacial y la denominación no mostraron recuperación posterior de los niveles basales. Estas tendencias son similares en los dos grupos. Conclusión Los resultados obtenidos no confirman la instauración de un proceso específico de deterioro neurocognitivo postintervención en la estenosis aórtica complicada. El perfil de deterioro no presenta diferencias significativas entre los grupos, pero es más evidente en los pacientes con TAVI, debido a la influencia de las variables de selección de la muestra. (AU)
INTRODUCTION Cognitive impairment secondary to cerebrovascular events is a common complication of aortic valve replacement interventions. Our aim is to study the deterioration profile of patients who have undergone surgical valve replacement or transcatheter valve implantation (TAVI) and whether it differs according to the intervention they underwent and their baseline risk factors. PATIENTS AND METHODS We conducted a prospective observational study with two non-equivalent groups of patients (TAVI group and surgical group) Intergroup comparisons were carried out in several cognitive domains, with a baseline assessment and follow-up measurements six and 12 months after the intervention. RESULTS The TAVI group performed less well than the surgical group in executive and visuospatial functions, with scores partially determined by age (p < 0.01) and prior intellectual level (Pearson prior intelligence quotient-scalar test means: 0.665; p < 0.001). Mean scores at the three measurement points indicate a decline in executive function performance at six months, which is restored at 12 months. Sustained increases in memory were recorded at both time points, while visuospatial function and naming showed no subsequent recovery of the baseline levels. These trends are similar in both groups. CONCLUSION. The results obtained do not confirm the appearance of a specific process of post-intervention neurocognitive impairment in complicated aortic stenosis. The deterioration profile does not show any significant differences between groups, but is more evident in TAVI patients, due to the influence of variables related to sample selection. (AU)
Asunto(s)
Disfunción Cognitiva , Estenosis de la Válvula Aórtica/rehabilitación , Implantación de Prótesis de Válvulas Cardíacas/rehabilitación , Estudios ProspectivosRESUMEN
Comprehensive geriatric assessment (CGA)-based cardiac rehabilitation (CR) program is essential for patients before and after transcatheter aortic valve implantation (TAVI). This study aimed to explore the values of CGA and exercise capacity in CR for patients referred to TAVI. A retrospective analysis was conducted in 90 patients referred to TAVI from January to October 2019. CR strategies started before TAVI. The association between clinical characteristics, CGA, and change in six-minute walk distance (Δ6MWD) was analyzed with multivariate regression models. Most of patients had cognitive impairment (50%), malnutrition (61%), and frailty (83%). After the CR, the proportion of cognitive impairment, malnutrition, and frail patients was significantly decreased by 21%, 40%, and 57%, respectively (p = 0.002, p <0.001, p <0.001). The 6MWD at a month after discharge (291.9 ± 98.8 m) was significantly improved than that at discharge after TAVI (218.8 ± 114.3m, p <0.001). The multivariate regression analysis indicated body mass index (BMI; Δ6MWD:12.0, 95% confidence interval [CI] 0.3 to 23.8, pâ¯=â¯0.045), frailty (Δ6MWD: -57.9, 95% CI -81.8 to -34.1, p <0.001) and malnutrition (Δ6MWD: -25.1, 95% CI -47.0 to -3.2, pâ¯=â¯0.026) as the associated predictors of Δ6MWD. In conclusion, functional status in patients referred to TAVI could be improved by CGA-based CR. BMI, frailty, and malnutrition were associated with the efficacy of CR on exercise capacity. CGA can play the important role in the evaluation and making strategies for CR in patients.
Asunto(s)
Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/rehabilitación , Rehabilitación Cardiaca , Tolerancia al Ejercicio/fisiología , Evaluación Geriátrica , Reemplazo de la Válvula Aórtica Transcatéter/rehabilitación , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Estudios Retrospectivos , Prueba de PasoRESUMEN
INTRODUÇÃO: A estenose aórtica é relacionada a fatores de risco para aterosclerose, principalmente ao envelhecimento. A prevalência na faixa etária entre 65 e 74 anos é de 1,3%, e acima de 75 anos, 2,8%. Pacientes com estenose aórtica têm risco aumentado de morte cardiovascular (HR 2,14; IC 95% 1,21-3,76). As manifestações clínicas são relacionadas à insuficiência cardíaca, podendo também estarem presentes dor no peito (angina) e síncope. O prognóstico, após início dos sintomas, é de 50% de mortalidade em dois anos, sendo recomendada a cirurgia de troca valvar aórtica, mas cerca de 30% dos idosos têm a cirurgia contraindicada pelo alto risco cirúrgico. O TAVI é uma opção de tratamento percutâneo (transapical ou transfemoral), com troca valvar sem necessidade de toracotomia e circulação extracorpórea. Apresenta benefícios em relação ao tratamento clínico tais como maior sobrevida e qualidade de vida, reduzindo sintomas relacionados à insuficiência cardíaca e o número de internações hospitalares, porém, associa-se com riscos imediatos como necessidade de implante de marcapasso, hemotransfusões, insuficiência renal, diálise, acidente vascular cerebral, lesões vasculares, tamponamento cardíaco e morte. Como os resultados de eficácia são distintos de acordo com a via de acesso à valva aórtica, este relatório contempla apenas TAVI por via transfemoral. TECNOLOGIA: Implante percutâneo transfemoral de válvula aórtica (TAVI). PERGUNTA DE PESQUISA: Em pacientes com estenose aórtica grave considerados inoperáveis, o TAVI, em comparação com o tratamento clínico, é seguro e custo-efetivo? EVIDÊNCIAS CLÍNICAS: Um ensaio randomizado (PARTNER B), além de registros e estudos observacionais, apresentaram ganhos em sobrevida e na qualidade de vida com o TAVI. Resultados de 5 anos do PARTNER B, com 179 pacientes em cada braço de intervenção, revelam menor mortalidade (71,8% versus 93,6%), HR 0,50 (IC95% 0,39-0,65), menor chance de hospitalização (47,6% versus 87,3%; p < 0,0001) e maior chance de estar em classe funcional NYHA I e II (New York Heart Association) (86% versus 60%) nos pacientes do grupo TAVI. Acidente vascular cerebral foi mais frequente até o seguimento de três anos do TAVI (14,4% TAVI versus 4,12% braço clínico; p = 0,0007). AVALIAÇÃO ECONÔMICA: Avaliação do tipo custo-utilidade em modelo de Markov, com ciclos mensais, horizonte temporal de 5 anos, perspectiva do SUS, revela razão de custo-utilidade incremental (RCUI) de R$189.920,69/QALY. Na análise de sensibilidade determinística, observou-se que o custo do TAVI é o parâmetro com maior impacto na RCUI. Considerando um limiar de 3 PIB per capita por ano de vida ajustado por qualidade (QALY) e analisando separadamente os componentes do custo TAVI como o custo do procedimento (considerado fixo e equivalente a R$ 28.244,41) e o custo da prótese (variável), estimou-se que, para o TAVI ser considerado custo-efetivo, o custo máximo do procedimento TAVI deve ser de R$ 57.292,1 e consequentemente, o custo máximo isolado da prótese equivalente a R$ 29.047,69. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: O impacto orçamentário é proporcional à quantidade de procedimentos de TAVI realizados. Baseado no pressuposto de realização de um máximo de 80 procedimentos por mês no Brasil, foi estimado um impacto em torno de 78 milhões de reais no primeiro ano e um impacto total, em 5 anos, de aproximadamente 467 milhões de reais. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foram realizadas pesquisas nos bancos de dados de ensaios clínicos e patentes Clinical Trials , Cortellis , ECRI, Espacenet e Patentscope e no site do FDA. Para isto, foram utilizados os descritores "severe aortic stenosis" e "aortic stenosis". Dentre os resultados obtidos foram desconsiderados os implantes que já são comercializados no mercado do brasileiro, de modo a proporcionar uma melhor prospecção de mercado. Foi identificado um TAVI registrado no FDA e quatro pedidos patentários internacionais que possuem depósito brasileiro, contudo devido a sua recente inclusão internacional ainda não possui pedido em fase nacional. CONSIDERAÇÕES FINAIS: A principal vantagem do TAVI é permitir a troca valvar aórtica sem a necessidade de toracotomia ou circulação extracorpórea, o que o coloca como opção terapêutica para pacientes com estenose aórtica inoperáveis. Demanda expertise médica e estrutura hospitalar com suporte de sala de hemodinâmica e cirurgia cardíaca. O controle na qualidade do atendimento e no impacto orçamentário estão diretamente relacionados a quantidade de centros e de procedimentos por centro que poderão ser autorizados para realização do TAVI. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Pelo exposto, os membros da Conitec, em sua 95ª reunião ordinária, no dia 04 de março de 2021, recomendaram por unanimidade, a não incorporação no SUS do TAVI para tratamento de pacientes com estenose aórtica grave inoperáveis. Considerou-se que, apesar das evidências que suportam o benefício clínico da intervenção, os dados econômicos de relação de custo-utilidade incremental e impacto orçamentário são desfavoráveis. A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: A Consulta Pública nº 15/2021 foi realizada entre os dias 18/03/2021 e 06/04/2021. Foram recebidas 17 contribuições, sendo 12 pelo formulário para contribuições técnico-científicas e cinco pelo formulário para contribuições sobre experiência ou opinião de pacientes, familiares, amigos ou cuidadores de pacientes, profissionais de saúde ou pessoas interessadas no tema. RECOMENDAÇÃO FINAL: Pelo exposto, o Plenário da Conitec, em sua 96ª Reunião Ordinária, no dia 05 de maio de 2021, deliberou por unanimidade recomendar a incorporação do implante percutâneo da válvula aórtica (TAVI) para tratamento da estenose aórtica grave em pacientes com estenose aórtica grave sintomática inoperáveis. Os membros da Conitec consideraram o benefício clínico com ganhos em sobrevida e qualidade de vida dos pacientes para recomendar a incorporação desta tecnologia que está condicionada, no máximo, ao valor considerado custo-efetivo na análise para o Sistema Único de Saúde (SUS). Assim, foi assinado o Registro de Deliberação nº 606/2021. DECISÃO: Incorporar o implante percutâneo de válvula aórtica (TAVI) para tratamento da estenose aórtica grave em pacientes inoperáveisno âmbito do Sistema Único de Saúde SUS, conforme Portaria nº 32, republicada no Diário Oficial da União nº 123, Seção 1, página 195, em 02 de julho de 2021.
Asunto(s)
Humanos , Estenosis de la Válvula Aórtica/rehabilitación , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Sistema Único de Salud , Brasil , Análisis Costo-BeneficioRESUMEN
More than 300,000 patients worldwide have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). The rise in TAVR as a treatment option is driven in large part by evidence showing its benefits compared with medical treatment in patients with symptomatic severe AS who were too ill to undergo surgical aortic valve replacement. Cardiac rehabilitation (CR) is recommended after valvular cardiac surgery for improving exercise capacity, with data also now showing its utility to improve quality of life, moderate frailty, and increase survival. This review describes the state of the art of CR for TAVR.
Asunto(s)
Estenosis de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/cirugía , Rehabilitación Cardiaca/métodos , Calidad de Vida , Reemplazo de la Válvula Aórtica Transcatéter/rehabilitación , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Evaluación de la Discapacidad , Terapia por Ejercicio/métodos , Tolerancia al Ejercicio , Femenino , Evaluación Geriátrica/métodos , Humanos , Italia , Masculino , Aptitud Física/fisiología , Cuidados Posoperatorios/métodos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
Fragmented care following elective surgery has been associated with poor outcomes. The association between fragmented care and outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. We examined patients who underwent TAVI from 2011 to 2015 at 374 sites in the STS/ACC TVT Registry, linked to Center for Medicare and Medicaid Services claims data. Fragmented care was defined as at least one readmission to a site other than the implanting TAVI center within 90 days after discharge, whereas continuous care was defined as readmission to the same implanting center. We compared adjusted 1-year outcomes, including stroke, bleeding, heart failure, mortality, and all-cause readmission in patients who received fragmented versus continuous care. Among 8,927 patients who received a TAVI between 2011 and 2015, 27.4% were readmitted within 90 days of discharge. Most patients received fragmented care (57.0%). Compared with the continuous care group, the fragmented care group was more likely to have severe chronic lung disease, cerebrovascular disease, and heart failure. States that had lower TAVI volume per Center for Medicare and Medicaid Services population had greater fragmentation. Patients living >â¯30 minutes from their TAVI center had an increased risk of fragmented care 1.07 (confidence interval [CI] 1.06 to 1.09, pâ¯<â¯0.001). After adjustment for comorbidities and procedural complications, fragmented care was associated with increased 1-year mortality (hazards ratio 1.18, CI 1.04 to 1.35, pâ¯=â¯0.010) and all-cause readmission (hazards ratio 1.08, CI 1.00 to 1.16, pâ¯=â¯0.051. In conclusion, fragmented readmission following TAVI is common, and is associated with increased 1-year mortality and readmission. Efforts to improve coordination of care may improve these outcomes and optimize long-term benefits yielded from TAVI.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Alta del Paciente , Evaluación de Procesos, Atención de Salud/métodos , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/rehabilitación , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/rehabilitación , Femenino , Estudios de Seguimiento , Humanos , Masculino , Readmisión del Paciente/tendencias , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
Sex-based differences in outcomes have been shown to affect caregiving in medical disciplines. Increased spending due to postacute care transfer policies has led hospitals to further scrutinize patient outcomes and disposition patterns after inpatient admissions. We examined sex-based differences in rehabilitative service utilization after transcatheter aortic valve implantation (TAVI). We queried all TAVI discharges in the National Inpatient Sample database from 2012 to 2014 (nâ¯=â¯40,900). Thirteen thousand eight hundred fifteen patients were discharged to home and 12,175 patients were discharged to rehabilitation facility; those not discharged routinely or to a rehabilitation facility were excluded. Patients with nonhome discharges were older (83.3 vs 79.0 years) and female (58.3% vs 37.7%) with a greater number of chronic conditions (9.91 vs 9.03) and number of Elixhauser co-morbidities (6.5 vs 5.8, all p < 0.05). Nonhome discharge patients also had a significantly longer length of stay (LOS) (11.3 days vs 5.3 days) and higher hospitalization costs ($66,246 vs $48,710, all p < 0.001) compared to home-discharged patients. Overall in-hospital mortality for female patients who underwent TAVI was higher compared to males (4.6% vs 3.6%, p < 0.05). On multivariable logistic regression, female sex was an independent predictor for disposition to rehabilitation facilities after TAVI (odds ratio 2.17; 95% confidence interval: 1.88 to 2.50; p < 0.001). Other independent predictors for females discharged to rehabilitation included the presence of rheumatoid arthritis and collagen vascular disease, body mass index greater than 30 kg/m2, depression, and sum of Elixhauser co-morbidities (all p < 0.001). In conclusion, nonhome discharge TAVI patients added LOS and hospital costs compared to home discharge TAVI patients, and female sex was one of the major predictors despite the lower co-morbidities.
Asunto(s)
Estenosis de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/cirugía , Servicios de Atención de Salud a Domicilio , Hospitalización , Alta del Paciente , Centros de Rehabilitación , Reemplazo de la Válvula Aórtica Transcatéter/rehabilitación , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/mortalidad , Femenino , Mortalidad Hospitalaria , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Factores Sexuales , Resultado del Tratamiento , Estados UnidosRESUMEN
The beneficial effects of exercise training (EX) on cardiac pathology are well recognized. Previously, we found that the effects of EX on cardiac dysfunction in mice critically depend on the underlying etiology. EX exerted beneficial effects after myocardial infarction (MI); however, cardiac pathology following pressure overload produced by transverse aortic constriction (TAC) was aggravated by EX. In the presented study, we investigated whether the contrasting effects of EX on cardiac dysfunction can be explained by an etiology-specific response of endothelial nitric oxide (NO) synthase (eNOS) to EX, which divergently affects the balance between nitric oxide and superoxide. For this purpose, mice were exposed to eight weeks of voluntary wheel running or sedentary housing (SED), immediately after sham, MI, or TAC surgery. Left ventricular (LV) function was assessed using echocardiography and hemodynamic measurements. EX ameliorated LV dysfunction and remodeling after MI, but not following TAC, in which EX even aggravated fibrosis. Strikingly, EX attenuated superoxide levels after MI, but exacerbated NOS-dependent superoxide levels following TAC. Similarly, elevated eNOS S-glutathionylation and eNOS monomerization, which were observed in both MI and TAC, were corrected by EX in MI, but aggravated by EX after TAC. Additionally, EX reduced antioxidant activity in TAC, while it was maintained following EX in MI. In conclusion, the present study shows that EX mitigates cardiac dysfunction after MI, likely by attenuating eNOS uncoupling-mediated oxidative stress, whereas EX tends to aggravate cardiac dysfunction following TAC, likely due to exacerbating eNOS-mediated oxidative stress.
Asunto(s)
Estenosis de la Válvula Aórtica/enzimología , Estenosis de la Válvula Aórtica/rehabilitación , Infarto del Miocardio/enzimología , Infarto del Miocardio/rehabilitación , Óxido Nítrico Sintasa de Tipo III/metabolismo , Condicionamiento Físico Animal , Animales , Modelos Animales de Enfermedad , Ecocardiografía , Fibrosis , Ratones , Ratones Endogámicos C57BL , Actividad Motora , Óxido Nítrico/metabolismo , Estrés Oxidativo , Conducta Sedentaria , Superóxido Dismutasa/metabolismo , Superóxido Dismutasa-1/metabolismo , Función Ventricular IzquierdaRESUMEN
OBJECTIVES: Evaluate the role of balloon aortic valvuloplasty (BAV) in improving candidacy of patients for transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients who are not candidates for TAVR may undergo BAV to improve functional and clinical status. METHODS: 117 inoperable or high-risk patients with critical aortic stenosis underwent BAV as a bridge-to-decision for TAVR. Frailty measures including gait speed, serum albumin, hand grip, activities of daily living (ADL); and NYHA functional class before and after BAV were compared. RESULTS: Mean age was 81.6 ± 8.5 years and the mean Society of Thoracic Surgeons predicted risk of mortality was 9.57 ± 5.51, with 19/117 (16.2%) patients non-ambulatory. There was no significant change in mean GS post-BAV, but all non-ambulatory patients completed GS testing at follow-up. Albumin and hand grip did not change after BAV, but there was a significant improvement in mean ADL score (4.85 ± 1.41 baseline to 5.20 ± 1.17, P = 0.021). The number of patients with Class IV congestive heart failure (CHF) was significantly lower post BAV (71/117 [60.7%] baseline versus 18/117 [15.4%], P = 0.008). 78/117 (66.7%) of patients were referred to definitive valve therapy after BAV. CONCLUSIONS: When evaluating frailty measures post BAV, we saw no significant improvement in mean GS, however, we observed a significant improvement in non-ambulatory patients and ADL scores. We also describe improved Class IV CHF symptoms. With this improved health status, the majority of patients underwent subsequent valve therapy, demonstrating that BAV may improve candidacy of patients for TAVR.
Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Valvuloplastia con Balón , Reemplazo de la Válvula Aórtica Transcatéter , Actividades Cotidianas , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/cirugía , Valvuloplastia con Balón/efectos adversos , Valvuloplastia con Balón/métodos , Femenino , Fuerza de la Mano , Humanos , Masculino , Cuidados Preoperatorios/métodos , Recuperación de la Función , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
Este documento abarca la evaluación y manejo de pacientes con estenosis aórtica severa.
Asunto(s)
Humanos , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/rehabilitación , Marcapaso Artificial , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Enfoque GRADEAsunto(s)
Estenosis de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Insuficiencia de la Válvula Mitral/rehabilitación , Insuficiencia de la Válvula Mitral/cirugía , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/rehabilitación , Cuidados Críticos/métodos , Medicina Basada en la Evidencia , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
AIMS: To evaluate feasibility, safety, and outcome of an exercise-based residential cardiac rehabilitation program in transcatheter aortic valve implantation (TAVI) patients compared to elderly patients after surgical valve replacement (sAVR). METHODS: From January 2010 to January 2013, 65 consecutive TAVI and 70 sAVR older than 70 years were enrolled. Six-min walk test (6MWT) distance, Barthel index, Morse Fall Scale (MFS) on admission and discharge, Cumulative Illness Rated State-Comorbidity Index (CIRS-CI), and echocardiography were assessed. Patients underwent a 3-week intensive cardiac rehabilitation program. RESULTS: Compared with sAVR, TAVI had worse CIRS-CI (4.8â±â1.5 vs. 3.4â±â1.5; Pâ=â0.00001), left ventricle ejection fraction (55.3â±â9 vs. 59.2â±â7.7; Pâ=â0.008), Barthel index (67â±â24 vs. 79â±â21; Pâ=â0.0018), and MFS (36â±â22 vs. 25â±â19; Pâ=â0.002) on admission and at discharge (Barthel index 85â±â17 vs. 93â±â14; Pâ=â0.005 and MFS 30â±â20 vs. 20â±â12; Pâ=â0.0001), despite a significant improvement at discharge of Barthel index (85â±â17 vs. 67â±â24; Pâ=â0.001) and MFS (36â±â22 vs. 30â±â20; Pâ>â0.01). TAVI attended safely cardiac rehabilitation, but tolerated a significantly lower workload and had reduced 6MWT both on admission and discharge compared with sAVR (162â±â87vs. 216â±â82; Pâ=â0.00001, and 240â±â92 vs. 33295; Pâ=â0.00001, respectively), despite a net improvement at discharge in 6MWT (240â±â92 vs. 162â±â92; Pâ<â0.001). CONCLUSION: Intensive cardiac rehabilitation after TAVI is safe, well tolerated, and leads to a net improvement in disability, risk of falls, and exercise capacity, similar to that observed in less disabled sAVR patients, favoring home discharge and relatively independent life at home. A persistent higher disability, comorbidity profile, and risk of falls at discharge characterize TAVI patients compared with sAVR patients of similar age.
Asunto(s)
Estenosis de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/cirugía , Rehabilitación Cardiaca/métodos , Ejercicio Físico , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Comorbilidad , Ecocardiografía Doppler , Femenino , Humanos , Italia , Masculino , Estudios Prospectivos , Factores de Riesgo , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
Due to the demographic change and an aging population, the prevalence of the most frequent valve disease, aortic stenosis (AS), is still rising.
Asunto(s)
Rehabilitación Cardiaca/tendencias , Reemplazo de la Válvula Aórtica Transcatéter/rehabilitación , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/cirugía , Humanos , Resultado del TratamientoRESUMEN
OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. METHODS: The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. RESULTS: The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. CONCLUSIONS: In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.
Asunto(s)
Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/mortalidad , Insuficiencia de la Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/rehabilitación , Europa (Continente)/epidemiología , Femenino , Estudios de Seguimiento , Hemodinámica/fisiología , Humanos , Masculino , Estudios Prospectivos , Diseño de Prótesis , Calidad de Vida , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/rehabilitación , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica/rehabilitación , Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/tendencias , Terapia por Ejercicio/tendencias , Implantación de Prótesis de Válvulas Cardíacas/tendencias , Anciano , Anciano de 80 o más Años , Terapia por Ejercicio/métodos , Femenino , Humanos , Masculino , Estudios RetrospectivosRESUMEN
CONTEXT: Aortic valvular stenosis, or narrowing of the valve orifice, is a progressive disease that generally affects patients over the age of 65 years in Western countries and is usually caused by degenerative calcification. Aortic stenosis causes increasing resistance against the ejection of blood from the left ventricle towards the aorta. After symptoms appear (dyspnea, angina, syncope), the disease rapidly progresses causing severe limitation of physical capacity, heart failure, and high risk of mortality. Aortic stenosis represents the third most common cardiovascular disease among adults and the most frequent cardiac valve illness among elderly persons in the industrialized world. Its prevalence is estimated at at 2.8% in the population aged 75 and older in the United States. In Quebec, the number of octogenarians will double to about 780,000 persons by 2035, representing about 9% of the total population. Aortic stenosis will thus become more frequent and is expected to have an increasingly important impact on the Quebec health care system. Until recently, the only effective therapy for severe or symptomatic aortic stenosis was surgical valve replacement, but about a third of elderly patients can be refused this procedure due to their health status or aortic anatomy, which renders surgery too risky. In 2002, a percutaneous technique for implanting an aortic valve was developed, allowing the delivery by catheter and deployment of an aortic valve bioprosthesis, without recourse to open-heart surgery. Since then, the number of transcatheter aortic valve implantations (TAVIs) carried out worldwide has increased at a rapid rate. However, there are no Canadian clinical practice guidelines specific to TAVI, and the criteria for selection of patients raise important questions. Currently in Quebec, several institutions either have already set up a TAVI program or are in the process of doing so. A narrative review of the literature up to 2009 and an analysis of the Quebec experience was published in 2010 by a working group of the Réseau québécois de cardiologie tertiaire (RQCT). Following the release of this document, the ministère de la Santé et des Services sociaux (MSSS) recommended that this procedure be used only for patients who cannot be treated by traditional surgical methods due to an excessive risk of complications and be offered only by university hospitals or institutes with experienced multidisciplinary teams (performing a minimum of 30 procedures a year). Also, the MSSS gave the Institut national d'excellence en santé et en services sociaux (INESSS) the mandate to perform an evaluation of TAVI. OBJECTIVES OF THIS EVALUATION: 1. Synthesize, via a systematic review, the recent evidence on effectiveness, safety and economic issues related to TAVI using the Cribier-Edwards / Edwards SAPIEN or CoreValve bioprostheses for adult patients with severe, symptomatic aortic stenosis, with an emphasis on clinical results at 1 year; and to 2. Synthesize, via a narrative review, the principal organizational aspects of delivering this procedure, including the selection of patients before implantation and key considerations concerning ethics and the patient's perspective. METHODS: A systematic search of the scientific literature published between January 2008 and January 2011 was carried out using bibliographic databases, 2008 being the year when clinical results on mortality at 1 year began to become available. Given the relative lack of publications from registries, on quality of life and regarding economic issues, we also selected several oral presentations from scientific conferences. Using primary research articles and registry reports that provided survival data at 1 year as the main source of information, we examined clinical results for TAVI patients at 30 days and at 1 year. In order to summarize issues pertaining to organizational aspects and patient eligibility, we retrieved relevant information from the following sources: 1) the most recent expert consensus documents from North America and Europe; 2) health technology assessment (HTA) reports published between 2008 and 2010, and the 2011 update of a report by the National Institute for Health and Clinical Excellence (NICE); 3) relevant articles retrieved from our literature search; and 4) a key research article and accompanying editorial, published in June 2011, concerning cohort A of the PARTNER randomized controlled trial. RESULTS: In the systematic review of clinical results, 17 studies met our selection criteria: 13 were research studies (1 randomized controlled trial, 4 controlled cohort studies, 8 case series), and 4 were analyses of registries (2 national, 2 from industry), which can be considered as case series. Most studies were from outside North America. In the clinical trial (PARTNER B cohort), 179 patients were randomized to transfemoral TAVI, and 179 were randomized to medical treatment (most of the patients in this group also underwent balloon aortic valvuloplasty (BAV) for aggravation of their aortic stenosis). We also retained 3 HTA reports and 2 systematic review. In each of the 17 studies, the patients eligible for TAVI were considered either inoperable, not suitable for surgery or at high surgical risk. In almost every study, it was indicated that patient selection was based on the consensus decision of a multidisciplinary team. In general, TAVI patients were elderly (with a mean age of at least 81 years) and the majority were in New York Heart Association (NYHA) class 3 or 4, but the extent of surgical risk varied greatly across studies.
Asunto(s)
Humanos , Estenosis de la Válvula Aórtica/rehabilitación , Bioprótesis , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Evaluación en Salud/economía , Evaluación de la Tecnología Biomédica/organización & administración , Resultado del TratamientoAsunto(s)
Enfermedades de las Válvulas Cardíacas/fisiopatología , Enfermedades de las Válvulas Cardíacas/rehabilitación , Aptitud Física , Deportes , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/rehabilitación , Estudios Transversales , Muerte Súbita Cardíaca/epidemiología , Muerte Súbita Cardíaca/etiología , Ecocardiografía , Electrocardiografía Ambulatoria , Prueba de Esfuerzo , Enfermedades de las Válvulas Cardíacas/diagnóstico , Enfermedades de las Válvulas Cardíacas/mortalidad , Hemodinámica/fisiología , Humanos , Hallazgos Incidentales , Masculino , Persona de Mediana Edad , Factores de Riesgo , Deportes/clasificación , Deportes/fisiología , Voleibol/fisiologíaRESUMEN
OBJECTIVE: High-risk patients with aortic stenosis are increasingly referred to specialist multidisciplinary teams (MDTs) for consideration of trans-catheter aortic valve implantation (TAVI). A subgroup of these cases is unsuitable for TAVI, and high-risk conventional aortic valve replacement (AVR) is undertaken. We have studied our outcomes in this cohort. METHODS: Data prospectively collected between March 2008 and November 2009 for patients (n = 28, nine male) undergoing high-risk AVR were analysed. The mean age was 78.4 ± 9.2 years. The mean additive EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 10.0 ± 3.6 and mean logistic EuroSCORE was 19.9 ± 18.8. Three patients had undergone previous coronary artery bypass grafting (CABG). RESULTS: The mean ejection fraction was 51 ± 16%, mean valve area 0.56 ± 0.19 cm², and mean peak gradient 91 ± 27 mm Hg. Ascending aortic, right axillary artery and femoral artery cannulation was used in 64%, 29% and 7% of cases, respectively. Median cross-clamp and cardiopulmonary bypass times were 84 (68-143) min and 111 (94-223) min. The median (range) inserted valve size was 21 (19-25) mm. Median intensive care and overall hospital stay were 5 (2-37) and 11 (5-44) days, respectively. In-hospital mortality was 4% (one patient). Postoperative complications included re-operation for bleeding (7%), renal failure (21%), tracheostomy (14%), sternal wound infection (7%), atrial fibrillation (25%) and permanent pacemaker implantation (7%). Kaplan-Meier survival at median follow-up of 359 (148-744) days was 81% (one further death of non-cardiac aetiology). Quality-of-life assessment at follow-up also yielded satisfactory results. CONCLUSIONS: MDT assessment of high-risk aortic stenosis in the era of TAVI has increased the number of referrals. Conventional open surgery remains a valid option for these patients, with acceptable in-hospital mortality and early/midterm outcomes but high in-hospital morbidity.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/rehabilitación , Contraindicaciones , Puente de Arteria Coronaria , Métodos Epidemiológicos , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/rehabilitación , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Procedimientos Quirúrgicos Mínimamente Invasivos , Diseño de Prótesis , Psicometría , Calidad de Vida , Resultado del TratamientoRESUMEN
OBJECTIVES: To assess the influence of concomitant hypertension on left ventricular hypertrophy regression and exercise capacity in patients operated for aortic stenosis. DESIGN: We performed echocardiography 1 week, 6- and 18-month postoperatively in 78 patients, aged 70 (28-86) years, who received Medtronic Hall (33), Biocor (8), Carpentier-Edwards S.A.V. (14) and Freestyle (23) prosthetic valves for severe aortic stenosis. Forty nine patients participated in treadmill tests with ergospirometry at the 6- and 18-month visits. RESULTS: Left ventricular mass index was comparably reduced in normotensive and hypertensive patients (34 vs. 40 g/m2 after 6 months, and 43 vs. 46 g/m2 after 18 months, ns). In multiple regression analysis, adjusting for baseline left ventricular mass index, larger reduction in left ventricular mass index was associated with younger age and having a Freestyle prosthesis, but not with gender or history of hypertension (multiple R2=0.68, p < 0.05). Exercise capacity assessed as peak oxygen uptake increased from early to late evaluation in normotensive patients (VO2max 24.27 vs. 27.08 ml/kg/min, p < 0.05) while remained unchanged in hypertensive patients (VO2max 22.2 vs. 21.1 ml/kg/min). In multiple regression analysis, higher improvement in exercise capacity was predicted by male gender, younger age and absence of hypertension, while no independent association was found with Freestyle prosthesis (multiple R2 = 0.37, p < 0.05). CONCLUSIONS: In patients operated for aortic stenosis, concomitant hypertension is associated with lack of improvement in exercise capacity in spite of early left ventricular hypertrophy reduction comparable to what is found in normotensive patients.
Asunto(s)
Estenosis de la Válvula Aórtica/rehabilitación , Tolerancia al Ejercicio/fisiología , Hipertensión/fisiopatología , Hipertrofia Ventricular Izquierda/rehabilitación , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Presión Sanguínea/fisiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis de RegresiónRESUMEN
Cardiac rehabilitation is an important aspect of cardiac care strategies. This article outlines the importance of such care using a case-study approach to highlight the impact that rehabilitation programmes can have on individual patients.