Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 13 de 13
Filtrar
1.
J Am Coll Cardiol ; 78(9): 931-956, 2021 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-34446165

RESUMO

The regulatory landscape for device-based heart failure (HF) therapies has seen a major shift in the last 7 years. In 2013, the U.S. Food and Drug Administration released guidance for early feasibility and first-in-human studies, thereby encouraging device innovation, and in 2016 the U.S. Congress authorized the Breakthrough Devices Program to expedite access for Americans to innovative devices indicated for diagnosis and treatment of serious illnesses, such as HF. Since December 2016, there has been an increase in the number of HF devices for which manufacturers are seeking approval through the breakthrough designation pathway. This has led to a rapid uptake in the development and evaluation of device-based HF therapies. This article reviews the current and future landscape of device therapies for chronic HF and associated comorbidities and the regulatory environment that is driving current and future innovation.


Assuntos
Desenho de Equipamento/tendências , Insuficiência Cardíaca , Aprovação de Equipamentos , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Coração Auxiliar/classificação , Coração Auxiliar/normas , Humanos , Estados Unidos
2.
Eur J Heart Fail ; 23(7): 1134-1143, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33932262

RESUMO

AIMS: Inappropriate control of blood volume redistribution may be a mechanism responsible for exercise intolerance in heart failure with preserved ejection fraction (HFpEF). We propose to address this underlying pathophysiology with selective blockade of sympathetic signalling to the splanchnic circulation by surgical ablation of the right greater splanchnic nerve (GSN). METHODS AND RESULTS: In a single-arm, prospective, two-centre trial, 10 patients with HFpEF (50% male, mean age 70 ± 3 years) all with New York Heart Association (NYHA) class III, left ventricular ejection fraction >40%, pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg with supine cycle ergometry, underwent ablation of the right GSN via thoracoscopic surgery. Patients were evaluated at baseline, 1, 3, 6 and 12 months after the procedure. The primary endpoint was a reduction in exercise PCWP at 3 months. There were no adverse events related to the blockade of the nerve during 12-month follow-up but three patients had significant peri-procedural adverse events related to the surgical procedure itself. At 3 months post-GSN ablation, patients demonstrated a reduction in 20 W exercise PCWP when compared to baseline [-4.5 mmHg (95% confidence interval, CI -14 to -2); P = 0.0059], which carried over to peak exercise [-5 mmHg (95% CI -11 to 0; P = 0.016). At 12 months, improvements were seen in NYHA class [3 (3) vs. 2 (1, 2); P = 0.0039] and quality of life assessed with the Minnesota Living with Heart Failure Questionnaire [60 (51, 71) vs. 22 (16, 27); P = 0.0039]. CONCLUSION: In this first-in-human study, GSN ablation in HFpEF proved to be feasible, with a suggestion of reduced cardiac filling pressure during exercise, improved quality of life and exercise capacity.


Assuntos
Insuficiência Cardíaca , Idoso , Cateterismo Cardíaco , Feminino , Insuficiência Cardíaca/cirurgia , Humanos , Masculino , Estudos Prospectivos , Qualidade de Vida , Nervos Esplâncnicos/cirurgia , Volume Sistólico , Função Ventricular Esquerda
3.
ESC Heart Fail ; 8(4): 3327-3338, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34002946

RESUMO

Heart failure (HF) does not occur in a vacuum and is commonly defined and exacerbated by its co-morbid conditions. Neurohormonal imbalance and systemic inflammation are some of the key pathomechanisms of HF but also commonly encountered co-morbidities such as arterial hypertension, diabetes mellitus, cachexia, obesity and sleep-disordered breathing. A cornerstone of HF management is neurohormonal blockade, which in HF with reduced ejection fraction has been tied to a reduction in morbidity and mortality. Pharmacological treatment effective in patients with HF with reduced ejection fraction did not show substantial effects in HF with preserved ejection fraction. Here, we review novel device-based therapies using neuromodulation of extra-cardiac targets to treat cardiometabolic disease.


Assuntos
Diabetes Mellitus , Insuficiência Cardíaca , Síndromes da Apneia do Sono , Comorbidade , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Humanos , Síndromes da Apneia do Sono/etiologia , Síndromes da Apneia do Sono/terapia , Volume Sistólico
4.
Eur J Heart Fail ; 23(7): 1076-1084, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33886137

RESUMO

Volume recruitment from the splanchnic compartment is an important physiological response to stressors such as physical activity and blood loss. In the setting of heart failure (HF), excess fluid redistribution from this compartment leads to increased cardiac filling pressures with limitation in exercise capacity. Recent evidence suggests that blocking neural activity of the greater splanchnic nerve (GSN) could have significant benefits in some patients with HF by reducing cardiac filling pressures and improving exercise capacity. However, to date the long-term safety of splanchnic nerve modulation (SNM) in the setting of HF is unknown. SNM is currently used in clinical practice to alleviate some forms of chronic abdominal pain. A systematic review of the series where permanent SNM was used as a treatment for chronic abdominal pain indicates that permanent SNM is well tolerated, with side-effects limited to transient diarrhoea or abdominal colic and transient hypotension. The pathophysiological role of the GSN in volume redistribution, the encouraging findings of acute and chronic pilot SNM studies and the safety profile from permanent SNM for pain provides a strong basis for continued efforts to study this therapeutic target in HF.


Assuntos
Insuficiência Cardíaca , Hipotensão , Exercício Físico , Insuficiência Cardíaca/terapia , Humanos , Nervos Esplâncnicos
6.
J Clin Sleep Med ; 15(12): 1747-1755, 2019 12 15.
Artigo em Inglês | MEDLINE | ID: mdl-31855160

RESUMO

STUDY OBJECTIVES: Early evidence with transvenous phrenic nerve stimulation (PNS) demonstrates improved disease severity and quality of life (QOL) in patients with central sleep apnea (CSA). The goal of this analysis is to evaluate the complete prospective experience with PNS in order to better characterize its efficacy and safety, including in patients with concomitant heart failure (HF). METHODS: Using pooled individual data from the pilot (n = 57) and pivotal (n = 151) studies of the remede System in patients with predominant moderate to severe CSA, we evaluated 12-month safety and 6- and 12-month effectiveness based on polysomnography data, QOL, and cardiac function. RESULTS: Among 208 combined patients (June 2010 to May 2015), a remede device implant was successful in 197 patients (95%), 50/57 pilot study patients (88%) and 147/151 pivotal trial patients (97%). The pooled cohort included patients with CSA of various etiologies, and 141 (68%) had concomitant HF. PNS reduced apnea-hypopnea index (AHI) at 6 months by a median of -22.6 episodes/h (25th and 75th percentile; -38.6 and -8.4, respectively) (median 58% reduction from baseline, P < .001). Improvement in sleep variables was maintained through 12 months of follow-up. In patients with HF and ejection fraction ≤ 45%, PNS was associated with improvement in systolic function from 27.0% (23.3, 36.0) to 31.1% (24.0, 41.5) at 12 months (P = .003). In the entire cohort, improvement in QOL was concordant with amelioration of sleep measures. CONCLUSIONS: Transvenous PNS significantly improves CSA severity, sleep quality, ventricular function, and QOL regardless of HF status. Improvements, which are independent of patient compliance, are sustained at 1 year and are associated with acceptable safety.


Assuntos
Terapia por Estimulação Elétrica/métodos , Nervo Frênico/fisiopatologia , Apneia do Sono Tipo Central/fisiopatologia , Apneia do Sono Tipo Central/terapia , Idoso , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Projetos Piloto , Polissonografia , Estudos Prospectivos , Resultado do Tratamento
7.
Int J Cardiol ; 220: 408-13, 2016 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-27390963

RESUMO

Accessibility to the available traditional forms of cardiac rehabilitation programs in heart failure patients is not adequate and adherence to the programs remains unsatisfactory. The home-based telerehabilitation model has been proposed as a promising new option to improve this situation. This paper's aims are to discuss the tools available for telemonitoring, and describing their characteristics, applicability, and effectiveness in providing optimal long term management for heart failure patients who are unable to attend traditional cardiac rehabilitation programs. The critical issues of psychological support and adherence to the telerehabilitation programs are outlined. The advantages and limitations of this long term management modality are presented and compared with alternatives. Finally, the importance of further research, multicenter studies of telerehabilitation for heart failure patients and the technological development needs are outlined, in particular interactive remotely controlled intelligent telemedicine systems with increased inter-device compatibility.


Assuntos
Reabilitação Cardíaca/métodos , Insuficiência Cardíaca/reabilitação , Telerreabilitação/métodos , Medicina Baseada em Evidências/métodos , Terapia por Exercício/métodos , Insuficiência Cardíaca/diagnóstico , Humanos , Telemedicina/métodos
8.
Eur J Heart Fail ; 17(6): 631-8, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25914265

RESUMO

AIMS: In heart failure (HF), exercise training programmes (ETPs) are a well-recognized intervention to improve symptoms, but are still poorly implemented. The Heart Failure Association promoted a survey to investigate whether and how cardiac centres in Europe are using ETPs in their HF patients. METHODS AND RESULTS: The co-ordinators of the HF working groups of the countries affiliated to the European Society of Cardiology (ESC) distributed and promoted the 12-item web-based questionnaire in the key cardiac centres of their countries. Forty-one country co-ordinators out of the 46 contacted replied to our questionnaire (89%). This accounted for 170 cardiac centres, responsible for 77,214 HF patients. The majority of the participating centres (82%) were general cardiology units and the rest were specialized rehabilitation units or local health centres. Sixty-seven (40%) centres [responsible for 36,385 (48%) patients] did not implement an ETP. This was mainly attributed to the lack of resources (25%), largely due to lack of staff or lack of financial provision. The lack of a national or local pathway for such a programme was the reason in 13% of the cases, and in 12% the perceived lack of evidence on safety or benefit was cited. When implemented, an ETP was proposed to all HF patients in only 55% of the centres, with restriction according to severity or aetiology. CONCLUSIONS: With respect to previous surveys, there is evidence of increased availability of ETPs in HF in Europe, although too many patients are still denied a highly recommended therapy, mainly due to lack of resources or logistics.


Assuntos
Terapia por Exercício/estatística & dados numéricos , Insuficiência Cardíaca/reabilitação , Unidades de Cuidados Coronarianos , Europa (Continente) , Pesquisas sobre Atenção à Saúde , Humanos , Internet , Centros de Reabilitação/economia , Inquéritos e Questionários
9.
Eur J Heart Fail ; 16(9): 929-41, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25175894

RESUMO

The relationship between exercise capacity, as assessed by peak oxygen consumption, and outcome is well established in heart failure (HF), but the predictive value of cardiopulmonary exercise testing (CPET) has been recently questioned, for two main reasons. First, the decisional power of CPET in the selection of heart transplantation candidates has diminished, since newer therapeutic options and the shortage of donor hearts have restricted this curative option to extremely advanced HF patients, frequently not able to perform a symptom-limited CPET. Secondly, the use of CPET has become more complex and sophisticated, with many promising new prognostic indexes proposed each year. Thus, a modern interpretation of CPET calls for selective expertise that is not routinely available in all HF centres. This position paper examines the history of CPET in risk stratification in HF. Throughout five phases of achievements, the journey from a single CPET parameter (i.e. peak oxygen consumption) to a multiparametric approach embracing the full clinical picture in HF-including functional, neurohumoral, and laboratory findings-is illustrated and discussed. An innovative multifactorial model is proposed, with CPET at its core, that helps optimize our understanding and management of HF patients.


Assuntos
Teste de Esforço/métodos , Tolerância ao Exercício/fisiologia , Insuficiência Cardíaca Sistólica/diagnóstico , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas , Insuficiência Cardíaca Sistólica/fisiopatologia , Humanos , Valor Preditivo dos Testes , Prognóstico , Reprodutibilidade dos Testes
10.
Eur J Heart Fail ; 14(5): 451-8, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22499542

RESUMO

The practical management of heart failure remains a challenge. Not only are heart failure patients expected to adhere to a complicated pharmacological regimen, they are also asked to follow salt and fluid restriction, and to cope with various procedures and devices. Furthermore, physical training, whose benefits have been demonstrated, is highly recommended by the recent guidelines issued by the European Society of Cardiology, but it is still severely underutilized in this particular patient population. This position paper addresses the problem of non-adherence, currently recognized as a main obstacle to a wide implementation of physical training. Since the management of chronic heart failure and, even more, of training programmes is a multidisciplinary effort, the current manuscript intends to reach cardiologists, nurses, physiotherapists, as well as psychologists working in the field.


Assuntos
Terapia por Exercício/psicologia , Insuficiência Cardíaca/terapia , Cooperação do Paciente/psicologia , Insuficiência Cardíaca/psicologia , Humanos
11.
Eur J Heart Fail ; 13(4): 347-57, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-21436360

RESUMO

The European Society of Cardiology heart failure guidelines firmly recommend regular physical activity and structured exercise training (ET), but this recommendation is still poorly implemented in daily clinical practice outside specialized centres and in the real world of heart failure clinics. In reality, exercise intolerance can be successfully tackled by applying ET. We need to encourage the mindset that breathlessness may be evidence of signalling between the periphery and central haemodynamic performance and regular physical activity may ultimately bring about favourable changes in myocardial function, symptoms, functional capacity, and increased hospitalization-free life span and probably survival. In this position paper, we provide practical advice for the application of exercise in heart failure and how to overcome traditional barriers, based on the current scientific and clinical knowledge supporting the beneficial effect of this intervention.


Assuntos
Terapia por Exercício , Exercício Físico/fisiologia , Insuficiência Cardíaca/terapia , Reabilitação Cardíaca , Doenças Cardiovasculares/prevenção & controle , Desfibriladores Implantáveis , Europa (Continente) , Fidelidade a Diretrizes , Conhecimentos, Atitudes e Prática em Saúde , Insuficiência Cardíaca/fisiopatologia , Humanos , Sociedades Médicas
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...