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1.
Circulation ; 115(16): 2136-44, 2007 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-17420340

RESUMO

BACKGROUND: Cardiac resynchronization therapy has emerged as an important therapy for advanced systolic heart failure. Among available cardiac resynchronization therapy pacing modes that restore ventricular synchrony, it is uncertain whether simultaneous biventricular (BiV), sequential BiV, or left ventricular (LV) pacing is superior. The Device Evaluation of CONTAK RENEWAL 2 and EASYTRAK 2: Assessment of Safety and Effectiveness in Heart Failure (DECREASE-HF) trial is the first randomized trial comparing these 3 cardiac resynchronization therapy modalities. METHODS AND RESULTS: The DECREASE-HF Trial is a multicenter trial in which 306 patients with New York Heart Association class III or IV heart failure, an LV ejection fraction < or = 35%, and a QRS duration > or = 150 ms were randomized to simultaneous BiV, sequential BiV, or LV pacing. LV volumes and systolic and diastolic function were assessed with echocardiography at baseline, 3 months, and 6 months. All groups had a significant reduction in LV end-systolic and end-diastolic dimensions (P<0.001). The simultaneous BiV pacing group had the greatest reduction in LV end-systolic dimension (P=0.007). Stroke volume (P<0.001) and LV ejection fraction (P<0.001) improved in all groups with no difference across groups. CONCLUSIONS: Compared with LV pacing, simultaneous BiV pacing was associated with a trend toward greater improvement in LV size. There is little difference between simultaneous BiV pacing and sequential BiV pacing as programmed in this trial.


Assuntos
Estimulação Cardíaca Artificial/métodos , Insuficiência Cardíaca/terapia , Idoso , Estimulação Cardíaca Artificial/efeitos adversos , Cardiomiopatias/complicações , Feminino , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/fisiopatologia , Ventrículos do Coração , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/terapia , Isquemia Miocárdica/complicações , Volume Sistólico , Sístole , Resultado do Tratamento , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/fisiopatologia , Insuficiência da Valva Tricúspide/terapia , Ultrassonografia
2.
Int J Cardiol ; 266: 187-192, 2018 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-29705650

RESUMO

BACKGROUND: In a randomized trial, baroreflex activation therapy (BAT) improved exercise capacity, quality of life and NT-proBNP in patients with heart failure with reduced ejection fraction (HFrEF). In view of different mechanisms underlying HFrEF, we performed a post-hoc subgroup analysis of efficacy and safety of BAT in patients with and without coronary artery disease (CAD). METHODS AND RESULTS: Patients with left ventricular ejection fraction <35% and NYHA Class III were randomized 1:1 to guideline-directed medical and device therapy alone or plus BAT. Patients with a history of CAD, prior myocardial infarction or coronary artery bypass graft were assigned to the CAD group with all others assigned to the no-CAD group. Of 71 BAT treated patients, 52 had CAD and 19 had no CAD. In the control group, 49 of 69 patients had CAD and 20 had no CAD. The system- or procedure-related major adverse neurological or cardiovascular event rate was 3.8% in the CAD group vs. 0% in the no-CAD group (p = 1.0). In the whole cohort, NYHA Class, Minnesota Living with Heart Failure score, 6-minute hall walk distance and NTproBNP were improved in BAT treated patients compared with controls. Statistical analyses revealed no interaction between the presence of CAD and effect of BAT (all p > 0.05). CONCLUSION: No major differences were found in BAT efficacy or safety between patients with and without CAD, indicating that BAT improves exercise capacity, quality of life and NTproBNP in patients with ischemic and non-ischemic cardiomyopathy. CLINICALTRIALS. GOV IDENTIFIER: NCT01471860 and NCT01720160.


Assuntos
Barorreflexo/fisiologia , Doença da Artéria Coronariana/terapia , Terapia por Estimulação Elétrica/métodos , Insuficiência Cardíaca/terapia , Volume Sistólico/fisiologia , Biomarcadores/sangue , Doença da Artéria Coronariana/sangue , Doença da Artéria Coronariana/fisiopatologia , Terapia por Estimulação Elétrica/instrumentação , Feminino , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Estudos Retrospectivos , Resultado do Tratamento
3.
J Am Soc Hypertens ; 11(2): 81-91, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-28065708

RESUMO

Baroreflex activation therapy (BAT) is a device-based therapy for patients with treatment-resistant hypertension. In a randomized, controlled trial, the first-generation system significantly reduced blood pressure (BP) versus sham. Although an open-label validation study of the second-generation system demonstrated similar BP reductions, controlled data are not presently available. Therefore, this investigation compares results of first- and second-generation BAT systems. Two cohorts of first-generation BAT system patients were generated with propensity matching to compare against the validation group of 30 second-generation subjects. The first cohort was drawn from the first-generation randomized trial sham group and the second cohort from the active therapy group. Safety and efficacy were compared for the second-generation group relative to the first generation. At 6 months, second-generation BAT outperformed first-generation sham systolic BP reduction by 20 ± 28 mm Hg (mean ± standard deviation, P = .008), while BP reduction in first- and second-generation active groups was similar. At 12 months, efficacy was comparable between all three groups after the sham group had received 6 months of therapy; 47% of second-generation patients achieved goal systolic BP of 140 mm Hg or less after 12 months, comparable to 50% of patients at goal in the first-generation group (P > .999). Implant procedure time, system/procedural safety, and pulse generator longevity improved with the second-generation system. Propensity-matched cohort analysis of the first- and second-generation BAT systems suggests similar therapeutic benefit and superior BP reduction of the second-generation system relative to sham control. Implantation procedure duration and perioperative safety were improved with the second-generation device. These findings should be validated in a prospective randomized trial.


Assuntos
Vasoespasmo Coronário/terapia , Terapia por Estimulação Elétrica/instrumentação , Terapia por Estimulação Elétrica/métodos , Eletrodos Implantados , Hipertensão/terapia , Idoso , Anti-Hipertensivos/uso terapêutico , Barorreflexo/fisiologia , Determinação da Pressão Arterial , Terapia por Estimulação Elétrica/efeitos adversos , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Pontuação de Propensão , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Resultado do Tratamento
4.
Semin Thorac Cardiovasc Surg ; 28(2): 320-328, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28043438

RESUMO

The purpose of this publication is to describe the intraoperative experience along with long-term safety and efficacy of the second-generation baroreflex activation therapy (BAT) system in patients with heart failure (HF) and reduced ejection fraction HF (HFrEF). In a randomized trial of New York Heart Association Class III HFrEF, 140 patients were assigned 1:1 to receive BAT plus medical therapy or medical therapy alone. Procedural information along with safety and efficacy data were collected and analyzed over 12 months. Within the cohort of 71 patients randomized to BAT, implant procedure time decreased with experience, from 106 ± 37 minutes on the first case to 83 ± 32 minutes on the third case. The rate of freedom from system- and procedure-related complications was 86% through 12 months, with the percentage of days alive without a complication related to system, procedure, or underlying cardiovascular condition identical to the control group. The complications that did occur were generally mild and short-lived. Overall, 12 months therapeutic benefit from BAT was consistent with previously reported efficacy through 6 months: there was a significant and sustained beneficial treatment effect on New York Heart Association functional Class, quality of life, 6-minute hall walk distance, plasma N-terminal pro-brain natriuretic peptide, and systolic blood pressure. This was true for the full trial cohort and a predefined subset not receiving cardiac resynchronization therapy. There is a rapid learning curve for the specialized procedures entailed in a BAT system implant. BAT system implantation is safe with the therapeutic benefits of BAT in patients with HFrEF being substantial and maintained for at least 1 year.


Assuntos
Barorreflexo , Seio Carotídeo/inervação , Terapia por Estimulação Elétrica , Insuficiência Cardíaca/terapia , Implantação de Prótese , Volume Sistólico , Função Ventricular Esquerda , Biomarcadores/sangue , Terapia por Estimulação Elétrica/efeitos adversos , Terapia por Estimulação Elétrica/instrumentação , Tolerância ao Exercício , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Neuroestimuladores Implantáveis , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Complicações Pós-Operatórias/etiologia , Implantação de Prótese/efeitos adversos , Implantação de Prótese/instrumentação , Qualidade de Vida , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento
5.
Circulation ; 105(11): 1304-10, 2002 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-11901040

RESUMO

BACKGROUND: Long-term ventricular resynchronization therapy improves symptom status. Changes in left ventricular remodeling have not been adequately evaluated. METHODS AND RESULTS: Fifty-three patients with systolic heart failure and bundle-branch block underwent implantation of biventricular stimulation (BVS) devices as part of a randomized trial. Echocardiograms were acquired at randomization and at 6-week intervals until completion of 12 weeks of continuous BVS. There were no changes in heart rate or QRS duration after 12 weeks of BVS. Serum norepinephrine values did not change with BVS. After 12 weeks of BVS, left atrial volume decreased. Left ventricular end-systolic and end-diastolic dimensions and left ventricular end-systolic volume also decreased after 12 weeks of BVS. Sphericity index did not change. Measures of systolic function, including left ventricular outflow tract and aortic velocity time integral and myocardial performance index, improved. CONCLUSIONS: Long-term resynchronization therapy results in atrial and ventricular reverse remodeling and improved hemodynamics.


Assuntos
Bloqueio de Ramo/terapia , Ecocardiografia , Ventrículos do Coração , Marca-Passo Artificial , Remodelação Ventricular , Adulto , Idoso , Bloqueio de Ramo/complicações , Bloqueio de Ramo/fisiopatologia , Volume Cardíaco , Diástole , Eletrocardiografia , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Frequência Cardíaca , Ventrículos do Coração/fisiopatologia , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Norepinefrina/sangue , Sístole , Resultado do Tratamento , Função Ventricular Esquerda
6.
JACC Heart Fail ; 3(6): 487-496, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25982108

RESUMO

OBJECTIVES: The objective of this clinical trial was to assess the safety and efficacy of carotid BAT in advanced HF. BACKGROUND: Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Baroreflex activation therapy (BAT) results in centrally mediated reduction of sympathetic outflow and increased parasympathetic activity. METHODS: Patients with New York Heart Association (NYHA) functional class III HF and ejection fractions ≤35% on chronic stable guideline-directed medical therapy (GDMT) were enrolled at 45 centers in the United States, Canada, and Europe. They were randomly assigned to receive ongoing GDMT alone (control group) or ongoing GDMT plus BAT (treatment group) for 6 months. The primary safety end point was system- and procedure-related major adverse neurological and cardiovascular events. The primary efficacy end points were changes in NYHA functional class, quality-of-life score, and 6-minute hall walk distance. RESULTS: One hundred forty-six patients were randomized, 70 to control and 76 to treatment. The major adverse neurological and cardiovascular event-free rate was 97.2% (lower 95% confidence bound 91.4%). Patients assigned to BAT, compared with control group patients, experienced improvements in the distance walked in 6 min (59.6 ± 14 m vs. 1.5 ± 13.2 m; p = 0.004), quality-of-life score (-17.4 ± 2.8 points vs. 2.1 ± 3.1 points; p < 0.001), and NYHA functional class ranking (p = 0.002 for change in distribution). BAT significantly reduced N-terminal pro-brain natriuretic peptide (p = 0.02) and was associated with a trend toward fewer days hospitalized for HF (p = 0.08). CONCLUSIONS: BAT is safe and improves functional status, quality of life, exercise capacity, N-terminal pro-brain natriuretic peptide, and possibly the burden of heart failure hospitalizations in patients with GDMT-treated NYHA functional class III HF. (Barostim Neo System in the Treatment of Heart Failure; NCT01471860; Barostim HOPE4HF [Hope for Heart Failure] Study; NCT01720160).


Assuntos
Barorreflexo , Terapia por Estimulação Elétrica/métodos , Idoso , Barorreflexo/fisiologia , Feminino , Insuficiência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Implantação de Prótese/métodos , Volume Sistólico/fisiologia , Resultado do Tratamento
7.
Eur J Heart Fail ; 17(10): 1066-74, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26011593

RESUMO

AIMS: Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Carotid baroreceptor stimulation (baroreflex activation therapy, BAT) results in centrally mediated reduction of sympathetic and increase in parasympathetic activity. Because patients treated with cardiac resynchronization therapy (CRT) may have less sympathetic/parasympathetic imbalance, we hypothesized that there would be differences in the response to BAT in patients with CRT vs. those without CRT. METHODS AND RESULTS: New York Heart Association (NYHA) Class III patients with an ejection fraction (EF) ≤35% were randomized (1 : 1) to ongoing guideline-directed medical and device therapy (GDMT, control) or ongoing GDMT plus BAT. Safety endpoint was system-/procedure-related major adverse neurological and cardiovascular events (MANCE). Efficacy endpoints were Minnesota Living with Heart Failure Quality of Life (QoL), 6-min hall walk distance (6MHWD), N-terminal pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), and HF hospitalization rate. In this sample, 146 patients were randomized (70 control; 76 BAT) and were 140 activated (45 with CRT and 95 without CRT). MANCE-free rate at 6 months was 100% in CRT and 96% in no-CRT group. At 6 months, in the no-CRT group, QoL score, 6MHWD, LVEF, NT-proBNP and HF hospitalizations were significantly improved in BAT patients compared with controls. Changes in efficacy endpoints in the CRT group favoured BAT; however, the improvements were less than in the no-CRT group and were not statistically different from control. CONCLUSIONS: BAT is safe and significantly improved QoL, exercise capacity, NTpro-BNP, EF, and rate of HF hospitalizations in GDMT-treated NYHA Class III HF patients. These effects were most pronounced in patients not treated with CRT.


Assuntos
Barorreflexo , Terapia por Estimulação Elétrica , Insuficiência Cardíaca/terapia , Idoso , Barorreflexo/fisiologia , Terapia de Ressincronização Cardíaca , Feminino , Insuficiência Cardíaca/fisiopatologia , Humanos , Neuroestimuladores Implantáveis , Masculino , Pessoa de Meia-Idade , Volume Sistólico , Função Ventricular Esquerda
8.
J Am Soc Hypertens ; 6(2): 152-8, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22341199

RESUMO

The objective of this study was to assess long-term blood pressure control in resistant hypertension patients receiving baroreflex activation therapy (BAT). Following completion of the randomized Rheos Pivotal Trial, patients participated in open-label, nonrandomized follow-up to assess safety and efficacy of BAT. Blood pressure reductions were measured relative to a pre-implant baseline as well as the results achieved at the completion of 1 year of follow-up in the randomized phase. Clinically significant responder status was assessed according to FDA-mandated criteria. Of the 322 patients implanted, 76% (n = 245) qualified as clinically significant responders, an additional 10% were indeterminate. Among long-term responders receiving BAT, the mean blood pressure drop was 35/16 mm Hg. Medication use was reduced by the end of the randomized phase and remained lower through the follow-up period. Among responders, 55% achieved goal blood pressures (<140 mm Hg or <130 mm Hg in diabetes or kidney disease). Blood pressures of all active patients remained stable from completion of the randomized phase through long-term follow-up. BAT substantially reduced arterial pressure for most patients participating in the Rheos Pivotal Trial. This blood pressure reduction or goal achievement was maintained over long-term follow-up of 22 to 53 months.


Assuntos
Barorreflexo/fisiologia , Pressão Sanguínea/fisiologia , Terapia por Estimulação Elétrica/métodos , Hipertensão/terapia , Seio Carotídeo/fisiologia , Estudos de Coortes , Fontes de Energia Elétrica , Terapia por Estimulação Elétrica/efeitos adversos , Eletrodos Implantados , Feminino , Seguimentos , Humanos , Hipertensão/mortalidade , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento
9.
J Am Coll Cardiol ; 58(7): 765-73, 2011 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-21816315

RESUMO

OBJECTIVES: We sought to determine the effect of baroreflex activation therapy (BAT) on systolic blood pressure (SBP) in patients with resistant hypertension. BACKGROUND: The Rheos Pivotal Trial evaluated BAT for resistant hypertension in a double-blind, randomized, prospective, multicenter, placebo-controlled Phase III clinical trial. METHODS: This was a double-blind randomized trial of 265 subjects with resistant hypertension implanted and subsequently randomized (2:1) 1 month after implantation. Subjects received either BAT (Group A) for the first 6 months or delayed BAT initiation following the 6-month visit (Group B). The 5 coprimary endpoints were: 1) acute SBP responder rate at 6 months; 2) sustained responder rate at 12 months; 3) procedure safety; 4) BAT safety; and 5) device safety. RESULTS: The trial showed significant benefit for the endpoints of sustained efficacy, BAT safety, and device safety. However, it did not meet the endpoints for acute responders or procedural safety. A protocol-specified ancillary analysis showed 42% (Group A) versus 24% (Group B) achieving SBP ≤140 mm Hg at 6 months (p = 0.005), with both groups achieving over 50% at 12 months, at which point Group B had received 6 months of BAT. CONCLUSIONS: A clinically meaningful measure, those achieving a SBP of ≤140 mm Hg, yielded a significant difference between the groups. The weight of the overall evidence suggests that over the long-term, BAT can safely reduce SBP in patients with resistant hypertension. Future clinical trials will address the limitations of this study and further define the therapeutic benefit of BAT.


Assuntos
Barorreflexo/fisiologia , Pressão Sanguínea/fisiologia , Terapia por Estimulação Elétrica , Hipertensão/terapia , Seio Carotídeo , Método Duplo-Cego , Terapia por Estimulação Elétrica/efeitos adversos , Eletrodos Implantados , Feminino , Humanos , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade
10.
Artigo em Inglês | MEDLINE | ID: mdl-19963854

RESUMO

The baroreflex, whose role is well-known in short-term blood pressure regulation, has until recently been unexploited as a practical therapy for hypertension. Recent advancements in approach and technology embodied in the Rheos System have enabled chronic electrical activation of the baroreflex. Chronic results from feasibility studies indicate that Rheos Therapy has an acceptable safety profile and may lead to long-term control of pressure in drug-resistant hypertension patients. Other effects include significant reductions in left ventricular mass and left atrial size. The spectrum of therapeutic impact suggests that Rheos Therapy may improve long-term outcomes in drug-resistant hypertension and possibly benefit related populations. Larger-scale study in randomized, controlled trials are ongoing to verify chronic benefits.


Assuntos
Barorreflexo/fisiologia , Estimulação Elétrica/instrumentação , Hipertensão/terapia , Adulto , Pressão Sanguínea/fisiologia , Estimulação Elétrica/métodos , Eletrocardiografia , Desenho de Equipamento , Europa (Continente) , Estudos de Viabilidade , Feminino , Esvaziamento Gástrico , Frequência Cardíaca/fisiologia , Ventrículos do Coração/anatomia & histologia , Humanos , Masculino , Pessoa de Meia-Idade , América do Norte , Função Ventricular
11.
J Am Coll Cardiol ; 46(12): 2208-14, 2005 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-16360048

RESUMO

OBJECTIVES: The aim of this study was to test the hypothesis that a longer septal-to-posterior wall motion delay (SPWMD) would predict greater reverse remodeling and an improved clinical response in heart failure patients randomized to cardiac resynchronization therapy (CRT) in the CONTAK-CD trial. BACKGROUND: The SPWMD predicted clinical benefit with CRT in two previous studies from the same center. METHODS: In this retrospective analysis of the CONTAK-CD trial, SPWMD was measured from the baseline echocardiogram of 79 heart failure patients (ejection fraction 22 +/- 7%, QRS duration 159 +/- 27 ms, 72% ischemic, 84% male) randomized to CRT and compared with six-month changes in echocardiographic and clinical parameters. Patients with a left ventricular end-systolic volume index (LVESVI) reduction of at least 15% were considered responders. RESULTS: The feasibility and reproducibility of performing the SPWMD measurements were poor. Larger values for SPWMD did not correlate with six-month changes in left ventricular end-diastolic volume index (p = 0.26), LVESVI (p = 0.41), or left ventricular ejection fraction (p = 0.36). Responders did not have a significantly different SPWMD than non-responders (p = 0.26). The SPWMD did not correlate with measures of clinical improvement. At a threshold of SPWMD >130 ms, the test characteristics to predict reverse remodeling or a clinical response were inadequate. CONCLUSIONS: The previous findings that SPWMD predicts reverse remodeling or clinical improvement with CRT were not reproducible in patients randomized in the CONTAK-CD trial.


Assuntos
Baixo Débito Cardíaco/complicações , Baixo Débito Cardíaco/terapia , Estimulação Cardíaca Artificial , Disfunção Ventricular Esquerda/etiologia , Remodelação Ventricular , Idoso , Baixo Débito Cardíaco/diagnóstico por imagem , Baixo Débito Cardíaco/fisiopatologia , Ecocardiografia , Estudos de Viabilidade , Feminino , Septos Cardíacos/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Valor Preditivo dos Testes , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
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