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1.
ESC Heart Fail ; 2021 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-33527654

RESUMO

AIMS: Determine the feasibility of implementing a heart failure (HF) management strategy that (i) uses a device-based, remote, dynamic, multimetric risk stratification model to predict the risk of HF events and (ii) uses a standardized, centrally administered, ambulatory medication intervention protocol to reproducibly and safely decrease elevated risk scores. METHODS AND RESULTS: Prospective, non-randomized, single-arm, multicenter feasibility study (Intervene-HF) was conducted in HF patients implanted with a cardiac resynchronization therapy with implantable cardio defibrillator (CRT-D) with TriageHF risk score feature. Certified HF nurses (CHFN) in the Medtronic Care Management Services Program implemented an ambulatory medication intervention strategy by following a standardized guided action pathway triggered by risk-based alert. When CHFN received notification of increased risk score (HF care alert), they implemented a 3 day course of diuretic up-titration (PRN) previously prescribed by a physician. Safety was monitored daily. Recovery after PRN was defined as ≥70% recovery of impedance toward baseline levels. Sixty-six patients followed for 8.2 ± 3.9 months had 49 HF care alerts. Twenty-three of 49 alerts did not receive PRN due to protocol-mandated criteria. Twenty-six of 49 alerts received PRN, 22 were completed, and 19 led to impedance recovery. Four interventions were stopped for safety without leading to an adverse event (AE). One of 26 PRNs was followed by a HF event. Eighty-five per cent (22/26) of PRNs were completed without an AE; 69% (18/26) met the recovery criteria. CONCLUSIONS: The Intervene-HF study supports the feasibility of testing, in a large randomized clinical trial, an ambulatory medication intervention strategy that is physician-directed, CHFN-implemented, and based on individualized device risk stratification.

5.
Curr Heart Fail Rep ; 17(5): 277-287, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32803641

RESUMO

PURPOSE OF REVIEW: Central sleep apnea occurs in up to 50% of heart failure patients and worsens outcomes. Established therapies are limited by minimal supporting evidence, poor patient adherence, and potentially adverse cardiovascular effects. However, transvenous phrenic nerve stimulation, by contracting the diaphragm, restores normal breathing throughout sleep and has been shown to be safe and effective. This review discusses the mechanisms, screening, diagnosis, and therapeutic approaches to CSA in patients with HF. RECENT FINDINGS: In a prospective, multicenter randomized Pivotal Trial (NCT01816776) of transvenous phrenic nerve stimulation with the remede System, significantly more treated patients had a ≥ 50% reduction in apnea-hypopnea index compared with controls, with a 41 percentage point difference between group difference at 6 months (p < 0.0001). All hierarchically tested sleep, quality of life, and daytime sleepiness endpoints were significantly improved in treated patients. Freedom from serious related adverse events at 12 months was 91%. Benefits are sustained to 36 months. Transvenous phrenic nerve stimulation improves quality of life in patients with heart failure and central sleep apnea. Controlled trials evaluating the impact of this therapy on mortality/heart failure hospitalizations and "real world" experience are needed to confirm safety and effectiveness.

6.
Circ Heart Fail ; 13(8): e006863, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32757642

RESUMO

BACKGROUND: Ambulatory hemodynamic monitoring with an implantable pulmonary artery (PA) sensor is approved for patients with New York Heart Association Class III heart failure (HF) and a prior HF hospitalization (HFH) within 12 months. The objective of this study was to assess the efficacy and safety of PA pressure-guided therapy in routine clinical practice with special focus on subgroups defined by sex, race, and ejection fraction. METHODS: This multi-center, prospective, open-label, observational, single-arm trial of 1200 patients across 104 centers within the United States with New York Heart Association class III HF and a prior HFH within 12 months evaluated patients undergoing PA pressure sensor implantation between September 1, 2014, and October 11, 2017. The primary efficacy outcome was the difference between rates of adjudicated HFH 1 year after compared with the 1 year before sensor implantation. Safety end points were freedom from device- or system-related complications at 2 years and freedom from pressure sensor failure at 2 years. RESULTS: Mean age for the population was 69 years, 37.7% were women, 17.2% were non-White, and 46.8% had preserved ejection fraction. During the year after sensor implantation, the mean rate of daily pressure transmission was 76±24% and PA pressures declined significantly. The rate of HFH was significantly lower at 1 year compared with the year before implantation (0.54 versus 1.25 events/patient-years, hazard ratio 0.43 [95% CI, 0.39-0.47], P<0.0001). The rate of all-cause hospitalization was also lower following sensor implantation (1.67 versus 2.28 events/patient-years, hazard ratio 0.73 [95% CI, 0.68-0.78], P<0.0001). Results were consistent across subgroups defined by ejection fraction, sex, race, cause of cardiomyopathy, presence/absence of implantable cardiac defibrillator or cardiac resynchronization therapy and ejection fraction. Freedom from device- or system-related complications was 99.6%, and freedom from pressure sensor failure was 99.9% at 1 year. CONCLUSIONS: In routine clinical practice as in clinical trials, PA pressure-guided therapy for HF was associated with lower PA pressures, lower rates of HFH and all-cause hospitalization, and low rates of adverse events across a broad range of patients with symptomatic HF and prior HFH. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02279888.

7.
Artigo em Inglês | MEDLINE | ID: mdl-32789619

RESUMO

Nocturnal hypoxemic burden is established as a robust prognostic metric of sleep-disordered breathing (SDB) to predict mortality and treating hypoxemic burden may improve prognosis. The aim of this study was to evaluate improvements in nocturnal hypoxemic burden using transvenous phrenic nerve stimulation (TPNS) to treat patients with central sleep apnea (CSA). The remede System Pivotal Trial population was examined for nocturnal hypoxemic burden. The minutes of sleep with oxygen saturation < 90% significantly improved in Treatment compared with control (p < .001), with the median improving from 33 min at baseline to 14 min at 6 months. Statistically significant improvements were also observed for average oxygen saturation and lowest oxygen saturation. Hypoxemic burden has been demonstrated to be more predictive for mortality than apnea-hypopnea index (AHI) and should be considered a key metric for therapies used to treat CSA. Transvenous phrenic nerve stimulation is capable of delivering meaningful improvements in nocturnal hypoxemic burden. There is increasing interest in endpoints other than apnea-hypopnea index in sleep-disordered breathing. Nocturnal hypoxemia burden may be more predictive for mortality than apnea-hypopnea index in patients with poor cardiac function. Transvenous phrenic nerve stimulation is capable of improving nocturnal hypoxemic burden. Graphical Abstract.

8.
Heart Rhythm ; 17(12): 2029-2036, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32619739

RESUMO

BACKGROUND: Central sleep apnea is common in heart failure patients. Transvenous phrenic nerve stimulation (TPNS) requires placing a lead to stimulate the phrenic nerve and activate the diaphragm. Data are lacking concerning the safety and efficacy of TPNS in patients with concomitant cardiovascular implantable electronic devices (CIEDs). OBJECTIVE: To report the safety and efficacy of TPNS in patients with concomitant CIEDs. METHODS: In the remede System Pivotal Trial, 151 patients underwent TPNS device implant. This analysis compared patients with concomitant CIEDs to those without with respect to safety, implant metrics, and efficacy of TPNS. Safety was assessed using incidence of adverse events and device-device interactions. A detailed interaction protocol was followed. Implant metrics included overall TPNS implantation success. Efficacy endpoints included changes in the apnea-hypopnea index (AHI) and quality of life. RESULTS: Of 151 patients, 64 (42%) had a concomitant CIED. There were no significant differences between the groups with respect to safety. There were 4 CIED oversensing events in 3 patients leading to 1 inappropriate defibrillator shock and delivery of antitachycardia pacing. There was no difference in efficacy between the CIED and non-CIED subgroups receiving TPNS, with both having similar percentages of patients who achieved ≥50% reduction in AHI and quality-of-life improvement. CONCLUSION: Concomitant CIED and TPNS therapy is safe. The presence of a concomitant CIED did not seem to impact implant metrics, implantation success, and TPNS efficacy. A detailed interaction protocol should be followed to minimize the incidence of device-device interaction.

9.
Rev Cardiovasc Med ; 21(1): 25-29, 2020 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-32259901

RESUMO

Low serum sodium concentration has long been recognized as an established marker of short- and long-term morbidity and mortality in patients with heart failure (HF), and is commonly included in various risk prediction models. Mechanisms leading to hyponatremia (e.g. maladaptive neurohormonal activation) could also lead to concurrent decline in serum chloride levels. Besides, chloride has distinct biological roles (e.g. modulation of renal tubular sodium transporters) that are relevant to the pathophysiology and therapy of HF, making it a potent cardiorenal connector. Several clinical studies have recently reported on a potentially overlooked link between low serum chloride levels and adverse outcomes in patients with a wide variety of HF syndromes, which could indeed be stronger than that of sodium. While evidence on predictive value of chloride is accumulating in various patient populations and settings, the limited available interventional studies have so far yielded conflicting results. It remains to be elucidated whether hypochloremia represents a marker of disease severity and prognosis, or it is an actual pathogenetic mechanism, hence being a potential novel target of therapy. Current ongoing studies are designed to better understand the mechanistic aspects of the role of hypochloremia in HF and shed light on its clinical applicability.


Assuntos
Síndrome Cardiorrenal/sangue , Cloretos/sangue , Insuficiência Cardíaca/sangue , Equilíbrio Hidroeletrolítico , Desequilíbrio Hidroeletrolítico/sangue , Desequilíbrio Hidroeletrolítico/fisiopatologia , Animais , Biomarcadores/sangue , Síndrome Cardiorrenal/tratamento farmacológico , Síndrome Cardiorrenal/epidemiologia , Síndrome Cardiorrenal/fisiopatologia , Diuréticos/uso terapêutico , Regulação para Baixo , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Prognóstico , Fatores de Risco , Equilíbrio Hidroeletrolítico/efeitos dos fármacos , Desequilíbrio Hidroeletrolítico/epidemiologia
11.
Heart Fail Clin ; 16(1): 81-97, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31735318

RESUMO

Abnormal fluid handling leads to physiologic abnormalities in multiple organ systems. Deranged hemodynamics, neurohormonal activation, excessive tubular sodium reabsorption, inflammation, oxidative stress, and nephrotoxic medications are important drivers of harmful cardiorenal interactions in patients with heart failure. Accurate quantitative measurement of fluid volume is vital to individualizing therapy for such patients. Blood volume analysis and pulmonary artery pressure monitoring seem the most reliable methods for assessing fluid volume and guiding decongestive therapies. Still the cornerstone of decongestive therapy, diuretics' effectiveness decreases with progression of heart failure. Extracorporeal ultrafiltration, an alternative to diuretics, has been shown to reduce heart-failure events.


Assuntos
Síndrome Cardiorrenal/etiologia , Diuréticos/uso terapêutico , Insuficiência Cardíaca/complicações , Hemodinâmica/fisiologia , Ultrafiltração/métodos , Síndrome Cardiorrenal/terapia , Progressão da Doença , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Humanos
12.
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.

13.
Sleep ; 42(11)2019 10 21.
Artigo em Inglês | MEDLINE | ID: mdl-31634407

RESUMO

STUDY OBJECTIVE: To evaluate long-term efficacy and safety of phrenic nerve stimulation (PNS) in patients with moderate-to-severe central sleep apnea (CSA) through 3 years of therapy. METHODS: Patients in the remede System Pivotal Trial were observed every 3 months after implant until US Food and Drug Administration approval. At the time of approval and study closure, all patients completed 24 months of follow-up; 33 patients had not reached the 36-month visit. Sleep metrics (polysomnography) and echocardiographic parameters are reported at baseline, 12, 18, and 24 months, in addition to available 36-month sleep results from polygraphy. Safety was assessed through 36 months; however, analysis focused through 24 months and available 36-month results are provided. RESULTS: Patients were assessed at 24 (n = 109) and 36 (n = 60) months. Baseline characteristics included mean age 64 years, 91% male, and mean apnea-hypopnea index 47 events per hour. Sleep metrics (apnea-hypopnea index (AHI), central apnea index, arousal index, oxygen desaturation index, rapid eye movement sleep) remained improved through 24 and 36 months with continuous use of PNS therapy. At least 60% of patients in the treatment group achieved at least 50% reduction in AHI through 24 months. Serious adverse events (SAEs) related to the remede System implant procedure, device, or therapy through 24 months were reported by 10% of patients, no unanticipated adverse device effects or deaths, and all events resolved. No additional related SAEs were reported between 24 and 36 months. CONCLUSION: These data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns. TRIAL REGISTRATION: NCT01816776.


Assuntos
Terapia por Estimulação Elétrica/métodos , Nervo Frênico/fisiopatologia , Apneia do Sono Tipo Central/terapia , Idoso , Terapia por Estimulação Elétrica/efeitos adversos , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Polissonografia , Estudos Prospectivos , Qualidade de Vida , Apneia do Sono Tipo Central/fisiopatologia , Resultado do Tratamento
15.
J Cardiovasc Electrophysiol ; 30(5): 792-799, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30834611

RESUMO

BACKGROUND: Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA. OBJECTIVE: To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remede System, Respicardia, Inc). METHODS: The remede System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration. RESULTS: In the remede System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty-two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months. CONCLUSION: In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.


Assuntos
Diafragma/inervação , Terapia por Estimulação Elétrica/instrumentação , Neuroestimuladores Implantáveis , Nervo Frênico/fisiopatologia , Implantação de Prótese , Respiração , Apneia do Sono Tipo Central/terapia , Terapia por Estimulação Elétrica/efeitos adversos , Humanos , Duração da Cirurgia , Desenho de Prótese , Implantação de Prótese/efeitos adversos , Apneia do Sono Tipo Central/diagnóstico , Apneia do Sono Tipo Central/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
16.
Card Fail Rev ; 5(1): 9-18, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30847239

RESUMO

Congestion is the predominant cause of more than 1 million annual heart failure hospitalisations and recurrent fluid overload predicts poor outcomes. Unresolved congestion trumps serum creatinine increases in predicting adverse heart failure outcomes. No pharmacological approach for acute heart failure has reduced these deleterious consequences. Simplified ultrafiltration devices permit fluid removal in lower acuity hospital settings, but results regarding safety and efficacy have been variable. However, adjustment of ultrafiltration rates to patients' vital signs and renal function has been associated with more effective decongestion and fewer heart failure events. Many aspects of ultrafiltration, including patient selection, fluid removal rates, venous access, prevention of therapy-related complications and costs, require further investigation.

17.
Circ Heart Fail ; 12(2): e005094, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30704291

RESUMO

BACKGROUND: Left ventricular assist device (LVAD) therapy improves the hemodynamics of advanced heart failure patients. However, it is unknown whether hemodynamic optimization improves clinical outcomes. The aim of this study was to investigate whether hemodynamic optimization reduces hospital readmission rate in LVAD patients. METHODS AND RESULTS: LVAD patients undergoing an invasive hemodynamic ramp test were prospectively enrolled and followed for 1 year. LVAD speed was optimized using a ramp test, targeting the following goals: central venous pressure <12 mm Hg, pulmonary capillary wedge pressure <18 mm Hg, and cardiac index >2.2 L/(min·m2). The frequency and cause of hospital readmissions were compared between patients who achieved (optimized group) or did not achieve (nonoptimized group) these goals. Eighty-eight outpatients (median 61 years old, 53 male) underwent ramp testing 236 days after LVAD implantation, and 54 (61%) had optimized hemodynamics after LVAD speed adjustment. One-year survival after the ramp study was comparable in both groups (89% versus 88%). The total hospital readmission rate was lower in the optimized group compared with the nonoptimized group (1.15 versus 2.86 events/y, P<0.001). This result was predominantly because of a reduction in the heart failure readmission rate in the optimized group (0.08 versus 0.71 events/y, P=0.016). CONCLUSIONS: LVAD patients, in whom hemodynamics were optimized, had a significantly lower rate of hospital readmissions, primarily because of fewer heart failure admissions. These findings highlight the importance of achieving hemodynamic optimization in LVAD patients.


Assuntos
Insuficiência Cardíaca/terapia , Coração Auxiliar , Hemodinâmica , Readmissão do Paciente , Implantação de Prótese/instrumentação , Função Ventricular Esquerda , Idoso , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervalo Livre de Progressão , Estudos Prospectivos , Desenho de Prótese , Implantação de Prótese/efeitos adversos , Recuperação de Função Fisiológica , Fatores de Risco , Fatores de Tempo
18.
Eur J Heart Fail ; 20(12): 1746-1754, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30303611

RESUMO

AIMS: The presence of central sleep apnoea (CSA) is associated with poor prognosis in patients with heart failure (HF). The aim of this analysis was to evaluate if using phrenic nerve stimulation to treat CSA in patients with CSA and HF was associated with changes in HF-specific metrics. METHODS AND RESULTS: All patients randomized in the remede System Pivotal Trial and identified at baseline with HF were included (n = 96). Effectiveness data from treatment and former control groups were pooled based on months since therapy activation. Changes from baseline to 6 and 12 months in sleep metrics, Epworth Sleepiness Scale, patient global assessment health-related quality of life, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and echocardiographic parameters are reported. HF hospitalization, cardiovascular death, and the composite of HF hospitalization or cardiovascular death within 6 months are reported by the original randomized group assignment for safety assessment. Sleep metrics and quality of life improved from baseline to 6 and 12 months. At 12 months, MLHFQ scores changed by -6.8 ± 20.0 (P = 0.005). The 6-month rate of HF hospitalization was 4.7% in treatment patients (standard error = 3.3) and 17.0% in control patients (standard error = 5.5) (P = 0.065). Reported adverse events were as expected for a transvenous implantable system. CONCLUSIONS: Phrenic nerve stimulation reduces CSA severity in patients with HF. In parallel, this CSA treatment was associated with benefits on HF quality of life.


Assuntos
Terapia por Estimulação Elétrica/métodos , Insuficiência Cardíaca/terapia , Nervo Frênico/fisiopatologia , Qualidade de Vida , Apneia do Sono Tipo Central/terapia , Idoso , Feminino , Seguimentos , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Polissonografia , Estudos Prospectivos , Apneia do Sono Tipo Central/etiologia , Apneia do Sono Tipo Central/fisiopatologia , Resultado do Tratamento
19.
Adv Chronic Kidney Dis ; 25(5): 434-442, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30309461

RESUMO

Acute decompensated heart failure has the highest rate of hospital readmission among all medical conditions and portends a significant financial burden on health care system. Congestion, the hallmark of acute decompensated heart failure, represents the primary reason for hospitalization and the driver of adverse outcomes in these patients. Although diuretic-based medical regimens remain the mainstay of management of acute decompensated heart failure, they often show suboptimal efficacy and safety profiles in this setting. Mechanical extraction of excess fluid through extracorporeal ultrafiltration therapy has been proposed as a mechanistically relevant option in this setting. The advent of simplified, portable, and user-friendly devices that are dedicated to ultrafiltration therapy for these patients has renewed the interest in this therapeutic modality. In this article, we provide a brief overview of the initial mechanistic studies followed by the key clinical findings of the most recent landmark trials. The shortcomings of these studies are discussed in detail because not only do they provide the appropriate context in which the results are to be interpreted, but more importantly they also highlight the existing knowledge gaps that need to be addressed in future studies. Finally, selected practical and conceptual considerations and controversies are reviewed with regard to evidence-based ultrafiltration therapy.


Assuntos
Síndrome Cardiorrenal/mortalidade , Síndrome Cardiorrenal/terapia , Progressão da Doença , Insuficiência Cardíaca/terapia , Ultrafiltração/métodos , Doença Aguda , Síndrome Cardiorrenal/classificação , Síndrome Cardiorrenal/fisiopatologia , Diuréticos/uso terapêutico , Medicina Baseada em Evidências , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/prevenção & controle , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Prognóstico , Medição de Risco , Índice de Gravidade de Doença , Análise de Sobrevida , Resultado do Tratamento
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