RESUMEN
The prognostic implications of intravascular volume status assessed by blood volume analysis (BVA) in ambulatory heart failure (HF) remain uncertain. The incremental benefits of assessing volume status, beyond the well-established filling pressures, in predicting HF outcomes are unknown.
Asunto(s)
Volumen Sanguíneo , Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/diagnóstico , Pronóstico , Volumen Sanguíneo/fisiología , Volumen Sistólico/fisiología , Masculino , Femenino , Determinación del Volumen Sanguíneo/métodos , Anciano , Persona de Mediana EdadRESUMEN
Among patients with chronic heart failure (HF) intravascular volume profiles vary significantly despite similar clinical compensation. However, little is known regarding changes in blood volume (BV) profiles over time. The objective of this analysis was to identify the extent and character of changes in volume profiles over time. A prospective analysis was undertaken in patients who were hospitalized and treated for fluid overload. Quantitative BV analyses were obtained in a compensated state at hospital discharge (baseline) and follow-up at 1, 3, and 6 mo. Data were available on 10 patients who remained stable without rehospitalization or medication change over a 6-mo period. Baseline BV profiles were highly variable at hospital discharge with an average deviation of +28% above normal in 6 patients and normal BV in 4 patients. Over the follow-up period, the median change in BV was -201 mL [-3% (-6, +3%)] from baseline with profiles remaining in the same volume category in 9 out of 10 patients. Crossover from normal BV to mild contraction (-13% of normal) occurred in one patient. Red blood cell mass demonstrated the largest change over 6 mo [median -275 (-410, +175) mL] with a deviation from normal of -14 (-20, +8) % (reflecting mild anemia). These findings suggest that BV profiles in clinically compensated patients with HF do not change substantially over a 6-mo period regardless of baseline expanded or normal BV. This lack of change in volume profiles particularly from an expanded BV has implications for long-term volume management, clinical outcomes, and also our understanding of volume homeostasis in HF.NEW & NOTEWORTHY The novel findings of this study demonstrate that blood volume profiles while highly variable in clinically compensated patients with HF on stable medical therapy do not change substantially over a 6-mo period regardless of baseline expanded or normal blood volumes. This lack of change in volume profiles particularly from an expanded blood volume has implications for long-term volume management and also for how we understand the pathophysiology of volume homeostasis in chronic HF.
Asunto(s)
Volumen Sanguíneo , Insuficiencia Cardíaca , Humanos , Volumen Sanguíneo/fisiología , Enfermedad Crónica , Volumen Sistólico/fisiologíaRESUMEN
BACKGROUND: Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections. METHODS: We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months. RESULTS: A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P = 0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). The mean (±SD) duration of follow-up was 20.7±8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98). CONCLUSIONS: Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications. (Funded by Medtronic; WRAP-IT ClinicalTrials.gov number, NCT02277990.).
Asunto(s)
Antibacterianos/administración & dosificación , Profilaxis Antibiótica , Infecciones Bacterianas/prevención & control , Desfibriladores Implantables/efectos adversos , Cardiopatías/terapia , Minociclina/administración & dosificación , Marcapaso Artificial/efectos adversos , Infecciones Relacionadas con Prótesis/prevención & control , Rifampin/administración & dosificación , Anciano , Antibacterianos/efectos adversos , Infecciones Bacterianas/epidemiología , Infecciones Bacterianas/mortalidad , Femenino , Humanos , Incidencia , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Minociclina/efectos adversos , Infecciones Relacionadas con Prótesis/epidemiología , Infecciones Relacionadas con Prótesis/mortalidad , Rifampin/efectos adversos , Método Simple Ciego , Nivel de AtenciónRESUMEN
To review and analyze the clinical outcomes of thermal therapy (≤1.4°C increase in core body temperature) in patients with heart failure (HF). A systematic review and meta-analysis regarding the effects of thermal therapy on HF was done by searching PubMed, Ovid Medline, Ovid Embase, Scopus, and internal databases up to date (2019). Improvement in the New York Heart Association (NYHA) class: Ten studies with 310 patients showed significant improvement in NYHA class. Only 7 among 40 patients remained in Class IV and 99 patients in Class III from 155 patients. Increased patients in lower classes indicate that more patients showed improvement. Sixteen studies on 506 patients showed an overall improvement of 4.4% of left ventricular ejection fraction (LVEF). Four studies reported improved endothelial dysfunction by 1.7% increase in flow-mediated dilation (FMD) on 130 patients. Reduction in blood pressure: Thermal therapy reduced both systolic blood pressure (SBP) and diastolic blood pressure by 3.1% and 5.31%, respectively, in 431 patients of 15 studies. Decrease in cardiothoracic ratio (CTR): Eight studies reported an average of 5.55% reduction of CTR in a total of 347 patients. Improvement in oxidative stress markers: Plasma brain natriuretic peptide (BNP) levels significantly decreased (mean difference of 14.8 pg/dL) in 303 patients of 9 studies. Improvement of quality of life: Among 65 patients, thermal therapy reduced cardiac death and rehospitalization by 31.3%. A slight increase in core body temperature is a promising, noninvasive, effective, and complementary therapy for patients with HF. Further clinical studies are recommended.
Asunto(s)
Terapias Complementarias/métodos , Insuficiencia Cardíaca/terapia , Calor/uso terapéutico , Calidad de Vida , Baños , Presión Sanguínea/fisiología , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/fisiopatología , Humanos , Estrés Oxidativo/fisiología , Baño de Vapor , Resultado del Tratamiento , Función Ventricular Izquierda/fisiologíaRESUMEN
Hyperkalemia is defined as serum potassium concentrations elevated above the upper limit of normal (> 5.0 mEq/L). It has become more common in cardiovascular practice due to the growing population of patients with chronic kidney disease and the broad application of drugs that modulate renal elimination of potassium by reducing production of angiotensin II (angiotensin-converting enzyme inhibitors, direct renin inhibitors, ß-adrenergic receptor antagonists), blocking angiotensin II receptors (angiotensin receptor blockers), or antagonizing the action of aldosterone on mineralocorticoid receptors (mineralocorticoid receptor antagonists). The risk of hyperkalemia is a major limiting factor for the use of these disease-modifying drugs in both acute and chronic cardiorenal syndromes. Thus, agents to control the plasma concentration of potassium are needed in the multidrug treatment of cardiorenal disease, including chronic kidney disease, heart failure, and acute kidney injury. Novel oral therapies in development for both acute and extended use in the management of hyperkalemia include patiromer sorbitex calcium and sodium zirconium cyclosilicate. Important biochemical differences between these compounds result in unique product profiles and electrolyte outcomes in patients treated for hyperkalemia. This review highlights the major mechanisms of hyperkalemia and key results from randomized trials in a range of clinical scenarios in patients with, and at risk for, hyperkalemia.
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Hiperpotasemia/tratamiento farmacológico , Hiperpotasemia/prevención & control , Polímeros/uso terapéutico , Poliestirenos/uso terapéutico , Potasio/sangre , Silicatos/uso terapéutico , Animales , Biomarcadores/sangre , Regulación hacia Abajo , Humanos , Hiperpotasemia/sangre , Hiperpotasemia/diagnóstico , Hiperpotasemia/etiología , Polímeros/efectos adversos , Poliestirenos/efectos adversos , Factores de Riesgo , Silicatos/efectos adversos , Resultado del TratamientoRESUMEN
Blood volume analysis provides a quantitative volume assessment in patients with equivocal or discordant clinical findings. Reports on its use in mechanical circulatory support are limited and it has never been described in patients with a total artificial heart. Our series demonstrates that patients supported with total artificial heart as a bridge to transplant have significant reductions in red blood cell volume and heterogeneous adaptations in their total blood volume and plasma volume. Pathologic derangements in our patient's total blood volume were targeted to restore euvolemia.
RESUMEN
AIMS: Quantitative methods have shown clinically significant heterogeneity in blood volume (BV) profiles across heart failure (HF) phenotypes. These profiles extend from hypovolaemia to normal BV and to variable degrees of BV hypervolaemia, frequently with similar clinical presentations. However, a comprehensive survey of BV profiles providing practical clinical guidance for the interpretation and management of quantitative plasma volume (PV) and red blood cell (RBC) mass findings has not been reported. The intent of this study is to advance this concept through a multicentre analysis. METHODS AND RESULTS: A retrospective analysis of clinical and BV data was undertaken in stable NYHA class II-III HF patients (N = 546). BV was quantitated using established nuclear medicine indicator-dilution methodology. Differing combinations of PV and RBC mass were identified contributing to marked heterogeneity in overall BV profiles. A quantitatively normal BV was identified in 32% of the cohort but of these only ~1/3 demonstrated a true normal BV (i.e., normal PV + normal RBC mass). The remaining portion of normal BV profiles reflected balanced combinations of compensatory PV expansion with RBC mass deficit (anaemia) (14% of cohort) and PV contraction with RBC mass excess (erythrocythemia) (6% of cohort). Main contributors to BV hypervolaemia were PV excess with a normal RBC mass (21% of cohort; 23% female) and PV excess with erythrocythemia (24% of cohort; 26% female). Hypovolaemia was predominately defined by RBC mass deficit with a normal PV (6% of cohort; 57% female) or RBC mass deficit with PV contraction (5% of cohort; 48% female). CONCLUSIONS: Findings support the clinical relevance of identifying and accurately interpreting the varying combinations of PV and RBC mass in patients with chronic HF. This in turn helps guide appropriate individualized patient management strategies. A practical volume-based guideline is provided in an effort to aid clinician interpretation.
RESUMEN
BACKGROUND: This review delves into the intricate landscape of cardiorenal syndrome (CRS) and highlights the pivotal role of blood volume analysis (BVA) in improving patient care and outcomes. SUMMARY: BVA offers a direct and highly accurate quantification of intravascular volume, red blood cell volume, and plasma volume, complete with patient-specific norms. This diagnostic tool enhances the precision of diuretic and red cell therapies, significantly elevating the effectiveness of conventional care. KEY MESSAGES: Our objectives encompass a comprehensive understanding of how BVA informs the evaluation and treatment of CRS, including its subtypes, pathophysiology, and clinical significance. We delve into BVA principles, techniques, and measurements, elucidating its diagnostic potential and advantages compared to commonly used surrogate measures. We dissect the clinical relevance of BVA in various CRS scenarios, emphasizing its unique contributions to each subtype. By assessing the tangible impact of BVA on patient outcomes through meticulous analysis of relevant clinical studies, we unveil its potential to enhance health outcomes and optimize resource utilization. Acknowledging the challenges and limitations associated with BVA's clinical implementation, we underscore the importance of multidisciplinary collaboration among cardiologists, nephrologists, and other clinicians. Finally, we identify research gaps and propose future directions for BVA and CRS, contributing to ongoing advancements in this field and patients affected by this complicated clinical syndrome.
Asunto(s)
Determinación del Volumen Sanguíneo , Volumen Sanguíneo , Síndrome Cardiorrenal , Humanos , Síndrome Cardiorrenal/fisiopatología , Síndrome Cardiorrenal/clasificación , Síndrome Cardiorrenal/terapia , Volumen Sanguíneo/fisiología , Determinación del Volumen Sanguíneo/métodosRESUMEN
BACKGROUND: The effects of exercise in patients with breast cancer (BC), has shown some profit, but consistency and magnitude of benefit remains unclear. We aimed to conduct a meta-analysis to assess the benefits of varying types of exercises in patients with BC. METHODS: Literature search was conducted across five electronic databases (MEDLINE, Web of Science, Scopus, Google Scholar and Cochrane) from 1st January 2000 through 19th January 2024. Randomized controlled trials (RCTs) assessing the impact of different types of exercise on outcomes related to fitness and quality of life (QOL) in patients with BC were considered for inclusion. Outcomes of interest included cardiorespiratory fitness (CRF), health-related quality of life (HRQOL), muscle strength, fatigue and physical function. Evaluations were reported as mean differences (MDs) with 95% confidence intervals (CIs) and pooled using random effects model. A p value < 0.05 was considered significant. RESULTS: Thirty-one relevant articles were included in the final analysis. Exercise intervention did not significantly improved the CRF in patients with BC when compared with control according to treadmill ergometer scale (MD: 4.96; 95%Cl [-2.79, 12.70]; P = 0.21), however exercise significantly improved CRF according to cycle ergometer scales (MD 2.07; 95% Cl [1.03, 3.11]; P = 0.0001). Physical function was significantly improved as well in exercise group reported by 6-MWT scale (MD 80.72; 95% Cl [55.67, 105.77]; P < 0.00001). However, exercise did not significantly improve muscle strength assessed using the hand grip dynamometer (MD 0.55; 95% CI [-1.61, 2.71]; P = 0.62), and fatigue assessed using the MFI-20 (MD -0.09; 95% CI [-5.92, 5.74]; P = 0.98) and Revised Piper scales (MD -0.26; 95% CI [-1.06, 0.55] P = 0.53). Interestingly, exercise was found to improve HRQOL when assessed using the FACT-B scale (MD 8.57; 95% CI [4.53, 12.61]; P < 0.0001) but no significant improvements were noted with the EORTIC QLQ-C30 scale (MD 1.98; 95% CI [-1.43, 5.40]; P = 0.25). CONCLUSION: Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types but the effects on CRF vary with cycle versus treadmill ergometer. Exercise failed to improve fatigue-related symptoms and muscle strength. Large RCTs are required to evaluate the effects of exercise in patients with BC in more detail.
RESUMEN
Studies have shown poor correlation between intra-cardiac pressures and blood volume (BV) measurements including HF. The impact of sex and left ventricular ejection fraction (LVEF) on this relationship has not been studied. We obtained pressure (pulmonary artery diastolic pressure (PADP)) and volume (total blood volume (TBV) and estimated stress blood volume (eSBV)) measurements from HF patients at the time of CardioMEMS implantation. A total of 20 patients were included. There was no significant difference between PADP, TBV, and eSBV between sexes. There was only a moderate correlation between PADP and eSBV in men but not in women or with TBV in both sexes. HFrEF had higher PADP and eSBV than HFpEF. There was a consistent lack of correlation between PADP and both TBV and eSBV. Further studies evaluating mid- to long-term implications of pressure-volume profiles as well as changes following decongestion therapy are warranted to better understand the pressure-volume interplay and determine appropriate decongestion strategy for each pressure-volume phenotype.
Asunto(s)
Insuficiencia Cardíaca , Masculino , Femenino , Humanos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Volumen Sistólico , Función Ventricular Izquierda , Volumen Sanguíneo , PronósticoRESUMEN
BACKGROUND: Lead dislodgement has been shown to be the most common complication in the first 30 days after pacemaker insertion. Although it is rare, pneumopericardium with tamponade can also result. OBJECTIVES: We present a case of an extremely rare delay from cardiac pacemaker insertion to lead migration with resulting pneumopericardium and cardiac tamponade. CASE REPORT: A 65-year-old woman with a past medical history significant for congestive heart failure, chronic obstructive pulmonary disease, and third-degree heart block, requiring pacemaker insertion 2 years prior with a revision 1 year prior, presented to the Emergency Department complaining of sudden-onset pleuritic chest pain. Her work-up revealed a pneumopericardium with atrial pacemaker lead migration into the right middle lobe of the lung. She suddenly developed hypotension and respiratory distress and required pericardiocentesis and, ultimately, surgical repair for a perforated right atrium. CONCLUSION: Pacemaker migration can lead to pneumopericardium and tamponade, even up to 1 year after placement.
Asunto(s)
Taponamiento Cardíaco/etiología , Marcapaso Artificial/efectos adversos , Neumopericardio/etiología , Implantación de Prótesis/efectos adversos , Anciano , Taponamiento Cardíaco/cirugía , Dolor en el Pecho/etiología , Femenino , Atrios Cardíacos/lesiones , Lesiones Cardíacas/etiología , Lesiones Cardíacas/cirugía , Humanos , Neumopericardio/cirugía , Falla de PrótesisRESUMEN
BACKGROUND: End point committees are routinely used to adjudicate efficacy and safety end points in clinical trials. The 2,708-patient ß-Blocker Evaluation of Survival Trial (BEST) originally determined hospitalization type via investigator case report forms (CRFs), which captured whether a hospitalization was due to worsening heart failure (HF). Recently, the BEST End Points Committee (EPC) completed a blinded adjudication of all hospitalizations, allowing a comparison of the CRF method to the EPC method of determining hospitalization type. We sought to compare the investigator-determined mode of hospitalizations with the adjudicated events, to quantify the degree of agreement, and to compare the clinical trial results by method of event classification. METHODS: The BEST EPC reviewed all 5,086 hospitalizations that occurred in BEST. Events were identified using investigator-reported hospitalizations, as well as those documented by FDA Form 3500 (MedWatch) reports. RESULTS: The investigators identified more HF hospitalization events than adjudication (2,466 vs 1,729, P < .0001, paired analysis). Eight hundred thirty-four (34%) HF hospitalizations identified in CRFs were not confirmed by adjudication. Ninety-seven (6%) adjudicated events were not identified by the investigator reported method. One thousand six hundred thirty-two events were similarly identified by both methods. CONCLUSIONS: The EPC adjudication identified fewer HF hospitalizations than did the investigator reported method with no change in the hazard ratio for this end point. Our findings suggest that independent end point committees may improve reliability through reduced variance, thus providing similar outcome results with fewer events and no increase in CIs.
Asunto(s)
Antagonistas Adrenérgicos beta/uso terapéutico , Comités de Monitoreo de Datos de Ensayos Clínicos , Insuficiencia Cardíaca/tratamiento farmacológico , Registros de Hospitales , Hospitalización/estadística & datos numéricos , Investigadores , Femenino , Insuficiencia Cardíaca/mortalidad , Mortalidad Hospitalaria/tendencias , Humanos , Masculino , Persona de Mediana Edad , Tasa de Supervivencia/tendencias , Resultado del Tratamiento , Estados UnidosRESUMEN
PURPOSE OF REVIEW: Anemia is a relatively common finding in heart failure. Anemia in heart failure patients has been independently associated with reduced exercise tolerance, increased heart failure hospitalizations and increased all-cause mortality. Anemia would appear to be a reasonable treatment target for patients with heart failure. The review will discuss the potential causes of anemia in heart failure patients and give an up-to-date overview of treatment trials. RECENT FINDINGS: Studies assessing the pathophysiology of anemia in heart failure patients have recently demonstrated the potential importance of iron deficiency, abnormal iron metabolism and hemodilution. Treatment studies have focused on the use of erythropoiesis-stimulating agents, with recent trials showing mixed results. SUMMARY: Despite initial studies indicating a possible beneficial effect of erythropoiesis-stimulating agents in the treatment of anemic heart failure patients, clinical trial data, to date, have failed to show convincing evidence for morbidity or mortality benefit, and information on the long-term safety is lacking. Ongoing large-scale trials will have the potential to provide such information in the future.
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Anemia/tratamiento farmacológico , Insuficiencia Cardíaca/complicaciones , Hematínicos/uso terapéutico , Compuestos de Hierro/uso terapéutico , Anemia/epidemiología , Anemia/etiología , Anemia/fisiopatología , Anemia Ferropénica/tratamiento farmacológico , Anemia Ferropénica/prevención & control , Hospitalización , Humanos , Inflamación , Guías de Práctica Clínica como Asunto , Prevalencia , Pronóstico , Diálisis Renal , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Antitachycardia pacing (ATP) is routinely used to terminate ventricular tachyarrhythmias (VTs). However, little guidance exists on the most effective programming of ATP. OBJECTIVE: This study evaluated whether additional ATP sequences are more effective in reducing implantable cardioverter-defibrillator shocks. METHODS: In patients from the Shock-Less study, the number of overall shocks were compared between patients programmed to ≤3 ATP sequences (VT zone) and ≤1 ATP sequence (fast ventricular tachycardia [FVT] zone) (nominal group) and patients programmed to receive additional ATP sequences in VT (>3) or FVT (>1) zones. RESULTS: Of the 4112 patients (15% receiving secondary prevention; 77% men; mean age 65.9 ± 12.6 years), 1532 patients (37%) were programmed with additional ATP sequences (1025 with >3 ATP sequences in the VT zone; 699 patients with >1 ATP sequence in the FVT zone). Over a mean follow-up period of 19.6 ± 10.7 months, 4359 VT/FVT episodes occurred in 591 patients. Compared with the nominal group, in patients with additional ATP programming, there was a 39% reduction in the number of shocked VT episodes (0.46 episodes per patient-year vs 0.28 episodes per patient-year; incidence rate ratio [IRR] 0.61; P < .001) and a 44% reduction in the number of shocked FVT episodes (0.83 episodes per patient-year vs 0.47 episodes per patient-year; IRR 0.56; P < .001). The reduction in shocked VT episodes was observed in both primary (IRR 0.68; 95% confidence interval 0.51-0.90; P = .007) and secondary (IRR 0.51; 95% confidence interval 0.35-0.72; P < .001) prevention patients. CONCLUSION: Programming more than the nominal number of ATP sequences in both the VT and FVT zones is associated with a lower occurrence of implantable cardioverter-defibrillator shocks in clinical practice.
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Arritmias Cardíacas/terapia , Desfibriladores Implantables/normas , Cardioversión Eléctrica/normas , Frecuencia Cardíaca/fisiología , Prevención Secundaria/métodos , Anciano , Diseño de Equipo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. METHODS: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. RESULTS: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. CONCLUSIONS: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.
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Antibacterianos/economía , Profilaxis Antibiótica/economía , Dispositivos de Terapia de Resincronización Cardíaca/economía , Desfibriladores Implantables/economía , Costos de los Medicamentos , Implantación de Prótesis/economía , Infecciones Relacionadas con Prótesis/economía , Implantes Absorbibles/economía , Antibacterianos/uso terapéutico , Dispositivos de Terapia de Resincronización Cardíaca/efectos adversos , Toma de Decisiones Clínicas , Ahorro de Costo , Análisis Costo-Beneficio , Árboles de Decisión , Desfibriladores Implantables/efectos adversos , Humanos , Modelos Económicos , Estudios Multicéntricos como Asunto , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/instrumentación , Infecciones Relacionadas con Prótesis/microbiología , Infecciones Relacionadas con Prótesis/prevención & control , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: Prior investigations suggest that superimposing continuous flow on aortic flow (continuous aortic flow augmentation) produces vasodilation, cardiac unloading, and improved cardiac performance. METHODS AND RESULTS: We compared percutaneous continuous aortic flow augmentation (flow Asunto(s)
Aorta/fisiopatología
, Aorta/cirugía
, Insuficiencia Cardíaca/fisiopatología
, Insuficiencia Cardíaca/cirugía
, Corazón Auxiliar
, Adulto
, Anciano
, Velocidad del Flujo Sanguíneo/fisiología
, Determinación de Punto Final/métodos
, Femenino
, Insuficiencia Cardíaca/mortalidad
, Humanos
, Masculino
, Persona de Mediana Edad
, Vasodilatación/fisiología
RESUMEN
BACKGROUND: The landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial first demonstrated that implantation of left ventricular assist devices (LVADs) as destination therapy (DT) can provide survival superior to any known medical treatment in patients with end-stage heart failure who are ineligible for transplantation. In the present study, we describe outcomes of DT in the post-REMATCH era in the United States. METHODS AND RESULTS: The present study included 280 patients who underwent HeartMate XVE LVAD implantation between November 2001 and December 2005. A preoperative risk score for in-hospital mortality after LVAD implantation was established in 222 patients with complete data. All patients were followed up until death or December 2006. The 1-year survival after LVAD implantation was 56%. The in-hospital mortality after LVAD surgery was 27%. The main causes of death included sepsis, right heart failure, and multiorgan failure. The most important determinants of in-hospital mortality were poor nutrition, hematological abnormalities, markers of end-organ or right ventricular dysfunction, and lack of inotropic support. Stratification of DT candidates into low (n=65), medium (n=111), high (n=28), and very high (n=18) risk on the basis of the risk score calculated from these predictors corresponded with 1-year survival rates of 81%, 62%, 28%, and 11%, respectively. CONCLUSIONS: Appropriate selection of candidates and timing of LVAD implantation are critical for improved outcomes of DT. Patients with advanced heart failure who are referred for DT before major complications of heart failure develop have the best chance of achieving an excellent 1-year survival with LVAD therapy.
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Insuficiencia Cardíaca/cirugía , Corazón Auxiliar , Anciano , Fármacos Cardiovasculares/uso terapéutico , Causas de Muerte , Falla de Equipo/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/mortalidad , Trasplante de Corazón , Corazón Auxiliar/estadística & datos numéricos , Enfermedades Hematológicas/complicaciones , Mortalidad Hospitalaria , Hospitalización , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Desnutrición/complicaciones , Persona de Mediana Edad , Insuficiencia Multiorgánica/etiología , Insuficiencia Multiorgánica/mortalidad , Calidad de Vida , Sistema de Registros/estadística & datos numéricos , Estudios Retrospectivos , Riesgo , Sepsis/etiología , Sepsis/mortalidad , Análisis de Supervivencia , Tasa de Supervivencia , Resultado del Tratamiento , Estados Unidos/epidemiología , Disfunción Ventricular Derecha/etiología , Disfunción Ventricular Derecha/mortalidadRESUMEN
The aim of this work was to review and provide a summary of published literature on the clinical impact of thermal therapy (ie, warm water immersion, traditional sauna bathing, and dry infrared sauna) in patients with heart failure. Medline and Embase database literature searches were conducted, and studies that included measurement of heart failure-related clinical parameters were reviewed. Thermal therapy was found to have a positive impact on key heart failure-related parameters across multiple studies. Significant improvements were noted across a wide scope of heart failure-related parameters in the areas of (1) endothelial function, (2) hemodynamics, (3) cardiac geometry, (4) neurohormonal markers, and (5) quality of life. Of special note, thermal therapy also conveyed a strong antiarrhythmic effect in heart failure patients. The clinical evidence highlights repeatable and compelling data showing that thermal therapy may provide an important and viable adjunct in the treatment of heart failure.
Asunto(s)
Insuficiencia Cardíaca/terapia , Calor/uso terapéutico , Bases de Datos como Asunto , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/psicología , Humanos , Calidad de Vida , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
Neurologic events during left ventricular assist device (LVAD) support are associated with significant morbidity and death. To evaluate this problem, we analyzed neurocognitive function and the frequency and incidence of neurologic events in 21 consecutive patients who were undergoing long-term support with the HeartMate XVE LVAD (Thoratec Corporation; Pleasanton, Calif). The mean duration of LVAD support was 531 days (range, 55-1, 309 d); the cumulative support time was 11,188 days (30.7 yr). No patients received anticoagulant therapy, and most received aspirin. None experienced strokes or transient ischemic attacks. Twenty patients were discharged from the hospital; 2 were later readmitted because of transient changes in neurologic status (metabolic encephalopathy) that ultimately resolved. Neurologic function, as measured by the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Score (MRS), was abnormal before LVAD implantation but normal 6 and 12 months after (mean NIHSS, 23.6 before vs 0 after; mean MRS, 0.68 before vs 0.18 after). Neurocognitive function, as evaluated by the Boston Naming Test, Trail Making Test part B, and Block Design Test, also improved during LVAD support. Together, these findings indicate that few neurologic events occur during long-term HeartMate XVE LVAD support in the absence of anticoagulation therapy. They also suggest that modifications made to the HeartMate LVAD since the REMATCH trial have resulted in fewer complications, and that better patient selection and supportive care have improved outcomes.