Implantable cardioverter-defibrillators for primary prevention of sudden death in heart failure: are there enough bangs for the bucks?
Explore the source record for details and available documents.
Biomedical subjects
Publications and source records attributed to Lynne Warner Stevenson.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
This clinical perspective addresses the practical aspects of the decision to implant an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden death in patients with symptomatic heart failure and reduced left ventricular ejection fraction, based on a distillation of recent trial experience. Potentially eligible patients are selected on the basis of left ventricular ejection fraction < 30% to 35% and anticipated survival with good functional capacity beyond 1 year. Communication with these patients focuses on a horizon of 5 years, during which for every 100 patients receiving devices, approximately 30 patients are predicted to die with or without an ICD, while 7 to 8 lives may be saved with the ICD. These estimates are presented in the context of adverse events, including unnecessary shocks, and the possibility that circumstances may arise for which the defibrillator may be inactivated to allow natural death.
Explore the source record for details and available documents.
UNLABELLED: Approximately 50% of patients hospitalized for heart failure have preserved systolic function. These patients are more likely to be older, women, and hypertensive. Their duration of hospitalization is similar to that of heart failure patients with systolic dysfunction, but their in-hospital mortality risk is lower. This mortality risk is increased in the setting of renal insufficiency, and the two most important risk predictors are elevated blood urea nitrogen and systolic blood pressure < or = 125 mm Hg. Medical treatment strategies for patients with preserved systolic function are inconsistent and reflect the need for efficacious evidence-based treatment regimens. OBJECTIVES: The aims of this analysis were to describe the clinical characteristics, management, and outcomes of patients hospitalized for acute decompensated heart failure (HF) with preserved systolic function (PSF). BACKGROUND: Clinically meaningful characteristics of these patients have not been fully studied in a large database. METHODS: Data from >100,000 hospitalizations from the Acute Decompensated Heart Failure National Registry (ADHERE) database were analyzed. RESULTS: Heart failure with PSF was present in 50.4% of patients with in-hospital assessment of left ventricular function. When compared with patients with systolic dysfunction, patients with PSF were more likely to be older, women, and hypertensive and less likely to have had a prior myocardial infarction or be receiving an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker. In-hospital mortality was lower in patients with PSF compared with patients with systolic dysfunction (2.8% vs. 3.9%; adjusted odds ratio [OR]: 0.86; p = 0.005), but duration of intensive care unit stay and total hospital length of stay were similar. Serum creatinine >2 mg/dl was associated with increased in-hospital mortality in both systolic function groups (PSF: 4.8%; systolic dysfunction: 8.4%; p < 0.0001), and the most powerful predictors of in-hospital mortality in both groups were blood urea nitrogen >37 mg/dl (OR: 2.53; 95% confidence interval [CI]: 2.22 to 2.87) and systolic blood pressure < or =125 mm Hg (OR: 2.58; 95% CI: 2.33 to 2.86). CONCLUSIONS: Heart failure with PSF is common and is characterized by a unique patient profile. Event rates are worrisome and reflect a need for more effective management strategies.
Explore the source record for details and available documents.
Advanced heart failure (HF) is associated with frequent hospitalizations, poor quality of life, and increased mortality. Despite optimal medical management, readmission rates remain high and account for approximately two thirds of all costs related to HF management. Evaluation of patients with HF is critical for the appropriate selection and monitoring of therapy as well as for the prevention of recurrent hospitalizations. This evaluation can be complex and relies on integration of the bedside evaluation and information available from invasive and other noninvasive diagnostic techniques. The clinical examination remains the cornerstone of HF evaluation. Key features of the history and physical examination can be used to assign hemodynamic profiles based on the absence or presence of congestion and adequacy of perfusion. These hemodynamic profiles provide prognostic information and may be used to guide therapy. Direct measurement of hemodynamics may be helpful in patients in whom the physical examination is limited or discordant with symptoms. Although the pulmonary artery catheter (PAC) is not recommended during routine therapy of patients hospitalized with HF, it is reasonable to consider the use of PAC monitoring to adjust therapy in patients who demonstrate recurrent or refractory symptoms despite ongoing standard therapy adjusted according to clinical assessment. This is particularly relevant in centers with experience in hemodynamic monitoring for HF. B-type natriuretic peptide (BNP) testing has been shown to facilitate diagnosis of the etiology of dyspnea in the urgent setting for patients without a prior diagnosis of HF. Furthermore, BNP levels provide important prognostic information in patients with chronic HF, but serial BNP testing has not been validated as a guide to inpatient or outpatient management. Echocardiographic assessment can provide prognostic information about ventricular function and size as well as information about hemodynamic status. Development of validated and reproducible noninvasive techniques to monitor patients with acute HF will be an important step in maximizing interventions to improve outcomes in this patient population.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Advanced heart failure has been defined as persistent symptoms (NYHA class III-IV) that limit daily life despite routine therapy with agents of known benefit. Although these symptoms can occur both with low and preserved ejection fraction, the majority of reported experience is with low ejection fraction, usually <25%. For this population with expected one year mortality of 30-50%, over twice the mortality of the landmark trials of medical therapy, there is little trial data to guide management, which is based largely on collected experience. Once the disease has progressed to this stage, therapy focuses upon the twin goals of symptom relief and prolongation of survival and is guided according to the hemodynamic profiles defined by clinical assessment. As symptoms at this stage relate largely to the congestion, therapy is targeted to reduction of elevated pulmonary venous and/or systemic venous pressures to near normal levels. The most common obstacle to relief of congestion is the increasingly recognized cardio-renal syndrome, for which both understanding and therapy are currently limited. Design of the outpatient regimen for advanced heart failure must be tailored to the individual patient. Many patients with advanced heart failure cannot tolerate "target" doses of neurohormonal antagonists, and spironolactone should be used only when clinical and renal function are sufficiently stable and frequently monitored in order to avoid life-threatening hyperkalemia. The clinical benefit of bi-ventricular pacing is substantial for the small proportion of patients likely to benefit. The vast majority of patients will never be eligible for cardiac transplantation or ventricular assist devices. To derive maximal benefit from all available therapies, heart failure disease management with collaboration of physicians and specialized nurses offers the greatest benefit to the greatest number of patients with advanced heart failure.
PURPOSE OF REVIEW: Angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers and aldosterone antagonists have all been shown to decrease the morbidity and mortality related to heart failure. The population of patients with a diagnosis of heart failure represents a heterogeneous group, ranging from asymptomatic left ventricular dysfunction to chronic decompensation with advanced heart failure; and the clinical roles of these agents can vary within this diverse heart failure population. This article will review the recent developments pertaining to renin-angiotensin-aldosterone system modulation therapy and help to clarify some of the relevant issues surrounding the role and relevance of these drugs in the currently established multi-drug regimen of heart failure patients. RECENT FINDINGS: Clinical trials such as OPTIMAAL, VALIANT and EPHESUS have added insight into the role of angiotensin II receptor blockers and aldosterone in the post-myocardial infarct heart failure patient. The CHARM series has provided new information into the role of angiotensin II receptor blocker therapy in patients who are angiotensin-converting enzyme intolerant and those with heart failure and normal ejection fraction. In addition further data is now available about the benefits and risks when considering a strategy of either angiotensin-converting enzyme plus angiotensin II receptor blocker or angiotensin-converting enzyme plus aldactone in chronic heart failure patients. SUMMARY: Important recent clinical trials have helped to add insight on the role of renin-angiotensin-aldosterone system in heart failure. Choosing between a class of drug or particular strategy depends on knowledge of the patient populations studied in clinical trials as well as the inherent risks involved.
BACKGROUND: Left ventricular assist devices (LVADs) have improved survival in patients with end-stage heart failure. Compared with previous trials, the Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure (REMATCH) trial enrolled patients with more advanced heart failure and high prevalence of intravenous inotropic therapy. This study analyzes, on a post hoc basis, outcomes in patients undergoing inotropic infusions at randomization. METHODS AND RESULTS: Of 129 patients randomized, 91 were receiving intravenous inotropic therapy at randomization to LVAD or optimal medical management (OMM). Mean systolic pressure was 100 versus 107 mm Hg in those not receiving inotropes, serum sodium was 134 versus 137 mEq/L, and left ventricular ejection fraction was 17% for both groups. LVADs improved survival throughout follow-up for patients undergoing baseline inotropic infusions (P=0.0014); for the LVAD group versus the OMM group, respectively, 6-month survival was 60% versus 39%, 1-year survival rates were 49% versus 24%, and 2-year survival rates were 28% versus 11%. For 38 patients not undergoing inotropic infusions, 6-month survival was 61% for those with LVADs and 67% for those with OMM, whereas 1-year rates were 57% and 40%, respectively (P=0.55). Quality-of-life scores for survivors improved. Median days out of hospital for patients on inotropic therapy at randomization were 255 with LVAD and 105 with OMM. CONCLUSIONS: Despite severe compromise, patients undergoing inotropic infusions at randomization derived major LVAD survival benefit with improved quality of life. Patients not undergoing inotropic infusions had higher survival rates both with and without LVAD, but differences did not reach significance. Future studies should prespecify analyses of inotropic and other therapies to determine how disease severity and parallel medical treatment influence the benefits offered by mechanical circulatory support.
OBJECTIVES: We sought to characterize decisions regarding listing of heart transplant candidates and to determine the impact of delayed listing for a transplant on survival. BACKGROUND: Evaluation and listing for heart transplantation have evolved over the past decade, with the complex decision process often extending beyond the time of initial review. Little is known about the current impact of decisions and timing of listing on outcomes. METHODS: Decisions were prospectively recorded during the initial committee discussions regarding patients referred for heart transplant evaluation. Survival and transplantation rates were assessed. RESULTS: A total of 214 patients were evaluated for heart transplantation (age 49 +/- 11 years, ejection fraction 21 +/- 9%, New York Heart Association class III +/- I, peak oxygen consumption 13 +/- 4 ml/kg/min). At the initial evaluation, 44% of patients were deemed eligible, 25% were potentially eligible, 19% were ineligible, and 12% were deferred. For eligible patients, 37% of patients were listed within 10 days of evaluation, and a total of 71% of patients were ever listed. Regardless of transplantation, the three-year survival rate in eligible patients not listed early was similar to that in patients listed immediately (85% vs. 77%, p = 0.34). Ineligible and potentially eligible patients had a higher three-year mortality rate than did eligible patients if transplantation occurred (51% vs. 17%, p < 0.001) or not (57% vs. 19%, p = 0.04). CONCLUSIONS: Using current accepted guidelines, many patients referred for transplant evaluation were not considered eligible for transplantation, and those who were eligible were not often listed immediately. Eligible patients not listed initially did well in the long term, and patients with relative contraindications had worse outcomes with or without a transplant.
OBJECTIVES: The goal of this study was to determine the prevalence of worsening renal function (WRF) among hospitalized heart failure (HF) patients, clinical predictors of WRF, and hospital outcomes associated with WRF. BACKGROUND: Impaired renal function is associated with poor outcomes among chronic HF patients. METHODS: Chart reviews were performed on 1,004 consecutive patients admitted for a primary diagnosis of HF from 11 geographically diverse hospitals. Cox regression model analysis was used to identify independent predictors for WRF, defined as a rise in serum creatinine of >0.3 mg/dl (26.5 micromol/l). Bivariate analysis was used to determine associations of development of WRF with outcomes (in-hospital death, in-hospital complications, and length of stay). RESULTS: Among 1,004 HF patients studied, WRF developed in 27%. In the majority of cases, WRF occurred within three days of admission. History of HF or diabetes mellitus, admission creatinine > or =1.5 mg/dl (132.6 micromol/l), and systolic blood pressure >160 mm Hg were independently associated with higher risk of WRF. A point score based on these characteristics and their relative risk ratios predicted those at risk for WRF. Hospital deaths (adjusted risk ratio [ARR] 7.5; 95% confidence intervals [CI] 2.9, 19.3), complications (ARR 2.1; CI 1.5, 3.0), and length of hospitalizations >10 days (ARR 3.2, CI 2.2, 4.9) were greater among patients with WRF. CONCLUSIONS: Worsening renal function occurs frequently among hospitalized HF patients and is associated with significantly worse outcomes. Clinical characteristics available at hospital admission can be used to identify patients at increased risk for developing WRF.