Heart Failure: Data wanted on Effective Management Strategies for Patients with HF and PSF

August 20, 2007 By Grendel Burrell [mailto:grendel.burrell@gmail.com]

A large percentage of patients with heart failure (HF) have preserved systolic function. Discard the conventional wisdom that these patients do better after hospital discharge. They don’t. Data from OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) reveal a high prevalence of HF with preserved systolic function (PSF) and demonstrate equally high rates of rehospitalization and post discharge mortality as patients with HF and left ventricular systolic dysfunction (LVSD). Heart failure with PSF is not a disease that is well understood but is very common. The objective of this analysis of the OPTIMIZE-HF database was to evaluate the characteristics, treatments, and outcomes of patients with both preserved and reduced systolic function heart failure.

OTPIMIZE-HF was a registry designed to improve the medical care and education of hospitalized patients with heart failure and to accelerate the initiation of evidence-based heart failure guideline-recommended therapies by initiating them before hospital discharge. It was designed to evaluate the demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients hospitalized with heart failure. GlaxoSmithKline sponsored this Phase IV study. At least four other publications have resulted from this initiative (1-4), and these add to the growing body of knowledge about the characteristics and management of patients with heart failure.

259 hospitals in the United States participated in the OPTIMIZE-HF registry. These hospitals submitted data on 48,612 patients with HF from March 1, 2003, through December 31, 2004, and data on admission, hospital, discharge care, and outcomes were accumulated. In the most recent analysis of OPTIMIZE-HF, describing “Characteristics, Treatments, and Outcomes of Patients With Preserved Systolic Function Hospitalized for Heart Failure”, published online August 6, 2007, 20,118 patients with left ventricular systolic dysfunction (LVSD) were compared to the 21,149 patients with PSF (left ventricular ejection fraction [EF] ≥40%). Additional analyses were also performed for the comparison between the preserved and reduced systolic function groups, by defining PSF as EF > 50% (J Am Coll Cardiol, 2007; 50:768-777, doi:10.1016/j.jacc.2007.04.064 (Published online 6 August 2007)).

The elderly, women, and Caucasians were more likely to have a nonischemic etiology for their HF and to have PSF (≥ EF 40%). Length of hospital stay was the same in both PSF and LVSF groups, but the risk of in-hospital mortality was lower in patients with PSF (≥ EF 40%) (2.9% vs. 3.9%; p < 0.0001). In the follow up period, 60- to 90-day post-discharge, patients with PSF (≥ EF 40%) had a similar mortality risk (9.5% vs. 9.8%; p = 0.459). Rates of rehospitalization (29.2% vs. 29.9%; p =0.591) were essentially the same when patients with PSF were compared with patients with LVSD. When PSF defined as EF >50% the findings were comparable.

The ACC/AHA Clinical Performance Measures for Adults With Chronic Heart Failure (5) includes the following heart failure inpatient performance measures: discharge instructions, evaluation of left ventricular systolic function, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for left ventricular systolic dysfunction, adult smoking cessation advice/counseling, and anticoagulant at discharge for patients with atrial fibrillation. These performance measures are similar to those advanced by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in the JCAHO ORYX core measure sets (Joint Commission on Accreditation of Healthcare Organizations. Specifications Manual for National Hospital Quality Measures. 2006. and incorporate elements of diagnosis, patient education, treatment, and self-management).

Three of these performance measures, discharge instructions, smoking cessation counseling, and anticoagulation for atrial fibrillation apply to both heart failure patients with LVSD and those with PSF. However, in this OPTIMIZE-HF study patients with PSF were less likely to have received care in conformity with these measures.

Fonarow et al, in a previously published an analysis of OPTIMIZE-HF, “Association Between Performance Measures and Clinical Outcomes for Patients Hospitalized With Heart Failure” with the purpose of ascertaining the relationship between current American College of Cardiology/ American Heart Association (ACC/AHA) performance measures for patients hospitalized with heart failure and relevant clinical outcomes, found that “Current heart failure performance measures, aside from prescription of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker at discharge, have little relationship to patient mortality and combined mortality/rehospitalization in the first 60 to 90 days after discharge.” (6)

Fonarow told WikiDoc, “Clinical trials data demonstrating that the use of angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and beta blockers reduce mortality exists only for patients with HF and LVSD. The influence on these therapies on survival for patients with PSF remains unclear.”

Using a risk- and propensity-adjusted model, the authors found no significant relationships between 60- to 90-day mortality and rehospitalization rates in patients with PSF and discharge use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker or beta-blocker.

In the United States, there are 5 million individuals in 2003, and 550,000 new cases are reported each year. . Heart failure is the leading cause of hospitalization in persons older than 65 years (7), responsible for almost 3.6 million hospitalizations as the primary or a secondary discharge diagnosis each year. The increased hospitalizations for HF over the past decade are substantially influenced by changes in hospitalization rates in women (8). Estimated direct and indirect costs for heart failure in 2006 in the US are expected to be $29.6 billion. Because heart failure is a substantial cause of morbidity, mortality, and health care expenditures, it is especially important to utilize evidence-based therapies that have been demonstrated to improve clinical outcomes.

The authors of the most recent OPTIMIZE-HF analysis conclude “Despite the burden to patients and health care systems, data are lacking on effective management strategies for patients with HF and PSF.” When asked what he thought should be the next steps in the clinical investigation of patients with HF and PSF, Fonarow replied, “Randomized clinical trials assessing therapies such as aldosterone antagonists, statins, devices, and other potential therapies for patients with heart failure and PSF are urgently needed.”

References:


 * 1) ref1 pmid=17646603


 * 1) ref2 pmid=17643576


 * 1) ref3 pmid=17448416


 * 1) ref4 pmid=17174643


 * 1) ref5 pmid=16168305


 * 1) ref6 pmid=17200476


 * 1) ref7 pmid=11790925


 * 1) ref8 pmid=14691422

Other online references:

http://www.jointcommission.org/PerformanceMeasurement/PerformanceMeasurement/Historical+NHQM+manuals.htm

http://circ.ahajournals.org/cgi/content/short/113/6/e85