Treatment goals for heart failure (HF) must shift from a focus on prevention of repeated hospitalizations to address patients earlier, before they reach inpatient care, a newly published study concludes. The authors’ real-world data analysis of 103,138 subjects found that "the relative proportion of [worsening heart failure [WHF] events occurring outside a hospitalized setting is increasing and driving the underlying growth in HF-related morbidity." The findings were published Monday online with authors led by Kaiser Permanente's Andrew P. Ambrosy, MD, ahead of the July 12 edition of the Journal of the American College of Cardiology. Treatment focus shift is long time coming More than 1 million hospitalizations are attributed to WHF every year in the U.S., accounting for 6.5 million hospital days and the majority of the $40 billion annually spent on HF-related care, the researchers said. In a bid to reduce 30-day readmissions, the Affordable Care Act (ACA) launched the Hospital Readmission Reduction Program in 2012, including a financial penalty for hospitals with higher than predicted risk-adjusted 30-day readmission rates for major conditions, including HF. The policy saw a modest readmission rate reduction but came with the "unintended consequence" of shifting some HF-related care to the outpatient setting, the researchers said, spotlighting hospitalization as a surrogate for acuity. Nearly all HF therapies now mention hospitalization reduction in their primary endpoint, editorialists stressed in an accompanying dossier. Recent data suggest that adjudicating episodes of WHF in ambulatory patients would increase the overall event rate by as much as 30%. "Thus, there is a growing interest in the field to disentangle WHF from location of care and move away from using hospitalization as a surrogate for acute decompensated HF. However, little is known about the contemporary epidemiology of outpatient WHF," the researchers said. Study design The current study was, therefore, set up to describe the incidence of WHF events across the care continuum from ambulatory encounters to hospitalizations. The researchers studied 10 calendar-year cohorts (from 2010 to 2019) of adults with diagnosed HF within Kaiser Permanente Northern California (KPNC) – a large, integrated health-care delivery system with 21 hospitals and more than 260 freestanding clinics. HF diagnosis was defined as being previously hospitalized with a principal discharge diagnosis of HF and/or having three or more ambulatory visits coded for HF based on International Classification of Diseases, Ninth Revision. Clinical encounters included all hospitalizations, emergency department visits – including observation stays – and outpatient encounters including urgent care visits or clinical appointments with a primary care provider or a cardiologist. Episodes of WHF were identified using previously validated machine-learning-based natural language processing (NLP) algorithms to parse relevant unstructured documentation in the electronic health record occurring within 72 hours of each qualifying encounter, ascertaining "symptoms" and "signs." WHF was defined as one or more symptomatic and two or more objective findings, including one or more signs of a need for augmented therapy and one or more changes in therapy. The 103,138-patient cohort's mean age was 73.6 years, 47.5% were women, the majority (63.5%) were white, and mean left ventricular ejection fraction (LVEF) was 51.4%. Antihypertensive drugs were used by the vast majority (90.7%), while 73.8% used beta-blockers, 69.4% used diuretic agents, 67.2% used statins, and 66.6% used angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB)/angiotensin-neprilysin inhibitor (ARNI) medications. Patients with end-stage kidney disease, stage D HF and those with less than 6 months of health plan membership before the index date were excluded. Findings There were 1,136,750 unique WHF encounters, including 743,039 (65.4%) outpatient encounters, 224,670 (19.8%) emergency department visits/observation stays, and 169,041 (14.9%) hospitalizations. A total 126,008 WHF episodes were identified, including 34,758 (27.6%) outpatient encounters, 28,301 (22.5%) emergency department visits/observation stays, and 62,949 (50%) hospitalizations. These findings were similar among the subgroups of HF patients with reduced, midrange, preserved, and unknown LVEF. In the 34,758 outpatient WHF encounters, the criterion for changes in HF-related therapy was met through new administration of intravenous loop diuretic agents in 1.8%, new initiation of oral loop or combination diuretic therapy based on pharmacy dispensing data in 18.3%, through doubling (i.e., 100% increase) of oral loop diuretic agents based on pharmacy dispensing data in 4.6%, and through note-based provider documentation of new initiation and/or any augmentation of oral diuretic agents in 75.3%. During the 10-year study period, the annual incidence of WHF (measured as events per 100 person-years) rose from 25 to 33, "primarily caused by outpatient encounters," which grew on a steady basis from 6.7 events to 9.7, and emergency department visits/observation stays, growing from 4 to 6.8. The rise in annual incidence of outpatient WHF was consistent across all LVEF categories. "This underscores the growing importance of outpatient WHF events to appreciating the patient journey (P value < 0.05 for trend)," said the researchers. The 30-day risk of WHF episodes was 8.2% for outpatients, 10.6% for emergency department/observation patients and 12.4% for hospitalized patients. Point of care 'not necessarily' reliable WHF substitute The study's findings suggest that emergency department visits with an associated diagnosis code for HF, while an indicator for overall level of health-care utilization, are "not necessarily a reliable surrogate for WHF," the researchers said. "This has implications for formulating public policy and conducting prospective studies based on [emergency department]-related outcomes." They continued: "Applying validated NLP-based algorithms to structured and unstructured [electronic health record] data is technically feasible and highly accurate for detecting WHF events across the entire spectrum of care settings. "In fact, [emergency department] visits/observation stays and outpatient encounters made up approximately one-half the episodes of WHF, and the relative proportion of WHF events occurring outside a hospitalized setting is increasing and driving the underlying growth in HF-related morbidity." The researchers also stressed that although only approximately 5% of outpatient encounters with an associated diagnosis code for HF met the prespecified diagnostic criteria for an episode of WHF, "given the sheer absolute number of ambulatory visits, this cumulatively accounted for more than one-quarter of WHF events." They concluded by calling for future patient-oriented research to incorporate composite outcome measures which include WHF events across the care continuum. In an accompanying editorial, James L. Januzzi Jr., MD, from Massachusetts General Hospital, Harvard Medical School, and the Baim Institute for Clinical Research, Boston; and Javed Butler, MD, MPH, MBA, from Baylor Scott and White Health, Dallas, and the University of Mississippi, stressed that "now is the time to consider how to manage – or prevent – worsening HF." They called for the immediate institution of therapies that are already proven to reduce the risk of HF disease progression. "This is an all-hands-on-deck moment: education, utilization of clinician and patient-facing tools, care prompts within the electronic health record to trigger better GDMT [guideline-directed medical therapy] adherence, or even establishment of 'GDMT clinics' are all important steps to rapidly institute quality HF care and are the best chance to keep our patients stable early in their journey, preserve health status, and to reduce the risk of later disease progression," they concluded. Sources: Ambrosy AP, Parikh RV, Sung SH, et al. Analysis of Worsening Heart Failure Events in an Integrated Health Care System. J Am Coll Cardiol 2022;80:111-122. Januzzi JL, Bitler J. The Importance of Worsening Heart Failure: Hiding in Plain Sight. J Am Coll Cardiol 2022;80:123-125. Image Credit: blacksalmon – stock.adobe.com