Outpatient Worsening Heart Failure as a Target for Therapy

Abstract

As the public health and economic burdens of heart failure continue to grow, recognizing the entity of outpatient WHF is critical. Efforts to reduce heart failure hospitalization should include developing effective therapies and care strategies for outpatient WHF. The outpatient WHF population represents a major opportunity for therapeutic advancements that could fundamentally change heart failure care delivery.

Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes

“…Consistent with evolving practice in HF clinical trials and accumulating data suggesting similarly poor prognosis for worsening HF patients in the inpatient and outpatient care settings, we suggest CV outcome trials consider capture of worsening HF events (according to pre-specified criteria) irrespective of the location of care (including ambulatory clinics, urgent care facilities, emergency departments, and hospitals). (58,60–62) Although such a procedure may carry a modest increase in trial cost and complexity, inclusion of the spectrum of worsening HF events may improve power for detecting therapeutic signals and would be congruent with trends among healthcare systems towards increasing emphasis on outpatient management of worsening HF to decrease costs associated with hospitalization. (62,63)…”

“…(58,60–62) Although such a procedure may carry a modest increase in trial cost and complexity, inclusion of the spectrum of worsening HF events may improve power for detecting therapeutic signals and would be congruent with trends among healthcare systems towards increasing emphasis on outpatient management of worsening HF to decrease costs associated with hospitalization. (62,63)…”

Outpatient versus inpatient worsening heart failure: distinguishing biology and risk from location of care

“…Only a minority of WHF patients experience rapid and severe deterioration leading to an immediate emergency department (ED) presentation. 7 By contrast, most experience gradual worsening of signs and symptoms over a more extended period, an observation further supported by invasive monitoring showing gradual increases in filling pressures days to weeks before onset of worsening symptoms and hospital presentation. 14 Likewise, markers of organ injury are not specific to the hospital stay.…”

“…7 Multiple analyses from clinical trial cohorts have found WHF patients treated in the outpatient setting to have subsequent mortality similar to hospitalized populations. 8–10 Importantly, these studies suggest that clinical characteristics, rather than location of care or recentness of hospitalization, are the dominant determinants of risk.…”

Relationship between timing of trial randomization, protocol completion, and clinical outcomes among patients hospitalized for heart failure: from the ASTRONAUT trial

“…These findings are consistent with reports highlighting the subacute nature of many worsening HF episodes and potential influences of non-biologic factors (e.g., country-specific and local healthcare infrastructure/resources, financial incentives, patient preferences) in dictating exact timing or occurrence of HF hospitalization. 9 Nonetheless, noting that NYHA class at randomization was more severe among patients randomized earlier in ASTRONAUT, early in-hospital enrollment may be preferable for trials focused on short-term symptomatic improvement with in-hospital endpoints (e.g., dyspnea relief).…”