Heart failure (HF) is a chronic syndrome whereby the heart is unable to effectively pump blood—and therefore oxygen—throughout the body. This impairment causes a domino effect in the body’s renin-angiotensin system that signals the kidneys to retain sodium and water, a condition known as congestion. Congestion can cause symptoms ranging in severity from problematic weight gain and swelling to severe fatigue and respiratory difficulties.

HF affects approximately 6.5 million adults in the United States with approximately 1 to 2 million new cases identified, and 75,000 attributable deaths, annually.*, †

The number of HF cases in the United States is expected to grow to over 8 million by 2030.*

Managing congestion in heart failure.

Congestion often is managed with a class of drugs called diuretics that work by helping the kidney remove excess salt and water. Many patients are able to manage their congestion symptoms through use of oral diuretics taken daily at home. Even with regular adherence to oral diuretics, some patients experience fluid overload and may require intravenous diuretic treatment in the hospital setting.

Drowning in fluid

Drowning in Fluid

The role of congestion in heartfailure

The Problem

Congestion

is recognized as a defining symptom of heart failure (HF). Fluid overload is a major triggerfor medical attention, often resulting in escalating symptoms (e.g., shortness of breath, fatigue, edema, and weight gain) that lead to hospitalization.

stethoscope stethoscope
6.5M

U.S adults are diagnosed with HF1

70%

of patients with worsening HF experience edema and shortness of breath2

59%

of HF admissions are directly attributed to volume overload3

Current Therapies

Are diuretics keeping your patients' heads above water?

While oral diuretics are a mainstay in the treatment and prevention of fluid overload in HF patients, there is a critical need to develop new diuretic treatment therapies that intervene in the worsening heart failure cycle.

heart
flow diagram flow diagram

Oral Diuretics

Oral diuretics are used by HF patients to maintain normal fluid status. When fluid accumulates, oral doses are increased, but their efficacy and bioavailability can be variable and unpredictable.4,5

When the absorption of oral diluretics proves to be insufficinent, patients must be administered IV diuretics.

Intravenous Loop Diuretics

IV diuretics typically administered in an expensive and inconvenient acute care setting. Hospitalization puts patients at an increased risk for morbidity and mortality.

Hospitalizations

From bad to worse.

In worsening heart failure, fluid overload/sodium retention is one of the most common triggers of hospital admissions in patients over 65.

3.8M

heart failure events in the US annually7

1 to 2M

hospitalizationsin the U.S annually1,8

800,000

patients with symptomatic HF admitted by an emergency physician annually.9

Up to 50%

admissions may be unneccessary9

Back again. And again

Patients hospitalized for decompensated heart are often discharged and transitioned back to oral diuretic before their fluids return to baseline levels. Presence of congestion at discharge was associated with an increased risk of 30-day all-cause mortality and hospitalization for heart failure.10

30 to 50%

of patients discharged with residual congestion11,12,13

25%

of patients readmitted within 30 days of discharge14

10%

mortality rate within 30 days of hospitalization for HF1

The need

A new model for treatment.

New outpatient alternatives are needed to address increased congestion when oral treatment fails and to reduce the need for the cycle of re-hospitalization.

Outpatient Parenteral Antimicrobial Treatment (OPAT)

The ongoing challenges with OPAT.

Outpatient parenteral antimicrobial therapy (OPAT), first introduced in 1977, is a patient management strategy whereby intravenous antibiotics are administered via a long-term intravenous catheter when hospitalization is unnecessary. This is done with the goal of improving the patient experience while reducing healthcare costs. As such, OPAT is a dominant component of home infusion services.

Today, antibiotics account for 132 million OPAT doses and are expected to see an 8.8% compounded annual growth rate from 2016 to 20233, 4

OPAT is predominantly administered intravenously via a peripherally inserted central catheter (PICC or PICC line), which must remain in place over several days or weeks. Although effective, this approach requires extensive coordination of care and can result in multiple medical complications including PICC line site infections, bloodstream infections, PICC line occlusions and blood clots, that may require unscheduled ER and medical visits.5, 6, 7

Outpatient infusion services require labor-intensive coordination, professionally trained medical personnel and significant associated resources. Additionally, home infusion of OPAT is not covered for most Medicare patients, so these services can be cost prohibitive and logistically problematic. As a result, Medicare patients that require OPAT are often dependent on infusion centers, clinics, or nursing homes for care.

3 132 million doses calculated based on IMS 2015 and AMR 2017 data sets.

4
https://www.globenewswire.com/news-release/2016/05/23/842296/0/en/Home-Infusion-Therapy-Market-size-worth-26-3-Billion-by-2023-Global-Market-Insights-Inc.html

5 Shrestha NK et al. Open Forum Infectious Diseases 1, S214-S214, 2014.

6 Shrestha NK et al. Antimicrob Chemother 73, 1972-1977, 2018.

7 Norris AH et al. Clinical Infectious Diseases 68, e1-e35, 2018.

*Varini, Heart Disease and Stroke Statistics 2020 (v0.1).
†Agarwal SK et al. American Journal of Epidemiology183(5):462-470, 2016.