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Lower Rates of HF and All-Cause Hospitalizations During PAP-Guided Therapy for Ambulatory HF
Quick Takes
- Efficacy of pulmonary artery pressure (PAP) guided therapy in the year following sensor implantation was demonstrated in the reduction of heart failure (HF) and all-cause hospitalizations in patients with New York Heart Association (NYHA) Class III HF.
- Adding to the CHAMPION trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients), benefits extended across subgroups of race, sex, ejection fraction, and other HF characteristics.
- Benefits and safety were demonstrated in academic and non-academic medical settings, making the findings generalizable to routine clinical practice.
Study Questions:
At 1 year after pulmonary artery sensor implantation, is PAP-guided therapy effective at reducing hospitalizations in patients with NYHA Class III HF, and is it safe?
Methods:
Multiple centers (104 hospitals, 35% of which were academic medical centers) participated in this prospective, open-label, single-arm study of 1,200 patients with NYHA Class III HF who received CardioMEMS (Abbott Laboratories; Abbott Park, IL) PAP sensor implants. Criteria for implantation were a prior HF hospitalization within 12 months and, if HF with reduced ejection fraction, taking beta-blocker for 3 months and angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for 1 month (as recommended by HF therapy guidelines). The primary efficacy outcome was number of HF hospitalizations in 12 months post-transplant (with PAP-guided therapy) compared to pre-implant HF hospitalizations in previous 12 months (usual care). The primary safety outcomes were freedom from device-related complications and pressure sensor failure at 2 years.
Results:
The rate of HF hospitalization was significantly lower at 1 year post-implant compared with the 12 months prior to implantation (0.54 vs. 1.25 events/patient-years; 58% reduction), and the rate of all-cause hospitalizations was also significantly lower 12 months after implantation (1.67 vs. 2.28 events/patient-years; 28% reduction). HF hospitalization reduction was greatest in patients with preserved ejection fraction (>50%) and observed across subgroups for race, sex, and other HF population characteristics. Mean PAP declined over the post-implant year, with the greatest declines observed in patients with the highest baseline mean PAP. Freedom from device- or system-related complications was 99.6% (5 complications); freedom from pressure senor failure was 99.9% (1 failure). Patient compliance with daily and weekly PAP transmissions was 85% and 100%, respectively.
Conclusions:
PAP-guided therapy for patients with NYHA Class III HF reduced PAP and hospitalizations for HF and all causes, in a variety of clinical settings, and regardless of ejection fraction, sex, race, device support, or cardiomyopathy. Rates of adverse events were very low, and patient compliance with regular transmission of PAP data was relatively high.
Perspective:
Three million patients are hospitalized annually in the United States with primary or secondary diagnoses of HF despite advances in therapy. This study demonstrates the beneficial effects of PAP-guided therapy in reducing HF hospitalization with minimal adverse effects, which is consistent with the pivotal CHAMPION trial. This study adds to the CHAMPION trial findings by demonstrating efficacy across race, sex, and ejection fraction status and safety in employing the technology and strategy in routine clinical practice settings.
Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure
Keywords: Heart Failure, Hospitalization, Pulmonary Artery, Stroke Volume, Angiotensin-Converting Enzyme Inhibitors, Adrenergic beta-Antagonists, Angiotensin Receptor Antagonists
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