HEART FAILURE (HF)
SYSTEM
For pulmonary artery pressure monitoring
PROVEN IN A VARIETY OF CLINICAL STUDIES
STUDY DATA | DESIGN | N | HF HOSPITALIZATION | PA PRESSURE | HFpEF | SAFETY | QOL | ADHERENCE | NYHA CLASSIII | ELEVATED BNP1,* | NYHA CLASS II1,* |
---|---|---|---|---|---|---|---|---|---|---|---|
CHAMPION Pivotal Study2 WT Abraham | RCT | 550 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |||
Proven Benefits in HFpEF Patients3 Adamson | RCT Subgroup | 119 | ✔ | ✔ | ✔ | ✔ | |||||
Synergistic Impact With GDMT4 Givertz | Retrospective | 456 | ✔ | ✔ | |||||||
First 2,000 Commercial Implants5 Heywood | Retrospective | 2,000 | ✔ | ✔ | ✔ | ✔ | |||||
Economic Impact6 Desai | Retrospective Database | 1,114 | ✔ | ✔ | |||||||
Propensity-matched Outcomes7 J Abraham | Retrospective Database | 2,174 | ✔ | ✔ | |||||||
MEMS-HF European Study8 Angermann | Single-arm | 234 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ||
U.S. Post-approval Study9 Shavelle | Single-arm | 1,200 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |||
GUIDE-HF Study10 Lindenfeld | RCT | 1,000 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |
COAST UK Cowie | Single-arm | 100 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | |||
Monitor-HF Brugts | RCT | 348 | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
PROVEN STUDIES
The CardioMEMS HF System has shown proven benefits in a variety of clinical studies including four prospective trials studying more than 3,000 people2,8-10 and four large retrospective studies of more than 5,000 patients.5-7,12
Regardless of trial design, the CardioMEMS HF System has demonstrated significant clinical benefits in over 8,000 heart failure patients.3,5-8,10-12
TV
TV
- Setoguchi S, et al. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007;154(2):260-266.
- Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized controlled trial. The Lancet. 2011;377(9766):658-666.
- Adamson PB. Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: new insights from continuous monitoring devices. Current Heart Failure Reports. 2009;6:287-292.
- Givertz MM, Stevenson LW, Costanzo MR, et al., on behalf of the CHAMPION Trial Investigators. Pulmonary artery pressure–guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2017;70:1875-86.
- Heywood JT, Jermyn R, Shavelle D, et al. Impact of practice-based management of PA pressures in 2000 patients implanted with the CardioMEMS sensor. Circulation. 2017; 135: 1509–17.
- Desai AS, et al. Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in “Real-World” Clinical Practice. J Am Coll Cardiol. 2017; 69(19):2357–65.
- Abraham J, et al. Association of Ambulatory Hemodynamic Monitoring with Clinical Outcomes in a Concurrent Matched Cohort Analysis. JAMA Cardiology. 2019;4(6):556-563.
- Angermann C, AßmusB, et al. Pulmonary-Artery-Pressure-Guided Therapy in Ambulatory Patients with Symptomatic Heart Failure: The CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF). European J of Heart Failure. 2020. 10.1002/ejhf.1943.
- Shavelle D, Desai A, Abraham W, et al. Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure. Circulation: Heart Failure. Published online 2020. doi.org/10.1161/CIRCHEARTFAILURE.119.006863.
- Lindenfeld J, Zile MR, Desai AS, et al. Hemodynamic-guided management of heart failure (GUIDE-HF): a randomized controlled trial. The Lancet 2021;398:991-1001
- Cook, C. et al. The annual global economic burden of heart failure. Int J Cardiol 171, 368-375 (2014)
- Brugts, J et al. Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. The Lancet. May 20, 2023. doi.org/10.1016/S0140-6736(23)00923-6.