Lindenfeld et al.
This is the largest prospective trial. Designed to evaluate heart failure hospitalizations, mortality, quality of life, and functional capacity. The goal is to expand device indication to include NYHA Class II-IV, and patients with elevated BNP/NT-proBNP levels or prior heart failure hospitalization.1
Learn more about this trial at
www.guidehf.com.
Shavelle et al.
Prospective single-arm trial including 1,200 patients. At one year, results showed a reduction in pulmonary artery pressures and a 57% reduction in HFH regardless of ejection fraction. To date, trial exceeded the predefined 2-year safety endpoints and demonstrated excellent patient data transmission.2
Angermann et al.
First prospective multicenter CardioMEMS HF System study from Europe including 234 patients. Findings are consistent with previous studies confirming reduction in PA pressures, HFH, and improved patient-reported quality of life. The study met all safety endpoints and showed a reduction in pulmonary artery pressures with 62% reduction in heart failure hospitalizations (HFH).3
Abraham et al.
A retrospective study of 2,174 patients utilizing a Medicare beneficiary claims database for propensity matching. At one year, there was a 24% reduction in HFH with a 30% reduction in mortality.4
Desai et al.
Retrospective real-world study including 1,114 patients from a Medicare database. At one year, there was a 34% reduction in HFH and a $13,190 reduction in heart failure hospitalization costs per patient-year.5
Heywood et al.
Large retrospective real-world study including the first 2,000 consecutive implants following commercialization. Results showed a reduction in PAP regardless of EF and that patients consistently transmitted data. These results were consistent with findings from the pivotal trial.6
Givertz et al.
A CHAMPION trial subgroup analysis of patients with reduced ejection fraction. This analysis established benefit with the combination of guideline-directed medical therapy (GDMT) and CardioMEMS HF System remote hemodynamic monitoring. Patients on “optimal” therapy tolerating an ACEi/ARB/ARNi and BB had a 43% reduction in HFH with a 57% reduction in mortality per patient-year. Patients on “partial” therapy able to tolerate at least one ACEi/ARB and/or BB had a 33% reduction in HFH with a 37% reduction in mortality per patient-year.7
Adamson et al.
A CHAMPION trial subgroup analysis of 119 patients with preserved ejection fraction (>= 40%). At 6 months, heart failure hospitalizations were 46% lower in the treatment cohort when compared with the control. This is the first study to demonstrate the CardioMEMS™ HF System as the ONLY proven solution for HFpEF patients.8
Abraham et al.
Pivotal randomized prospective trial including 550 patients. Results showed a 33% annualized reduction in HFH regardless of ejection fraction.9
Study | N | Reduce HFH | Reduce PAP | Increase Survival | HFpEF Benefit | Increase QoL | Safety | Adherence | Med changes |
---|---|---|---|---|---|---|---|---|---|
CHAMPION Pivotal Study 2016. Pivotal, Prospective Study - Abraham | N=550 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Real-world Study 2017. Retrospective - Heywood | N=2000 | ✓ | ✓ | ✓ | |||||
Economic Impact 2017. Retrospective - Desai | N=1114 | ✓ | |||||||
Optimizing GDMT 2017. Retrospective, CHAMPION Subgroup - Givertz | N-=456 | ✓ | ✓ | ✓ | |||||
Propensity-Matched Cohort 2019. Retrospective - J. Abraham | N=2174 | ✓ | ✓ | ||||||
US Post-Approval Study 2020. Prospective - ;Shavelle | N=1200 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
MEMS-HF 2019. Prospective, multi-center, EU - Angermann | N=234 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Proven Management in HFpEF Patients - Adamson | N=119 | ✓ | ✓ | ✓ |
* Unpublished
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