CardioMEMS HF System

2017

Synergistic Impact with Guideline-Directed Medical Therapy

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

2017

First 2000 Commercial Implants

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

2017

Real-World Economic Impact

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

2019

Propensity-Matched Cohort Outcomes

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

2020

MEMS-HF European Study

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

2020

US Post-Approval Study

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

GUIDE-HF Randomized

Lindenfeld et al.

Results from the randomized arm of the GUIDE-HF trial included 1,000 patients to evaluate the effect of the CardioMEMS HF System on a composite primary endpoint including heart failure hospitalization, all-cause mortality, and urgent HF visits. There was a significant 19% reduction in the primary endpoint in the pre-COVID analysis driven by a 28% reduction in HF hospitalizations. GUIDE-HF results reaffirm all previous studies and demonstrate a benefit in earlier and less severe stages of heart failure.¹

Key Highlights

• Clinical benefit seen in NYHA Class II & III patients
• Similar benefit seen in patients enrolled with a previous HFH or elevated BNP alone
• GUIDE-HF results led to expanded FDA indication for the CardioMEMS HF System

2023

Meta-Analysis of HFrEF Patients in CHAMPION,GUIDE-HF, and LAPTOP-HF

Lindenfeld et al.

This patient-level meta-analysis includes 1,350 HFrEF patients from CHAMPION, GUIDE-HF, and LAPTOP-HF studies to assess the impact on heart failure hospitalizations over 12 months, and survival over the full follow-up across trials. This combined patient population confirmed previous findings of decreased heart failure hospitalizations and improved survival with the use of devices such as the CardioMEMS HF System.¹⁰

Key Clinical Highlights

• Significantly improved survival over control in HFrEF patients at 24 months
• 36% decrease in heart failure hospitalizations at 12 months
• First ever meta-analysis to demonstrate a significant improvement for HFrEF patients managed hemodynamically