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CardioMEMS HF System

Remote Pulmonary Pressure Monitor

CardioMEMS HF System
Clinical Evidence

CardioMEMS Clinical Evidence & Data

The CardioMEMS™ HF System for remote pulmonary pressure monitoring has demonstrated significant clinical benefits in a variety of clinical studies and trial designs in over 8,000 heart failure patients.
 

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Key Outcomes

Supported by Multiple Study Designs

There are a variety of study designs that each come with inherent strengths and limitations. The CardioMEMS HF System for remote pulmonary pressure monitoring has demonstrated significant clinical benefit regardless of study design.

RANDOMIZED CONTROLLED

The “gold standard” of clinical trials. All patients are implanted and followed prospectively. Patients are blinded to group assignment. Treatment is compared to control.

SINGLE-ARM

The patient’s pre-implant history serves as the comparator to what the patient experiences prospectively after implant.

PROPENSITY MATCHED

Retrospective analysis comparing similar baseline patients over the same time period. Those who were not implanted serve as the “control.”

Study Design Randomized Controlled
Study Design Single-Arm
Study Design Propensity Matched

CardioMEMS HF System Data at a Glance

StudyDesignNReduce HFHReduce PAPHFpEF BENEFITSafetyIncrease QoLAdherenceElevated BNP
CHAMPION Pivotal Study4 – AbrahamRCT550✓✓✓✓✓  
Proven Management in HFpEF Patients5 – AdamsonRCT Subgroup119✓✓✓    
First 2000 Commercial Implants8 – HeywoodRetrospective2,000 ✓✓  ✓ 
Propensity-Matched Cohort2 – AbrahamRetrospective Database2,174✓      
MEMS-HF European Study7 – AngermannSingle-arm234✓✓✓✓✓✓ 
US Post-Approval Study6 – ShavelleSingle-arm1,200✓✓✓✓ ✓ 
GUIDE-HF Study1 – LindenfeldRCT1,000✓✓✓✓ ✓✓
GUIDE-HF Single Arm11 – MehraSingle-arm1,001✓✓  ✓ ✓
MONITOR-HF12 – BrugtsRCT348✓✓✓✓✓✓✓
2023

MONITOR-HF Trial

Brugts et al.

The MONITOR-HF trial (N = 348) was a prospective, multicenter study with 25 participating sites in the Netherlands, representing 1/3 of all Dutch hospitals. The objective of the trial was to evaluate the effectiveness of remote hemodynamic monitoring on quality of life and heart failure hospitalizations in heart failure patients compared to standard care. This was the first RCT to evaluate PA pressure monitoring against a usual care group, for whom clinician contact was not increased as part of the trial.12


Key Highlights

  • Significant and clinically meaningful 7-point improvement in patient-reported quality of life
  • 44% reduction in heart failure hospitalizations
  • Patients showed significant reduction in mean PA pressures at 12 months.
MONITOR-HF Trial
2023

Single-Arm Trial of Guide-HF Trial

Mehra et al.

The single arm of the prospective GUIDE-HF trial (N = 1,001) measured HF outcomes in NYHA Class III patients of the CardioMEMS HF System between both groups at 12 months post-implant. The study was designed to determine whether NYHA Class III patients who received hemodynamic-guided management with the CardioMEMS HF System experienced equivalent outcomes in patients with a prior HFH versus those with elevated NT-proBNP/BNP alone.11


Key Highlights

  • Patients with elevated BNP demonstrated significantly lower risk of HF events at 12 months compared to the group with a prior HFH, but both groups demonstrated similar and significant benefits from hemodynamic-guided management
  • Prior HFH group showed a 54% reduction in HFH after 1 year, but patients with an elevated BNP level without a prior HFH had half the event rate of those with a prior HFH
  • Results from the GUIDE-HF single arm study suggest that preventing the first HFH through hemodynamic-guided management may lead to a lower risk for subsequent HFH, and better outcomes
Single Arm Trial of Guide-HF Trial
2023

Hemodynamic Management Meta-Analysis

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
1,000 Randomized Patients
2021

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
1,000 Randomized Patients
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.6

57% HFH reduction regardless of HF
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).7

62% HFH reduction
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.2

24% HFH reduction | 30% Mortality reduction
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.9

$13K reduction in cost
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.8

First 2000 commercial implants
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.3

43% reduction on optimal GDMT
2014

Proven Management in HFpEF Patients

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.5

46% lower heart failure hospitalizations
2011

CHAMPION Pivotal Trial

Abraham et al.

Pivotal randomized prospective trial including 550 patients. Results showed a 33% annualized reduction in HFH regardless of ejection fraction.4

33% reduction in HFH

References

  1. Lindenfeld J, Zile MR, Desai AS, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomized controlled trial. The Lancet. 2021;398:991-1001.
  2. 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.
  3. 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.
  4. Abraham WT, Stevenson LW, Bourge RC, et al. (2016). Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: Complete follow-up results from the CHAMPION randomised trial. Lancet, 387(10017), 453-461.
  5. Adamson et al. Wireless Pulmonary Artery Pressure Monitoring Guides Management to Reduce Decompensation in Heart Failure With Preserved Ejection Fraction. Circulation: Heart Failure. 2014;7;935-944.
  6. Shavelle D, et al. Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure: One year outcomes from the CardioMEMS Post- Approval Study. Circulation: Heart Failure. 2020; e006836.
  7. Angermann, C, Aßmus, B, 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.
  8. 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.
  9. 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.
  10. Lindenfeld, J, Costanzo, M, Zile, M. et al. Implantable Hemodynamic Monitors Improve Survival in Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2024 Feb, 83 (6) 682–694.
  11. Mehra M, Costanzo MR, Zile M, et al; GUIDE-HF Trial Investigators. Primary results of the prospective single arm trial of hemodynamic-guided management of heart failure (GUIDE-HF). Presented at: HFSA Conference; October 2023; Cleveland, OH.
  12. 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. https://doi.org/10.1016/S0140-6736(23)00923-6.
Manuals & Resources

Manuals & Resources

Customer Service

Customer Service

This device is commercially available for use in select international markets.

MAT-2109749 v3.0

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