CARDIOVASCULAR
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Clinical Evidence

Clinical Evidence

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.9

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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.8

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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

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43% reduction on optimal GDMT
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

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First 2000 patients
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

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Graph pointing down showing $13,000 reduction in cost
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

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CardioMEMS trial results show 24% HFH reduction and 30% mortality reduction
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

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CardioMEMS study results show 62% HFH reduction and improved quality of life
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

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CardioMEMS trial results show 57% HFH reduction regardless of EFF and reduction in PA pressures
ENROLLING

GUIDE-HF Trial

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

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Primary outcomes were presented at ESC Congress 2021 and are published in The Lancet.

Please note that there are elements addressed in the GUIDE-HF Primary Outcomes data that remain off-label for the CardioMEMS HF System.

3,6000 patients and expand indications

Clinical Studies Overview

 
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

References

  1. Lindenfeld J, et al. Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF). Am Heart J. 2019;214:18-27.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

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