CardioMEMS HF System Clinical Evidence | Abbott
CARDIOVASCULAR
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CARDIOMEMS HF SYSTEM

Clinical Evidence

The CardioMEMS™ HF System has proven clinical benefit in a variety of clinical studies including 4 prospective trials totaling over 3,000 patients.

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 has demonstrated significant clinical benefit regardless of study design.
 

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.”

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.

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


CardioMEMS HF System Data at a Glance

 

Study Design N Reduce HFH Reduce PAP HFpEF Benefit Safety Increase QoL Adherence Elevated BNP
CHAMPION Pivotal Study 2016. Pivotal, Prospective Study - Abraham RCT N=550    
Proven Management in HFpEF Patients - Adamson RCT Subgroup N=119          
Optimizing GDMT 2017. Retrospective, CHAMPION Subgroup - Givertz Retrospective N=456            
Real-world Study 2017. Retrospective - Heywood Retrospective N=2000        
Economic Impact 2017. Retrospective - Desai Retrospective Database N=1114            
Propensity-Matched Cohort 2019. Retrospective - J. Abraham Retrospective Database N=2174            
MEMS-HF 2019. Prospective, multi-center, EU - Angermann Single-arm N=234  
US Post-Approval Study 2020. Prospective - Shavelle Single-arm N=1200  
GUIDE-HF Study 9 - Lindenfeld RCT N=1000

* Unpublished

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

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.

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

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1,000 randomized patients and expanded indication

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. 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.

Indications, Safety & Warnings

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