- MONITOR-HF is the third randomized, controlled trial globally
to show a significant health benefit for indicated heart failure
- CardioMEMS is a paperclip-sized sensor that can remotely flag
to a patient's clinical team the early warning signs of worsening
PARK, Ill., May 24, 2023
/PRNewswire/ -- New data presented from an investigator-sponsored
European trial found managing indicated1 heart failure
patients with Abbott's CardioMEMS™ HF System resulted in a
significant1 improvement in patient-reported
quality-of-life scores as early as three months after use with the
remote monitoring sensor. The MONITOR-HF trial also resulted in a
significant 44% reduction in heart failure-related hospitalizations
among chronic heart failure patients who used guideline-directed
medical therapy (GDMT). GDMT refers to the European and U.S.
guidelines for heart failure management2 that uses a
combination of up to four heart medications. MONITOR-HF is the
third randomized, controlled clinical trial globally to show a
significant health benefit and quality-of-life improvement for
heart failure patients using the CardioMEMS HF System.
The MONITOR-HF results were announced recently at a
late-breaking presentation at the European Society of Cardiology's
annual meeting of the Heart Failure Association in Prague and simultaneously published in The
Lancet. The trial was funded by the Dutch Ministry of Health
with clinical research organization costs paid by Abbott.
New Data Reveal Improved Quality of Life
MONITOR-HF trial met its primary endpoint and found that heart
failure participants who received a CardioMEMS sensor reported a
clinically meaningful improvement in their quality-of-life as
quantified by a 7-point mean increase on the Kansas City
Cardiomyopathy Questionnaire's (KCCQ) score compared to patients in
the control group, who did not receive the pressure sensor and
whose scores decreased. In heart failure, the KCCQ is a clinical
standard assessment3 that has been recommended to
capture and measure patient-reported quality of care. The
questionnaire4 asks patients how difficult it is to
complete common activities such as walking a short distance, doing
household chores and socializing with family and friends.
"The Dutch health care system is known for its structured
approach to heart failure management at outpatient clinics with
general access to guideline-directed medical therapies," said J.J.
(Jasper) Brugts, M.D., Ph.D., principal investigator for the
MONITOR-HF trial and associate professor at Erasmus Medical Center
in Rotterdam, Netherlands. "This
approach raises the bar, making the MONITOR-HF results even more
meaningful given that patients who were already receiving a high
standard of care reported significant improvements in their
quality-of-life while using the CardioMEMS monitoring system."
The CardioMEMS sensor is a paperclip-sized device that, once
placed in the pulmonary artery during a minimally invasive
procedure, monitors for pressure changes that indicate worsening
heart failure. It wirelessly transmits daily readings to a
patient's clinical team – empowering the patient and their care
team to manage their condition from virtually anywhere.
"Heart Failure is a global health problem with a devastating
impact on patient lives and high rate of morbidity and mortality,"
said Philip B. Adamson, M.D., chief
medical officer of Abbott's heart failure business. "These results
demonstrate once again that a proactive, remote-centered approach
using pressure monitoring with CardioMEMS leads to better health
outcomes and higher patient satisfaction across multiple health
indicators than medication alone."
MONITOR-HF is a prospective,
randomized study with 348 patients enrolled in 25 centers in
the Netherlands, representing
one-third of the country's hospitals. Patients had New York Heart
Association (NYHA) Class III heart failure with a previous heart
failure-related admission or an urgent care visit requiring
intravenous diuretics within the past year. Patients were randomly
assigned to either hemodynamic monitoring using the Abbott
CardioMEMS or the standard of care for heart failure management
using GDMT. In the Netherlands,
all participating sites had dedicated outpatient clinics where
patients were seen at three months, six months, and every six
months thereafter. Patients implanted with the Abbott CardioMEMS
device were managed for at least one year and risk for
complications remained low at 2.3%, which is consistent with
MONITOR-HF was designed and run by the Erasmus University Medical Center in Rotterdam, Netherlands. Abbott covered the
clinical study costs with no part in the design, conduct of the
study or any of its analyses.
The CardioMEMS sensor first received approval from the U.S. Food
and Drug Administration (FDA) in 2014 and the European Conformity
(CE) mark in 2016.
U.S. Indications and Important Safety Information
U.S. important safety information for the CardioMEMS HF System,
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1"Remote Haemodynamic Monitoring of Pulmonary Artery
Pressures in Patients with Chronic Heart Failure"; Brugts et al;
Presented at the European Society of Cardiology Heart Failure
Association annual meeting, Prague, Czech
Republic, May 20, 2023.
2 National Library of Medicine. Optimizing
Foundational Therapies in Patients with HFrEF. Optimizing
Foundational Therapies in Patients With HFrEF - PMC (nih.gov).
Accessed: May 4, 2023.
3 Science Direct. Journal of the American College of
Cardiology. Interpreting the Kansas City Cardiomyopathy
Questionnaire in Clinical Trials and Clinical Care: JACC
State-of-the-Art Review - ScienceDirect. Accessed: May 2, 2023.
4 Agency for Clinical Innovation. Cardiomyopathy
Questionnaire (Kansas City KCCQ). Cardiomyopathy questionnaire
(Kansas City) (KCCQ-12)
(nsw.gov.au) Accessed: May 5,