Nav: Home

CardioMEMS sensor reliably safe, cuts hospitalizations by more than half

March 18, 2019

NEW ORLEANS (March 17, 2019) -- In the year following placement of a CardioMEMS heart failure sensor--designed to wirelessly measure and monitor pulmonary artery pressures that can signal worsening heart failure--patients experienced a 58 percent reduction in hospitalization for heart failure, according to research presented at the American College of Cardiology's 68th Annual Scientific Session. Reductions in hospitalizations were seen in both men and women, across all ejection fraction ranges and regardless of race.

Heart failure, which affects nearly 6 million Americans, is a condition in which the heart cannot pump enough blood at the right pressures to meet the body's needs. CardioMEMS is a small sensor--the size of a small paperclip--that is placed directly into a patient's pulmonary artery, which connects the heart and the lungs. In a minimally invasive outpatient procedure, doctors use the femoral vein in the groin to thread the sensor up to the heart. Once implanted, the device can detect rising pressures in the pulmonary artery, which can be an early warning of fluid backing up in the lungs and pending onset of congestive heart failure even before symptoms of shortness of breath or weight gain are reported. Pressures are recorded and transmitted electronically from a patient's home to a secure website so health care providers can review the readings and proactively adjust medical therapies to keep patients at their target pressures.

This prospective, open-label trial was initiated as a post-approval study to evaluate the efficacy and safety of the CardioMEMS sensor in clinical practice per U.S. Food and Drug Administration (FDA) mandates. The device was approved by the FDA in May 2014 for use in patients who have New York Heart Association (NYHA) Class III heart failure that limits daily life and who have been hospitalized for heart failure in the previous year. The study included 1,200 patients at 104 clinical sites in the U.S. Participants were an average of 69 years old and included 38 percent women, 17 percent non-white, 30 percent with preserved ejection fraction (HFpEF) and 53 percent with reduced ejection fraction.

"This study was done in a large number of patients with substantial representation of women and minorities and showed the device to be not only safe but markedly effective in keeping people out of the hospital," said David Shavelle, MD, associate professor at Keck School of Medicine of USC and the study's lead author. "Our findings further validate the concept that remote monitoring of pulmonary artery pressures, which is a surrogate to a patients' volume status, allows adjustment of medical therapy in a timely manner to prevent future heart failure hospitalizations. This represents an important advance in heart failure management, as these patients are at very high risk of hospitalizations and complications."

The primary efficacy endpoint was heart failure hospitalization rates in the year after the sensor was implanted compared to the year before. Heart failure is among the top conditions that result in hospitalizations among people age 65 years and older. Patients in the study had an average of 1.24 heart failure hospitalizations in the year prior to implant and 0.52 hospitalizations in the year after having the device implanted. This translated to a 58 percent reduction in heart failure-related hospitalizations, researchers said. Similar reductions in hospitalizations were seen in patients with the greatest burden of hospitalizations (more than two hospitalizations in the previous year).

"Having the device cut the risk of hospitalizations by more than half," Shavelle said. "The benefits of lower hospitalizations were seen across all subgroups of patients, and we also validated that this treatment can decrease hospitalizations in patients with HFpEF."

The sensor prevented hospitalizations regardless of patients' ejection fraction, preserved ejection fraction (50 percent or higher, which is considered normal), reduced ejection fraction (<40 percent) or mid-range ejection fraction (41-50 percent). is a measure of how well the heart squeezes blood out to body. there were also clear benefits for females and racial>

Additionally, patients with or without an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator and those with an ischemic or non-ischemic cardiomyopathy also saw lower rates of hospitalizations with the CardioMEMS sensor.

Moreover, having the device also appeared to reduce all-cause hospitalizations for conditions like pneumonia, chronic obstructive pulmonary disease or arrhythmias by 28 percent. Other analyses showed the combined rate of heart failure-related hospitalizations or death also dropped by 44 percent after the sensor was placed.

"If you can maintain more normal cardiac filling pressures and less heart stress, you are less likely to be seriously affected and need hospitalization for other conditions such as lung disease or liver disease, which are affected by heart function," Shavelle said. "We believe that having the sensor monitored by their care team also encourages patients to follow their medication plan and gives them a sense of security that is particularly important for those living far away from a hospital."

The CardioMEMS sensor also met its safety endpoint--freedom from device or system-related complications or sensor failure at one year. To assess safety, researchers tracked whether there were any device or system-related complications and episodes of sensor failure where they were unable to get pressure readings from the device even after troubleshooting the external electronics. Based on the data, only four patients had device- or system-related complications, and there was only one episode of sensor failure, Shavelle said. Reported another way, at one year post-implant, study participants had 99.7 percent freedom from device/system-related complications and 99.9 percent freedom from sensor failure.

An ongoing study is evaluating the use of the CardioMEMS sensor for patients with other classes of heart failure (NYHA Class II and IV) and for patients at risk but without a prior hospitalization for heart failure.
-end-
This study was funded by Abbott Vascular.

The ACC's Annual Scientific Session will take place March 16-18, 2019, in New Orleans, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCinTouch, @ACCMediaCenter and #ACC19 for the latest news from the meeting.

The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its more than 52,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.

American College of Cardiology

Related Heart Failure Articles:

New hope for treating heart failure
Heart failure patients who are getting by on existing drug therapies can look forward to a far more effective medicine in the next five years or so, thanks to University of Alberta researchers.
Activated T-cells drive post-heart attack heart failure
Chronic inflammation after a heart attack can promote heart failure and death.
ICU care for COPD, heart failure and heart attack may not be better
Does a stay in the intensive care unit give patients a better chance of surviving a chronic obstructive pulmonary disease (COPD) or heart failure flare-up or even a heart attack, compared with care in another type of hospital unit?
Tissue engineering advance reduces heart failure in model of heart attack
Researchers have grown heart tissue by seeding a mix of human cells onto a 1-micron-resolution scaffold made with a 3-D printer.
Smoking may lead to heart failure by thickening the heart wall
Smokers without obvious signs of heart disease were more likely than nonsmokers and former smokers to have thickened heart walls and reduced heart pumping ability.
After the heart attack: Injectable gels could prevent future heart failure (video)
During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells in the heart.
Heart failure after first heart attack may increase cancer risk
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared to first-time heart attack survivors without heart failure, according to a study today in the Journal of the American College of Cardiology.
Scientists use 'virtual heart' to model heart failure
A team of researchers have created a detailed computational model of the electrophysiology of congestive heart failure, a leading cause of death.
Increase in biomarker linked with increased risk of heart disease, heart failure, death
In a study published online by JAMA Cardiology, Elizabeth Selvin, Ph.D., M.P.H., of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues examined the association of six-year change in high-sensitivity cardiac troponin T with incident coronary heart disease, heart failure and all-cause mortality.
1 in 4 patients develop heart failure within 4 years of first heart attack
One in four patients develop heart failure within four years of a first heart attack, according to a study in nearly 25,000 patients presented today at Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure by Dr.

Related Heart Failure Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Anthropomorphic
Do animals grieve? Do they have language or consciousness? For a long time, scientists resisted the urge to look for human qualities in animals. This hour, TED speakers explore how that is changing. Guests include biological anthropologist Barbara King, dolphin researcher Denise Herzing, primatologist Frans de Waal, and ecologist Carl Safina.
Now Playing: Science for the People

#SB2 2019 Science Birthday Minisode: Mary Golda Ross
Our second annual Science Birthday is here, and this year we celebrate the wonderful Mary Golda Ross, born 9 August 1908. She died in 2008 at age 99, but left a lasting mark on the science of rocketry and space exploration as an early woman in engineering, and one of the first Native Americans in engineering. Join Rachelle and Bethany for this very special birthday minisode celebrating Mary and her achievements. Thanks to our Patreons who make this show possible! Read more about Mary G. Ross: Interview with Mary Ross on Lash Publications International, by Laurel Sheppard Meet Mary Golda...