Breaking News
April 18, 2019 - Gordana Vunjak-Novakovic Elected to American Academy of Arts & Sciences
April 18, 2019 - Podcast: KHN’s ‘What The Health?’ You Have Questions, We Have Answers
April 18, 2019 - Diabetic drug shows potential to be repurposed as heart disease treatment for non-diabetic patients
April 18, 2019 - New estimation method assesses natural variations in sex ratio at birth
April 18, 2019 - UTA scientist receives $1.17 million grant for cancer research
April 18, 2019 - Coagulation factor VIIa prevents bleeds in hemophilia animal models
April 18, 2019 - Researchers identify risk factors for severe infection after knee replacement
April 18, 2019 - Mass drug administration can offer community-level protection against malaria
April 18, 2019 - FDA’s added sugar label could have substantial health and cost-saving benefits
April 18, 2019 - Researchers identify cause of inherited metabolic disorder
April 18, 2019 - Single strip of white paint not sufficient to protect people who ride bikes
April 18, 2019 - Partner status influences link between sexual problems and self-efficacy in breast cancer survivors
April 18, 2019 - Colorectal Neoplasia Risk Up for Hodgkin Lymphoma Survivors
April 18, 2019 - Rigid spine muscular dystrophy – Genetics Home Reference
April 18, 2019 - Simple bile acid blood test could tell risk of stillbirth
April 18, 2019 - Center for Experimental Therapeutics aims to enable all steps of drug development | News Center
April 18, 2019 - Falling for telephone scams could be an early sign of dementia
April 18, 2019 - Researchers annotate key neuronal proteins in lamprey genome
April 18, 2019 - Study uncovers new biomarker for personalized cancer treatments
April 18, 2019 - Scientists enter research collaboration to find a cure for cancer
April 18, 2019 - Study to compare benefits of tai chi and mindfulness meditation on MS symptoms
April 18, 2019 - Gestational diabetes during pregnancy may increase risk of type 1 diabetes in children
April 18, 2019 - Is a New Remedy for Body Odor on the Horizon?
April 18, 2019 - Orthostatic hypotension – Genetics Home Reference
April 18, 2019 - Healing the heartbreak of stillbirth and newborn death
April 18, 2019 - Conference to highlight advances in human immune monitoring, bioinformatics | News Center
April 18, 2019 - Bacteria use viruses for self-recognition, study reveals
April 18, 2019 - New adhesive patch could help reduce post-heart attack muscle damage
April 18, 2019 - Researchers analyze the effects of dark play in a serious video game
April 18, 2019 - Filial cannibalism and offspring abandonment may be forms of parental care
April 18, 2019 - Two proteins act in concert to maintain a healthy heart in mice, shows study
April 18, 2019 - Scientists create a functioning 3D printed heart
April 18, 2019 - Non-invasive vagus nerve stimulation improves disease symptoms in patients with rheumatoid arthritis
April 18, 2019 - Majority of men struggle to understand diagnosis and treatment of prostate cancer
April 18, 2019 - Researchers create new small molecules that may combat equine encephalitis viruses
April 18, 2019 - Animal-assisted therapy improves social behavior in patients with brain injuries
April 18, 2019 - Some viruses help protect harmful bacteria in CF patients | News Center
April 18, 2019 - Outpatient healthcare providers inappropriately prescribe antibiotics to 40% of patients
April 18, 2019 - Men who have a resting heart rate of 75 bpm are twice as likely to die early
April 18, 2019 - Novel serum biomarkers to detect NAFLD-related fibrosis
April 18, 2019 - New study delves deeper into individual genomic differences than ever before
April 18, 2019 - Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients
April 18, 2019 - Emotional mirror neurons found in rats
April 18, 2019 - Sylvia Plevritis appointed chair of biomedical data science | News Center
April 18, 2019 - Yeast strain provides manufacturing boost to low-calorie sweetener derived from lactose
April 18, 2019 - One in five children and youth suffer from a mental disorder
April 18, 2019 - Improper inhaler use common in children with asthma
April 18, 2019 - C-Path and CDISC release global Therapeutic Area Standard for HIV research
April 18, 2019 - Integrating AI to analyze imaging data allows early recognition of heart disease
April 18, 2019 - Low-cost, high-speed algorithm may allow animal-free chemical toxicity testing
April 18, 2019 - HPV-negative cervical cancers are more aggressive with worse prognosis
April 18, 2019 - AI detects prostate cancer with same level of accuracy as experienced radiologists
April 18, 2019 - Study resolves sex differences in psychiatric illness risk
April 18, 2019 - Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
April 18, 2019 - Cocktail of common antibiotics can fight resistant E. coli
April 18, 2019 - Persis Drell to give keynote address at medical school diploma ceremony | News Center
April 18, 2019 - EpicTogether: Remembering Our Why
April 18, 2019 - Study identifies novel loci contributing to asthma susceptibility in adults
April 18, 2019 - Gut bacteria and pregnancy
April 18, 2019 - New study finds that screening could help prevent rare types of cervical cancer
April 17, 2019 - Spatial orgnization of the genome can be altered using small molecules
April 17, 2019 - AEDs Tied to Higher Pneumonia Risk in Alzheimer Patients
April 17, 2019 - Telemedicine tied to more antibiotics for kids, study finds
April 17, 2019 - Two medical students awarded 2019 Soros Fellowships for New Americans | News Center
April 17, 2019 - Sociologist Constance A. Nathanson Awarded Guggenheim Fellowship
April 17, 2019 - Empathy and hormones could account for aggressive behavior in children, shows study
April 17, 2019 - Researchers develop oral appliance to help sufferers of sleep apnea
April 17, 2019 - Neuronal transport factor detects its target transcripts in more complex manner than previously thought
April 17, 2019 - New drug-delivery system senses high oxidant levels, responds to body chemistry and environment
April 17, 2019 - Health Tip: Horseback Trail Riding Safety
April 17, 2019 - Scientists outline the promises and pitfalls of machine learning in medicine
April 17, 2019 - $12 million grant renewal for flu vaccine research | News Center
April 17, 2019 - Lisa Kachnic, MD, Joins Columbia University as Chair of Radiation Oncology
April 17, 2019 - New study sheds light on how extreme temperature hampers spermatogenesis in insects
April 17, 2019 - Study tests high-tech, non-pharmaceutical way to address ADHD and distractibility
April 17, 2019 - New EZ-2 evaporator for clinical biochemistry sample preparation
April 17, 2019 - Fat shaming celebrities may make women more judgemental about being overweight
April 17, 2019 - Magic mouthwash effectively reduces mouth sore pain caused by radiation therapy
April 17, 2019 - CBD could help slip medications into the brain
April 17, 2019 - Scientists characterize 2017 pneumonic plague outbreak in Madagascar
CardioMEMS heart failure sensor reliably safe, effectively reduces hospitalizations

CardioMEMS heart failure sensor reliably safe, effectively reduces hospitalizations

image_pdfDownload PDFimage_print

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). Ejection fraction is a measure of how well the heart squeezes blood out of the heart to the body. There were also clear benefits for females and racial/ethnic minorities. Females had a 61 percent reduction in heart failure hospitalization and blacks had a reduction of 53 percent.

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.

Tagged with:

About author

Related Articles