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; as per research presented at the American College of Cardiology’s 68thAnnual Scientific Session.
Reductions in hospitalization in both men and women, across all ejection fraction ranges and regardless of race. Heart failure, which affects nearly 6 million Americans; that 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 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 recorded and transmitted electronically from a patient’s home to a secure website so health care providers; they can review the readings and proactively adjust medical therapies to keep patients at their target pressures. This prospective; open label trial initiated 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.
Hospitalization Heart failure
The device which approved by the FDA Class III heart failure that limits daily life; so who was hospitalized for heart failure in the previous year. The primary efficacy endpoint was heart failure hospitalization rate 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. Have the device cut the risk of hospitalizations by more than half,” Shavelle said. The benefits of lower hospitalizations were saw across all subgroups of patients; and we also validated that this treatment can decrease hospitalizations in patients.
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 have the device implanted. This translated to a 58 percent reduction in heart failure-related hospitalizations, researchers said. Similar reduction in hospitalizations was saw in patients with great burden of hospitalizations.
The sensor prevented hospitalizations regardless of patients ejection fraction, preserved ejection fraction, reduced ejection fraction or mid-range ejection fraction. 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.
They believed that have sensor monitored by care; team also encourages patients to follow their medication plan and gives 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); for patients at risk but without a prior hospitalization for heart failure.