March 17, 2019
Postapproval Study Supports Safety and Efficacy of CardioMEMS Sensor
March 17, 2019—The American College of Cardiology (ACC) announced that findings from the postapproval study for the CardioMEMS heart failure sensor (Abbott Vascular) were presented by David Shavelle, MD, at the ACC's 68th Annual Scientific Session, being held March 16–18 in New Orleans, Louisiana.
The CardioMEMS device is designed to wirelessly measure and monitor pulmonary artery pressures that can signal worsening heart failure. This prospective, open-label trial was initiated as a postapproval study to evaluate the efficacy and safety of the device in clinical practice per 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.
According to the ACC, the data from the study demonstrated that in the year following placement of a CardioMEMS device patients experienced a 58% reduction in hospitalization for heart failure. Reductions in hospitalizations were seen in both men and women, across all ejection fraction ranges, and regardless of race.
Dr. Shavell commented in the ACC announcement, “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. 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.”
He further observed, “Having the device cut the risk of hospitalizations by more than half. 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.”
As summarized by ACC, the study was composed of 1,200 patients at 104 clinical sites in the United States. Patients enrolled in the study were an average age of 69 years and included 38% women, 17% nonwhite, 30% with preserved ejection fraction (HFpEF), and 53% with reduced ejection fraction.
The primary efficacy endpoint was heart failure hospitalization rates in the year after the sensor was implanted compared to the year before.
The investigators found that patients in the study had an average of 1.24 heart failure hospitalizations in the year before implantation and 0.52 hospitalizations in the year after implantation, which translates to a 58% reduction in heart failure-related hospitalizations.
Similar reductions in hospitalizations were seen in patients with the greatest burden of hospitalizations (more than two hospitalizations in the previous year).
The investigators reported that the sensor prevented hospitalizations regardless of patients’ ejection fraction, preserved ejection fraction (≥ 50%, which is considered normal), reduced ejection fraction (<40%) or mid-range ejection fraction (41–50%). There were also clear benefits for female patients who had a 61% reduction in heart failure hospitalization, and black patients had a reduction of 53%.
Additionally, patients with or without an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator, and those with an ischemic or nonischemic cardiomyopathy, also saw lower rates of hospitalizations with the CardioMEMS sensor.
Moreover, having the device also appeared to reduce all-cause hospitalizations for conditions, such as pneumonia, chronic obstructive pulmonary disease, or arrhythmias, by 28%. Other analyses showed the combined rate of heart failure-related hospitalizations or death also decreased by 44% after the sensor was placed.
Dr. Shavelle stated, “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. 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.”
Additionally, the CardioMEMS sensor also met its safety endpoint—freedom from device or system-related complications or sensor failure at 1 year.
The investigators assessed safety by tracking whether there were any device-related 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.
Dr. Shavelle reported that based on the data, only four patients had device- or system-related complications, and only one episode of sensor failure. Thus, at 1 year after implantation, the study participants had 99.7% freedom from device/system-related complications and 99.9% 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 previous hospitalization for heart failure, noted the ACC announcement.