MacNeal Hospital launches first clinical trial in Illinois of novel monitoring device for congestive heart failure patients

MacNeal Hospital is the first hospital in Illinois to participate in a national, randomized clinical trial using daily vital signs and lung pressure measurement to manage patients with congestive heart failure (CHF). The PROACTIVE-HF trial utilizes a new monitoring system, coupled with a pressure sensor, implanted directly into a blood vessel in the lung. This system provides information that is recorded and transmitted over a cellular or Wi-Fi connection to a patient’s provider, allowing for medication changes, if necessary, to prevent further health deterioration or hospitalization.

Cardiologists Gregory Macaluso, MD, and James Sur, MD, performed the first implant of the new CordellaÔ Heart Failure System in Illinois (the fourth in the U.S.) at MacNeal’s recently renovated, state-of-the-art Cardiac Catherization Lab. MacNeal is part of Loyola Medicine.

“The increase in lung pressure is the earliest signal that the heart is straining or decompensating,” said Dr. Macaluso of Heart Care Centers of Illinois. “This device can detect changes in a patient’s heart before most symptoms can occur.”

The sensor is implanted into a lung blood vessel using a common outpatient cardiac procedure. Lung pressures are then recorded daily and transmitted via a small hand-held reader to a secure website that is accessible to providers. In addition, providers may be alerted if pressures fall outside of a pre-specified range.

“This allows more proactive, closer monitoring of the patient and an opportunity to fine-tune helpful, guideline-directed medication,” said Dr. Macaluso. “Ultimately, it reduces

the likelihood of admission to the hospital, which can be associated with worse health outcomes.”

Additionally, the device is coupled with a monitoring system that measures blood pressure, weight, oxygen levels and symptoms, providing a comprehensive overview of a patient’s health. Most importantly, patients do not need to leave their home to transmit this health data.

“This is a huge benefit as we move into the future of remote monitoring of patients and in light of the COVID-19 pandemic,” said Dr. Macaluso. Cardiovascular disease is the leading cause of death in the United Sates and patients diagnosed with cardiovascular disease are at higher risk for severe COVID-19 complications.

“As one of the region’s top cardiovascular hospitals, MacNeal is pleased to participate in this innovative clinical trial that has the potential to substantially improve care and treatment for patients living with heart disease,” said Charles J. Bareis, MD, chief medical officer at MacNeal. MacNeal was recently named to the 2020 IBM Watson Health® 50 Top Cardiovascular Hospitals list for the second consecutive year.

A total of 1,000 patients are expected to participate this national clinical trial. The Cordella Heart Failure System is manufactured by Endotronix in Lisle, Illinois. For more information on the Cordella Heart Failure System clinical trial, please contact MacNeal at 708-783-3305.