Results from a recent clinical study demonstrated that a cardiac implant system can safely be used in individuals with pulmonary arterial hypertension (PAH), and the device provided useful information to guide health care professionals and their patients to make changes that improved hemodynamics (blood flow).
A recently published paper in Chest, a peer-reviewed journal published by the American College of Chest Physicians, reported on doctors’ and scientists’ experience with a cardiac implant, CardioMEMS™ HF System, in 26 people with PAH.
The CardioMEMS HF System is a device that currently can be implanted directly in the pulmonary arteries of some patients with heart failure. The completely sealed capsule uses microelectromechanical systems (MEMS) technology and is designed to last the lifetime of the patient. The miniaturized, wireless system monitors pulmonary artery pressures and heart rate through sensors in the device. The device is read by an electronic receiver in the patient’s home and transmits this data directly to his or her health care professionals. Most patients transmit this information daily.
In 2014, the CardioMEMS HF System was approved by the U.S. Food and Drug Administration (FDA) for patients with New York Heart Association (NYHA) functional class III heart failure who have been hospitalized for heart failure in the previous year. A clinical trial¹ leading to the approval of the device for heart failure patients demonstrated that patients with the device had fewer heart failure-related hospitalizations and improved quality of life.
Led by Raymond L. Benza, MD, doctors and scientists from Allegheny General Hospital, a PHA-Accredited Center of Comprehensive Care; Duke University, a PHA-accredited Center of Comprehensive Care; University of Arizona Medical Center and The Ohio State University conducted a study to see if the cardiac implant device could also be safely used in people with PAH. The study was funded by the National Institutes of Health and Abbott.
Twenty-six PAH patients from Allegheny General Hospital and Duke University with functional class III or IV right-sided heart failure who were on average 51 years old were enrolled in the study and had a CardioMEMS HF System placed in their pulmonary arteries. Doctors and scientists monitored the device readings at least weekly and followed patients for an average of 2.5 years.
Study results showed that the device was safe, with no series adverse events after device placement during a non-surgical procedure. Using the readings from the device, doctors adjusted some patients’ PH-therapies at their discretion. They then noted improvements in pulmonary artery pressure and cardiac output in subsequent readings. Scientists were able to measure associations between functional improvements (specifically, functional class, six-minute walk distance and health-related quality of life) and the hemodynamic improvements measured by the CardioMEMS system.
More research is needed, with larger clinical trials, to better understand the role of the device in people with PAH and whether longer-term outcomes are impacted.
¹Abraham WT, et al. The Lancet. 2011;377(9766): 658-66