June 14, 2021 by Adrienne Sylver
Miami Cardiac & Vascular Institute is First in S. Florida to Implant New Sensor System in a Heart Failure Patient as Part of Global Trial
Miami Cardiac & Vascular Institute, part of Baptist Health, became the first center in South Florida to implant a new sensor, the Cordella System, in a heart failure patient that enables clinicians to better monitor and adjust therapy and medications remotely, without the need for additional office visits.
The Institute is one of 90 centers selected to be part of a global clinical trial for heart failure patients using the Cordella Pulmonary Artery Sensor System to measure, record, and transmit pulmonary artery pressure and other vital data from home-based patients to their clinicians.
Endotronix, a digital health and medical technology company, received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in August 2019 to launch the multi-center, PROACTIVE-HF trial. During the trial, physicians are evaluating the safety and efficacy of the Cordella Sensor in more than 950 patients.
Clinical studies have previously found that pulmonary artery, pressure-guided management can reduce heart failure-related hospitalizations and improve patient outcomes.
The first patient at Miami Cardiac & Vascular Institute to receive the Cordella System implant is in his early 70s. Patients who qualify for the Cordella System implant fall into the group of patients with marked limitation of physical activity. They may be comfortable at rest, but less-than-ordinary activity causes fatigue, palpitations, or dyspnea.
“The patient underwent the outpatient procedure to implant the Cordella System successfully,” said Sandra Chaparro, M.D., cardiologist and director of the Advanced Heart Failure Program at the Institute. “He’s a patient that has heart failure. In this case, it’s heart failure with reduced ejection fraction.” Ejection fraction is a measurement of how much blood the left ventricle pumps out with each contraction. An ejection fraction of 60 percent means that 60 percent of the total amount of blood in the left ventricle is pushed out with each heartbeat. A normal heart’s ejection fraction may be between 50 and 70 percent, says the American Heart Association.
The patient suffers from pulmonary hypertension related to his left-sided heart failure, and he is diabetic, said Dr. Chaparro. “The sensor is implanted percutaneously into the pulmonary artery. After that, the patient waits in the holding area for two hours and then is discharged home”.
As part of the Cordella System, the patient went home with a tablet, on which clinicians can monitor the patient’s vital stats, including blood pressure, weight, and pulse oximetry, which is their oxygenation percentage. The intent of the comprehensive monitoring is to keep heart failure patients from requiring frequent visits to the hospital. The patient can perform a brief daily reading at home, and the data is securely sent to the clinician.
“One of the novelties of this pulmonary artery sensor is that we are able to see if the patient is accumulating fluid inside the heart before we can see manifestations on weight or symptoms,” explains Dr. Chaparro. “So, if we are aware that the pressures are elevated, then with that information we can intervene by making medical changes, for example, with diuretics or with blood pressure medicines. And with that, we can avoid a readmission to the hospital.”
Dr. Chaparro said there is another system, the CardioMEMS HF System from Abbott Laboratories, that is a commercially available sensor. Endotronix states that its Cordella System has technological and portability advantages over the CardioMEMS system.
With the Cordella System, “we have access through the Internet to displays from different monitors with all the information, in terms of the vital signs,” adds Dr. Chaparro. “With that data, then we can make the adjustments that are necessary to prevent decompensation. In the United States, there are six million people diagnosed with heart failure. Half of them have reduced ejection fraction and half of them have preserved ejection fraction.”
One of the key benefits of the Cordella System is that the patient’s ejection fraction does not need to be in a specific range.
“The beauty of this device (Cordella System) is that it can be implanted in any patient, regardless of ejection fraction,” said Dr. Chaparro. “We are looking for the patients who are on optimal medical therapy and who are compliant. That would decrease the number of patients that would qualify for clinical trials in general.”