Physicians already recognised the importance of remote management for heart failure patients long before the COVID-19 pandemic. However, the current situation has heightened the urgency of the transition for this vulnerable population. In this commentary, Michael Kiernan reviews how remote monitoring of heart failure patients could help to reduce heart failure hospitalisations.
Heart failure patients often have a reduced quality of life with frequent office and emergency room visits and/or rehospitalisations to stabilise worsening symptoms. Outcomes remain stubbornly poor with 50% of patients dying within five years of diagnosis. Added to that, recent COVID-19 data from China showed a four times higher mortality rate for patients with a history of cardiovascular disease. Given this population’s increased risk of negative outcomes with COVID-19, avoiding unnecessary exposure whenever possible is important. The risk is real, and thankfully technology options now exist to provide high quality heart failure management within the patient’s home.
One such technology monitors congestion through increases of intra-cardiac and pulmonary artery pressures using an implantable sensor, which begin a few days to weeks prior to the onset of overt heart failure signs and symptoms. Prior investigations have shown that intervening earlier using pulmonary artery pressure-guided management, to inform medication adjustments, has demonstrated a reduction in heart failure hospitalisations while also improving patient quality of life.
Building on that data, in February 2020, our team at Tufts Medical Center was excited to be one of the first implanting US sites for the pivotal PROACTIVE-HF trial using the novel Cordella pulmonary artery (PA) sensor (Endotronix). In addition to the sensor, the Cordella system incorporates vital sign data from non-implantable sensors including weight, blood pressure, blood oxygen, heart rate, and patient recorded symptoms. Each day, the patient collects and shares data in less than five minutes, providing a comprehensive clinical picture over time.
Although the recent escalation of COVID-19 has paused elective surgeries, the Cordella system without the sensor has proven clinically useful for the remote management of heart failure patients in our clinic. The FDA approved system enables trend-based management of key non-invasive metrics and provides secure patient communication tools.
After the US addresses the acute COVID-19 needs, our team is eager to continue the clinical research with the Cordella sensor. The landmark PROACTIVE-HF trial of over 960 patients is designed to support US market access and inform a national coverage decision (NCD) from the Centers of Medicare and Medicaid (CMS) for the wireless, implantable Cordella pulmonary artery sensor. The dual arm trial compares heart failure disease management with remote telemonitoring using daily patient vital sign data versus daily vital sign data plus pulmonary artery pressure data. Both groups will adhere to guideline-directed medical therapy for heart failure as well as protocolised PA pressure therapy guidelines for the treatment arm. Through this study, we look forward to advancing the research in support of pulmonary artery pressure-guided management for heart failure.
The Cordella system and Cordella sensor are designed to improve upon existing therapies for all key stakeholders: the patient, the implanting physician, and the disease management team, which commonly includes a heart failure nurse specialist working in collaboration with a supervising cardiologist. For the managing team, the Cordella system offers comprehensive patient data to facilitate trend-based monitoring in the home. The system provides notifications if metrics fall outside physician determined limits and is monitored by our heart failure staff using the clinician portal to remotely review patient data. Lastly, the user-friendly patient design makes it easy for patients to use and communicate with our office through secure messaging software. The handheld reader for the sensor makes it easy for patients to regularly transmit their data to our team for close monitoring. Given our early experience with this technology, we are optimistic about the potential benefits of using the Cordella System and Cordella Sensor with our patients.
The Cordella system, without the sensor, is available for commercial use in the USA and EU and is currently in cardiology centres across the USA. The Cordella sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE Mark Trial) and the USA (PROACTIVE-HF IDE Trial).
Michael Kiernan is director of Cardiac Assist at Tufts Medical Center, Boston, USA