CardiON: Home Monitoring for Heart Failure Management
- Wes Bernier
- Trent Langston
- Nichaluk Leartprapun
- Qian Liu
- Jackie Wanjala
- David Kass, MD
- Peter Johnston, MD
- Chao-Wei Hwang, MD, PhD
- Viachaslau Barodka, MD
- Majd AlGhatrif, MD
- Stuart Russell, MD
- Soumyadipta Acharya, MD, PhD
- Youseph Yazdi, MBA, PhD
- Lawrence Aronhime, MBA
- Matt Oberdier, PhD
- Aditya Polsani, MS
- Michael Parlato, MSE
- Clifford Weiss, MD
- Umang Anand, PhD, Boston Scientific
- Andrew Bicek, PhD, Boston Scientific
- Paul Chouinard, Boston Scientific
Abstract:
Heart failure affects the lives of 5.1 million Americans and cost the U.S. economy $39.2 Billion in 2010. An important aspect of managing HF is proper intravascular fluid optimization. The parameter that best quantifies fluid status is Left-Ventricular End-Diastolic Pressure. However, the current standards of care in obtaining fluid status assessment involve either a catheterization procedure that is accurate but inaccessible for regular use or inaccurate, nonspecific and subjective physical examinations. This inadequate assessment of a patient’s fluid status can lead to suboptimal medical dosing and, subsequently, increased incidences of rehospitalization. In recognition of this significant clinical need, CardiON is developing a safer, cheaper and more accurate way of monitoring LVEDP.
CardiON’s scientific insight comes from the observation of the interplay between various cardiovascular pressure, acoustic, and electrical waveforms. Using multiple noninvasive hemodynamic measurements, our system employs a patient-specific algorithm to derive LVEDP in real time. So far, the team has developed and validated its approach using retrospective human data and pig experiments. CardiON has been able to demonstrate high correlations of LVEDP values (R-square > 0.9, p < 0.001) with the new noninvasive approach as compared to the invasive gold standard. Furthermore, preliminary analysis demonstrated no clinically significant differences between the actual and predicted LVEDP values (Prediction S.E. <3mmHg). CardiON’s LVEDP values fall well within the precision and accuracy thresholds that clinicians desire. Johns Hopkins clinicians and CardiON’s Boston Scientific collaborators have expressed great excitement and anticipation in this new LVEDP monitor.
Moving forward, CardiON hopes to finalize the design of the prototype and continue validation of the patient specific algorithms in a way that informs possible future generalization. CardiON has obtained provisional patents on its designs and algorithms and hopes to begin pursuing regulatory approval (De Novo, Class II) in the near future. By enabling quantitative assessment of fluid status in all settings, CardiON hopes to revolutionize the way patients all over the world live with heart failure.