Use of the ClearSight® System for Continuous Noninvasive Hemodynamic Monitoring during Heart Valve Interventions: Review of the Literature and Single-Site Experience

Abstract

During interventional and structural cardiology procedures, such as mitral valve (MitraClip, BMV), aortic valve (TAVR, BAV), tricuspid valve (MitraClip), left atrial appendage (Watchman, Lariat), atrial septum (ASD/PFO closure), and coronary artery intervention (high-risk PCI), among others, patients are at a high risk of hemodynamic instability and require continuous monitoring. This is conventionally achieved through arterial catheterization and transpulmonary thermodilution. However, such invasive techniques are time-consuming and have been associated with steep learning curves, vascular complications, and increased risk of infection. In line with the ongoing simplification and improvement of the catheter-based valve intervention, it is logical to investigate the effectiveness of continuous noninvasive hemodynamic monitoring in this setting. Over the last 2 years, our team has performed over 400 valve procedures with continuous hemodynamic monitoring via the noninvasive ClearSight system. This system is based on a finger-cuff and automated volume-clamp technology integrated into a simplified clinical platform (EV1000 NI). Although current evidence suggests that the technology results in slight differences in arterial pressure (AP) and cardiac output (CO) relative to the current, commercially available, invasive approaches, we have found the bias to be acceptable. Both the noninvasive and the invasive approaches have the same percentage of error when compared to the true CO and provide beat-by-beat detection of acute changes facilitating shorter response times. In addition to AP and CO, the system provides up-to-date information on stroke volume (SV), stroke volume variation (SVV), and systemic vascular resistance, which can be useful in aiding decision-making and provide better postoperative outcomes, such as shorter length of stay (LOS), decreased postoperative infection, decreased postoperative arrhythmia, decreased postoperative renal failure, decreased postoperative congestive heart failure (CHF), and decreased readmission. Additionally, the simplicity of the system setup has translated into a time saving of up to 3 hours per day, allowing one team to perform an additional 2 to 3 valve interventions without moving rooms. Moving forward, a formal study comparing patient outcomes and cost-effectiveness between invasive and noninvasive hemodynamic monitoring techniques in valve replacement would be insightful.