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.

Noninvasive continuous arterial pressure monitoring during anesthesia induction in patients undergoing cardiac surgery

“…Gellert and Bramlage suggested heart valve interventions/surgery as a possible application for the ClearSight™ system for (REF). In this review, the bias of MAP in 16 studies from 2009 to 2018 was from -4,2 (SD 13,7) mmHg to 6,2 (SD 11,7) mmHg.,[ 16 ] which is comparable to the difference found in our study. They conclude that the ClearSight™ system can be used to accurately monitor hemodynamics during these interventions.…”

Non-Invasive Continuous Measurement of Haemodynamic Parameters—Clinical Utility

“…Furthermore, the non-invasive blood pressure measurement during fast heart stimulation, accurately and immediately showed significant alternations in the haemodynamic parameters [ 55 ]. Similar results in accuracy of blood pressure and cardiac output were obtained in two studies in which the ClearSight system was applied and compared to the invasive monitoring in patients with aortic and mitral valve replacement [ 56 , 57 ]. Another study found that an agreement between NICO and invasive hemodynamic monitoring was clinically acceptable, but had a tendency to underestimate CO compared to the termodilution method [ 49 ].…”

Comparison of oscillometric, non-invasive and invasive arterial pressure monitoring in patients undergoing laparoscopic bariatric surgery – a secondary analysis of a prospective observational study

“…However, Eley and coworkers argued that NIBP cuffs were not based on the mid-arm circumference, as recommended by the American Heart Association [ 36 ] and that patient allocation to correctly sized cuffs is essential for a validation [ 27 ]. Our study did not focus on a cost-effectiveness analysis for the different blood pressure monitoring methods used in the bariatric population and non-manufacturer derived data on this subject is yet limited [ 37 , 38 ]. The acquisition costs could be a barrier to the introduction in anesthesia departments [ 39 ].…”