摘要
Objectives
The objective of the present study, which was conducted in patients undergoing transcatheter aortic valve replacement, was to compare continuous noninvasive arterial pressure measured with the ClearSight device (Edwards Lifesciences, Irvine, CA) with invasive radial artery pressure used as the reference method. The authors hypothesized that the ClearSight device is an accurate, precise, safe, and efficient method for arterial blood pressure measurement comparable with an invasive radial arterial line. Design
The study included the retrospective review of 20 consecutive patients scheduled for elective transcatheter aortic valve replacement with the SAPIEN 3 transcatheter heart valve (Edwards Lifesciences) at a single tertiary academic hospital, who underwent monitoring with both the ClearSight device and an invasive radial arterial pressure line. The patients underwent transcatheter aortic valve replacement from October to December 2019. Setting
Single tertiary academic medical center. Participants
The study comprised 20 patients, with 2,243 unique blood pressure data points. Interventions
None. Measurements and Main Results
A statistically significant correlation between the invasive radial arterial pressure line and the ClearSight device was observed for systolic blood pressure (correlation coefficient 0.86; p < 0.001), diastolic blood pressure (correlation coefficient 0.56; p < 0.001), and mean arterial pressure (correlation coefficient 0.78; p < 0.001). Bland-Altman analysis was used to assess the agreement of systolic blood pressure, diastolic blood pressure, and mean arterial pressure between the two methods. Results for systolic blood pressure between the arterial line and ClearSight device were as follows: bias = 9.8 ± 10.1, percentage bias = 7.6%, and mean error = 15.8%. Results for diastolic blood pressure between the arterial line and ClearSight device were as follows: bias = –5.9 ± 7.8, percentage bias = 10.7%, and mean error = 28.4%. Results for mean arterial pressure between the arterial line and ClearSight device were as follows: bias = 0.3 ± 7.4, percentage bias = 0.4%, and mean error = 18.3%. The concordance rates of systolic blood pressure, diastolic blood pressure, and mean arterial pressure were 100%, 95.1%, and 98.8%, respectively. Conclusions
The accuracy, agreement, and precision of the ClearSight device were convincing for mean arterial pressure, systolic blood pressure, and diastolic blood pressure for patients with severe aortic stenosis undergoing elective transcatheter aortic valve replacement.