Biomaterial Database

Continuous Noninvasive Arterial Pressure Monitoring for Transcatheter Aortic Valve Replacement. 2021

Shu Y Lu, and Adam A Dalia

Department of Anesthesiology, Pain Medicine, and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA; Department of Critical Care Medicine, Massachusetts General Hospital Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA.

OBJECTIVE 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. METHODS 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. METHODS Single tertiary academic medical center. METHODS The study comprised 20 patients, with 2,243 unique blood pressure data points. METHODS None. 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.

UI	MeSH Term	Description	Entries
D001794	Blood Pressure	PRESSURE of the BLOOD on the ARTERIES and other BLOOD VESSELS.	Systolic Pressure,Diastolic Pressure,Pulse Pressure,Pressure, Blood,Pressure, Diastolic,Pressure, Pulse,Pressure, Systolic,Pressures, Systolic
D001795	Blood Pressure Determination	Techniques used for measuring BLOOD PRESSURE.	Blood Pressure Determinations,Determination, Blood Pressure
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001021	Aortic Valve	The valve between the left ventricle and the ascending aorta which prevents backflow into the left ventricle.	Aortic Valves,Valve, Aortic,Valves, Aortic
D001024	Aortic Valve Stenosis	A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.	Aortic Stenosis,Aortic Valve Stenoses,Stenoses, Aortic,Stenoses, Aortic Valve,Stenosis, Aortic,Stenosis, Aortic Valve,Valve Stenoses, Aortic,Valve Stenosis, Aortic
D012189	Retrospective Studies	Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.	Retrospective Study,Studies, Retrospective,Study, Retrospective
D016896	Treatment Outcome	Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.	Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D062186	Arterial Pressure	The blood pressure in the ARTERIES. It is commonly measured with a SPHYGMOMANOMETER on the upper arm which represents the arterial pressure in the BRACHIAL ARTERY.	Aortic Blood Pressure,Aortic Pressure,Aortic Pulse Pressure,Aortic Tension,Arterial Blood Pressure,Arterial Tension,Blood Pressure, Aortic,Blood Pressure, Arterial,Mean Aortic Pressure,Mean Arterial Pressure,Aortic Blood Pressures,Aortic Pressure, Mean,Aortic Pressures,Aortic Pressures, Mean,Aortic Pulse Pressures,Aortic Tensions,Arterial Blood Pressures,Arterial Pressure, Mean,Arterial Pressures,Arterial Pressures, Mean,Arterial Tensions,Blood Pressures, Aortic,Blood Pressures, Arterial,Mean Aortic Pressures,Mean Arterial Pressures,Pressure, Aortic,Pressure, Aortic Blood,Pressure, Aortic Pulse,Pressure, Arterial,Pressure, Arterial Blood,Pressure, Mean Aortic,Pressure, Mean Arterial,Pressures, Aortic,Pressures, Aortic Blood,Pressures, Aortic Pulse,Pressures, Arterial,Pressures, Arterial Blood,Pressures, Mean Aortic,Pressures, Mean Arterial,Pulse Pressure, Aortic,Pulse Pressures, Aortic,Tension, Aortic,Tension, Arterial,Tensions, Aortic,Tensions, Arterial
D065467	Transcatheter Aortic Valve Replacement	Surgical treatment for severe AORTIC VALVE STENOSIS. Transcatheter aortic valve replacement (TAVR) is used as an alternative option in patients who are deemed at high risk or inoperable for traditional open-heart surgery.	Transcatheter Aortic Valve Implantation