Radiography Clinical Trial
Official title:
Cardiac Afterload Indices Measured in Ascending and Descending Aorta: Rational for the Use of Velocity-Pressure Loop in the Operating Room
In surgical patients considered with "high cardiovascular risk", by their field or by the
nature of their intervention, it is recommended to use hemodynamic monitoring including a
continuous measurement device of arterial pressure and cardiac output (CO). However,
targeting mean arterial pressure (MAP) with boluses of selective peripheral vasopressors
(without positive inotropic or chronotropic effects) could have deleterious effects on CO.
Thus, it seems important to use a combined analysis of MAP and CO to estimate the
afterload-related cardiac performance (ACP) The investigators recently proposed a cardiac
afterload monitoring, in the descending thoracic aorta, based on a combined analysis of flow
velocity signal recorded by trans-oesophageal Doppler and aortic pressure, the
Velocity-Pressure Loop (VP Loop). VP Loop, and its derived indicators, especially Global
AfterLoad Angle (GALA), could be useful during hemodynamic management for continuous cardiac
afterload monitoring. However, in cardiology unit, cardiac afterload is usually measured at
the ascending aorta behind the aortic valves.
The main objective of this study is to compare VP Loop parameters build in the ascending and
descending thoracic aorta according to patient cardiovascular risk factors.
Main objective In order to personalize patient approach and better care during surgery, the
investigators recently proposed a cardiac afterload monitoring, in the descending thoracic
aorta, based on a combined analysis of flow velocity signal recorded by trans-oesophageal
Doppler and aortic pressure, the Velocity-Pressure Loop (VP Loop). Cardiac afterload is
usually measured at the ascending aorta behind the aortic valves. The main objective of this
study is then to compare VP Loop parameters build in the ascending and descending thoracic
aorta according to patient cardiovascular risk factors.
Cardiac afterload is measured under general anesthesia in the ascending and descending aorta,
using recognized arterial indices describing it and parameters derived from the VP loop.
Cardiac afterload can be schematically defined by the combination of three components:
peripheral vascular resistance (PVR), total arterial compliance (Ctot) and aortic wave
reflections (WR). WR could be assessed by pulse wave pressure analysis with the augmentation
index (Aix) or after pulse wave pressure separation into a forward and backward wave with the
wave reflection index (WRi) or the wave reflection area (WRa).
Aortic pressure measurements As required by the standard of care of the interventional
neuroradiology procedure, the neuroradiologist also cannulated the femoral artery. At the end
of the procedure, during catheter withdrawal, pressure waveforms are recorded at two
predefined aortic locations: in the ascending aorta and in the descending thoracic aorta just
in front of the esophageal Doppler probe.
Aortic velocity recording VP Loop in ascending aorta and aortic velocity are measured in the
flushing chamber of the left ventricle from the apical five-chamber view by trans-thoracic
echocardiography (TTE) (Philips, EPIQ 7). Descending aortic velocity is measured with a
transesophageal Doppler CardioQ-ODM+ (Deltex Medical, Chichester, UK) in order to construct
the VP Loop in descending thoracic aorta.
VP Loop construction Digitalization of pressure and velocity signals are performed with the
IntelliVue MP60 monitor (Philips, Eindhoven, The Netherlands) at a sampling frequency of 125
Hz and saved using ixTrend software (ixellence, Wildau, Germany) on a computer.
Briefly, the velocity coordinates is plotted on the x axis and the pressure coordinates on
the y axis. The investigators characterise the VP Loop by 4 points (A, B, C, D), allowing us
to identify 3 angles: Alpha, Beta and GALA.
The goal of this study is to evaluate in patients cardiac after-load obtained by VP loop and
to compare VP Loop parameters build in the ascending and descending thoracic aorta according
to patient cardiovascular risk factors.
Experimental design This is a single-center, interventional, category II prospective study
(minimal risks and constraints) Population concerned Patients will be included if their
perioperative risk required a continuous monitoring of MAP and CO. The study involves major
patients under general anaesthesia in interventional neuroradiology.
Research Proceedings For all patients, data from trans-oesophageal Doppler, trans-thoracic
echocardiography (TTE) and hemodynamic data are collected at the end of the procedure. During
catheter withdrawal, pressure waveforms are recorded at two predefined aortic locations: in
the ascending aorta and in the descending thoracic aorta just in front of the esophageal
Doppler probe. All data from monitoring are connected to the main monitor.
Individual benefit:
There is no benefit for the patient
Collective benefit:
Targeting mean arterial pressure (MAP) with boluses of selective peripheral vasopressors
(without positive inotropic or chronotropic effects) could have deleterious effects on
cardiac output. Thus, it seems important to use a combined analysis of MAP and CO with low
invasive methods to estimate the Afterload-related cardiac performance (ACP) in surgical
patients considered with "high cardiovascular risk".
Risks and minimal constraints added by the research No added risk. Patients are included if
their perioperative risk required a continuous monitoring of MAP and CO. The standard of care
for the interventional neuroradiology procedure needs a catheterization of the femoral artery
using the Seldinger technique and insertion of a catheter. All the other ones measures are
obtained non-invasively.
Patients are assigned to one of two groups according to their risk of increased arterial
stiffness as reported in cardiological publications. The criteria used by investigators are
as follows: age > 50 years old as a major criterion 20 and cardio-vascular risk factors
(history of congestive heart failure, history of cardiovascular event, current smoking,
diabetes mellitus, dyslipidemia, and arterial hypertension) as minor criteria. Patients were
classified into the high risk group (Hi-risk) if they had at least one major criterion or two
minor criteria or into the low risk group (Lo-risk) if they presented with no or one minor
criterion.
During their interventional neuroradiology procedure, all patients' routine monitoring will
consist of electrocardiogram, pulsated oxygen saturation, end-tidal CO2, respiratory rate,
tidal volume and monitoring of neuromuscular function.
For all patients whatever the comorbidities, anesthesia induction will be performed using a
target-controlled infusion (Orchestra® Base Primea - Fresenius Kabi France).
According to our standard of care, intra-operative episodes of hypotension (mean arterial
pressure (MAP) < 65 mmHg or < 80% baseline) are treated by Norepinephrine bolus of 10 µg.
For all patients, data from trans-oesophageal Doppler, trans-thoracic echocardiography (TTE)
and hemodynamic data are collected at the end of the procedure. During catheter withdrawal,
pressure waveforms are recorded at two predefined aortic locations: in the ascending aorta
and in the descending thoracic aorta just in front of the esophageal Doppler probe.
Number of selected subjects Selection of patients up to 55 analysable patients Number of
Centre : 1 Research Agenda inclusion period: 12 months duration of participation (treatment +
follow-up): duration of the interventional neuroradiology procedure: 1 day total duration: 12
months Number of planned inclusions by centre and month : 5 Number of subjects required : 55
Statistics
Continuous variables will be expressed as mean ± SD and qualitative variables are expressed
as n (%). For comparison between LR and HR, investigators used the t-test or chi-squared test
for continuous or categorical variables. The comparison of hemodynamic parameters between
ascending and descending aorta is performed by a paired t-test. A Pearson correlation is used
to study the relationship between different hemodynamic indices. Receiver operating
characteristic curves (ROC) and Area under the curves (AUC) will be performed to calculate
the performance of each cardiac afterload index to discriminate LR and HR patients. P-value
less than 5% is considered significant.
The sample size calculation is based on the following assumptions: incidence of Hi-risk
patients of 50%, as previously reported, incidence of increase of intrinsic arterial
stiffness (after-load). In low risk patients a difference in arterial stiffness between low-
and high-risk patients at 30%, power at 80% and type I error at 5%. Accordingly, the
calculated sample size is 55 patients for the entire population.
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