Clinical trial NCT03385785: Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure
Official title: Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Ventricular Dysfunction, Left
Keywords: Transcatheter aortic valve replacement
Pressure Recording Analytical Method
Ventriculo-arterial coupling
Monitoring
Hemodynamic
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients hospitalized for TAVI

Brief summary: Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications.

Intrinsic ventricular performance can be characterized using three parameters:

* Ventricular elastance (Ees for End Systolic Elastance) which represents the index of ventricular contractility independently of the load.
* Arterial elastance (Ea for Arterial Elastance) which represents the post-load
* The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency.

For patients with high surgical risk (EuroSCORE II\> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended for aortic valve replacement. Many complications may occur after TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved.

Cardiac energy analysis plays an additional role in understanding the clinical patients conditions. On this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions.

Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (Ea) cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed.

TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables before and after aortic valve replacement by TAVI


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* elective TAVI intervention with femoral access
* consent

Exclusion Criteria:

* permanent arrhythmias
* pacemaker dependency
* moderate to severe mitral or tricuspid valve regurgitation
* intracardiac shunt

Primary outcomes:
measure: Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance
timeFrame: Change from baseline CCE at 30 minutes after transcatheter aortic valve implantation
Secondary outcomes:
measure: Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation
timeFrame: Change from baseline at 24 hours after transcatheter aortic valve implantation
measure: Myocardial ischemia risk
timeFrame: Change from baseline at 24 hours after transcatheter aortic valve implantation
measure: Myocardial ischemia
timeFrame: Change from baseline at 24 hours after transcatheter aortic valve implantation
Other outcomes:
Locations:
city: Nancy
country: France
facility: FRITZ
Study officials:
affiliation: Central Hospital, Nancy, France
name: Caroline FRITZ, MD
role: PRINCIPAL_INVESTIGATOR
References: