Brief Title
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)
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
Study Type
Observational [Patient Registry]
Primary Outcome
Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance
Secondary Outcome
Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation
Condition
Aortic Valve Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
20
Start Date
September 14, 2017
Completion Date
November 1, 2018
Primary Completion Date
May 1, 2018
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
Gender
All
Ages
18 Years - N/A
Contacts
Caroline FRITZ, MD, +33383157379, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03385785
Organization ID
RNI2017/PRAMTAVI-FRITZ/YB
Responsible Party
Sponsor
Study Sponsor
Central Hospital, Nancy, France
Study Sponsor
Caroline FRITZ, MD, Principal Investigator, Central Hospital, Nancy, France
Verification Date
September 2017