Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure

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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