Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure (PRAM-TAVI)

Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)

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 Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis; Ventricular Dysfunction, Left

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Caroline FRITZ, MD; Phone Number: +33383157379; Email: c.fritz@chru-nancy.fr
• Study Contact Backup: Name: Bruno LEVY, MD, PhD; Phone Number: +33383154469; Email: b.levy@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • FRITZ
    • Contact: Caroline FRITZ, MD; Phone Number: +33383157379; Email: c.fritz@chru-nancy.fr
    • Contact: Bruno LEVY, MD,PhD; Phone Number: +33383154469; Email: b.levy@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patients hospitalized for TAVI

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcatheter aortic valve implantation (TAVI) impact on cardiac energy performance	Mesurement of the cardiac cycle efficency (CCE) by PRAM method (Pressure Recording Analytical Method)	Change from baseline CCE at 30 minutes after transcatheter aortic valve implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic cardiac energy performance modification after transcatheter aortic valve implantation	Echocardiography explorations (end diastolic diameter, end systolic diameter, diastolic wall thickness, systolic wall thickness, end diastolic volume, end systolic volume, percent fractional shortening, percent ejection fraction)	Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia risk	Buffington index (calculated as : mean arterial pressure / heart rate)	Change from baseline at 24 hours after transcatheter aortic valve implantation
Myocardial ischemia	Serum troponin level	Change from baseline at 24 hours after transcatheter aortic valve implantation

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Caroline FRITZ, MD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Hemodynamic; Monitoring; Transcatheter aortic valve replacement; Pressure Recording Analytical Method; Ventriculo-arterial coupling
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: RNI2017/PRAMTAVI-FRITZ/YB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No