Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II) (PLUTO-II)

The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Aortic Stenosis; Valvular Heart Disease; Mitral Insufficiency; Tricuspid Insufficiency
• Intervention / Treatment: Other: Pressure volume (PV) loop measurement

Detailed Description

Pressure-Volume (PV) loop monitoring is a tool allowing direct visualization of individual cardiac and hemodynamic physiology, including parameters reflecting cardiac mechanoenergetics (a derivative of the myocardial metabolic demand) as well as the ventricular-arterial coupling. The concepts of changing biventricular cardiac and hemodynamic physiology induced by structural heart interventions, including Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Edge-to-Edge Mitral Repair (mitral TEER) and Transcatheter Edge-to-Edge Tricuspid Repair (tricuspid TEER) are largely based on hypotheses, computer simulations and non-invasive (echocardiographic) estimations. PVL monitoring has the potential to identify unique characteristics of TAVI, mitral TEER and tricuspid TEER from the perspective of changing baseline cardiovascular physiology, including (a change in) interference between both ventricles (i.e. the ventricular crosstalk). Perprocedural (biventricular) PV loop monitoring can be of direct clinical relevance by appreciating the ventricular tolerance of increased cardiac afterload induced by the particular intervention in individual patients. In future, real-time PV loop analysis can be adjunctive to the individual decision-making process during routine structural interventions.

• Study Type: Observational
• Enrollment (Estimated): 157

Contacts and Locations

• Study Contact: Name: Antoon JM van den Enden, MD; Phone Number: +31 10 7038896; Email: a.vandenenden@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus Medical Center
      • Principal Investigator: Nicolas M Van Mieghem, Prof MD PhD
      • Contact: Antoon JM van den Enden; Phone Number: +31 70 308896; Email: a.vandenenden@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective TAVI or mitral TEER.

Description

Inclusion Criteria:

- Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).

Exclusion Criteria:

• Confirmed or suspected (concomitant) congenital heart disease.
• Mechanical circulatory support (including Impella, PulseCath, Intra-Aortic Balloon Counterpulsation or Extracorporeal Membrane Oxygenation) was used during the procedure aiming to improve native cardiac output.
• No (written) informed consent was obtained.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A: Transaortic Valve Implantation (TAVI); Elective TAVI with biventricular PV loop monitoring (throughout the procedure)	Other: Pressure volume (PV) loop measurement; Pressure volume (PV) loop measurement using a conductance catheter
Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER); Elective mitral TEER with biventricular PV loop monitoring (throughout the procedure)	Other: Pressure volume (PV) loop measurement; Pressure volume (PV) loop measurement using a conductance catheter
Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER); Elective tricuspid TEER with biventricular PV loop monitoring (throughout the procedure)	Other: Pressure volume (PV) loop measurement; Pressure volume (PV) loop measurement using a conductance catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac mechanoenergetics	The change in cardiac mechanoenergetics (stroke work, potential energy and pressure-volume area in mmHg/mL) induced by the particular procedure	Periprocedural time window

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke volume (mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Preload recruitable stroke work (mmHg/mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Tau (ms)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Intraventricular dyssynchrony (%)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
dP/dt min and dP/dt max (mmHg/sec)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL)	With Ees/Ea ratio reflecting ventricular-vascular coupling	Periprocedural change (directly before vs. after the procedure)
End-systolic and end-diastolic volume (mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
End-systolic and end-diastolic pressure (mmHg)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Starling Contractile Index (mmHg/mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
V0, V15, V30 and V100 mmHg (mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
SW/PVA ratio (based on the primary outcome)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Beta (ventricular stiffness constant, unitless)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Mortality	All-cause	30-day follow-up
Hospital stay	in days	30-day follow-up
Postprocedural morbidity (%)	including acute kidney failure, cardiac decompensation and unexpected need for vasopressor or inotropic support (all yes/no)	30-day follow-up

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Nicolas M Van Mieghem, Prof MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): May 14, 2024
• Study Completion (Estimated): May 14, 2025

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pressure-volume loop; Cardiac mechanoenergetics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Diseases; Aortic Valve Stenosis; Mitral Valve Insufficiency; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: PLUTO-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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