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)
- Conditions
- Heart FailureValvular Heart DiseaseMitral InsufficiencyTricuspid InsufficiencyAortic Stenosis
- Interventions
- Other: Pressure volume (PV) loop measurement
- Registration Number
- NCT06204783
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 157
- Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER) Pressure volume (PV) loop measurement Elective mitral TEER with biventricular PV loop monitoring (throughout the procedure) Cohort A: Transaortic Valve Implantation (TAVI) Pressure volume (PV) loop measurement Elective TAVI with biventricular PV loop monitoring (throughout the procedure) Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER) Pressure volume (PV) loop measurement Elective tricuspid TEER with biventricular PV loop monitoring (throughout the procedure)
- Primary Outcome Measures
Name Time Method Cardiac mechanoenergetics Periprocedural time window The change in cardiac mechanoenergetics (stroke work, potential energy and pressure-volume area in mmHg/mL) induced by the particular procedure
- Secondary Outcome Measures
Name Time Method Mortality 30-day follow-up All-cause
Hospital stay 30-day follow-up in days
Preload recruitable stroke work (mmHg/mL) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL) Periprocedural change (directly before vs. after the procedure) With Ees/Ea ratio reflecting ventricular-vascular coupling
End-systolic and end-diastolic volume (mL) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
V0, V15, V30 and V100 mmHg (mL) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
Beta (ventricular stiffness constant, unitless) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
Stroke volume (mL) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
Starling Contractile Index (mmHg/mL) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
Postprocedural morbidity (%) 30-day follow-up including acute kidney failure, cardiac decompensation and unexpected need for vasopressor or inotropic support (all yes/no)
Tau (ms) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
Intraventricular dyssynchrony (%) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
End-systolic and end-diastolic pressure (mmHg) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
SW/PVA ratio (based on the primary outcome) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
dP/dt min and dP/dt max (mmHg/sec) Periprocedural change (directly before vs. after the procedure) Based on perprocedural conductance catheter measurements
Trial Locations
- Locations (1)
Erasmus Medical Center
🇳🇱Rotterdam, Zuid-Holland, Netherlands