Aortic Stenosis, Heart Failure, Mitral Insufficiency, Tricuspid Insufficiency, Valvular Heart Disease
Conditions
Keywords
Pressure-volume loop, Cardiac mechanoenergetics
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.
Interventions
OTHERPressure volume (PV) loop measurement
Pressure volume (PV) loop measurement using a conductance catheter
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Preload recruitable stroke work (mmHg/mL) | Periprocedural change (directly before vs. after the procedure) | Based on perprocedural conductance catheter measurements |
| 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 |
| dP/dt min and dP/dt max (mmHg/sec) | 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 |
| End-systolic and end-diastolic pressure (mmHg) | 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 |
| V0, V15, V30 and V100 mmHg (mL) | 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 |
| Beta (ventricular stiffness constant, unitless) | Periprocedural change (directly before vs. after the procedure) | Based on perprocedural conductance catheter measurements |
| Mortality | 30-day follow-up | All-cause |
| Hospital stay | 30-day follow-up | in days |
| Postprocedural morbidity (%) | 30-day follow-up | including acute kidney failure, cardiac decompensation and unexpected need for vasopressor or inotropic support (all yes/no) |
| Starling Contractile Index (mmHg/mL) | Periprocedural change (directly before vs. after the procedure) | Based on perprocedural conductance catheter measurements |
Countries
Netherlands
Contacts
Primary ContactAntoon JM van den Enden, MD
Outcome results
None listed