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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Transaortic Valve Implantation (TAVI) | Elective TAVI with biventricular PV loop monitoring (throughout the procedure) |
| |
| Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER) | Elective mitral TEER with biventricular PV loop monitoring (throughout the procedure) |
| |
| Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER) | Elective tricuspid TEER with biventricular PV loop monitoring (throughout the procedure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure volume (PV) loop measurement | Other | Pressure volume (PV) loop measurement using a conductance catheter |
|
| 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 |
| 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 |
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Inclusion Criteria:
- Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).
Exclusion Criteria:
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Adult patients undergoing elective TAVI or mitral TEER.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoon JM van den Enden, MD | Contact | +31 10 7038896 | a.vandenenden@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas M Van Mieghem, Prof MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41241186 | Derived | van den Enden AJM, van den Dorpel MMP, Mondellini GM, Mattace-Raso AM, Adrichem R, Bastos MB, Schreuder JJ, Lenzen MJ, Kardys I, Geleijnse ML, Nuis RJ, Daemen J, Burkhoff D, Van Mieghem NM. Immediate changes in left ventricular cardiac mechanics following transcatheter aortic valve replacement for severe aortic stenosis - an in-vivo pressure-volume analysis study. Am Heart J. 2026 Mar;293:107302. doi: 10.1016/j.ahj.2025.107302. Epub 2025 Nov 14. |
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| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006349 | Heart Valve Diseases |
| D001024 | Aortic Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000082862 | Aortic Valve Disease |
| D014694 | Ventricular Outflow Obstruction |
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