The primary objective of this study is to describe and to quantify the change in cardiac mechanoenergetics, expressed by PVL monitoring (reflected by the parameters stroke work, potential energy and pressure-volume area), in patients undergoing…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints comprise the differences in cardiac mechanoenergetics
in individual patients, measurements before the intervention will be compared
to measurements obtained immediate following the structural heart intervention
in all cohorts. Cardiac mechanoenergetics are reflected by the parameters
stroke work (SW, mmHg ml-1) and potential energy (PE, mmHg ml-1), together
forming the pressure volume area (PVA, mmHg ml-1). SW, PE and PVA are obtained
using real-time PVL measurements. Study parameters will be investigated for
both ventricles, irrespective of study cohort.
Secondary outcome
Secondary endpoints of the study are differences in the following parameters,
all derived from PVL plots and subsequent calculations. According to the
primary endpoints, measurements before the intervention will be compared to
measurements obtained immediate following the structural heart intervention.
All parameters will be investigated for both the left and right ventricle,
irrespective of study cohort. The following parameters will be investigated:
• Stroke volume (SV, mL).
• Preload recruitable stroke work (PRSW in mmHg ml-1, calculated as SW / EDV)
(reflecting myocardial contractility, largely independent of heart size).
• Tau (reflecting lusitropy in ms).
• Intraventricular dyssynchrony (in % on a systolic as well as diastolic level).
• dP/dt (reflecting the maximal and minimal intraventricular pressure changes
in mmHg s-1 as dP/dt max and dP/dt min).
• End-systolic elastance (Ees) and effective arterial elastance (Ea), both in
mmHg -1 with Ees/Ea indicating ventricular-arterial coupling.
• End-diastolic volume (EDV, mL).
• End-diastolic pressure (EDP, mmHg).
• End-diastolic pressure-volume relation (EDPVR, mmHg mL-1).
• EDV / dP/dt max (reflecting the myocardial contractile state).
• End-systolic volume (ESV, mL).
• End-systolic pressure (ESP, mmHg).
• End-systolic pressure-volume relation (ESPVR, mmHg mL-1).
• Starling contractile index (SCI, dP/dt max / EDV) (the preload adjusted
contractility index in mmHg s-1 ml-1).
• SW / PVA ratio (an index of ventricular function and efficiency from
perspective of cardiomechanics).
• V0 (mL, ventricular volume at 0 mmHg) (for the correct interpretation of
ESPVR).
• V15 (mL, ventricular volume at 15 mmHg) (as a guide for RV contractility).
• V30 (mL, ventricular volume at 30 mmHg (reflecting ventricular compliance).
• V100 (mL, ventricular volume at 100 mmHg (reflecting LV contractility).
• Ventricular stiffness constant β (ml-1).
The following parameters will also be obtained at the time of PVL measurement
(i.e. before and after the structural heart intervention):
• Cardiac output (L min-1 measured by thermodilution, making use of a Swan-Ganz
pulmonary artery catheter). Cardiac output measurements facilitates stroke
volume estimation, necessary for the volumetric calibration of PVL estimates).
Both forward as well as power cardiac output will also be obtained.
• PAP and PCWP (both in mmHg).
• Level of vasopressor and inotropic drug support (e.g. norepinephrine in x µg
kg min-1), defined according to the vasoactive-inotropic score (VIS) (25).
• Details obtained from routine cardiac imaging (transthoracic or
transesophageal echocardiography or CT) assessments during procedural work-up,
especially focussing on ventricular dimensions and valvular (mal)functioning.
During a 30-day follow-up (irrespective of study cohort), patient records will
be screened for all-cause mortality, hospital and ICU stay (in days) and
necessity for vasopressor in inotropic drug support. The following laboratory
results (available results closest following surgery) will be copied from
patient records (no additional blood test required): creatinine level (µmol
L-1), NT-pro-BNP (pmol L-1) and high-sensitive troponin T level (ng L-1). Acute
kidney failure in the 30-day follow-up period will be defined according to 2005
KDIGO guidelines (26). Patients records will also be screened 1 month and 1
year following the structural heart intervention to appreciate patient
morbidity as well as routine echocardiographic quantifications reflecting
ventricular dimensions and valvular (mal)functioning.
Background summary
Pressure-Volume Loop (PVL) monitoring is a monitoring tool for the direct
visualization of individual cardiac and hemodynamic physiology, including
parameters reflecting cardiac mechanoenergetics (a derivative of the myocardial
metabolic demand, reflected by the parameters stroke work, potential energy and
pressure-volume area) as well as the ventricular-arterial coupling. The
concepts surrounding 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 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) PVL monitoring can be of direct clinical
relevance given the ability of PVL monitoring to appreciate the ventricular
tolerance of increased cardiac afterload induced by the particular intervention
in individual patients. In future, real-time PVL analysis can be adjunctive to
the individual decision-making process during routine structural heart
interventions.
A substudy will be added to the protocol investigating the interaction between
PEEP and LV Pressure-Volume Area for patients who will undergo mitral TEER.
Study objective
The primary objective of this study is to describe and to quantify the change
in cardiac mechanoenergetics, expressed by PVL monitoring (reflected by the
parameters stroke work, potential energy and pressure-volume area), in patients
undergoing structural heart interventions. Study objectives will be
investigated throughout multiple patient cohorts addressing structural heart
interventions: patient undergoing TAVI (cohort A), mitral TEER (cohort B) and
tricuspid TEER (cohort C).
Secondary objectives of this study are:
(1) to assess the change in different parameters reflecting cardiac and
hemodynamic physiology induced by structural heart interventions, derived from
PVL-monitoring, beyond the change in cardiac mechanoenergetics
(2) to compare changes in cardiac and hemodynamic physiology (derived from
PVL-monitoring) induced by structural heart interventions, between patients
with improved or stabilized functional capacity versus worsening in functional
capacity (reflected by New York Heart Association (NYHA) class)
(3) to assess changing interventricular dependence (i.e. the ventricular
crosstalk) induced by endovascular valvular interventions, expressed by
biventricular PVL measurements.
(4) for cohort A: to investigate the hemodynamic impact of ventricular
tachypacing during TAVI on PVL-derived parameters reflecting cardiac and
hemodynamic physiology, including an appraisal of (the physiological effects
of) conceivable ventricular stunning
Study design
Single-center prospective observational (non-therapeutic, medical device) study
with invasive measurements.
Study burden and risks
Participating in the PLUTO-II trial does not offer any benefit to the included
patient, apart from ameliorating (scientific) perspectives regarding cardiac
physiology surrounding structural heart interventions as well as regarding
hemodynamic research in general. Study questions could not be answered without
participation of patients belonging to the study group in question (i.e.
patients undergoing elective TAVI, mitral TEER or tricuspid TEER) and the study
is thereafter considered group-related. The risks and burden directly
attributable to study participation are considered moderate. Potential
complications directly attributable to invasive PVL monitoring are comparable
to diagnostic heart catheterization, including (groin) hematoma,
retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, vascular
dissection, thrombosis and embolism, death, myocardial infarction, stroke and
arrhythmia. Diagnostic heart catheterization includes a risk for developing
major complications of less than 1% and a mortality risk of 0.05%. Additional
vascular access including sheath insertion might be mandatory for
pressure-volume loop monitoring. Of note, the aforementioned risk is already
present and inherent to the scheduled intervention. Swan-Ganz pulmonary artery
catheter insertion is always necessary, allowing thermodilution-based
volumetric calibration of PVL measurements. The insertion of a Swan-Ganz
pulmonary artery catheter comprehends a risk of possible complications,
including development of pulmonary infarction, vascular lesions as well as
morbidity directly attributable to central venous access, but can be customary
in structural heart interventions. The incidence of complicated Swan-Ganz
insertion is estimated between 2 and 17%, with an incidence of pulmonary artery
lesions between 0.1 and 1.5% and puncture site infection approaching 17% (the
latter increasing with prolonged Swan-Ganz insertion). Individual enrolled
patients do not benefit from participation in this prospective study.
Potential complications of the alveolar recruitment (e.g. barotrauma and
hemodynamic instability) are considered negligible as the safe airway pressure
threshold (defined as Peak Pressure < 40 cmH20) will be safeguarded
continuously during the study measurement.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for TAVI.
- Scheduled for mitral TEER (Mitraclip).
- Scheduled for tricuspid TEER (Triclip).
Patients undergoing elective TAVI, mitral TEER or tricuspid TEER are eligible
for study participation irrespective of device specifications or device
manufacturer. Such technical details, (including valve size or brand), do not
preclude study eligibility.
Exclusion criteria
- Age < 18 years.
- Confirmed or suspected (concomitant) congenital heart disease.
- Mechanical circulatory support (including Impella, PulseCath, Intra-Aortic
Balloon Counterpulsation or Extracorporeal Membrane Oxygenation) used during
the procedure aiming for improved cardiac output.
- No (written) informed consent was obtained.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79303.078.22 |
| Other | Wordt t.z.t. geregistreerd |