Back to resultsPULsecath mechanicaL Support Evaluation (PULSE)
Primary Purpose
Coronary Artery Disease, Heart Failure, Cardiogenic Shock
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
iVAC2L pVAD
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring pressure-volume loops, cardiac mechanics, high-risk PCI
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥ 18 years;
- Informed Consent must be signed by the patient, prior to HR-PCI;
- The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%);
- Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation.
Exclusion Criteria:
- No written informed consent;
- Left ventricular thrombus;
- Interventricular septal defect;
- Significant peripheral arterial disease or arterial lumen size < 6mm at the level of the common femoral artery;
- Significant aortic valve disease (more than mild aortic stenosis/regurgitation);
- Cardiogenic shock;
- Previous stroke within the last 3 months;
- Major bleeding event within last 3 months;
- Chronic kidney disease with a GFR < 25 mL/min;
Sites / Locations
- Clinic Pasteur
- Erasmus Medical Center
- Kings College London, St. Thomas' Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iVAC2L pVAD
Arm Description
Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L.
Outcomes
Primary Outcome Measures
Change in Pressure-volume Area (PVA)
Numerical continuous variable representing the change in Myocardial Oxygen Consumption (MVO2) following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PVA will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.mL
Secondary Outcome Measures
Change in Cardiac Output
Numerical continuous variable representing the change in Cardiac Output (CO), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in CO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: L/min
Change on the Mean Pulmonary Capillary Wedge Pressure
Numerical continuous variable representing the change in Mean Pulmonary Capillary Wedge Pressure (mPCWP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in mPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Change in the PCWP v-wave
Numerical continuous variable representing the change in PCWP v-wave (vPCWP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in vPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Change in Mean Pulmonary Artery Pressure
Numerical continuous variable representing the change in Mean Pulmonary Artery Pressure (mPAP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in mPAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Change in Pulmonary Artery Oxygen Saturation
Numerical continuous variable representing the change in Pulmonary Artery Oxygen Saturation, also known as Mixed Oxygen Saturation (SVO2), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SVO2 will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: %
Change in Right Atrial Pressure
Numerical continuous variable representing the change in Right Atrial Pressure (RAP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in RAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Change in Preload-recruitable Stroke Work
Numerical continuous variable representing the change in Preload-recruitable Stroke Work (PRSW), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PRSW will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg
Change in the Starling Contractile Index
Numerical continuous variable representing the change in the Starling Contractile Index (SCI), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SCI will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/ml⋅s
Change in End-systolic Wall Stress
Numerical continuous variable representing the change in the End-systolic Wall Stress (WSes), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in WSes will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Change in the first derivative of pressure over time
Numerical continuous variable representing the change in the first derivative of pressure over time (+dP/dtmax), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in +dP/dtmax will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/s
Change in Systemic Vascular Resistance
Numerical continuous variable representing the change in the Systemic Vascular Resistance (SVR), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm^(-5))
Change in Pulmonary Vascular Resistance
Numerical continuous variable representing the change in the Pulmonary Vascular Resistance (PVR), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm^(-5))
Change in Cardiac Power Output
Numerical continuous variable representing the change in the Cardiac Power Output (CPO), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in CPO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: Watts
Change in Hematocrit
Numerical continuous variable. Change in Hematocrit (Ht) as an indicative of bleeding or hemolysis. Unit: %
Change in Hemoglobin
Numerical continuous variable. Change in Hemoglobin (Hb) as an indicative of bleeding or hemolysis. Unit: mmol/L
Change in Platelet Count
Numerical continuous variable. Change in Platelet Count as an indicative of bleeding events. Unit: 10^9/L
Change in haptoglobin
Numerical continuous variable. Change in haptoglobin as an indicative of hemolytic events. Unit: g/L
Change in total and conjugated bilirubin
Numerical continuous variable. Change in total and conjugated bilirubin as an indicative of hemolytic events. Unit: umol/L
Change in lactate dehydrogenase
Numerical continuous variable. Change in lactate dehydrogenase as an indicative of hemolytic events. Unit: U/L.
Change in hs-troponin
Numerical continuous variable. Change in hs-troponin as an indicative of myocardial necrosis. Unit: ng/L
Change in creatinephosphokinase
Numerical continuous variable. Change in creatinephosphokinase (CK) as an indicative of myocardial necrosis. Unit: U/L
Change in creatinophosphokinase MB mass assay
Numerical continuous variable. Change in creatinophosphokinase MB mass assay (CKMB-mass) as an indicative of myocardial necrosis. Unit: ug/L
Change in N-terminal pro b-type natriuretic peptide
Numerical continuous variable. Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) as an indicative of chamber overload. Unit: pmol/L
Change in serum lactate
Numerical continuous variable. Change in serum lactate as an indicative of hypoperfusion states. Unit: mmol/L.
Change in serum creatinine
Numerical continuous variable. Change in serum creatinine as an indicative of acute kidney injury. Unit: umol/L
All-cause mortality
Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Acute myocardial infarction
According to the "Fourth Universal Definition of Acute Myocardial Infarction". Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Stroke or transient ischemic attack
As per VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Repeat revascularization
As per ARC definition - Circulation. 2007;115:2344-2351. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Major Bleeding
Major bleeding (BARC 3 to 5), according to the BARC Bleeding Classification (BARC definitions 2011. Circulation. 2011; 123(23): 2736-47. Time-to-event variable, measured in days.
Major vascular complications
Major vascular complications (e.g.: arteriovenous fistula, limb ischemia), as per VARC-2 definitions (VARC 2 definitions 2013, J Thorac Cardiovasc Surg 2013;145:6-23) . Time-to-event variable, measured in days.
Acute renal dysfunction
Acute renal dysfunction (AKIN 1 or above), using the AKIN Classification as described in the VARC-2 definitions (VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23).
Increase in Aortic regurgitation
Increase in aortic regurgitation by more than one grade (TTE). Binary outcome obtained at the second echocardiogram, performed at discharge.
Severe hypotension
Severe hypotension (MAP < 60mmHg for more than 10 minutes despite fluid resuscitation or use of vasoactive amines to maintain MAP ≥ 60 mm Hg), or shock, defined based on the definition from the SHOCK trial (1) SBP ≤ 90mmHg for at least 30 minutes, (2) Need for vasopressors to maintain SBP > 90mmHg; (3) evidence of end-organ hypoperfusion; (4) Evidence of elevated filling pressures. A similar concept has been applied in the BCIS-1 study to measure procedural instability (JAMA. 2010;304(8):867-874).
Ventricular arrhythmias
VT requiring cardioversion and / or need for CPR. Binary outcome, VF at anytime during follow up. Time-to-event analysis, measured in days.
Angiographic failure
Angiographic failure/ procedural failure, as defined in the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Circulation. 2011;124:e574-e651): post PCI TIMI flow < III, residual stenosis (>50% post-balloon or > 10% post stenting), or presence of thrombus, side branch loss or flow limiting dissection. It is a binary outcome (yes/no answer). No time-to-event analysis will be applied.
Time of hospitalization
Time to hospital discharge (in days).
Change in Left ventricular ejection fraction
Numerical continuous variable. Change in LVEF measured by trans-thoracic echocardiography at baseline and discharge. Not a time-to-event variable. Unit: %
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03200990
Brief Title
PULsecath mechanicaL Support Evaluation
Acronym
PULSE
Official Title
PULsecath mechanicaL Support Evaluation (PULSE) - Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.
Detailed Description
This is a mechanistic exploratory study. The objective is to determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors and cardiac enzymes will be made during and after the use of mechanical circulatory support. These specific patterns are so far unknown. Knowledge of optimal patterns may help in determining the ideal circulatory device platform.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Heart Failure, Cardiogenic Shock
Keywords
pressure-volume loops, cardiac mechanics, high-risk PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iVAC2L pVAD
Arm Type
Experimental
Arm Description
Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L.
Intervention Type
Device
Intervention Name(s)
iVAC2L pVAD
Intervention Description
To determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors, and cardiac enzymes, will be made during and after the use of mechanical circulatory support.
Primary Outcome Measure Information:
Title
Change in Pressure-volume Area (PVA)
Description
Numerical continuous variable representing the change in Myocardial Oxygen Consumption (MVO2) following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PVA will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.mL
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Secondary Outcome Measure Information:
Title
Change in Cardiac Output
Description
Numerical continuous variable representing the change in Cardiac Output (CO), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in CO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: L/min
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change on the Mean Pulmonary Capillary Wedge Pressure
Description
Numerical continuous variable representing the change in Mean Pulmonary Capillary Wedge Pressure (mPCWP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in mPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in the PCWP v-wave
Description
Numerical continuous variable representing the change in PCWP v-wave (vPCWP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in vPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Mean Pulmonary Artery Pressure
Description
Numerical continuous variable representing the change in Mean Pulmonary Artery Pressure (mPAP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in mPAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Pulmonary Artery Oxygen Saturation
Description
Numerical continuous variable representing the change in Pulmonary Artery Oxygen Saturation, also known as Mixed Oxygen Saturation (SVO2), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SVO2 will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: %
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Right Atrial Pressure
Description
Numerical continuous variable representing the change in Right Atrial Pressure (RAP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in RAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Preload-recruitable Stroke Work
Description
Numerical continuous variable representing the change in Preload-recruitable Stroke Work (PRSW), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PRSW will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in the Starling Contractile Index
Description
Numerical continuous variable representing the change in the Starling Contractile Index (SCI), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SCI will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/ml⋅s
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in End-systolic Wall Stress
Description
Numerical continuous variable representing the change in the End-systolic Wall Stress (WSes), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in WSes will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in the first derivative of pressure over time
Description
Numerical continuous variable representing the change in the first derivative of pressure over time (+dP/dtmax), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in +dP/dtmax will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/s
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Systemic Vascular Resistance
Description
Numerical continuous variable representing the change in the Systemic Vascular Resistance (SVR), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm^(-5))
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Pulmonary Vascular Resistance
Description
Numerical continuous variable representing the change in the Pulmonary Vascular Resistance (PVR), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm^(-5))
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Cardiac Power Output
Description
Numerical continuous variable representing the change in the Cardiac Power Output (CPO), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in CPO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: Watts
Time Frame
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Title
Change in Hematocrit
Description
Numerical continuous variable. Change in Hematocrit (Ht) as an indicative of bleeding or hemolysis. Unit: %
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in Hemoglobin
Description
Numerical continuous variable. Change in Hemoglobin (Hb) as an indicative of bleeding or hemolysis. Unit: mmol/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in Platelet Count
Description
Numerical continuous variable. Change in Platelet Count as an indicative of bleeding events. Unit: 10^9/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in haptoglobin
Description
Numerical continuous variable. Change in haptoglobin as an indicative of hemolytic events. Unit: g/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in total and conjugated bilirubin
Description
Numerical continuous variable. Change in total and conjugated bilirubin as an indicative of hemolytic events. Unit: umol/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in lactate dehydrogenase
Description
Numerical continuous variable. Change in lactate dehydrogenase as an indicative of hemolytic events. Unit: U/L.
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in hs-troponin
Description
Numerical continuous variable. Change in hs-troponin as an indicative of myocardial necrosis. Unit: ng/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in creatinephosphokinase
Description
Numerical continuous variable. Change in creatinephosphokinase (CK) as an indicative of myocardial necrosis. Unit: U/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in creatinophosphokinase MB mass assay
Description
Numerical continuous variable. Change in creatinophosphokinase MB mass assay (CKMB-mass) as an indicative of myocardial necrosis. Unit: ug/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in N-terminal pro b-type natriuretic peptide
Description
Numerical continuous variable. Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) as an indicative of chamber overload. Unit: pmol/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in serum lactate
Description
Numerical continuous variable. Change in serum lactate as an indicative of hypoperfusion states. Unit: mmol/L.
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
Change in serum creatinine
Description
Numerical continuous variable. Change in serum creatinine as an indicative of acute kidney injury. Unit: umol/L
Time Frame
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Title
All-cause mortality
Description
Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time Frame
30 days follow up
Title
Acute myocardial infarction
Description
According to the "Fourth Universal Definition of Acute Myocardial Infarction". Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time Frame
30 days follow up
Title
Stroke or transient ischemic attack
Description
As per VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time Frame
30 days follow up
Title
Repeat revascularization
Description
As per ARC definition - Circulation. 2007;115:2344-2351. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time Frame
30 days follow up
Title
Major Bleeding
Description
Major bleeding (BARC 3 to 5), according to the BARC Bleeding Classification (BARC definitions 2011. Circulation. 2011; 123(23): 2736-47. Time-to-event variable, measured in days.
Time Frame
30 days follow up
Title
Major vascular complications
Description
Major vascular complications (e.g.: arteriovenous fistula, limb ischemia), as per VARC-2 definitions (VARC 2 definitions 2013, J Thorac Cardiovasc Surg 2013;145:6-23) . Time-to-event variable, measured in days.
Time Frame
30 days follow up
Title
Acute renal dysfunction
Description
Acute renal dysfunction (AKIN 1 or above), using the AKIN Classification as described in the VARC-2 definitions (VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23).
Time Frame
30 days follow up
Title
Increase in Aortic regurgitation
Description
Increase in aortic regurgitation by more than one grade (TTE). Binary outcome obtained at the second echocardiogram, performed at discharge.
Time Frame
30 days follow up
Title
Severe hypotension
Description
Severe hypotension (MAP < 60mmHg for more than 10 minutes despite fluid resuscitation or use of vasoactive amines to maintain MAP ≥ 60 mm Hg), or shock, defined based on the definition from the SHOCK trial (1) SBP ≤ 90mmHg for at least 30 minutes, (2) Need for vasopressors to maintain SBP > 90mmHg; (3) evidence of end-organ hypoperfusion; (4) Evidence of elevated filling pressures. A similar concept has been applied in the BCIS-1 study to measure procedural instability (JAMA. 2010;304(8):867-874).
Time Frame
First 48 hours after the start of PCI.
Title
Ventricular arrhythmias
Description
VT requiring cardioversion and / or need for CPR. Binary outcome, VF at anytime during follow up. Time-to-event analysis, measured in days.
Time Frame
30 days follow up
Title
Angiographic failure
Description
Angiographic failure/ procedural failure, as defined in the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Circulation. 2011;124:e574-e651): post PCI TIMI flow < III, residual stenosis (>50% post-balloon or > 10% post stenting), or presence of thrombus, side branch loss or flow limiting dissection. It is a binary outcome (yes/no answer). No time-to-event analysis will be applied.
Time Frame
Assessed at the end of the PCI. This time point (end of PCI) can be variable and is estimated in 40 to 270 minutes after the beginning of the procedure.
Title
Time of hospitalization
Description
Time to hospital discharge (in days).
Time Frame
30 days follow up
Title
Change in Left ventricular ejection fraction
Description
Numerical continuous variable. Change in LVEF measured by trans-thoracic echocardiography at baseline and discharge. Not a time-to-event variable. Unit: %
Time Frame
From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is ≥ 18 years;
Informed Consent must be signed by the patient, prior to HR-PCI;
The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%);
Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation.
Exclusion Criteria:
No written informed consent;
Left ventricular thrombus;
Interventricular septal defect;
Significant peripheral arterial disease or arterial lumen size < 6mm at the level of the common femoral artery;
Significant aortic valve disease (more than mild aortic stenosis/regurgitation);
Cardiogenic shock;
Previous stroke within the last 3 months;
Major bleeding event within last 3 months;
Chronic kidney disease with a GFR < 25 mL/min;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas v. Mieghem, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic Pasteur
City
Toulouse
Country
France
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3015CE
Country
Netherlands
Facility Name
Kings College London, St. Thomas' Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35331637
Citation
Bastos MB, McConkey H, Malkin O, den Uil C, Daemen J, Patterson T, Wolff Q, Kardys I, Schreuder J, Lenzen M, Zijlstra F, Redwood S, Van Mieghem NM. Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial. Cardiovasc Revasc Med. 2022 Sep;42:133-142. doi: 10.1016/j.carrev.2022.03.013. Epub 2022 Mar 14.
Results Reference
derived
PubMed Identifier
34317072
Citation
Dedic A, Bastos MB, Van Mieghem NM. Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock. JACC Case Rep. 2020 Sep 23;2(12):1882-1883. doi: 10.1016/j.jaccas.2020.07.026. eCollection 2020 Oct.
Results Reference
derived
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PULsecath mechanicaL Support Evaluation
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