Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation100 enrolled

Overview

Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes. Mechanical circulatory support (MCS) devices may offer hemodynamic stabilization during PCI, potentially improving short- and long-term outcomes. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention. The transaortic system for short-term circulatory support with pulsatile blood flow iVAC 2L consists of an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) with a patented two-way rotary valve. The pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole. The primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.

Although coronary artery bypass grafting (CABG) remains the standard treatment for patients with multivessel coronary artery disease, there is growing interest in performing protected percutaneous coronary intervention (PCI) in high-risk patients. Protected PCI involves the use of temporary mechanical circulatory support (MCS) devices during and shortly after the procedure to maintain hemodynamic stability and reduce the risk of complications such as acute left ventricular failure. This approach offers a safer alternative to open-heart surgery in patients for whom CABG poses significant operative risks. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention. On admission patients will undergo ECG, echocardiography, routine blood tests including complete blood count and basic metabolic panel. After then the patient's risk will be assessed by the institution's heart team (presence of severe coronary artery disease, acute coronary syndrome, other comorbidities including renal disease, diabetes mellitus, chronic and acute heart failure etc.). For placement of the iVAC 2L transaortic device the patient will be transported to the X-ray operating room. The transaortic system for short-term circulatory support with pulsatile blood flow that consists of three main components: an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) and a patented two-way rotary valve. The pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole. Advantages of the iVAC 2L include a minimally invasive implantation technique, pulsatile flow that may be more physiologic compared to continuous flow devices, and a lower risk of hemolysis and vascular complications compared to other MCS devices. After surgery further monitoring of the patient will be carried out in the intensive care unit. During hospitalization treatment and diagnostic evaluation of patients will be done according to current clinical practice guidelines. The primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Multidisciplinary heart team consensus for high-risk PCI. HR-PCI was defined as any percutaneous intervention for coronary disease involving an unusually high risk of periprocedural circulatory collapse. * Signed Informed Consent to participate in the study Exclusion Criteria: * Femoral artery diameter \< 6.0mm * Significant biventricular or right heart failure * Thrombus in the left ventricle * Presence of a mechanical aortic valve * Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less) or moderate-to-severe aortic insufficiency (echocardiographic assessment graded as ≥+2) * Severe peripheral arterial disease precluding placement of the iVAC2L * Combined cardiorespiratory failure * Presence of an atrial or ventricular septal defect (including post infarct VSD) * Left ventricular rupture * Cardiac tamponade * Presence of any other subtype of shock * Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.) * Recent major bleeding event (\< 3 months) * Recent stroke (\< 3 months)

Outcomes

Primary Outcomes

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 frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.

Secondary Outcomes

Major vascular complications

Complications include development of limb ischemia after PCI, bleeding in access site, development of arteriovenous fistula and infectious access site complications, as per VARC-2 definitions.

Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.

Incidence of recurrent myocardial infarction or reinfarction

According to the Fourth Universal Definition of Myocardial Infarction (ESC, 2018)

Time frame: During the 360-day follow-up period

Angiographic failure

Angiographic failure/procedural failure, as defined in the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Circulation: post-procedure TIMI flow \< grade 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).

Time frame: Immediately after PCI.

Incidence of intraprocedural complications

Including life-threatening ventricular arrhythmias, cardiac arrest, and progression of cardiogenic shock (as per SCAI classification)

Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.

Left ventricular myocardial function

Ejection fraction, measured in percentages; based on trans-thoracic echocardiographic assessment

Time frame: At day 7 after PCI or at discharge, if earlier.

Incidence of acute kidney injury

Assessed via changes in serum creatinine and/or urine output, according to KDIGO 2012 criteria

Time frame: At day 7 after PCI or at discharge, if earlier.

Angiographic characteristics

SYNTAX score (to estimate the complexity of coronary artery disease, higher score is associated with poor clinical outcomes) before and after the procedure, anatomical characteristics of the coronary arteries (three-vessel, unprotected left main, last remaining vessel and bifurcational lesions), the use of intravascular imaging (ex. IVUS).

Time frame: From the beginning of the PCI until its conclusion. The PCI is estimated to be from 40 to 270 minutes.

Number of Participants with ventricular arrhythmias

VT requiring cardioversion and/or need for CPR. Binary outcome, VF during hospitalization.

Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.

Number of participants with progression of cardiogenic shock

As defined by SCAI-CSWG in 2022

Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.

Number of participants with major bleeding

Major bleeding (BARC 3 to 5) after PCI, according to the BARC Bleeding Classification 2011.

Time frame: At day 7 after PCI or at discharge, if earlier.

Number of participants with acute myocardial infarction

According to the Fourth Universal Definition of Acute Myocardial Infarction (ESC, 2018). 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 frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.

Number of participants with stroke or transient ischemic attack

As per VARC 2 definitions 2013. 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 frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.

Repeat revascularization

As per ARC definition 2007. 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 frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.

Intraprocedual device-related characteristics

Implantation failure, device operating mode (internal or ECG synchronized), duration of device runtime (measured in minutes), device dislocation, use of other MCS

Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.

Change in Left ventricular ejection fraction

Numerical continuous variable. Change in LVEF measured by trans-thoracic echocardiography at baseline and discharge. Measured in percentages.

Time frame: From baseline (before the PCI) to the moment of discharge, typically on the 5-7 day after PCI.

Severity of aortic valve regurgitation