PULsecath mechanicaL Support Evaluation

This is a mechanistic exploratory study. The objective is to determine the effects of the new
PFLVAD PulseCath® iVAC2L and the CFLVAD Impella CP 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
and will be compared with the LV-to-arterial continuous flow CFLVAD Impella CP. Ten cases
treated with Impella CP will be included in this study to obtain the exact same variables for
comparing purposes. Knowledge of optimal patterns may help in determining the ideal
circulatory device platform. If a difference is demonstrated, a randomized trial could be
designed to detect differences in clinical outcomes between pulsatile and continuous flow
circulatory support.

Inclusion Criteria:

1. Patient is ≥ 18 years;

2. Informed Consent must be signed by the patient, prior to HR-PCI;

3. The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may
present with left ventricular systolic dysfunction (ejection fraction ≤40%);

4. 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:

1. No written informed consent;

2. Left ventricular thrombus;

3. Interventricular septal defect;

4. Significant peripheral arterial disease or arterial lumen size < 6mm at the level of
the common femoral artery;

5. Significant aortic valve disease (more than mild aortic stenosis/regurgitation);

6. Cardiogenic shock;

7. Previous stroke within the last 3 months;

8. Major bleeding event within last 3 months;

9. Chronic kidney disease with a GFR < 25 mL/min;