New Mechanical Circulatory Support for HighRisk PCI Nicolas

Within the past 12 months, I have had a financial interest/arrangement or affiliation with

Van Diepen et al. Circulation 2017, In press

MCS Assets Ø High-risk PCI ü Poor LV function ü Very complex coronary anatomy

Additional personal considerations Ø MCS may provide HD stability to perform a challenging execution

IABP vs. Continuous MCS Meta-analysis ✗ ✗ ✗ ü Continuous MCS improves HD parameters

PROTECT II – Impella 2. 5 vs. IABP Intention to trea n = 448

PROTECT II – Impella 2. 5 vs. IABP As treated analysis O’Neill et al.

Cardiac Flow support by MCS * PHP Heartmate i. VAC 2 L – Pulse.

Abbott Thoratec PHP Catheter 13 F Outer Sheath Flexible Inner Sheath Collapsible Nitinol Cannula

Pulse. Cath i. VAC 2 L Ø 17 F catheter across aortic valve is

i. VAC 2 L Hemodynamic Effects 1 F M. Bastos, J. Schreuder, N. Van

Pulse Trial ü Prospective observational study ü 4 Centers ü N = 40 patients

In Conclusion ² Literature on MCS in Shock/high-risk PCI is relatively scarce ² Small

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New Mechanical Circulatory Support for High-Risk PCI Nicolas M. Van Mieghem, MD, Ph. D, FESC, FACC Director of Interventional Cardiology Thoraxcenter, Erasmus MC, Rotterdam

Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship • Grant/Research Support & consulting Fees Company • Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Acist, Claret, Terumo, Pulse. Cath, Essential Medical

Van Diepen et al. Circulation 2017, In press

MCS Assets Ø High-risk PCI ü Poor LV function ü Very complex coronary anatomy ü Three-vessel disease in-hospital mortality 5% to 15% ü Treating single remaining vessel ü Unprotected LM stem disease Ø Cardiogenic Shock Ø EP Ablation with concomitant poor RV or LV function

Additional personal considerations Ø MCS may provide HD stability to perform a challenging execution ² Poor LV or diffuse CAD ü Heavy calcification ± atherectomy ü Complex bifurcation Ø No compromise when aiming for a perfect result Ø Alternative to “quick and dirty” approach ² In younger patients ² When perfect result is required

IABP vs. Continuous MCS Meta-analysis ✗ ✗ ✗ ü Continuous MCS improves HD parameters at expense of access complications Thiele et al. EHJ 2017: 38: 3523 -31

PROTECT II – Impella 2. 5 vs. IABP Intention to trea n = 448 t As treated O’Neill et al. Circulation 2012; 126: 1717 -1727

PROTECT II – Impella 2. 5 vs. IABP As treated analysis O’Neill et al. Circulation 2012; 126: 1717 -1727

Cardiac Flow support by MCS * PHP Heartmate i. VAC 2 L – Pulse. Cath* * Pulsatile Adapted from JACC Interventions 2016; 9: 871 -83

MCS Effects

MCS Landscape M Bastos, NM Van Mieghem

New MCS Technologies

Abbott Thoratec PHP Catheter 13 F Outer Sheath Flexible Inner Sheath Collapsible Nitinol Cannula Collapsible Elastomeric Impeller Flexible Atraumatic Tip w/ Guidewire Lumen Van Mieghem et al. Euro. Intervention 2016. Epub ahead of print

Pulse. Cath i. VAC 2 L Ø 17 F catheter across aortic valve is connected to an extracorporeal membrane pump Ø i. VAC 2 L actively aspirates blood from the left ventricle in systole and ejects this blood into the ascending aorta during diastole Ø Pump is compatible with standard IABP console as a driver Van Mieghem et al. Euro. Intervention 2015; 11: 835 -9

i. VAC 2 L Hemodynamic Effects 1 F M. Bastos, J. Schreuder, N. Van Mieghem Euro. Intervention 2018 In Press

Pulse Trial ü Prospective observational study ü 4 Centers ü N = 40 patients ü High-risk PCI ü i. VAC 2 L (or Impella CP) & PV Loops with conductance catheter ü Assess hemodynamic unloading of LV

In Conclusion ² Literature on MCS in Shock/high-risk PCI is relatively scarce ² Small sample sizes ² Tough & slow enrollments ² New MCS technologies emerge ² Further research needed to ü Understand MCS support ü Refine indications ü Guide MCS selection