Destination LVAD Therapy: Are We There Yet?

Joseph C. Cleveland, Jr., MDProfessor of Surgery, Vice - Chair Faculty Affairs

Surgical Director Cardiac Transplantation and MCSUniversity of Colorado Anschutz Medical CenterCardiovascular Summit 3/6/16

Disclosures

• Heartware: Grant Support as PI of Endurance Trial

• St Jude/Thoratec: National PI of Momentum 3 trial

• Edwards Lifesciences: Co-Investigator of Partner II S3i trial

• Will speak about Investigational Device • Heartmate 3

Objectives

• Address knowledge gaps in Ventricular Assist Devices

• Understand appropriate patient selection for LVAD

• Understand Ongoing Trials for LVAD Therapy

LVAD Indications

• Acute Cardiogenic Shock– Postcardiotomy– AMI– Myocarditis

• Bridge to Transplantation• Destination Therapy

LVAD Indications

• Acute Cardiogenic Shock– Postcardiotomy– AMI– Myocarditis

• Bridge to Transplantation• Destination Therapy

Destination Therapy = Long Term Durable Mechanical Support

• Patients who are not candidates for heart transplantation– NYHA Class IV– Optimal medical treatment (ACE and B Blockers)

for 45 of 90 days– IABP dependent for 7 days– IV Inotrope dependent for 14 days– LV EF <25%– Peak VO2 < 14 ml/kg/min*

Why are Patients Deemed DT

• Age (>65)*• Co-morbid conditions

– COPD– PVD– Diabetes Mellitus

• Adherence/Compliance*

Rose EA, et al New England Journal of Medicine 2001

Heartmate XVE 2001-2006

Heartware HVAD 2009-Present*

Heartmate II LVAD 2005-Present* FDA Approved for BTT, not DT

Destination Therapy survival improvement over time

1. Jorde UP, Khushwaha SS, Tatooles AJ, et al. Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry. Presented at the ISHLT annual meeting, April 25, 2013.

DT Now Accounts for Almost 50% of LVAD Placements

LVAD Therapy in 2015

Good of LVADs

• Survival has improved dramatically over 25 years– 25% to 80% 1 year survival– 4 years – ½ of these patients are alive !

• Continuous flow technology has allowed for smaller size and more reliable pumps

• ROADMAP Trial leads some credence to the concept of earlier implantation = better results

Bad/Ugly of LVADS

Adverse Events

HeartMate 3™

with Full MagLev™

Designed with a Healthy Respect for the Blood

*Caution: Investigational device. Limited by Federal US law to investigational use

How much difference is there?From a Red Blood Cell’s Point of View

Gap Size # of Red Blood Cells

Full MagLev 1,000μm 167

Hydrodynamic Bearing 50μm 8

6-8 μm

Stacked RBCs

Summary

• Destination Therapy for LVAD continues to increase

• One year survival approximates 80%• Adverse events remain the limiting factor to

increasing adoption of this technology• Full mag lev technology offers promise for

reducing adverse events