j. cleveland destinatin lvad therapy are we there yet
TRANSCRIPT
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