The VentrAssist U.S. The VentrAssist U.S. Pivotal Bridge to Pivotal Bridge to Cardiac Cardiac Transplantation Trial Transplantation Trial A Boyle, N Moazami, R John, G Ewald, A Anyanwu, S Pinney, S Desai, N Burton, J Teuteberg, R Kormos, M Parides, A Gelijns, D Ascheim, U Rawiel, L Joyce, and the VentrAssist Investigators University of Minnesota, Washington University, Mt. Sinai School of Medicine, Inova Fairfax Hospital, University of Pittsburgh
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The VentrAssist U.S. The VentrAssist U.S. Pivotal Bridge to Cardiac Pivotal Bridge to Cardiac
Transplantation TrialTransplantation Trial
A Boyle, N Moazami, R John, G Ewald, A Anyanwu, S Pinney, S Desai, N Burton, J Teuteberg, R Kormos, M Parides, A Gelijns, D Ascheim, U
Rawiel, L Joyce, and the VentrAssist Investigators
University of Minnesota, Washington University, Mt. Sinai School of Medicine, Inova Fairfax Hospital, University of Pittsburgh
Presenter Disclosure InformationAndrew J. Boyle, MD
The following relationships exist related to this presentation:
Scientific Advisor Ventracor no financial relationship
Bridge To Transplant Pivotal Trial DesignBridge To Transplant Pivotal Trial Design
Multi-center, prospective, single-arm study
Performance goal set by FDA (75% success rate)
Null hypothesis: Treatment with VentrAssist LVAD is non-inferior to the Performance Goal
Non-inferiority margin = 10%
Pre-specified Interim Analysis after 98 outcomes (70%): Null hypothesis rejected if 74 or more successes (observed success rate of 75.5%)
Study EnrollmentStudy EnrollmentTarget Enrollment
n = 144
Pre-specified interim analysis 2/09
98 patients reached endpoint and available for outcomes analysis
138 patients enrolled and available for SAE analysis
One patient received a BiVAD and not a VentrAssist device.One patient received a Thoratec LVAD and not a VentrAssist device.One patient had an esophageal perforation during initial implant procedure and did not receive a VentrAssist device.
EndpointsEndpointsPrimary endpoint:
• Success
― Survival to transplantation or
― On support for ≥180 days and listed UNOS 1A/1B
• Failure
― Mortality prior to outcome
― Device replacement prior to outcome
Secondary endpoints:
• INTERMACS defined SAEs
• Quality of life
• Functional status
• Neurocognitive function
Inclusion CriteriaInclusion Criteria
Age ≥ 18 yrs
BSA ≥ 1.5 m2
Approved for transplant & listed as Status 1A or 1B
Clinical indication for BTT LVAD
Exclusion CriteriaExclusion Criteria Cardiotomy within 30 days
Acute MI within 48 hours
Hypertrophic or restrictive cardiomyopathy
Prior heart transplant or LVAD
Mechanical aortic or mitral valve
> 1+ aortic insufficiency
Platelets < 80,000 or coagulopathy
Anticipated need for RVAD
PVR > 8 Woods units
Creatinine > 3.5 mg/dl or dialysis
Liver function tests > 5 X upper limits of normal
Stroke < 90 days
Contraindication to anticoagulation
Clinical SitesClinical Sites• University of Minnesota• Washington University• Fairfax Inova• Mt. Sinai• St. Vincent’s Indianapolis• Mayo Clinic• Northwestern University• University of Alabama• University of Pittsburgh• Newark Beth Israel• Allegheny General• Sacred Heart
• University of Florida • Columbia University• Montefiore Hospital• Ohio State University• University of Pennsylvania• University of Utah• Duke University• St. Luke’s Medical Center• University of Maryland• Methodist Hospital• University of Rochester• University of Washington
Other (2): controller failure, inflow cannula malposition
Outcomes following replacement: 3 transplanted, 2 alive on support, and 3 deaths
NYHA Class Over Time (n= 138)NYHA Class Over Time (n= 138)
p-value <0.001
Minnesota Living with Heart Failure Minnesota Living with Heart Failure Questionnaire (N=138)Questionnaire (N=138)
NYHA Class Over Time (N=138)
MINNESOTA LIVING WITH HEART FAILURE QUESTIONAIRE - N=138
Better(0)
Worse (105)
p-value < 0.0001
EuroQoL (N=138)EuroQoL (N=138)
Worse (0)
Better(100)
p-value < 0.0001
• LVA3 Percutaneous lead – 6.4mm diameter• Continuous lead from pump to controller
• LVA4 Percutaneous lead - 3mm diameter• Intermediate connector and extension lead
VentrAssist LVA3 & LVA4VentrAssist LVA3 & LVA4
Lead conductor fractures reported in 11/187 LVA4 patients worldwide Cause was accidental damage [n=3] or likely stress failure where a contributing
factor was not wearing the lead support belt [n=8] No stress failures in patients wearing the lead support belt Patient outcomes include death [n=2], pump exchange [n=3] (1 later
transplanted); emergency repair [n=6] (1 later transplanted, 1 later death), Product Advisory issued to emphasize the importance of lead support belt. Additional corrective actions are under consideration