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The VentrAssist U.S. Pivotal Bridge to Cardiac Transplantation Trial

The VentrAssist U.S. Pivotal Bridge to Cardiac 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

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The VentrAssist U.S. Pivotal Bridge to Cardiac Transplantation Trial

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  1. The VentrAssist U.S. Pivotal Bridge to Cardiac 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

  2. Presenter Disclosure Information Andrew J. Boyle, MD The following relationships exist related to this presentation: Scientific Advisor Ventracor no financial relationship Consulting Fees Thoratec Modest Level

  3. VentrAssist: 1st Centrifugal LVAD • Small size (298 g) • Single moving part - rotor • No valves, diaphragms or mechanical bearing • Diamond-like carbon coating on blood contacting surfaces • Hydrodynamic suspension (rotor is supported by the blood within the pump) • Rotor contains high-strength magnets • Controller delivers power to copper coils via lead • Magnetic forces from the coils spin the rotor

  4. VentrAssist Components • Implantable blood pump • Powered via percutaneous lead • Controller logs parameters & alarms • Battery or AC power supply • Laptop PC for clinician use Inflow cannula Outflow cannula Percutaneous lead Blood pump Controller and battery receptacle

  5. US Feasibility Study Outcomes At 6 months, 86% of patients were transplanted or alive on support Boyle A et al. ISHLT, Boston, MA, 2008.

  6. Worldwide VentrAssist Experience* * As of 3/3/09

  7. Bridge 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%)

  8. Study Enrollment Target 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.

  9. Endpoints • Primary 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

  10. Inclusion Criteria • Age ≥ 18 yrs • BSA ≥ 1.5 m2 • Approved for transplant & listed as Status 1A or 1B • Clinical indication for BTT LVAD

  11. Exclusion 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

  12. Clinical 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

  13. Baseline Characteristics

  14. Baseline Labs

  15. Baseline Medical History

  16. Primary Endpoint (n=98) Protocol defined outcomes (only 1 per patient)

  17. Clinical Duration of Support (n=98) ΔPatients on support who reached outcome Clinical outcomes independent of protocol defined endpoints as of Jan 27, 2009 (patients may have multiple outcomes)

  18. Study Outcomes: Interim Analysis Population (n=98)

  19. Outcomes – KM Survival Curve (n=98) Patients at Risk 98 83 76 60 52 41 35

  20. Cause of Death on LVAD Support

  21. Serious Adverse Events Total Support = 19435 Person-Days as of January 27, 2009 Does not includeSAEs after replacement to a device other than VentrAssist

  22. BTT Adjudicated SAEs (cont’d)

  23. Device Replacements • 8 device replacements in 8 patients • 5 device replacements < 180 days on support • primary reasons for replacement • Device Failure (2) • Pump Thrombus (2) • Percutaneous lead failure (2) • Other (2): controller failure, inflow cannula malposition • Outcomes following replacement: 3 transplanted, 2 alive on support, and 3 deaths

  24. NYHA Class Over Time (n= 138) p-value <0.001

  25. Minnesota Living with Heart Failure Questionnaire (N=138) Worse (105) p-value < 0.0001    Better (0)

  26. EuroQoL (N=138) Better (100) p-value < 0.0001 Worse (0)

  27. VentrAssist LVA3 & LVA4 • LVA3 Percutaneous lead – 6.4mm diameter • Continuous lead from pump to controller • LVA4 Percutaneous lead - 3mm diameter • Intermediate connector and extension lead • 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

  28. VentrAssist Inflow Cannulas

  29. Conclusions • VentrAssist LVAD exceeded performance goal at pre-specified interim analysis • 85% of patients transplanted or alive on support at 180 days • Statistically & clinically significant improvement in QOL & functional status over duration of support • Adverse event profile similar to other current LVADs and improved over pulsatile VADs • Projects ongoing to improve percutaneous lead & inflow cannula design

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