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Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application, pumpsandpipesmdhc
 

Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application, pumpsandpipesmdhc

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Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application, pumpsandpipesmdhc Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application, pumpsandpipesmdhc Presentation Transcript

  • “ Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application” George P. Noon, MD Professor of Surgery Chief, Division of Transplant & Assist Devices Meyer-DeBakey Chair of Investigative Surgery Pumps & Pipes
  • Heart Failure Hospitalizations The number of heart failure hospitalizations is increasing in both men and women CDC/NCHS: Hospital discharges include patients both living and dead. AHA Heart and Stroke Statistical Update 2001
  • CIRCULATORY ASSIST DEVICES The Methodist Hospital/Baylor College of Medicine IABP (1971-2001) 2880 Roller Pump (1971-1988) 94 DeBakey VAD (1963-1966) 6 Liotta, Hall, Crawford (1963) 1 Symbion/Jarvik (1987-1989) 4 Novacor ® LVAS (1987-2005) 53 BioMedicus ® (1986-2005) 274 MicroMed DeBakey-Noon VAD ® (2000-2005) 36 Thoratec ® LVAD (1998-2005) 31 HeartMate ® VAD (2001-2005) 17 Abiomed ® BVS 5000 (2002-2004) 7 Abiomed ® AB 5000 (2003-2004) 1
  •  
  • Biomedical Engineering Role in Development of Total Artificial Heart and Assist Pumps
  • Biomedical Engineering
    • Pump Design
    • Blood Contact Surface
    • Controller
    • Power Source
  • Biomedical Engineering
    • Blood trauma and clotting
    • Blood contacting surface
    • Duration of contact
    • Stasis
    • Cavitation
    • Heat
    • Shear
  • Biomedical Engineering
    • Pump Testing
        • Mock Loop
        • Animal
        • Human
  • First NASA Axial Flow Prototype Two rotating components
  • NASA - Ames Research Center
    • Flow Field inside impeller
    • Minimize hemolysis
    • Increase efficiency
    • Provide effective washout
    Geometry from Johnson Space Center
  • Licensed NASA Blood Pump (1996)
  • Hemolysis Test Setup
  • Red Cells
  • Hemolyzed Red Cells
    • 2½ year bench study demonstrated no significant bearing wear
    • 35 clinical pumps returned for evaluation - no evidence of bearing wear
    Bearing Wear Studies performed by Marconi
    • Titanium construction: 95 Grams
    • Speed: 7,500 - 12,500 RPM
    • Continuous, axial flow pump
    • Flow rates: 10+ liters/minute
    • Technology licensed from
    • NASA
    The DeBakey-Noon VAD
  • Schematic Illustration of the DeBakey VAD
  • Bovine tests at Baylor College of Medicine, Texas A&M Ex-Vivo In-Vivo
  • Novacor  HeartMate  DeBakey-Noon VAD  Device Comparison
  • DeBakey VAD ® and DeBakey VAD Child
  • Controller Pump Patient Home Support System Data Acquisition System Result: MicroMed DeBakey VAD ® System
  • DeBakey-Noon VAD ® Patient Ergonomics
  • Comparative VAD Space Requirements HeartMate ® XVE LVAD Adult Male DeBakey VAD ® 6 year old girl
  • DeBakey VAD ® Implantations More than 110 years of cumulative patient experience Total Patients – 437
    • Average support duration – 106 days
    • 61 patients > 180 days
    • Longest support duration – 841+ days
    International
    • 286 Patients implanted
    As of October 2007 United States
    • 151 Patients implanted
  • Physiologic Blood Flow Systemic Pulmonary Textbook of Medical Physiology, Arthur C. Guyton
  • Speed, Flow and Delta Pressure
  • Hypoperfusion Operating Range Potential for Suction Flow Characteristics
  • Arterial Pressure - Green VAD Flow - Yellow Pump speed VAD flow (kRPM) (L/min) OFF -2.0 7600 2.3 8900 4.5 10,800 5.6 10 0 -4 0 140 10 0 -4 0 140 10 0 -4 0 140 10 0 -4 0 140
  •  
  • Milan Smaller Patients Possible Miniaturization benefits large and small patients. Milan Zurich Muenster
  • Continuous Flow Provides Adequate Circulatory Support
    • Resuscitation
    • Rehabilitation
    • Maintenance
  • Results - CFD Baseline Rear Hub Washout Final Rear Hub Washout Increase gap shows an improved circulation pattern in the rear hub
  • Results - CFD Baseline Diffuser Inlet Angle Final Diffuser Inlet Angle Flow is entering the diffuser correctly on the pressure side of the blade indicating a small “angle of attack.”
  • EU Pediatric Device
    • Required CFD of the inflow cannula
    • Results demonstrated pediatric inflow cannula with 2 L/min washed at least as good as adult cannula with 4 L/min
  • Results – Flow Visualization Results from increased gap: Less turbulence in the diffuser Baseline Design 2.0x Gap
  • Results – Hemolysis at 4 L/min INCREASING THE GAP WITHOUT MODIFYING THE DIFFUSER INLET ANGLE DEMONSTRATES A TREND TO SLIGHLY HIGHER HEMOLYSIS 2.0X gap Baseline Baseline 2.0X gap, 32 ° TUNING THE DIFFUSER INLET ANGLE WITH THE LARGER GAP DEMONSTRATES A TREND OF HEMOLYSIS LOWER THAN THE BASELINE VALUE; HOWEVER, THERE IS NO STATISTICAL DIFFERENCE IN HEMOLYSIS BETWEEN THE BASELINE AND FINAL DESIGN N.I.H. = 0.006 N.I.H. = 0.014 N.I.H. = 0.009 N.I.H. = 0.006
  • X2 Pump Design ½ cm shorter intra-ventricular and 1cm shorter extra-ventricular length for improved anatomical fitting Smoother inlet flare for improved blood flow into the pump Seamless connection to pump housing for improved blood flow Smaller flow probe cover Titanium ring integral to gelatin sealed graft for easy, leak-free assembly
  • On the horizon…
  • Clinical Benefits of the MicroMed DeBakey-Noon VAD Size Surgeon Patient Implant Less Awareness Explant Drive Line Smaller Patients Noiseless Device Infection  5% Adequate Circulatory Support Less Expensive
  • Conclusion
    • Increasing incidence of heart failure
    • Transplantation limited by donor supply
    • Cardiac assist devices increasingly used as
      • Bridge to Transplant
      • Bridge to Recovery
      • Destination Therapy