Safety Evaluation of the Pericardial HeartWare MVAD System
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1 Safety Evaluation of the Pericardial HeartWare MVAD System Edwin C. McGee, Jr. M.D. Surgical Director, Heart Failure, Heart Transplantation, and Mechanical Assistance Bluhm Cardiovascular Institute, Northwestern Memorial Hospital Associate Professor Northwestern University s Feinberg School of Medicine Chicago, IL USA
2 Evolution in Design Based on Original Technology Miniaturized single piece wide-blade impeller with helical flow channels Simplified assembly / Impeller self-aligns Magnetically levitated impeller resists hydraulic thrust and dynamic shock forces. Hydrodynamic bearings provide radial stiffness.
3 Potential Advantages of the MVAD Pump Placed via thoracotomy - May lead to lower adverse events and reduce recovery time Potential for smaller sized patients and/or smaller hearts (pediatric) Partial and full flow support Potential for right and left ventricular support (RVAD/LVAD)
4 MVAD System GLP Study: Objectives Evaluate the safety of the HeartWare MVAD System in a healthy ovine animal model. Surgical procedure System performance Hemocompatibility - Hematological - Biochemical Biocompatibility - Gross pathological evaluation - Histology
5 Methods Nine (n=9) sheep were implanted via a left thoracotomy with the MVAD Pump without CPB. - Anticoagulation Warfarin 2 mg BID PO No attempts were made to adjust the INR to therapeutic levels Primary endpoint was survival of animals to study term (90 days) without device complications. Secondary endpoints included: - hemocompatibility - performance and handling - system performance - biocompatibility
6 Surgical Implantation Gimbaled Sewing Ring Attachment Graft Anastomosis steerable sewing ring
7 Surgical Implantation MVAD Pump implanted in left ventricle
8 MVAD System GLP Study: Outcomes GLP Sheep # Weight (kg) POD Comments MVAD GLP survived to term MVAD GLP survived to term MVAD GLP pericardial effusion* MVAD GLP survived to term MVAD GLP survived to term MVAD GLP tamponade* MVAD GLP survived to term MVAD GLP survived to term MVAD GLP survived to term *iatrogenic
9 Speed (RPM) Flow (L/PM) Flow & Speed Parameters* (n=7) Average Speed Average Flow No system restarts *Unaudited data Time (days) 0
10 Hematological/Biochemical Data* (n=7) Parameters Baseline Day 14 Day 28 Day 63 Explant PT (sec) 14 ± 2 12 ± 5 12 ±.5 13 ± ± 0.9 PTT (sec) 49.4 ± ± ± ± ± 3.6 INR 1.8 ± ± ± ± ± 0.1 Plasma Free Hemoglobin (mg/dl) 3.6 ± ± ± ± ± 3.2 LDH (IU/L)** 427 ± ± ± ± ± 76 BUN (mg/dl) 22.9 ± ± ± ± ± 3.0 Creatinine (mg/dl) 0.8 ± ± ± ± ± 0.1 SGPT (IU/L) 12.7 ± ± ± ± ± 4.9 SGOT (IU/L) 87.1 ± ± ± ± ± 15.5 Direct Bilirubin (mg/dl) 0.0 ± ± ± ± ± 0.0 Total Bilirubin (mg/dl) 0.1 ± ± ± ± ± 0.0 *Unaudited data **Blood work returns to normal POD 14
11 Intraventricular View Endothelial layer adhered to sintered titanium
12 MVAD Pump Explant (study-term) No wear marks on impeller or housing No thrombus on impeller No thrombus on volute MVAD pump outflow 90 day explanted impeller MVAD pump volute
13 Sheep Necropsy (study-term) End organ gross and histological results were unremarkable
14 Summary Surgical implantation via small thoracotomy without CPB completed in all 9 animals Gimbaled (steerable) sewing ring proved feasible and facilitates inflow orientation This series exhibited excellent device performance and biocompatibility Exceptional hemocompatibility as evidenced by the LDH and plasmafree HgB - No device related thrombo-embolic events despite sub-therapeutic INR Successful GLP study precedes commencement of human clinical trials
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