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Destination Therapy with a Totally Implantable Left Ventricular Assist Device System: Results of the LionHeart CUBS Trial John P. Boehmer, M.D. Penn State College of Medicine Aly El-Banayosy, Reiner Koerfer, Latif Arusoglu, Bad Oeynhausen Heart Center, Bad Oeynhausen, Germany; Rolald Hetzer, Yuguo Weng, Michael Jurmann, Deutsches Herzzentrum Berlin, Berlin, Germany; Mario Vigano, Mauro Rinaldi, Policlinico San Matteo, Pavia, Italy; Alain Pavie, Pascal LePrince, La Pitie Hospital, Paris, France; Ernest Wolner, Georg Wieselthaler, University of Vienna, Vienna, Austria; Ludwig vonSegesser, CHUV Hospital Vaudois, Lusanne, Switzerland; Thorsten Whaler, Ulrich Franke, Klinikum der Friedrich Schiller Universitat, Jena, Germany; Walter E Pae, Jr; Penn State College of Medicine, Hershey, PA LionHeart LVAS • Destination Therapy Device • Evolution of Thoratec Pneumatic VAD • Fully Implanted with Transcutaneous Energy Transmission (no percutaneous lead) • Fully Automatic Cardiac Output Control • Modular Design Clinical Utility Baseline Study (CUBS) Purpose…. to determine the safety and performance of the LionHeart LVAS to serve as a permanent method of circulatory support for patients with endstage heart failure who are ineligible for heart transplantation CUBS Trial: Overview and Duration • Prospective, single-arm, multicenter study • Enroll 30-40 patients at European centers with at least one year follow-up • Primary endpoints safety and performance based on comparison to historical controls • Study period was from October 1999 to December 2002….3960 pt. days Patient Selection CUBS Trial Key Inclusion Criteria • LVEF < 30% within 90 days prior to enrollment • NYHA class IV heart failure under tailored medical management • Heart failure for 6 weeks • Peak O2 by CPX < 14cc/kg/min or unable to exercise • Ineligible for heart transplantation • Good communication skills Patient Selection CUBS Trial Key Exclusion Criteria • BSA < 1.5 m2 or > 2.25 m2 • Severe COPD (FEV1 < 1.2 L/min or <40% predicted) • Fixed pulmonary HTN (> 6 Woods units) • Severe renal dysfunction (Cr > 3.0 mg/dL or requiring ongoing hemodialysis) • CVA within past 6 months or impending CVA • Inability to relocate within 4 hours of the implanting site Patient Selection CUBS Trial Changes to Inclusion/Exclusion Criteria • Inclusion Criteria – Remove poor prognostic indicators (simplify screening) – Remove criterion for low CI (simplify screening) • Exclusion Criteria – Renal dysfunction modified to serum Cr < 2.0 mg/dL within 7 days of implant and no hemofiltration in that time period – Add criterion for carotid artery duplex without hemodynamically significant lesion CUBS: Patients • 26 male patients enrolled • Three were ineligible, but received the device – CVVHD at time qualifying creatinine was drawn – Pulmonary hypertension > 6 Wood units – Metastatic thyroid cancer with poor prognosis • Reasons not eligible for heart transplant – Age > 65 years – Systemic lupus erythematosis – Insulin dependent diabetes with end-organ dysfunction CUBS Study Group • Bad Oeynhausen Heart Center…Korfer, El-Banayosy, Arusoglu….9 • Deutsches Heart Center Berlin…Hetzer, Weng, Jurmann….3 • Policlinico san Matteo, Pavia…Vigano, Rinaldi…4 • LaPitie Hospital, Paris.. Pavie, LaPrince… 3 • University of Vienna… Wolner, Wieselthaler… 1 • CHUV University Hospital Vaudois, Lausanne… vonSegesser….1 • Klinikum der Friedrich Schiller Universitat, Jena…Whaler, Franke….1 CUBS: Patients LionHeart CUBS N = 26 LionHeart CUBS N = 23 REMATCH OMM N = 61 REMATCH LVAD N = 68 64 + 6.2 65 + 4.2 68 + 8.2 66 + 9.1 Male (%) 100 100 82 78 Ischemic (%) 58 61 69 78 LVEF 22 + 5.0 22 + 5.1 17 + 4.5 17 + 5.2 BP systolic (mm Hg) 104 + 17 104 + 18 103 + 17 101 + 15 BP diastolic (mm Hg) 62 + 12 62 + 12 62 + 11 61 + 10 Age (years) CUBS: Patients LionHeart CUBS N = 26 LionHeart CUBS N = 23 REMATCH OMM N = 61 REMATCH LVAD N = 68 PCWP (mm Hg) 24 + 8.0 24 + 8.3 24 + 7.4 25 + 9.9 CI (L/min/m2) 1.7 + 0.4 1.7 + 0.4 2.0 + 0.6 1.9 + 1.0 ACEI (%) 89 87 51 62 Beta blocker 68 72 20 24 Inotropic agents (%) 52 45 72 65 9.5 + 3.0 9.4 + 2.9 -- 9.2 + 2.0 Peak VO2 Survival Survival in the CUBS Trial 100 90 80 70 60 50 40 30 20 10 0 41% (20-61%) 34% (13-55%) 0 6 12 18 Months 24 30 Survival in the CUBS Trial REMATCH CUBS 100 100 80 41% 34% 60 40 20 Survival (%) Survival (%) 80 60 LV assist device 40 20 25% Medical therapy 0 0 6 12 18 Months 24 30 23% 52% 0 0 6 12 8% 18 Months 24 30 Survival Conditional on Discharge 2 Year Survival 120 Day Survivors Percent Survival 100 90 80 70 60 50 40 30 20 10 0 0 4 8 12 Months 16 20 24 CUBS: Cause of Death Sepsis Device failure Cerebrovasc. disease Other cardiovascular Cardiac procedure Perioperative bleeding Non-periop bleeding Total <6 mo >6 mo Total 3 1 4 0 2* 2* 0 0 0 4 1 5 1 0 1 2 0 2 2 0 2 12 4 16 * - Sac failures occurred beyond 2 years, as anticipated Serious Adverse Events*: CUBS OVERALL DEVICE RELATED Freq. N Rate Freq. N Rate Neurologic dysfunction 12 11 0.6924 1 1 0.0577 Non-neurologic bleed 8 7 0.4616 0 0 0 Perioperative bleed 3 3 0.1731 3 3 0.1731 Local infection 4 4 0.2308 4 4 0.2308 Pump pocket infection 1 1 0.0577 1 1 0.0577 Sepsis 3 3 0.1731 1 1 0.0577 Device Failure 2 2 0.1154 2 2 0.1154 Events *Rate/pt.-year Serious Adverse Events*: REMATCH LVAD vs. CUBS LionHeart CUBS (N=23) REMATCH LVAD (N=68) Neurologic dysfunction 0.69 0.39 Non-neurologic bleeding 0.40 0.56 Perioperative bleed 0.17 0.46 Local infection 0.23 0.39 Pump pocket infection 0.06 0.14 Sepsis 0.17 0.60 Device failure 0.12 0.08 EVENT *Rate/pt.-year CUBS: Adverse Events Related to LVAD CUBS N = 23 0.34 REMATCH N = 68 Perioperative bleeding 0.23 0.46 Device infection 0.17 0.41 Infection of pump interior 0.00 0.23 LVAD malfunction *Rate/pt.-year 0.75 CUBS: Major Serious AEs by Type 0.35 Infection AEs Rate AE/30 pt days 0.3 Bleeding AEs 0.25 Neuro 0.2 0.15 0.1 0.05 0 0-30 days 31-90 days 91-180 days Days from enrollment 181-365 days Summary: Clinical Experience • A compliance chamber is feasible • Transcutaneous energy transmission of this magnitude is possible • Excellent mobility including swimming and bathing Summary: Clinical Experience • Overall adverse event rate appears comparable to prior benchmark • Excellent device reliability – two sac failures at 2 & 2.5 years, one motor controller failure, but importantly, no pump changes up to two years (expected sac life) • Minimal device related pocket infections • Actuarial survival approximately 86% at 1 month, 45% at 6 months, 41% at 1year and 34% at 2 years