Pediatric Mechanical Circulatory Support - What to Use
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1 Pediatric Mechanical Circulatory Support - What to Use Ronald K. Woods, MD, PhD Associate Professor Medical College of Wisconsin Pediatric Cardiothoracic Surgery Children s Hospital of Wisconsin
2 Disclosure I have no relevant financial relationships to disclose.
3 Brief History 1964 NHLI establishes US Artificial Heart Program 1966 DeBakey implants VAD after failure to wean from CPB after AVR, MVR; 10 days of support; home in 1 month 1969 Cooley implants TAH, supported for 64 hrs, died after Tx 1975 NHLI sponsored ECMO trial 1975 NIH sponsored multicenter trial for temporary LVAD support with Pierce-Donachy pump (Thermo Electron Corp Thoractec) 1977 NHLI Heart and Vascular Division issues RFP for totally implantable VAD 1982 DeVries implants Jarvik 7 (TAH) in Barney Clark, survives 112 days
4 Brief History 1984 Portner s Novacor (implantable) provides first successful bridge to Tx 1994 FDA approves HeartMate LVAD for BTT 1996 REMATCH trial HeartMate VE 1998 Debakey micromed implanted (axial-flow pump) 1999 LionHeart 2002 HeartMate XVE approved for destination therapy 2008 HeartMate II approved for BTT 2010 HeartMate II approved for destination 2011 Berlin Excor pediatric VAD approved for BTT 2012 HeartWare approved as BTT
5 Classifications Paracorporeal vs Intracorporeal Pulsatile vs Continuous Flow Axial vs Centrifugal vs Impeller Short-term vs Long-term Development in general has gone from large, extracorporeal, pulsatile, shorter term to small, intracorporeal, continuous, longer-term
6 Variety of Devices Thoratec products HeartMate (IP, IVAD, PVAD, XVE, II) HeartWare Micromed DeBakey Novacor Abiocor Abiomed Syncardia Levitronix TandemHeart Rotaflow Impella Jarvik Berlin Excor Medos and others
7 Mechanical support - Options
8 Practical Considerations Realistically, how many devices can you stock? Number of VADs per year and experience with device? What is really needed to cover your patient population?
9 Our Current CHW Strategy Berlin EXCOR HVAD Rotaflow (paracorporeal for AV loop) Syncardia (70cc sunset for 50cc trial site) Infant Jarvik (trial site,???)
10 Our Current CHW Strategy - EXCOR 5 pump sizes from 10ml to 60ml Paracorporeal Original trial bleeding complications high CVA (thromboembo 2x hemorr)
11 Our Current CHW Strategy - EXCOR
12 HeartWare-HVAD Titanium, suspended impeller, passive magnetic and hydrodynamic No bearings Device weight 160 gm Intrapericardial placement (modifications) 10 L/min? Preload and afterload sensitive BSA 1.5? Neo-pump pocket creation? Good performance documented in > 2500 implants
13 Centrifugal Head AV Loop Paracorporeal, centrifugal All size patients Cannulation options for both RVAD and LVAD arrangement Support time (days to few weeks)
14 SynCardia Total Artificial Heart Pneumatic displacement with polyurethane bladder Flow is measured by air flow 70 cc displacement (50 entering IDE) BSA 1.7 ish (1.5?) Flow up to 9 L/min >1250 implants and > 70% BTT Size, sensitization?
15 Infant Jarvik 2000 (as part of PumpKIN) Rotor supported by 2 ceramic bearings Titanium impeller < 0.8 BSA 4-15 kg 3L/min at reasonable power Adult Jarvik implanted in 200 patients worldwide CE mark in 2005 Infant Jarvik (PumpKIN)???
16 Patient Category < 17-20kg range Short-term to intermediate AV loop or EXCOR Longer - term EXCOR >20kg Short-term to intermediate AV loop Long-term HVAD if size fit
17 Patient Category Specific Circumstances BiVAD scenarios RVAD AV loop to explant or conversion to durable Total artifical heart Post-transplant rejection Challenge Total artificial heart if size fit
18 Patient Category Specific Circumstances (continued) Single ventricle Infant/toddler Glenn EXCOR Adolescent/teen or older HVAD (modifications per specific mode of failure and anatomical considerations) TAH, modifications Creativity (TAH 0.5, fenestration, shunt,) Very sick patients bridge to bridge strategy
19 On the Horizon CircuLite Synergy HeartMate III then X? MVAD Both Thoratec and HeartMate are working on wireless energy transfer Increasing trend toward INTERMACS 2-5 ROADMAP trial will eval HM II in ambulatory IIIb/IV patients not dependent on inotropes completion date scheduled for Dec 2015 REVIVE-IT NHLBI sponsored trial eval HM II in class III patients, primary completion date Jan 2015
20 Thank you
21 Syncardia 0.5 and/or Fenestration
22 On the Horizon CircuLite Synergy Implantable miniaturized axial flow Designed for partial support (adult) L/min CE mark in 2012 US IDE trial planned You adjust RPM
23 On the Horizon HeartMate III Centrifugal flow Magnetically levitated rotor Theorized to provide capability for pulsatile Finishing animal trials First clinical implant was scheduled for 2013
24 On the Horizon HeartMate X Axial flow Design still being finalized
25 On the Horizon HeartWare MVAD Continuous axial flow with wide blade impeller Same suspension technology as HVAD 1-5 L/min
26 On the Horizon Wireless power Thoratec partnering with WiTricity High-efficiency energy transfer using resonant coils HeartWare also working on transcutaneous energy transfer HeartAssist Monitoring
27 On the Horizon Patient selection Increasing trend toward INTERMACS 2-5 ROADMAP trial will eval HM II in ambulatory IIIb/IV patients not dependent on inotropes completion date scheduled for Dec 2015 REVIVE-IT NHLBI sponsored trial eval HM II in class III patients, primary completion date Jan 2015
28 Pediatric Issues and Areas of Focus PHTS database, 2006 report 99 children, mean age 13 yr, mean weight 56 kg 6 mo survival > 14 y/o > 90% < 10 y/o < 38% 2013 report from Berlin EXCOR database 47 centers, 204 patients, median age 1.6 yrs, median weight 10kg median support time 40 days (1,435) 12 mo survival 75% Lower weight, bivad, increased bili risk factors for early mortality Reduced GFR strongest risk factor for late mortality
29 Pediatric Issues and Areas of Focus EXCOR (cont) Early mortality 65% if < 5 kg 14% if > 10 kg Major bleeding 45% Major infection 44% Neuro morbidity 29% Thromboembolic 2X > Hemorrhagic 80% had GFR < 30% predicted
30 Basic Connections
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