Ventricular Assist Device Therapy Update- TCH experience Barbara A. Elias BSN, RN CCRN VAD Coordinator Congenital Heart Surgery
Disclosures I will be discussing the off-label use of medical devices Authorization granted by parents/patients for photo images utilized during this presentation Page 1 Page 1 xxx00.#####.ppt 4/10/19 10:42:27 AM
Objectives Explain indications for VAD therapy Describe different forms of VAD therapy Explain potential complications of VAD therapy Describe VAD therapy trends unique to TCH Page 2 Page 2 xxx00.#####.ppt 4/10/19 10:42:27 AM
Indications for MCS intervention All states of cardiac failure that are either reversible (variable period of time) or that require transplantation Patient population -CMO/Myocarditis -Malignant arrhythmia -Failure to wean off CPB and post op arrest -Failing Fontan? /Single Ventricle? -TCAD- re-transplant? Page 3 Page 3 xxx00.#####.ppt 4/10/19 10:42:28 AM
Current MCS Protocol at TCH Respiratory only Child in need of mechanical support Cardiac only Cardiopulmonary support VA ECMO VV ECMO VAD Lung Recovery Lung Transplant YES Acute process: Myocarditis Acute graft rejection Unknown process Short-term VAD Rotaflow (any size) Impella 2.5/CP (BSA>0.7) Impella 5.0: LV>7cm, Ao >1.5 Expected Recovery (<2 weeks) NO only LV support needed Bridge to decision NO biventricular support needed Chronic process: DCM End stage CHD BiVAD HeartWare Syncardia TAH 50cc: BSA >1.2 and <1.8 Syncardia TAH 70cc: BSA >1.7 Long-term VAD EXCOR Berlin : >5kg and BSA <0.7 Jarvik 2015 : >8kg and <30kg HeartWare : BSA 0.7 (Heartmate III: BSA 1.2) Recovery (BTR) Heart Transplant (BTT) Bridge to Candidacy (BTC) Destination (DT) Page 4 Page 4 xxx00.#####.ppt 4/10/19 10:42:28 AM
Individualized VAD Strategy ücareful evaluation of the patient s disease process üconsideration of prior surgeries (Sternotomy, how many more?) üselection of the optimal assist device (size, flow needed, BSA) üappropriate cannulas (Inflow/outflow position, size of cannula, bridging Berlin w/ Rotaflow?) üpersonalized flow calculations Weight x 150 (constant) = 100% flow (Ex: 9kg x 150 = 1350mls for 100% Flow) (10cc Berlin Pump X 130 BPM = 1300cc/min approx. 100% Flow) Page 5 Page 5 xxx00.#####.ppt 4/10/19 10:42:29 AM
Contraindications Catastrophic neurologic injury/ intracranial hemorrhage MSOF, uncontrolled sepsis/active infection *Fungal Multiple anomalies/metabolic disease Active bleeding/anticoagulation intolerance Hypercoagulable Too small or too big Number of Sternotomy procedures- How many is too many? Congenital staging procedures? Page 6 Page 6 xxx00.#####.ppt 4/10/19 10:42:30 AM
Berlin Heart Assist Devices utilized at TCH HeartWare Heartmate II Heartmate III Jarvik 2015 SynCardia Impella Rotaflow Page 7 Page 7 xxx00.#####.ppt 4/10/19 10:42:30 AM
Device Variations HeartWare (Long term), Heartmate 3 (Long term), and Rotaflow (Short term) - Centrifugal Flow (Mag- Lev)- 3 rd Generation Jarvik, Heartmate II (Long term) and Impella (Short term) - Axial Flow- 2 nd Generation Berlin Heart and SynCardia (Long term) - Pneumatic-Pulsatile Pump- 1 st Generation Intracorporeal / Paracorporeal / Extracorporeal Page 8 Page 8 xxx00.#####.ppt 4/10/19 10:42:32 AM
Short Term VAD Support Indications - Need for post operative support Failure to wean from bypass Bridging between forms of MCS Temporary RV Support ( w/ LVAD) - Low cardiac output state Not related to surgery Myocarditis Cardiomyopathy Acute transplant rejection Page 9 Page 9 xxx00.#####.ppt 4/10/19 10:42:32 AM
Impella (Axial flow) ØMotor size is 12 fr. ØCan flow up to 2.5-5.0LPM (RP for right sided support) ØHas been used in tandem with ECMO ØPlacement is key ØInsertion in Cath lab/or ØUse: 2015- present Ø (N: 31) Page 10 Page 10 xxx00.#####.ppt 4/10/19 10:42:33 AM
Maquet Rotaflow (Centrifugal flow) Constrained Vortex -Negative Pressure at Inlet of pump -Positive Pressure at Outlet of pump Complications: -Hemolysis/Thrombosis -Bleeding -Temperature maintenance -Air entrapment Use: 2009 - present N: 48 Page 11 Page 11 xxx00.#####.ppt 4/10/19 10:42:34 AM
Long Term VAD Support: Centrifugal Pumps A magnetically levitated pump rotates and causes fluid to accelerate before being released at the outflow port. - Pump inlet is under negative pressure which draws in fluid. - Pump outlet (CO or flow) is PRELOAD dependent and AFTERLOAD sensitive. Page 12 Page 12 xxx00.#####.ppt 4/10/19 10:42:35 AM
HeartWare Ø Magnetically suspended Impeller- Hydrodynamic-no bearings, made of Titanium- Continuous Flow Ø Operating speeds of 1800 to 4000 RPM Ø Can Flow up to 10 LPM Ø Recommended BSA 0.7 Ø Power sources: Battery/Wall/Car adaptors Ø 6 hrs to charge fully depleted batteries Ø No Pump Pocket Ø Smallest patient @ TCH: 13.2kg Ø Percutaneous drive line connects to external controller. Ø A portion of the drive like contains a woven polyester fabric which encourages tissue in-growth at the skin exit site. Ø Use: 2011- present (N: 55) Page 13 Page 13 xxx00.#####.ppt 4/10/19 10:42:36 AM
Clinical screen HeartWare Monitor Used to adjust device parameters Displays real time and historical pump information (flow/power, alarms) (Password Protected) Controller Regulates pump function and monitors the system Indicates alarms and battery life Displays alarms/intervention Controller has 30 day data storage Lithium Ion Batteries Each battery allows up to 6-12hrs of operation Recharges up to 500 cycles Page 14 Page 14 xxx00.#####.ppt 4/10/19 10:42:36 AM
HeartWare Pump Waveform Characteristics Flow Waveform Maximum value of the HVAD flow waveform (PEAK) > 2 liters above trough) Minimum value of the HVAD flow waveform (TROUGH) Waveform Peak Heart Rate Beginning of Diastole Trough value should be >2 L/min and there should be >2 L/min of pulsatility Flow Pulsatility Flow Pulsatility Waveform Trough Beginning of Systole Difference between waveform maximum (peak) and minimum (trough) Dependent on heart contractility and HVAD operating points - Systole à max HVAD flow - Diastole à min HVAD flow NOTE: Flow waveforms provide additional information about the patient condition, preload/afterload/potential conditions (RV failure, Tamponade, dysrhythmia) Page 15 Page 15 xxx00.#####.ppt 4/10/19 10:42:38 AM
Long Term VAD Support: Axial Flow Pumps Works off of the same principle as the Archimedes screw. Advantageous over pulsatile pumps because of their valve free structure with continuous flow. Axial pumps operate at higher RPMs (>8000) compared to centrifugal pumps at lower RPMs (>2000) which can potentially lead to clinical implications such as hemolysis. Page 16 Page 16 xxx00.#####.ppt 4/10/19 10:42:39 AM
Heartmate II Ø Most widely used ventricular assist device in the world, made of Titanium Ø Limiting factor is the pump size because a pump pocket must be created for implantation Ø Recommended for patients w/ BSA >1.3 Ø Delivers up to 12 liters flow Ø Power sources: Battery/wall Ø Battery support: 10-12hrs (pair) Ø 4 hr recharge time (fully depleted batteries) Ø Controller supplies 15minutes emergency power (accidental power d/c) Ø Controller displays speed/flow/power, records alarms/data-event recording Ø Use: 2008-2014 (N: 17) Page 17 Page 17 xxx00.#####.ppt 4/10/19 10:42:40 AM
Access to: - Setting adjustments - (Speed/alarm limits) - Alarm log file - Save/transfer data Clinical Screen Displays: - Primary operating parameters - Information updated every second - Alarms color coded (red-high priority, yellow- low priority) Page 18 Page 18 xxx00.#####.ppt 4/10/19 10:42:40 AM
LONG TERM VAD Support: Pneumatic (Pulsatile) Pumps- Berlin Heart ØFirst generation of ventricular assist devices ØPneumatic driver (compressor) / Hand pump ØDiaphragm separates the blood/air chamber ØTri-leaflet polyurethane valves (unidirectional flow) ØMulti cannula: Atria/ Apex/ Arterial (diameter 5mm -12mm) ØMulti size: 10, 15, 25, 30, 50, 60mls ØUse: 9/2005- present Ø(N: 55) Page 19 Page 19 xxx00.#####.ppt 4/10/19 10:42:41 AM
Driver (IKUS )-Pump Console Ø A sturdy mobile driving unit called the IKUS controls the Berlin pump Ø Houses compressors (3) and pressure/suction regulators Ø Displays information about the pump parameters Ø Access for pump setting adjustments (Password protected) Ø Computer logs alarms Ø 30 minute battery supply (hours of service) Ø Alert every 10 minutes (when on battery) Ø Power display/hours of service Ø Hand pump (loss of power) Ø Weight: 219 pounds Page 20 Page 20 xxx00.#####.ppt 4/10/19 10:42:41 AM
Long Term VAD Support: Pneumatic (Pulsatile) Pumps: SynCardia Total Artificial Heart (TAH) Size limitation: (10cm AP measured at T10; Pump size: 50mls / 70-mls) No Rhythm (Complete Caridectomy) Pneumatic driver (C2 or Freedom driver-pulsatile) Powered by Wall adaptor/ battery/ hand-pump Made of Polyurethane, 4 Mechanical valves (25mm) Use: 5/2011 - present (N: 2) Page 21 Page 21 xxx00.#####.ppt 4/10/19 10:42:42 AM
SynCardia TAH System 70cc TAH 50cc TAH 400 ml 270 ml Implantable TAH Drivelines External Driver Page 22 Page 22 xxx00.#####.ppt 4/10/19 10:42:44 AM 22
Preload What we have learned VAD Operating Characteristics Conditions that may lead to a decrease in preload: - Compromised right ventricular volume (e.g. RVF, Tamponade) - Low intravascular volume - Increase in pump speed (a volume/speed mismatch) - Increased ventilator settings (Peep, PS) A reduction in preload may lead to: - Reduced VAD Flow (Cardiac Output) - Suction condition (Chamber Collapse) Afterload Conditions that may lead to an increase (or high) afterload: - Increased system vascular resistance, kink outflow graph - Increased pump speed A high afterload may lead to: - Retrograde flow/flow stagnation (increased risk of pump thrombosis) - Reduced VAD flow (Cardiac Output) Page 23 Page 23 xxx00.#####.ppt 4/10/19 10:42:45 AM
Protocol Tests Result/Range/Indication PT-INR (Coumadin) HeartWare/Jarvik: 2-3 (often 2.5-3) Berlin/TAH : 2.5-3.5 PTT PTT Hepzyme ACT 60-80 (VAD- Heparin- varies with patient) 70-80 (VAD- BiVAL- varies with patient) 180-200 (ECMO) DIC panel ECMO panel Fibrinogen** D- Dimer ** Anti-Thrombin** Daily (if on BiVAL)à Monday/Thursday Daily (if on Heparin)àMonday/Thursday Increases w/ inflammation Increase as fibrin formation Treat when <100 Heparin LDH, Plasma Hgb, U/A for blood LDH Isoenzymes **(Misc Labs in EPIC- send out) ECHO CXR VS 0.3-0.5 units/ml (Berlin, TAH) 0.2-0.4 (HeartWare) Daily daily when assessing for hemolysis When LDH >1000 Monthly (VAD optimization, inflow cannula, AI, AV opening) Daily->monthly (Effusion, pneumothorax, pump placement) Per unit policy: DOPPLER BP STANDARD OF CARE on continuous flow VAD s (70-80mmHg) Page 24 Page 24 xxx00.#####.ppt 4/10/19 10:42:45 AM
TCH VAD program approach ~ Benefits of Extended VAD Support ØNutritional Optimization (BSA growth) ØStability of home, care system-support system ØMedication/care/clinic compliance ØBetter Transplant Candidacy Pre VAD 1 Year Post VAD support Page 25 Page 25 xxx00.#####.ppt 4/10/19 10:42:46 AM
Potential Complications associated w/ VAD therapy Driveline infections Device Malfunction, driveline integrity Gastrointestinal bleeding (AVM s) rare in younger pts Epistaxis Thromboembolic events (Improvement w/ BiVAL) Renal failure Psychosocial issues and risk taking behaviors What s new to help reduce associated complications... Page 26 Page 26 xxx00.#####.ppt 4/10/19 10:42:47 AM
Mechanical updates~ New Devices Jarvik 2015 Pump (Axial flow) Pumpkin Clinical Trial Flow: 1-3.5 liters per minute (LPM) Running Speed: 10,000 to 18,000 rpm Power consumption: < 7 watts Afterload sensitive -Goal Doppler: 40-50mmHg (8-10kg) -Goal Doppler: 50-60mmHg (10-20kg) No Inflow Page 27 Page 27 xxx00.#####.ppt 4/10/19 10:42:47 AM
Jarvik 2015 Pump (Axial flow) Used for >8kg and <30kg (Fits 6 kg) Controller displays power /alarms (no flow, speed adjusted with dial) Power: 1 or 2 batteries (19.5hrs each) Battery charge time 6 hrs Use: 2018 present (N: 4) Jarvik supportedsee controller and batteries Page 28 Page 28 xxx00.#####.ppt 4/10/19 10:42:48 AM
System Components Overview Lithium-ion Battery FlowMaker Controller Jarvik 2015 VAD Li-ion Battery Charger See IU475 6 for further detail Y Cable Li-ion Battery Cable Extension Cable 29 Page 29 Page 29 xxx00.#####.ppt 4/10/19 10:42:49 AM
Jarvik 2015 Performance (HQ curve) Typical MAP (via arterial pressure line or doppler) = 60 mmhg Typical CVP (via venous pressure line or estimated) = 10 mmhg Pressure drop across VAD (outlet P inlet P) = 60 10 = 50 mmhg Pump speed = 16,000 rpm DP = 50 mmhg PO = 2.4 LPM See IU0475 1 for further detail 30 Page 30 Page 30 xxx00.#####.ppt 4/10/19 10:42:50 AM
Mechanical updates ~ New Devices Heartmate III (Centrifugal flow) Made of Titanium-Fully Magnetically Levitated Large pump gap-space designed to reduce blood trauma across rotor Artificial pulse (automatic speed ramp every 2 seconds by 2000rpm) Textured blood contacting surfaces (creates pseudo-neo-intima) Full support (2 10 L/min) Modular Driveline (replacement of portion if damaged) Pocket Controller displays 6 recent alarms, flow/speed/power/pi Battery supply 10-12 hrs/mobile power unit Requires BSA 1.2 Page 31 Page 31 xxx00.#####.ppt 4/10/19 10:42:51 AM
System Components Power Module (Hmate II) 14 V Li-Ion Batteries (Hmate II) Universal Battery Charger (Hmate II) Mobile Power Unit (NEW) Pocket Controller (NEW) System Monitor (Hmate II) Go Gear Wearable's (Hmate II) Modular Driveline (NEW) Page 32 Page 32 xxx00.#####.ppt 4/10/19 10:42:51 AM
TCH VAD program approach Ø VAD evaluation protocol checklist Ø VAD training pre -> post implant Ø Close the Pre-implant education loop with patient/families meeting (VAD Ambassadors) Ø VAD Rounding list Ø VAD D/C protocol Ø Protocols: bleeding/stroke Ø Community outreach post-implant Ø 24hr VAD Call phone HOT LINE Ø 3D CT pre-op Virtual Fit Page 33 Page 33 xxx00.#####.ppt 4/10/19 10:42:52 AM
HeartWare Placement Techniques The standard Intrapericardial placement often results in unfavorable inflow arrangement Infra-diaphragmatic placement decreases angle of inlet to septum Page 34 Page 34 Adachi, I. A modified implantation technique of the HeartWare ventricular assist device for pediatric patients. J Heart Lung Transplant 2015 Jan;34(1):134-6 xxx00.#####.ppt 4/10/19 10:42:52 AM
HeartWare HVAD Driveline Placement Technique Rectus Sparing Approach Ø Driveline is the Achilles Heel of implantable VAD s Ø Less developed abdominal wall muscles in sick children Ø Reduce trauma to tunneling track Ø Reduces postoperative pain/inflammation Ø Assists in prevention of driveline infections Ø Better seeding ingrowth of the driveline (anchored!) Image 2014 Texas Children s Hospital Page 35 Page 35 xxx00.#####.ppt 4/10/19 10:42:53 AM
TCH VAD approach~ Complicated Anatomy Fontan ~ Single Ventricle Page 36 Page 36 xxx00.#####.ppt 4/10/19 10:42:54 AM
TCH VAD approach ~ Can a heart remodel / recover? HeartWare Recovery on Device to Explant! Page 37 Page 37 xxx00.#####.ppt 4/10/19 10:42:55 AM
TCH VAD program approach individualized care Some dressings/vad packs too big, some too smallà find the size that works Page 38 Page 38 xxx00.#####.ppt 4/10/19 10:42:55 AM
TCH VAD program ~ Dedicated VAD Clinic -Regimented Outpatient protocol -Labs -Doppler BP management -Screening speed adjustment ECHO -RHC -Cardiac CT Page 39 Page 39 xxx00.#####.ppt 4/10/19 10:42:56 AM
Community Integration- Outreach back to local area Page 40 Page 40 xxx00.#####.ppt 4/10/19 10:42:57 AM
Home discharge locations of current TCH VAD supported patients as of 4/2019 Snyder Dallas Round Rock Austin Houston Clear Lake Orange LaPorte Laredo Page 41 Page 41 xxx00.#####.ppt 4/10/19 10:42:57 AM
Patients return to home, school, celebrating family and life... Page 42 Page 42 xxx00.#####.ppt 4/10/19 10:42:58 AM
Camp Pump it Up. (Letting kids be kids) Page 43 Page 43 xxx00.#####.ppt 4/10/19 10:42:59 AM
1 st Annual TCH VAD Celebration Day 6/30/2018 Coming to 8/9/2019-2 nd Annual TCH SUPER-HERO VAD CELEBRATION DAY save the date details to come Page 44 Page 44 xxx00.#####.ppt 4/10/19 10:43:02 AM
Key Points Pediatric patients can be implanted with CF adult devices Pediatric VAD patients have good outcomes and can be discharged home safely Children can return to school and travel with CF devices Pediatric VAD patients learn a NEW NORMAL way of life Pediatric MCS is entering a new era w/ a PARADYGM SHIFT Device related complications may increase w/ prolonged support Multi-Disciplinary approach is necessary for successful outcomes! Page 45 Page 45 xxx00.#####.ppt 4/10/19 10:43:03 AM
Challenges Program development-financial support-education Availability of technology Sizing of device to fit child - inflow cannula placement Timing of device implant, transitioning to adult program Anatomic/Congenital challenges/prior Surgery Page 46 Page 46 xxx00.#####.ppt 4/10/19 10:43:04 AM
Future Directions.. üsmaller device Miniaturized ü Water Proof ülonger battery supply üdurable components ü Internal charging pad ü Cordless driveline ü Pediatric friendly Page 47 Page 47 xxx00.#####.ppt 4/10/19 10:43:04 AM
Future Developments Synergy (CicuLite) Heart Assist 5 Pedia Flow HeartWare MVAD Page 48 Page 48 xxx00.#####.ppt 4/10/19 10:43:05 AM
If I only had a Heart -VAD Thank you!! Page 49 Page 49 xxx00.#####.ppt 4/10/19 10:43:08 AM