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1 30 July 2016 เอกราช อร ยะช ยพาณ ชย Heart Failure and Transplant Cardiology Disclosure Speaker, CME service: Merck, Otsuka, Servier Consultant, non-cme service: Novartis, Menarini 1
2 5 Rx options for stage D HF 1. Heart transplant 2. MCS/VAD 3. Chronic home inotrope 4. Palliative care 5. Experimental surgery or meds DEPEND ON 1. Patient s goal of care 2. Transplant candidacy 3. Available time (prognosis) Indications for MCS Bridge to transplant (BTT) In a patient who is on waiting list Destination therapy (DT) In a patient who is not a transplant candidate Bridge to To recovery: Shock, post cardiac surgery, acute MI, myocarditis To decision: Evaluation for OHT candidacy status Short term: High risk PCI, valve intervention, ablation ESC guideline 2
3 Continuous flow Pulsatile flow 7/31/2016 Terminology/ type of MCS Duration of support: Flow characteristic: Degree of support: Implant approach: Pump location: Type Non-durable (short-term) vs nondurable (long-term) Pulsatile vs Continuous Partial support vs Full support Percutaneous vs Surgical Intra vs Extracorporeal LVAD, RVAD, ECMO, TAH Types of MCS Temporary MCS Long-term MCS IABP* INCOR/EXCOR BerlinHeart* HeartMate XVE LVAD Thoratec VAD Total Artificial Heart CentriMag* ECMO* Impella Recover TandemHeart HeartMate II* HeartMate III* HVAD 3
4 Heart Transplant LVAD Indication Gold standard - In a very selected patient - Candidacy Improve survival + QoL - Bridge to transplant - Destination therapy - Bridge to decision 1-yr survival 85-90% 70-80% Limitation Limited donors Many devices Cultural and believe Financially restrict Experiences - Worldwide - Thailand Self-care 4000 / year 20 /year Immunosuppressant Endomyocardial biopsy transplant patient >5,000 / year 5 patients Anticoagulation Wound dressing VAD patient Short-term MCS 12 yo with DCM On dob On list April 2016 Tranaplant July
5 IABP* TandemHeart Impella CetriMag* ECMO* Short-term MCS Improve hemodynamics but not outcomes Eur Heart J 2014;35:
6 JACC 2015;65:e7-26 Durable (Long-term) VAD 6
7 REMATCH study Pts w chronic stg D HF who is not a transplant candidates N = 129 RCT to pulsatile flow LVAD OMM LVAD resulted in a survival benefit QoL Established DT as indication for MCS NEJM 2001; 345: y Survival 2-y Survival 52% LVAD 23% LVAD 29% OMM 8% OMM Improving survival with continuous-flow LVAD Fang JC, NEJM 2009;361:2282 7
8 VAD trials JACC 2015;65: VAD survival outcome 8
9 Thailand experience Pump Drive line Battery Controler Power cable 9
10 HeartMate 3 System Overview System Components 14 V Li-Ion Batteries Power Module System Monitor Universal Battery Charger Go Gear Wearable's Mobile Power Unit* *New for HM 3 Implant operation 10
11 MagLev Centrifugal Pump 11
12 LVAD placement Pre VAD Post VAD Outflow cannula 12
13 Outcome Improve survival 1-year survival = 70-80% Improve quality of life High event rate (1st year event) Infection 5-25% RV failure 10% Stroke 10% GI Bleeding 5% Pump thrombosis/malfunction rare Aortic insufficiency JACC. 2009;54: Patient care Continuous flow = No pulses HR (listen only) Doppler BP = mmhg Never CPR Anticoagulation Drive line care (dressing) Hemolysis/bleeding Basic VAD parameters 1 JHLT Apr 2010; Slaughter et al; Vol 29; No 4S. Clinical Management of continuous-flow Left Ventricular Assist Devices in Advanced Heart Failure 13
14 SYSTEM MONITOR CLINICAL SCREEN DISPLAYS: Pump parameters Mode Monitor/Controller Communication 2 highest priority alarm messages We set the SPEED Optimum Speed Setting (RPM) Normal Cardiac Index Normal LV Size No Septal Shift Intermittent Aortic valve Opening 14
15 VAD parameter Speed: Fixed speed is set by the clinician Power Direct measurement of pump motor energy use in Watts Pum flow estimator Estimated based on power and speed Value Speed (RPM) FLOW (LPM) Pulsatility Index (PI) 2-6 Power (Watts) Pulsatility Index (PI) The magnitude of flow pulses through the pump. Averaged over 15-second intervals Normal RPM 3-6 LPM 3-6 Watts All parameters depend on patient condition and characteristics What should I do if? What do you do if your pt with IABP has.. A massive GI bleed, hypoxia, hypotension IABP poor augmentation, balloon rupture ALWAYS EVALUATING PATIENT, NOT THE PUMP 15
16 No Chest Compression Ok to cardioversion/defib When to put an LVAD A 71 yo female with HFrEF (EF 18%, LV 8.1 cm) Admitted at other hospital for 2 months for cardiogenic shock Cannot wean off Dobutamine (after multiple attempts) Cr 0.5, INR 1.3, Alb 3.0 RA3, RV 45/16, PCWP 14 16
17 When to implant a VAD Good timing 17
18 REVIVE-HF ROAD MAP ROADMAP trial (JACC 2015;66: ) Prospective, multi-center, non-randomized, controlled, observational study HF stg D, NYHA III-IV, EF < 25%), INTERMACS 4-7 HM II resulted in survival (80 vs 64%) QoL, adverse events REVIVE-IT trial Prospective, RCT in HF NYHA III Sponsor by NHLBI clinical hold J Heart Lung Transplant 2015;34:S80. Case A 71 yo female with HFrEF (EF 18%, LV 8.1 cm) Admitted at other hospital for 2 months for cardiogenic shock Cannot wean off Dob Alb 3.0 Cr 0.5 INR 1.3 RA3, RV 45/16, PCWP 14 18
19 ESC 2016: AHA/ACC 2013: Rec. Class IIa (BTT and DT) Guideline and further reading 19
20 Conclusion Search for alternative approach for transplantation are inevitable. o MCS, VAD, stem cell, etc. There are many types of VADs and MCS For many indications LVAD is available with acceptable outcome It is far from perfect (RV failure, infection, clot/bleed) Early referral is a key to preserved treatment options in patient with terminal HF. Thank you aekarach.a@chula.ac.th 20
21 Back up slide Implant strategiesreal world Circulation2011;123:
22 Future Better clinical understanding (for less S/E) Longer support Surg: Implantation techniques, complex anatomy Need better technology Smaller Full implant No driveline Need better patient selection Less sick patient? Advancing the field Recovery Pediatric Compete with OHT (survival 4 vs 10 yr) Total Artificial Heart 22
23 ROADMAP 23
24 Univariate Predictors of RV failure Thorac Cardiovasc Surg 2010;139: Heart Failure Clin 11 (2015)
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