1. Professor Davor Miličić, MD, PhD, FESC MECHANICAL SUPPORT TO THE FAILING HEART Department of Cardiovascular Medicine, Zagreb University School of Medicine, University Hospital Center Zagreb

2. Epidemiology  Heart failure  23 million people  1-2% total population  >6% people aged over 65 yrs  End stage heart failure: refractory to maximal conventional treatment (drugs, CRT, AICD, ultrafiltration, mortality ≥ 50% within 1 year)  Heart transplantation  ~ 5000/year (ISHLT)

3. Heart transplantation “Heart transplantation is an accepted treatment for end stage HF. Although controlled trials have not been conducted, there is a consensus that transplantation, provided through proper selection criteria, significantly increases survival, exercise capacity, return to work, and quality of life compared with conventional treatment.” ESC guidelines for the diagnosis and treatment of the chronic heart failure, European Heart Journal 2008; 29:2388-2442

4. Transplantation is insufficient for treatment all patients with the end stage HF  Limited availability of donor hearts  Patients on HTx lists die  Problem of a possibly reversible advanced HF  Problem of patients with temporary contraindication for HTx  Problem of patients with absolute contraindication for HTx  Solution: drugs, VAD

6. Mechanical myocardial support  IABP  ECMO  VAD  TAH

7. Goals of mechanical support  Temporary treatment - bridging to:  Transplantation  Recovery  Higher class VAD  Destination therapy

8. “Mechanical support of the failing heart is today an established therapy option for terminal, end-stage heart failure patients” G.M. Wieselthaler

9. History  First implantation  VAD (DeBakey 1963)  Artificial heart (Cooley 1969)

11. Criteria for implantation of VAD  Maximal inotropic support, with/without IABP  Hemodynamic criteria  BP syst < 80 mmHg with: CI < 2.0 (2.2) L/min/m 2 ili PCWP > 20 mmHg

12. Contraindications*  Absolute (?) - multiple previous cardiac surgeries - severe peripheral artery disease  Relative - recent PE - acute GI inflammation or bleeding - cachexia * Harefield & Royal Brompton Hospital, London, UK

13. VAD: options?

14. VAD: classification  Short term  Medium term  Long term  Pulsatile  Nonpulsatile

15. Criteria for VAD selection  Failure of one or two ventricles?  Prediction of mechanical support duration  Anticipation of final outcome  Logistic circumstances

16. Ultra short term, percutaneous VAD  Tandemheart  Cath lab  Fem. approach  Up to 14 days  Flow 4 L/min

17. Tandemheart

18. Short term/Pulsatile VAD  Abiomed  Two-chamber  Pneumatic  Paracorporeal  Stroke volume 80 ml  Uni or BiVAD  Polyurethane valves  Mobilization in hospital  Application 7 days

19. ABIOMED BVS 5000

20. Short term/Nonpulsatile VAD  Levitronix Centrimag  Magnetic levitation  Up to 30 days  Flow up to 9L  Minimal mobilization in hospital

22. Medium term VAD  Thoratec VAD  Paracorporeal  Pneumatic pulsatile  LVAD, RVAD, BiVAD  Stroke vol. 65 ml  Polyurethane bubbles  Mechanical valves  Application about 6 mo (up to 1.5 yr)

23. Thoratec VAD  Bridge to HTx (60%)  Bridge to Recovery viral myocarditis, postpartum cardiomyopathy, heart rejection  Cost → 35000 $  Complications – bleeding (31%), infections associated with device (18%), thromboembolism (14%)  Thoratec IVAD?

24. Long term VAD  Novacor LVAS  55-65% survival to HTx  Average duration of support 85 days (max. 962 days)  Anticoagulation necessary  Embolic CV accidents ~ 25%  Redesigned cannula (CVA 10%)

25. Long term/Pulsatile VAD  HeartMate  Increased mobility  Possible hospital discharge  Stroke vol. 83 ml  Preperitoneal location

26. HeartMate

27. REMATCH  REMATCH Trial  Pulsatile HeartMate VAD  LVAD vs. maximal med. therapy (3-year follow up)  End point - death, quality of life, complications, hospital admission  48% mortality reduction  Higher rate of complications and greater number of hospitalization days

28. REMATCH

29. Post - REMATCH

30. Long term/Nopulsatile VAD  Advantages  Small device  Less material contact - higher durability  Noiseless  Disadvantages  Hemolysis at high RPM  Intracavitary negative pressure  No solution “B”

31. Long term/Nonpulsatile VAD  Centrifugal pumps (axial flow)  Continuously rotating propeller  No proof that lack of pulsatility is harmful

32. First full implantable, miniaturized axial-pump for clinical application axial-pump for clinical application diameter 30,5 mm length 76,2 mm weight 93 g Mechanical Circulatory Support

33. Centrifugal devices  Jarvik 2000  HeartMate II  MicroMed DeBakey

34. 3rd Generation HeartWare: MVAD 2008 -

35. FUTURE VS TODAY Chronic Non-hospitalized HF patient Quality of life improvement therapy Partial Elective Endovascular IX Cardiologist or CT Surgeon Low Target Patient Population Treatment Goal Level of Support Placement Procedure Device Implantation Physician Placing Implantation Risks End-Stage Hospitalized HF patient Life-saving therapy Full Emergency ALWAYS Surgical CT Surgeon High Current Assist Devices

36. Complications  bleeding/thromboembolism  CVA  infection  device failure  ARF  Respiratory insufficiency

37. Total artificial heart  Heart explantation  Wireless energy transmission  Longest implantation 512 days

38. What can we expect ?? -- next 2 - 5 yrs new pump concepts in clinical application -- new generation pump is predominantly rotary pump -- further improvement of existing pump concepts -- challenge will bring prizes down -- very long lasting VADs for chronic implants -- true alternative to clinical heart transplantation??? VAD-therapy today: -- BRIDGE TO or destination Tx for terminal HF pts -- due to growing experience reasonable outcome -- sophisticated technology provides good long-term results -- individual pump-types for individual patients Future of Mechanical Circulatory Support

39. Life is like driving a bicycle. To keep your balance you must keep moving. Albert Einstein

40. Thank you for your attention attention!