Mechanical circulatory support devices

LVAD, Heartmate

1. DR . ROHIT WALSE SENIOR RESIDENT DM CARDIOLOGY SCTIMST MECHANICAL CIRCULATORY SUPPORT DEVICES

2. SCOPE OF DISCUSSION INTRODUCTION EVOLUTION DEVICE TERMINOLOGY TEMPORARY DEVICES LONG TERM DEVICES RECOMMENDATIONS

3. INTRODUCTION Definition - M echanical C irculatory S upport (MCS) Devices are mechanical pumps designed to assist or replace the function of either the left or the right ventricle or both ventricles of the heart .

4. EVOLUTION

5. INDICATIONS

6. CHARACTERISTICS OF MCS DEVICES Location of the pumping chamber Specific ventricle/s supported Pumping mechanism Indicated duration of support-temporary/long term

7. TERMINOLOGY PUMP LOCATION Extracorporeal- Outside the body Paracorporeal - Outside but adjacent to body Intracorporeal - Implanted within the body Orthotopic - In the normal position of heart

8. TERMINOLOGY VENTRICLE SUPPORTED LVAD RVAD BiVAD TAH

9. TERMINOLOGY INTENDED USE Short term: days to week Long term: months to year

10. TERMINOLOGY PUMP MECHANISM Pulsatile flow Continuous flow rotary pump with axial design Continuous flow rotary pump with centrifugal design

11. TEMPORARY DEVICES

12. IABP- Intra Aortic Balloon Counter Pulsation PUMP MECHANISM COUNTERPULSATION ENERGY SOURCE PNEUMATIC METHOD OF PLACEMENT PERCUTANEOUS OR OPERATIVE VENTRICLE SUPPORTED LV DEGREE OF SUPPORT PARTIAL

13. MECHANISM Inflation at aortic valve closure: Increases aortic diastolic blood pressure Increases diastolic coronary perfusion Net neutral effect on cerebral perfusion Increases C.O./“runoff” to subdiaphragmatic organs Deflation prior to systole: Reduces impedance to LV ejection (afterload) Reduces myocardial oxygen consumption

14. A = One complete cardiac cycle B = Unassisted aortic end diastolic pressure C = Unassisted systolic pressure D = Diastolic Augmentation E = Reduced aortic end diastolic pressure F = Reduced systolic pressure

15. INDICATIONS OF IABP Cardiogenic shock complicating AMI Prior to high risk PCI Prior to high risk CABG Severe acute MR Ventricular septal rupture  Rescue after failed PCI going to CABG Bridge to VAD in patients awaiting transplant

16. CONTRAINDICATIONS Severe Aortic Insufficiency Aortic Aneurysm Aortic Dissection Limb Ischemia Thromboembolism

17. Balloon sizing

18. IABP- CLASS I

19. Study Population Inclusion Endpoints Results TACTICS 2005 57 AMI patients with CS status post- fibrinolytic therapy All-cause mortality at 6 months 1. 43% of the fibrinolysis-only group had died versus 34% of the fibrinolysis–IABP group (P=0.23) 2. Patients with Killip class >II, 6-month mortality was 80% Vs 39% ( P=0.05). Agreed with the Class I C recommendation that IABP be considered for “ cardiogenic shock not quickly reversed with pharmacological therapy as a stabilizing measure for angiography and prompt revascularization”(AHA 1999)

20. Study Population Inclusion Endpoints Results Prondzinsky et al 2010 45 AMI patients with CS S/P primary PCI Change in APACHE II scores over 4 days Inflammatory markers, brain natriuretic peptide levels, hemodynamic values, and in-hospital mortality BNP levels were lower in patients receiving IABP therapy In-hospital mortality was similar (38.6% versus 28.6%; P =ns).

21. Study Population Inclusion Endpoints Results IABP-SHOCK II 2012 600 AMI patients with CS of <12 hours duration 30-day mortality 39.7% in the IABP group versus 41.3% in the optimal medical therapy group; P =0.69 )

22. ACC/AHA 2013 [ESC 2012- IIb ] IIa - IABP can be useful for patients with cardiogenic shock after STEMI who do not quickly stabilise with pharmacoinvasive therapy.

23. ESC-2014 Guidelines IABP insertion should be considered in patients with hemodynamic instability/cardiogenic shock due to mechanical complications IIa C Routine use of IABP in patients with cardiogenic shock is not recommended III A

24. Mortality in the IABP and the control group (66.3% versus 67.0 %; P =0.98 ). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P >0.05 ). 2018

25. IABP as BTT N= 32 IABP therapy (BTT) Vs 135 Electively transplanted patients 80% - S urvived to transplant without additional MCS Mortality at 1 year -9.4 % versus 11.1%; ( P =0.80 )

26. N = 88 patients with end-stage heart failure Axillary– subclavian IABP therapy. Survival to recovery, transplantation, or durable mechanical support- 93.2% Access site complications - 9.1%

27. IMPELLA PUMP MECHANISM CONTINUOUS FLOW ROTARY PUMP ENERGY SOURCE ELECTRIC METHOD OF PLACEMENT PERCUTANEOUS OR OPERATIVE VENTRICLE SUPPORTED LV / RV DEGREE OF SUPPORT PARTIAL

28. SUPPORT IMPELLA 2.5 1-3 L/MIN IMPELLA CP 3.5-4 L/MIN IMPELLA 5.0 5 L/MIN

29. Advantages Does not require EKG or arterial waveform triggering Facilitates stability even in the setting of tachyarrhythmias or electromechanical disassociation

30. Disadvantages Risk of device migration Device malfunction because of thrombosis Hemolysis Bleeding requiring transfusion Arrhythmias Limb ischemia Tamponade , aortic or mitral valve injury , and stroke.

31. ISAR-SHOCK trial 26 AMI patients with CS Impella LP 2.5 or IABP therapy 1 Endpoint: C hange in C.I. after 30 minutes of support Impella LP 2.5 : 0.49±0.46 vs IABP therapy: 0.11±0.31 L/min/m2; P =0.02 2 Endpoint: 30-day mortality- 46 % in both groups

32. IMPRESS TRIAL N = 48 AMI patients with CS Impella CP Vs IABP therapy Device placement - either prior to PCI, during PCI, or immediately after PCI. 30 day mortality - Similar (50% - Impella CP or 46% -IABP therapy , P =0.92) Six-month mortality - 50 % in both groups

33. Case series N = 40 March 2009 to December 2015 Survival to transplant, LVAD, recovery- 75% Conclusion : Effective as a bridge to transplantation, a bridge to bridge and a bridge to recovery

34. TANDEM HEART PUMP MECHANISM CONTINUOUS FLOW ROTARY PUMP ENERGY SOURCE ELECTRIC METHOD OF PLACEMENT PERCUTANEOUS VENTRICLE SUPPORTED LV DEGREE OF SUPPORT PARTIAL (2-4L/MIN)

35. N=41 AMI patients with CS Hemodynamic support with either IABP therapy Vs the TandemHeart . The primary end point- I mprovements in cardiac index[CI], pulmonary artery pressure , and PCWP were seen in patients receiving the TandemHeart Secondary end points- 30-day mortality was similar (43% versus 45 %; P =0.86 )

36. N= 33 Presenting within 24 hours of developing CGS IABP (n = 14) Vs TandemHeart pVAD (n = 19 ) Mean duration of support - 2.5 days TandemHeart pVAD - significantly greater increase in cardiac index and mean arterial blood pressure and significantly greater decreases in PCWP . Overall 30-day survival and severe adverse events were not significantly different between the 2 groups

37. 80 ischemic and 37 patients nonischemic CMP Tandemheart support for 5.8 +/- 4.75 days Outcome Ischemic DCM Non ischemic DCM P value 30 day mortality 40.2% 32% Ns 6 months mortality 45.3% 35% Ns

38. ECMO blood is aspirated via a 18- to 21-Fr venous inflow cannula in the femoral or internal jugular vein, directed into a membrane oxygenator, and returned to the arterial system via a 15- to 22-Fr outflow cannula in the femoral or axillary artery, PUMP MECHANISM CONTINUOUS FLOW ROTARY PUMP ENERGY SOURCE VARIABLE METHOD OF PLACEMENT PERCUTANEOUS OR OPERATIVE VENTRICLE SUPPORTED LV & RV DEGREE OF SUPPORT FULL (4-6 L/MIN)

39. Mortality (2004-2014) ~ 47%

40. N =138 AMI patients with CS not requiring CPR 2008-2013 ECMO-associated complications - 39% Outcome Survival At discharge 47% 6 months 41% 1 year 38%

41. ENCOURAGE MORTALITY RISK SCORE A ge >60, Female sex, BMI > 25, Glasgow coma score <6, Creatinine >150 μmol /L, Lactate (<2, 2-8, or >8 mmol /L ) Prothrombin activity <50%

42. ENCOURAGE SCORE 6 MNTH SURVIVAL PROBABILITY 0-12 80% 13-18 58% 19-22 25% 23-27 20% ≥28 7%

43. 6 PARAMETERS: Older age Left main coronary artery disease Inotropic score > 75, CK-MB > 130 IU/L, Serum creatinine > 150 umol /L , Platelet count < 100 × 10 9 /L

44. 975 patients with in-hospital cardiac arrest events who underwent CPR for longer than 10 min 113 Conventional CPR group vs 59 extracorporeal CPR group ROSC - 24 [52%] CPR VS 42 [91%]-ECPR

45. N- 295 1992-2007 Multiinstitutional data from the extracorporeal Life Support Organization(ELSO) registry Survival - 27% of adults with cardiac arrest facing imminent mortality

46. ECMO IN ADVANCED HF Patients with CS because of acute myocarditis, primary graft dysfunction, rejection As a bridge to bridge or bridge to transplant

47. N= 81 V-A ECMO for CS secondary to DCM, myocarditis, postcardiotomy, posttransplantation . Median follow up- (11 months) In-hospital mortality- 58 % Long term survival- 34.5% The majority of patients (57%) experienced >1 major ECMO-related complication.

48. N= 517 V-A ECMO after cardiac surgery Mean duration - 3.28±2.85 days. Successful weaning -63.3 % 24.8%- Discharged. Outcome Survival 6 months 17.6% 1 yr 16.5% 5 yrs 13.7%

49. SUMMARY

50. LONG TERM DEVICES 1 st / 2 nd / 3 rd generation devices

51. Patients eligible for implantation of a left ventricular assist device (ESC 2016)

52. 1 st generation devices Pulsatile positive displacement pumps HeartMate I , Thoratec P aracorporeal Ventricular Assist Device ( PVAD) Novacor .

53. HeartMate I REMATCH trial – approved for destination therapy.

54. 2 nd generation devices Continuous flow devices - axial flow pumps HeartMate II Jarvik 2000 Berlin Heart INCOR

55. HEARTMATE II PUMP MECHANISM CONTINUOUS FLOW ROTARY PUMP(AXIAL DESIGN) ENERGY SOURCE ELECTRIC MOTOR METHOD OF PLACEMENT OPERATIVE VENTRICLE SUPPORTED LV IMPLANTABLE PUMP PREPERITONEAL PLACEMENT INDICATION BTT, DT

56. HEARTMATE II- BTT N = 133 Survival - 75 % at 6 months - 68 % at 12 months

57. HEARTMATE II- DT 134( Heartmate II) Vs 66 (Pulsatile flow device) 2 Yr survival - 58% vs. 24%, (P=0.008)

58. 3 rd generation devices Centrifugal pumps that have been designed for their long durability Heart ware Heartmate III

59. HVAD- Heartware PUMP MECHANISM CONTINUOUS FLOW ROTARY PUMP (CENTRIFUGAL DESIGN) ENERGY SOURCE ELECTRIC MOTOR METHOD OF PLACEMENT OPERATIVE VENTRICLE SUPPORTED LV IMPLANTABLE PUMP INTRAPERICARDIAL PLACEMENT INDICATION BTT, DT

60. HEARTWARE- HVAD

61. ADVANCE TRIAL 140 HeartWare vs 499 Control ( Heartmate II)

62. P value < 0.001 for non inferiority

63. ENDURANCE TRIAL 297 HeartWare vs 148 Control ( Heartmate II) Non transplant eligible candidates

64. ENDURANCE TRIAL

65. Endpoint : 12-month incidence of transient ischemic attack or stroke with residual deficit 24 weeks post-event

66. ENDURANCE SUPPLEMENTAL TRIAL

67. HEARTMATE 3 PUMP MECHANISM CONTINUOUS FLOW ROTARY PUMP (CENTRIFUGAL DESIGN) ENERGY SOURCE ELECTRIC MOTOR METHOD OF PLACEMENT OPERATIVE VENTRICLE SUPPORTED LV IMPLANTABLE PUMP INTRAPERICARDIAL PLACEMENT INDICATION BTT, DT

68. HEARTMATE III

69. MOMENTUM 3 TRIAL N- 1028 HM III Vs Heart Mate II Survival At 6 months At 2 yrs HeartMate 3 88% 75% HeartMate II 83% 61% P value <0.001 0.0001

70. MOMENTUM 3 TRIAL

71. SUMMARY Approved BTT 2017 Approved DT 2019

72. BIVENTRICULAR SUPPORT Severe biventricular failure or predominant right ventricular failure with significant left ventricular disease, or those with complex congenital heart disease. Total artificial heart (TAH) - SynCardia temporary Total a rtificial Heart

73. TAH PUMP MECHANISM PULSATILE, VOLUME DISPLACEMENT ENERGY SOURCE PNEUMATIC METHOD OF PLACEMENT OPERATIVE VENTRICLE SUPPORTED BV IMPLANTABLE PUMP ORTHOTOPIC PLACEMENT INDICATION BTT, DT 160g two artificial ventricles 70 mL SV - 9.5 L / minute Patients must have a BSA > 1.7 m 2 A distance of ≥10 cm from the 10 th anterior vertebral body to the inner table of the sternum on CT

74. SYNCARDIA

75. N= 116 70 cc Syncardia Survival to transplant- 79% (TAH) Vs 46% (Control) [P<0.001] One-year survival rate- 70% (TAH) Vs 31% controls (P<0.001 ) One-year and five-year survival rates after transplantation -86% and 64% N E ngl J Med 2004; 351:859-867

76. FDA Approval as BTT- 2004 FDA Approval for 50 cc Syncardia - March 10, 2020

77. pLVAD Project by Chitra

78. RECOMMENDATIONS ESC AHA

79. Thank You!