This document provides an overview of mechanical circulatory support devices. It discusses the evolution of such devices and their terminology. Temporary devices discussed include intra-aortic balloon pumps and Impella pumps. Long-term devices discussed include pulsatile flow devices like HeartMate I as well as continuous flow devices like HeartMate II, HeartWare HVAD, and HeartMate 3. Clinical trials are summarized that evaluated these devices as bridges to transplant or destination therapy. Biventricular support devices like the total artificial heart are also covered. The document concludes with recommendations from organizations on the use of these devices.

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- Mechanical Circulatory Support
(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

7. INDICATIONS

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

9. 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

10. TERMINOLOGY
• VENTRICLE SUPPORTED
 LVAD
 RVAD
 BiVAD
 TAH

11. TERMINOLOGY
• INTENDED USE
 Short term: days to week
 Long term: months to year

12. TERMINOLOGY
• PUMP MECHANISM
 Pulsatile flow
 Continuous flow rotary pump with axial
design
 Continuous flow rotary pump with centrifugal
design

13. TEMPORARY DEVICES

14. 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

15. 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

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

17. 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

18. CONTRAINDICATIONS
• Severe Aortic Insufficiency
• Aortic Aneurysm
• Aortic Dissection
• Limb Ischemia
• Thromboembolism

19. IABP- CLASS I

20. 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)

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

22. 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)

23. 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.

24. 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

26. • 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

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

28. • 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%

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

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

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

32. 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.

33. • ISAR-SHOCK trial
• 26 AMI patients with CS
• Impella LP 2.5 or IABP therapy
• 10 Endpoint: Change 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
• 20 Endpoint: 30-day mortality- 46% in both
groups

34. • 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

35. • 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

36. 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)

38. • N=41
• AMI patients with CS
• Hemodynamic support with either IABP therapy
Vs the TandemHeart.
• The primary end point- Improvements 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)

39. • 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

40. • 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

41. 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)

42. • Mortality
(2004-2014)
~ 47%

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
• 1st/ 2nd/ 3rd generation devices

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

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

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

54. 2nd 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

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

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

59. 3rd generation devices
• Centrifugal pumps that have been designed
for their long durability
• Heart ware
• Heartmate III

60. 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

61. HEARTWARE- HVAD

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

63. • P value < 0.001 for non inferiority

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

65. ENDURANCE TRIAL

68. 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

69. HEARTMATE III

71. 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

72. MOMENTUM 3 TRIAL

73. SUMMARY
Approved BTT 2017
Approved DT 2019

74. BIVENTRICULAR SUPPORT
• Severebiventricular 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 artificial
Heart

75. 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 m2
• A distance of ≥10 cm from the 10th anterior
vertebral body to the inner table of the sternum
on CT

76. SYNCARDIA

77. • 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 Engl J Med 2004; 351:859-867

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

79. pLVAD Project by Chitra

80. RECOMMENDATIONS
• ESC
• AHA

81. Thank You!