The document discusses short-term mechanical circulatory support devices like extracorporeal membrane oxygenation (ECMO) and the Impella pump. ECMO can be used to provide both cardiac and respiratory support through peripheral or central cannulation. It discusses indications, configurations, complications and management of ECMO. The Impella is an axial flow pump that is placed via catheter into the heart to unload the left ventricle and increase cardiac output, protecting the myocardium with less invasive placement compared to other devices.

1. Assistenze short term:
bridge to recovery, bridge to decision,
bridge to transplantation
C. Amarelli
Assistenze meccaniche al circolo:
scelta, impianto e gestione.

2. Assistenze short-term

3. Assistenze short-term
“The brilliant success of the RCT has now become a form of intellectual tyranny”
Freireich

4. Assistenze short-term

5. Assistenze short-term

7. Assistenze short-term

8. First successful ECMO patient, 1971
J Donald Hill MD and Maury Bramson BME, Santa
Barbara, Ca, 1971. (Courtesy of Robert Bartlett, MD)

10. Assistenze short-term
• Cardiopulmonary bypass (CPB)
• Complete cardiopulmonary support in the operating room
• Extracorporeal membrane oxygenation (ECMO)
• Partial cardiopulmonary support
• Veno-arterial: cardiac and pulmonary support
• No Blood-air interface
• Lower Priming
• Heparin-coated or low-thrombogenicity

11. Assistenze short-term
ECMO physiology
• Replaces/augments both pulmonary and cardiac function
• Perfusate mixes in the aorta with blood from left ventricle (arriving
from compromised lungs);
• O2/CO2 content = content of bloodreturning from the circuit + that
of pulmonary source;
• Systemic bloodflow = ECMO flow + patient’s own flow
• EtCO2 – measures the return of native lung function

12. Assistenze short-term
Indications:
• Post-cardiotomy
ü when unable to get pt off cardiopulmonary bypass
followingcardiac surgery
• Post-heart transplant
ü usually due to primary graft failure
• Severe cardiac failure due to almost any other cause
ü Decompensated cardiomyopathy
ü Myocarditis
ü Acute coronary syndrome with cardiogenic shock
ü Profound cardiac depression due to drug overdose or sepsis

13. Assistenze short-term
Several considerationsmust be weighed:
• Likelihood of organ recovery: only appropriate if disease process
is reversible with therapy and rest on ECMO
• Cardiac recovery: to either wait for further cardiac recovery to
allow implant of device (LVAD) or to list for transplantation.
• Disseminated malignancy
• Advanced age
• Known severe brain injury
• Unwitnessed cardiac arrest or cardiac arrest of prolonged
duration.
• Technical contraindications to consider: aortic dissection or aortic
incompetence

14. Assistenze short-term
Veno-arterial (VA) configuration
• Blood being drained from the venous system and returned
to the arterial system.
• Provides both cardiac and respiratory support.
• Achieved by either peripheral or central cannulation

15. Central vs. Peripheral Cannulation
Advantages
– Flow from Central ECMO is directly from the outflow cannula
into the aorta provides antegrade flow to the arch vessels,
coronaries and the rest of the body
– In contrast, the retrograde aortic flow provided by peripheral
leads to mixing in the arch.
Assistenze short-term

16. Assistenze short-term

17. Assistenze short-term

18. Assistenze short-term

19. Assistenze short-term
Centralvs. PeripheralCannulation
Advantages for Central
Flow from Central ECMO is directly from the outflow cannula into the
aorta provides antegrade flow to the arch vessels, coronaries and the
rest of the body
In contrast, the retrograde aortic flow provided by peripheral leads to
mixing in the arch.

20. Assistenze short-term
Disadvantages
• Previously insertion of central ECMO required leaving chest open to allow the
cannulae to exit.
• Increased the risk of bleedingand infection
• Newer cannulae are designed to be tunneled through the subcostal
abdominal wall allowingthe chest to be completelyclosed.
• Central cannula are costly(approximately4times as much as peripheral)
• Not safelyperformed bedside.

21. Things to Think About
— Mechanical ventilation must be continued during ECMO support to
try to maintain oxygen saturation of blood ejected from the left
ventricle to at least above 90% in case of lung oedema.
— ECMO flow can be very volume dependent
— ECMO flow will drop:
Ø Hypovolemia
Ø Cannula malposition
Ø Pneumothorax
Ø Pericardial tamponade.

22. Surgeons give fluid
Intensivists give Lasix
(or use CVVH)
Assistenze short-term
Things to Avoid

23. Complications
V-A ECMO critical Issues
Bleeding and Thrombosis
Aortic flow competitionà Pulmonary Oedema
Left heart overload à Lower likelyhood of myocardial recovery
Hypoxic coronary perfusion à Lower likelyhood of myocardial recovery
Hypoxic cerebral perfusion/late implant à Neurologic sequelae (Time-dependent)

24. Complications of ECMO
• Bleeding/Hemolysis
– Out of proportion to the degree of coagulopathy and patient
platelet count
• Coagulopathy
– Continuous activation of contact and fibrinolytic
systems by the circuit
– Consumption and dilution of factors within minutes of
initiation of ECMO

25. Complications of ECMO
• Thrombocytopenia
– Platelets adhere to surface fibrinogen and are activated
– Resultant platelet aggregation and clumping causes
numbers to drop
• Non-pulsatile perfusion to end organs
– Kidneys
– Splanchnic circulation seems to be particularly susceptible
– GI bleeding, ulceration and perforation
– Liver impairment

26. Complications of ECMO

27. Complications of ECMO

28. Complications of ECMO

29. Complications of ECMO
• Mechanical Complications
– Tubing rupture
– Pump malfunction
– Cannula related problems
• Air embolism/Thromboembolism
• Neurological: Intracerebral bleeds
– Largely associated with sepsis
• Manifest as seizures or brain death
• Local complications: Leg ischemia
– Particularly at peripheral insertion site of VA

30. Complications of ECMO
Prevent Limb Ischemia
• Separate arterial and venous cannulation
• Non-occlusive cannulation of femoral vessels
• Cannulation of Common femoral artery
• If feasible without delay reperfusion use a T-graft
to perfuse both proximally and distally
• Monitor limb perfusion (NIRS) and upgrade to
central ECMO or to limb reperfusion

31. CANNULATION TECHNIQUE
• Open
• Semi-open
• Percutaneous
Assistenze short-term

32. Assistenze short-term
Femoral artery cannulation:
• Chances of distal limb ischemia
• Distal perfusion catheter is commonly used
• Percutaneous reperfusion may be also performed
Distal Leg Perfusion 7/9 Fr Cannula

33. Peripheral Femoral Cannulation – VA ECMO
Assistenze short-term

34. Complications of ECMO

35. Complications of ECMO

36. CANNULATION
When doing central ECMO
a Left atrial vent line can
be utilized to monitor the
LA pressure
Assistenze short-term

37. Complications of ECMO
Avoid Left Ventricular distension:
• Lower flows warranting optimal sVO2 (>75%) measured on venous cannula (TIMING)
• Reduce systemic afterload / mean pressure to leave aortic valve open
• Inotropes
• Check for pulsatility on arterial wave (aortic valve opening at Echo)
• Check for good right drainage (less flow trough pulmonary artery)à if needed upgrade to
central ECMO with left ventricular venting

38. Complications of ECMO

40. Assistenze short-term

41. Assistenze short-term

42. Assistenze short-term

43. Assistenze short-term

44. Management of Complications
• Regular measurements of blood tests (Q6-Q8h)
– Coagulation Profile
– Platelet Count
– Hemoglobin
– Creatinine to evaluate for renal insufficiency
• Aggressive replacement of clotting factors,
electrolytes, PRBC

45. Weaning of ECMO – VA ECMO
• Depends on cardiac recovery, Factors:
– Increasing blood pressure
– Return or increasing pulsatilityon the arterial pressure
waveform
– Falling pO2 by a right radial arterial line
• indicating more blood is being pumped through the heart which may be
less well oxygenated,
– Falling central venous and/or pulmonary pressures.
• It is important to note that cardiac outputs from pulmonary
artery catheter are inaccurate on ECMO
– Most of the circulating blood volume is bypassing the
pulmonary circulation

46. Weaning of ECMO – VA ECMO
Hemodynamically stable patients underwent ECMO flow reduction trials to 1.5
L/min under clinical and Doppler echocardiography monitoring. When a patient
had partially or fully recovered from severe cardiac dysfunction, tolerated the
weaning trial, and had left ventricular ejection fraction (LVEF) [20–25% and
aortic time–velocity integral (VTI)[10 cm under minimal ECMO support, device
removal was considered.

47. Adult Heart Transplants
Kaplan-Meier Survival by VAD usage
(Transplants: January 1999 – June 2012)
0
20
40
60
80
100
0 1 2 3 4 5 6 7 8 9 10 11 12
Survival (%)
Years
Pulsatile flow (N=3,497) Continuous flow (N=2,856)
ECMO (N=142) No LVAD / No Inotropes (N=10,271)
No LVAD / Inotropes (N=10,606)
All pair-wise comparisons with pulsatile flow and ECMO were
significant at p < 0.05. No other pair-wise comparisons were
significant at p < 0.05.
2014
JHLT. 2014Oct; 33(10): 996-1008

48. Assistenze short-term
Periodo procedure
2011-20142007-20102003-20061999-2002
Percentuale
100,0%
80,0%
60,0%
40,0%
20,0%
0,0%
Si
No
Supporto
ventricolare
VAD

49. Assistenze short-term

50. Assistenze short-term

51. Ossigenare sempre?

52. Altre soluzioni tecniche

53. IABP

54. The TandemHeart® System
Percutaneous extracorporeal platform for temporary
circulatory support for
• RV >4.0 L/min
•LV 5.0 L/min
Certified 30 days

55. TandemHeart: A better option for
improving outcomes
q Why TandemHeart?
– Highest percutaneous flow
– Direct Ventricle decompression/unloading
– Cross-functional utility (Cardiology, C-T Surgery, ICU )
– Versatile configurations
Ambulance Emergency
Room
Cath Lab
or OR
TandemHeart
IABP/pressors
Decision
Recovery
Surgery
Dialysis Death
Severe Heart Attack Bridge
Risky Procedure w/
Low Survival Rate
Transplant

56. TandemHeart: A Versatile Platform
Perc Right RA-PA (Fem) Perc Right w/ LVAD V-A ECMO V-V ECMO
Surgical Left (Apex) Surgical Left (LA) Surgical Right (RA-PA) Surgical Left w/ Oxy Surgical Bi-VAD
Perc Right RA-PA (IJ)

57. • A single platform and a full toolbox, with the right tool for each job.
TandemHeart: A Versatile Platform
The percutaneous ventricular assist device in severe refractory cardiogenic
shock.
Kar, et al. J Am Coll Cardiol. 2011 Feb 8;57(6):688-96.

58. The area inside the resulting PV loop is equal to
the work being done by the heart in a single cardiac cycle
Smaller area inside the PV loop means less work being done by the LV
(more work being done by the support system)
Measuring Performance in Circulatory Support

59. TandemHeart vs. LV-Axial Support
• TandemHeart operates at 90
mmHg pressure, similar to a
healthy native heart
• All LV-axial devices operate at
lower pressures (60 mmHg)
• Performance is defined by a
combination of pressure and flow
• Power Output combines pressure
and flow performance into a single
measurement
∆ Pressure
(mmHg)
Flow
(L/min)
Power
(Watts)
Healthy Left Ventricle 90 5.0 1.00
TandemHeart @ 7,500 rpm 90 4.4 0.88
21 Fr Axial @ P9 60 4.4 0.59
14 Fr Axial @ P8 60 3.3 0.44
12 Fr Axial @ P8 60 2.1 0.28
1.00
0.880.59
0.44
0.28
1.0
2.0
3.0
4.0
5.0
6.0
50 60 70 80 90 100
Average Flow (L/min)
Average ∆ Pressure (mmHg)
Power Output (Watts)
Healthy Left Ventricle
TandemHeart @ 7,500 rpm
21 Fr Axial @ P9
14 Fr Axial @ P8
12 Fr Axial @ P8

61. IMPELLA è una micropompa assiale
intravascolare a supporto del sistema
circolatorio del paziente
La rotazione dell’IMPELLA produce una
pressione negativa che aspira il sangue
attraverso l’area di inflow e lo pompa in aorta
ascendente attraverso l’area di outflow
bypassando la valvola aortica
Il flusso generato è proporzionale alla velocità
di rotazione gestita attraverso la console
TECNOLOGIA IMPELLA

62. *
Assistenza Cardiaca ideale Piattaforma Impella
Sicurezza, Facilità
d’uso
Supporto Emodinamico
Sistemico
Protezione del
Miocardio
• Ripristina o aumenta la
gittata cardiaca netta
• Riduce la richiesta di O2
• Aumenta la disponibilità di O2
• La più piccola pompa cardiaca del
mondo
• Indipendente dal ritmo cardiaco e
dai farmaci inotropi
PRINCIPI DELLA PIATTAFORMA IMPELLA

63. Potenza Gittata
Cardiaca
EDV, EDP PAM Flusso
Protezione Miocardica Supporto Emodinamico
Inflow
(ventricolo)
Outflow
(radice aortica)
Lavoro meccanico
Tensione parietale
Resistenza microvascolare
Flusso Coronarico
RISULTATI FISIOLOGICI DEL SUPPORTO IMPELLA
Richiesta di O2 Richiesta di O2

64. IMPELLA: FAMIGLIA DI PRODOTTI
IMPELLA 2.5 IMPELLA 5.0 IMPELLA LD
Flow Rate (L/min) 2.5 5.0 5.0
Circulatory Support Partial High-Flow High-Flow
Catheter Size 9 Fr 9 Fr 9 Fr
Pump Size 12 Fr 21 Fr 21 Fr
Insertion Method Percutaneous
via Introducer Sheath
Peripheral
via Arterial Cut-down
Direct
Surgical Insertion
Guidewire thickness 0,018” 0,025” N/A
Cannula Geometry Curved/Pigtail Curved/Pigtail Straight
Micro-axial Pumps
L’ Impella® 2.5 è indicata per l’uso clinico in cardiologia e cardiochirurgia fino a 5 giorni
L’ Impella® 5.0 è indicata per l’uso clinico in cardiologia e cardiochirurgia fino a 10 giorni

65. Cardiac Power Output
EstimatedIn-HospitalMortality(%)
Impella increasesCPO (Seyfarth)
Systemic Hemodynamic Support
In AMI Cardiogenic Shock … Fincke et al. (2004)
Impella devices DO NOT have specific labeling for AMI Cardiogenic Shock. See Slides 1 & 2 for
specific Indications for Use of Impella 2.5 and Impella 5.0, LD
CPO = CO x MAP x 0,0022 (watt)

66. IABP vs. LV-Axial Support

67. Impella Recover ® Microaxial-VADs
Recover LD & RD = thoracic; LP = transfemoral
Recover®LP 5.0
Recover®LD
Recover®LP 2.5
Recover®RD
Impella: Differentsolution for every setting

68. Comparison of RV Support Alternatives
CentriMag Impella RP TandemHeart
Effective and safe HDE HDE
510(k),
500 patients
Easy to implant
and explant
Surgical,
OR Implant
OR Explant
Groin,
Rigid,
Perc/CCL
IJ/Neck,
Flexible,
Perc/CCL
Easy to transport
Stable, but
Pump off patient
Pump in patient,
but groin limits
Away from groin,
Ambulatory pump
Easy to care for
Open chest,
Surgical cannulae
Groin
Away from groin,
Ambulatory pump
Economical
Cheapest system,
Add'l OR cost,
Add'l ICU cost
Expensive
Less than Impella,
Lower explant/ICU
cost vs. Centrimag
(patient consent & IRB
required)

69. Assistenze short-term

70. Assistenze short-term

71. Assistenze short-term

72. Assistenze short-term

73. Assistenze short-term
New Indications in TCS
Intended TCS may be a strategy to reduce of organ damage during
high risk cardiac procedures (PTCA, CABG, LVAD, TAVI etc.).
E costa pure meno!

74. Assistenze short-term

75. Assistenze short-term

76. Assistenze short-term

77. Assistenze short-term

78. Assistenze short-term

79. Assistenze short-term
“The key to the success of ECMO
may be the time of initiation”
Plotkin et al., U of M, 1994

80. Assistenze short-term
Conclusioni
• L’assistenza meccanica di breve termine necessita di una
organizzazione logistica e di competenze che permettano l’impianto
anche al lettodel paziente.
• Non appena raggiunta la stabilità e ripristinata la funzione degli
organi è cruciale la pianificazione dello step successivo (impianto
LVAD long-term, correzione chirurgica, trapianto di cuore o polmone).
• La mortalità della assistenza meccanica del circolo dipende in
maniera diretta dal timing con cui il sistema è stato impiantato e dalla
rapiditàcon cui è stata ripristinata la funzione d’organo.

81. Assistenze short-term

82. Thank you for your time.

83. “The use of statistics in medical research has been compared to a
religion: it has its high priests (statisticians), supplicants (journal
editors and researchers), and orthodoxy (for example, p<.05 is
“significant”)”
Benjamin Freedman
Alternatives to RCTs should be considered:
• when therapies are potentially life-saving
• when the technologies are developing rapidly
• when RCTs are not the most efficient method
• when non-randomized data is compelling
Healer versus Investigator
The Fundamental Conflict