IABP, IMPELLA, PEECUTANEOUS HEART PUMP, ECMO, TANDEM HEART, IMPELLA RP, TANDEMLIFE PROTEK DUO, HEARTMATE II, HEARTMATE 3, TOTAL ARTIFICIAL HEART, SYNCARDIA

1. MECHANICAL CIRCULATORY
SUPPORT DEVICES
MODERATOR- DR ANKIT SAHU
PRESENTER- SATYA PRASAD MAHAPATRA
28/03/24

2. • INTRODUCTION
• DEVICE TERMINOLOGY
• TEMPORARY DEVICES
• LONG TERM DEVICES
• RECOMMENDATIONS
• CONCLUSION
• REFERENCES

3. INTRODUCTION
• Mechanical circulatory support (MCS) devices are mechanical pumps
designed to assist or replace the function of the left and/or right
ventricle(s) of the heart
Rihal, C.S., Naidu, S.S., Givertz, M.M., Szeto, W.Y., Burke, J.A., Kapur, N.K., Kern, M., Garratt, K.N., Goldstein, J.A.,
Dimas, V. and Tu, T., 2015. 2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of
percutaneous mechanical circulatory support devices in cardiovascular care: endorsed by the American Heart
Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion;
Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie
d’intervention. Journal of the American College of Cardiology, 65(19), pp.e7-e26.

4. MCS DEVICES STRATEGIES
• Cardiac recovery in the short term
• Bridge to transplantation
• Destination therapy in refractory heart failure.
• High-risk procedures such as complex PCI or thrombolysis for pulmonary
embolism.
Møller JE, Helgestad OK. Advanced Mechanical Circulatory Support in Refractory Cardiogenic Shock: Is Timing the
Key to Success?. Circulation: Heart Failure. 2020 Mar;13(3):e006846.
Werdan, Karl, et al. "Mechanical circulatory support in cardiogenic shock." European heart journal 35.3 (2014): 156-
167.

5. INDICATIONS FOR MCS
• Mechanical complications of AMI
• Acute heart failure/acute on
chronic heart failure
• Post-cardiotomy shock
• Acute cardiac allograft failure
• Post-transplant RV failure
• Refractory arrhythmias
• Difficulty weaning from
cardiopulmonary bypass
• Prophylactic use for high-
risk/complex PCI
• High-risk or complex ablation of VT
• High-risk percutaneous valve
interventions
Atti V, Narayanan MA, Patel B, Balla S, Siddique A, Lundgren S, Velagapudi P. A comprehensive review of mechanical
circulatory support devices. Heart International. 2022;16(1):37.

6. Terminology Describing Characteristics of MCS
Braunwald's: A Textbook of Cardiovascular Medicine (Braunwald's Heart Disease) 12th edition

7. Terminology Describing Characteristics of MCS
Braunwald's: A Textbook of Cardiovascular Medicine 12th edition

8. SHORT-TERM MECHANICAL CIRCULATORY SUPPORT
DEVICES
• LV support devices
• RV support devices
• Biventricular support devices
Atti V, Narayanan MA, Patel B, Balla S, Siddique A, Lundgren S, Velagapudi P. A comprehensive review of
mechanical circulatory support devices. Heart international. 2022;16(1):37.

9. 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
Scheidt S, Wilner G, Mueller H, Summers D, Lesch M, Wolff G, Krakauer J, Rubenfire M, Fleming P, Noon G, Oldham
N. Intra-aortic balloon counterpulsation in cardiogenic shock: report of a cooperative clinical trial. New England Journal
of Medicine. 1973 May 10;288(19):979-84.

10. IABP 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

11. IABP ARTERIAL WAVE FORM
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

12. INDICATIONS OF IABP CONTRAINDICATIONS
• CS 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
• Severe Aortic Insufficiency
• Aortic Aneurysm
• Aortic Dissection
• Limb Ischemia
• Thromboembolism
Khan, Tahir M., and Abdul H. Siddiqui. "Intra-aortic balloon pump." (2019).

13. Study Population Inclusion Endpoints Results
TACTICS TRIAL
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).
While early IABP use was not associated with
a definitive survival benefit when added to
fibrinolysis for patients with MI and
hemodynamic compromise in this small trial,
its use suggested a possible benefit for
patients with the most severe heart failure or
hypotension
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)
Magnus Ohman, E., et al. "Thrombolysis and counterpulsation to improve survival in myocardial infarction
complicated by hypotension and suspected cardiogenic shock or heart failure: results of the TACTICS Trial." Journal
of thrombosis and thrombolysis 19 (2005): 33-39.

14. 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).
Prondzinsky, Roland, et al. "Intra-aortic balloon counterpulsation in patients with acute myocardial infarction
complicated by cardiogenic shock: the prospective, randomized IABP SHOCK Trial for attenuation of multiorgan
dysfunction syndrome." Critical care medicine 38.1 (2010): 152-160.

15. Study Populat
ion
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)
Use of IABP did not significantly reduce 30-day
mortality in patients with cardiogenic shock
complicating acute myocardial infarction for whom
an early revascularization strategy was planned
All-cause mortality at 6 years: 66.3% with IABP
versus 67.0% with no IABP (p = 0.98)
Thiele, Holger, et al. "Intraaortic balloon support for myocardial infarction with cardiogenic shock." New England journal
of medicine 367.14 (2012): 1287-1296.

16. RECOMMENDATIONS OF IABP IN STEMI
ESC 2017 IABP insertion should be considered in patients with
hemodynamic instability/cardiogenic shock due to
mechanical complications
IIa C
Short-term mechanical supportc may be considered in
patients in refractory shock.
IIb C
Routine use of IABP in patients with cardiogenic shock
is not recommended
III B
Ibanez, Borja, et al. "2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting
with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting
with ST-segment elevation of the European Society of Cardiology (ESC)." European heart journal 39.2 (2018): 119-
177.

17. • 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
Thiele, Holger, et al. "Intraaortic balloon pump in cardiogenic shock complicating acute myocardial infarction: long-
term 6-year outcome of the randomized IABP-SHOCK II trial." Circulation 139.3 (2019): 395-403.

18. LEFT VENTRICLE TO ARTERIAL CIRCULATORY
SUPPORT
• Impella • HeartMate percutaneous
heart pump
Impella 2.5 Impella 5.5
Impella cardiac
power (CP)® Impella expandable cardiac power (ECP)® device
2.5 L/min 5.0 L/min 3.5 L/min 3.5 L/min
12 Fr system 21 Fr system 14 Fr system 9 Fr System

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

20. MECHANISM OF IMPELLA SUPPORT
• Unloads the left ventricle - ↓LVEDP and LV wall tension,
↓ LV work and myocardial oxygen demand
• ↑ MAP, diastolic pressure, CO and CPO---> improved
systemic perfusion and increased coronary flow(combined
mechanism of increased aortic pressure working
synergistically with LV unloading and decreased wall
tension)
• ↓ pulmonary capillary pressure and a secondary reduction
in right ventricular afterload.
Atkinson, Tamara M., et al. "A practical approach to mechanical circulatory support in patients undergoing percutaneous coronary
intervention: an interventional perspective." JACC: Cardiovascular Interventions 9.9 (2016): 871-883.

21. Advantages Disadvantages Contraindications
1. Does not require EKG or
arterial waveform
triggering
2. Facilitates stability even in
the setting of
tachyarrhythmias or
electromechanical
disassociation
1. Risk of device migration
2. Device malfunction
because of thrombosis
3. Hemolysis
4. Bleeding requiring
transfusion
5. Arrhythmias
6. Limb ischemia
7. Tamponade, aortic or
mitral valve injury, and
stroke.
1. LV thrombus
2. Mechanical aortic valves
3. Severe peripheral vascular
disease and very severe
aortic stenosis may
preclude its implantation.
IMPELLA
Salter, Benjamin S., et al. "Temporary mechanical circulatory support devices: practical considerations for all
stakeholders." Nature Reviews Cardiology 20.4 (2023): 263-277.

22. ISAR-SHOCK trial PROTECT II Trial IMPRESS trial PROTECT III STUDY
2008, Circulation 2012, Circulation 2017, JACC 2020, Circulation
Efficacy study of LV assist
device to treat patients with
cardiogenic shock.
Impella LP 2.5 or IABP therapy
One of the largest RCTs in
patients with high-risk PCI
Although the trial was not
completed due to futility.
Impella versus IABP reduces
mortality in STEMI patients
treated with primary PCI in
severe cardiogenic shock.
Post-marketing surveillance
of the Impella 2.5/Impella
CP
25 patients with AMI-CS. 452 patients to during high-risk
PCI
48 patients with AMI-CS 1134 pt
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
Impella 2.5 was associated with
greater increase in cardiac
index (CI).
20 Endpoint: 30-day mortality-
46% in both groups
No difference in 30-day
mortality between the two
Primary endpoint of a 30-day
composite outcome of 11
adverse events was not
significantly different between
the two groups.
30 day mortality- Similar (50%
-Impella CP or 46% -IABP
therapy, P=0.92)
Six-month mortality - 50% in
both groups
Found no difference in 30-day
and 6-month mortality
between the two groups.
PROTECT III study
demonstrates improved
completeness of
revascularization, less
bleeding, and improved 90-
day clinical outcomes
compared to PROTECT II for
Impella-supported high-risk
percutaneous coronary
intervention among
patients with severely
depressed LVEF.

23. PROTECT IV STUDY STEMI-DTU
Ongoing(2027) Ongoing( November 2024, follow up 2030)
Impella CP® or Impella 2.5 placement prior to high-risk PCI vs
Subjects randomized to the Control group will be treated per
standard of care PCI with or without an intra-aortic balloon
pump (IABP)
The trial investigates whether mechanical unloading of the
left ventricle (LV) using the Impella CP device before primary
PCI can reduce infarct size and improve prognosis compared
to primary PCI alone without LV unloading.
1252 participants 668 subjects with anterior STEMI
The composite rate of all-cause death, stroke, myocardial
infarction (MI), unplanned clinically driven revascularization,
durable left ventricular assist device (LVAD) implant or heart
transplant, or other hospitalization for cardiovascular causes
at 3-year follow-up.
This trial aims to generate robust clinical evidence to achieve
a Class I guideline recommendation for Impella in high-risk
PCI, benefiting patients with complex coronary artery
disease and compromised heart function
Infarct size as a percentage of LV mass evaluated by cardiac
magnetic resonance at 3-5 days after PCI.
STEMI-DTU aims to determine whether LV unloading with
Impella CP prior to primary PCI can significantly impact
infarct size and patient prognosis in STEMI cases.

24. HEARTMATE PERCUTANEOUS HEART PUMP(PHP)
• Second-generation
• Catheter-based microaxial three-
blade Impeller pump
• Can provide flows up to 4 to 5
L/min.
• Delivered percutaneously into the
femoral artery via an integrated 14
Fr sheath.
• The pump expands to 24 Fr once it
is placed across the aortic valve.
• Pumps the blood from LV to the
aorta.
Van Mieghem, N. M., et al. Design and Principle of Operation of the HeartMate PHPTM(Percutaneous. Vol. 74.
EIJ-‐D-‐15-‐00467, 2018.

25. SHIELD I TRIAL SHIELD II TRIAL
2018 2022
Evaluate the use of the HeartMate percutaneous heart
pump, a catheter-based axial flow pump, designed to
provide partial left ventricular support, in patients
undergoing high-risk PC
Patients undergoing high-risk percutaneous coronary
intervention (HR-PCI) were compared using the PHP
versus Impella systems.
50 pt 54 pt
• Initial results of the HeartMate percutaneous heart
pump for mechanical circulatory support during high-
risk PCI are encouraging.
• Hemodynamic stability was achieved in all patients
with a low incidence of adverse events.
Terminated
(Abbott has decided to discontinue our percutaneous
heart pump (PHP) program and the SHIELD II trial because
the product was not meeting the needs of the patients it
was intended to serve.)

26. RIGHT ATRIUM TO SYSTEMIC ARTERIAL
CIRCULATORY SUPPORT

27. EXTRACORPOREAL MEMBRANE OXYGENATION
• 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)
Donker DW, Brodie D, Henriques JP, Broomé M. Left ventricular unloading during veno-arterial ECMO: a review of
percutaneous and surgical unloading interventions. Perfusion. 2019 Mar;34(2):98-105.

28. ECMO
• Provide cardiopulmonary support for
prolonged periods.
• Two varieties :
1. VENOVENOUS (VV) ECMO
2. VENOARTERIAL (VA) ECMO.
• VA-ECMO provides both respiratory and
haemodynamic support in acute
cardiorespiratory failure and assist CPR in
cardiac arrest, known as extracorporeal
cardiopulmonary resuscitation.
Keebler, Mary E., et al. "Venoarterial extracorporeal membrane oxygenation in cardiogenic shock." JACC: Heart Failure
6.6 (2018): 503-516.

29. ECMO
COMPLICATIONS
• Bleeding
• Infection
• limb ischaemia
• Harlequin syndrome
CONTRAINDICATIONS
• Multiorgan failure
• Prolonged cardiopulmonary
resuscitation
• Aortic dissection
• Severe aortic regurgitation.
Vyas A, Bishop MA. Extracorporeal membrane oxygenation in adults. InStatPearls [Internet] 2023 Jun 21. StatPearls
Publishing.

30. ECMO IN ADVANCED HF
• Patients with CS because of
• Acute myocarditis,
• Primary graft dysfunction,
• Rejection
• As a bridge to bridge or bridge to transplant
Rao P, Khalpey Z, Smith R, Burkhoff D, Kociol RD. Venoarterial extracorporeal membrane oxygenation for
cardiogenic shock and cardiac arrest: cardinal considerations for initiation and management. Circulation: Heart
Failure. 2018 Sep;11(9):e004905.

31. Study Population Inclusion Endpoints Results
ECMO-CS
2022
122 Patient
with CS
Patients must
fulfill criteria
for rapidly
deteriorating
or severe
cardiogenic
shock
• composite of death from any cause
• 30-day incidence of resuscitated
cardiac arrest (10.3.% vs 13.6%),all-
cause mortality (50.0% vs 47.5%;
serious adverse events (60.3% vs
61.0%; sepsis, pneumonia, stroke, leg
ischemia, and bleeding was not
statistically different between the
immediate VA-ECMO and the no
immediate VA-ECMO groups.
• Immediate implementation of VA-
ECMO in patients with rapidly
deteriorating or severe cardiogenic
shock did not improve clinical
outcomes compared with an early
conservative strategy
Ostadal, Petr, et al. "Extracorporeal membrane oxygenation in the therapy of cardiogenic shock: results of the ECMO-
CS randomized clinical trial." Circulation 147.6 (2023): 454-464.

32. ECLS-SHOCK, AUG 2023, NEJM EURO-SHOCK, FEB 2021,
EUROINTERVENTION
ANCHOR RCT, 2022, FRONTIER CARDI-
VASCULAR MEDICINE
Optimal medical therapy vs. VA-ECMO
plus optimal medical therapy
Optimal medical therapy vs. Early VA-
ECMO plus optimal medical therapy
Optimal medical therapy vs. Early VA-
ECMO and IABP plus optimal medical
therapy
420 patients 35 patients 400 patients
At 30 days, death from any cause was
(47.8%) in the ECLS group and (49.0%)
in the control group.
In patients with acute myocardial
infarction complicated by cardiogenic
shock with planned early
revascularization, the risk of death
from any cause at the 30-day follow-
up was not lower among the patients
who received ECLS therapy than
among those who received medical
therapy alone
Thirty-day all-cause mortality occurred
in 43.8% of patients randomised to
VA-ECMO and in 61.1% of patients
randomised to standard therapy. One-
year all-cause mortality was 51.8% in
the VA-ECMO group and 81.5% in the
standard therapy arm. Vascular and
bleeding complications occurred more
often in the VA-ECMO arm (21.4% vs
0% and 35.7% vs 5.6%, respectively).
Due to the limited number of patients
recruited to the trial, no definite
conclusions could be drawn from the
available data.
Treatment failure at day 30 (death in
the ECMO group and death or rescue
ECMO in the control group)
Suspended (problem with the device
(dilatator of the introducer) used to
introduce the intra arterial balloon)
VA-ECMO IN AMI-CS TRIALS

33. LEFT ATRIUM TO SYSTEMIC ARTERIAL
CIRCULATORY SUPPORT

34. TANDEM HEART
• First totally percutaneous biventricular MCS device to come to market.
• FDA approved for 6 hours of use and CE marked for use up to 30 days
• As the blood is directly withdrawn from the left atrium, the device unloads the
LV by reducing left ventricular end diastolic pressure, left ventricular end
diastolic volume, stroke work and myocardial oxygen demand
PUMP MECHANISM CONTINUOUS FLOW ROTARY
PUMP
ENERGY SOURCE ELECTRIC
METHOD OF PLACEMENT PERCUTANEOUS
VENTRICLE SUPPORTED LV
DEGREE OF SUPPORT PARTIAL (2-4L/MIN)
Vranckx P, Foley DP, de Feijter PJ, Vos J, Smits P, Serruys PW. Clinical introduction of the Tandemheart, a percutaneous left ventricular assist device, for
circulatory support during high-risk percutaneous coronary intervention. Int J Cardiovasc Intervent. 2003;5(1):35-9. doi: 10.1080/14628840304611. PMID:

35. MECHANISM OF TANDEM SUPPORT
 By unloading the left ventricle - ↓pulmonary capillary wedge
pressure and LV preload ---> improves peripheral tissue perfusion,
despite a mild increase in afterload due to the pumping of blood back
into the femoral arteries .
 The device is preload dependent.
 Both the LV and the pump contribute flow to the aorta
simultaneously (thereby working in parallel, or tandem, rather than in
series)
 There is high risk of thromboembolism necessitating the need for
systemic anticoagulation with heparin.
Vranckx P, Foley DP, de Feijter PJ, Vos J, Smits P, Serruys PW. Clinical introduction of the Tandemheart, a
percutaneous left ventricular assist device, for circulatory support during high-risk percutaneous coronary intervention.
Int J Cardiovasc Intervent. 2003;5(1):35-9. doi: 10.1080/14628840304611. PMID: 12623563.

36. TANDEM HEART
Complications
• Associated with transseptal
puncture
1. Cardiac wall perforation
2. Aortic root puncture
3. Pericardial effusion or
tamponade
Contraindications
• Aortic regurgitation
• Peripheral vascular disease.
Thiele H, Sick P, Boudriot E, Diederich KW, Hambrecht R, Niebauer J, Schuler G. Randomized comparison of intra-aortic balloon
support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by
cardiogenic shock. European heart journal. 2005 Jul 1;26(13):1276-83.
Burkhoff D, Cohen H, Brunckhorst C, O'Neill WW, TandemHeart Investigators Group. A randomized multicenter clinical study to
evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with
intraaortic balloon pumping for treatment of cardiogenic shock. American heart journal. 2006 Sep 1;152(3):469-e1.

37. Thiele et al Burkhoff et al
Year 2005 2006
Population Single center, 41 Multi center, 33
Comparison Tandem Heart Vs IABP Tandem Heart Vs IABP
Results &
Conclusion
compared the TandemHeart with IABP in AMI-
CS and observed greater improvement in
haemodynamics with the TandemHeart
compared with IABP, with no significant
difference in 30-day mortality.
compared the TandemHeart with IABP placed within 24
hours of developing CS after AMI (70%) or
decompensated heart failure (30%). Compared with
IABP, the TandemHeart was associated with a greater
increase in cardiac index and MAP, and a greater
decrease in PCWP; however, there was no difference in
30-day mortality and adverse events.
Thiele H, Sick P, Boudriot E, Diederich KW, Hambrecht R, Niebauer J, Schuler G. Randomized comparison of intra-
aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial
infarction complicated by cardiogenic shock. European heart journal. 2005 Jul 1;26(13):1276-83.
Burkhoff D, Cohen H, Brunckhorst C, O'Neill WW, TandemHeart Investigators Group. A randomized multicenter clinical
study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional
therapy with intraaortic balloon pumping for treatment of cardiogenic shock. American heart journal. 2006 Sep

38. TandemHeart can be considered in the following clinical scenarios:
1) Severe LV dysfunction (ejection fraction <35%)
2) CS unresponsive to the Impella 2.5 or Impella CP
3) Acute mechanical complications of myocardial infarction such as
acute mitral regurgitation and ventricular septal rupture
Rihal CS, Naidu SS, Givertz MM, Szeto WY, Burke JA, Kapur NK, Kern M, Garratt KN, Goldstein JA, Dimas V, Tu T.
2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory
support devices in cardiovascular care: endorsed by the American Heart Assocation, the Cardiological Society of India,
and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of
Interventional Cardiology-Association Canadienne de Cardiologie d’intervention. Journal of the American College of
Cardiology. 2015 May 19;65(19):e7-26.

39. CentriMag
• Produce a continuous non-pulsatile blood
flow with minimal contact between rotor and
bloodstream.
• extremely preload and afterload sensitive.
• They are FDA approved for use up to 6 hours
as LV assistance, while they can be used up to
30 days for RV assistance.
• CentriMag- for use up to 30 days for any
indication.
John, Ranjit, et al. "Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term
circulatory support." The Journal of thoracic and cardiovascular surgery 141.4 (2011): 932-939.

40. CentriMag
• Borisenko et al. :
• Meta-analysis of 53 studies
• CentriMag used as LVAD (72%)
or as part of ECMO (25%).
• 30-day survival rate ranged from
41% to 66%.
• John et al. :
• 38 patients who received the
CentriMag for AMI-CS (n=14), RV
failure after LVAD implantation
(n=12) or post-cardiac surgery
(n=12),
• 30-day survival rate 44% when
the device was used for
biventricular support and 58%
when used for RV support.
Borisenko, Oleg, et al. "Thoratec CentriMag for temporary treatment of refractory cardiogenic shock or severe
cardiopulmonary insufficiency: a systematic literature review and meta-analysis of observational studies." Asaio
Journal 60.5 (2014): 487-497.
John, Ranjit, et al. "Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-
term circulatory support." The Journal of thoracic and cardiovascular surgery 141.4 (2011): 932-939.

41. MCS Device IABP Impella 2.5/CP/5.5 TandemHeart VA-ECMO
CO (L/min) 0.5–1.0 2.5/3.0–4.0/5.0 4.0–5.0 4.0–10.0
Pump mechanism Pneumatic Axial flow Centrifugal Centrifugal
Cannula size 7–9 Fr 13–22 Fr Drainage 21 Fr;
Return 15–17 Fr
Drainage 18–21 Fr;
Return 15–22 Fr
Advantages Bedside insertion; no
anticoagulation
Direct ventricular
unloading
Addition of pulmonary
support
Addition of pulmonary
support
Disadvantages Minimal
hemodynamic support
Mandatory
anticoagulation;
hemolysis
Immobilization Incomplete LV
unloading
Complications Limb/spinal cord
ischaemia; bleeding;
aortic dissection
Limb ischaemia;
bleeding; haemolysis;
ventricular
arrhythmias
Cardiac perforation;
tamponade bleeding;
air embolism; residual
ASD
Limb ischaemia;
bleeding; stroke; air
embolism; circuit
clots; DIC; oxygenator
failure; altered drug
pharmacokinetics
Contraindications Severe PAD; AAA;
significant AI
LV thrombus;
mechanical AV; severe
PAD
VSD; significant AI; left
atrial thrombus
Severe PAD; significant
AI; aortic dissection
SUMMARY-

42. HEMODYNAMICS EFFECT OF MCS
Atkinson, Tamara M., et al. "A practical approach to mechanical circulatory support in patients undergoing percutaneous coronary
intervention: an interventional perspective." JACC: Cardiovascular Interventions 9.9 (2016): 871-883.

43. SUMMARY OF RECOMMENDATIONS
Force, Task, et al. "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed
by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of
Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC." European Journal
of Heart Failure 24.1 (2022).

44. Byrne, Robert A., et al. "2023 ESC guidelines for the management of acute coronary syndromes: developed by the
task force on the management of acute coronary syndromes of the European Society of Cardiology (ESC)." European
Heart Journal: Acute Cardiovascular Care 13.1 (2024): 55-161.

45. RIGHT VENTRICLE SUPPORT DEVICES
Divided based on flow
Axial flow pump Centrifugal flow pump
1. Impella RP 1. TandemHeart right ventricular
assist device [TH-RVAD]
2. Protek Duo
3. VA-ECMO.

46. IMPELLA RP
• Minimally invasive, 22-Fr three-dimensional catheter-
based microaxial flow pump that can be used for up to 14
days.
• The blood is aspirated from the inflow cannula placed in
the inferior vena cava and ejected through the outflow
cannula placed in the pulmonary artery.
• It can provide flow of up to 4 L/min and unloads the RV.
• The Impella RP has also been used to provide
haemodynamic support in patients with malignant
ventricular arrhythmias and severe mitral regurgitation.
Kapur, Navin K., et al. "Effects of a percutaneous mechanical
circulatory support device for medically refractory right ventricular
failure." The Journal of heart and lung transplantation 30.12 (2011):
1360-1367.

47. IMPELLA RP
• COMPLICATIONS:
1. Risk of device migration
2. Device malfunction because of
thrombosis
3. Hemolysis
4. Bleeding requiring transfusion
5. Arrhythmias
6. Limb ischemia
7. Tamponade, aortic or mitral valve
injury, and stroke.
• CONTRAINDICATIONS
1. Tricuspid regurgitation
2. Pulmonary regurgitation
Kapur, Navin K., et al. "Effects of a percutaneous mechanical circulatory support device for medically refractory right
ventricular failure." The Journal of heart and lung transplantation 30.12 (2011): 1360-1367.

48. TANDEMHEART RIGHT VENTRICULAR ASSIST
DEVICE
• Extracorporeal centrifugal flow pump that
pumps the blood from the inflow cannula
placed in the right atrium to the outflow
cannula in the pulmonary artery.
• Both are venous cannulas, generally accessed
through the left and right femoral veins,
respectively.
• TH-RVAD is not currently FDA approved for RV
support.
Kapur, Navin K., et al. "Effects of a percutaneous mechanical circulatory support device for medically refractory right
ventricular failure." The Journal of heart and lung transplantation 30.12 (2011): 1360-1367.

49. TANDEMLIFE PROTEK DUO
• Support the RV
• The inflow cannula is positioned in the right
atrium
• The outflow portion is in the pulmonary artery.
• In patients with coexisting respiratory failure, an
oxygenator can be added to provide better
oxygenation compared with VV-ECMO.
• This configuration has been used in the
management of
• RV failure after LVAD implantation
• Pulmonary hypertensive crisis.
Salna, Michael, et al. "Novel percutaneous dual-lumen cannula-
based right ventricular assist device provides effective support
for refractory right ventricular failure after left ventricular assist
device implantation." Interactive CardioVascular and Thoracic
Surgery 30.4 (2020): 499-506.

50. RV SUPPORT TRIAL
Trial Population Inclusion Result
RECOVER RIGHT TRIAL
2004
30 patients Impella RP was used for
refractory RV failure after
cardiac surgery in 18
patients and after LVAD
implantation in 12 patients
The device immediately
reduced CVP and improved
cardiac index and had an
overall 30-day survival rate
of 73.3%.
THRIVE RETROSPECTIVE
STUDY
2013
46 patients TandemHeart in acute
right ventricular failure
TH-RVAD acutely improved
haemodynamics such as
MAP, right atrial pressure,
pulmonary artery systolic
pressure and cardiac index,
and in-hospital mortality
was found to be 57%.

51. LONG-TERM MECHANICAL CIRCULATORY
SUPPORT DEVICES

52. Types of long-term mechanical circulatory
support devices
1st Generation 2nd Generation 3rd Generation
Pump Design Pulsatile flow Continuous flow
(Axial Pump)
Continuous flow
(Centrifugal Pump)
LVAD Type HeartMate IP 1000
Novacor LVAD
HeartMate II
INCOR
Jarvik 2000
DeBakey
HVAD
DuraHeart
HeartMate 3
Desai, Suneel Ramesh, and Nian Chih Hwang. "Advances in left ventricular assist devices and mechanical circulatory
support." Journal of Cardiothoracic and Vascular Anesthesia 32.3 (2018): 1193-1213.

53. INDICATIONS FOR LEFT VENTRICULAR ASSIST
DEVICE SUPPORT
1. LV ejection fraction ≤25%
2. Peak oxygen consumption ≤14 mL/kg/min or unable to perform test
3. NYHA class IV heart failure
4. CI <2.2 L/min/m2, while not on inotropes and meet one of the
following:
• On OMT, based on current guidelines for at least 45 out of the
last 60 days and are failing to respond, or
• Have advanced heart failure for at least 14 days and are
dependent on IABP or similar temporary MCS for at least 7 days
Kormos, Robert L., et al. "The Society of Thoracic Surgeons Intermacs database annual report: evolving indications,
outcomes, and scientific partnerships." The Journal of Heart and Lung Transplantation 38.2 (2019): 114-126.

54. ABSOLUTE
CONTRAINDICATIONS
• Irreversible neurological or
neuromuscular disorders
• Irreversible renal disease
• Irreversible hepatic disease
• Active mental illness or
psychological instability
• Medication non-adherence
• Severe RV dysfunction without
options for RVAD support
RELATIVE
CONTRAINDICATIONS
• Age >80 years
• Morbid obesity or cachexia
• Musculoskeletal disease that
impairs rehabilitation
• Active systemic infection or
prolonged intubation
• Untreated malignancy
• Severe peripheral vascular disease
• Drug, tobacco, alcohol use within 6
months
• Psychological instability
Centers for Medicare & Medicaid Services. Decision Memo for Ventricular Assist Devices as Destination Therapy
(CAG-00119R). Assessed November 21, 2016

55. HEARTMATE II
• Continuous, axial flow pump with a titanium-coated
rotor generate flows of up to 10 L/min at pump
speeds of 6,000–10,000 rpm.
• FDA approval for bridge to transplantation in April
2008 and for destination therapy in January 2010.
Belkin MN, Kagan V, Labuhn C, Pinney SP, Grinstein J. Physiology and Clinical
Utility of HeartMate Pump Parameters. J Card Fail. 2022 May;28(5):845-862. doi:
10.1016/j.cardfail.2021.11.016. Epub 2021 Dec 31. PMID: 34980564; PMCID:
PMC9106934.
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. Starling, Randall C., et al. "Risk assessment and comparative effectiveness of left ventricular assist device and
medical management in ambulatory heart failure patients: the ROADMAP study 2-year results." JACC: Heart
Failure 5.7 (2017): 518-527.
Study Population Inclusion Endpoints Results
ROADMAP TRIAL
2017
Compared
HeartMate II with
optimal medical
therapy
200
Prospectiv
e
Non-
randomize
d trial
NYHA
functional
class IIIB/IV, at
least 1
hospitalization
for HF or 2
unscheduled
emergency
department
visits in the last
1 year, and
6MWD <300 m
survival on
original ther
apy
with
improvemen
t in 6-min
walk
distance ≥75
m.
• More LVAD patients met the primary endpoint at
2 years: 30% LVAD versus 12% OMM (odds ratio:
3.2 [95% confidence interval: 1.3 to 7.7];
p = 0.012).
• Survival at 1 year and 2 years was greater
with the LVAD than with optimal medical
therapy.
• Pump thrombosis remains a major concern
with this device due to direct contact
between mechanical bearing and blood

57. STUDY POPULATION INCLUSION END POINTS RESULTS
PREVENT
TRIAL
2017
300 • subject was
receiving HMII
as his or her first
LVAD and
• age ≥18 years
Pump Thrombosis
at 3 months
(primary end-point)
and at 6 months
after implantation.
• Incidence of pump thrombosis at 3 months
and 6 months was 2.9% and 4.8%,
respectively
• Full adherence to implant techniques, heparin
bridging, and pump speeds ≥9,000 RPMs
resulted in a significantly lower risk of PT
(1.9% vs 8.9%; p < 0.01) and lower composite
risk of suspected thrombosis, hemolysis,
and ischemic stroke (5.7% vs 17.7%; p < 0.01)
at 6 months.
Maltais, Simon, et al. "PREVENtion of HeartMate II pump thrombosis through clinical management: the PREVENT
multi-center study." The Journal of Heart and Lung Transplantation 36.1 (2017): 1-12.

58. HEARTWARE VENTRICULAR ASSIST DEVICE(HVAD)
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

59. ADVANCE TRIAL
• 140 HeartWare vs 499 Control (Heartmate II)
Aaronson, Keith D., et al. "Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart
transplantation." Circulation 125.25 (2012): 3191-3200.

60. • P value < 0.001 for non inferiority
Aaronson, Keith D., et al. "Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart
transplantation." Circulation 125.25 (2012): 3191-3200.

61. ENDURANCE TRIAL
• 297 HeartWare vs 148 Control (Heartmate II)
• Non transplant eligible candidates
Rogers, Joseph G., et al. "Intrapericardial left ventricular assist device for advanced heart failure." New England
Journal of Medicine 376.5 (2017): 451-460.

62. ENDURANCE TRIAL
Rogers, Joseph G., et al. "Intrapericardial left ventricular assist device for advanced heart failure." New England Journa
of Medicine 376.5 (2017): 451-460.

64. 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

65. STUDY POPULATI
ON
INCLUSION ENDPOINTS RESULTS CONCLUSION
MOMENTUM 3
TRIAL
2019
1028 Centrifugal-
flow LVAD with
axial-flow
device in
patients with
advanced-
stage heart
failure
survival at 2
years free of
disabling stroke
or reoperation
to replace or
remove a
malfunctioning
device
397 pt (76.9%) in the
centrifugal-flow pump
group vs 332 (64.8%) in the
axial-flow pump group,
remained alive and free of
disabling stroke or
reoperation to replace or
remove a malfunctioning
device at 2 years (relative
risk, 0.84; 95% confidence
interval [CI], 0.78 to 0.91;
P<0.001)
patients with advanced heart
failure, a fully magnetically
levitated centrifugalflow left
ventricular assist device was
associated with less frequent
need for pump replacement
than an axial-flow device and
was superior with respect to
survival free of disabling stroke
or reoperation to replace or
remove a malfunctioning device

66. 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
Mehra, Mandeep R., et al. "A fully magnetically levitated left ventricular assist device." New England Journal of
Medicine 380.17 (2019): 1618-1627.

67. MOMENTUM 3 TRIAL
Mehra, Mandeep R., et al. "A fully magnetically levitated left ventricular assist device." New England Journal of
Medicine 380.17 (2019): 1618-1627.

68. SUMMARY
Approved BTT 2017
Approved DT 2019

69. TAH (SYNCARDIA)- BIVENTRICULAR SUPPORT
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

70. • 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
Copeland, Jack G., et al. "Cardiac replacement with a total artificial heart as a bridge to transplantation." New
England Journal of Medicine 351.9 (2004): 859-867.

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

72. CONCLUSION
• CS is a life-threatening condition due to cardiac pump dysfunction
and is associated with high mortality.
• Despite technological advancements and rigorous research on CS,
managing patients who are resistant to conventional pharmacological
therapies remains a challenge.
• More RCTs investigating MCS use in various clinical scenarios of CS are
needed to guide optimal use of these devices in the future.
• Future focus of mcs- Miniaturization and biventricular support
applications

73. TAKE HOME MESSAGES
• Early recognition and management of CS pivotal in limiting death and
dysfunction
• MCS devices offer a viable option in improving QoL and survival
• “Right device at the right time in the right patient” should be the
strategy

74. REFERENCES
• Atti V, Narayanan MA, Patel B, Balla S, Siddique A, Lundgren S, Velagapudi P. A
comprehensive review of mechanical circulatory support devices. Heart International.
2022;16(1):37.
• Atkinson, Tamara M., et al. "A practical approach to mechanical circulatory support in
patients undergoing percutaneous coronary intervention: an interventional
perspective." JACC: Cardiovascular Interventions 9.9 (2016): 871-883.
• Byrne, Robert A., et al. "2023 ESC guidelines for the management of acute coronary
syndromes: developed by the task force on the management of acute coronary
syndromes of the European Society of Cardiology (ESC)." European Heart Journal:
Acute Cardiovascular Care 13.1 (2024): 55-161.
• Force, Task, et al. "2021 ESC Guidelines for the diagnosis and treatment of acute
and chronic heart failure: Developed by the Task Force for the diagnosis and
treatment of acute and chronic heart failure of the European Society of Cardiology
(ESC). With the special contribution of the Heart Failure Association (HFA) of the
ESC." European Journal of Heart Failure 24.1 (2022).
• Bernhardt, Alexander M., et al. "The international society for heart and lung
transplantation/heart failure society of America guideline on acute mechanical
circulatory support." The Journal of Heart and Lung Transplantation 42.4 (2023): e1-
e64.