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.
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
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
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
25.
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
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)
37.
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)
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%
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
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
National Heart, Lung, and Blood Institute, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and others,
provide important prognostic information for patients with advanced heart failure (HF) receiving mechanical support
18 hospitals without primary angioplasty capabilities in the U.S., Australia, and Europe between November 1996
2018
The mean duration of IABP therapy was 21±16 days
Eighty percent of patients had their IABPs surgically implanted in the right subclavian artery. The median duration of IABP support was 21 days (maximum 135 days).
Cardiac index- no difference at 4 hrs & 24 hrs. Feasibility and safety of a percutaneously delivered LVAD; effective and superior hemodynamic support.
92% H/O cardiac arrest requiring resuscitation.
More bleeding events (8 versus 2)- Impella CP than in the IABP group.
Case series- JACC
Oxygenated blood is withdrawn from the LA via a 21-Fr inflow cannula placed via transseptal puncture and then reinjected into the lower abdominal aorta or iliac arteries via a 15- to 17-Fr outflow cannula
Nineteen patients (90%) required blood transfusions (median 8.0 U, interquartile range, 3.8–16.5 U; IABP n=8; P=0.002), and 13 patients (62%) had signs of disseminated intravascular coagulation
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,
(leg ischemia, femoral hemorrhage because of arterial laceration, cannula insertion-site infection, pulmonary edema, and circuit-related hemolysis)
Inotropic score, in μg/kg/min, was calculated as follows: dopamine + dobutamine + 100 × epinephrine + 100 × norepinephrine + 15 × milrinone
CAUSE OF ARREST- CARDIAC+ NON CARDIAC
Peripheral ECMO was switched to central ECMO in 3 patients (6%) because of leg ischemia or inadequate support.
major bleeding (32%), femoral vein thrombosis (10%), arterial ischemia (19%), vena cava thrombosis (7.4%), surgical wound infection (17%), pulmonary edema (12%), and stroke (8.6%)
29%- percutaneous cannuation; no mortality difference in central vs peripheral cannulation
Excellent hemodynamic support and improved survival
Titanium microspheres and a fibrillar textured inner surface that promoted the formation of a "pseudointima" that resists thrombogenesis.
350g, 10 L/min
150 g, 50cc, 10 L/min
2-year survival free from disabling stroke (with “disabling” defined as a modified Rankin scale score of ≥4 assessed 24 weeks after the stroke), with the patient alive with the originally implanted device, having undergone elective transplantation, or with the device explanted because of left ventricular recovery