Assistenze short	term:		
bridge	to	recovery,	bridge	to	decision,
bridge	to	transplantation
C.	Amarelli
Assistenze meccaniche al circolo:
scelta, impianto e gestione.
Assistenze short-term
Assistenze short-term
“The	brilliant	success	of	the	RCT	has	now	become	a	form	of	intellectual	tyranny”	
Freireich
Assistenze short-term
Assistenze short-term
Assistenze short-term
First	successful	ECMO	patient,	1971
J Donald Hill MD and Maury Bramson BME, Santa
Barbara, Ca, 1971. (Courtesy of Robert Bartlett, MD)
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
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
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
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
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
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
Assistenze short-term
Assistenze short-term
Assistenze short-term
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.
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.
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.
Surgeons	give	fluid
Intensivists	give	Lasix
(or	use	CVVH)
Assistenze		short-term
Things	to	Avoid
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)
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
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
Complications	of	ECMO
Complications	of	ECMO
Complications	of	ECMO
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
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
CANNULATION	TECHNIQUE
• Open
• Semi-open	
• Percutaneous
Assistenze short-term
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
Peripheral Femoral Cannulation – VA ECMO
Assistenze short-term
Complications	of	ECMO
Complications	of	ECMO
CANNULATION
When doing central ECMO
a Left atrial vent line can
be utilized to monitor the
LA pressure
Assistenze short-term
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
Complications	of	ECMO
Assistenze short-term
Assistenze short-term
Assistenze short-term
Assistenze short-term
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
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
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.
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
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
Assistenze short-term
Assistenze short-term
Ossigenare sempre?
Altre soluzioni tecniche
IABP
The	TandemHeart® System
Percutaneous	extracorporeal	platform	for	temporary	
circulatory	support	for
• RV														>4.0	L/min
•LV															5.0	L/min	
Certified 30	days
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
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)
• 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.
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
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
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
*
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
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
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
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)
IABP	vs.	LV-Axial	Support
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
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)
Assistenze short-term
Assistenze short-term
Assistenze short-term
Assistenze short-term
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!
Assistenze short-term
Assistenze short-term
Assistenze short-term
Assistenze short-term
Assistenze short-term
Assistenze short-term
“The	key	to	the	success	of	ECMO	
may	be	the	time	of	initiation”
Plotkin et	al.,	U	of	M,	1994
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.
Assistenze short-term
Thank you for your time.
“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

Short-term MCS. When and how?