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SOLO	I	PAZIENTI	STABILI	CON	VAD	
ANDREBBERO TRAPIANTATI
C.	Amarelli
It doesn’t matter how well intentioned you are.	If you can’t solve	your problems effectively,	
you may be	doing more	harm than good.	Having a	system to	solve	your problems will help	
ensure you problem solve	effectively.
• Define and Identify the Problem -
• If you don’t know what problem you are trying to solve or if you try to solve the
wrong problem you won’t be successful. Find out what the facts are and not only
develop a statement about what exactly the problem is you are trying to solve, but
what your goal is in solving it.
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
• Define and Identify the Problem -
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Define and	Identify the	Problem -
Adult	Heart	Transplants
%	of	Patients	Bridged	with	Mechanical	Circulatory	Support*	(Transplants:	January	
2000	– December	2012)
0
10
20
30
40
50
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
%	of	patients
Year
*	LVAD,	RVAD,	TAH,	ECMO
2014
JHLT. 2014Oct; 33(10): 996-1008
Adult Heart Transplants
Donor and Recipient Characteristics
1992-2000
(N = 37,538)
2001-2005
(N = 17,249)
2006-6/2013
(N = 26,294)
p-value
Pre-operative support (multiple items may be
reported)
Hospitalized at time of transplant 60.4% 47.9% 44.5% <0.0001
On IV inotropes 55.8%1 47.3% 42.2% <0.0001
Ventilator 3.4% 3.3% 2.7% 0.0005
IABP 6.5% 6.8% 6.6% 0.6612
Mechanical circulatory support 18.82 24.1 35.1 <0.0001
LVAD 11.9%2 16.9% 29.8% <0.0001
RVAD - 4.9%3 3.6% 0.0031
TAH 0.1%2 0.1% 1.0% <0.0001
ECMO 0.3%4 0.5% 1.1% <0.0001
1
Based on 4/1994-2000 transplants.
2
Based on 11/1999-2000 transplants.
3
Based on 2005 transplants.
4 Based on 5/1995-2000 transplants.
2014
JHLT. 2014Oct; 33(10): 996-1008
Adult	Heart	Transplants
%	of	Patients	Bridged	with	Mechanical	Circulatory	Support*	by	Year	and	
Device	Type
0
10
20
30
40
50
2005 2006 2007 2008 2009 2010 2011 2012
%	of	patients
Year
ECMO VAD+ECMO
TAH LVAD+RVAD
RVAD LVAD
*	LVAD,	RVAD,	TAH,	ECMO2014
JHLT. 2014Oct; 33(10): 996-1008
Figure 21
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	6	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
Figure	7	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
Figure	7	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
Figure	7	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Competing Outcomes Over Time by Initial Implant Strategy
(A) 6 months; (B) 12 months; and (C) 24 months. BTC = bridge to candidacy;
BTT = bridge to transplant.
Figure	7	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
Device Strategies Over Time
(A) BTT;
(B) BTC: likely;
(C) BTC: moderate;
(D) BTC: unlikely;
(E) DT.
Strategies have been grouped
according to original intent. BTC:
likely = BTC and likely to be
transplanted; BTC: moderate =
BTC and moderately likely to be
transplanted; BTC: unlikely = BTC
and unlikely to be transplanted;
• Analyze the Problem –
• Don’t assume you know what is causing the problem. Do your research and find out
if your assumptions are valid or not. This is what freethought, skepticism and
science is all about.
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
• Analyze the Problem –
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
• Identifying Possible Solutions -
• make a list of possible solutions. Don’t assume there are only a couple of solutions
available. Brainstorm, make a list, think outside the box, but don’t limit your
potential by liming your list of possible solutions. (the website lists several methods
to develop the list – and it is worth reading through!.
Figure	21	
Complicationsafter VAD	implantation:
• Pump Relatedà Pump Replacement
• AnticoagulationRelated à Appropriate	medical treatment
• With	possibilityof	surgical conservative	treatment
• Without possibilityof	surgical conservative	treatment
Figure	21	
Current Situation	for	Heart Transplant:
• Lenghtening waiting list
• Decreasing quality of	donor organs
• Considerablemortality on	the	waiting list
• Considerablepostoperative PGF/mortality
Figure	21	
The	4	basic Ethical Principlesof	Listing	for	Transplant:
• Beneficence – To	do	good.
• Non	Malificence (primun non	nocere)	– to	do	no	harm
• Autonomy- Patient’s right	to	make informed decisions
• Distributive	Justice.
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
• Identifying Possible Solutions -
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
• Evaluating Solutions –
• what are the pros and cons of each proposed solution, will this really solve our problem, or
make it worse.
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
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
Adult	Heart	Transplants
Kaplan-Meier	Survival	by	VAD	usage	Conditional	on	Survival	to	6	Months	
(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=2,941) Continuous	flow	(N=2,545)
ECMO		(N=72) No	LVAD	/	No	Inotropes		(N=8,939)
No	LVAD	/	Inotropes	(N=9,488)
No	pair-wise	comparisons	were	significant	at	p	<	0.05.
2014
JHLT. 2014Oct; 33(10): 996-1008
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
Figure	21
• Selecting the	Best	Solution	–
• After evaluating your possible solutions and	ranking	them as you need to	choose
the	one you think has the	best	chance	of	success	that will help	you accomplish the	
goal	you set	in	task	1.	 If none	of	the	solutions will work,	you need to	re-evaluate
how you defined the	problem and	go	back	to	step one taking into account	what
you have learned through this process.	No,	this isn’t a	pain,	it is what is sometimes
required if you want to	actually solve	your problem.
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
• Developan	Action	Plan	–
• what tasks need to	be	done,	who will do	them,	when do	they need to	be	done,	
what could go	wrong and	how will you get around problems,	who can	help	you,	or	
can	you do	it yourself?
• Implement the	Solution	–
• Now that you have a	plan – get to	it and	start	implementing it.	If you need to	
change it,	do	so,	but if you don’t take	action,	the	problem isn’t going to	get
solved. There ain’t nothing to	it but to	do	it.
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
Figure	21	
Conclusioni
Il trapianto del paziente portatore di LVAD ha risultati sovrapponibili
se non superiori al trapianto su paziente senza LVAD quando il VAD
ha corretto la perfusione degli organi periferici e la congestione
venosa e polmonare e convertito un paziente ospedalizzato in un
paziente ambulatoriale.
Il VAD complicato si associa a una mortalità aumentata soprattutto
quando effettuato in condizioni di urgenza in precario compenso
clinicosenza poter allocare un organo “ideale”.
Figure	21	
Conclusioni
Le complicanze del LVAD (soprattutto le
infettive) vanno trattate, nei limiti del
possibile, in maniera “conservativa” o con la
sostituzione del LVAD evitando di consumare
le poche risorse disponibili per terapie
rescue.
L’allocazione del donatore al VAD stabile (BTT
o BTC in cui il target è stato raggiunto) va
opportunamente regolata in maniera da
garantire al paziente portatore di LVAD un
donatore “ideale” prima che intervengano le
complicanze del LVAD.
Figure	21	
Conclusioni
Il trapianto non può rappresentare la exit-strategy del fallimento della
VAD-therapy.

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Amarelli SITO-SICCH Riunione Intersocietaria 2015

  • 2. It doesn’t matter how well intentioned you are. If you can’t solve your problems effectively, you may be doing more harm than good. Having a system to solve your problems will help ensure you problem solve effectively.
  • 3. • Define and Identify the Problem - • If you don’t know what problem you are trying to solve or if you try to solve the wrong problem you won’t be successful. Find out what the facts are and not only develop a statement about what exactly the problem is you are trying to solve, but what your goal is in solving it.
  • 4. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 5. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions • Define and Identify the Problem -
  • 6. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 7. Define and Identify the Problem - Adult Heart Transplants % of Patients Bridged with Mechanical Circulatory Support* (Transplants: January 2000 – December 2012) 0 10 20 30 40 50 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 % of patients Year * LVAD, RVAD, TAH, ECMO 2014 JHLT. 2014Oct; 33(10): 996-1008
  • 8. Adult Heart Transplants Donor and Recipient Characteristics 1992-2000 (N = 37,538) 2001-2005 (N = 17,249) 2006-6/2013 (N = 26,294) p-value Pre-operative support (multiple items may be reported) Hospitalized at time of transplant 60.4% 47.9% 44.5% <0.0001 On IV inotropes 55.8%1 47.3% 42.2% <0.0001 Ventilator 3.4% 3.3% 2.7% 0.0005 IABP 6.5% 6.8% 6.6% 0.6612 Mechanical circulatory support 18.82 24.1 35.1 <0.0001 LVAD 11.9%2 16.9% 29.8% <0.0001 RVAD - 4.9%3 3.6% 0.0031 TAH 0.1%2 0.1% 1.0% <0.0001 ECMO 0.3%4 0.5% 1.1% <0.0001 1 Based on 4/1994-2000 transplants. 2 Based on 11/1999-2000 transplants. 3 Based on 2005 transplants. 4 Based on 5/1995-2000 transplants. 2014 JHLT. 2014Oct; 33(10): 996-1008
  • 9. Adult Heart Transplants % of Patients Bridged with Mechanical Circulatory Support* by Year and Device Type 0 10 20 30 40 50 2005 2006 2007 2008 2009 2010 2011 2012 % of patients Year ECMO VAD+ECMO TAH LVAD+RVAD RVAD LVAD * LVAD, RVAD, TAH, ECMO2014 JHLT. 2014Oct; 33(10): 996-1008
  • 10. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 11.
  • 12.
  • 13.
  • 14. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20. Figure 6 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
  • 21. Figure 7 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
  • 22. Figure 7 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
  • 23. Figure 7 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Competing Outcomes Over Time by Initial Implant Strategy (A) 6 months; (B) 12 months; and (C) 24 months. BTC = bridge to candidacy; BTT = bridge to transplant.
  • 24. Figure 7 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions Device Strategies Over Time (A) BTT; (B) BTC: likely; (C) BTC: moderate; (D) BTC: unlikely; (E) DT. Strategies have been grouped according to original intent. BTC: likely = BTC and likely to be transplanted; BTC: moderate = BTC and moderately likely to be transplanted; BTC: unlikely = BTC and unlikely to be transplanted;
  • 25. • Analyze the Problem – • Don’t assume you know what is causing the problem. Do your research and find out if your assumptions are valid or not. This is what freethought, skepticism and science is all about.
  • 26. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions • Analyze the Problem –
  • 27. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
  • 28. • Identifying Possible Solutions - • make a list of possible solutions. Don’t assume there are only a couple of solutions available. Brainstorm, make a list, think outside the box, but don’t limit your potential by liming your list of possible solutions. (the website lists several methods to develop the list – and it is worth reading through!.
  • 29. Figure 21 Complicationsafter VAD implantation: • Pump Relatedà Pump Replacement • AnticoagulationRelated à Appropriate medical treatment • With possibilityof surgical conservative treatment • Without possibilityof surgical conservative treatment
  • 30. Figure 21 Current Situation for Heart Transplant: • Lenghtening waiting list • Decreasing quality of donor organs • Considerablemortality on the waiting list • Considerablepostoperative PGF/mortality
  • 31. Figure 21 The 4 basic Ethical Principlesof Listing for Transplant: • Beneficence – To do good. • Non Malificence (primun non nocere) – to do no harm • Autonomy- Patient’s right to make informed decisions • Distributive Justice.
  • 32. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) • Identifying Possible Solutions -
  • 33. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 34. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 35. • Evaluating Solutions – • what are the pros and cons of each proposed solution, will this really solve our problem, or make it worse.
  • 36. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
  • 37. 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
  • 38. Adult Heart Transplants Kaplan-Meier Survival by VAD usage Conditional on Survival to 6 Months (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=2,941) Continuous flow (N=2,545) ECMO (N=72) No LVAD / No Inotropes (N=8,939) No LVAD / Inotropes (N=9,488) No pair-wise comparisons were significant at p < 0.05. 2014 JHLT. 2014Oct; 33(10): 996-1008
  • 39. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 40. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 41.
  • 42. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
  • 44. • Selecting the Best Solution – • After evaluating your possible solutions and ranking them as you need to choose the one you think has the best chance of success that will help you accomplish the goal you set in task 1. If none of the solutions will work, you need to re-evaluate how you defined the problem and go back to step one taking into account what you have learned through this process. No, this isn’t a pain, it is what is sometimes required if you want to actually solve your problem.
  • 45.
  • 46.
  • 47.
  • 48.
  • 49.
  • 50. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 51. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 52. • Developan Action Plan – • what tasks need to be done, who will do them, when do they need to be done, what could go wrong and how will you get around problems, who can help you, or can you do it yourself? • Implement the Solution – • Now that you have a plan – get to it and start implementing it. If you need to change it, do so, but if you don’t take action, the problem isn’t going to get solved. There ain’t nothing to it but to do it.
  • 53. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010) Copyright © 2014 International Society for Heart and Lung Transplantation Terms and Conditions
  • 54. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 55. Figure 21 The Journal of Heart and Lung Transplantation 2014 33, 555-564DOI: (10.1016/j.healun.2014.04.010)
  • 56. Figure 21 Conclusioni Il trapianto del paziente portatore di LVAD ha risultati sovrapponibili se non superiori al trapianto su paziente senza LVAD quando il VAD ha corretto la perfusione degli organi periferici e la congestione venosa e polmonare e convertito un paziente ospedalizzato in un paziente ambulatoriale. Il VAD complicato si associa a una mortalità aumentata soprattutto quando effettuato in condizioni di urgenza in precario compenso clinicosenza poter allocare un organo “ideale”.
  • 57. Figure 21 Conclusioni Le complicanze del LVAD (soprattutto le infettive) vanno trattate, nei limiti del possibile, in maniera “conservativa” o con la sostituzione del LVAD evitando di consumare le poche risorse disponibili per terapie rescue. L’allocazione del donatore al VAD stabile (BTT o BTC in cui il target è stato raggiunto) va opportunamente regolata in maniera da garantire al paziente portatore di LVAD un donatore “ideale” prima che intervengano le complicanze del LVAD.
  • 58. Figure 21 Conclusioni Il trapianto non può rappresentare la exit-strategy del fallimento della VAD-therapy.