Slides from the first meeting of ECTTA held in Budapest. The presentation focused on the role of EUROMACS data in the expansion of knowledge on Mechanical Circulatory Support.

1. Collect data and speed up clinical research.
The ambition of EUROMACS.
C. Amarelli
Department of Cardiovascular Surgery and Transplants
Ospedale Monaldi - Azienda Ospedaliera dei Colli - Napoli
Budapest, October 3, 2014

2. Heart Transplantation and MCS field experienced the
transition from the pionieristic era to the era of
Evidence-based Medicine and cost-effective analysis.
Collect data and speed up clinical research.
The ambition of EUROMACS.

3. Collect data and speed up clinical research.
The ambition of EUROMACS.
The DUAL essence of HTX and
MCS.
Rationalism:
Using deductive process departing
from “fundamentals” ascertained
intuitively or experimentally is
possible to reach to new
knowledges.
Empiricism:
Nihil est in intellectu quod prius
non fuerit in sensu.

4. Transplant and Mechanical Circulatory support were
conceived from pionieers approaching this field with a
rationalistic approach.
Small numbers and local policies similar remain similar to
a “grandmother recipe” and long-term may be necessary
to build scientifical data and knowledge.
Collect data and speed up clinical research.
The ambition of EUROMACS.

5. Rationalistic Principles of HTX in the pionieristic era.
To transplant an health heart in place of a diseased one and apply known
drugs to prevent biological phenomena examined in experimental transplants
of organs and tissues in humans and animals.
Collect data and speed up clinical research.
The ambition of EUROMACS.

6. Collect data and speed up clinical research.
The ambition of EUROMACS.

7. “However, because many patients
were dying soon after, the number of
heart transplants dropped from 100 in
1968, to just 18 in 1970.
It was recognized that the major
problem was the body's natural
tendency to reject the new tissues”
In 1971 only 30 out of 170 transplanta
were alive.

8. • revolutionized transplantation
• increased survival rates
• 1st in a new generation of anti-
rejection drugs
Cyclosporin was isolated from the
fungus Tolypocladium inflatum.
From two soil samples, the first from
Wisconsin, USA and the second from
the Hardanger Vidda in Norway.
Introduced in 1978, the drug
cyclosporine revolutionized
transplantation by depressing T cell
activation and reducing organ rejection.

9. 1983: Cyclosporine Approved for Use: The US FDA approves
Cyclosporine, an immunosuppressant drug isolated from a fungus.
Cyclosporine revolutionizes organ transplantation because it
selectively suppresses the transplant recipient's immune system,
allowing the patient to tolerate the grafted organ but preventing
routine infections.

10. Empiricism:
Heart Transplantation using a triple association of Cyclosporin,
Azathioprine and Corticosteroids has become the gold standard
treatment of ES-CHF.
The Lessons of Columbus
Traveling Into the Unknown
He Found the Wrong Place
Named the Wrong People
Introduced Unintended Consequences
Became Famous
Collect data and speed up clinical research.
The ambition of EUROMACS.

11. Collect data and speed up clinical research.
The ambition of EUROMACS.
Rationalistic Principles of MCS in the pionieristic era.
To implant a pump to replace a diseased heart or support a diseased
ventricle and apply known drugs to prevent biological phenomena examined
in experimental animals.

12. Giving the clinical setting of the patients, the continue
evolution of the field and the small number of patients
treated, large trials may be an inadequate instrument to
examine the “real-world” policies and results.
In the field of Heart Transplantation and MCS the ISHLT
registry and the INTERMACS registry have produced a
huge amount of informations to update knowledges in a so
dinamic field.
Collect data and speed up clinical research.
The ambition of EUROMACS.

13. Adult and Pediatric Heart Transplants
Number of Transplants by Year and Location
0
500
1000
1500
2000
2500
3000
3500
4000
4500
5000
Numberoftransplants
Other
Europe
North America
NOTE: This figure includes only the heart transplants
that are reported to the ISHLT Transplant Registry. As
such, the presented data may not mirror the changes in
the number of heart transplants performed worldwide.
JHLT. 2013 Oct; 32(10): 951-964
2013

14. Adult and Pediatric Heart Transplants
Median Donor Age by Location
0
5
10
15
20
25
30
35
40
45
50
Mediandonorage(years)
Europe North America Other
JHLT. 2013 Oct; 32(10): 951-964
2013

15. Adult Heart Transplants
Ischemic time Distribution By Location
(Transplants: January 2006 – June 2012)
0%
20%
40%
60%
80%
100%
Europe North America Other
%ofTransplants
< 2 hours 2-<4 hours 4-<6 hours 6+ hours
JHLT. 2013 Oct; 32(10): 951-964
2013

16. Adult Heart Transplants
% of Patients Bridged with Mechanical Circulatory Support*
(Transplants: January 2000 – December 2011)
0
10
20
30
40
50
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
%ofpatients
Year
* LVAD, RVAD, TAH.
ECMO is excluded.
JHLT. 2013 Oct; 32(10): 951-964
2013

17. 1. To open up a large international database for the
purpose of scientific research
2. The Extent and the Quality of the Database is such
that it meets the Needs of Individual Centers
3. To enable comparison with all centers, but also with
Intermacs-data or other registries
4. Annual Reports about the development of the MCS
Therapy
5. Internal Quality Assurance and audits
EUROMACS AIMS

18. 2009 Inception, preparation and planning
2009 - 2010 Selection of database developer
2010 – 2011 Building the database
2011 - 2012 Testing and bug fixing
April 26, 2012 The Registry goes „Live“
2012 – 2013 Amalgamation with the EACTS
2013 – 2014 Scientific Output, Innovation,
Improvement and Growth
EUROMACS History

19. Current Situation of EUROMACS
• Presently 170 members from 35 Countries:
Austria, Azerbaijan, Belarus, Belgium, Croatia,
Czech Republic, Denmark, France, Germany,
Greece, Israel, Italy, Netherlands, Kazakhstan,
Kuwait, Latvia, Lithuania, Norway, Poland, Russia,
Serbia, Sweden, Spain, Switzerland, Turkey, UK
• Also from Brazil, India, Lebanon, Thailand, Japan,
USA and Australia
• 52 Institutional members, 27 agreements,
275 agreements in process
• 1123 cases registered per June 30, 2014
19

20. Agreements with EUROMACS (Sept 17, 2014)
Deutsches Herzzentrum Berlin,
Berlin
Katholieke Universiteit
Leuven, Leuven
Universitätsklinikum
Eppendorf, Hamburg
National Research Cardiac
Surgery Center Kazakhstan,
Astana
Ospedale S. Orsola,
Rome
Onze Lieve Vrouwen
Ziekenhuis, Aalst
Ege University School of
Medicine, Izmir
Aristotle University,
Thessaloniki
Erasmus Medisch Centrum,
Rotterdam
Rigshospitalet, Copenhagen Kinderspital, Zürich Ospedale S. Camillo, Rome
Central Clinic Hospital, Baku IKEM, Prague Inselspital, Bern
Ospedale Papa Giovanni XXIII,
Bergamo
Center for Cardiovas-
cular & TX-surgery, Brno
Universitäts Herzentrum
Freiburg-Bad Krozingen
Ospedale Niguarda Ca’Granda,
Milano
National Institute
Cardiology, Minsk
Universtitätsklinikum
Schleswig-Holstein, Lübeck
Gottsegen Gy. Hungarian Institute
of Cardiology, Budapest
Heart Center of the
Semmelweis University,
Budapest
Herz- und Diabeteszentrum
Nordrein-Westfalen,
Bad Oeynhausen
Clinica Universidad de Navarra,
Pamplona
Ospedale dei Colli
Napoli
Klinikum Karlsburg
Karlsburg

21. • The patient data are your data (not our data)
• The dataset is comparable with Intermacs
with many additional improvements, based
upon the experience of large centers
• No age limitation (pediatric and adults)
• No device limitation (basic characteristics of
all devices are in the registry)
• Participation is absolutely free of charge
• On-site assistance if required
21
What makes Euromacs Different:

22. The registry is patient oriented
The database consists of two major parts:
1. First Implant
2. Follow-up
Structure of the Euromacs Database

23. The architecture is intuitive and data
entry is facilitated by the program

24. The ambition of collect data and speed up clinical research.
The experience of EUROMACS.

27. Possible
Bridge to
Transplant
Destination Bridge to
Transplant
Rescue Bridge to
Recovery
Other
477 183 308 64 9 82
Bridge to
Recovery
0% Bridge to
Transplant
27%
Destination
16%
Other
9%
Possible
Bridge to
Transplant
42%
Rescue
6%
Euromacs Registry Patient Distribution n=1123

28. Younger
than 17
17 - 65 66 – 83
(oldest)
60 936 127
0-16 years
5%
17-65 years
69%
>65 years
26%
Euromacs Registry Age Distribution

29. Type of Device, n=1123
LVAD
893
RVAD
12
BIVAD
65
LVAD+RVAD (temp)
62
Total Artificial Heart
15
Unspecified
76
0
100
200
300
400
500
600
700
800
900
1000

31. Stable but
inotrope
dependent
Progressive
decline
Critical
cardiogenic
shock
Unspe-
cified
Resting
sympto
ms
Exertion
intolerant or
limited
Adv.
NYHA
Class 3
302 342 136 77 220 43 3
Stable, but
inotrope
dependent
27%
Progressive
decline
31%
Critical
cardiogenic
shock
12%
Exertion
limited
7%
Resting
symptoms
20%
Adv NYHA Cl.3
0%
Exertion
intolerant
3%
Patient severity of disease according to
Euromacs-Intermacs profile n=1123

32. Major
Bleeding
Major
Infection
Device
Malfunction
Neurological
Dysfunction
Combination Other
137 236 113 102 11 3
Major
Bleeding
23%
Major
Infection
39%
Device
Malfunction
19%
Neurological
Dysfunction
17%
Combination
2% Other
0%
Euromacs Registry of Serious Adverse Events N=591

33. Infection &
Sepsis
Cerebro-
vascular
Cardio-
pulmonary
Multi Organ
Failure
Major
Bleeding
Other (device
malfunction= 4)
60 28 37 87 28 35
Infection &
Sepsis
18%
Cerebro-
vascular
9%
Cardio-
pulmonary
11%
Multi-Organ
Failure
27%
Bleeding
9%
Other
26%
Euromacs Registry Causes of Death N=326

34. The Future, 2014 and beyond
26.10.2104
1. Benchmarking tools available via the
EUROMACS website (with password)
2. Comparison with US and other registries
through iMacs
3. Increased scientific output “on demand”,
innovation of software, > user friendliness
4. Quantitative growth, 2015: >2000 cases

35. 8/10/17 35
Dashboard to compare “my hospital” with all of
Euromacs

36. Second page enables the user to compare hospitals
on a single indicator
Drop-down list to select the
desired indicator
Time trend graph to show
performance over time
Filters enable the user to
select the procedure
viewed in the graph

37. The future….
8/10/17 37
1. Organ donor quantity decreases further
2. Recipients will get older, numbers will grow
3. Increasing need for destination therapy
4. Innovated VAD’s need long-term evaluation

38. Conclusions
8/10/17 38
1. As MCS therapy is still in development, we need
to register our European MCS patient data for
scientific purposes. The accumulation of data in
EUROMACS increases the significance of
outcomes
1. The cooperation with the EACTS ensures
sufficient quality and quantity of our registry
3. EUROMACS offers you a democratic
professional organisation which is aimed at
fulfilling YOUR scientific and clinical demands

39. The Future: between hope and reality.
31 years of follow-up
While waiting for a donor heart transplant,
the longest a patient has been supported by
the SynCardia temporary Total Artificial
Heart is 1,374 days prior to transplant.

40. Worldwide Clinical Experience*
More than 7,000 patients worldwide have now
been implanted with the HeartMate II LVAS.
§ Patients supported ≥ 1 year: 2439
Patients supported ≥ 2 years: 851
§ Patients supported ≥ 3 years: 269
§ Patients supported ≥ 4 years: 83
§ Patients supported ≥ 5 years: 20
§ Patients supported ≥ 6 years: 1
*Based on clinical trial and device tracking dataAs of March 201
The Future: between hope and reality.

41. The Future: between hope and reality.

42. Empiricistic lesson:
Late indication to Heart
Transplant lead to worsen results
and to high rate of perioperative
complications.
-Cardiac Cachexia
-Pulmonary Hypertension
-End-organ Dysfunction
Lead to a Bad Prognosis.

43. Empiricism:
MCS is capable to lead patient with worsening clinical
conditions to candidacy warranting optimal results.
CHF
Transplant
LVAS
LVAS
Transplant
LVAS
Recovery &
Weaning
LVAS
Cell
Therapy
Recovery &
Weaning

44. The informations coming from EUROMACS registry
will help a multispecialistic team to “tailor” the best
strategy to warrant optimal outcomes to patients with
ES-CHF.
Collect data and speed up clinical research.
The ambition of EUROMACS.
theodeby@euromacs.org
camarell@tiscali.it