11th Sept

The official newspaper of the EACTS Annual Meeting 2010
In this issue…
Left atrial exclusion
Joel Dunning discusses
exclusion of the left atrial
appendage
2
3D Echo guidance
Sunil Mankad
reports on the
superiority of
3D echocardiography
SATURDAY 11 SEPTEMBER
Welcome to the 24th EACTS
Annual Meeting in Geneva
Welcome to the 24th Annual Meeting in Geneva. With a wide range of educational
formats presenting the latest and the best information on new technologies and
techniques in cardiothoracic surgery, this Annual Meeting will be the largest
educational event in cardio-thoracic surgery for 2010. Here are some associated
highlights that shouldn’t be missed.
4
Sutureless AVR?
Sven Martens and Malakh
Shrestha examine the benefits
of sutureless aortic valve
replacement.
6
Thoracic programme
Paul Van Schil
outlines the
highlights of
this year’s
Thoracic
Domain
Programme.
8
SBRT for long tumours
Suresh Senan
examines the
evidence for
the utilisation
of this
technology in
patients with
stage I NSCLC
9
Training in thoracic
surgery
Kalliopi Athanassiadi
summarises current status and
future perspectives…
10
T
he cutting edge of cardiothoracic surgery will be presented
with the Techno College on
Saturday September 11st. During
this program experts will explore the
latest developments in atrial fibrillation, Aortic surgery, Minimally
Invasive Aortic Valve Surgery,
Minimally Invasive Mitral Valve
Surgery. The congenital Techno-college program will deal with the
Senning operation, Brain Monitoring
and Paediatric Mechanical
Circulatory Support. At the same
time the thoracic surgeons will
explore additional surgical means to
improve oncological outcome and
discuss the Training in Thoracic
Surgery looking at innovative ways
to teach thoracic surgical techniques.
On Sunday, during the
Postgraduate course, special emphasis
will be given to one of the most common anomalies in mitral valve disease,
the posterior mitral valve leaflet prolapse. How to assess it, when to operate and what are the surgical
options? A glimpse in the future of
mitral valve repair will also be present-
encircles the world.”
During the abstract sessions on
the Monday and Tuesday the latest
developments in the different areas
of our profession will be presented.
Original clinical and non-clinical
research will be shared with you.
Invited discussants will try to put
ed with a lecture on the Mitraclip.
known pioneers in Cardiac surgery
these findings in perspective and an
During the past few years, the
and has meant a lot to our profesactive participation of the audience is
results of (randomized) trials that
sion. The EACTS will honor him with
highly appreciated.
may influence our profession have
an honorary membership and he will
The Monday and Tuesday special
appeared in literature. The results of present the guest lecture entitled
topic sessions will highlight a specific
the Heartmate II, Bari-2D, STICH,
‘Transmission of knowledge in cararea in cardio-thoracic and vascular
Endoscopic vein harvesting, Rooby
diac surgery’.
Pieter Kappetein surgery. Experts will emphasize conand Fame trial will be reported. A
Following the Honorary membertroversies and areas of consensus on
unique primer is that the 3-year
ship lecture the ‘Great debate’ will
ate day will close with the Guest
issues that you encounter every day
results of the SYNTAX trial will this
take place. ‘Transcatheter aortic
Lecture of Professor Rolf Heuer,
in your practice.
year for the first time be presented
valve implantation: From concept to Director-General CERN, European
“Learning from experience” is a
at the EACTS meeting. All these trievidence-driven practice’ is the title
Organisation for Nuclear Research.
new type of session during the
als will be debated by an invited dis- and promises to be another highAs we are in Geneva, right on top
EACTS meeting. Sometimes you
cussant and there will be time for
light of the day.
of the Large Hadron Collider this
encounter a specific case, problem,
questions from the audience.
During the Post-graduate course
provides a unique opportunity to
or complication in daily practice that
Around mid-day the new revascu- there will be parallel programs for
get some insights on one of the
you want to share with your collarization guidelines will be introcongenital cardiac surgery, thoracic
largest and most unique scientific
leagues. Not just because it is a
duced by William Wijns, cardiologist
surgery, vascular surgery and perfuprojects in the world.
unique pathological or anatomical
and Phillipe Kolh, cardiac surgeon.
sion. For the first time we will also
At CERN, the world’s largest and phenomenon but it is a case with a
These guidelines are created through offer a Nurses and Physician
most complex scientific instruments clear learning point.
a joined effort by the European
Assistants program. The care of
are used to study the basic conYour experience may help others
Society of Cardiology and EACTS.
patients is getting more and more
stituents of matter – the fundato solve similar problems. This type
Both Prof Wijns and Prof Kolh
complex and through the energy of
mental particles. By studying what
of sessions will also be a platform to
chaired the guidelines committee and specialized nurses the quality of care happens when these particles colconfer messages on short series of
have put a lot of work and effort in
is improving. By organizing this
lide, physicists learn about the laws patients. Just because the experience
it. Congratulations to both of them
course the EACTS recognizes that
of Nature.
with a technique is still limited (e.g.
and we cannot thank them enough
treatment of the cardio-thoracic
We can end the day with the
complications in transcatheter valves)
for this tremendous masterpiece.
patients is a team effort.
words of Albert Einstein,
or because the type of disease is relContinued on page 2
Prof Carpentier is one of the best
Last but not least: The postgradu- “Knowledge is limited. Imagination
Paediatric MCS
Brian Duncan
assesses
current ECMO
and VAD
technology.
12
Techno College 2010
The nominees…
transapical aortic valve implantation. New
transapical devices and an update on tissue
engineered heart valves will complete the
session. The mitral session will present new
technologies such as adjustable neochordae,
sion mainly circles around techniques for
transapically placed neochordae, and tranhybrid procedures using debranching surscatheter mitral valve replacement.
gery with endovascular repairs. A novel
The format of the EACTS Techno College
approach for the treatment of complex
will again mix oral presentations with video
ascending/arch pathologies by a transapical presentations and live surgeries. Based on an
endovascular approach, will be presented by initiative from the Techno College
Gino Gerosa from Padua.
Committee, Jörg Seeburger from the Leipzig
The aortic valve session will feature video Heartcenter has gathered data from 200 live
and live presentations on robotic assisted
surgeries performed at past Techno Colleges
and other techniques for sutureless valve
and other European live surgical meetings.
implantation. Michael Mack from Dallas will The results are presented during this year’s
lead a debate on transfemoral versus
Continued on page 2
EACTS Techno College to focus on the
surgical treatment of atrial fibrillation
13–20
Product listings
24
Floor plan
25
Forthcoming Events 22
A message from the Chair of EACTS New
Technology Committee: Volkmar Falk,
Zurich, Switzerland
T
his year’s EACTS Techno College focuses on surgical treatment of atrial fibrillation featuring presentations on
hybrid approaches combining endoscopic
and catheter-based techniques as well as
single-port applications. In addition, the
value of navigation for surgical treatment of
atrial fibrillation is discussed. The aortic ses-
Volkmar Falk
2 Saturday 11 September 2010 EACTS Daily News
Adult Cardiac
Saturday 11 September 2010
Techno College: Domain Acquired
Cardiac Disease Programme
08:00
Welcome
V Falk, P Vouhé
08:10 Session 1: Atrial Fibrillation
Room ABC
Moderators: K Khargi, G Wimmer-Greinecker
To close or not to close – the appendage story
J Dunning
Navigation in atrial fibrillation – a surgeon’s
perspective
R Damiano
Hybrid atrial fibrillation – current state
M La Meir
New Technology Innovation Award Presentation
To be announced
Video Presentations
Surgical technique to create connecting
ablation lines off pump
A Yilmaz
Single port off pump subxyphoid approach –
Sub-X maze
S Bolling
Live Surgery
Single port subxyphoid approach for surgical
ablation – Convergent procedure
B Gersak
10:10 Session 2: Aortic Surgery
Moderators: J Bachet, F Beyersdorf
Genetically guided decision making in aortic
surgery
E Arbustini
Hybrid brachiocephalic debranching with
thoracic endovascular aneurysm repair
J Bavaria
Hybrid open/endovascular repair of
thoracoabdominal aortic aneurysms N Cheshire
Cerebrospinal fluid drainage in
thoracoabdominal aortic aneurysms repair:
malpractice if not used?
M Schepens
Video Presentations
Transapical deployment of endovascular
thoracic aortic stent grafts
G Gerosa
Live Surgery
Double transposition for distal arch aneurysm
M Grabenwöger, M Czerny
12:10 Lunch
13:10 Session 3: Minimally Invasive Aortic Valve
Surgery
Moderators: M Mack, T Walther
Transapical aortic valve implantation J Kempfert
Transcatheter aortic valve implantation –
transfemoral or transapical?
M Mack
Tissue engineered heart valves – 2010 update
F Baaijens
Video Presentation
The concept of sutureless aortic valve
replacement
M Shrestha
Robotic sutureless valve implantation
R Suri
Live Surgery
Second generation sutureless valve
implantation
S Martens
Transcatheter (transfemoral) aortic valve
replacement and cerebral protection device
J Schofer
Welcome
Continued from page 1
atively new (e.g. H1N1 virus infection), does not mean that we cannot learn from the experience of
others. These sessions will have a
specific format of presentation;
limited number of slides, structure
of the slides is determined and the
sessions will be chaired by panelist
instead of moderators. There is
more time for discussion during
which the panelist will debate the
various treatment options of the
presented case or cases. We hope
by introducing this type of sessions
we will create a platform to share
information on emerging practices.
The programming of the
Wednesday morning was not
always easy. Many colleagues used
this opportunity to travel back
home. “Why does the EACTS
meeting not stop on the Tuesday
afternoon?” was a remark that
was a frequently heard. Experience
shows that every last day of a
meeting attracts fewer visitors. By
stopping one day earlier might
simply shift this phenomenon to
an earlier time. Spending 2.5 days
of the normal working week is not
too much for education and in
some institutions colleagues alternate; where one half visits the
congress the first days and the
other half are present during the
last days. The format of the
Wednesday morning has also
changed, which proved to be a
tremendous success last year. The
sessions focus on advanced techniques: techniques that are relatively new but have entered the
operating theaters or wards in
many institutions but still questions on how to introduce or
apply the procedures retain.
Experts that have a larger experience will share their knowledge
and are open for a lively debate
during which they will interact
with the audience. To makes these
sessions a success an active participation of you, is a must. We recognized that this is only possible
when the number of participants
is limited; with this in the back of
our mind we created no less than
9 different sessions to divide the
number of visitors, also in order to
address the different interest of
our members.
Last but not least we encourage
you to visit the exhibition area.
Many manufacturers nowadays
choose the EACTS meeting, being
the largest cardio-thoracic meeting
in the world, to introduce new
devices. In addition to the lectures
given, it is also clear that the exhibition is a unique place where the
latest developments in our field are
presented. We thank the industry
therefore warmly for their active
participation in the congress.
Special thanks also to our staff
for making this meeting happen.
Kathy McGree, Sharon Pidgeon,
Amanda Cameron, Elvira Lewis,
Eileen Moriarty and Rianne
Kalkman cannot be thanked
enough for their indispensible help
not only during this event but also
through the year. Owen Haskins,
Peter Walton and their team thank
you to make this daily newspaper
a valuable source of communication to inform you about the content of our conference.
If you appreciate what the
EACTS presents during these days
and you want to support the work
of the Association then I encourage
you to become a member of
EACTS. Membership fee is still very
low and you will receive the
European Journal of CardioThoracic Surgery and the Interactive
CardioVascular and Thoracic
Surgery journal as well as a reduced
rate for the annual meeting. This
application can be done through
the Web site of the EACTS
(ww.eacts.org) or at the EACTS
booth in the exhibition area.
Thank you for being here in
Geneva, I am confident that you
will return home with valuable
information that you can apply to
your practice and I am sure that
with your friends you will have a
good time as well.
EACTS Techno College
Continued from page 1
main conference (Monday; Preoperative Evaluation
and Optimizing Patient Outcome I; 14:00–15:00;
Room C). From the results it can be concluded that
live surgery that is conducted by the standards of
EACTS are safe and can be performed with excellent short and long-term outcomes.
This year’s Techno College Innovation Award
saw a record participation with 28 applications
ranging from iterations of surgical procedures to
software solutions. The number of submissions
underlines the importance of this Award.
The Techno-College continues to grow in stature
since it was first held as part of the EACTS Annual
Meeting in 2003. The attendance last year in
Vienna was record-breaking with over 1,400 participants.
The New Technology Committee is committed
to building on the achievements of the past
decade by continually highlighting the new innovations and techniques, which have become the
Event’s trademark.
Techno College participants 2003–2009
Session 1: Room ABC Atrial fibrilation (08:10)
Left atrial exclusion, not as safe as you think
Joel Dunning
James Cook University Hospital,
Middleborough, UK
Y
ou are doing coronary artery
bypass grafting and a MAZE
procedure on a 67 year old
patient who is otherwise a low-risk
patient. At the end of the procedure
you decide to oversew the left atrial
appendage and you confidently state
to your resident that if the patient
ends up in AF that you will still be
able to stop the Warfarin as the
appendage is tied off.
Two months later your cardiologist
stops you in the corridor and says that
your patient went into flutter and he
did a TOE prior to cardioverting. To his
surprise there was still a 1cm stump of
appendage and this contained clot.
Lets stop there. But if you think
that exclusion of the left atrial
appendage is a ‘no-brainer’ that will
Joel Dunning
always benefit your patients then
think again. I will present a summary
of the literature on left atrial
appendage exclusion. It includes contemporary papers from the
Cleveland Clinic, The Mayo Clinic and
centres in New York reporting very
poor success rates of Left atrial
A full literature review is presented that finds no papers showing that
warfarin can safely be stopped in
patients in atrial fibrillation just
because the appendage has been
excluded and there is actually only
weak evidence that it reduces stoke
rates at all.
The literature on percutaneous left
atrial exlusion devices such as the
PLAATO and the WATCHMAN device
is presented, and finally the latest
devices to allow effective and complication free left atrial appendage
closure are discussed.
However, I will finish with a warnClipped left atrial appendage ing that the effectiveness of all left
atrial appendage exclusions should
appendage exclusion with suture
be confirmed intraoperatively with
and even stapling techniques. Some TOE and also that no patient who
of these reports state that as few as would otherwise require warfarin
50% of patients receive an adequate should have this stopped based only
exclusion and in the patients who
on the fact that their appendage is
leave a stump or have residual flow, closed, unless entered into of one of
50% contain thrombus and 50% of
the currently running or a new clinithese patients get a stroke.
cal trial.’
15:10 Coffee
15:40 Session 4: Minimally Invasive Mitral Valve
Surgery
Moderators: V Falk, H Vanermen
3D echo guidance in mitral and aortic valve
surgery
S Mankad
Mitra-Clip indications and results
R Corti
Transcatheter mitral valve replacement
J Bavaria
Transapical chordal replacement – first clinical
experience
J Seeburger
Video Presentation
Minimally invasive mitral valve repair using an
adjustable mitral valve ring
H Vanermen
Percutaneous ventricular repair of the
mitral valve
T Tuebler
Live Surgery
18:00
Adjustable neochordae (animal lab) F Maisano
Aortic valve implantation (Trifecta). Disinfectant
sealing (Integuseal)
M Borger
Closing Remarks
V Falk
Choosing the type of prosthesis in mitral position
Ottavio Alfieri
San Raffaele University
Hospital, Milano, Italy
P
reservation of the native
valve should be the goal of
the surgeon treating mitral
valve disease. The advantages
of mitral valve repair over
replacement include a lower
operative risk, a better longterm outcome and a superior
quality of life with no prosthesis
related problems.
Unfortunately however mitral
valve repair is not always possible , and not infrequently valve
replacement has to be considered as a necessary alternative.
This circumstance is extremely
rare in degenerative mitral valve
disease, but more common in
other situations like rheumatic
disease or acute endocarditis
with extensive leaflets involvement. Valve replacement can
also be a convenient option for
functional mitral regurgitation
in the context of a dilated cardiomyopathy (ischemic or
idiopatic), particularly when the
left ventricular remodeling is
considerably advanced and the
leaflets tethering is severe (large
tenting area and coaptation
deapth> 1.5cm.).
In the current surgical practice therefore mitral valve
replacement is still a relatively
common operation, and the
choice of the prosthesis is a relevant issue, to be carefully
assessed considering all the
present knowledge and the
evolution in heart valve therapy.
It should be emphasized
however that in a large proportion of patients the long-term
outcome is not determined by
the type of prosthesis but
rather by patient-related factors (cardiac and non-cardiac).
A number of factors have to
be taken into account in the
decision-making process leading to the choice of the type of
prosthetic valve: the age of
the patient, the presence of
atrial fibrillation or other risk
factors for thrombo-embolism,
the expected life span, the
probability of adherence and
compliance with warfarin therapy, the patient’s wishes and
expectations.
Although cardiac surgeons
are usually inclined to implant
mechanical valves in mitral
position, reserving tissue valves
only to patients above 70-75
years of age, there are good
reasons nowadays to support a
more liberal use of biological
valves.
Certainly all bioprostheses
are at risk for structural valve
deterioration (SVD), particularly
in the younger population, and
the rate of SVD after mitral
valve replacement is greater
then after the aortic valve
dure is emerging as a realistic
low-risk perspective even in
very old patients.
Due to accelerated SVD,
young patients are not candidates to receive a biological
valve. However for certain subgroups of young patients with
low expected survival (patients
with severe left ventricular dysfunction, patients in dialysis or
with heavy comorbidities, intraOttavio Alfieri venous drug abusers, etc.) a
bioprosthesis is a reasonable
choice.
replacement. However for
new-generation bioprostheses
A biological valve can be
implanted in mitral position in implanted even in patients with
patients 61 to 70 years of age, atrial fibrillation, if restoration
SVD has been reported to be
of sinus rhythm can be realistiless then 5% at 10 years ! This cally expected following surgiresult represents a great
cal ablation of the arrhythmia.
improvement indeed in tissue
Finally, a tissue valve reprevalves performance.
sents the best option when for
For patients with SVD folsome reason adherence to antilowing mitral valve replacecoagulation therapy is a probment with a tissue valve, a
lem and/or the risk of bleeding
transapical valve-in-valve proce- is increased.
4 Saturday 11 September 2010 EACTS Daily News
Adult Cardiac
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Session 4: Room ABC Minimally invasive mitral valve surgery (15:40-18:00)
3D Echo guidance in mitral and aortic valve surgery
Sunil Mankad
Echocardiography Lab
Education, Mayo Clinic,
Rochester, USA
T
he superiority of
mitral valve repair
over mitral valve
replacement for patients
with severe mitral regurgitation is well established1. Furthermore, more
liberal referral of asymptomatic patients with
mitral regurgitation for
early surgical repair is
supported by recent
data2,3. The feasibility of
mitral valve repair
depends on the mitral
valve anatomy and accuracy in defining the mechanism of mitral regurgitation is paramount.
Echocardiography is the
current method of choice
Figure 1 (left). Flail middle scallop (P2) of mitral valve; yellow arrows demonstrate torn
chordae and white arrows and asterisk demonstrate prolapsing middle scallop.
Figure 2 (right): Example of Barlow’s mitral valve; the arrows demonstrate the most
severely prolapsing scallops (middle and medial scallops of anterior and posterior leaflets).
for assessing the feasibility of mitral repair.
However, current rates
of mitral valve repair vs
replacement are not optimal4, in part due to limita-
tions of 2D echocardiographic techniques. The
superiority of 3D echocardiography in assessing
mitral valve pathology is
now established 5-8. 3D
echocardiography provides unique “en face”
views of the mitral valve
(figures 1 and 2), thus
allowing a better understanding of the topo-
graphical aspects of
pathology which can help
refine our understanding
of the spatial relationships
of intracardiac valvular
structures.
3D echocardiography
provides new indices not
described by 2D echocardiography and makes
existing ones more accurate. 3D echocardiography
is accurate, reproducible
and not time exhaustive.
It enhances preoperative
and intraoperative decision-making in mitral surgery. Illustrative examples
demonstrating the incremental value of 3D
echocardiography in the
assessment of mitral
pathology will be
reviewed.
Finally, parameters
measured by novel 3D
Sunil Mankad
aortic valve software
including measurement of
aortic valve area throughout the cardiac cycle,
valve coaptation and commisural height, commisural-hinge plane angle,
inter-commisural distance
and angle, leaflet
length/height, and 3D
measurement of aortic
root and ascending aorta
will be reviewed. These
parameters may be of
value in valve sparing aortic procedures and decision-making in aortic
valve surgery.
References
1. Suri RM, Schaff HV, Dearani JA et al. Survival
advantage and improved durability of mitral repair
for leaflet prolapse subsets in the current era. Ann
Thor Surg 2006; 82:819-27.
2. Enriquez-Sarano M, Sundt TM 3rd. Early surgery is
recommended for mitral regurgitation. Circulation
2010; 121(6):804-11.
3. Kang DH, Kim JH, Rim JH et al. Comparison of
early surgery versus conventional treatment in
asymptomatic severe mitral regurgitation.
Circulation 2009 119(6):797-804.
4. Gammie JS, Sheng S, Griffith BP et al. Trends in
mitral valve surgery in the United States: results
from the Society of Thoracic Surgeons Adult
Cardiac Surgery Database. Ann Thorac Surg 2009;
87(5):1431-7.
5. Grewal J, Mankad S, Freeman WK et al. Real-time
three-dimensional transesophageal echocardiography in the intraoperative assessment of mitral
valve disease. J Am Soc Echocardiogr 2009;
22(1):34-41.
6. Pepi M, Tamborini G, Maltagliati A et al. Head-tohead comparison of two- and three-dimensional
transthoracic and transesophageal echocardiography in the localization of mitral valve prolapse. J
Am Coll Cardiol 2006; 48(12):2524-30.
7. Fabricius AM, Walther T, Falk V et al. Three-dimensional echocardiography for planning of mitral
valve surgery: current applicability? Ann Thorac
Surg 2004; 78(2):575-8.
8. García-Orta R, Moreno E, Vidal M et al. Threedimensional versus two-dimensional transesophageal echocardiography in mitral valve repair.
J Am Soc Echocardiogr. 2007; 20(1):4-12.
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Adult Cardiac
Session 2: Room ABC Aortic surgery (10:10-12:10)
Aortic Surgery
F Beyersdorf,
Freiburg, Germany and
J Bachet, Abu Dhabi,
United Arab Emirates
A
ortic surgery is one of
the fields in cardiac
surgery that progresses very fast.
Considered for a long time
as a surgical challenge with
major risks and uncertain
results, it has become in 50
years an essential element of
cardiovascular surgery, performed in many centres
throughout the world with
reproducible and reliable
techniques and results.
Innovative developments in
recent years have, indeed,
resulted in a significant
decrease in mortality and
morbidity for all types of aortic surgery.
Nevertheless, a very
resourceful, inventive and
active cardiologic, radiologic
and biotechnological environment is presently challenging
conventional aortic surgery.
Endovascular techniques
and hybrid procedures have,
indeed, gained special attention and a growing acceptance rate among cardiac surgeons.
In the EACTS Aortic
Surgery Session, many of the
still controversial aspects will
be discussed after careful
selected presentations have
been given. These include
pros and cons of the various
methods of cerebral protection. The parameters for
assessing the quality of cerebral perfusion techniques will
also be discussed.
Hybrid techniques can be
used for aortic arch surgery.
There will be a debate if
either the open techniques or
the hybrid techniques are
superior.
The endovascular surgical
approach has reduced significantly the paraplegia and
paraparesis rates in descending and thoraco-abdominal
aortic surgery. Fortunately
these severe neurologic morbidity rates have also
decreased when open techniques are being used. The
hypothesis for these improvements will be discussed. In
addition potential drawbacks
of the endovascular technique
will be addressed.
In summary many of the
fast developing innovative
techniques in aortic surgery
will be critically discussed in
this session and advantages as
well as disadvantages of each
technique will be presented.
Session 3: Room ABC
Minimally invasive aortic valve surgery (13:10-15:10)
Session 3: Room ABC
Minimally invasive aortic valve surgery (13:10-15:10)
Sutureless aortic valve replacement
with the ATS 3f Enable bioprosthesis
Sven Martens Goethe-University
Hospital, Frankfurt, Germany
ment. I want to point out that in our
center, the majority of implants was performed using a minimal invasive access,
mplantation of a sutureless aortic valve a partial upper sternotomy.
prosthesis after resection of the native
However, exact positioning of the valve
aortic valve, allowing for reduced carwas still time consuming in some cases.
diopulmonary bypass and aortic crossThe next generation of the valve (Enable
clamp time, might be an alternative treat- II) incorporates more comfortable posiment option for patients with increased
tioning and quicker deployment.
risk for morbidity and mortality after car- Significant changes in the design of the
diac surgery. The ATS 3f Enable
Enable II, which are presented in a video
Bioprosthesis is a self-expanding valve
case during the Techno College on
with a unique tubular design that allows
Saturday are: A shorter height of the
for sutureless implant in the aortic position after resection of the aortic valve.
Our group in Frankfurt participated in a
prospective, multicenter clinical study
evaluating the safety and efficacy of this
bioprosthesis in patients undergoing aortic valve replacement with or without concomitant procedures.
Midterm results will be presented at
the EACTS meeting 2010 in Geneva on
Tuesday 14th of September. In short,
valve implantation resulted in a significant
improvement of patients’ symptoms.
Echocardiography revealed low mean gradients at one and two years after the
operation. Overall, the data collected on
140 patients confirm the safety and clinical utility of the ATS 3f Enable
Sven Martens
Bioprosthesis for aortic valve replace-
I
stent frame, a uniform expansion of the
valve and a larger annulus sealing zone.
In addition, new delivery tools facilitating
minimally invasive procedures had been
developed. Sutureless aortic valve replacement with the Enable II has some similarities to transcatheter aortic valve procedures, with the advantage that the diseased valve can be removed and the
annulus decalcified. The disadvantage is
the requirement of cardiopulmonary
bypass and aortic cross-clamping for this
innovative procedure.
Perceval S* valve: The results
of the first 180 patients
device diameter. The system
features an aortic pericardial
valve implanted
ortic valve replacement is the objective to facilitate valve implan- in more than 10,000 patients with
treatment of choice for aor- tation, shorten ischemic and perfu- proven durability and optimal
hemodynamics. The valve is colsion time after removal of the distic valve stenosis when it is
lapsed in the delivery system witheased valve.
symptomatic or severe(<=
The surgical approach offers the out folding the leaflets.
0.6cm²/m²) or with left ventricular
Between April 2007 and
unique advantage of removing all
dysfunction.
Important comorbidities particu- calcifications, enabling concomitant February 2008 the Perceval PILOT
Trial included 30 patients which
larly in an increasing elderly patient procedures at the same time and
population referred for aortic valve the self anchoring valve is implant- had this self anchoring valve
ed and deployed while under direct implanted. All patients had an age
replacement require alternative
>=75 years and significant aortic
treatment options aimed at reduc- visual control.
valve disease. Perceval S was
Perceval S is a self expandable
ing the trauma as well as ECC and
surgical aortic valve with an unique implanted after accurate and comaortic cross clamp time without
plete surgical removal of the disself anchoring frame enabling the
hemodynamic compromise. To
surgeon to replace the diseased
eased valve. Using these techniques
comply with these requirements,
endovascular and transapical valves valve without suturing. It comprises the first experience in 30 patients at
a functional component made of
3 different locations in Europe
were developed. They offer the
bovine pericardium fixed in a metal showed an extremely secure valve
advantage of being performed
positioning with no problem of
without circulatory bypass but leave frame made of super elastic alloy.
diminished blood flow to the corothe aortic valve calcification in place The self anchoring frame design is
characterized by two ring segments, nary ostia, and significant reduction
with associated risks.
of surgery time. Also, these valves
The concept of a sutureless valve at the proximal and distal end, a
number of connecting elements to are associated with a very low incihas been recently renewed, in
support the stentless valve and to
dence of paravalvular leakage. In
attempt to offer a valid and comabout 50% of the patients
prehensive curative option, allowing allow the prosthesis anchoring to
described, a concomitant coronary
the surgeon to treat older and sick- the aortic root, in the sinuses of
bypass grafting was performed
er patients when delivering golden Valsalva. It provides minimal transvalvular gradient due to an optimal without adding any risk to the
standard clinical outcomes. These
valves are being developed with the ratio between internal and external patient. An added value of this
A
J Bachet (inset)
and (main picture)
F Beyersdorf,
Initial clinical experience with the
Edwards Project Odyssey aortic
valve replacement system
Malakh Shrestha
Hanover Medical School, Germany
M
inimally invasive surgical options for
the replacement of aortic valves
continue to be refined. Project
Odyssey (Edwards Lifesciences, Irvine CA) is
designed to facilitate less invasive surgical
procedures via mini-sternotomy and combines Edwards traditional valve technology
with the latest transcatheter technology to
offer a rapid deployment aortic valve with
more efficient implantation.
Method
The system consists of a stented tri-leaflet
bovine pericardial bioprosthesis with balloon
expandable, cloth-covered stent frame, delivered via aortotomy. Implantation occurred in
patients with isolated aortic valve replacement or with concomitant procedures.
Native leaflets were excised and the annulus
debrided. The valve was lowered to the
annulus with the frame aspect first, using
three guiding sutures and secured in a supraannular position. Following frame expansion
with a balloon catheter, the three sutures
were tied and the aortotomy was closed.
3f Enable II
Conclusion
Aortic valve replacement using a rapid
valve represents a decrease of both
the aortic cross clamp time (60%)
and cardiopulmonary bypass time
(40%) when compared to STS database.
Meanwhile an experience of 150
patients who received a Perceval S
valve in 9 centers with a follow-up
of more than 2 years will be reported at this meeting. The self anchoring Perceval S valve has provided
excellent results, stable over time
with a minimal mortality and
morbidity. These experiences
underscore short ischemic and
perfusion time, minimal
transvalvular gradients,
ease and reproducible
implantation even in small
annuli. Due to its unique
design, the safe Perceval S
system changes surgical paradigm and is opening an innovative field to treat sicker
patients towards a broader application of minimal invasive aortic valve
replacement.
We look forward sharing the
experience of the first 180 patients
with up to 3 years Follow-up during
the Sorin Group Lunch Symposium,
room Mont Blanc on Monday, 13th
of September 12:45–2pm.
*Investigational Device
Malakh Shrestha
deployment valve is safe and feasible. It may
provide meaningful reductions in intra-operative times. This Surgical video shows the
implantation of such a prosthesis. Such
devices may enable broader application of
minimally invasive AVR as its implantation is
technically simpler and more reproducible.
8 Saturday 11 September 2010 EACTS Daily News
Adult Cardiac
Session 4: Room ABC Minimally invasive mitral valve surgery (15:40-18:00)
Transapical chordal replacement – First clinical experience
Joerg Seeburger
Heart Centre Leipzig, Germany
has expandable jaws used to capture and control the
flail leaflet segment where the new artificial chordae
tendinae, made of ePTFE, will be deployed. Effective
he concept of beating
leaflet capture is confirmed by observing the four fiber
heart transapical implanoptic monitor lights changing from red (blood pool) to
tation of neo-chordae to
white (leaflet tissue). Next, the penetration of the leaflet
the mitral valve with the
with the needle is performed to retrieve the suture.
NeoChord DS1000 instrument
Once the device is completely retrieved, the suture is
has been recently introduced.
secured to the leaflet with a girth hitch knot. After the
This new operation has been
desired number of “NeoChords” have been deployed
successfully evaluated in acute
and the desired operative result has been achieved, the
and chronic animal studies. Currently, the Transapical
final step of the procedure is to manually secure the
Artificial Chordae Tendinae (TACT) trial is underway to properly tensioned “NeoChords” at the LV apex with a
evaluate the efficacy and safety of the NeoChord proFrench eye needle over additional felt pledgets. The final
cedure in clinical practice. The EACTS Techno College
adjustment of the “NeoChord” is achieved under
presentation “Transapical Chordae Replacement – First echocardiographic guidance.
Clinical Experience” reports the First-In-Man procedures
The clinical experience is still in its infancy due to the
utilizing the NeoChord DS1000 instrument and
limited number of procedures. As of mid-August,
progress of the TACT study.
2010, a total of eight patients have undergone the
In the NeoChord procedure, a transapical access that NeoChord procedure for severe, isolated MR due to
is similar to that used for transapical aortic valve implan- PML prolapse. Procedural success (meaning successful
tation is used to insert the instrument into the left ven- implantation of at least one NeoChord to the MV) has
tricle. 2-D or 3-D transesophageal echocardiography
been a promising seven of eight patients (88%).
imaging is used to guide the procedure. The instrument Significant reduction of MR was achieved in all seven
T
prolapse of the posterior leaflet with chordae rupture
and no concomitant pathologies. Echocardiography
assessment of MV tissue quality to ascertain tissue
thickness is necessary to confirm a good substrate for
NeoChord fixation. Maintain suture safety margin: The
clinical results have demonstrated that one NeoChord is
insufficient to achieve durable results. Therefore, three
NeoChords appear to be optimal regarding the near
linear distribution of suture stress. Proper suture tensioning: Securing multiple sutures with the proper tension and apical placement has contributed to the successful outcomes in the early procedures.
NeoChord DS1000
The goal of MV repair is to restore physiologic leaflet
motion and to preserve a large mitral orifice and suffipatients. All patients had an uneventful postoperative
cient line of coaptation. Chordal replacement restores
course with short recovery times. However, three
leaflet function, creating the largest possible mitral oripatients required late reoperation for recurrent MR.
fice area, preserving ventriculo-annular continuity while
The early clinical results from the TACT study provide minimizing leaflet tension. In conclusion, the early clinipreliminary data that the NeoChord procedure is feasi- cal results from the TACT study suggest beating heart
ble and safe in selected patients. Not surprisingly, the
MV repair can be safely performed with the new delivinitial clinical procedures have been associated with a
ery system. If further favourable results are achieved
learning experience highlighted by the following devel- the NeoChord procedure may influence future treatopments: Patient Selection is crucial: Patient indication ment of selected patients. Clearly, long term evaluation
consists of severe mitral regurgitation due to isolated
is warranted.
Session 4: Room ABC Minimally invasive mitral valve surgery (15:40-18:00)
Dynamic devices for mitral repair demonstrated in a live case on
an animal model: from the anatomical to the physiological surgery
Francesco Maisano
Ospedale San Raffaele,
Milano, Italy
P
reclinical testing is an
important and valuable
step in the research and
development of new medical
technologies and techniques.
Francesco
Open heart procedures in the
Maisano
animal can be carried out similarly to human interventions, although there
are several differences between clinical surgery
and animal experiments. Over the last 15 years,
a reliable beating heart model for mitral device
testing has been developed and demonstrated
live. More specifically, the experiment, will
show the implant of adjustable mitral neochordae device, a new investigational technology,
currently undergoing initial clinical evaluation.
Adjustable devices for mitral repair bring a
new light into the surgical scenario: overcoming
the classical limitation of repair surgery being
performed on the cardioplegic heart.
Adjustable length neochordae and annuloplasty
systems allow fine tuning of valve performance
under beating heart conditions. The V-Chordal
system (Valtech Cardio, Israel) is a surgically
implantable device implanted with a sutureless
technique in the tip of the papillary muscle
through an atriotomy. Two or more neochordae
connected to the device are then sutured to the
free edge of the prolapsing segment of the
leaflet.
A flexible, small diameter cable is temporarily
left across the atriotomy to remotely activate
the adjustment mechanism during echo-guided
tuning of valve performance. The neochordae
length is then adjusted (mm-level resolution)
on the beating heart, under echo-guidance, to
optimize coaptation. One or more devices can
be used to treat wider lesions. Although the VChordal system has been designed to be used in
combination with the Cardinal TM adjustable
annuloplasty ring, in animal experiments isolated neochordae implant has been carried out to
assess device functionality.
The V-chordal device is one of a family of
adjustable devices designed to be easily
implanted with surgical precision, using wellestablished anatomical landmarks. Subsequent
to implantation, mitral valve performance can
be tuned under physiological loading conditions. The animal model is the ideal setting to
elucidate mechanisms of function and demonstrate safety and efficacy of these new systems
which could become a new standard to treat
mitral regurgitation in the future.
The V-Chordal System has been implanted from the
tip of the papillary muscle to the free edge of the
leaflet. The Adjustment cable is left in place to
adjust chordal length on the beating heart
View from the operating room. A left thoracotomy is done and the
procedure is performed on the beating heart. After implant, the devices
are tuned under fluoroscopic and echocardiographic guidance
Thoracic Disease Programme Room K (09:30-16:00)
EACTS thoracic programme
Paul Van Schil
Chair Thoracic Domain
racic surgery and specific methods to
improve surgical outcome in oncology.
The main topics of the thoracic
hanks to the outstanding efforts Postgraduate Course are an update in
of our lively Thoracic Domain we pleural problems and lung cancer, as
were able to create a comprewell as a discussion on randomized
hensive thoracic programme. A broad clinical trials. We also contribute to the
range of topics which are of interest to specific nurses’ programme which is
thoracic and cardiothoracic surgeons
organised for the first time.
are covered. For each day of the conSpecial invited lectures will be given
ference there is a clear thoracic surgi- by Frank Detterbeck on the creation of
cal track. Many outstanding surgeons ITMIG (International Thymic
from all over the world contribute to
Malignancies Interest Group), Keith
this programme.
Kerr on gene expression profile in
The thoracic Techno College on
mesothelioma and therapeutic implicaSaturday is devoted to training in tho- tions (European Organisation for
T
Research and Treatment of Cancer,
EORTC lecture) and P. Pesko on stage
III oesophageal cancer.
We received many outstanding
abstracts of which we could select the
top category for oral presentation.
Several abstracts of our domain will
compete for the Young Investigators’
Award.
On Tuesday afternoon a robotic
symposium is organized together with
cardiac surgeons to learn from their
experience. In the Wednesday morning
session, “Learning from experience”,
specific cases are discussed in collaboration with thoracic surgical residents.
EACTS working groups on thymic
diseases, chest wall disorders, lung
perfusion, robotic surgery and regenerative medicine will convene during the
conference.
The EACTS Thoracic Domain is very
pleased that you are able to participate in this congress and we sincerely
hope you will appreciate our programme and close interaction with
your colleagues. Please contact a
member of the Thoracic Domain if you
would like to join a working group or
to provide your comments or suggestions for future meetings. Enjoy your
stay in Geneva!
Paul Van Schil
EACTS Daily News Saturday 11 September 2010 9
Thoracic
Session 1: Room K Additional surgical means to improve oncological outcomes 09:30-10:55)
Photodynamic
therapy for the
thoracic surgeon
K Moghissi
Yorkshire Laser Centre, Goole, UK
P
DT is the treatment modality
which has thee components:
n A chemical photosensitiser (the
drug).
n A light, usually emitted by a
laser, whose wave length matches the absorption band of the
drug.
n Oxygen.
The principle of PDT is
Photodynamic Phenomenon that
results from interaction between
the drug and the corresponding
light in the presence of oxygen,
with generation of toxic species,
principally singlet oxygen, bringing
about cellular necrosis and tissue
destruction. The Phenomenon has
been known since the beginning
of the 20 century but its clinical
application notably for cancer has
been developed in the past 25–30
years
In clinical practice PDT is carried
out as a two step procedure;
The first is presensitisation, in
which the drug is administered to
the patient. It is retained preferentially in cancer tissues compared
with the normal. The second is illumination, in which the presensitised tissue is exposed to the laser
light. The interaction between the
light and the photosensitiser in the
presence of tissue oxygen brings
about photodynamic reaction.
K Moghissi
By reasons of ease of access for
illumination the central lung cancer
and oesophageal cancer cases
were amongst the first to be treated by endoscopic PDT. Currently
PDT for lung and oesophageal cancer is an approved procedure and
practised in many countries world
wide.
I believe the future Thoracic
Surgeons should develop expertise
in interventional procedures particularly endoscopic PDT with its current and potential application.
In practice PDT in three types of
cancer would be of particular relevance to thoracic surgeons:
Lung Cancer: PDT is indicated,
a) Locally advanced endo bronchial
tumours for palliation of symptoms
b) Early endobronchial tumours, in
patients ineligible for surgery.
These include
n Local recurrence after Resection.
n Metachronous tumours
n Synchronous endo bronchial
tumours
n Multi focal endo bronchial cancers.
Many publications testify that in
locally advanced disease PDT
achieves a good palliation with survival benefit in properly selected
cases.
In early cancers the treatment is
carried out with the intention of
cure. The overall 5 years survival
PDT in this group is 60-65%.
Photodetection using fluorescence
bronchoscopy is necessary to
assess the extent of early cancer.
Oesophageal cancer: Over 60%
of patients with oesophageal cancer are unsuitable for surgery at
presentation and a significant
number have severe to total dysphagia (scale 3-4). Also, a number
of patients who are ontologically
operable are ineligible for resectional surgery
a) In locally advanced cases PDT
has shown to relieve malignant
endo luminal obstruction and
alleviate dysphagia.
b) In early stage cancer PDT offers
over 50% 5 years survival.
Diffuse Malignant Mesothelioma
(DMM): A number of trials have
been carried out to fine tune the
drug dosage and to sort out the
methodology. In these trials, mostly
for those with advanced disease, a
combination of surgery (decortication) and PDT has been found to
be useful. This is an exciting area
which merits more investigations
to include PDT in Multidisciplinary
Therapy of DMM.
Stereotactic radiosurgery for lung tumours
Suresh Senan
VU University Medical Center, The Netherlands
S
tereotactic body radiotherapy (SBRT) is a
form of high-precision focal irradiation using
radiation doses that are 5–10 times higher
than those used for conventional radiotherapy.
Prospective trials in stage I lung cancer have
reported local control rates in excess of 88%. In
both The Netherlands and Japan, SBRT has now
replaced conventional radiotherapy in unfit
patients with peripheral lung tumors, an
approach supported by the findings of a metaanalysis of published studies.
A commonly held misconception is that SBRT
delivery is only possible using specific brands
treatment units (linear accelerators or linacs).
Another misconception is that rigid patient immobilization systems are a necessary component, as
are the use of implanted radio-opaque markers.
Guidelines for lung SBRT have now been developed in the Netherlands and in the EORTC to facilitate ‘generic’ approaches to lung SBRT, and the
nine (of 11) Dutch centers do so using conventional linacs. Tumor location can now be verified using
on-board CT-sans prior to, and during, treatment
delivery. Complete delivery is now possible in 11
minutes or less using the approach of volumetric
modulated arc therapy. Prospective data shows
that high-grade toxicity is uncommon, even in
patients aged ≥75 years, and that quality of life
after is maintained after SBRT. Population-based
studies reveal that introduction of SBRT has led to
a significant reduction in the proportion of elderly
patients who did not receive any anti-cancer therapy for a stage I NSCLC, and that the increased utilization of radiotherapy led to a 12.5% increase in
survival of Dutch patients in an eight-year period.
SBRT outcomes reported in patients unfit for
surgery have led to interest worldwide in evaluating SBRT in fit patients with stage I NSCLC. This
should be addressed in prospective randomized
trials, although the often strong biases of both
patients and physicians have historically made
surgical versus non-surgical treatment compar-
Suresh Senan
isons difficult. Concerns that local control postSBRT may have been exaggerated by the inclusion of patients with benign histology may be
less relevant in selected Western European countries where the incidence of benign disease has
repeatedly been shown to be low after resection
for clinical stage I NSCLC. The risk for occult nodal
metastases is concern, particularly in younger
patients who may be fit to receive adjuvant
chemotherapy, but implementation of endoscopic
nodal staging may reduce this risk.
In the absence of randomized trials, populationbased consecutive series take on added importance, since this study design provides the next
strongest level of evidence. Dutch data will be
used to highlight developments that may improve
accrual to trials of SBRT and surgery. Populationbased comparative-effectiveness research are ideal
to compare the effectiveness of alternative medical strategies, especially in groups such as the elderly or those with severe COPD, who have historically been underrepresented in clinical trials.
10 Saturday 11 September 2010 EACTS Daily News
Thoracic
Saturday 11 September 2010
Session 2: Room K Additional surgical means to improve oncological outcomes (11:15-12:30)
Domain Thoracic Disease Programme
09:30 Session 1: Additional Surgical Means to
Improve Oncological Outcome
Room K
Moderators: K Moghissi, T Treasure
09:30
10:00
10:15
10:30
10:45
Photodynamic therapy for the thoracic surgeon
K Moghissi
Lasers: New applications in pulmonary surgery
G Marulli
Radiofrequency ablation: Extending indications
for lung tumours
Y Colson
Stereotactic radiosurgery for lung tumours
S Senan
Discussion
10:55 Coffee Break
11:15 Session 2
Moderators: R Schmid, P van Schil
11:15
11:30
11:45
12:00
12:15
Nanotechnology and lymph node targeting
Y Colson
Intraoperative sentinel lymph node mapping in
lung cancer
M Lucchi
Molecular staging in lung cancer
K Syrigos
Isolated lung perfusion for resectable lung
metastases
P van Schil
Discussion
12:30 Lunch
14:00 Session 3: Training in Thoracic Surgery:
Present and Future
Moderators: K Athanassiadi, J M Wihlm
14:00
14:15
14:30
14:50
15:00
14:00
Analysis of problems in training
P Rajesh
Introducing simulators in medical education
K Athanassiadi
Virtual and augmented reality for training and
education in surgery
L Soler
Discussion
Hands-on simulation workshop
Close
Molecular staging
in lung cancer
Nektaria Makrillia and
Kostas Syrigos
Athens School of Medicine,
Sotiria General Hospital,
Athens, Greece.
L
ung cancer remains the
leading cause of cancerrelated death worldwide,
despite the enormous scientific
research conducted in this field.
The TNM staging system provides a framework to assess
prognosis and to select the best
possible combination of treatment modalities for a newlydiagnosed patient. Nevertheless,
even the revised 7th edition of
TNM staging has inherent inaccuracies, as it does not always
account for survival differences,
nor does it include any information regarding the biological
profile of the tumor. Additional
information concerning prognosis and appropriate treatment is
necessary to complement the
TNM system and can be
obtained through molecular biological staging.
Molecular staging refers to
the assessment of tumor markers associated with carcinogenesis in order to improve the prog-
nostic system used in clinical
practice and to provide individualized treatment based on
tumor biological profile. This is
achieved by identifying biomarkers in primary tumors or regional
lymph nodes and by detecting
occult regional and distant
micrometastases via DNA, RNA
and protein expression analysis.
Promising prognostic biomarkers include oncogenes and
tumor suppressor genes, as well
as markers of cell proliferation,
tumor invasion, metastasis and
epigenetic modifications,.
Whole genome amplification
enables mutation detection of
multiple genes even in low-volume biopsies.
Molecular techniques further
contribute to more accurate
staging by allowing the detection of micrometastasis in surgically removed regional lymph
nodes, not identified through
routine histopathological examination. This may lead to
improved prognostic stratification and selection of adjuvant
therapy. Biological detection of
occult distant metastasis in the
bone marrow and in peripheral
blood has also been reported.
Furthermore, molecular
markers seem to be extremely
useful in selecting the appropriate therapeutic approach as
they help in predicting treatment sensitivity and resistance
and in monitoring treatment
efficacy. Several biomarkers
which predict response to
chemotherapy have been identified, such as ERCC1 and
RRM1. EGFR mutations in adenocarcinomas are associated
with sensitivity to EGFR-tyrosine
kinase inhibitors (TKIs) supporting the need for gene profiling
in first-line, maintenance as
well as second-line treatment.
Specific mutations and gene
amplifications have also been
recognized in primary and
acquired resistance to EGFRTKIs, suggesting the importance of molecular monitoring
of therapy. Information concerning response to TKIs can
also be obtained through rapidly developing proteomic techniques. Lately, molecular analysis revealed the EML4-ALK
translocation as a vital NSCLC
oncogene, which is mutually
exclusive with EGFR or KRAS
mutations and predicts poor
Session 1: Room K Additional surgical means to improve oncological outcomes
(09:30-10:55)
Training in thoracic surgery:
Present and future
Kalliopi Athanassiadi
Evangelismos General Hospital,
Athens, Greece.
H
istorically, surgical training has
followed an apprenticeship
model. The resident begins operating with a senior surgeon and learns
by doing the operation and gradually
assuming more responsibility for each
portion of the procedure. One can easily
realize, how important the teaching is.
Thoracic Surgery residents will assist and
teach interns, while being taught by
senior and chief residents and attending
surgeons. In many countries, attending
surgeons mainly instruct and assist residents during cases. After all, surgery is a
skilful craft, which can only be mastered
by sufficient exposure, solid caseload
and professional guidance by an experienced surgeon or an academic professor
at a University clinic.
Today, we all should admit that the
true meaning of "University" – which
represents a shortening of the Latin
term "universitas magistrorum et scholarium" ("community of masters and
scholars"), has been lost in surgical residency training programs. No matter
how well intentioned and idealistic the
senior colleagues and mentors may be
regarding surgical training the existing
system makes it nearly impossible for
them to teach.
On the other hand, surgical education
is becoming a progressively more complex endeavor. In this era of limited work
hours for residents, rapidly changing
technology, concern about patient safety
and quality of medical care offered, and
financial pressures, new and creative
educational techniques must be used to
ensure that surgeons in training achieve
proficiency in more complex problems
during shorter training periods and that
practicing surgeons can be rapidly
trained in new technologies.
One of the ideal learning opportunities might be simulated and virtual
environments. There have been
already industries such as the aerospace
that have evolved simulation as a valuable training tool. No passenger would
ride on a commercial flight during a
pilot’s first experience in the cockpit;
thus, completion of simulator training is
required for every commercial pilot. In
the same manner, simulation can transform the process of learning thoracic
surgery providing a means of developing technical competency while posing
far less risk to our patients.
Developing realistic training scenarios
that take full advantage of the technology is a critical success factor.
Simulation allows the trainee to practice
on his or her own time instead of being
constrained by work hour limitations
and availability of animal laboratory
facilities. Furthermore, it allows repetitive practice of fine technical skills and
assessments based on direct observations. The experienced surgeon can also
use effective simulators to rapidly
develop new procedures, to practice
safe skill development, and to assist in
introducing new technology into clinical
practice. Apart from individual skills at
all levels which are an obvious target
for simulation, team simulation can
expose all members of the surgical team
to the entire process of patient care
including communication that should
not be underestimated. Team training
effectively improves communication
among team members and helps individuals recognize their roles within the
team. Scenarios with emphasis on quality indicators can improve the efficiency
Kostas Syrigos
response to EGFR-TKIs. Other
markers that prospectively recognize patients who benefit
from VEGF-targeted therapy are
under investigation.
Recent knowledge gained in
these exciting scientific fields
paves the way to a molecularly-
Session 2: Room K Additional surgical means to
improve oncological outcomes (11:15-12:30)
Isolated lung perfusion
for resectable lung
metastases
Paul E Van Schil
Antwerp University Hospital, Belgium
S
Kalliopi Athanassiadi
of peri-operative procedures, present
rare events to the team before they are
encountered in the operating room, and
model activities surrounding patient
transport and handoff to train the team
to reduce or eliminate errors during this
crucial exchange.
Thoracic surgeons have a tendency to
assume leadership, as evident in their
choice of a highly complex and demanding profession. In addition, the practice
of Thoracic Surgery involves extensive
use of technology. The modern era of
graduate medical education has evolved
from traditional approaches to an
emphasis on patient safety and supervision of trainees. Training of technical
operative skills before teaching is a
major tenet of modern training paradigms. So, in the near future, all educational programs should be re-structured.
It is rather clear that simulators and animal laboratories always under expert
guidance should become a mandatory
part of Thoracic Surgery Curriculum in
order that the residents develop their
basic skills before entering into the reallife operating room.
oriented lung cancer staging
system, without undermining
the value of classic TNM staging. Ongoing clinical trials will
clarify how molecular staging
will be incorporated in the rapidly evolving treatment algorithms.
urgical resection is a widely accepted
treatment for pulmonary metastases
on the condition that a complete
resection can be obtained. However,
many patients will develop recurrent disease in the thorax despite the use of systemic chemotherapy, dosage of which is
limited because of systemic toxicity.
Similar to the basic principles of isolated limb and liver perfusion, isolated lung
perfusion is an attractive and promising
surgical technique for the delivery of
high-dose chemotherapy with minimal
systemic toxicity. The use of biological
response modifiers, like tumour necrosis
factor, is also feasible. Other related
methods of delivering high-dose locoregional chemotherapy include embolic
trapping (chemo-embolization) and pulmonary artery infusion without control
of the venous effluent.
Isolated lung perfusion has proven to
be highly effective in experimental models of pulmonary metastases with a clear
survival advantage. Lung levels of cytostatic drugs are significantly higher after isolated lung perfusion compared to intravenous therapy without systemic exposure. Phase I human studies with different chemotherapeutic drugs have shown
that isolated lung perfusion at different
perfusion temperatures is technically feasible with low morbidity and without
compromising the patient’s pulmonary
function. At the present time, isolated
lung perfusion is evaluated as adjuvant
therapy for patients who are operated for
lung metastases, especially for metastatic
epithelial and sarcoma tumours.
Further clinical studies are necessary to
determine its definitive effect on local
recurrence, long-term toxicity, pulmonary
function and survival. Less invasive techniques using pulmonary artery catheters
with blood flow occlusion will also be
developed to allow repetitive application
pre- and postoperatively.
Paul Van Schil
EACTS Daily News Saturday 11 September 2010 11
Sorin Group Kids™ D100 neonatal oxygenator:
tailoring perfusion for the smallest
S
ince 2007, Sorin Group has been providing
Kids™ D100 to the medical community: the
world’s smallest blood oxygenator expressly
engineered for neonatal patients up to 5 kg in body
weight undergoing cardiopulmonary bypass.
Neonatal Congenital Cardiac Patients are the most
critical and require the very best in terms of therapeutic treatment and surgical-perfusion tools. According
to the EACTS congenital data base, a 30-day mortality rate in Neonatal Cardiac Patients is still as high as
9%. All available strategies should be undertaken in
order to improve the clinical outcome.
We at Sorin Group believe that such critical neonatal patients deserve a tailored approach to perfusion,
which is possible only with specific and dedicated
devices. Kids™ D100 extremely low priming volume
(31ml) and port configuration make it the device of
choice to minimize hemodilution and limit or avoid
blood transfusion.
Thanks to the Kids™ D100 oxygenator, it is possible to set up a complete miniaturized neonatal perfusion system requiring a priming volume as low as 110
ml tip-to-tip without any compromise in performance
and safety. This miniaturized system includes the
Kids™ D130 neonatal arterial filter, specifically
designed to be used in combination with the Kids™
D100 oxygenator to protect the patient from gas
embolism.
Kids™ D100 has a low foreign surface area in contact with blood and its membrane lung is truly tailored for gas exchange in neonatal patients. Tailored
gas exchange means avoiding hypocarbia and hyperoxia, thus helping to better control vasoconstriction
and limiting neurological lesions.
The Kids™ D100 oxygenator and the Kids™ D130
arterial filter are CE marked and FDA approved, and
the Kids™ D100 oxygenator is the device of choice
of over 80 pediatric cardiac surgery institutions in
Europe and North America. This choice is supported
by several in vivo and in vitro studies published in the
last three years.
The Kids™ D100 oxygenator and the Kids™ D130
arterial filter are Ph.i.s.i.o. coated to improve haemocompatibility of the cardiopulmonary bypass system:
Ph.i.s.i.o. is a stable, uniform, inert and non- thrombogenic coating made of phosphorylcholine, a physiological molecule naturally present in cell membranes. The Ph.i.s.i.o. coating lowers coagulation activation and preserves platelets, thus reducing post-op
bleeding and the need for blood transfusion, as supported by more than 10 years’ scientific literature.
The wellknown Sorin Group S5
heart-lung machine is
available in a “mastmounted” configuration, allowing for
extremely short tubing
lines, thus contributing
to further miniaturizing
the cardiopulmonary
bypass circuit and reducing hemodilution.
Sorin Group tubing
lines and cannulae comKids™ D100
plete the perfusion set tailored for the smallest patients and are also available
with Ph.i.s.i.o. coating for a tip-to-tip coated circuit.
The Sorin Group Kids™ D101 infant oxygenator
and the Kids™ D131 infant arterial filter have been
on the market since 2008 to complete the Kids™
pediatric product range with devices specifically
designed for infant patients.
For further information, please come and join us
at the Sorin Group booth #1020 or contact:
info.cp@sorin.com.
Session 1: Room K
Additional surgical means to
improve oncological outcomes
(09:30-10:55)
Introducing
simulators
in medical
education
Kalliopi Athanassiadi,
Evangelismos General Hospital, Athens, Greece
T
he traditional apprenticeship model in surgical
training is currently being changed. As our healthcare system evolves, concerns for patient safety,
service, and outcome data have taken precedence over
training. Also introduction of new techniques requiring
new skill sets become increasingly more important and
the notion that “the operating room is not the place to
learn” is now more valid than ever.
Changes in surgical training, financial pressures, and
resident work hour limitations, have compelled surgical
educators to evaluate more effective methods of teaching psychomotor skills. On the other hand, advances in
computing power have enabled continued growth in
virtual reality, visualization, and simulation technologies.
Nowdays, the ideal learning opportunities afforded
by simulated and virtual environments have prompted
their exploration as learning modalities for surgical education and training. Other professions have used simulations-based education for decades such as the aerospace that had a success with flight simulation.
Medical simulation is a novel, intermediate stage in
medical education between the classroom and clinical
settings. One should consider that simulators need to
provide a realistic and graduated training experience
and have valid educational objectives; they also should
be cost-effective and of relatively low maintenance. The
experienced surgeon can also use effective simulators to
rapidly develop new procedures, to practice safe skill
development, and to assist in introducing new technology into clinical practice.
The application of simulation to thoracic surgery has
been limited. However, simulation training in cardiothoracic surgery has recently gained attention as a tool to
help attending surgeons educate, as well as improve
and rejuvenate, resident learning
Integrating simulation into traditional medical education and continuing medical education is a challenge
worth to take.
12 Saturday 11 September 2010 EACTS Daily News
Congenital
Techno College: Domain Congenital
Disease Programme
13:30 Session 1 : Senning,
Room G
Moderators: C Schreiber, P Vouhé
13:30
14:10
14:25
Modified Senning operation for corrected
transposition, technical considerations (video)
V Hraska
Long term results after the Senning operation
J Hörer
Discussion
14:45 Session 2: Brain Monitoring Current
Practice and New Horizons
Moderators: E da Cruz, P Pouard
14:45
15:10
15:20
15:45
15:55
16:20
Goal-directed cerebral therapy to prevent
ischemic injury
J Tweddell
Discussion
Technical and physiological considerations
during selective continuous perfusion – results
on neurodevelopment tests
C Brizard
Discussion
Non-invasive neurological monitoring: current
status and future developments
A Hoskote
Discussion
16:30 Coffee Break
16:45 Session 3: Paediatric Mechanical
Circulatory Support
Session 2: Brain monitoring - current practice and new horizons Room G (14:45-16:30)
Peri-operative brain monitoring in pediatric cardiac patients:
Anticipating the present, predicting the future?
accepted that the main objective when
managing critically-ill patients is to protect tissue perfusion. However, current
evidence shows that clinicians’ ability to
detect anomalies on tissue perfusion is
very limited. Hence, the need for the
development of sophisticated, consishe last two decades have seen a
tently efficient, and if possible non-invamarked improvement in the mansive, technologies and strategies that
agement of critically-ill children
might allow caregivers to optimize the
with congenital or acquired cardiac disacute care of these patients, and quite
ease. This can be explained by multiple
likely their long term outcomes.
factors, including interdisciplinary manExcellent care, anticipation and preagement, advancement of diagnostic
vention of complications can only be
and therapeutic techniques, and very
achieved with a multimodality monitorimportantly, the anticipation and preven- ing approach, rather than based upon
tion of complications. Early detection
isolated values. The adjunct use of lacand rectification of hemodynamic
tates, near infra-red spectroscopy,
derangements, goal-oriented therapy
Biospectral Index monitoring, continuous
and multi-organ protection have impact- electroencephalography, continuous
ed not only immediate but also mid and SvO2 monitoring, pulse contour analysis
long term outcomes. It is currently
technologies and other developing techEduardo da Cruz
The Children’s Hospital of Denver,
University of Colorado Denver, USA and
Philippe Pouard
Hopital Necker-Enfants Malades,
Paris, France
T
niques have been instrumental in optimizing clinical management of pediatric
patients, although there are still many
aspects to elucidate by solid randomized, prospective and multicentric studies
in the pediatric population.
Current devices may help to identify
early and clinically imperceptible
changes in regional perfusion. The brain
has been one of the main targets of this
technological development.
Conceivably, currently available tools
provide early information and may steer
clinical decisions to enhance tissue perfusion, reduce neurologic morbidity, and
reduce the risks of hypoxic brain injuries
or hypoxic-ischemic encephalopathies,
by avoiding prolonged periods of low
cerebral perfusion. This is all the more
important that pre-operative neurologic
abnormalities are not infrequent, even if
often underestimated.
The importance of brain monitoring
goes well beyond the acute management
of these patients though. Understanding
pathophysiologic patterns of brain perfusion prior, during and after cardiac surgery is crucial for our patients’ future.
Literature suggests that in patients with
abnormal brain perfusion in their perioperative period, the above technologies
may be instrumental in predicting and
improving neuro-developmental outcomes, and in preventing periventricular
leukomalacia.
The best way to predict the future is
to create it (Peter Ferdinand Drucker).
Although we might conclude, when
more consistent prospective data will be
available, that some of these technologies are more glittering than valid, we
remain hopeful that the available
resources will help us to ensure a
brighter future to our patients.
Moderators: W Brawn, J Comas
16:45
17:05
17:15
17:35
17:45
18:15
18:30
Bridge to bridge, low weight patients and
support for functional single ventricle
physiology – what to do, Part I
M Kostolny
Discussion
Modified implantation techniques, weaning and
management after complications – what to do,
Part II
R Sodian
Discussion
Current and emerging trends in paediatric
mechanical circulatory support (MCS): Available
and future devices for children
B Duncan
Discussion
Close
Recommended reading:
1. Tibby SM, Hatherill M, Marsh MJ, Murdoch IA. Clinicians' abilities to
estimate cardiac index in ventilated children and infants. Arch Dis
Child 1997; 77: 516-518.
2. Gottlieb EA, Fraser CD Jr, Andropoulos DB, Diaz LK. Bilateral monitoring of cerebral oxygen saturation results in recognition of aortic cannula malposition during pediatric congenital heart surgery. Paediatr
Anaesth 2006; 16: 787-789.
3. Dent CL, Spaeth JP, Jones BV, Schwartz SM, Glauser TA, Hallinan B,
Pearl JM, Khoury PR, Kurth CD. Brain magnetic resonance imaging
abnormalities after the Norwood procedure using regional cerebral
perfusion. Thorac Cardiovasc Surg 2005; 130: 1523-1530.
4. Hoffman GM, Mussatto KA, Brosig CL, Ghanayem NS, Musa N,
Fedderly RT, Jaquiss RD, Tweddell JS. Systemic venous oxygen saturation after the Norwood procedure and childhood neurodevelopmental
outcome. J Thorac Cardiovasc Surg 2005; 130: 1094-1100.
5. Tweddell JS, Ghanayem NS, Hoffman GM. Pro: NIRS is "standard of
care" for postoperative management. Semin Thorac Cardiovasc Surg
Pediatr Card Surg Annu 2010; 13: 44-50.
6. Johnson BA, Hoffman GM, Tweddell JS, Cava JR, Basir M, Mitchell
ME, Scanlon MC, Mussatto KA, Ghanayem NS. Near-infrared spectroscopy in neonates before palliation of hypoplastic left heart syndrome. Ann Thorac Surg 2009; 87: 571-577.
7. Tweddell JS, Ghanayem NS, Mussatto KA, Mitchell ME, Lamers LJ,
Musa NL, Berger S, Litwin SB, Hoffman GM. Mixed venous oxygen
saturation monitoring after stage 1 palliation for hypoplastic left heart
syndrome. Ann Thorac Surg 2007; 84: 1301-1310.
8. Ghanayem NS, Mitchell ME, Tweddell JS, Hoffman GM. Monitoring the
brain before, during, and after cardiac surgery to improve long-term
neurodevelopmental outcomes. Cardiol Young 2006; 16: 103-109.
9. Hirsch JC, Charpie JR, Ohye RG, Gurney JG. Near infrared spectroscopy (NIRS) should not be standard of care for postoperative management. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu
2010; 13: 51-54.
10.Li J, Van Arsdell GS, Zhang G, Cai S, Humpl T, Caldarone CA, Holtby
H, Redington AN. Assessment of the relationship between cerebral
and splanchnic oxygen saturations measured by near-infrared spectroscopy and direct measurements of systemic haemodynamic variables and oxygen transport after the Norwood procedure. Heart
2006; 92:1678-1685.
11.Newburger JW, Bellinger DC. Brain injury in congenital heart disease.Circulation 2006; 113: 183-185.
12.McQuillen PS, Nishimoto MS, Bottrell CL, Fineman LD, Hamrick SE,
Glidden DV, Azakie A, Adatia I, Miller SP. Regional and central venous
oxygen saturation monitoring following pediatric cardiac surgery: concordance and association with clinical variables. Pediatr Crit Care Med
2007; 8: 154-160.
13.Kim M, Ward D, Cartwright C, Kolano J, Chlebowski S, Henson L.
Estimation of jugular venous O2 saturation from cerebral oximetry or
arterial O2 saturation during isocapnic hypoxia. J Clin Monit 2000;
16: 191-199.
14.Abdul-Khaliq H, Troitzsch D, Berger F, Lange PE. [Regional transcranial
oximetry with near infrared spectroscopy (NIRS) in comparison with
measuring oxygen saturation in the jugular bulb in infants and children for monitoring cerebral oxygenation]. Biomed Tech (Berl) 2000;
45: 328-332.
15.Wider MD. Hemodynamic Management and Regional Hemoglobin
Oxygen Saturation (rSO2) of the Brain, Kidney and Gut. Neonatal intensive care: the journal of perinatology-neonatology 2009; 22: 57-60.
16.Kaufman J, Almodovar MC, Zuk J, Friesen RH. Correlation of abdominal site near-infrared spectroscopy with gastric tonometry in infants
following surgery for congenital heart disease. Pediatric Critical Care
Med 2008; 9: 62-68.
17.Kane JM, Steinhorn DM. Lack of irrefutable validation does not
negate clinical utility of near-infrared spectroscopy monitoring: learning to trust new technology. J Crit Care 2009; 24: 472.e1-7.
18.Hoffman GM, Ghanayem NS, Tweddell JS. Noninvasive assessment of
cardiac output. Semin Thorac Cardiovasc Surg Pediatr Card Surg
Annu 2005: 12-21.
19.Hoffman GM, Stuth EA, Jaquiss RD, Vanderwal PL, Staudt SR,
Troshynski TJ, Ghanayem NS, Tweddell JS. Changes in cerebral and
somatic oxygenation during stage 1 palliation of hypoplastic left heart
syndrome using continuous regional cerebral perfusion. J Thorac
Cardiovasc Surg 2004; 127: 223-233.
20.Hoffman GM, Ghanayem NS, Kampine JM, Berger S, Mussatto KA,
Litwin SB, Tweddell JS. Venous saturation and the anaerobic threshold
in neonates after the Norwood procedure for hypoplastic left heart
syndrome. Ann Thorac Surg 2000; 70: 1515-1520.
21.Petrova A, Mehta R. Near-infrared spectroscopy in the detection of
regional tissue oxygenation during hypoxic events in preterm infants
undergoing critical care. Pediatr Crit Care Med 2006; 7: 449-454.
22.Lemmers PM, Toet MC, van Bel F. Impact of patent ductus arteriosus
and subsequent therapy with indomethacin on cerebral oxygenation
in preterm infants. Pediatrics 2008; 121: 142-147.
23.Bailey SM, Hendricks-Muñoz KD, Wells JT, Mally P. Packed Red Blood
Cell Transfusion Increases Regional Cerebral and Splanchnic Tissue
Oxygen Saturation in Anemic Symptomatic Preterm Infants. Am J
Perinatol 2010. [Epub ahead of print]
24.Johnson BA, Hoffman GM, Tweddell JS, Cava JR, Basir M, Mitchell
ME, Scanlon MC, Mussatto KA, Ghanayem NS. Near-infrared spectroscopy in neonates before palliation of hypoplastic left heart syndrome. Ann Thorac Surg 2009; 87: 571-577.
25.Fenton KN, Freeman K, Glogowski K, Fogg S, Duncan KF. The significance of baseline cerebral oxygen saturation in children undergoing
congenital heart surgery. Am J Surg 2005; 190: 260-263.
26.Charpie JR, Dekeon MK, Goldberg CS, Mosca RS, Bove EL, Kulik TJ.
Serial blood lactate measurements predict early outcome after neonatal repair or palliation for complex congenital heart disease. J Thorac
Cardiovasc Surg 2000; 120: 73-80.
27.Munoz R, Laussen PC, Palacio G, Zienko L, Piercey G, Wessel DL.
Changes in whole blood lactate levels during cardiopulmonary bypass
for surgery for congenital cardiac disease: an early indicator of morbidity and mortality. J Thorac Cardiovasc Surg 2000; 119: 155-162
28.Spenceley N, Skippen P, Krahn G, Kissoon N. Continuous central
venous saturation monitoring in pediatrics: a case report. Pediatr Crit
Care Med 2008; 9: e13-16.
29.Seear MD, Scarfe JC, LeBlanc JG. Predicting major adverse events after
cardiac surgery in children. Pediatr Crit Care Med 2008; 9: 606-611.
30.Galli KK, Zimmerman RA, Jarvik GP, Wernovsky G, Kuypers MK,
Clancy RR, Montenegro LM, Mahle WT, Newman MF, Saunders AM,
Nicolson SC, Spray TL, Gaynor JW. Periventricular leukomalacia is
common after neonatal cardiac surgery. J Thorac Cardiovasc Surg
2004; 127: 692-704. Erratum in: J Thorac Cardiovasc Surg 2004;
128:498.
Session 3: Paediatric mechanical circulatory support Room G (16:45-18:30)
Current and emerging trends in paediatric
mechanical circulatory support (MCS):
Available and future devices for children
Brian W. Duncan
BioEnterprise, Cleveland, OH, USA
E
a strategy for device selection using a clinical decision support tool will be provided.
lization during support. A recent report
noted improving results for infant support
in the latest cohort of patients with survival rates approaching those achieved in
adults.1 In addition, the Levitronix
CentriMag (Thoratec Corp., Pleasanton,
CA, USA), Medos HIA-VAD (Medos
Medizintechnik, Stolberg, DE) and the
HeartMate II (Thoratec Corp.) have been
reported in clinical series to successfully
support pediatric patients.
xtracorporeal membrane oxygenation Currently available pediatric mcs
(ECMO) and ventricular assist devices devices
(VADs) limited to short-term use hisThe Berlin Heart VAD (Berlin Heart AG,
torically have been the therapeutic mainBerlin, Germany) is a pulsatile, paracorpostays for pediatric mechanical circulatory
real VAD that is suitable for the entire size
support (MCS). However, over the past
range of pediatric patients including
five years, there have been a number of
neonates. The Berlin Heart VAD has been
important advances that have resulted in
used successfully in pediatric patients for
important new treatment options for chil- more than 20 years with the worldwide
dren that require MCS. Of particular inter- experience now exceeding 800 patients.
Devices of the future
est, a number of new VADs designed
The Berlin Heart VAD appears to have
A number of promising development prospecifically for children are currently avail- fewer bleeding complications compared to grams around the world are focusing on
able clinically, while early development of
ECMO with decreased blood product utithe pediatric population in attempts to cresome innovative devices for pediate next generation devices that
atric circulatory support holds
address issues related to biocompatibilpromise for the future. In addition
ity and further miniaturization. In the
to providing new life-saving
United States, the Pediatric Circulatory
approaches to treatment of medSupport Program was established by
ically refractory heart failure in chilthe National Heart, Lung and Blood
dren, these advances have also creInstitute (NHLBI) in 2004, to support
ated the potential for confusion in
the pre-clinical development of innovadevice selection. The purpose of
tive technologies designed to provide
this review is to provide an
pediatric circulatory support.2 In 2010,
overview of devices in current use
the NHLBI provided US$23.6 million
and research programs currently in
through the Pumps for Kids, Infants
Figure 1: Graphical representation of the clinical and Neonates (PumpKIN) program, to
development aimed at producing
setting in which pediatric heart failure occurs, support device development into clininext generation technologies useful
determined by patient age (Y-axis) and the cal trials. The technologies of the four
in the management of children with
anticipated duration of support (X-axis). programs funded by PumpKIN constiadvanced heart failure. In addition,
tute an array of next generation devices
aimed at providing cardiorespiratory support for children.
Selection of pediatric mcs
devices using a decision
support matrix
In an attempt to aid in the selection of the
most appropriate device in any given case,
a decision support matrix has been developed which attempts to define the relevant
clinical setting of pediatric heart failure
according to 1) patient size and 2) the
anticipated duration of support (Figure 1).
On this “Clinical Decision Support
Matrix”, patient age is plotted on the Yaxis while the anticipated duration of support is plotted on the X-axis. The clinical
setting is then described by one of four
quadrants: young patients requiring shortterm support, young patients requiring
long-term support, older children and adolescents requiring short-term support and
older children requiring long-term support.
This two-dimensional graph may be used
to match the most appropriate device to a
given clinical setting after consideration of
each device’s characteristics. Figure 2 considers ECMO as an example of how this
decision matrix is used; ECMO is suitable
for patients of all sizes and therefore spans
the entire Y-axis. ECMO is limited to only
short-term usage, which is demonstrated
on the X-axis from days to weeks. The
Berlin Heart VAD is also shown as an example; this system is suitable for patients of
any size as indicated on the Y-axis (Figure
3). In terms of anticipated duration of support, the device may be used for relatively
brief periods of support; however, it is suit-
Figure 2: ECMO considered with the
clinical decision support matrix
Figure 3: The Berlin Heart considered
within the clinical decision support matrix
able for extended durations, such as may
be required during bridge to transplantation. Any device available for pediatric circulatory support can be similarly evaluated
using this Clinical Decision Support Matrix.
References
1 Hetzer R, Potapov EV, Stiller B, et al. Improvement in
survival after mechanical circulatory support with
pneumatic pulsatile ventricular assist devices in pediatric patients. Ann Thorac Surg 82:933, 2006.
2 Baldwin JT, Borovetz HS, Duncan BW, et al. The NHLBI
Pediatric Circulatory Support Program. Circulation
113:147, 2006.
3 Duncan BW. Matching the mechanical circulatory support device to the child with heart failure. ASAIO J
52:e15, 2006.
EACTS Daily News Saturday 11 September 2010 13
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 •
A new system of devices for
conservative and minimally invasive
treatement of mitral regurgitation
The intertrigonal rigid
in a greater effective
arch is adapted to act
transvalvular area
as a spacer between
than conventional
the anterolateral
rings. Fitters and clips
trigone and the posare safely implanted
teromedial trigone foland removed by our
itral repair represents 50 lowing the coaptation
transcatheter delivery
% of mitral procedures in line of the anterior
system. The arch repwest countries. 20-30%
mitral leaflet. 2) a
resents an effective
of cases have a recurrence of
series of fitters and
support for fitters and
mitral regurgitation in the follow
clips (many sizes and
Philippe Caimmi clips implantation and
up. Hence a number of new gen- shapes are available)
it allows a more staeration rings are under study to
that can be implanted by a tranble and precise correction of recurimprove the durability of the mitral scatheter approach on the interrent regurgitations. Our system of
repairing. We present here a new trigonal arch at the origin of regur- devices is effective to treat mitral
system of devices for conservative gitant jets. In vitro and in vivo
regurgitation and recurrences after
and minimally invasive treatment
studies shown that new ring acts
annuloplasty and to avoid re-operof mitral regurgitation. The puran efficient annuloplasty without
ation for those complications.
poses of this innovation are: firstly affecting the 3D annular moveMore extensive experimental in
to improve the effectiveness of
ment and the complete opening of vivo series are mandatory to commitral repair without interfering
the anterior mitral leaflet, resulting plete the clinical transfer.
with the major physiology of the
mitral valve, secondly to allow a
minimally invasive correction of
recurrent regurgitation after annuloplasty, either introperatively or
postoperatively ( in the early or
late follow up). The system was
developed by the author at the
University of Eastern Piedmont. It
is composed by two new patented
devices: 1) a prosthesis for mitral
annuloplasty, comprising an annular structure, in which the annular
structure is composed of a flexible
support segment, adapted to be
fixed by suture along a posterior
portion of the mitral annulus
which extends from the anterolateral trigon to the posteromedial
trigone, and of an intertrigonal
rigid arch interconnecting the ends
The new system of devices for conservative and minimally invasive
of the flexible support segment.
treatment of mitral regurgitation
Philippe Primo Caimmi
University Hospital “Maggiore
della Carità” and
University of Eastern Piedmont
“A Avogadro”, Novara, Italy
M
A
CUTE’s mission is
to provide innovative thoracic solutions that improve the
quality of life for those in
need, by developing high
quality products with a
passion for problem solving, partnering with the
healthcare community,
empathizing with
patients, and delivering
outstanding service.
The RibLoc® Rib
Fracture Plating System is
indicated for flail chest,
multiple fractures, nonunion fractures and acute
pain. The plate’s unique
u-shape with locking
screw technology provides superior fixation by
stabilizing the rib on
three surfaces. The precise targeting and instrumentation provide
straightforward insertion
that reduces OR time
Stable Fixation:
The plate’s innovative
U-shape and locking
screws allow fixation to
be independent of
bone quality and/or
screw purchase in the
bone. The plate supports the fracture on
three surfaces and
avoids the neurovascular bundle on the inferior margin. This shorter U-shape construct
has shown to be biomechanically more stable when compared to
a longer anterior plate1.
Anterior plates require
bone purchase into the
weak membranous bone
for stability.
Smaller Incision
Sizes:
The plates in the RibLoc
system are 4.6cm, 6.1cm
and 7.6cm in length and
require four to six screws
for fixation. This reduces
the incision size necessary
and speeds up the procedure (about 5 minutes
per plate). Anterior plating requires much larger
incisions and many more
screws.
Straightforward,
Repeatable
Technique:
The plates are available in
four widths to match the
anterior/posterior thickness of the rib. Color
coding of the plates,
screws and instrumentation ensures that the correct length of screw is
used for the rib. The
innovative targeting
guides aid the surgeon
installing the plates in a
straightforward, precise
and repeatable manner.
All of these features were
carefully developed to
save OR time.
Reference
1 J. Rafe Sales, MD1, Thomas J.
Ellis, MD1, Joel Gillard, BS, Qi Liu,
MS, Joyce Chen, MD,Bruce Ham,
MD, FACS, & John C. Mayberry,
MD, FACS. Biomechanical Testing
of a Novel, Minimally Invasive Rib
Fracture Plating System. Journal
of Trauma 2008: 64(5) 1270-127
14 Saturday 11 September 2010 EACTS Daily News
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
Complementary devices for simple post-pump
optimization of aortic valve competency in valve
sparing operations for degenerative aortic disease
are attached. The upper end of the woven aortic graft is anastomosed to healthy distal aortic
tissue as usual. The woven aortic graft is then
trimmed to length and anastomosed to the
n conventional aortic valve sparing operabraided root graft.
tions diseased aortic and root tissue is
Finally a circumferentially compressible PTFE
excised. A short woven graft is trimmed to
approximate the shape the sinuses and sutured band containing a drawstring is placed around
to the aortic root/aortic valve remnants. A long the outside of the aortic root graft at the level
woven graft is then anastomosed to the distal of the sino-tubular junction and retained by
aorta and sewn to the root graft. The surgeon three equally spaced sutures that encircle the
band (Figures 1 & 2). The band is comprised of
must correctly judge the sinotubular diameter
expanded PTFE tubing (outside diameter
(STD). If the STD is oversized the aortic valve
will be regurgitant, likewise if the STD is
undersized leaflet buckling will result. Both
require correction.
In the new method two commentary new
devices allow easy STD adjustment under postbypass TEE to achieve optimum leaflet coaptation. The devices comprise a braided aortic root
graft1 and an adjustable diameter aortic band2.
The graft, having a 25mm inflow diameter, is
heat set to incorporate the three sinuses.
Above the STD the graft is outwardly flared to
32mm diameter. Due to the braided construction its STD is readily adjustable, unlike woven
or knitted grafts. Following excision of diseased
tissue of the sinuses of Valsalva and the aorta,
the braided aortic root graft is sewn in place
Figure 1: Cross-sectional view through aortic
and the aortic remnants of the valve leaflets are
root graft, aortic valve, adustable diametre
sewn to the graft. The two coronary buttons
band and ascendingaortic graft
John T M Wright
Genesee BioMedical, Denver, USA
I
the PTFE tube to form a circular loop. Further
tightening reduces the diameter of the STD as
shown comparing Figures 3 before contraction
and Figure 4 following contraction. Heart-Lung
bypass is terminated, and under TEE the drawstrings are adjusted to achieve near zero aortic
regurgitation. The drawstrings are then tied.
3.8mm, lumen 1.8mm about 90mmlong) that
These new devices have the potential to
is linearly compressible. A small orifice is locat- eliminate the need for additional surgical intered in the wall of the tube midway between its vention to correct defects of the repair, reduce
ends. The first end of a long size 2 braided
pump bypass time and to allow fine tuning of
Polyester suture is threaded through the midaortic valve leaflet coaptation, thus potentially
orifice with the help of a simple “U” shaped
improving operative results. The devices are
tool of 0.25mm diameter stainless steel wire) to currently under active development
exit at one end of the tube. The exiting first
References
1 US Provisional Patent Application 61/374,537, Wright John
end of the long suture is passed around the
T. M. “Braided Aortic Root Graft and Method of Valveaortic root graft and using the “U” tool second
Sparing”
end of the tube PTFE tube to emerge from the 2 US Patent Application Publication US 2010/0191254,
Wright John T. M. “Band Forming Apparatus”
orifice. Pulling on the two suture ends caused
John T M Wright
Figure 2: Cross-section plan view taken
along AA of Figure 1
Figure 3
Figure 4:
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
Minimally invasive mitral valved stent The CardioGard emboli
Georg Lutter, Saskia
Pokorny
University Hospital
Schleswig-Holstein, Kiel,
Germany
Lucian Lozonschi
University of Wisconsin
School of Medicine and
Public Health, Madison,
USA
P
ercutaneous mitral
valve repair techniques have been
developed in an
attempt to offer
patients less invasive
alternatives to the surgical repair of mitral
valve regurgitation. The
principal limitation with
current percutaneous
mitral valve repair techniques is the lack of
true approximation to
surgical approaches.
This invention is a selfexpanding, repositionable mitral valved stent
for replacement of the
mitral valve, preserving
the subvalvular mitral
valve apparatus. A minimal invasive trans-apical approach enables
the positioning of the
stent in the beating
heart, “off pump”.
Mitral valved stent
implantation has the
potential to achieve
post procedural results
similar to that of surgical repair or replacement. Avoiding the
need of an open chest
surgery and a cardiopulmonary bypass, mitral
valved stent implantation might furthermore
offer a possibility for
the treatment of multimorbid patients with
mitral regurgitation.
The new valved stent
has three components:
1) an atrial fixation system consisting of metal
Georg Lutter and Saskia Pokorny
springs; 2) a ventricular
body made of a nitinol
self-expanding stent
(Nitinol Devices &
Components, Fremont,
CA) that accommodates
a bioprosthetic heart
valve (diameter 25 to
32mm); and 3) a ventricular fixation system
comprised of four tethering strings (cords)
attached to body of the
stent and designed to
be anchored to the ventricular wall. To guarantee the sealing, minimize paravulvular leakage and to allow easier
repositioning, an ultrathin polytetrafluoroethylene (PTFE) membrane,
usually used for covered
stents (Zeus Inc.,
Orangeburg, South
Carolina, USA) is
sutured onto the atrial
springs and over the
ventricular component.
The valved stent is
inserted through the
apex of the heart, using
a self designed, flexible
catheter-based delivery
system. Thereto, the
valved stent is being
crimped onto the proximal portion of the
catheter delivery system
(proximal capsule). An
internal pusher allows a
smooth transition
between the tip and the
distal part of the proximal capsule. After insertion, the valved stent is
slowly released into the
heart, self-expanding
Fig.1: Atrial view
Fig. 2: Ventricular View
into its final shape
without the necessity
for a balloon dilatation.
The mitral valved
stent was implanted in
pigs of the `German or
American Landrace`
with a follow up time
of six hours up to 29
days to verify:
n The implantability
according to the
trans-apical technique
developed
n The haemodynamical
stability after implantation
n The stent function
and its’ position
n To determine mitral
regurgitation and
possible left ventricular outflow tract
obstruction
The scientific results
achieved have been
published. Short term
animal survival was possible by achievement of
effective mitral valved
stent anchoring and
functioning. No valved
stent embolization was
seen in any of the animals implanted. The
average mean transvalvular gradient across
the valved stent immediately after deployment,
at six hours and after
one week remained low.
The gradient across the
neighboring LVOT was
not affected. Further
refinements in the stent
construction and design
will be tested to assess
its’ durability.
The new mitral
valved stent can be
deployed in a reproducible manner to
achieve reliable stent
stability, minimal gradients across the LVOT
and adequate valved
stent function in shortterm follow up.
protection aortic cannula
Benny Dilmoney
CEO, CardioGard, Israel
plementary steps during the cardiac surgery.
Animal studies performed at Rambam Hospital,
Haifa, Israel, conducted by CardioGard’s medical
he CardioGard emboli protection cannula
director, Dr. Gil Bolotin, director of the cardiac
is a novel aortic cannula which provides
surgery department in Rambam Health Care
proper perfusion to the patient while
Campus, have confirmed the ease of use of the
removing gaseous and solid embolic matter
CardioGard embolic protection cannula.
which is the main cause of postoperative neuroComputational Fluid Dynamics (CFD) tests
logical complications of cardiac surgery.
were conducted in order to optimize the design.
Atheroembolism is a known risk in cardiac
The following parameters were examined:
surgery. An external manipvelocity field, shear
ulation on the aorta such as
stress, velocity magnitude
aortic cross clamping, parat a central cross section
tial occlusion clamping, canand trajectories of partinulation and the "sandcles released from the
blasting" effect release the
clamp region.
atherosclerotic material
In vitro trials were confrom the aortic intima. The
ducted on a silicone aorta
released embolic matter
model in order to assess
leads to neurological comthe efficiency of the
plications. 6.1% of the
CardioGard cannula in
patients undergoing corocapturing particles. These
nary artery bypass surgery
trials have shown remark(CABG) suffer from postopable results. The suction
erative neurological injury
feature of the cannula
where 3.1% of the patients
has captured more than
present predictors of stroke.
50% of the emboli at a
Currently there is no
suction rate of 0.5 [L/min]
simple-to-use cannula for
and approximately 90%
Figure 1: The CardioGard cannula of the emboli at a sucemboli removal during onpump procedures. The majorition rate of 1.5 [L/min].
ty of aortic cannulae used today provide perfuAdditional in-vitro experiments quantified the
sion to the patient's body without removing the CardioGard cannula back-pressure and pressure
emboli.
gradient. The results were similar to the comThe CardioGard emboli protection cannula is a monly used cannulae today.
24 French double lumen aortic cannula.
The CardioGard 24 French aortic cannula is in
Resembling conventional aortic cannulae, the
an ongoing regulatory process for achieving the
CardioGard cannula is used in conjunction with
CE mark and the CardioGard 22 French aortic
cardiopulmonary bypass (CPB) without altering
cannula is under development. Commercial
the surgical technique used with conventional
launch is planned for early 2011.
cannula. During the procedure, the CardioGard
cannula delivers oxygenated blood to the
patient and uses a patent pending suction feature in order to capture embolic matter.
The CardioGard cannula features a tip configuration which diffuses the flow through the primary designated outlet and aspirates blood
with gaseous and solid embolic matter back to
the CPB machine for filtration. The cannula's
unique aspiration lumen location changes the
flow within the aorta by adding reverse streamlines which guide the emboli towards the suction lumen inlet for removal from the patient's
circulatory system.
The CardioGard cannula does not require sup- Figure 2: Cannulation using the CardioGard Cannula
T
16 Saturday 11 September 2010 EACTS Daily News
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
Hybrid operating rooms:
Bringing 3D imaging into
the cardio-thoracic OR
Georg Nollert
Siemens, Germany
A
n increasing number of operating
rooms are being equipped with
high-end angiographic C-arms.
These so-called “hybrid ORs” (figure 1)
enable advanced imaging in 2D and CT-like
3D imaging (“syngo DynaCT”). In cardiothoracic surgery they prove to be especially
useful for transcatheter aortic valve implantations (“TAVI”).
The majority of aortic valve implantations
are still being done in open procedures
where imaging is not required. Current
developments, however, result in enormous
growth of TAVIs. Until recently TAVI procedures had only been supported by 2D imaging (fluoroscopy), which has limitations in
planning, finding the best projection, and
evaluating the results.
Our innovative syngo Aortic ValveGuide*
supports image-guided TAVIs by an automated process based on syngo DynaCT 3D
images. It supports planning, execution,
and evaluation of TAVIs to make them
quicker, safer and easier.
All the necessary steps can be done in
one single procedure in the hybrid OR
based on 2D and 3D imaging with the
angiographic C-arm. Leaving the sterile
area to use a workstation, or even a trans-
Figure 2: The C-arm acquires 3D images
by rotating around the patient.
The images are automatically
reconstructed, segmented and landmarks
and the ‘perpendicularity ring’ are
detected in less than 30 seconds.
Courtesy of German Heart Center Munich
Figure 3: By rotating the 3D image the
ring degenerates into a line once a
perfectly perpendicular projection with
the C-arm is achieved.
The 3D volume can be overlaid with live
fluoroscopy for further orientation and
device guidance.
Courtesy of German Heart Center Munich
image can then be rotated to achieve an
optimal perpendicular projection with the
C-arm. This is indicated by the ring degenerating into a line (figure 3). With the push
of a button, the C-arm moves into that
exact position. The software also allows for
Figure 1: Hybrid operating room at Rikshospitalet Oslo, equipped with the necessary measurements of the anatoSiemens’ Artis zeego angiographic C-arm my, e.g. maximum diameter of sinuses.
Courtesy of Rikshospitalet Oslo, Norway
During imaging the 3D syngo DynaCT
images can be overlaid onto live fluoroscopy
fer to radiology for a CT scan is no longer These images are sent to the workstation
for further device guidance (Figure 3). They
necessary.
and automatically reconstructed and segautomatically adapt to movements of the
mented in less than 30 seconds. The softtable, C-arm or zoom. It is also possible to
Automated processes for safe
ware automatically detects the relevant
change the image to a ‘contour view’, which
landmarks and marks them in color – the
displays only the contours of the aorta as
and easy valve implantations
At the beginning of the procedure 3D
coronary ostia and a “perpendicularity
well as the anatomic landmarks. This way
images are acquired with the C-arm rotatring”. This ring is 1cm below the hinge
the visibility of the live fluoro image is higher
ing around the patient for five seconds.
points of the aortic cusps (figure 2). The
than when overlaying the full 3D volume.
Benefitting the surgeon and
the patient
The new solution makes TAVIs more efficient because the imaging greatly facilitates
the positioning of the valve. It can help save
dose and contrast media in comparison to
conventional CT and consequently will be
safer for the user and the patient. And
most importantly, it saves time and manual
work by doing most of the steps fully automatically and much quicker than with existing conventional solutions.
*works in progress. This information
about this product is preliminary. The
product is under development and not
commercially available in the US, and its
future availability cannot be ensured.
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
Newly designed bar and stabilizer for the
minimally invasive repair of pectus carinatum
Mustafa Yüksel,
Marmara University
Hospital, Istanbul,
Turkey
A
modified
technique
of Nuss procedure for pectus
carinatum (PC)
repair was defined by Abramson,
mainly consisting of a presternally
placed metal bar compressing the
sternum, fixed on both sides of the
chest wall on metal plates. Having
been inspired by Abramson’s presentations in congresses and in
close collaboration with him, we
have been performing his minimally invasive procedure for pectus
carinatum repair since the beginning of 2006. In our first three PC
cases in 2006 and 2007, standard
bars and stabilizers for the Nuss
procedure were used presternally.
At the beginning of 2008, in search
of a higher degree of success and
stamina, a new bar and stabilizing
system for the minimally invasive
surgical correction of PC were
designed by us, to get a better
result in compressing the sternum
and stabilizing the bar on both
sides of the chest wall on the ribs.
Our newly designed bar and stabilizing system is made of 316L
steel (Tasarimmed Medical Devices
Manufacturing and Marketing Inc.,
Istanbul, Turkey). We have operated 35 patients between the ages
of 10 and 27, with this system in
the last three years, and the results
have been very satisfactory both
for the patients and us (Fig 1 a,b).
Our newly designed bar has a
diagonal edge on one side to fit
in the stabilizer with the same
manner and several notches on
the other side for the screw to
settle in and secure the bar at the
Figure 1 a,b: Preoperative and postoperative lateral views of a patient.
desired level. The stabilizers are
designed with a curve on both
sides to fit on the costae better
than the standard stabilizers. The
seat of the bar is designed with a
diagonal groove on one side and
one screw hole on the other side
to hold a stronger grip of the bar.
A patent application has been
made for this new system.
All operations were done by the
same surgeon (M.Y.), with the principles defined by Abramson. The
ribs for placement of the stabilizers are chosen and encircled subperiostally with steel wires. The
stabilizers are placed perpendicular
on the ribs and secured with the
steel wires. The appropriate size
bar is selected using templates and
then bent into a convex configuration as needed. Using clamps, a
subcutaneous tunnel is prepared
and a polyvinyl chloride tube with
a trocar is passed presternally from
one incision to the other. The trocar is removed from the lumen of
the tube, and the bar is inserted in
it with concavity facing posteriorly,
to withdraw it through the
presternal tunnel. Compressing the
bar over the sternum, both edges
are placed into the stabilizers at
appropriate level and secured with
one screw each on both sides. A
postoperative chest X-ray is
obtained to see the bar in place
and to look for pneumothorax (Fig
2 a,b).
Our newly designed bar and stabilizing system enables extra grip
with the fit-in diagonal groove on
one side and with the easy-toplace screw on the other, making
the bar almost impossible to disengage. In addition, it can be adjusted for the patient very precisely
with the use of its notches.
Together with the stabilizers, this
bar is a safe and easy-to-use prosthesis for minimally invasive surgical correction of PC deformities.
Figure 2 a,b: Postoperative posteroanterior and lateral X-rays of a patient.
Clinical use of Transcutaneous Active banding
to balance flows during Bi-Ventricular support
with two rotary LVADs
Arnt Fiane
Oslo University Hospital, Norway
M
echanical circulatory
support has proven to
be an effective therapy
to treat end stage heart failure
patients. Whilst most patients
require left ventricular support,
up to 40% also require additional right ventricular support.
Due to the lack of a clinically
available implantable rotary
RVAD, two rotary LVADs are
being considered for treatment
of end stage bi-ventricular heart
failure. This approach requires
an alteration in right pump performance to produce suitable
haemodynamics for the pulmonary circulation.
The current solution, pioneered by Professor Roland
Hetzer of the Berlin Heart
Centre, relies on the use of conventional graft banding techniques during the surgical procedure to reduce the diameter of a
Heartware HVAD ventricular
assist device outflow graft to
5mm, in order to reduce the
outflow pressure to that required
of the pulmonary circulation.
However, this diameter may
be unsuitable for all patients
and thus multiple reoperations
would be required to re-band
the graft to obtain suitable
hemodynamics. Additionally,
pulmonary hemodynamics have
been found to be extremely sensitive to this diameter. Finally,
Caption
changes in physiologic state may
necessitate further banding
changes to match vascular
resistances.
To address the limitations of
the current technique, Fiane
used the FloWatch PAB (pulmonary artery banding) system
to actively and transcutaneously
alter the right outflow graft
diameter from the bedside following surgery, and thus produce optimal hemodynamics in
patients implanted with two
HVAD devices configured to
treat BiVentricular failure.
The novelty of Dr Fiane’s
innovation relates to the combination of previously unrelated
medical device technologies
used in different clinical therapies, in order to solve a developing clinical problem, which will
directly translate to reduced reoperations and thus improve
patient outcomes.
This innovative application of
technologies has been recently
submitted for consideration for
an oral presentation at the
annual International Society for
Rotary Blood Pumps (IRSBP) in
October, 2010, whilst the practical result is demonstrated by the
improved haemodynamics
observed in the first ever patient
implanted with the device combination in May 2010.
Caption
Caption
EACTS Daily News Saturday 11 September 2010 17
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
PHOENIX combines tissue stimulation and bone marrow cell therapy
Jeff Kasalko
Principal Engineer, Cardiogenesis Corp., CA, USA
C
oronary artery disease (CAD) is a manifestation
of atherosclerosis which often results in patients
suffering from angina, myocardial infarction,
congestive heart failure and ultimately death. Currently
available options for treating CAD include lifestyle
changes in conjunction with drug therapy, percutaneous coronary intervention (PCI) including techniques
such as stent placement, and coronary artery bypass
graft surgery (CABG). The objective of each of these
approaches is to improve blood flow to the heart and
prevent the complications related to myocardial
ischaemia.
Unfortunately an increasing number of patients
have exhausted surgical or percutaneous options and
continue to have severe angina despite maximal medical therapy. These patients are characterized by moderately compromised ejection fractions, triple vessel
coronary artery disease and a history of failed prior
interventions, including previous bypass surgery. The
hallmark of this patient population is the presence of
diffuse coronary artery disease which makes traditional
surgical and percutaneous treatment options alone less
likely to provide optimal, durable results.
Transmyocardial revascularization (TMR) is an
approved surgical procedure to treat refractory angina
patients with advanced CAD in which 1mm transmural
laser channels are created in ischemic myocardium
which cannot be conventionally revascularized due to
diffuse CAD or small vessel disease. TMR provides
Figure 2. Sequence of delivery of laser energy and therapeutic material
Figure 1. PHOENIX Handpiece Delivery System
durable angina relief and has been shown to improve
exercise toleranace1 and a long-term survival benefit
compared to medical management2. The therapy has
been utilized in over 40,000 patients in the treatment
of severe angina symptoms.
The mechanisms of TMR have been shown to be
multi-factorial. The denervation from the laser energy
provides acute effects, with the angiogenic response
resulting from the local and systemic wound healing
process providing longer term effects3. Cardiogenesis
has developed an advanced delivery system
(PHOENIX™) to combine the laser tissue stimulation
and the delivery of autologous bone marrow cells. This
combination treatment is theorized to increase the
angiogenic effect achieved with TMR to improve
patient outcomes.4 Early experience with the PHOENIX
utilizing autologous bone marrow cells has been
encouraging.5 The results of the STAR-heart study of
bone marrow derived cells in the treatment of ischemic
cardiomyopathy demonstrates the potential of bone
marrow cells to enhance hemodynamic performance,
exercise tolerance and long term survival.6
The PHOENIX handpiece is the first device specifically designed to allow physician-directed injections of
biologic or pharmacologic agents to pre-determined
areas of myocardium with reversible ischemia in conjunction with delivery of TMR therapy. The PHOENIX is
designed for use with the Cardiogenesis Ho:YAG TMR
laser console. Laser energy is delivered to the
myocardium through the fiberoptic component of the
handpiece. The fiberoptic consists of 37 fibers, 100 µm
References
1 Burkhoff D, Schmidt S, Schulman SP, et al.
Transmyocardial laser revascularization compared with continued medical therapy for
treatment of refractory angina pectoris: a
prospective randomised trial. Lancet. 1999
Sep 11;354(9182):885-90.
2 Allen KB, Dowling RD, Angell WW, et al.
Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial. Ann Thorac Surg. 2004
in diameter with an overall diameter of approximately
1mm. Immediately after channel creation, three needles are advanced distally into the surrounding tissue
for fluid delivery. Three injection needles are incorporated within the distal guide shaft, surrounding the
fiberoptic bundle at the distal-most tip. Proximal to the
handle is an injection port to permit introduction of
the fluid.
An Investigative Device Exemption has been submitted for combining laser stimulation and bone marrow
derived cells using the PHOENIX delivery system. A
multi-center randomized trial of the combination therapy is pending.
Apr;77(4):1228-34.
3 Atluri P, Panlilio CM, Liao GP, et al.
Transmyocardial Revascularization to
Enhance Myocardial Vasculogenesis and
Hemodynamic Function. J Thorac Cardiovasc
Surg 2008;135:283-291
4 Patel AN, Spadiccio C, Kuzman M, Park E,
Fischer DW, Stice SL, Mullangi C, Toma C.
Improved cell survival in infarcted myocardium using a novel combination transmyocardial laser and cell delivery system. Cell Trans
2007;16;899-905.
5 Reyes G, Allen KB, Aguado B, Duarte J. Bone
marrow laser revascularisation for treating
refractory angina due to diffuse coronary
heart disease. Eur J Cardiothorac Surg 2009
32:192-194.
6 Strauer BE, Yousef M, Schannwell CM, et al.
The Acute and Long-Term Effects of
Intracoronary Stem Cell Transplantation in 191
Patients with Chronic Heart Failure: The STARheart Study. Eur J Heart Fail.2010 12;721-729.
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
metrical disproportion of the aortico-mitral annulus.
n No murmur in valve prosthesis
n No need for anticoagulant theraum from which other biologic
py
he Replacement
valve prosthesis are made
n Potential to be used in patients
Aortic Valve
n Separate leaflets may be used
with endocarditis
Leaflets is techaccording to the native dimenn Potential usage for patients with
nique for replacing
sion of the valve
previous implanted prosthesis
one or more diseased
n In vitro results,confirmed with ini- n Potential use in patients who are
or dysfunctional
tial clinical results showed prowith physically active way of leavleaflets in an aortic
portional increasing of haemodying
heart valve.These
namic parameters(CO,mean flow n Low cost
unique leaflets are
rate,systolic pressure gradient) as n Potential to be implanted using
attached directly onto a patient’s
in normal valve.
mechanical device (staplers technative aortic ring to provide good
n Adequate increasing of aortic
nique)
haemodynamic performance withvalve area and cardiac output
n In case of need for re-operation,it
out familiar negative incumbencies
during physical stress (confirmed
is possible to implant percutaassociated with artificial aortic
by dobutamin stress echo results)
neous aortic valve,or if it is pervalves.This real stentless aortic valve
n Decreases aorta wall stress shearformed classic transthoracic way
bioprosthesis ensures haemodynamFigure 1: Schematic view
Figure 2: In vivo ultrasound measurments
ing,no (or low) transvalvular presit is easy to explant the valve and
ic improvement with a normal
sure gradients in patients
to implant new prosthesis
transvalvular gradient in patients.It
Features and benefits
n Insures haemodynamic improven Potential for implantation in the
can even be successfully implanted
um (72 pts.) and replacing valve
tance is measured between two
ment,no signs for stenosis
pulmonary artery position
in children,patients with a small
cusps on the aortic fibrous ring of
commisuraes and leaflet is created
replacement aortic valve
n Adequate for usage even in
Research indicates there are no
root or bicuspid valve.
the patient. This innovative aortic
in a semicircular shape.In such con- leaflets
patients with small root or bicus- products on the market comparable
The Replacement Aortic Valve
valve is called really stentless,
figurations the three elements con- n Is close to native aortic valve
morphology
pid aorta valve
in design or function to the
Leaflets was in vitro tested in
because the newly created leaflets
tact and overlap in closed valve simn Real stentless valve,no
n Easy for implantation in patients
Replacement Aortic Valve Leaflets.
Laboatory for biofluidmechanic at
are directly sutured onto the
ilar to the closing of a native heart
ring,leaflets are directly sutured
with an aortico-mitral
Basic parameters
Humbold niversity,Charitee Campus patient’s native aortic ring. This
aortic valve. This allows the surgeon
to the aortic annulus
disease,when surgeon has to
SPG=14 ± 3.5
Virchow,Berlin.In clinical practice we valve was created from the same
to replace the aortic leaflets sepan Easy and simple implantation
change both valves mitral and
SV=64 ± 9.5
performed on 113 patients, using
pericardium which other biologic
rately, creating new comissuraes.
n Created from the same pericardiaortic one.There will be no geoSF =78 ± 9.8
bovine (41 pts.) or equine pericardi- valve prosthesis are made.The disZan Mitrev
Special Hospital for Surgery Fillip II
Skopje, Macedonia
Replacement aortic valve leaflets
T
Figure 3: Suturing of the second new created leaflet
Figure 4: Suturing of the last leaflet
Figure 8: I stadium / recovery, Dobutamin stress echo – graphic view of the measurments
Figure 5: Newly created valve
Figure 6: Preoperative
(severe Ao valve stenosis)
Figure 7: Postoperative. Implanted
real stentless Ao valve EAO-3.6cm2
18 Saturday 11 September 2010 EACTS Daily News
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
StriCS: A Continuous Cardiac
Metabolic Monitoring System
Jan Liska
Karolinska University Hospital,
Stockholm, Sweden
T
he StriCS system, is a
novel diagnostic device
for peri- and postoperative cardiac metabolic monitoring developed by cardiothoracic surgeons at the
Jan Liska
Karolinska Institutet. The system comprises of a microdialysis catheter placed into the Coronary Sinus (CS) via
percutaneous insertion, and a sensor module and a
monitor, which provide real-time and continuous
measurements of metabolic markers such as lactate,
glucose and pyruvate inside the CS (Figures 1, 2). The
system gives an indication of ischemic events and thus
enables early intervention.
Peri- and postoperative myocardial infarction is one
of the most serious complications in connection with
cardiac surgery, especially following coronary artery
bypass grafting, and is a major cause of morbidity and
mortality1. Incidence rates vary from 3% to 21%2.
Early detection of peri- and postoperative ischemia
and upcoming infarction is essential for effective salvage treatment. Existing methods for detection, such
as echocardiography, ECG, and cardiac-specific
enzymes, all have significant limitations due to the
underlying cardiac disease state and operative trauma.
The present invention is based on the technology of
microdialysis which is a method widely accepted in
pre-clinical research and to some lesser degree used
clinically in neuro trauma patients, with more than
13,000 publications in the literature.
The present inventive step consists of the development of a technology for microdialysis of blood
(intravascular) compared to the previously well recognized method of tissue microdialysis.
Porcine and clinical studies have shown that
intravascular and tissue microdialysis are detecting
ongoing or new ischemia faster and more reliably than
other standard monitoring tools3,4,5.
The present technology is under clinical investigation
in several ongoing studies with more than 150 patients
enrolled, preliminary data confirm preclinical studies.
The catheter is positioned into the CS through percutaneous insertion via the right internal jugular vein
with the guidance of trans-esophageal echo. The
insertion initially requires some skilled and experienced person for displaying the CS on the echo, but
then the catheter is quite easy manoeuvred into position. The learning curve is short once understanding
the technique.
At the distal end of the catheter there is a soft tip
to avoid tissue damage, and also a small Iridium
band to further enhance the echo contrast and position, it also serves as a marker for displaying postoperative X-ray position.
The system and technique also allows for metabolic
monitoring of venous outflow from other vital endorgans of importance related to cardiac surgery, such
as the brain, kidney and liver, however no clinical studies have yet been performed on this indication.
Parallel to the development of the StriCS system, a
system for continuous real-time glucose monitoring as
well has been developed; the Eirus system. Eirus is
based on the same technology as for the StriCS system, except that the catheter is modified for the placement in the superior vena cava.
In 2001 Van den Berghe et al6 showed a reduction
of the in-hospital mortality in critically ill patients by
34% by maintaining blood glucose values between
4.4 and 6.1mmol/l with the use of intensive insulin
therapy (IIT). In particular cardiac surgery patients benefited from IIT with a reduction of mortality by 59%.
However, doubt about IIT has since then been raised
due to the increased risk for hypoglycaemia and the
difficulties of accurately and repeatedly analyzing
blood glucose samples. Eirus aims to overcome these
Figure 2
Figure 1
difficulties by being easy to use and provide accurate
measurements in the ICU setting. Clinical evaluation of
the Eirus system in 50 patients subjected to cardiac
surgery was performed at the Karolinska University
Hospital, Stockholm, Sweden. Preliminary data show
an extremely good correlation to blood gas values
(n=1124) and from a clinical and interventional perspective well within the safety demands of international standards (Figure 3).
In conclusion the novel technique of intravascular
microdialysis applied in StriCSTM and EirusTM systems (www.microdialysis.se) have the potential of
considerably reducing mortality and morbidity in
patients subjected to cardiac surgery, as well as in
other critically ill patients, by continuous metabolic
Figure 3
monitoring in the CS, and continuous real-time
measurements of central venous blood glucose
respectively, without blood sampling.
References
to the diagnosis of perioperative myocardial
1 John C. Chen, Padma Kaul, Jerrold H. Levy,
infarction and various complications of carAxel Haverich, Philippe Menasché, Peter K.
diac surgery. Crit Care Med. 2001
Smith, Michel Carrier, Edward D. Verrier,
;29(10):1880-6.
Frans Van de Werf, MD, Russel Burge, Paul
3 Bäckström T, Lockowandt U, Liska J, Sylven
Finnegan, Daniel B. Mark, Stanton K.
C, Franco-Cereceda A. Monitoring of
Shernan, MD; for the PRIMO-CABG
porcine myocardial ischemia and reperfusion
Investigators. Myocardial infarction followby intravascular microdialysis. Scand
ing coronary artery bypass graft surgery
Cardiovasc J 2002; 36: 27-34
increases healthcare resource utilization. Crit 4 Bäckström T and Franco-Cereceda A.
Care Med. 2007; 35(5): 1296-1301.
Intravasal microdialysis is superior to
2 Benoit MO, Paris M, Silleran J, Fiemeyer A,
intramyocardial microdialysis in detecting
Moatti N. Cardiac troponin I: its contribution
local ischaemia in experimental porcine
myocardial infarction. Acta Physiol Scand
2004; 180: 5–12
5 Pöling J, Rees W, Klaus S, Bahlmann L,
Hübner N, Mantovani V, Warnecke H.
Myocardial metabolic monitoring with the
microdialysis technique during and after
open heart surgery. Acta Anaesthesiologica
Scandinavica 2007; 51: 341-346
6 Van den Berghe G, Wouters P, Weekers F,
Verwaest C, Bruyninckx F, Schetz M,
Vlasselaers D, Ferdinande P, Lauwers P,
Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med
2001;345:1359-67.
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
Real-time assessment of both the anatomic and functional results of CABG: SPY-QC
and peak fluorescence intensity and
myocardial perfusion.3 By comparing the
post-grafting (graft + native perfusion) to
the pre-grafting (native perfusion only)
t is now recognized that both anatomic
image data, the change in regional myocar(angiographic) and functional (antidial perfusion that results from the bypass
ischemic) components of revascularization
graft can be quantified. Thus, the SPY-QC
are important. The assessment of myocarfunctional analysis complements the angiodial perfusion to document the antigraphic visual assessment of the epicardial
ischemic effect of bypass grafting is thus
coronary, graft and anastomotic integrity
important and timely. Measurement of both
from fluorescence angiography.
Bruce Ferguson and Cheng Chen
the visual, angiographic characteristics of
The SPY ICFVA data acquisition and
grafts and the change in myocardial perfuautomated SPY-QC analysis is completed
sion as a consequence of grafting address- Intraoperative Coronary Vascular
within the normal work flow of either
es both of these key revascularization com- Fluorescence Angiography (ICVFA) System
OPCAB or on-pump CABG procedures. The
ponents. Quantifying the graft’s impact on
(Novadaq Technologies, Inc., Toronto,
SPY-QC display includes a time-synchroregional myocardial perfusion provides key
Ontario, Canada). This technique has been nized ‘contact sheet’ of pre- and post-graftnew information about graft integrity, its
in use worldwide since 2005 (Figure 1) to
ing images for visual comparison (Figure 2).
longevity potential and the overall function- validate the angiographic quality of bypass The raw ICFVA infrared image data are
al (anti-ischemic) consequence of the CABG grafts in CABG.1,2
converted to a color (1 = blue, 255 = red)
The ICFVA data (34-sec fluorescence
procedure.
scale for better visualization and analysis
angiographic image loops) can be separat- fidelity. The quantitative SPY-QC display is a
The SPY-QC image analysis software is
ed into three distinct components (arterial, movie that illustrates: 1) the peak intensitydesigned to quantitatively assess perfusion
microvascular, and venous phases).
in the region of myocardium supplied by
synchronization of the two image loops; 2
the bypassed epicardial coronary vessel. It is Experimental data have confirmed a linear
and 3) the colorized, intensity- and timecorrelation between fluorescence intensity
an adjunct and supplement to the SPY
synchronized, pre-graft and post-graft
Cheng Chen and T Bruce Ferguson Jr
East Carolina Heart Institute,
Greenville, USA
I
image loops that play simultaneously for
Identifying these factors at surgery will
visual comparison; and 4) the revascularizaallow them to be linked to short- and
tion-induced change in myocardial perfulong-term graft patency, functional, and
sion (RICMP), illustrated by the green line in
mortality issues;
the upper right of the display, that accumu- 3 Both anatomic (angiographic) and funclates during the arterial and microvascular
tional (anti-ischemic) components of
phases; this change is indexed to the baserevascularization can be simultaneously
line perfusion measured in the pre-graft
evaluated with SPY ICFVA and SPY-QC
sequence (Figure 3).
technologies to assess CABG quality in
SPY-QC, now in Beta-testing internationreal-time, in a cost-effective manner with
ally in over 200 patients, potentially
minimal patient risk.
changes the dynamic of surgical revascular- References
1. Desai ND, Miwa S, Kodama D, et al. Improving the
ization by revealing multiple new aspects
quality of coronary bypass surgery with intraoperative
about CABG in real time:
angiography: vaildation of a new technique. J Am Coll
Cardiol 2005; 46:1521-5.
1 Quantifying the measurement of perfu2. Waseda K, Ako J, Hasegawa T, Shimada Y, Ikeno F,
sion at CABG gives insight into the
Ishikawa T, Demura Y, Hatada K, Yock PG, Honda Y,
dynamic between anatomic and funcFitzgerald PJ, Takahashi M: Intraoperative Fluorescence
Imaging System for On-Site Assessment of Off-Pump
tional (anti-ischemic) benefits of revascuCoronary Artery Bypass Graft.
larization;
3. Detter C, Wipper S, Russ D, Iffland A, Burdorf L, Thein
2 SPY ICVFA and SPY-QC, in providing a
E, Wegscheider K, Reichenspurner, Reichart B:
Flurorescent Cardiac Imaging: A Novel Intraoperative
platform for both pre- and post-grafting
Method for Quantitative Assessment of Myocardial
assessment, can identify both competiPerfusion During Graded Coronary Artery Stenosis.
tive flow and collateral flow circumCirculation 2007; 116:1007-14.
4. Ferguson TB Jr, Chen C, Dullum M, Davis Z,
stances. Moreover, these technologies
Kantamneni V, Ramchandani M, Poa L: Intra-operative
create the opportunity for a physiologic
Angiography in CABG as a Quality Metric: The Victoria
Registry. Circulation (in press).
evaluation of the results of grafting.
Figure 1: SPY ICFVA angiogram
(above) of LITA to LAD graft, with
(below) POD 7 angiogram.
Figure 2: Time-synchronized comparing Pre-grafting injection sequence (top) with postgrafting injection sequence (bottom). Visually compare panel H, top and bottom.
Figure 3: Final frame of the movie loop that displays and quantified the difference in
regional myocardial perfusion as a result of bypass grafting to the LAD.
20 Saturday 11 September 2010 EACTS Daily News
Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010 • Techno College Award Nominee 2010
Vettath’s Anastamotic Obturator (VAO) –
a proximal anastamosis enabling device
Vettath’s Anastomotic Obturator
that the needle passes through the aortic
wall, goes into the groove of the obturator,
This metallic instrument is made of solid
and comes out between the aorta and the
steel. It is 18cm in length and comes in
small and medium sizes, 5mm and 6mm in metal, thus taking the intima. The sutures
diameter, respectively. The inserting end has
he use of side clamp to perform the
top end of a saphenous vein graft dur- a ridge 2.5cm from the end of the VAO.
ing OPCAB still remains an Achilles heel This ridge projects perpendicularly like a
in patients with atheromatous aorta. In spite shelf 2mm from the steel rod. There are
of avoiding the pump, it has been noted that three grooves in the inserting end. The shelf
helps prevent blood from spurting directly
when the aorta is side clamped the risk of
neurological deficit is significant in atheroma- into the eye. The grooves allow the needle
to pass through the rod and thereby include
tous aorta. Hence we had devised this simple, cost effective reproducible and reusable the aortic intima in the suture.
device which enables the surgeon to perform
Surgical Technique
the proximal anastamosis without the side
The aortic site proposed for anastomosis is
clamp. With the use of the device two or
marked with diathermy. Two 3.0 polypropythree top end have been performed. The
technique is published before and the video lene purse-string sutures are applied 1cm
is available on the net. The extended use of apart from the site. The aorta is stabbed with
this VAO enable the surgeon to perform the a no. 11 blade knife, followed by a 4mm
anastamosis in redo CABGs also. As the top aortic punch for the VAO. The punch hole is
blocked with the left index finger. The purse
end of the occluded vein graft is usually
devoid of the atheromatous plaque, this part strings are tightened to prevent bleeding.
Once the obturator is in and the snare is
could be used to anastamose the new vein
tightened the proximal vein anastomosis is
graft on to the aorta. Also in case of AVR
and CABG, where a side clamp is difficult to performed as usual with 5.0 polypropylene
suture. The sutures in the vein have to be
apply, again this VAO could be utilized.
Hence this could remain a useful tool in the inside out, and in the aorta, they have to be
outside in. The aortic sutures are placed so
hands of the cardiac surgeon.
Murali Vettath
Malabar Institute of Mediacal Sciences Ltd.,
Kozhikode, India
are placed all around the aortic punch hole
and are loosely held. Once the suturing is
complete, the obturator is removed, and the
left index finger is positioned on the aortic
punch hole to prevent bleeding. The loose
sutures are pulled and tightened with a
nerve hook. The two ends of the sutures are
held firmly with controlled traction by the
assistant during this procedure. Once all of
the sutures are in place, the two ends are
tied snugly. The two snares on the purse
string are removed, and they are tied in place
with care, to avoid a purse string effect. The
vein is then deaired, and hemostasis is
attained.
We have performed more than 500
such anastamosis and re- angio done on
many of them have shown excellent
patency. We have had no stroke in these
patients as well.
T
Next-Gen TAVI
More precise and elegantly simple technology
could mean greater safety and improved
outcomes for heart valve patients
JenaValve Technology has completed FIM
procedures for its transapical platform and is in
product development for its transfemoral
platform
Ronald Trahan
T
ranscatheter Aortic Valve
Implantation – TAVI – emerged
in 2002 and has become an
established therapeutic alternative to
surgical aortic valve replacement
(SAVR) for high-risk patients suffering
from aortic heart valve stenosis. For
example, at EuroPCR 2010 (May
2010), one-year follow-up data from
the European SOURCE registry were
reported. Among 1,038 patients
implanted with the Edwards SAPIEN®
prosthesis via TAVI, overall survival
was 76.1%–81.1% among those
“JenaValve’s next
treated transfemorally and 72.1%
generation of TAVI systems
among those treated transapically.
are designed to enable a
Indeed, TAVI is considered a “hot”
physician to advance,
medtech sector, with more than
rotate, reposition or retract
10,000 patients worldwide having
our unique, patentbeen successfully treated via non-surprotected feelers as
gical TAVI. However, it is now clear
that while the dexterity, skill and expe- necessary, leading to correct
and precise placement of
rience of a heart surgeon or cardioloour prosthesis.”
gist is critically important to the successful outcome of TAVI, equally and Helmut J. Straubinger, Chief
Executive Officer, JenaValve
acutely vital are the design and features of the TAVI system being used.
“Anatomically correct and precise placement of a prosthetic valve
into a patient annulus is the key to TAVI’s success and safety. A critical mass of published data confirm that TAVI, performed transapically or transfemorally, is effective,” says Helmut J. Straubinger, CEO,
JenaValve Technology. “The question now is, ‘Can we make TAVI
safer?’”
Nonetheless, the worldwide heart valve market was approximately
$1.5 billion in 2008, according to Millenium Research, growing at a
3–5% annual rate as a result of an increasing elderly population.
The TAVI market sector is currently dominated by two multinational
companies – Edwards Lifesciences and Medtronic/CoreValve. While
TAVI systems have received European regulatory approval (CE Mark),
TAVI is not yet approved by the FDA for sale in the United States.
“We believe JenaValve is positioned strongly in the TAVI market
and look forward to European approval in early 2011 of our
transapical TAVI system,” says Straubinger. “One of our competitive
advantages is that we employ biological valves – designed for durability – in both our transapical and transfemoral TAVI systems. We
also believe that our systems are designed to be simpler and more
precise for use by surgeons and cardiologists. No doubt, 2010 is our
breakout year.”
Clockwise from above: Murali Vettath;
Two 3.0 polypropylene purse-string sutures are applied 1cm apart from the site;
Close up of the groove on the Vettath's Anastamotic Obturator
Raising standards through education and training
25
th
Annual
Meeting
1–5 October 2011
Lisbon, Portugal
For information please contact:
EACTS Executive Secretariat
3 Park Street, Windsor
Berkshire SL4 1LU, UK
Telephone: +44 (0) 1753 832166
Fax: +44 (0)1753 620407
Email: info@eacts.org
Website: www.eacts.org
22 Saturday 11 September 2010 EACTS Daily News
Dendrite hosts largest
AF registry to date
D
endrite Clinical Systems is delighted to
announce that its unique clinical and specialist database software, is hosting the
largest global disease registry involving 55,000
atrial fibrillation patients. The GARFIELD (Global
Anticoagulant Registry in the Field) Registry, an
innovative research initiative to understand the
burden of atrial fibrillation (AF) on a global scale.
The Registry will eventually enrol 55,000 patients.
The web-based registry, hosted by Dendrite
Clinical Systems, is the first real attempt to quantify the global burden of AF, as well as to provide
insights into how advances in both anticoagulation and AF management can best be used to
reduce the impact of this disease on patients and
on healthcare systems worldwide. At each site,
consecutive newly-diagnosed patients will be
entered into the Registry to avoid any potential
bias. All entered patients will be newly diagnosed with AF and have at least one additional
risk factor for stroke. Patients will be included
whether or not they receive anti-coagulant therapy so the real-world effectiveness of current
treatment strategies and the burden of current
treatment failure can be properly understood.
“The largest study of its kind to date, and
involving unselected patients in randomly identified sites in up to 50 countries around the world,
GARFIELD is unique in focusing on identifying
real life outcomes,” said Professor Ajay Kakkar
Director of the Thrombosis Research Institute
(TRI) and Professor of Surgical Sciences at Queen
Mary University of London.
In August 2009, the TRI an affiliated institute of
Queen Mary University of London, announced
the launch of the Registry, an innovative research
initiative to understand the burden of atrial fibrillation (AF) on a global scale. The Registry is
prospectively following 50,000 patients newlydiagnosed with AF who are also candidates for
anticoagulant therapy to prevent thrombosis
leading to stroke over a six-year period.
GARFIELD is launching in 32 countries in the
Americas, Eastern and Western Europe, Asia,
Africa and Australia, but will ultimately follow
patients from 1,000 centres in 50 countries.
Developed by Dendrite, the online registry is
now available in eleven languages (Chinese,
Dutch, English, French, German, Italian, Japanese,
Korean, Polish, Portuguese, and Spanish), and has
several unique software adjustments, which integrated the baseline record with four monthly follow up. Therefore, the database has been split
into three separate components to accommodate
the registry design:
n Baseline record: To record the patient’s condition when they were first diagnosed with AF.
n Follow-up events: To record the patient’s condition, as it changes during the course of the two
years the patient is monitored. Changes in the
patient’s condition can be recorded daily, if
necessary, as each new record is dated.
n Follow-up records: To sign off the data entered
for each four monthly interval. If there is no
change in the patient’s condition, the ‘sign off’
indicates that the patient records has been
reviewed and the lack of any follow-up events
is correct (INR testing regime and results are
recorded here).
For the retrospective cohort it is also necessary to
“sign off” the retrospective component of the
patient monitoring. This is the time between the
original diagnosis and the time the patient joined
the study. This time period can be anything
between six month and two years. The patient
records change colour as each follow-up interval
approaches, and is signed off. For example, the
follow up record becomes orange when a followup record is due within the next ten days, and red
National and International database reports
The fourth VERITY report was
published in 2007 and
documents the diagnosis and
treatment of 12,500 cases of
venous thromboembolism
from 56,000 patient entries.
Published in conjunction with
the European Society for
Vascular Surgery, the report
contains the records of
33,000 patients with
abdominal aortic aneurysms
in six countries from a tenyear period. A second
VASCUNET Report was
published in 2008.
when the follow-up
record is late. In addition, the GARFIELD
training portal has training videos to show you
how to log onto the
registry and enter a
patient record, and
there is a training database for you to try out
the registry for yourself.
“We hope Garfield
will allow us to identify
persisting unmet needs
Ajay Kakkar
and to quantify the reallife clinical and economic
value of current and future treatment options in
stroke prevention,” said Dr Peter Walton,
Managing Director, Dendrite Clinical Systems. “The
design and development of the GARFIELD Registry
has proved a long process. Not only has the
Registry been translated into different languages,
but also we have had to take into account the
unique datasets and various care settings in each
country and adapt our software accordingly. We
believe this registry showcases the inherent flexibility of our software, which can be applied in
almost any imaginable clinical scenario.”
The GARFIELD Registry has been made possible
through a research grant from Bayer Schering
Pharma.
Single-centre reports
Published in September 2010
under the auspices of the
European Society for CardioThoracic Surgery, the latest
installment will record in
excess of 1,000,000 patient
entries, from some 366
hospitals in 29 countries.
Published in conjunction with
the British Society for
Interventional Radiology, the
Registry of Oesophageal
Stenting reports on some 400
patient cases from 17 centres
in the UK.
The latest report released in
July 2008 documents over
400,000 operations and is
the most comprehensive selfaudit ever undertaken by a
single medical specialty.
The Centre published its
eighth consecutive annual
clinical audit on surgical
activity. The report included
data on over 13,500 patients
over a ten-year period
(1997–2006) that underwent
cardiac and vascular surgery.
The Centre published its
eighth consecutive annual
clinical audit on surgical
activity. The report included
data on over 13,500 patients
over a ten-year period
(1997–2006) that underwent
cardiac and vascular surgery.
This annual report was first
published in 2007 and has
evolved to reporting both the
hospital’s own ‘risk-adjusted’
data and ‘observed’ vs.
‘expected’ outcomes.
To buy your copy of ‘Fourth EACTS Adult Cardiac Surgery Database Report’ (ISBN 1-903968-26-7)
Please visit Dendrite Clinical Systems on Booth 1330
Dear EACTS Delegate,
“The data presented in this current
report are overwhelming, and the
level of analysis and presentation is
outstanding, and a credit to all the
surgeons, hospitals and professional
societies who have contributed data.”
In conjunction with the European Association for Cardio-Thoracic Surgery (EACTS),
Dendrite Clinical Systems is delighted to announce the release of the Fourth
EACTS Adult Cardiac Surgery Database Report’. The 420-page comprehensive
report documents over one million patient records from 366 hospitals across 29
countries.
This unique publication includes analyses of patient characteristics, the type of
surgery, operative risk factors and post-operative outcomes including in-hospital
mortality and length-of-stay. In addition, analysed pooled data shows overall
trends over time and compares the incidence of risk factors and outcomes
between countries. These analyses are set against data on populations, health
status and economic statistics from the World Health Organisation.
Pascal Vouhé, President EACTS
“The EACTS Adult Cardiac Surgical
Database is a kind of enormous
observational study that offers a
wealth of information about the
common conditions that allow for a
definition of optimum management.”
Highlights include:
The overall the proportion of isolated coronary artery bypass graft (CABG)
surgery has decreased over time from 69.4% in 1999 to 51.6% in 2008.
n Marked variations between countries in the proportion of isolated coronary
artery bypass surgery, isolated valve and combined valve and CABG surgery.
n Significant variations in the incidence of female gender between countries,
Spec
whilst overall the proportion of female patients in the database has increased
EACTS ial
n Mortality rates for women are significantly higher (p<0.001) than for men.
price
n Overall in-hospital mortality rates for isolated CABG surgery; isolated valve surgery; and for
combined CABG and valve surgery.
n The average age of patients coming to coronary surgery ranges from 58 years up to 67 years
between countries.
n The overall mortality for patients under 56 years of age undergoing CABG surgery is 0.9% and 6.7% for those over 80.
n Large increases in the proportion of patients undergoing biological rather than mechanical aortic valve implantation from
60.5% to 77.7% for isolated AV surgery and from 68.5% up to 86.5% for combined AV and CABG surgery.
n The mortality for mitral repair is significantly lower than for replacement (2.1% versus 6.8% respectively for isolated valve
surgery), particularly for the elderly:
€40
Pieter Kappetein,
General Secretary EACTS
“We hope that this report will provide
interesting and useful information to
those who define and develop Health
Policy (both inside and outside the
European Community), the individual
countries, commissioners and
regulators of healthcare, as well as
the professional societies that
support cardiac surgery, the hospitals
who provide care and the patients
who need it.”
Jan Gummert, Chairman of the
EACTS database committee
Visit us at EACTS 2010
on Booth 1330
24 Saturday 11 September 2010 EACTS Daily News
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Ethicon
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Labcor Laboratorios Ltda.
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Terumo/Vascutek/Terumo Heart
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ASANUS GmbH
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CORONEO INC.
Edwards Lifesciences
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Leica Microsystems (Schweiz) AG
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Scanlan International, Inc.
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Terumo/Vascutek/Terumo Heart
Transonic Systems Europe
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Minimally Invasive Cardiac
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Minimally Invasive Cardiac
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ASANUS GmbH
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Scanlan International, Inc.
Transonic Systems Europe
Wexler Surgical
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Vivostat A/S
Wexler Surgical
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GUNZE LIMITED
Labcor Laboratorios Ltda.
Terumo/Vascutek/Terumo Heart
CORONEO INC.
Edwards Lifesciences
Estech Inc.
Fehling Instruments GmbH & Co. KG
GEISTER Medizintechnik GmbH
Integra Surgical
JOTEC GmbH
Kardium
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KLS Martin Group
Labcor Laboratorios Ltda.
Micromedics
PETERS SURGICAL
Pluromed, Inc.
PRAESIDIA S.R.L.
Scanlan International, Inc.
Sciencity Co., Ltd
Terumo/Vascutek/Terumo Heart
Transonic Systems Europe
Wexler Surgical
Post-Op Infusion Devices
Sutures & Anastomotic Devices
REDAX S.R.L.
A&E Medical Corporation
Assut Medical Sàrl
BioCer Entwicklungs GmbH
California Medical Laboratories
CryoLife Europa Ltd.
Ethicon
GUNZE LIMITED
Labcor Laboratorios Ltda.
PETERS SURGICAL
Pluromed, Inc.
PRAESIDIA S.R.L.
Vivostat A/S
Patches and membranes –
Biomaterials
Baxter Healthcare SA
BioCer Entwicklungs GmbH
Ceremed, Inc.
GUNZE LIMITED
Labcor Laboratorios Ltda.
Tissuemed Ltd
Vivostat A/S
Patches And Membranes –
Synthetic and Biological Grafts
Professional Services, Database
Software & Services
Dendrite Clinical systems
HRA Research
KARL STORZ GmbH & Co KG
Terumo / Vascutek / Terumo Heart
Prosthetic Heart Valves –
Mechanical and Tissue Valves
CardiaMed B.V.
Edwards Lifesciences
JenaValve Technology
JOTEC GmbH
Labcor Laboratorios Ltda.
On-X Life Technologies, Inc.
Sciencity Co., Ltd
SORIN GROUP
Terumo / Vascutek / Terumo Heart
Aortic Annuloplasty Rings
CORONEO INC.
Edwards Lifesciences
Labcor Laboratorios Ltda.
Sciencity Co., Ltd
SORIN GROUP
X-ray imaging systems
Mitral & Tricuspid Annuloplasty
Rings
Prosthetic Vascular Grafts –
Synthetic and Tissue Grafts
Philips Healthcare
Edwards Lifesciences
Labcor Laboratorios Ltda.
MiCardia Corporation
PETERS SURGICAL
Sciencity Co., Ltd
SORIN GROUP
JOTEC GmbH
Labcor Laboratorios Ltda.
MAQUET Cardiovascular
Terumo/Vascutek/Terumo Heart
Products for post-operative
care
BracePlus
HEART HUGGER/General Cardiac
Vivostat A/S
Publishing Companies
Operating Room Equipment
B. BRAUN Aesculap
CAS Medical Systems, Inc.
GEISTER Medizintechnik GmbH
KARL STORZ GmbH & Co KG
KLS Martin Group
Labcor Laboratorios Ltda.
Leica Microsystems (Schweiz) AG
MediStim ASA
Percutaneous Valve Clips
Dendrite Clinical systems
ELSEVIER
Wisepress Bookshop
Abbott Vascular International BVBA
Monitoring Device – Oximetry
Surgical Instruments
ASANUS GmbH
Assut Medical Sàrl
B. BRAUN Aesculap
California Medical Laboratories
Ceremed, Inc.
CAS Medical Systems, Inc.
Hamamatsu Photonics
Pick up your EACTS Daily News every day!
As part of their commitment to education, each year the European
Association for Cardio-Thoracic Surgery publishes the EACTS
Daily News. The Association and the newspaper publishers,
Dendrite Clinical Systems, would like to thank the authors for the
time and cooperation. In addition, they would also like to thank the
sponsors of the newspaper without whose continued support the
newspaper would not be possible.
Publisher
Dendrite Clinical Systems
Editor in Chief
Pieter Kappetein
Managing Editor
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Copyright 2010 ©: Dendrite Clinical Systems and the European Association for CardioThoracic Surgery. All rights reserved. No part of this publication may be reproduced, stored
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If you would like to make any comments regarding EACTS Daily News please visit Dendrite at Stand 1330
1102 A&E Medical Corporation
1053 Abbott Vascular
International BVBA
1031 Acute Innovations LLC
1304 Andocor NV
1306 Asanus Medizintechnik
GmbH
1308 Assut Medical Sarl
1141+1143
AtriCure Europe BV
1440 Atrium Europe BV
1320 ATS Medical
1574 Avalon Laboratories LLC
1240 B Braun Aesculap
1412 Baxter Healthcare SA
1033 bemedtec Berthold
Medizintechnik &
Consulting
1434 Berlin Heart GmbH
1611+1613
BioCer EntwicklungsGmbH
1208 BracePlus
1013 California Medical
Laboratories Inc
1037 Cardia Innovation AB
1045 CardiaMed BV
1570 Cardiomedical GmbH
1041 CAS Medical Systems Inc
1300 Ceremed Inc
1572 Chase Medical
1064 Cook Medical
1029 CorMatrix Inc
1332 Coroneo Inc
1526 Cryolife Europa Ltd
1330 Dendrite Clinical Systems
1025 Doctor's Research Group
Inc
1220 Edwards Lifesciences
1040 Elsevier
1340 Estech Inc
1310 Ethicon
1210 Eurosets
1204 Evaheart
1410 Fehling Instruments GmbH
& Co KG
1344 Geister Medizintechnik
GmbH
1431 Genesee BioMedical Inc
1562 Geneva Tourism &
Convention Bureau
1035 Geomed®Medizin-Technik
GmbH & Co. KG
1104 Gore & Associates
1504 Gunze Limited
1644 Hamamatsu Photonics
1433 Heart Hugger / General
Cardiac Technology
1540 HeartWare International Inc
1626 HRA Research
1430 infinitas medical GmbH
1334 Integra Surgical
1206 Jarvik Heart Inc
Stand Exhibitor
Exhibitors
1051 Jena Valve Technology
GmbH
1336 Jotec GmbH
1302 Kardium
1552 Karl Storz GmbH & Co KG
1550 KLS Martin Group
1435 Labcor Laboratorios
1015+1021
Landanger/DelacroixChevalier
1014
1012
Fire
route
Entrance
1010
1111
1020
1030
1141
1143
1100 Leica Microsystems
(Schweiz) Ag
1541 Levitronix GmbH
1130 Maquet Cardiovascular
1140 Maquet Cardiovascular/
Philips Healthcare
1612 Medex Research
1050 Medi-Stim ASA
1530 Medos Medizintechnik Ag
1120 Medtronic International
Trading Sárl
1011
1013
1015
1023
1025
1027
1029
1031
1033
1035
1016
1040
1041
1037
1042
1100
1110
1140
1130
1240
1106
1334
1336
1344
1304
1442
154
1543
1104
1110 Medtronic International
Trading Sárl/Siemens Ag
Healthcare Sector
1502 MiCardia Corporation
1510 Micromed CV Inc
1614 Micromedics
1620 NeoChord Inc
1506 Novadaq Technologies Inc
1212 + 1311
On-X Life Technologies Inc
1640 Osypka
1102
1120
1204
1212
120
1206
1311
120
1208
1330
1542 Peters Surgical
1140 Philips Healthcare/Maquet
Cardiovascular
1023 Pluromed Inc
1564 Praesidia Srl
1642 PulseCath BV
1560 Qualiteam Srl
1543 Redax Srl
1500 Rumex International Co
1106+1108+1200+1202
Scanlan International Inc
1210
1220
1230
1340
1027
1011
1020
1030
1622
1646
1520
1230
1420
1624
130
1300
1332
1306
1308
1410
1412
1420
1430
1434
154
1541
Sciencity Co Ltd
Smartcanula LLC
Sorin Group
St Jude Medical
Symetis SA
SynCardia Systems Inc
Synthes GmbH
Terumo Europe, Vascutek
Thoratec Corporation
Tissuemed Ltd
1302
1310
1320
1431
1433
1435
1440
1510
150
1504
1506
150
Transonic Systems Europe
Vivostat
Wexler Surgical
Wisepress Online
Bookshop
150
1502
1610
1612
1614
1620
1622
1624
1626
Snack
1640
1642
1644
1646
1010 AATS – American
Association for Thoracic
Surgery
Societies
1043
1442
1610
1042
1500
1611
161
1613
161
1520
1526
1530
1540
1542
1574
157
Internet
1043
1045
1550
1050
1051
1564
156
1552
Catering
1560
1562
157
1572
1053
1064
106
Fire route
1570
Fire route
1016 CTSNet – Cardiothorcic
Surgery Network
1111 EACTS – European
Association for
Cardio-Thoracic Surgery
1014 ISMICS – International
Society for Minimally
Invasive Cardiothoracic
Surgery
1012 STS – Society of Thoracic
Surgeons
Fire route
EACTS Daily News Saturday 11 September 2010 25
Floor plan
26 Saturday 11 September 2010 EACTS Daily News
St Jude Medical: Dedication to Education
S
t. Jude Medical is dedicated to
developing medical technologies and services that put
more control into physicians’ hands
while reducing the risks inherent in
medical device procedures. To this
end, St. Jude Medical has increased
its focus on physician education,
providing more opportunities for
health care providers to gain
advanced experience with St. Jude
Medical technologies outside of the
patient-care setting.
The St. Jude Medical Advanced
Learning Centers demonstrate the
company’s commitment to physicians as they seek to improve
patient outcomes and lower risks.
With practical, hands-on curricula
on advanced topics in heart valve
replacement and repair, vascular
closure and electrophysiology, the
St. Jude Medical Advanced
Learning Center provides a place
where physicians and fellows can
come together to share and learn
from each other.
The first St. Jude Medical
Advanced Learning Center opened
in 2008 in Brussels, Belgium and
has since trained more than 2000
physicians with the help of thought
leaders, physician faculty and under
the supervision of course directors
who are able to share best practices in an open, welcoming envi-
ronment. Soon after, a second center opened in Austin, Texas USA
and a center will open later this
year in Beijing, China followed by
one in Tokyo, Japan early 2011.
“The St. Jude Medical Advanced
Learning Centers provide an excellent forum for physicians to learn
through hands-on experiences and
by sharing their clinical experience
in a small group setting,” said
Denis Gestin, president of the St.
Jude Medical International Division.
“This allows physicians to gain
valuable insight for improved
patient care and helps to reduce
the learning curve that might be
involved with such procedures.”
The programs are designed so
that physicians in each stage of
their career can learn topics from
a fundamental understanding of a
particular therapy to the use of
advanced, game-changing technologies. The course content is the
responsibility of the independent
course director. This person is a
medical specialist and such has a
in-depth understanding of the
steps necessary to mastering the
use or application of a specific
therapy.
For Cardiac Surgeons, The St
Jude Medical Advanced Learning
Center in Brussels offers the following programs:
Cardiac Surgeon
Curriculum:
EACTS 2010
During the EACTS 2010 the St.
Jude Medical Advanced Learning
Center will exhibit several education opportunities.
These include wet lab sessions
for junior surgeons on the Bentall
procedure, basic mitral valve repair
techniques and surgical suggestions
for small aortic roots.
European Valve Repair
At the Training village physicians
Group workshops:
will have opportunity to work on
These workshops, featuring live
porcine hearts to enhance the valve
case transmissions, are organized
implantations techniques and learn
a.o. In Milan, Lyon and Homburg
advanced mitral repair techniques
Saar, under faculty supervision of
in collaboration with the European
the EVRG group and cover different Valve Repair Group.
levels of education in Valve Repair. www.sjm.com
A three module curriculum covering an Aortic, Mitral and Atrial
Fibrilation module, under the
course direction of Prof. Dr.
Thorsten Wahlers, Germany, Prof.
Dr Anno Diegeler, Germany and
Prof Ruggero De Paulis, Italy.
Forthcoming Events in 2010
11–15 September
24th Annual Meeting of the
European Association for
Cardio-Thoracic Surgery
EACTS
11–15 October
EACTS Advanced Teaching
Course
Palexpo, Geneva, Switzerland
Abstract submission deadline:
1 April 2010
For information, contact:
EACTS Executive Secretariat
3 Park Street, Windsor, Berkshire
SL4 1LU, UK
Phone: +44 1753 832 166
Fax:
+44 1753 620 407
Email: info@eacts.co.uk
St. Andrea Hospital, Rome, Italy
8–12 November
EACTS Postgraduate Leadership
Course for Cardio-Vascular and
Thoracic Surgeons
For information, contact:
Windsor, United Kingdom
19–20 November
EACTS Course "Right ventricular
outflow tract management from
neonates to adults: an
interdisciplinary view"
EACTS Executive Secretariat
3 Park Street, Windsor, Berkshire
SL4 1LU, UK
Phone: +44 1753 832166
Fax:
+44 1753 620407
Email: info@eacts.co.uk
For information, contact:
Palma de Majorca Spain
For information, contact:
EACTS Executive Secretariat
3 Park Street, Windsor, Berkshire
SL4 1LU, UK
Phone: +44 1753 832166
Fax:
+44 1753 620407
Email: info@eacts.co.uk
For information, contact:
EACTS Executive Secretariat
3 Park Street, Windsor, Berkshire
SL4 1LU, UK
Phone: +44 1753 832166
Fax:
+44 1753 620407
Email: info@eacts.co.uk
EACTS Executive Secretariat
3 Park Street, Windsor, Berkshire
SL4 1LU, UK
Phone: +44 1753 832166
Fax:
44 1753 620407
Email: info@eacts.co.uk
3–4 December
2nd EACTS Cardiac and
Pulmonary Regeneration
Meeting
Vienna, Austria