Professional Societies: Fostering and monitoring innovation … · · 2013-12-05Professional Societies: Fostering and monitoring innovation in CVS . ... 1-tissue scaffold is preserved,

José L. Pomar,MD, PhD

Professor of Surgery

The Thorax Clinic Institute

University of Barcelona

Barcelona, Spain

Professional Societies: Fostering and

monitoring innovation in CVS

Tissue Heart Valves

Homografts: From calves to cryopreservation (UK)

Heterografts: Early studies to nowadays (France)

Porcine versus Perciardial (France and UK)

Stented vs stentless (Toronto)

Tissue engineering (Boston)

TAVI (France)

Sutureless tissue valves (Italy)

Gordon Murray, 1956

Charles Hufnagel (first prosthetic valve 1952)

Homografts in 1962…from Oxford to London & Australia

Carlos M.G. Durán Brian Barratt-Boyes Donald N. Ross

From the lab to straight human implantation

Lariboisière and Broussais Hospitals

François Broussais 1772-1838 Alain Carpentier

Charles Dubost

First commercially available THV

Hancock porcine

Warren Hancock

Warren Hancock

Other times….

Bill Clinton and John F. Kennedy Sarkozy

Alain Cribier and the TAVI

The Transcatheter Heart Valve Implants

Still durability of TAVI remains unknown

Stent design

Tissue handling

Native valve

Residual AR

AV block

TE

Embrella med movie.wmv

Quick evolution of designs

CENTERA Transcatheter Heart Valve

Modifying

stresses, stent

shape, device

profile, skirt,

Also in the mitral position …

Why Irreversible Electroporation (IRE) for tissue ablation?

Irreversible electroporation does not involve thermal heating

1-tissue scaffold is preserved, 2- heat sink effect is irrelevant

Normal rat artery

Rat artery one week after

IRE treatment

Vascular smooth muscle cells in

the Tunica Media are destroyed

but the extracellular matrix is

still functional

(Maor et al. PLoS ONE 4:3 e4757 2009)

Regulatory bodies

CE mark

FDA approval

Somethings are unregulable

Repaired Congenital Heart Diseases in the Adult

The heart physiology

The body adaptation after years

The imaging of the unknown

The new coming symptoms

Their adequate treatment

The best surgical approach for residual complications

Support of Professional Societies

Improve treatment of CV patients through

Continuous education of professionals: Excellence

Incentivize research to achieve

Evidence of the benefits of the diverse therapeutical

options

Safe innovations

“Education of the community through classic and new

communication tools”

Types of CTS Scientific Associations

National

International

Types of Scientific Associations

National: Inclusive

International: Inclusive

Exclusive

Most relevant Scientific Associations

AATS

STS EACTS

CTSNet

ASCVS, ESCVS, ESTS, SHVD …

Scientific Associations: An exclusive

Number of members: For some years 400

US and International members

Membership committee

About 50% acceptance rate

Requisites are for rather high academic level

Great offer of courses and opportunities. Reputation.

Membership

Founded in 1917 by the earliest pioneers in the field of thoracic surgery, the

American Association for Thoracic Surgery (AATS) is now an international

organization of over 1,200 of the world’s foremost cardiothoracic surgeons

representing 35 countries.

Members of the AATS are surgeons with a proven record of distinction within the

international cardiothoracic surgical field and have made meritorious

contributions to the extant knowledge base about cardiothoracic disease and its

surgical treatment.


Annual Meeting

Aortic at the Big Apple

Mitral Conclave

Slow Asian and Middle East expansion


EXCELLENCE IN RESEARCH AS A MAIN GOAL

Scientific Associations: An inclusive

Purpose

Founded in 1964, The Society of Thoracic Surgeons is a not-for-

profit organization representing over 6,600 surgeons,

researchers and allied health care professionals worldwide

who are dedicated to ensuring the best possible outcomes for

surgeries of the heart, lung, and esophagus, as well as other

surgical procedures within the chest.


Staff Core Values

With a staff of approximately 50 employees, The Society of

Thoracic Surgeons is headquartered in Chicago and has an

additional office near Capitol Hill in Washington, DC. A team of

dedicated professionals, the STS staff strives for excellence as it

upholds the staff core values of respect, teamwork, innovation,

quality service, and ownership.


STS National Database

The STS National Database was established in 1989 as an initiative for quality

improvement and patient safety among cardiothoracic surgeons. There are three

components to the STS National Database, each focusing on a different area of

cardiothoracic surgery—Adult Cardiac, General Thoracic, and Congenital Heart

Surgery, with the availability of Anesthesiology participation within the Congenital

Heart Surgery Database. The Database has grown exponentially over the years, both

in terms of participation and stature.

Scientific Associations: EACTS

Francis Fontan Keyvan Mogishi Marko Turina

27 years ago…. From ESCVS to EACTS


OBJECTS

The Charity's objects are specifically restricted to the following:

1. To advance education in the field of cardiac, thoracic and vascular interventions

2. To promote for the public benefit research into

cardiovascular and thoracic physiology, pathology and therapy and to correlate and disseminate the useful results thereof.


The Bergamo School for CT Surgery

The Windsor Headquarters. Staff

The Freiburg Editorial office after Lausanne and Zurich

An outstanding Multi Media Manual

The first approximation to EuroPCR

Joint ventures with ESC

The Syntax, the Excel, and others…

The HEART TEAM model



OFFICE NAME TERM OF OFFICE

Chair Philippe H. Kolh 2012 - 2013

Member Joel Dunning 2008 - 2012

Ex-officio A. Pieter Kappetein 2011 - 2014

Member Ulf Lockowandt 2008 - 2012

Member Jose Luis Pomar 2012 - 2013

The Guidelines Committee

Scientific Associations: EACTS ESC/EACTS GUIDELINES

Guidelines on myocardial revascularizat ion

The Task Force on Myocardial Revascular izat ion of the European

Society of Cardiology (ESC) and the European Associat ion for

Cardio-Thoracic Surgery (EACTS)

Developed with the special cont r ibut ion of the European Associat ion

for Percutaneous Cardiovascular Intervent ions (EAPCI)‡

Authors/Task Force Members: W illiam W ijns (Chairperson) (Belgium)*, Philippe Kolh

(Chairperson) (Belgium)*, NicolasDanchin (France), Car lo Di Mar io (UK),

Volkmar Falk (Switzer land), Thierry Folliguet (France), Scot Garg (The Nether lands),

Kur t Huber (Austr ia), Stefan James (Sweden), Juhani Knuut i (Finland), Jose

Lopez-Sendon (Spain), Jean Marco (France), Lorenzo Menicant i (Italy)

Miodrag Ostojic (Serbia), Massimo F. Piepoli (Italy), Char lesPir let (Belgium),

Jose L. Pomar (Spain), N icolausReifar t (Germany), Flavio L. Ribichini (Italy),

Mar t in J. Schalij (The Nether lands), Paul Sergeant (Belgium), Patr ick W . Serruys

(The Nether lands), Sigmund Silber (Germany), Miguel Sousa Uva (Por tugal),

David Taggart (UK)

ESC Commit tee for Pract ice Guidel ines: Alec Vahanian (Chairperson) (France), Angelo Aur icchio (Switzer land),

Jeroen Bax (The Nether lands), Claudio Ceconi (Italy), Veronica Dean (France), Gerasimos Filippatos (Greece),

Chr ist ian Funck-Brentano (France), Richard Hobbs (UK), Peter Kearney (Ireland), Theresa McDonagh (UK),

Bogdan A. Popescu (Romania), Zeljko Reiner (Croat ia), Udo Sechtem (Germany), Per Anton Sirnes (Norway),

Michal Tendera (Poland), Panos E. Vardas (Greece), Pet r W idimsky (Czech Republic)

EACTS Clinical Guidelines Commit tee: Philippe Kolh (Chair person) (Belgium), Ot tavio Alfier i (Italy), Joel Dunning

(UK), Stefano Elia (Italy), Pieter Kappet ein (The Nether lands), Ulf Lockowandt (Sweden), George Sarr is (Greece),

Pascal Vouhe (France)

Document Reviewers: Peter Kear ney (ESC CPG Review Coordinator) (Ireland), Ludwig von Segesser (EACTS

Review Coordinat or) (Switzer land), Stefan Agewall (Norway), Alexander Aladashvi li (Georgia),

Dimit r ios Alexopoulos (Greece), Manuel J. Antunes (Portugal ), Enver Atalar (Turkey), Aar t Brutel de la Riviere

‡Other ESC entities having participated in the development of this document :

Associations: Heart Failure Association (HFA), European Association for Cardiovascular Prevention and Rehabilitation (EACPR), European Heart Rhythm Association (EHRA), Euro-

pean Association of Echocardiography (EAE).

Working Groups: Acute Cardiac Care, Cardiovascular Surgery, Thrombosis, Cardiovascular Pharmacology and Drug Therapy.

Councils: Cardiovascular Imaging, Cardiology Practice.

* Corresponding authors (the two chairpersons contributed equally to this document): William Wijns, Cardiovascular Center, OLV Ziekenhuis, Moorselbaan 164, 9300 Aalst,

Belgium. Tel: + 32 53 724 439, Fax: + 32 53 724 185, Email: [email protected]

Disclaimer . The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written. Health

professionals are encouraged to take them fully into account when exercising their clinical judgement. The guidelinesdo not, however, override the individual responsibility of health

professionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient, and where appropriate and necessary the patient’s

guardian or carer. It is also the health professional’s responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription.

& The European Society of Cardiology 2010. All rights reserved. For Permissions please email: journals.permissions@oxfor djournals.org.

Philippe Kolh, Cardiovascular Surgery Department, University Hospital (CHU, ULg) of Liege, Sart Tilman B 35, 4000 Liege, Belgium. Tel: + 32 4 366 7163, Fax: + 32 4 366 7164,

Email: [email protected]

The content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only. No commercial use is authorized. No part of the

ESC Guidelines may be translated or reproduced in any form without written permission from the ESC. Permission can be obtained upon submission of awritten request to Oxford

University Press, the publisher of the European Heart Journal and the party authorized to handle such permissions on behalf of the ESC.

European Heart Journal (2010) 31, 2501–2555

doi:10.1093/eurheartj/ehq277





TECHNO COLLEGE

Innovation of the last days

No science behind but some evidence of interest

Life vs life in a box demonstrations

Highly attended session during the Annual Meeting

Controversies: Off vs on pump CABG

EACTS News and Recent Publications

Editors: K. M. John Chan FRCS CTh, John R. Pepper FRCS

European Association for Cardio-Thoracic Surgery http://www.eacts.org/

Off- and on-pump CABG have similar early outcomes but

differences in repeat revascularisation and complication rates

29 March 2012

The CORONARY Trial recently reported similar outcomes for off- and on-pump CABG at the American

College of Cardiology Foundation. The results were also published in the NEJM.1 The trial

randomised 4752 patients from 79 centres in 19 countries who were receiving CABG to either an off-

pump or on-pump procedure. Surgeons in the trial who performed off-pump CABG had to have at

least two years’ experience of pe r fo rming the procedure and ha d to ha v e performed at least 100 off-

pump CABGs. The conversion rate from off-pump to on-pump CABG during coronary grafting was

2.6%.

At 30 days, there was no difference between off-pump and on-pump CABG in the primary composite

outcome of death, non-fatal stroke, non-fatal myocardial infarction or new renal failure requiring

dialysis (9.8% vs 10.3%; p=0.59), or in any of its individual components. There were, however,

important differences in revascularisation and complication rates in the two groups with off-pump

CABG having higher revascularisation rates compared to on-pump CABG (0.7% vs 0.2%; p=0.01), but

lower rates of transfusion (50.7% vs 63.3%; p<0.001), re-operation for bleeding (1.4% vs 2.4%;

p=0.02), respiratory complications (5.9% vs 7.5%; p=0.03) and acute kidney injury (28.0% vs 32.1%;

p=0.01) (Table 1). Patients in the off-pump CABG group received less number of grafts (3.0 vs 3.2;

p<0.001) and had a higher rate of incomplete revascularisation as assessed by the surgeon at the

time of surgery (11.8% vs 10.0%; p=0.05).

Off pump

CABG

On pump

CABG

HR 95% CI p

Composite primary outcome (%) 9.8 10.3 0.95 0.79 – 1.14 0.59

Repeat revascularisation (%) 0.7 0.2 4.01 1.34 – 12.0 0.01

Blood product transfusion (%) 50.7 63.3 0.80 0.75 – 0.85 <0.001

Re-operation for bleeding (%) 1.4 2.4 0.61 0.40 – 0.93 0.02

Acute kidney injury (%) 28.0 32.1 0.87 0.80 – 0.96 0.01

Respiratory complications (%) 5.9 7.5 0.79 0.63 – 0.98 0.03

Table 1. 30 day results of the CORONARY Trial.




Off- and on-pump CABG have similar early outcomes but

differences in repeat revascularisation and complication rates

29 March 2012

The CORONARY Trial recently reported similar outcomes for off- and on-pump CABG at the American

College of Cardiology Foundation. The results were also published in the NEJM.1 The trial

randomised 4752 patients from 79 centres in 19 countries who were receiving CABG to either an off-

pump or on-pump procedure. Surgeons in the trial who performed off-pump CABG had to have at

least two years’ experience of pe r fo rming the procedure and ha d to ha v e performed at least 100 off-

pump CABGs. The conversion rate from off-pump to on-pump CABG during coronary grafting was

2.6%.

At 30 days, there was no difference between off-pump and on-pump CABG in the primary composite

outcome of death, non-fatal stroke, non-fatal myocardial infarction or new renal failure requiring

dialysis (9.8% vs 10.3%; p=0.59), or in any of its individual components. There were, however,

important differences in revascularisation and complication rates in the two groups with off-pump

CABG having higher revascularisation rates compared to on-pump CABG (0.7% vs 0.2%; p=0.01), but

lower rates of transfusion (50.7% vs 63.3%; p<0.001), re-operation for bleeding (1.4% vs 2.4%;

p=0.02), respiratory complications (5.9% vs 7.5%; p=0.03) and acute kidney injury (28.0% vs 32.1%;

p=0.01) (Table 1). Patients in the off-pump CABG group received less number of grafts (3.0 vs 3.2;

p<0.001) and had a higher rate of incomplete revascularisation as assessed by the surgeon at the

time of surgery (11.8% vs 10.0%; p=0.05).

Off pump

CABG

On pump

CABG

HR 95% CI p

Composite primary outcome (%) 9.8 10.3 0.95 0.79 – 1.14 0.59

Repeat revascularisation (%) 0.7 0.2 4.01 1.34 – 12.0 0.01

Blood product transfusion (%) 50.7 63.3 0.80 0.75 – 0.85 <0.001

Re-operation for bleeding (%) 1.4 2.4 0.61 0.40 – 0.93 0.02

Acute kidney injury (%) 28.0 32.1 0.87 0.80 – 0.96 0.01

Respiratory complications (%) 5.9 7.5 0.79 0.63 – 0.98 0.03

Table 1. 30 day results of the CORONARY Trial.

FOCUS SESSIONS

Own Journal original articles

Reviews from other Journals




Tricuspid Valve Repair for Tricuspid Annular Dilatation shows benefit

15 April 2012

A randomised trial from Rome recently reported improved cardiac and functional outcomes when

tricuspid valve annnuloplasty was performed in the presence of tricuspid annular dilatation but

without significant functional tricuspid regurgitation.1 The study randomised 44 patients undergoing

mitral valve surgery with less than moderate functional tricuspid regurgitation but a dilated tricuspid

annulus (≥ 40mm) to either mitral valve surgery alone or to mitral valve surgery plus tricuspid valve

annuloplasty. At 12 months, patients who had concomitant tricuspid valve annuloplasty had less TR

(TR absent in 71% versus 19%, p=0.001; moderate-to-severe TR in 0% versus 28%, p=0.02), greater

right ventricular reverse remodelling, and greater improvement in the six minute walk test (+115m

versus +75m, p=0.008).

This study is consistent with an earlier study reporting worsening TR grade and NYHA functional class

if tricuspid annular dilatation is not corrected at the time of mitral valve surgery irrespective of the

grade of TR.2

A previous study from Leiden, Netherlands, also reported that tricuspid valve annuloplasty at the

time of mitral valve surgery in patients with tricuspid annular dilatation but without significant

functional tricuspid regurgitation (TR), improved right ventricular (RV) reverse remodelling and

prevented progression of TR.3 This study compared 80 patients undergoing mitral valve repair in

2002 in whom concomitant tricuspid annuloplasty was only performed if there was grade 3 or 4 TR

(13 patients), against 102 patients operated in 2004 in whom concomitant tricuspid annuloplasty

was performed if there was either grade 3 or 4 TR (21 patients) or tricuspid annular dilatation

greater than 40 mm measured by echocardiography irrespective of the degree of TR (43 patients). At

two years, in the 2002 cohort, where tricuspid annuloplasty was only performed if there was grade 3

or 4 TR, RV reverse remodelling was not demonstrated (RV long axis 69 ± 7 vs 70 ± 8 mm, p=0.30; RV

short axis 29 ± 7 vs 30 ± 7 mm, p=0.08). TR was absent or mild in the 13 patients who had

concomitant tricuspid annuloplasty, but progressed with RV dilatation in the 23 patients with

tricuspid annular dilatation who did not have concomitant tricuspid annuloplasty (p<0.001).

Conversely, in the 2004 cohort, where tricuspid annuloplasty was performed if either tricuspid

annular dilatation or significant TR was present, RV reverse remodelling was observed (RV long axis

71 ± 6 vs 69 ± 9 mm, p=0.01; RV short axis 29 ± 5 vs 27 ± 5 mm; p<0.0001) and TR severity decreased

(1.6 ± 1.0 vs 0.9 ± 0.6; p<0.0001).

ESC guidelines currently recommend tricuspid annuloplasty in patients undergoing left sided valve

surgery with severe TR or moderate TR with tricuspid annular dilatation greater than 40 mm

measured by echocardiography. The ACC/AHA guidelines recommend tricuspid annuloplasty at the

time of mitral valve surgery for severe TR and consideration of tricuspid annuloplasty in less than

severe TR if pulmonary hypertension or tricuspid annular dilatation is present.4,5




REFERENCES

1. Benedetto U, Melina G, Angeloni E, Refice S, Roscitano A, Comito C, Sinatra R. Prophylactic

tricuspid annuloplasty in patients with dilated tricuspid annulus undergoing mitral valve surgery.

J Thorac Cardiovasc Surg 2012; 143:632-8

2. Dreyfus GD, Corbi PJ, Chan KMJ, Bahrami T. Secondary tricuspid regurgitation or dilatation:

which should be the criteria for surgical repair? Ann Thorac Surg 2005;79:127-32.

3. Van de Veire NR, Braun J, Delgado V, Versteegh MIM, Dion RA, Klautz RJM, Bax JJ. Tricuspid

annuloplasty prevents right ventricular dilatation and progression of tricuspid regurgitation in

patients with tricuspid annular dilation undergoing mitral valve repair. J Thorac Cardiovasc Surg

2011;141:1431-9.

4. Vahanian A, Baumgartner H, Bax J, Butchart E, et al. Guidelines on the management of valvular

heart disease. Eur Heart J 2007;28:230-268.

5. Nishimura RA, Carabello BA, Faxon DP, Freed MD, Lytle BW, et al. 2008 focused update

incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular

heart disease. Circulation 2008;118:e523-e661

Reviews from other Journals

The literature

Special Boundary Roles in the

Innovation Process

Michael L. Tushman

Administrative Science Quarterly

Vol. 22, No. 4 (Dec., 1977), pp. 587-605

The recommended literature and societies

The International Society for Professional

Innovation Management (ISPIM


Too few surgeons apply for them….Why?


EACTS PRIORITIES FOR THE NEXT 3 YEARS

A Pan-European training Program

The quality improvement program (QUIP)

High quality data base

Guidelines reinforcement

Monitoring the good use of innovation

Conclusion

No surgical innovation without evaluation

Peter McCulloch MD a Corresponding AuthorEmail Address, Prof Douglas G Altman DSc b,

Prof W Bruce Campbell FRCS FRCP c, Prof David R Flum MD d, Prof Paul Glasziou PhD e,

Prof John C Marshall MD f, Prof Jon Nicholl DSc g, for the Balliol Collaboration‡

Achievement of improved design, conduct,

and reporting of surgical research will need

concerted action by editors, funders of health

care and research, regulatory bodies, and

professional societies. The Lancet, Volume 374, Issue 9695, Pages 1105 - 1112, 26 September 2009

End of the talk

Documents

Professional Societies: Fostering and monitoring innovation … · · 2013-12-05Professional Societies: Fostering and monitoring innovation in CVS . ... 1-tissue scaffold is preserved,