15th & 16th

October2018

Program

Nice - FranceHotel Plaza

6th edition

Hotel Plaza

2

• 11:30–12.25Welcomediscussions&rooftoplunch

• 12.30–13.00Session1–Heartfailureguidelineprocess–Rulesofengagement>> How are the ESC guidelines developed? G. Filippatos>> How are the US guidelines developed? J. Butler >> Resolving complaints about GL statements A. Coats>> What do regulators expect of guidelines G. Rosano>> Discussion on the present and future of guidelines: what about patient involvement? What about using real-world evidence to make/change recommendations?

• 13.00–14.15Session2–HFrEFvsHFpEF>> What is the meaning/rationale of HFmrEF? P. Ponikowski

• Discussion: is this progress or a failed experiment>> What if there were two successful trials in HFrEF and in HFpEF using the same agent: are there design and statistical considerations? Which should allow one trial to lead to a 1A recommendation for all HF?

• Example 1 e.g. LCZ & PARAGON-HF T. McDonagh• Example 2 e.g. SGLT2 inhibitors J. Butler• Discussion

>> What if there is one successful trial with one subgroup in HFrEF and one in HFpEF? Does it give two guidelines recommendations for both subgroups?

• Example 1: device example (CCM) W. Abraham• Example 2: telemedicine F. Koehler• Discussion: do GLs need to state key inclusion criteria of trials more precisely and respect them in their

recommendations?

• 14.15–15.40 Session 3 – Endovascular approaches for functional mitral regurgitation (FMR) andtricuspidregurgitation(TR)>> MitraClip update on French.MR to COAPT and more to come: what is the reason for the different results?

• The French.MR view J.-F. Obadia• The COAPT view W. Abraham• The RESHAPE-HF2 view G. Hasenfuß• FMR criteria for the trials – a short comparison S. von Bardeleben• Discussion: what can this mean for guidelines?

>> The alternatives to MitraClip • The Cardioband EU alternative G. Nickenig• The Carillon System S. von Bardeleben• Discussion: A) What device for whom? B) Does device blinding matter for guidelines?

>> The Cardioband EU device in for patients with severe TR G. Nickenig• Discussion

15.40–15.50Break

• 15.50–16.50:Session4–SpecialdiscussionpointsondevicesforHF(andhowdoguidelinesdealwithnovelcombinedend-points)>> The Barostim Neo Experience and FDA Expedited Access Pathway and the implications for guidelines J. Cleland>> The meaning of combined endpoints of “PROs + events” and their application in guidelines: the Corvia example G. Hasenfuß>> Discussion: what if a therapy works for sure, but we don’t know for what exactly?>> Device based monitoring technologies – State of affairs W Abraham>> Discussion

• 16.50–17.50:Session5–TreatmentalgorithmsforHFrEF>> The place of Sacubitril/Valsartan in the treatment algorithm of chronic heart failure

• The European point of view K. Dickstein• The US point of view I. Pina• Discussion: any change needed?

>> Why is symptom improvement (beyond diuretics) not in the guidelines?

October 15th, 2018

Program

3

• Can open trials show reliable results? What about exercise? A. Coats• Such trials need to be blinded – The IV iron example P. Ponikowski• Time for a treatment algorithm for symptom improvement in HF? L. Stevenson• Discussion

>> Where to fit LVADs in all of this? G. Filippatos• Discussion

17.50–18.00Break

• 18.00–18.40Session6–PreventionandtreatmentofDiabetes>> Prevention of HF in diabetes: a class effect? J. Butler>> Treatment of diabetes in HF – Time to have an algorithm in the GLs? P Seferovic

• Discussion

• 18.40–19.10:Session7–AdhocQ&Asession(part1)

• 08:45-09:25:Session8-AcuteHF>> Is short-term symptom improvement still a viable endpoint for guidelines?

• Comment 1 M. Metra• Comment 2 L. Stevenson

>> Procalcitonin in AHF to guide therapy M. Möckel• Discussion

• 09:25-09:45:Session9-Guidelinesandthecostoftherapy>> The general rule S Anker

• Maybe the exemption of the rule is now needed? The example of tafamidis for amyloid cardiomyopathy L. Stevenson• Discussion

• 09:45-10:30:Session10-WhataboutguidelineimplementationrecommendationsandsupportivecaretoenableGDMT>>The role of telemedicine F. Köhler>> What about supportive care approaches?

• Can a series of mid-size enablement studies make it into the GLs? J. Butler• Does it need M&M trials? I. Pina• The regulators opinion on all this K. Prasad• Discussion

10:30-10:50:Break

• 10:50-12:05:Session11-Newtechnologiesforbettercareofco-morbiditiesinHF>> Treating sleep apnea – the phrenic nerve stimulation update? A. Coats

• Discussion>> IV iron – New evidence to come P. Ponikowski

• Discussion>> Treatment of atrial fibrillation – What about recent ablation trials in HF? L. Stevenson

• Discussion

• 12:05-12:30:Session12-HFinspecialpopulations>> Should the HF guidelines comment on cardio-oncology? J. Cleland>> What about symptomatic & sicker subgroups of HF patients in need: different trials & different endpoints – Also different guidelines? (for frailty, elderly, stroke, cachexia) A. Coats

• Discussion

• 12:30-13:00:Session13-AdhocQ&Asession(part2)

• 13:00-14:30:Finalcommentsandclose–discussionsduringworkinglunch

October 16th, 2018

From 20:00: Networking Dinner

4

TMAFoundationCharlesSchoen-OperationsDirectorTel.:+33(0)608187708Email:charles.schoen@tmacademy.org

Information:www.tmacademy.org

An opportunityto meet a panel of international experts in Heart Failure

MD, PhD, FESC Professor of Cardiology and Cachexia Research Department of Cardiology Charité Campus Virchow-Klinikum Berlin, Germany

Prof. Stefan Anker

GUIDELINES FORUM CHAIRS

MD, FESC, FHFA, FACC, FCCPDean, School of MedicineUniversity of CyprusProfessor of Cardiology, University of Cyprus &National and Kapodistrian University of Athens

Prof. Gerasimos Filippatos

MD, PhD, FACC, FESCPresident-elect Heart failure Association of the ESCChair of internal medicineBelgrade University School of Medicine

Prof. Petar Seferovic

CONTACT US

CONFIRMED FACULTY

W. AbrahamJ. ButlerJ. ClelandA. CoatsK. Dickstein G. HasenfußF. KöhlerM. LainscakT. McDonagh M. Metra M. MöckelG. Nickenig J.-F. Obadia I. PinaP. PonikowskiK. Prasad (EMA)G. Rosano (EMA)L. StevensonS. von Bardeleben

About TMAThe Translational Medicine Academy (TMA) is an international academic Foundation with focused activities in Mission Critical Areas of high public health importance having signifi cant professional and patient therapeutic and educational gaps.

• The development and successful implementation of guidelines requires both communication and transparency between all stakeholders. The Guidelines Forum is a closed workshop during which meaningful discussions occur between academic faculty members covering relevant topics for industry attendees.

• A better understanding of the processes involved in guidelines development and implementation will help attendees that develop drugs, biomarkers and devices, to adapt and improve their research and development programs for the future.

• Case based discussions: the success and failure stories that inevitably accompany the release of new guidelines may be a source of inspiration for further research and development.

• Guidelines really shape clinical practice if doctors and their patients adopt them. Therefore, implementation is essential. This could also translate into earlier

and more efficient development of diagnostic and therapeutic tools for patients.

At the end of the meeting, all participants will have a better understanding of the unmet needs and knowledge gaps that need to be addressed by future research and development efforts, and of the most appropriate ways of progressing to conciliate and take advantage of clinical, societal, evidence-based medicine and regulatory requirements.

EDUCATIONAL OBJECTIVES