When is it too late to perform transcatheter mitral valve repair? Alec Vahanian, FESC,FRCP(Edin.) Bichat hospital University Paris VII

Transcription

1 When is it too late to perform transcatheter mitral valve repair? Alec Vahanian, FESC,FRCP(Edin.) Bichat hospital University Paris VII

2 I, (Alec Vahanian) DO have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. Consultant (Advisory Board) : Abbott, Valtech

3 General comments

4 (Grube Eur Heart J 2014;35: )

5 Factors Leading to the Decision of Inoperability in PARTNER (Makkar J Am Coll Cardiol. 2014;63(9): )

6 Patient Characteristics in Recent MitraClip Trials (Gafoor.EuroPCR 2015)

7 Primary MR (Gaasch. Circulation 2008;118: )

8 Post-Operative Left Ventricular Dysfunction LV EF pre-op (%) LV EF Post-op (%) Patients with LV dysfunction post-op (%) Crawford (1990) Sarano (1994) Leung (1996)

9 Functional MR and LV Remodelling Is FMR another variable associated with adverse outcomes or a risk factor which may potentially be treated?

10 When it is Too Late.. (Beaudoin. Circulation. 2013;128:S248-S252)

11 General comments The data

12 (Feldman, N Engl J Med 2011;364: )

13 MitraClip in High Risk Patients 50 patients 100% FMR All NYHA III/IV LVEF :19.5% (all<25%) At 6 mos : Survival 64.2% for pts in NYHA IV NYHA Class I/II in 72% «Patients with end stage HF and severelv dysfunction can be treated by the MitraClip as successful treatment promotes clinical benefit at 6Mos» (Franzen.Eur J Heart Failure 2011;13:569)

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15 ACCESS EU Registry (Schafer EuroPCR 2015)

16 ACCESS EU Registry (Schafer EuroPCR 2015)

17 MitraClip in High Risk Patients 167 patients 43% LES >20% 31% NYHA Class IV 46% LVEF <35% 20% NT-pro BNP> 10000pg/mL 7% died at 30d : 8/11 of low output due to end-stage HF Among the survivors, 55% were in NYHA Class I-II at 1 year (Neuss. Eur J Heart Fail 2013;15: )

18 Survival /BNP (Neuss. Eur J Heart Fail 2013;15: )

19 Heart Failure Rehospitalisation/LVEDV (Rudolph. Eur J Heart Fail 2013;15: )

20 Predictors of Death or Hospitalization for Heart Failure after MitraClip (Capodanno EuroPCR 2015)

21 Multivariate Predictors of Poor Outcomes after Mitraclip HR C.I. NT-pro BNP>10000pg/ml Age>80yr NYHA Class IV TAPSE < (Neuss. Eur J Heart Fail 2013;15: )

22 Severe TR is a predictor of 1-year mortality after MitraClip (Puls,Eur Heart J 2015 in Press)

23 General comments The data The Guidelines

24 ESC/ EACTS Guidelines for the Management of Valvular Heart Disease «The percutaneous MitraClip procedure may be considered in symptomatic patients with severe primary or secondary MR despite optimal medical therapy,who fulfil the echo criteria of eligibility, are judged inoperable or at high risk for surgery by a heart team, and who have a life expectancy greater than one year» (Recommendation class IIb, level of Evidence C) European Heart Journal doi: /eurheartj/ehs109 & European Journal of Cardio-Thoracic Surgery doi: /ejcts/ezs455).

25 2013 ACC/AHA Guidelines for the Management of Heart Failure Transcatheter mitral valve repair or mitral valve surgery for functional mitral insufficiency is of uncertain benefit and should only be considered after careful candidate selection and with a background of GDMT. (Class IIb, Level of Evidence: B) (Yancy. J Am Coll Cardiol 2013;62:e )

26 2014 ACC/AHA Recommendations for Chronic Primary MR Recommendations COR LOE Transcatheter mitral valve repair may be considered for severely symptomatic patients with chronic severe primary MR who have a reasonable life expectancy but a prohibitive surgical risk because of severe comorbidities IIb B (Nishimura. J Am Coll Cardiol 2014)

27 «MitraClip not Recommended» Moderate to severe mitral regurgitation and Conditionally suitable valve morphology or Life expectancy <12 months or LV-EF <15% or cardiothoracic operation planned due to other indications or Previously operated mitral valve or As surgical/interventional hybrid procedure or At low operative risk (Boekstegers. Clin Res Cardiol 2014;103:85-96)

28 Patient selection criteria for MitraClip therapy in patients with severe mitral regurgitation and severe congestive heart failure (Neuss. Eur J Heart Fail 2013;15: )

29 General comments The data The Guidelines What is next?

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32 Heart Valve Centres of Excellence «The optimal care of patients with complex heart valve disease is best performed in centres that can provide all available options for diagnosis and management, including the expertise for complex aortic or mitral valve repair, aortic surgery, and transcatheter therapies This has led to the development of Heart valve Centres of Excellence ((Nishimura et al. J Am Coll Cardiol 2014;63:e57 e185)

33 The «Heart Team» SURGEONS CARDIOLOGISTS (General, HF, EP, Interventionists) Anesthesiologists Treatment of Valve disease Other specialists: Geriatricians Imaging specialists (Echo, CT, MRI)

34 Modern Management of Heart Failure Multidisciplinary Team pproach Total artificial heart Medical therapy Assist devices CRT Cell therapy FMR repair and replacement Transplant

35 Conclusions There are only limited data dedicated to the «point of no return» in patients in whom percutaneous mitral valve intervention is considered. The prediction of the «point of no return» is made even more difficult because it is hardly possible to predict an absence of improvement. In addition functional improvement may be somewhat dissociated from survival benefit. The clinical decision-making process should be based on the judgement of the multidisciplinary heart team, on a case-by-case basis, taking into account both cardiac (LV, RV, MR, CAD, AF, ) and extra-cardiac conditions. Further clinical trials are needed to develop an optimized strategy for patients with valve disease and severe heart failure. The best treatment remains individualised and timely treatment of valve disease.

36 Thank You