Durability of Mitral Valve Surgery: Repair, Replacement or simply a clip? Christoph Huber Chirurgie Cardio Vasculaire HUG

Transcription

1 Durability of Mitral Valve Surgery: Repair, Replacement or simply a clip? Christoph Huber Chirurgie Cardio Vasculaire HUG

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3 La chirurgie cardiaque innovatrice et durable

4 Mitral valve disease Mitral regurgitation in 1.7% of the population, 56% of individuals with congestive heart failure. MR is a major cause of heart failure and disability. 1 Severe MR compromises left ventricular function, induces pulmonary hypertension, alters heart architecture and predisposes to atrial fibrillation Nkomo VT, Gardin JM, Skelton TN. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368: McCarthy KP, Ring L, Rana B. Anatomy of the mitral valve: understanding the mitral valve complex in mitral regurgitation. Eur J Echocardiogr. 2010;11:i3-i9.ar heart diseases: a population-based study. Lancet Sep 16;368(9540):

5 Prevalence of mitral valve disease > 70 years increased prevalence of 5.5% 1 MR second most frequently operated valve disease 2 Can remain asymptomatic Severe MR most likely becomes symptomatic after 6 years 1. Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study) Am J Cardiol. 1999;83(6): Lee EM, Porter JN, Shapiro LM, et al. Mitral valve surgery in the elderly. Journal of Heart Valve Disease. 1997;6(1):22 31.

6 Prevalence of mitral valve disease Prevalence of mitral and aortic valve disease 60-70y 2.3%, >70 5.5% Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet Sep 16;368(9540):

7 Paradigm shift in mitral surgery? 2014 Replacement Repair Replacement Repair Acker MA et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med Jan 2;370(1):23-32.

8 Paradigm shift in mitral surgery? Acker MA et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med Jan 2;370(1):23-32.

9 Paradigm shift in mitral surgery? 2014 Replacement Repair -No significant outcome difference between repair and replacement in regards of remodelling and survival Replacement is more durable Acker MA et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med Jan 2;370(1):23-32.

10 Paradigm shift in mitral surgery? Is it new? Gillinov AM et al. Repair versus replacement for degenerative mitral valve disease with coexisting ischemic heart disease. J Thorac Cardiovasc Surg. 2003;125(6): Repair = replacement De Bonis M et al. Mitral replacement or repair for functional mitral regurgitation in dilated and ischemic cardiomyopathy: is it really the same? Ann Thorac Surg. 2012;94(1): Repair better than replacement Acker MA et al. Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med. 2014;370(1): Replacement better than repair

11 Mitral valve Drawing from Walt Disney for Ch. Bailey 1946

12 Structural vs functional = Primary vs secondary In primary MR, the valvular incompetence is caused by compromised or structurally disrupted components of the valve apparatus in functional (secondary) MR the valve is structurally normal, with the regurgitation resulting from failure of coaptation of the mitral valve leaflets without coexisting structural changes of the valve itself.

13 Structural vs functional = Primary vs secondary normal Primary structural Primary structural Secondary functional

14 Structural vs functional = Primary vs secondary Functional / secondary Structural/primary

15 Geometric MR in Dilated Cardiomyopathy loss of closure cylinder Badhwar, Bolling, chapter in: Advances in Heart Failure, 2004

16 Geometric MR in Ischemia Badhwar, Bolling, chapter in: Advances in Heart Failure, 2004

17 Structural vs functional = Primary vs secondary Functional mitral regurgitation is a common clinical entity which will likely increase in the future due to predicted demographic changes. It is also associated with poor long-term survival.

18 Nishimura RA; American Heart Association AHA/ACC guideline for the management of patients with valvular heart disease: Guidelines. J Thorac Cardiovasc Surg Jul;148(1):e1-e132.

19 One fits all vs. tailored treatments options

20 One fits all vs. tailored treatments options

21 One fits all vs. tailored treatments options

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23 Durability of surgical mitral valve

24 Freedom from SVD > 60y Bourguignon T et al.. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged years. Eur J Cardiothorac Surg May;49(5):

25 Freedom from SVD 50 65y CONCLUSIONS: In patients aged years undergoing AVR with the Carpentier-Edwards Perimount bioprosthesis, the expected valve durability was 19 years. Age was not a significant risk factor for SVD within this age group. Patient selection and attention to timing of reinter- vention may be determinants of long-term outcomes. Bourguignon T et al.. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged years. Eur J Cardiothorac Surg May;49(5):

26 Mitral valve durability Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year followup of 450 implantations. The expected valve durability was 16.6 years for the entire cohort (11.4, 16.6, and 19.4 years for patients aged <60, 60 to 70, and >70 years, respectively Bourguignon T, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25- year follow-up of 450 implantations. J Thorac Cardiovasc Surg Nov;148(5): e1.

27 Durability of surgical mitral valves From 2008 through 2011 (our 4-year study period), 70 Magna valves were implanted in the mitral position at a single institution (the Cleveland Clinic) - Thermofix 90 % of patients were free from significant structural valve degeneration at 5 years Gabriel Loor et al. The Carpentier-Edwards Perimount Magna mitral valve bioprosthesis: intermediate-term efficacy and durability. J Cardiothorac Surg. 2016; 11: 20.

28 Factors leading to calcification Schoen FJ, Levy RJ. Tissue heart valves: current challenges and future research perspectives. J Biomed Mater Res. 1. Intrinsic cuspal calcification can be prevented or delayed by calcium mitigant treatment 2. Structural degeneration due to stress can be prevented or delayed by tissue selection, leaflet design and valve circularity *No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue treatment in patients.

29 Comparison of anti-calcification treatments Degree of Anti-Calcification Medtronic CoreValve Medtronic Engager Medtronic Engager Symetis Acurate TA JenaValve TA DirectFlow TF St Jude Portico Medtronic CoreValve Evolut Edwards SAPIEN XT THV None (Glutaraldehyde Fixation) Only one binding site addressed Both binding sites addressed (Residual glut. & Phospholipids)

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31 Durability Circle Low Leaflet Stress Ellipse Higher Leaflet Stress Areas of high stress can induce collagen degeneration that over time could lead to tearing and valve failure 1 Valve designs that reduce leaflet stresses are likely to have improved performance in long-term applications 2 1.Schoen Frederick J. Cardiac Valve Prostheses: Pathological and Bioengineering Considerations. J Cardiac Surg. 1987;2: Sun W., Li K., Sirois E. Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment. J Biomech. 2010;43:

32 Circularity at the annulus maximizes area and flow to minimize load on the left ventricle

33 The principles of aortic valve replacement have not changed since 1962 (1) Principles Surgical and transcatheter aortic valve Predictable procedure Optimal hemodynamics Low rate of complications Durability (1) Harken DF, et al. Aortic valve replacement with a caged ball valve. Am J Cardiol 1962;9:

34 The Alfieri stitch the double orifice valve Maisano F Alfieri O. The edge-to-edge technique: a simplified method to correct mitral insufficiency. Eur J Cardiothorac Surg 1998;13(3):240-5.

35 Mitraclip

36 Accelerated Development of TAVI devices

37 Current CE Mark Approved Devices* Medtronic CoreValve Edwards SAPIEN XT Symetis ACCURATE TA Edwards SAPIEN 3 JenaValve Medtronic Engager Sadra Medical Lotus St. Jude Portico Direct Flow Medical *As of 2014

38 DEVICES PENDING CE MARK APPROVAL Edwards CENTERA Medtronic Evolut R Symetis ACCURATE TF JenaValve Plus Colibri Heart Valve Heart Leaflet Technology NVT Allegra Trinity Valve

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40 Transcatheter mitral valve replacement Tendyn Edwards FORTIS Twelve Tiara Edwards CardiAQ

41 Transcatheter mitral valve replacement

42 Transcatheter mitral valve replacement Five transcatheter mitral valve systems implanted in humans: CardiAQ valve system (CardiAQ Valve Technologies, Inc.) Tiara valve (Neovasc Inc., Richmond, Canada); FORTIS valve (Edwards Lifesciences, Irvine, CA, USA); Tendyne valve (Tendyne Inc., Roseville, MN, USA); Twelve valve (Twelve, Inc., Redwood City, CA, USA). Common features: Nitinol self-expanding frames, Trileaflet valves, Bovine pericardial leaflets (Tendyne porcine), Fabric sealing skirt (CardiAQ is pericardial) Transapical delivery (CardiAQ also transseptal)

43 Transcatheter mitral valve replacement - Limitations

44 CardiAQ (A) The valve consists of a self-expanding nitinol frame that carries 3 leaflets of bovine pericardial tissue. Implantation sequence of CardiAQ valve: ( B ) coaxial align- ment, ( C ) opening of the ventricular anchors, ( D ) opening of the atrial anchors, and ( E ) final release of the CardiAQ valve before removal the delivery system. F, Left ventriculogram.

45 Tiara valve The D-shape of the valve, with atrial skirt and saddle-shaped valve. B, Transapical 32F delivery system. Implantation sequence ( C ) the coronary sinus wire outlines the mitral annulus; delivery system is through the mitral annulus into the left atrium; ( D ) opening of the atrial ( E ) the atrial skirt is open ( F ) final release of the Tiara valve, before removal of the delivery system.

46 Tendyn Self-expanding metal alloy frame made of an inner stent containing a trileaflet porcine pericardial valve and an outer stent. ( B ) access of left atrium with dilator and sheath; ( C ) advancement of valve within sheath, deploying valve in left atrium; tether traction is used to position the valve in native annulus; ( D ) the polymer tether allows the valve to be captured for repositioning

47 Endovalve The Endovalve system is a foldable nitinol structure that is designed to conform to the mitral annulus and attaches to the native valve with specially designed grippers

48 HighLife transcatheter mitral

49 Neocord transapical

50 Coronary sinus devices Carillion Monarc Coapsys Progressive design concepts in off-pump left ventricular remodeling mitral valve repair devices. David W. Yaffee et al. Ann Cardiothorac Surg July; 4(4):

51 Percutaneous Annuloplasty devices Cardioband Mitralign

52 Durabilité

53 Durabilité

54 Easy to get in but more difficult to get out

55 Sélection des patients

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57 Durability of Mitral Valve Surgery: Repair, Replacement or simply a clip? Christoph Huber Chirurgie Cardio Vasculaire HUG