Invited Lecture at the Hanshin Heart Valve Symposium on the State of the art mitral valve repair techniques (Osaka, 2009)

1. Francesco Maisano, MD
San Raffaele University Hospital
Milano - ITALY

2. Disclosures
• I disclose the following potential conflicts
– Edwards Lifesciences: consultant, royalties
– Micardia: consultant, stock options
– Valtech: Consultant
– Nycomed: consultant
– Medtronic: honoraria
– St Jude: honoraria

3. MV repair is superior to MVR
• Better preservation of LV function
• Avoidance of prosthesis related events
• Reduced hospital mortality
• Reduced morbidity and LOS
• Improved long term survival
Thourani et al, Circulation 2003; 108:298-304
Zaho et al, JTCVS 2007;1257-1263
Shuhaiber J et al, EJCTS 2007; 31:267-275
Perrier P et al, Circulation 1984;70:187
Akins CW, et al. ATS 1994; 58:668-676

4. MV repair: Art or Science?
The wedding of the
Virgin
Raffaello Sanzio,
1483 - 1520
Milano, PinacotecadiBrera

5. Techniques to treat MR
factors involved in the choice
Anatomy Function Ethiology

6. Mechanism of regurgitation
functional classification
« Surgeons are not basically concerned withlesions. We care more about
function. Therefore one may define the aim of a valve reconstuction as
restoring normal leaflet function rather than normal valve anatomy »
A. Carpentier, the French Correction 1984

7. structure function

8. Ethiology
Organic Functional
• Degenerative • Ischemic
• Barlow’s
• DCM
• Dystrophic
• Marfan’s • Secondary to AS
• Other
• Endocarditis
• Rheumatic
• Post-traumatic

9. Ethiology
Organic Functional
• Degenerative • Ischemic
• Barlow’s
• DCM
• Dystrophic
• Marfan’s • Secondary to AS
• Other
• Endocarditis
• Rheumatic
• Post-traumatic

10. Posterior leaflet prolapse/flail
• Quadrangular
resection
• Sliding plasty
• Chordal replacement
• Haircut technique
• Folding plasty
• Alfieri / E2E
• ….

11. Quadrangular
resection
Sliding plasty

12. Posterior leaflet chordal repair
• Minimally invasive
• when P1 and P3 are
hypoplasic
• to obtain wider
surface of
coaptation

13. ChordaeReplacement Versus
ResectionforRepairofIsolatedPosteriorMitralLeafletProlapse:
ÀÈgalité
Seeburgeret al. AnnThoracSurg 2009;87:1715–20)

14. Neochordae
Disadvantages
• Difficult sizing
Advantages
• Anatomical reconstruction
• No resection needed
Gillinov, JTCVS 2008

15. Adjustable chordae (Valtech Inc)

16. Anterior and Bileaflet disease
• Chordal replacement
• Alfieri / E2E
• Chordal transfer
• Papillary muscle
repositioning
• Triangular resection
• …..

17. The edge-to-edge technique
• First case performed in 1991
• Over 1500 published cases
accumulated worldwide
• About 15 yrs follow-up
• Technically simple and
reproducible
• Versatile
• Criticized by some surgeons
– Used only as a bailout

18. Surgical technique
Maisano F et al. EJCTS 1998

19. Special situations
• Calcified annulus
• Endocarditis
• Congenital
• Rheumatic

21. Hospital mortality and repair rate
STS National Adult Cardiac Database
• Hospital mortality for
isolated first time 100%
elective MV repair is 80%
2.5% (males) to 3.9% 60%
(females) 40%
20%
• Operative risk is higher 0%
in elderly 1991 1993 1995 1997 1999
pts, associated
Replacement Repair
CABG, NYHA III-IV, low
EF and reoperation
Savage EB, et al Ann Thorac Surg 2003;75:820–5

22. Influence Of Hospital Volumes
on Repair Prevalence and Risk
13.614 patients having elective isolated MR surgery between 2000
and 2003 in 575 US centers participating in the STS National
Cardiac Database
Gamie et al. Circulation. 2007;115:881-887

23. Age and comorbidities
• Older age is associated to
 Higher mortality
 Higher morbidity
 Longer LOS
• 2/3 of pts older than 70
years are denied surgery
(Euroheart Survey)
Mehta et al. Ann Thorac Surg 2002;74:1459-67

24. UNMET CLINICAL NEED
surgeryisoftendenied in the olderpatients
Isolated MR
(n=877)
2/3 of symptomatic
No Severe MR Severe MR
MR patients >70 are
(n=331) (n=546)
denied surgery
No Symptoms Symptoms
(n=144) (n=396)
No Intervention Intervention
(n=193) 49% (n=203) 51%
Mirabel et al, European Heart J 2007;28:1358-1365

25. Prevalenceof valve disease in the population: MR and
AR are epidemicin the elderly
US population older than
75 years (forecast 2015)
Severe MR 1,419,419
Severe AR 342,944
Severe TR ?
Health Research International Report 2009
Nkomo et al , Lancet 2006

26. LONG-TERM SURVIVAL

27. Very Long Term Survival for
>20 years in 162 pts with Organic MR
Braunberger, et al Circulation. 2001;104[suppl I]:I-8-I-11.

28. Preoperative LV Function Predicts Long Term Postoperative
Survival
100 Ejection Fraction
80 72%
Survival (%)
60 53%
EF  60%
40
EF 50-60%
EF < 50% 32%
20
P = 0.0001
0
0 2 4 6 8 10Years
Enriquez-Sarano M et al. Circulation 1994; 90: 830 - 37

29. Preoperative Symptoms and
Long Term Survival
• If mitral repair is performed before the onset of
severe symptoms (congestive heart
failure, arrhythmias), life expectancy is restored
David T et al, J Thorac Cardiovasc Surg 2003;125:1143-52

30. durability

31. Durability
• Definition
• Freedom from reoperation
• Recurrent MR
• Hemolysis
• Other valve disease
• Freedom from recurrent MR
• Methodology
• Single institutions vs Registry
• Visit vs phone calls
• Serial vs instant follow-up
• Internal vs Core lab review

32. A lesson from the interventional
cardiologists….EVEREST trial
• the first clinical trial for
treatment of patients with
MR to report a
prospective, systematic, a
nd integrative approach to
the analysis of MR severity
at baseline and follow-up
that included quantitative
parameters.
• CORE LAB
Foster E, et al Am J Cardiol 2007;100:1577–1583

33. Durability: Freedom from Reoperation
1072 patients with degenerative mitral regurgitation
operated upon at CCF between 1985 and 1997
Gillinov et alJ Thorac Cardiovasc Surg 1998;116:734-43

34. The Bad News….
Flameng W, et al. Circulation. 2003;107:1609-1613

35. Durability: Freedom from recurrent MR>2+
96%
Valve
anatomy
71%
Linearized rate of recurrent MR>2+: 3.7%pt-year
Surgical
Ethiology
expertise
Flameng W, et al. Circulation. 2003;107:1609-1613

36. Ethiology: controversial factor
Fibroelastic Deficiency
• Elderly pt, recent onset MR
• No excess tissue
• Thickening of prolapsing area, remaining valve
thinner and transparent
• Mild annular dilatation
• Chordae thinner
• Segmental lesions
Myxomatous degeneration
• Middle aged pt, long-lasting history of MR
• Excess tissue
• Myxoid appearance
• Annular dilatation
• Chordae thickened
• Diffuse type II lesions
Fornes et alCardiovascular Pathol 1999;8:81-92

37. Role of pathology on durability
• Barlow’s disease may be
associated with shorter
durability
Flameng W, et al JTCVS 2008;135:274-82

38. Durability: ALP vs PLP
Braunberger, et al Circulation. 2001;104[suppl I]:I-8-I-11.
Gillinov et al J Thorac Cardiovasc Surg 1998;116:734-43

39. Techniques for ALP treatment
Chordal shortening Chordal replacement
Smedira NG, et al,J Thorac Cardiovasc Surg 1996;112:287-92)

40. The influence of surgical technique:
ALP treated by E2E vs PLP treated by quadrang. resection
Freedom from reoperation MR grade at echo follow-up
P=N.S.
De Bonis et al, J Thorac Cardiovasc Surg 2006;131:364-70

41. Annuloplasty
• Annuloplasty is routinely performed during MV repair
• Annuloplasty reduces stresses on the suture and on the valve
structures and stabilizes annular diameter
• Lack of annuloplasty is associated to accelerated failure in the
overall surgical population
SI (kPa)
- 647
- 520
- 394
- 267
- 140
- 134
+ 113
+ 240
+ 367
+ 493
+ 620
+ 747
+873
+100
0
Maisano F, et al Eur J Cardiothorac Surg. 1999;15:419-25
Gillinov et al J Thorac Cardiovasc Surg 1998;116:734-43

42. Annuloplasty rings: one fits all?
Fedak, et al. Circulation. 2008;117:963-974

43. The solution for rheumatic disease
AnnuloFlo® System
The ring’srigidtitanium design
adheresto the classicapproach, while
the instrumentationredefines the
standard.

44. The solution for degenerative disesase
AnnuloFlex™ System
Reinforce the entire native annulus, or
only the posteriorportion. The
choiceisyourswith the AnnuloFlex
Annuloplasty Ring. The trueflexibilityof
the ring meansthree-
dimensionalcompliancethatmirrorsnatura
l valve dynamics.

45. MEMO 3D, the physiologic ring

46. Mitral repair without annuloplasty
Durability in selected patients
Chordal replacement Alfieri repair
Duebener LF, et al EJCTS 2000; 17:206-212
Maisano F, et al Eurointervention 2006; 6:181-186

47. Annular-to leaflet mismatch predicts need
for annuloplasty
mid esophageal mid esophageal mid esophageal
120° 90° 120°
Annuloplasty can be
avoided if SL/AL<1.4
SL AL
10% of current
surgical population
Maisano F, et al Am J Cardiol 2007;99:1434–1439

48. Coaptation
• Valve competence under variable loading
conditions (Coaptation Reserve)
• Reduction of stress on the
leaflets, subvalvar apparatus
• Excessive coaptation can be detrimental
(SAM)

49. Assessing coaptation
On Pump Off Pump Mitral Solutions
Adjustable rings
Micardia
Valtech

50. Valtech adjustable ring
24mm 35mm
adjustment
25mm
18 mm

51. Functional mitral regurgitation
• Valve structure is
preserved
• Left ventricular function
and shape is impaired
– Dilated Idiopathic
cardiomyopathy
– Ischemic cardiomiopathy
– IMR with preserved global LV
function

52. Mechanism of IMR - Tethering
2. Anterior leaflet
Tethering
(Seagull effect)
1. Apical and lateral
displacement of the
papillary muscles
2. Loweringof the
pointofcoaptation
(coaptationdepth)

53. Undersized annuloplasty is the
“conventional” method to treat FMR
Coaptation
lenght

54. Durability using conventional
non “disease-specific” rings
25-30% late
recurrence
rate
Hung et al. Circulation 2004.

55. New techniques to improve results
• Dedicated rings
– Preshaped
• Edwards Ethilogix
– Adjustable
• CardiacSolutions
• Micardia
• Subvalvar remodeling
– Chordal cutting
– Papillary muscle cinching
• External devices
– Coapsys
– Others

56. GEOFORM, IMR
Physio30 Geoform30
• Reduction of the SL
dimension
• Shortening of the
papillary muscle to
annulus distance
• Increasing coaptation
surface
PRE Post

57. Survival after undersized MVA
Surgical vs Medical Rx in DCM- CABG alone vs CABG+MVA in
MR IMR
A. Wu, et. Al. JACC 2005, 45 p. 381-387
Mihalijevic T et al. J Am Coll Cardiol 2007;49:2191–201

58. Reverse remodeling
Beeri et al. J Am Coll Cardiol 2008;51:476–86
De Bonis, et al . Ann Thorac Surg 2008;85:932–9

59. Duration of CHF is the main factor
De Bonis, et al . Ann Thorac Surg 2008;85:932–9

60. FMR: Early treatment the key ?
• Experimental model
of induced myocardial
infarction plus
controlled
ventriculoarterial
shunt simulating
MR overload
– Induction of MI
– Group 1: no MR treatment
– Group 2: MR abolished
Beeri R et al. Circulation 2007;116[suppl I]:I-288–I-293.

61. Early treatment of volume overload is
associated with reverse remodeling
Reverse remodeling in MI only, MI +MR Matrix metalloproteinase-2 and MMP
and MR repair inhibitors in MI only, MI +MR and MR
repair

62. conclusions
• Mitral repair is a surgical success story
 Low operative risk
 Recovery of life expectancy
 Low rate of recurrence when appropriate
procedures are performed
 Minimally invasive techniques are
increasingly performed
• Transcatheter techniques will face the
challenge of comparison with these
excellent results
– Increase the potential candidates for
treatment
– Reduce early risk in selected patients
– Enable earlier intervention