Pt Selection For Mitraclip Eacts 2010
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Patient selection
Francesco Maisano, Ospedale San Raffaele, Milano, Italy
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Disclosure Statement of Financial InterestWithin the past 12 months, I or my spouse/partner have had a financial Interest /arrangement or affiliation with the organization(s) listed below
Affiliation/Financial Relationship CompanyGrant/ Research Support:
Consulting Fees/Honoraria: Abbott, Edwards, Nycomed Medtronic, St Jude, Valtech Cardio
Major Stock Shareholder/Equity Interest:
Royalty Income: Edwards
Ownership/Founder:
Salary:
Intellectual Property Rights:
Other Financial Benefit:
• Consultant for Abbott: financial conflict• Performs both surgical mitral repair and
Mitraclip interventions: internal conflict
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EVEREST Trial Anatomic Eligibility
• Sufficient leaflet tissue for mechanical coaptation
• Non-rheumatic/endocarditic valve morphology
• Protocol anatomic exclusions– Flail gap >10mm – Flail width >15mm– LVIDs > 55mm– Coaptation depth >11mm – Coaptation length < 2mm
Feldman T et al., J Am Coll Cardiol 2009;54:686–94
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• Mitral repair is a surgical success storyLow operative riskRecovery of life expectancyLow rate of recurrence when appropriate
procedures are performedMinimally invasive techniques increasingly
performed
Current status of surgical repair of MR
Everest Peak, Himalaya complex
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Euro Heart Survey: 50% symptomatic patients with severe MR are denied surgery
Isolated MR(n=877)
Severe MR(n=546)
No Severe MR
(n=331)
No Symptoms
(n=144)
Symptoms(n=396)
No Intervention(n=193) 49%
Intervention(n=203) 51%
Mirabel et al, European Heart J 2007;28:1358-1365
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Risk of surgery
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STS database isolated primary MV operation
• isolated mitral regurgitation 47,126
Gammie et al, Ann Thorac Surg 2009;87:1431–9
Repair rate
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Hospital mortality and morbidity rate STS National Adult Cardiac Database
Gammie et al, Ann Thorac Surg 2009;87:1431–9
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Influence Of Hospital Volumeson Repair Prevalence and Risk
Gamie et al. Circulation. 2007;115:881-887
13.614 patients having elective isolated MR surgery between 2000 and 2003 in 575 US centers participating in the STS National Cardiac Database
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• Older age is associated toHigher mortality (x3)
Higher morbidity (x3)
Longer LOS (x1.5)
Age and comorbidities
Mehta et al. Ann Thorac Surg 2002;74:1459-67
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Durability
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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
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A lesson from the EVEREST trial
• the first clinical trial for treatment of patients with MR to report a prospective, systematic, and 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
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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
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Durability: Freedom from recurrent MR>2+
96%
71%
Linearized rate of recurrent MR>2+: 3.7%pt-year
FMR recurrence 5-10%pt/year
Flameng W, et al. Circulation. 2003;107:1609-1613Ciarca A. et al Am J Cardiol 2010;106:395-401Lee AP et al Circulation 2009;119:2606-14Hung J. et al. Circulation 2004;110:II85-90
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Techniques to treat MRfactors involved in the choice
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techniques
• Leaflet level– Resections– Plications– Edge-to-edge
• Chordal level– Chordal replacement– Chordal transposition
• Papillary muscle level– Papillary repositioning– Papillary cinching
• Annular level– annuloplasty
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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
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STRUCTURE AND FUNCTION
structure function
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Survival benefit
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Long term survival after surgical repair
Early treatment of DMR restores life expectancy
• Comorbidities and operative risk• Recurrent MR and MS• Lack of reverse remodeling
Surgical vs Medical Rx in DCM-MR
David T et al, J Thorac Cardiovasc Surg 2003;125:1143-52A. Wu, et. Al. JACC 2005, 45:381-387
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Surgery vs Mitraclip TM
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Is Mitraclip the first choice for DMR?
• In experienced centers, DMR is treated with repair at low risk, long term durability of repair is achieved in the majority of patients – 50% of Euro Heart Survey were not
referred• EHS
– Age and comorbidity increase the risk of surgery
• STS database
– Consider the quality of life issue• EVEREST QoL
– Individual cases
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Is mitraclip the first choice for FMR?
• Surgical treatment of FMR is associated with– High hospital mortality– High recurrence rate – Long hospital stay– Unproven survival benefit
• Mitraclip for FMR– Procedure more simple than for DMR– Improvement of symptoms at low risk– HRR suggests survival benefit– Failure does not modify the surgical option
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Surgery vs Mitraclip
Chance of correcting MR with Mitraclip
Ris
k o
f su
rger
yLo
w
H
igh
Low High
Risk of Mitraclip
procedure
• Risk of Mitraclip procedure
• Preservation of surgical option
• Long term results of Mitraclip
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Individualize the therapy
• Anatomy and function• Comorbidities, Life
expectancy• Compare risk and
probability of success• Preservation of surgical
option• Patient informed consent
for therapy• collaboration