Patient selection

Francesco Maisano, Ospedale San Raffaele, Milano, Italy

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

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

• 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

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

Risk of surgery

STS database isolated primary MV operation

• isolated mitral regurgitation 47,126

Gammie et al, Ann Thorac Surg 2009;87:1431–9

Repair rate

Hospital mortality and morbidity rate STS National Adult Cardiac Database

Gammie et al, Ann Thorac Surg 2009;87:1431–9

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

• 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

Durability

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

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

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

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

Techniques to treat MRfactors involved in the choice

techniques

• Leaflet level– Resections– Plications– Edge-to-edge

• Chordal level– Chordal replacement– Chordal transposition

• Papillary muscle level– Papillary repositioning– Papillary cinching

• Annular level– annuloplasty

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

STRUCTURE AND FUNCTION

structure function

Survival benefit

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

Surgery vs Mitraclip TM

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

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

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

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