Mitral Valve Surgery: Lessons from New York State

Joanna Chikwe, MD

Professor of Cardiovascular SurgeryIcahn School of Medicine at Mount Sinai

Chairman & Program DirectorDepartment of Cardiovascular Surgery Mount Sinai St Luke’s

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Disclosures

• Icahn School of Medicine at Mount Sinai receives royalties from Edwards Lifesciences and Medtronic for Dr. David Adams’ involvement in developing two mitral valve repair rings and one tricuspid valve repair ring.

• Dr. David Adams is the National Co-Principal Investigator of the CoreValve United States Pivotal Trial, which is supported by Medtronic. 

• None of the sponsoring organizations had any role in the design and conduct of the study.

• None of the other authors have any conflicts of interest to disclose..  

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Background

• In non-elderly patients undergoing mitral valve replacement, the optimal prosthesis type is controversial.1,2

• Current guidelines recommend either mechanical or bioprosthetic valves in patients under 70 years of age,3,4 and state that the balance of risks favors mechanical valves in patients <60 years.3

1Kaneko, Cohn & Aranki, Circulation 20132Suri & Schaff, Circulation 20133Nishimura, Otto, & Bonow et al, JACC 20144Vahanian, Alfieri, & Andreotti et al, Eur Heart J 2012

Current evidence base

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Study Setting Age range Patients Survival

Oxenham et al Heart, 2003 Randomized1975-1979

56-79 AVR: 211MVR: 261Both: 61

Mech (overall): 25.0%Bio (overall): 22.6%(p=0.39) at 20 years

Hammermeister et al JACC, 2000

Randomized1977-1982

56-79 AVR: 394MVR: 181

Mech (MVR): 19%Bio (MVR): 21%(p=0.30) at 15 years

Kaneko et al JTCVS, 2014 Cohort1991-2012

<65 MVR: 250 Mech: 62.6%Bio: 40.4%(p<0.004)

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Research question

• In non-elderly patients undergoing mitral valve replacement: • Is there a survival difference between prosthesis types?• If not, does the balance of complications such as stroke, reoperation, or major

bleeding favor one prosthesis type over the other?

• Statewide planning and research cooperative Syststem(SPARCS)• Mandatory• All admissions, all visits to the emergency room, all ambulatory visits• Administrative

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Methodology

• Inclusion criteria• Primary mitral valve replacement (n=5340)• 1997-2007• Age 50-69

• Exclusion criteria• Out-of-state residents (7.0%, n=)• Prior replacement of any valve (7.8%)• Concomitant valve replacement (21.9%)• Concomitant aortic/pulmonary valve repair (1.1%)• Concomitant CABG (33.4%)• Concomitant thoracic aortic surgery (1.2%)

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Trend in mitral prosthesis choice

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Bioprosthetic Mechanical prosthetic

Year

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Patient characteristicsCo-morbidity Bioprosthetic

(n=664)Mechanical(n=664)

P value

Male 42% 42% 0.7

Age 60.8 61.0 0.58

Endocarditis 3% 4% 0.46

Bleeding disorder 7% 8% 0.52

Hypertension 56% 58% 0.28

Diabetes 21% 24% 0.68

Coronary artery disease 39% 39% 0.11

Peripheral vascular disease 3% 5% 0.43

Cerebrovascular disease 8% 9% 0.63

Congestive heart failure 57% 60% 0.28

Atrial fibrillation 46% 44% 0.35

COPD 21% 23% 0.47

Chronic kidney disease 9% 10% 0.43

Liver disease 7% 9% 0.18

Cancer 4% 4% 0.89

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30-day outcomesComplication Bioprosthetic

(n=664)Mechanical(n=664)

P value

Mortality 5% 4% 0.12

Stroke 2% 2% 0.85

Atrial fibrillation 13% 10% 0.13

Acute kidney injury 4% 4% 0.67

Respiratory failure 21% 16% 0.014

Readmission 22% 20% 0.41

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Results: survival

59.9%57.5%

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Results: reoperation

5.0%

11.1%

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Results: major bleeding

9.0%

14.9%

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Results: stroke

14.0%

6.8%

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Summary of findings

• We did not observe a survival difference between mechanical and bioprosthetic mitral

valves in propensity matched patients aged 50 to 69 years.

• The 15-year cumulative incidence of stroke and major bleeding were both

significantly higher in the mechanical group

• The 15-year cumulative incidence of reoperation was lower in the mechanical

prosthesis group

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Conclusions

• The main trade-off is between reoperation and stroke: patients with mechanical valves had a lower risk of reoperation but a greater risk of stroke.

• These findings support the expanded use of bioprosthetic valves in younger patients undergoing mitral valve replacement.

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Strengths & limitations• Large sample size• All levels of care represented – from tertiary referral centers to community

hospitals• Important clinical endpoints

• Accuracy of coding• Unable to determine when patients were hospitalized outside of New York

State• Absence of potential confounding variables e.g. etiology of valve disease,

extent of coronary artery disease, and ventricular dysfunction• Lack of operative detail

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NYS work in progress

• Validating method of reliably identifying degenerative and ischemic patients

• Combining SPARCS data with clinical datasets such as New York State report cards:

• Additional validation of dataset

• Better information on LV function, valve dysfunction and precise distribution of coronary

artery disease

• More detailed operative

• Long-term outcomes of repair versus replacement in ischemic mitral valve disease

• Long-term outcomes of isolated CABG versus concomitant mitral surgery in patients with

ischemic MR undergoing CABG

• Impact of surgeon experience on degenerative mitral valve repair rates and durability

• Impact of atrial fibrillation on long-term outcomes after mitral valve surgery

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Thank you

David H. Adams MD

Yuting Chiang MSc, MD

Natalia Egorova PhD

Annetine Gellijns MD

Shinobu Itagaki MD

Alan Moskowitz MD

Nana Toyoda MD