Evidence-Based Management of Valvular Heart Disease

Evidence-Based Management

of Valvular Heart Disease

Robert O. Bonow, M.D.Bluhm Cardiovascular Institute

Northwestern Memorial Hospital Northwestern University Feinberg School of Medicine

Consultant: Edwards Lifesciences

Cardiology 2008:Innovations & Challenges

Cardiology 2008:Innovations & Challenges

Journal of the American College of Cardiology @ 2006 byt the American College of Cardiology and the American Heart Association, Inc. Published by Elsevier, Inc.

Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

doi:10.1016/j.jacc.2006.05.021

ACC/AHA PRACTICE GUIDELINES

ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart DiseaseA Report of the American College of Cardiology/American HeartAssociation Task Force on Practice Guidelines (Writing Committeeto Revise the 1998 Guidelines for the Management of PatientsWith Valvular Heart DiseaseDeveloped in Collaboration With the Society of Cardiovascular AnesthesiologistsEndorsed by the Society of Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons

WRITING COMMITTEE MEMBERS

Robert O. Bonow, MD, FACC, FAHA, Chair

Blase A. Carabello, MD, FACC, FAHA Bruce Whitney Lytle, MD, FACCKanu Chatterjee, MD, FACC, FAHA Rick A. Nishimura, MD, FACC, FAHA Antonio C. De Leon, Jr, MD, FACC, FAHA Patrick T. O’Gara, MD, FACC, FAHADavid P. Faxon, MD, FACC, FAHA Robert A. O’Rourke, MD, MACC, FAHAMichael D. Freed, MD, FACC, FAHA Catherine M. Otto. MD, FACC, FAHAWilliam H. Gaasch, MD, FACC, FAHA Pravin M. Shah, MD, MACC, FAHA Jack A. Shanewise, MD

www.acc.orgwww.americanheart.org


Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

doi:10.1016/j.jacc.2006.05.021


ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease

• Quantification of valve severity• Indications for mitral valve repair• Ischemic mitral regurgitation• Indications for aortic valve replacement • Low gradient, low output aortic stenosis• Bicuspid valves with aortic root dilatation• Endocarditis prophylaxis

Key recommendations:

Mitral Regurgitation

Mitral regurgitation Severe

Regurgitant volume (ml) >60Regurgitant fraction (%) >50

Regurgitant orifice (cm2) >0.4

Mitral regurgitation Severe

Regurgitant volume (ml) >60Regurgitant fraction (%) >50

Regurgitant orifice (cm2) >0.4

Aortic Stenosis

Aortic stenosis Severe

Jet velocity (m/sec) >4.0Mean gradient (mmHg) >40

Valve area (cm2) <1.0

Valve area (cm2/m2) <0.6

Aortic stenosis Severe

Jet velocity (m/sec) >4.0Mean gradient (mmHg) >40

Valve area (cm2) <1.0

Valve area (cm2/m2) <0.6


Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

doi:10.1016/j.jacc.2006.05.021



Mitral regurgitation and aortic stenosis:


Chronic Severe Mitral Regurgitation - 2006

Indications for operation:• Symptoms class I• LV systolic dysfunction class I

• EF <60% or serial EF• LVSD >40mm or serial ESD

• Pulmonary Hypertension class IIa• RV dysfunction class IIa• Atrial fibrillation class IIa• Severe MR with repair feasible?

ACC/AHA Guidelines 2006ACC/AHA Guidelines 2006

0

10

20

30

40

50

0 1 2 3 4 5 6 7 8 9

Pro

ced

ure

s

Society of Thoracic Surgeons Database, 2005

MV Repair

MV Replacement 5000

00

Year

19931993 19941994 19951995 19961996 19971997 19981998 19991999 20002000 20012001 20022002

4000

3000

2000

1000

20032003

Contemporary Use of Mitral Valve Repair

Should all asymptomatic patients

with chronic severe MR undergo

mitral valve repair?

…if you are certain it will be repaired?

Mitral RegurgitationSurvival of Patients With Flail Leaflets

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10 11

Time (years)

Su

rviv

al (

perc

ent)

Observed

from Ling et al, N Engl J Med 1996

55%

Expected

• 456 patients with MR• Evaluated 1991-2000• Initially asymptomatic with normal LVEF• Management by individual patient’s physician• Follow-up information collected in 2002

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8

Ca

rdia

c S

urv

iva

l (%

)

from Sarano et al. N Engl J Med 2005;352:875-883

0 1 2 3 4 5

Mitral RegurgitationNatural History of Asymptomatic Chronic MR

Time (years)

ERO 20-39 mm2

ERO <20 mm2

ERO >40 mm2

Valvular Heart Disease

Outcome of Watchful Waiting in Asymptomatic SevereMitral Regurgitation

Raphael Rosenhek, MD; Florian Rader, MD; Ursala Klaar, MD; Harald Gabriel, MD; Marcel Krejc, PhD;Daniel Kalbeck, PhD; Michael Schemper, PhD; Gerald Maurer, MD; Helmut Baumgartner, MD

Circulation 2006;113:2238-2244

41 patients with events:

21 symptoms10 LV criteria10 PA criteria 7 Atrial fibrillation 1 SBE

41 patients with events:

21 symptoms10 LV criteria10 PA criteria 7 Atrial fibrillation 1 SBE

2 deaths in patients2 deaths in patientswho refused surgerywho refused surgery

132 patients62 month follow-up

Indications for surgery:• Symptoms• LV dilatation (ESD >45mm)• LV dysfunction (EF <60%)• Atrial fibrillation• PA pressure > 50 mmHg

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10

from Rosen et al. Am J Cardiol 1994; 74: 374-380Sarano et al. N Engl J Med 2005;352:875-883

Rosenhek et al. Circulation 2006;113:2238-2244

0 1 2 3 4 5 6 7 8 9 10

Mitral RegurgitationNatural History of Asymptomatic Severe MR

Time (years)

Rosen

Rosenhek

Sarano

Aliv

e, A

sym

pto

ma

tic

with

ou

t Su

rger

y (%

)

ACC/AHA 2006 Guidelines for the Management of PatientsWith Valvular Heart Disease

www.acc.org www.amaericanheart.org

Chronic Mitral Regurgitation


Class IIaClass IIa

Class IClass I

Indications for surgery:

MV repair is reasonable in experienced surgical centers for asymptomatic patients with chronic severe MR with preserved LV function in whom the likelihood of successful repair without residual MR is greater than 90%.

MV repair is recommended over MV replacement in the majority of patients who require surgery, and patients should be referred to surgical centers experienced in MV repair.

Cardiovascular Surgery

Influence of Hospital Procedural Volume on Care Processand Mortality for Patients Undergoing Elective Surgery for

Mitral Regurgitation

James S. Gammie, MD; Sean O’Brien, PhD; Bartley P. Griffith, MD;T. Bruce Ferguson, MD; Eric D. Peterson, MD

Circulation 2007;115:881-887

STS Database2000-2003

13,674 patients575 NA hospitals

19 criteria for best practice: • Surgical training• Intraoperative echocardiography• Volume thresholds• Audit• Cardiology and imaging

Surgeon: >25/yrHospital: >50/yrSurgeon: >25/yrHospital: >50/yr

Operative mortality <1%5 year reoperation <5%Operative mortality <1%5 year reoperation <5%

INTERVENTIONAL CARDIOLOGY AND SURGERY

Mitral repair best practice: proposed standards

B Bridgewater, T Hooper, C Munsch, S Hunter, U von Oppell, S Livesty, B Keogh,F Wells, M Patrick, J Kneeshaw, J Chambers, N Masani, S Ray

Heart 2006;92:939-944


Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

doi:10.1016/j.jacc.2006.05.021





Carpentier’s Functional Classification

Type IIIb

Carpentier. J Thorac Cardiovasc Surg 1983;86:323-337

Restricted Leaflet MotionRestricted Leaflet Motion

0

20

40

60

80

100

0 1 2 3 4 5 6Time (years)

Su

rviv

al (

perc

ent)

Su

rviv

al (

perc

ent)

00 11

p=0.001

Effect of MR on Survival Post-MI

22 33 44 55

Ischemic MR

Grigioni et al. Circulation 2001;103:1759-1764

61%61%

47%47%

29%29%

ERO = 0

ERO 1-19

ERO ≥20

100100

8080

6060

4040

2020

00

0

20

40

60

80

100

0 1 2 3 4 5 6Time (years)

On

set o

f He

art

Fa

ilure

(%

)O

nse

t of H

ea

rt F

ailu

re (

%)

00 11

p=0.001

Development of Heart Failure

22 33 44 55

Ischemic MR

Grigioni et al. Circulation 2001;103:1759-1764

68%

46%

18%ERO = 0

ERO 1-19

ERO ≥20

100100

8080

6060

4040

2020

00

Ischemic Mitral Regurgitation

• Should it be repaired ?

• Moderate MR in a patient undergoing CABG ?

• How should it be repaired (or replaced)?

Ischemic Mitral Regurgitation

Moderate MR in a CABG patient

• Untreated MR persists and often progresses

• Even moderate MR has a poor prognosisin a patient undergoing CABG

• Late survival and functional class are more favorable with CABG plus mitral repair

Unlike repair of myxomatous MR, recurrent ischemic MR is common

……compared to CAGB alone…compared to CABG plus MVR

7.3.1. Mitral Valve Repair


3.6.5. Ischemic Mitral Regurgitation

ACC/AHA Guidelines for the Management of PatientsWith Valvular Heart Disease


CABG alone is usually insufficient and leaves many patients with significant residual MR, and these patients would benefit from concomitant MV repair at the time of CABG.

7.3.1.3. Ischemic Mitral Valve Disease:When functional MR is severe, it may be corrected by placement of an annuloplasty ring that decreases annular circumference, shortens the intertrigonal distance, reduces the septal-lateral annular diameter and restores the geometry of the annulus,thereby allowing the leaflets to coapt.


Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

doi:10.1016/j.jacc.2006.05.021





Aortic Stenosis

Aortic valve replacement:

• Improves symptoms

• Improves LV function

• Improves survival

Symptomatic Patients


Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

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Severe Aortic Stenosis

Indications for aortic valve replacement:• Symptomatic patients• Patients undergoing CABG or surgery on the aorta or another valve• Patients with LV systolic dysfunction

class Iclass I

class Iclass I

class Iclass I

Aortic Stenosis

Are asymptomatic patientsreally asymptomatic?

Aortic StenosisPredictive Value of Exercise Testing

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10 11 12

Sym

pto

m-F

ree

Su

rviv

al

(per

cen

t)

No symptomsn=79

Limiting symptomsn=46

p<0.001

Time (months)

Das et al Eur Heart J 2005;26:1309-1313



Aortic Stenosis


Class IIbClass IIb

Class IIbClass IIb

Exercise Testing:

Exercise testing in asymptomatic patients with AS may be considered to elicit exercise-induced symptoms and abnormal blood pressure responses.

Indications for Aortic Valve Replacement:

AVR may be considered for asymptomatic patients with severe AS and abnormal exercise response (e.g., development of symptoms or asymptomatic hypotension).

Aortic Stenosis

Are asymptomatic patientsat risk of sudden death?

Sudden Death in Asymptomatic Aortic Stenosis

Follow-up SD without n (years) symptoms

Chizner 1980 8 5.7 0Turina 1987 17 2.0 0Horstkötte 1988 35 “years” 3

Kelley 1988 51 1.5 0Faggiano 1992 37 2.0 0Otto 1997 123 2.5 0Rosenhek 2000 106 2.3 1Amato 2001 66 1.3 4Das 2005 125 1.0 0Pellikka 2005 622 5.4 11

Total 1190 3.7 19

Natural History of Asymptomatic AS

0

20

40

60

80

100

0 1 2 3 4 5

from Otto et al. Circulation 1997;95:2262-2270

Vmax > 4.0

Vmax < 3.0

Vmax 3.0 - 4.0

n=123Age 6316

Time (years)

Asy

mpt

om

atic

with

out

AV

R (

%)

00 11 22 33 44 55


0

20

40

60

80

100

0 1 2 3 4 5Time (years)

Asy

mpt

om

atic

with

out

AV

R (

%)

Otto

Rosenhek

0 1 2 3 4 5

Patients with Severe AS (Vmax >4 m/s)

from Otto et al. Circulation 1997;95:2262-2270Rosenhek et al. N Engl J Med 2000;343:611

Pellikka et al. Circulation 2005;111:3290-2395

Pellikka

0

20

40

60

80

100

0 1 2 3 4 5

Moderate or severe calcificationModerate or severe calcification

No or mild calcificationNo or mild calcification

p<0.001

Time (years)

Asy

mpt

om

atic

with

out

AV

R (

%)

Severe ASSevere AS


Rosenhek et al. N Engl J Med 2000;343:611



Aortic Stenosis

Class IIbClass IIb

Indications for Aortic Valve Replacement:

• AVR may be considered for adults with severe asymptomatic AS if there is a high likelihood of rapid progression (age, calcification, and CAD) or if surgery might be delayed at the time of symptom onset.

Average hospital mortality: 8.8%

• Low volume centers 13.0%

• High volume centers 6.0%

Goodney et al, Ann Thorac Surg 2003;76:1131-1337

Aortic Valve ReplacementHospital Mortality

Data from national Medicare database 1994-1999684 hospitals

142,488 AVRs

Medicare data

Identifying Risk of AVR

• STS risk calculator24 variablesvalidated in 210,000 patients

www.sts.org

• euroSCORE17 variablesvalidated in >500,000 patients

www.euroscore.org

Shroyer et al. Ann Thorac Surg 2003;75:1856-1865Nashef et al. Eur J Cardiovasc Surg 1999;16:9-13

Ambler et al. Circulation 2005;112:224-231

• Valve-specific risk calculator13 variablesvalidated in >16,000 patients

Conclusion Surgery was denied in 33% of elderly patients with severe, symptomatic AS. Older age andLV dysfunction were the most striking characteristics of patients who were denied surgery, whereas comorbidity played a less important role.


Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

doi:10.1016/j.jacc.2006.05.021






www.acc.org www.americanheart.org


Bicuspid Aortic Valve

Indications for surgery:

• Aortic root dilatationAo diameter >50 mm orrate of increase >5 mm/yr

• Patients with criteria for AVRAo diameter >45 mm

class Iclass I

class Iclass I


Vol. 48, No. 3, 2006 ISSN 0735-1097/06/$32.00

doi:10.1016/j.jacc.2006.05.021




• Quantification of valve severity• Indications for mitral valve repair• Ischemic mitral regurgitation• Indications for aortic valve replacement • Low gradient, low output aortic stenosis• Selection of aortic valve prostheses• Endocarditis prophylaxis

• No randomized trials• Few observational studies …some positive …most negative• Lots of “expert” opinion• No cost-effectiveness studies

Endocarditis Prophylaxis:Does It Make Sense?

Endocarditis Prophylaxis:Does It Make Sense?

Risk of endocarditis

versus

Risk from endocarditis

AHA Guideline

Prevention of Infectious Endocarditis

Guidelines From the American Heart Association

A Guideline from the American Heart AssociationRheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council onCardiovascular Disease in the Young, and the Council on Clinical Cardiology,Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care

and Outcomes Research Interdisciplinary Working Group

Walter Wilson MD, Chair; Kathryn A. Taubert, PhD, FAHA; Michael Green, MD, FAHA;Peter B. Lockhart, DDS; Larry M. Baddour MD; Matthew Levison, MD; Ann Bolger, MD, FAHA;

Christopher H. Cabell, MD, MHS; Masato Takahashi, MD, FAHA; Robert S. Baltimore, MD;Jane W. Newburger, MD; MPH, FAHA; Brian L. Strom, MD; Lloyd Y. Tani, MD;Michael Gerber, MD; Robert O. Bonow, MD, FAHA; Thomas Pallasch, DDS, MS;

Stanford T. Shulman, MD, FAHA; Anne H. Rowley, MD; Jane C. Burns, MD; Patricia Ferrien, MD;Timothy Gardner, MD, FAHA; David Goff, MD, PhD, FAHA; David T. Durack, MD, PhD

Circulation 2007;116:1736-1754

www.americanheart.orgwww.americanheart.org

Indications for antibiotic prophylaxis

Patients with:

• Prosthetic heart valves

• Previous infectious endocarditis

• Cyanotic congenital heart disease

• Congenital heart disease with indwelling shunts

• Cardiac transplantation with valvular abnormalities

www.americanheart.orgwww.americanheart.org

AHA Guideline

Prevention of Infectious Endocarditis

Guidelines From the American Heart Association

Documents

Evidence-Based Management of Valvular Heart Disease