UPDATED v2-Mitral Valve Disease - When to Intervene · Mitral Stenosis Mitral Regurg Tricuspid...
Transcript of UPDATED v2-Mitral Valve Disease - When to Intervene · Mitral Stenosis Mitral Regurg Tricuspid...
2/15/2019
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When to Intervene in Chronic Valvular Heart
Disease
2019
Costal Cardiac and Vascular Conference
Thomas M. Bashore MD
Professor of Medicine
Senior Vice Chief, Duke Medical CenterNo Disclosures
Duke Heart Center
Outline
• Overview‐ including percutaneous and surgical interventions
• The Stenotic Lesions– Aortic Stenosis
• Bicuspid aortic valve– Associated Ascending Aneurysm
• Calcific AS
– Mitral Stenosis– Tricuspid Stenosis
• The Regurgitant Lesions– A lesson in pressure‐volume relationships, the EF and guidelines– Aortic Regurgitation– Mitral Regurgitation– Tricuspid Regurgitation
• Summary
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Duke Heart Center
Mantra on When to Intervene
• Stenotic Valve Lesions– Intervene for Symptoms and Occasionally Severity – Change in 2014 Guidelines‐ Gradients not used to define
severity of lesions in most situations. Emphasis on calculated valve areas, valve appearance, LV filling rates
– Update in 2017‐ incorporated evolving TAVR indications– Look for reason to intervene even in asymptomatic AS
• Regurgitant Valve Lesions– Don’t Wait on Symptoms– Intervene for any Evidence of Ventricular Dysfunction when
due to significant regurgitation– Change in 2014 Guidelines‐ attempt made to better define
regurgitation severity.– Update in 2017‐ look for any reason to intervene
2014 AHA/ACC Valve Guidelines JACC 2014;63:e57-185 JACC 2017;70:252
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Duke Heart Center
Summary of the Classic“Significant or Severe” Gradients
• AS ‐ mean >40 mmHg
AVA <1.0 cm2
• MS ‐ mean >10 mmHg
MVA <1.5 cm2
• TS‐ mean >5 mmHg
Bonow RO et al JACC 2006;48:e1
Duke Heart Center
Aortic Valve Pathology
From The Visible Heart. Medtronic, Inc. , Demo version, 2000
From www.yale.med.edu
Bicuspid Valve
Calcific AS
Duke Heart Center
It’s Not Just the Bicuspid ValveAscending Aneurysm in 50%
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Duke Heart Center
The Root of the Problem(Or the Problem of the Root)
The Aortic Wall and a Mattress MMPs are like a Bad Dog
MMPSmooth Muscle
Elastin and Collagen
Fibrillin
Loss of fibrillin detaches smoothmuscle cells and turns on MMPs that
chew up the aortic wall.
Duke Heart Center
The Aortic Rootin Bicuspid Aortic Valve Disease
Possible Role for ARBs and Statins Has Faded
Normal Aortic Aneurysm in BAV
Fedak PWM et al Circulation 2002;106:900
Duke Heart Center
Complications from Ascending Aneurysm in Bicuspid AV Patients
Ascending Aneurysm
J Thorac CV Surg 1997;113:476
Both Genetic and HemodynamicForces Likely Contribute
NEJM 2014;370:1920
Right‐left fusion
Right‐NC fusion
Also morecommon withcoarctation
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Duke Heart Center
When to Operate on the Aortic Rootin Bicuspid Aortic Valve Patients
• Max. aortic diameter >5.5 cm at sinuses or ascending aorta regardless of need for AVR
• Aortic diameter >5.0 cm associated with risk factors:– Expansion rate >0.5 cm/year– Family history of dissection
• Aortic diameter >4.5 cm if AVR the reason for operation
JACC 2016;67:724
Duke Heart Center
Severe AS by Noninvasive Parameters
• AVA <1.0 cm2
– Peak instantaneous velocity >4.0 m/sec
– Mean gradient >40 mmHg– Dimensionless index <25%
LVOT
Peak velocities
2014 AHA/ACC Valve Guidelines JACC 2014;63:e57-185
Duke Heart Center
2014 AS GuidelinesSyndromes of Severe AS
Severe AS= abnormal systolic opening of the aortic valve with AVA ≤ 1.0 cm2
– High gradient Severe AS• ≥4.0 m/sec Doppler jet velocity• Mean gradient ≥40 mmHg
– Supersevere high gradient AS• ≥5.0 m/sec jet• Mean gradient ≥55 mmHg
– Low flow/low gradient AS with reduced LVEF (<50%)
– Low flow/low gradient AS with normal LVEF (>50%)
• Operate for symptoms and certain situations when asymptomatic
2014 AHA/ACC Valve Guidelines JACC 2014;63:e57-185
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Duke Heart Center
The Risk of Waiting InAsymptomatic Severe Aortic Stenosis
Pellikka et al Circulation;2005:111:3290
Years
Su
rviv
al f
ree
of
sym
pto
ms
(%)
0 1 2 3 4 5 6 7 8 9 10
100
60
20
0
80
40
At 5 yrs72% with symptoms or died
Duke Heart Center
Event‐free Survival in Asymptomatic AS and the Amount of Aortic Valve Calcium
Rosenhek R, et al. NEJM 2000;343:611
2017 European Guidelines suggest quantitating this with CT
Eur Heart J 2017;36:2739
Duke Heart Center
Event‐Free Survival in Asymptomatic AS and the Doppler Aortic Gradient
Eve
nt-
fre
e s
urv
iva
l
1.0
.8
.6
.4
.2
0.012 24 36 48 60
Time from enrollment (months)
>4 m/s
(>64 mmHg)
<3.0 m/s (< 36 mmHg)
3.0 – 4.0 m/s
(36-64 mmHg)
From Otto CM, et. al. Circulation 1997;95:2262. From Rosenhek R, et al. NEJM 2000;343:611
Rate of Change Important
>0.3 m/sec over a year
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Duke Heart Center
Use of BNP in Asymptomatic AS
Monin J‐L et al Circulation 2009;120:69‐75
107 patients followed for 2 years
Duke Heart Center
Evolving Role of BNP in Asymptomatic AS
Monin J‐L et al Circulation 2009;120:69‐75
107 patients followed for 2 years
Duke Heart Center
2017 Valvular GuidelinesSevere Aortic Stenosis (Updated)
Class LOE
Severe AS with symptoms 1 A
High risk symptomatic AS suitable for TAVR, but heart team favors AVR 1 A
“ASYMPTOMATIC” GROUPS
Even Asymptomatic severe AS if undergoing other cardiac surgery 1 B
Even Asymptomatic severe AS with reduced LVEF <50% due to AS 1 C
Asymptomatic severe AS with symptoms on stress test 1 C
Asymptomatic severe AS with fall in BP on stress test or decreased exercise tolerance
2a C
Asymptomatic super severe AS ( peak > 5.0 m/sec; mean >55) or severe valve calcium and rapid rate of gradient increase (>0.3 m/sec/year)
2a B
Severe AS and 3 x normal BNP 2b C
Severe AS and pulmonary hypertension at rest (peak >60 mmHg) 2a C
European Guidelines Only Eur Heart J 2017;36:2739 JACC 2017;70:252
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Duke Heart Center
Low Gradient, Low Output ASwith Poor LVEF
LVgram
Duke Heart Center
Dobutamine Challenge in Low Gradient/Low Output Poor LV AS
Baseline 20 mcg/kg/min 40 mcg/kg/min
LV
Ao
Positive Response: No real change in AVA despite increased gradient. Contractile Reserve present if SV increases by 20% (now questioned)
JACC 2017;70:252
Duke Heart Center
Low Flow/Low Gradient/Low EFSevere AS
Class LOE
AVR for symptomatic low flow/low gradient low EF (stage D2) AS if dobutamine stress can demonstrate aortic velocity >4.0 m/sec (or mean gradient >40 mmHg) with AVA of <1.0 cm2 (This is now a Class I indication in ESC Guidelines)
2a (1) C (B)
AVR for symptomatic low flow/low gradient/ low EF without flow reserve especially if CT calcium scoring high
2a C
European Guidelines only JACC 2014;63:e57-185Eur Heart J 2017;36:2739
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Duke Heart Center
Recent Data Regarding TAVR for Low Gradient, Low LVEF AS
From European TOPAS‐TAVI Registry (True or Pseudo‐severe AS Registry)
JAMA Cardiol 2019;4:64
In addition, no difference in clinical outcomes at one year follow up
Concluded results of dobutamine testing had no impact on final results
Duke Heart Center
Inconsistency Between Severe AVA and Valve Gradients in Patients with Normal LVEF
Minners J et al. Eur Heart J 2008;29:1043
N=3349Severe AS by valve area with low gradient
Duke Heart Center
Outcomes in Paradoxical Low Flow AS(Low Flow/Low Gradient Normal LVEF)
512 patientsAVA< 0.6 cm2/m2
Normal LVEF
Hachicha Z et al. Circulation 2007;115:2856
? Reliability and accuracy of the echo measurements
Peak Gradient Mean Gradient
100
50
0
6852
40 32
Normal Flow ASParadox Low Flow AS
1 2 3 4 5Follow‐up years
Survival (%)
100
80
60
40
20
Normal Flow= SVI>35 ml (65%)Paradox Low Flow= SVI <35 ml (35%)
PLF Med
NF Med
PLF Surg
NF Surg
P<0.001
P<0.001
P<0.001
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Duke Heart Center
Outcomes Based on Flow, Gradient and Intervention in AS with Normal LVEF
0
0.5
1
1.5
2
2.5
3
3.5
LowGradient/Normal
Flow
LowGradient/Low
Flow
HighGradient/Normal
Flow
HighGradient/Low
Flow
Med
AVR
Relative Risk Ratio for All‐Cause Mortality
Modified from Eleid M et al. Circulation 2013;128:1781
Low Flow and Low Gradient SevereAS – highest predictor of mortality;
‐ Improved survival with AVR
N=1704Patients
Duke Heart Center
Poor Outcomes in Low Flow/Severe ASwith Normal LVEF
Le Ven et al. JACC 2013;62:782; Hermann H et al. Circ 2013;127:2316
PARTNERS Trial
Canadian TAVR Registry
High Risk“Inoperable”
TAVR
Med Surg AVR
TAVRLF= SVI<35 ml/m2
Regardless of LVEF
Duke Heart Center
The Original Concept of Low Gradient/Low Flow AS and Normal LVEF
Pibarot P, et al. JACC Img 2009;2:400
Zva definition: Valvulo‐arterial Impedance
Arterial
Valvular
Systolic BP+
Gradient
Stroke Vol Index
Severe Afterload on theLV when Zva >4.5
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Duke Heart Center
Evolving Possibilities for Low Flow in Paradoxical Low Flow AS (Normal LVEF)
PronouncedConcentric
LVH
ImpairedDiastolicFilling
ImpairedLongitudinalContraction
Atrial Fibrillation
Mitral StenosisMitral Regurg
TricuspidRegurg
Reduced Stroke Volume(SVI <35 ml/min/m2)
Low Gradient, Low Flow AS
Myocardial Factors Hemodynamic Factors
Modified from Pibarot P et al. Circulation 2013;128:1729
Arterial Afterload
Duke Heart Center
2017 Valve GuidelinesLow Gradient AS with Normal LVEF
Class LOE
AVR should be considered in symptomatic patients with low flow/low gradient normal LVEF and severe AS by AVA if clinical, hemodynamic and anatomic data support AS as cause of symptoms
2a C
AVR is reasonable for moderate AS (velocity 3.0‐3.9 m/sec) who are undergoing other cardiac surgery
2a C
JACC 2017;70:252
Duke Heart Center
2017 ESC Valvular Guidelines in Low Flow/Low Gradient AS/Normal LVEF
Eur Heart J 2017;36:2739
SAVR should be considered if surgical risk low. Class 2a LOE C.TAVR only if surgical risk high.
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Duke Heart Center
Aortic Balloon Valvuloplasty
Balloon ValvuloplastyIn the Elderly
In Adults with Severe Calcific ASAs bridge to TAVR/SAVR onlyClass llb, LOE‐CBetter in patients with LVEF>45% and no TAVR or SAVR options due to comorbid disease. Can be considered as diagnostic test in pts with severe AS but comorbid disease (i.e. lung disease).
In Adolescents with Bicuspid ASIf severe AS (mean gradient >40 mmHg), symptoms, no calcium and <=mild ARClass llb, LOE‐B
JACC 2017;70:2522018 ACHD Guidelines, JACC 2018
No Class l indications
Eur Heart J 2017;36:2739
Duke Heart Center
Development of Artificial Heart Valves
Ball Valves
Flat Disc Valves
Tilting Disc Valves
Duke Heart Center
Root and Valve Replacements Today
Homograft Ross Procedure
PA Homo‐graft
RVLV
Bentall
JACC CV Interven 2015;8:678
Wheat
Bileaflet Mechanical StentlessBioprosthetic
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Duke Heart Center
Armenian Valve Replacement
Porcine Xenograft
Cost: One Dollar
And you get to eat the pig!
Testimonial from Dr. Ken Morris
Duke Heart Center
Examples of Newer “Sutureless” Aortic Valve Replacement Options
LivaNova Perceval® Valve
Edwards Intuity® Valve
Small Incision Devices
Duke Heart Center
Mini‐Thoracotomy AVR
Ann CV Surg 2015;4:27
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Duke Heart Center
First Percutaneous Valve Replacement
CowJugularVein
Duke Heart Center
First Percutaneous Aortic Valve Replacement
May 31, 2002
From www.theHeart.org
Cribier, A, et.al. Circulation 2002;106:3006
LV
LA
AO
VALVE
Estimated over 500,000TAVR procedures have been performedworldwide. 580 active sites in the U.S.
JACC 2019;73:340
Duke Heart Center
Current Percutaneous Valves in US
Balloon Expandable Edwards SAPIEN®
FDA Approved
Self‐expandingMedtronic CoreValve®
FDA Approved
Nat Reviews/Cardiology 2012;9:15
Others still being investigated, but fewer now than 5 years ago.
SAPIEN 3
Evolut R
SAPIEN
CoreValve
Initial Valves
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Duke Heart Center
CoreValve® Deployment
Duke Heart Center
SAPIEN® Valve Deployment
Duke Heart Center
TRANSAPICAL (OFF‐PUMP) AVR
Lichtenstein et. al. Circulation 2006;114:591
Recent data suggestspatients with apicalapproach patient doworse than with arterialapproach.
Vahl TP et al JACC 2016;67:1472
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Duke Heart Center
TAVR Outcomes
Need for pacerFollow up Gradients
Impact of Paravalular Leak
Leafletthrombosis
NEJM 2015;373:2015Vahl TP et al JACC 2016;67:1472
Duke Heart Center
Summary of Key TAVR Trials
TAVR MED TAVR MED TAVR MED TAVR MED TAVR MED
Partner 1B 11.2 12.1 30.7 50.7 10.0 4.5 10.5 4.2 4.5 7.8
TAVR SAVR TAVR SAVR TAVR SAVR TAVR SAVR TAVR SAVR
Partner 1A 11.8 11.7 24.2 26.8 6.0 3.1 6.8 1.9 5.7 7.8
CoreValve 7.3 7.5 14.2 19.1 8.8 12.6 7.1 1.4 22.3 11.3
Partner 2A 5.8 5.8 10.1 11.3 6.2 6.4 8.0 0.6 8.5 6.9
SURTAVI 4.4 4.5 8.1 8.8 5.4 6.9 5.3 0.6 25.9 6.6
NOTION 2.9 3.1 4.9 7.5 2.9 4.6 15.7 0.9 38.0 2.4
Partner 3
Evolut R
TRIAL STS SCORE MORTALITY STROKE >MILD AR PACEMAKER
Extreme Risk High Risk Intermediate Risk Low Risk
Sapien Randomized Trial of Low Risk Patients
Corevalve Randomized Trial of Low Risk Patients
Duke Heart Center
What Intervention Is Best in 2019?
Low Surgical Risk
Intermediate Surgical Risk
High SurgicalRisk
Inoperable
BenefitUnlikely
JACC 2013;62:Suppl S. Page S6.JACC 2017:69;1313
ComorbiditiesRisk Score (STS)FrailtyPhysical and Cognitive Function
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Duke Heart Center
Matching Surgical Risk to Therapy in AS
Low Surgical Risk
Intermediate Surgical Risk
High SurgicalRisk
Inoperable
BenefitUnlikely
TAVR vs SAVRAwaiting results from randomized low risk trials
TAVR vs SAVR. Data now appear about equivalent. Team discussion.
Mostly TAVRSurgical AfterTeam Discussion
TAVR AfterTeam Discussion
No Intervention Approximate breakdownof surgical risk in patientswith symptomatic AS.
JACC 2013;62:Suppl S. Page S6.JACC 2017:69;1313
Duke Heart Center
Mitral Stenosis
Fishmouth CommissuralFusion
SubmitralChordal Fusion
Duke Heart Center
Echo Score
Grades 1‐4. Thickening, Calcification, Mobility, Submitral Scar
Score < or =8. High ValvuloplastySuccess Rate.
Score >9. Lower Success Rate
Wilkins GT et al. Br Heart J 1988;60:299
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Duke Heart Center
Mitral Stenosis Definitions
• Moderate MS‐ MVA >1.5 cm2; T ½ <150 msec
• Severe MS‐ MVA <1.5 cm2; T ½ >=150 msec
• Supersevere MS‐ MVA <1.0 cm2; T ½ >=220 msec
Planimetry
Max P
½ Max P
Velocitym/s
Pressure m
mHg
Time
T ½
MVA = 220/T ½
LV
LA
Duke Heart Center
Beating Heart Surgery
Charles Bailey
Mitral Commissurotomy Knives
Netter. Ciba Heart 1992; page 191Bailey CP Dis Chest;1949;377
Duke Heart Center
Percutaneous Balloon Mitral Valvuloplasty
LALA
LVLV
LVLV
LALA
Pre-Valvuloplasty
Post
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Duke Heart Center
When to Intervene in MS
• Symptoms (Class I LOE A)– Including MVA >1.5 cm2 if abnormal hemodynamics with
exercise (Class IIb LOE C) or other cardiac surgery (Class IIb LOE C)
• Asymptomatic– Severe MS (MVA <1.5 cm2)
• New onset AF (if can do PBMV) (Class IIb LOE C)• Other cardiac surgery (Class I LOE C)• History of embolism, “smoke” in LA or PA systolic pressure >50 mmHg
– Very severe MS (MVA <1.0 cm2)• If can do PBMV (Class IIa LOE C)
JACC 2017;70:252
Eur Heart J 2017;36:2739
Duke Heart Center
MinithoracotomyMVR or Repair
With or without Robot
Duke Heart Center
Tricuspid Valve Stenosis
• Rare as an isolated lesion• Usually post‐op (TV repair or replacement)• Native cannot be repaired by surgery for the most
part and requires replacement• Considered severe: mean gradient >5 mm Hg• New Guidelines severe: T ½ >190 msec; TVA <1.0 cm2
• TVR Indications:– Class I (LOE C): Severe TS with symptoms– Class 1 (LOE C): Severe TS when left heart valves undergoing replacement or repair
– Class (IIb LOE C): Rarely balloon valvuloplasty if surgery not feasible
Eur Heart J 2017;36:2739JACC 2017;70:252
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Duke Heart Center
Summary of When to Intervene in Stenotic Valves
• AS– AVA <1.0 cm2
– Ugly valve (increased calcium, poor mobility)– Mean gradient (generally >40 mmHg)– Mean gradient 30‐40 mmHg if SV Index <35 cc/min/m2
• MS– MVA <1.5 cm2– Pressure half‐time >150 msec– Mean gradient >10 mmHg
• TS– TVA <1.0 cm2
– Pressure half‐time >190 msec– Mean gradient >5 mmHg
Duke Heart Center
Regurgitant Valve Lesions
• Importance of Understanding the Pressure‐volume Relationship and Symptoms
• Converting P‐V relationship Concepts to the Guideline Indications for Valve Intervention
Duke Heart Center
Effect of Hypertrophy Cause and the Diastolic PV Relationship
Hypertrophy:Pressure: Sarcomeres on top of each other(Concentric LVH)
Volume: Sarcomeresend‐to‐end (Eccentric)
Symptoms early with pressure overload (i.e. AS). Can usually wait on symptoms
Symptoms late with volume overload (i.e AR, MR). Cannot wait on symptoms
Diastolic Pressure
Volume
Normal
Volume Overload
PressureOverload
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Duke Heart Center
Deriving the Guideline Recommendations The Pressure‐Volume Relationship
PRESSU
RE
VOLUME
Mitral Closes
Aortic Opens
AorticCloses
MitralOpens
Duke Heart Center
Lines of Contractility and Compliance
PRESSU
RE
VOLUME
Contractility
Compliance
Every beat of the heart lives between these lines of contractility and diastolic compliance
Duke Heart Center
The Ejection Fraction Math
PRESSU
RE
VOLUME
Contractility
Compliance
The Ejection Fraction=
SVLVEDV
LVEDV
StrokeVolume We want to know contractility.
We got Ejection Fraction
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Duke Heart Center
The Problem With the EFand Valvular Heart Disease
Changing Afterload
SV
SV
Wider box with lower afterloadNarrower box with higher afterloadEF very afterload dependent
Examples:Aortic Stenosis‐ increases afterloadMitral Regurgitation‐decreases afterload
So EF can vary independent of what contractility is doing
Duke Heart Center
The Problem With the EFand Valvular Heart Disease
ReducedContractility
IncreasedContractility
Changing Contractility
SV
SV
Wider box with increased contractilityNarrower box with reduced contractilityEF very contractility dependent
The EF does goes up and down as contractility improves or worsens. The box gets bigger, the box gets smaller.
The Key in Valvular Disease: Note the LV end‐systolic dimension MUST go UP if contractility worsens
Duke Heart Center
Non‐invasive Parameters of Severe AR
• Jet width >65% of LVOT• Vena contracta >0.6 cm• Holodiastolic low reversal in proximal abdominal aorta• Duroziez’s and Hill’s sign on examination• Diastolic pressure half‐time not in guidelines (depends on acuity)• By MRI >50% regurgitant fraction
2014 AHA/ACC Valve Guidelines JACC 2014;63:e57-185
Diastolic flow reversal
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Duke Heart Center
Pre
ssur
e
NormalPV Loop
LVEDV
Aortic Regurgitation
AR
svP
ress
ure
NormalPV Loop
LVEDV
Aortic Regurgitation andLoss of Contractility
LVESV
ReducedESPVRslope
EF >55% EF <50%
ARSV
Deriving the Guideline RecommendationsAortic Regurgitation
Both Afterload and Preload Increase
Duke Heart Center
When to Operate in Severe AR
• Symptoms
• Asymptomatic
– LVEF <50% (Class I LOE B)
– When undergoing other cardiac surgery (Class I LOE C)
– LV End Systolic Dimension >5.0 cm (Class IIa LOE B)
– LV End Diastolic Dimension >6.5 (Class IIb LOE C)
– LVEDD>7.0 (Class llb LOE C)‐ ESC guidelines
JACC 2017;70:252Eur Heart J 2017;36:2739
Duke Heart Center
Noninvasive Parameters of Severe MR
• Vena contracta >0.7 cm
• ERO (Effective regurgitant orifice) > 0.4 cm2
• Regurgitant volume >60 ml
Vena Contracta
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Duke Heart Center
Pre
ssur
e
NormalPV Loop
LVEDV
Mitral Regurgitation
MR
sv
EF >60%
Deriving the Guideline RecommendationsMitral Regurgitation
Preload increase but afterload decrease
Pre
ssur
eNormalPV Loop
LVEDV
Mitral Regurgitation andLoss of Contractility
sv
LVESV
ReducedESPVRslope
EF <60%
MR
Duke Heart Center
When to Intervene inSevere Mitral Regurgitation
• Symptoms (Class I LOE B)• Asymptomatic
– LVEF <60% or falling on serial echoes (but >30%) (Class I LOE B)– LVESD >4.0 cm or enlarging on serial echoes (Class I LOE B)– Undergoing other cardiac surgery (Class I LOE B)– MVP with severe MR and 95% likelihood of repair (Class IIa LOE
B)– New onset atrial fib or resting PA systolic >50 mmHg (Class IIa
LOE B)‐ if repair likely
• Low LVEF (<30%) if symptomatic only (Class IIb LOE C)• Class III‐MV Replacement instead of MV repair if <1/2
posterior leaflet prolapsing
JACC 2017;70:252
Duke Heart Center
MitraClip™ Device
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Duke Heart Center
MitraClip® Deployment3‐D TEE Images
Looking down on mitral valve from the left atrium via TEE probe
Billowing of mitral leaflets toward LA
Catheter shown with device clamping down on mitral leaflet
Catheter
Final view of double orifice mitral valve with clip in place
Anterior Leaflet
Duke Heart Center
MitraClip® Results
• Introduced in 2003. Estimated >30,000 implanted now worldwide.
• EVEREST I (Endovascular Valve Edge‐to‐Edge Repair)‐ established safety. Most with MVP.
• EVEREST II 5 year data: Patients treated with MitraClip® had more need of surgery in first year due to residual MR, but after that results similar to surgery
• Subgroup of EVEREST II and REALISM registry of only high risk patients: suggest improved survival with MitraClip vs controls
• Some positive results also found in elderly with multiple comorbidities in ACCESS‐EU European registry and German TRAMI registry
• March 2013: FDA discounted positive registry data and only approved MitraClip® use for symptomatic high risk patients with MR>=3+ due to primary abnormality in mitral valve. Emphasis on P2 prolapse repair providing best results. Awaiting results in secondary MR.
Mauri et al. JACC 2013;62:317. Feldman T JACC 2015;66:2844
Duke Heart Center
What About Functional Ischemic MR?
• Due to papillary muscle displacement and loss of annular contribution
Carpentier Classification
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Duke Heart Center
Functional MRSome Facts and Challenges
• Murmur intensity may be soft• Ischemic MR shortens survival • Reducing MR by surgery improves symptoms, but no data improves survival independent of LV function
• PCI or CABG alone does not improve MR long term
• Surgical MVR results better than MV repair• Biventricular pacing may improve MR (if QRS wide) and symptoms, but still no data improves outcome
Pierard LA et al. Eur H J 2010;31:29962014 AHA/ACC Valve Guidelines
Duke Heart Center
MitraClip® ‐ Current Status for Functional MR
• Dueling Randomized Trials in 2018 regarding MitraClip for functional MR
– COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation):
• MitraClip: GOOD– MITRA‐FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation):
• MitraClip: NO GOOD
NEJM 2018;379:2297 NEJM 2018:279:2307
Duke Heart Center
Results of the 2 Randomized MitraClip®Trials
COAPT
MITRA‐FR COAPT
NEJM 2018;379:2297 NEJM 2018:279:2307
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Duke Heart Center
Possible Explanations for Discrepancy in the 2 MitraClip Trials
1. COAPT (U.S. and Canada); MITRA‐FR (France)
2. COAPT ‐2 years; MITRA‐FR‐ 1 year
3. COAPT‐ intensified run‐in with GDMT and MitraClip only after that failed. Sicker patients clinically in the COAPT group (easier to show good result)
4. Greater percentage of patients in COAPT got more than one MitraClip. More patients had moderate or worse MR at one year in the MITRA‐FR group.
5. Larger ERO (effective regurgitant orifice) in COAPT (41 mm2 vs 31 mm2)
6. Concept of disproportional ERO versus size of LV.
In COAPT, the ERO is larger than expected for size of LV
In MITRA‐FR, the ERO is about as expected for size of LV
Implications: COAPT had more patients with true valvular MR
Nishimura/Bonow NEJM 2018; Grayburn JACC 2018
Duke Heart Center
Percutaneous Mitral Valve Replacement Now Being Investigated
mayoclinic.org/tests‐procedures/pcc‐20384980 RevEspCardiol 2015;68:1165
Duke Heart Center
Noninvasive Parameters of Severe TR
• Central jet area >10 cm2
• Vena contracta > 0.7 cm
• Jet contour triangular with early peaking
• Hepatic systolic flow reversal
• Prominent CV wave in JVP
and pulsatile liver
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Duke Heart Center
Management of Severe TR
• Symptoms– When undergoing left heart valve repair/replacement ( Class I LOE C)
– When preserved RV and PAH “not severe” (Class IIa LOE C)
• Asymptomatic– Mild to moderate TR when undergoing left heart valve repair/replacement. TV repair ( Class IIa LOE‐C)
– Severe TR with mild or moderate symptoms in the setting of progressive RV dysfunction ( Class IIb LOE‐C)
2014 AHA/ACC Valve Guidelines JACC 2014;63:e57-185
Duke Heart Center
Summary of When to Intervene in Stenotic Valves
• For the most part, operate for symptoms or evidence of LV dysfunction or pulmonary hypertension
• AS– AVA <1.0 cm2
– Ugly valve (increased calcium, poor mobility)– Mean gradient (generally >40 mmHg)– Mean gradient 30‐40 mmHg if SV Index <35 cc/min/m2
• MS– MVA <1.5 cm2
– Pressure half‐time >150 msec– Mean gradient >10 mmHg
• TS– TVA <1.0 cm2
– Pressure half‐time >190 msec– Mean gradient >5 mmHg
Duke Heart Center
Summary inAortic Stenosis
• Still operate primarily for symptoms, though more and more options in the asymptomatic
• In AS‐ severe AS= AVA of <1.0 cm2 with ugly valve. Definitions then depend on stroke volume and LVEF.
Four clinical scenarios: 1. Normal LVEF, high gradient (40 mmHg mean) 2. Normal LVEF, super‐severe gradient (>55 mmHg mean)3. Normal LVEF, paradoxically low gradient (SVI <35
ml/min/m2 ). Most difficult to decide of all. Need to confirm low output by more than one method.
4. Low EF, low gradient (need to generate 40 mmHg mean with dobutamine still part of guidelines)
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Duke Heart Center
SummaryRegurgitant Valve Lesions
• Understanding PV relationships explains why the LVEF and LV end‐systolic dimensions critical
– Not waiting on symptoms still relevant
– In MR: Intervene for symptoms or for LVEF <60% or LVESD >4.0 cm (or progressively worsening)
– In AR: Intervene for symptoms or for LVEF <50% or LVESD >5.0 cm (or LVEDD >6.5 cm)
– In TR: Intervene for symptoms as long as RV function fairly well preserved. Repair if at least moderate severity when repairing/replacing mitral valve.
Duke Heart Center
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