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the management of acute myocardial
infarction in patients presenting with
ST-segment elevation
Stefan James
Professor of Cardiology
Uppsala University Uppsala, Sweden
2017 ESC Guidelines for the management
of acute myocardial infarction in patients
presenting with ST-segment elevation
The Task Force for the management of acute myocardial infarction in patients presenting
with ST-segment elevation of the European Society of Cardiology
Chairpersons: Borja Ibanez (Spain), Stefan James (Sweden).
Authors/Task Force Members: Stefan Agewall (Norway), Manuel J. Antunes (Portugal),
Chiara Bucciarelli-Ducci (UK), Héctor Bueno (Spain), Alida L. P. Caforio (Italy), Filippo Crea
(Italy), John A. Goudevenos (Greece), Sigrun Halvorsen (Norway), Gerhard Hindricks
(Germany), Adnan Kastrati (Germany), Mattie J. Lenzen (The Netherlands), Eva Prescott
(Denmark), Marco Roffi (Switzerland), Marco Valgimigli (Switzerland), Christoph Varenhorst
(Sweden), Pascal Vranckx (Belgium), Petr Widimský (Czech Republic).
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
TF Members
ESC
v vv
WG - Thrombosis
v v
v v v v
WG - Cardiovascular Pharmacotherapy
v WG - Cardiovascular Surgery
v
v v
v
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Level of evidence
159 recommendations
based
21%
on 477 references
Data derived from multiple randomized 37 A
A
clinical trials or meta-analyses. 23%
Data derived from a single randomized 78
B clinical trial or large non-randomized C 49%
studies.
Consensus of opinion of the experts
C and/or small studies, retrospective 44
studies, registries. 28%
B
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Classes of recommendations
159 recommendations
Classes Definition
Suggested
wording
III
16
Class I Evidence and/or general agreement that Recommended/
a given treatment or procedure is is indicated.
IIb 13
10%
beneficial, useful, effective. 8%
Class IIa Weight of evidence/opinion is in favour Should be
of usefulness/efficacy. considered.
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2017 NEW / REVISED CONCEPTS
MINOCA AND QUALITY INDICATORS:
• New chapters dedicated to these topics.
STRATEGY SELECTION AND TIME DELAYS:
• Clear definition of first medical contact (FMC).
• Definition of “time 0” to choose reperfusion strategy (i.e. the strategy clock starts at the time of
“STEMI diagnosis”).
• Selection of PCI over fibrinolysis: when anticipated delay from “STEMI diagnosis” to wire crossing is ≤120 min.
• Maximum delay time from “STEMI diagnosis” to bolus of fibrinolysis agent is set in 10 min.
• “Door-to-Balloon” term eliminated from guidelines.
TIME LIMITS FOR ROUTINE OPENING OF AN IRA:
• 0-12h (Class I); 12-48h (Class IIa); >48h (Class III).
ELECTROCARDIOGRAM AT PRESENTATION:
• Left and right bundle branch block considered equal for recommending urgent angiography if ischaemic
symptoms.
TIME TO ANGIOGRAPHY AFTER FIBRINOLYSIS:
• Timeframe is set in 2-24h after successful fibrinolysis.
PATIENTS TAKING ANTICOAGULANTS:
• Acute and chronic management presented.
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2017 NEW / REVISED CONCEPTS
MINOCA AND QUALITY INDICATORS:
• New chapters dedicated to these topics.
STRATEGY SELECTION AND TIME DELAYS:
• Clear definition of first medical contact (FMC).
• Definition of “time 0” to choose reperfusion strategy (i.e. the strategy clock starts at the time of
“STEMI diagnosis”).
• Selection of PCI over fibrinolysis: when anticipated delay from “STEMI diagnosis” to wire crossing is ≤120 min.
• Maximum delay time from “STEMI diagnosis” to bolus of fibrinolysis agent is set in 10 min.
• “Door-to-Balloon” term eliminated from guidelines.
TIME LIMITS FOR ROUTINE OPENING OF AN IRA:
• 0-12h (Class I); 12-48h (Class IIa); >48h (Class III).
ELECTROCARDIOGRAM AT PRESENTATION:
• Left and right bundle branch block considered equal for recommending urgent angiography if ischaemic
symptoms.
TIME TO ANGIOGRAPHY AFTER FIBRINOLYSIS:
• Timeframe is set in 2-24h after successful fibrinolysis.
PATIENTS TAKING ANTICOAGULANTS:
• Acute and chronic management presented.
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Modes of patient presentation, components of ischaemic time
and flowchart for reperfusion strategy selection
Total ischaemic time
Patient delay EMS delay System delay
FMC: EMS
<10’
Primary <90’ Reperfusion
≤120 min PCI (Wire crossing)
strategy
STEMI
diagnosis Time
to PCI?
<10’
>120 min Fibrinolysis <10’ Reperfusion
FMC: strategy (Lytic bolus)
Non-PCI centre
FMC: EMS
Term Definition
<10’ STEMI The time at which the ECG of a
Primary <90’ Reperfusion
≤120 min PCI (Wire crossing)
diagnosis patient with ischaemic symptoms is
strategy
STEMI
diagnosis Time interpreted as presenting ST-
to PCI? segment elevation or equivalent.
<10’ Fibrinolysis Reperfusion <10’
Ambiguous terms are eliminated:
>120 min
strategy (Lytic bolus)
FMC: “Door-to-balloon”
Non-PCI centre
“Door to door”
<10’ Primary <60’ Reperfusion
PCI (Wire crossing)
STEMI strategy
FMC: PCI centre diagnosis
Patient delay System delay
Total ischaemic time
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Modes of patient presentation, components of ischaemic time
and flowchart for reperfusion strategy selection
Total ischaemic time
Left and right bundle branch block are considered equal
Atypical ECG presentations
Patient delay EMS delay System delay
for recommending urgent angiography if ischaemic
§ Bundle branch block, symptoms.
FMC: EMS
§ Ventricular pacing, <10’
Primary <90’ Reperfusion
≤120 min PCI (Wire crossing)
§ Hyper-acute T waves, strategy
STEMI
diagnosis Time
§ Isolated depression in anterior leads, to PCI?
<10’
§ Universal ST depression with aVR elevationIn >120 min Fibrinolysis <10’ Reperfusion
FMC: strategy (Lytic bolus)
In the presence of symptoms, a primary PCI
Non-PCI centre
strategy (urgent angiography and PCI if Primary <60’
<10’
PCI Reperfusion
(Wire crossing)
indicated) should be followed.FMC: PCI centre STEMI strategy
diagnosis
Patient delay System delay
Total ischaemic time
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What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Thrombus Aspiration
TOTAL, TASTE
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Thrombus Aspiration
TOTAL, TASTE
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Thrombus Aspiration
TOTAL, TASTE
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Thrombus Aspiration
Engstrom et al, Lancet 2015 TOTAL, TASTE
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Thrombus Aspiration
TOTAL, TASTE
Frobert et al, NEJM 2013
Bivalirudin Jolly et al, NEJM 2015
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Complete
Valgimigli et al, NEJM 2015 Revascularization PRAMI, DANAMI-3-PRIMULTI, Shazad et al, Lancet 2014
CVLPRIT, Compare-Acute
Thrombus Aspiration
TOTAL, TASTE
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Thrombus Aspiration
TOTAL, TASTE
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Thrombus Aspiration
TOTAL, TASTE
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2012 CHANGE IN RECOMMENDATIONS 2017
Radial access
MATRIX
Bivalirudin
MATRIX, HEAT-PPCI
Enoxaparin
ATOLL, Meta-analysis
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
What is new in 2017 Guidelines on AMI-STEMI
2017 NEW RECOMMENDATIONS
• Additional lipid lowering therapy if • Complete revascularization during
LDL >1.8 mmol/L (70 mg/dL) despite index primary PCI in STEMI patients
on maximum tolerated statins. in shock.
IMPROVE-IT, FOURIER Expert opinion
• Cangrelor if P2Y12 inhibitors have not been given. • Routine use of deferred
CHAMPION stenting. DANAMI 3-DEFER
• Switch to potent P2Y12 inhibitors 48 hours after
fibrinolysis. Expert opinion I
• Extend Ticagrelor up to 36 months in high-risk IIa
patients. PEGASUS-TIMI 54
IIb
• Use of polypill to increase adherence. FOCUS
III
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Bhatt et al, NEJM 2013
What is new in 2017 Guidelines on AMI-STEMI
2017 NEW RECOMMENDATIONS
• Additional lipid lowering therapy if • Complete revascularization during
LDL >1.8 mmol/L (70 mg/dL) despite index primary PCI in STEMI patients
on maximum tolerated statins. in shock.
IMPROVE-IT, FOURIER Expert opinion
• Cangrelor if P2Y12 inhibitors have not been given. • Routine use of deferred
CHAMPION stenting. DANAMI 3-DEFER
• Switch to potent P2Y12 inhibitors 48 hours after
fibrinolysis. Expert opinion I
• Extend Ticagrelor up to 36 months in high-risk IIa
patients. PEGASUS-TIMI 54
IIb
• Use of polypill to increase adherence. FOCUS
III
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Bonaca et al, NEJM 2015
What is new in 2017 Guidelines on AMI-STEMI
2017 NEW RECOMMENDATIONS
• Additional lipid lowering therapy if • Complete revascularization during
LDL >1.8 mmol/L (70 mg/dL) despite index primary PCI in STEMI patients
on maximum tolerated statins. in shock.
IMPROVE-IT, FOURIER Expert opinion
• Cangrelor if P2Y12 inhibitors have not been given. • Routine use of deferred
CHAMPION stenting. DANAMI 3-DEFER
• Switch to potent P2Y12 inhibitors 48 hours after
fibrinolysis. Expert opinion I
• Extend Ticagrelor up to 36 months in high-risk IIa
patients. PEGASUS-TIMI 54
IIb
• Use of polypill to increase adherence. FOCUS
III
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
“Do not forget”
interventions in STEMI
patients undergoing a
primary PCI strategy
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www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
2017 ESC Guidelines for
the management of acute myocardial
infarction in patients presenting with
ST-segment elevation
Borja Ibanez MD PhD FESC
- Clinical Research Director, National Center for Cardiovascular Research Carlos III
(CNIC)
- Fundación Jiménez Díaz University Hospital & CIBERCV
Madrid, Spain
2
Fibrinolytic therapy
Recommendations Class Level
When fibrinolysis is the reperfusion strategy, it is recommended
to initiate this treatment as soon as possible after STEMI diagnosis,
I A
preferably in the prehospital setting.
TARGET TIME: STEMI DIAGNOSIS TO BOLUS 10 MIN
A fibrin-specific agent (i.e. tenecteplase, alteplase, reteplase) is
I B New
recommended.
A half-dose of tenecteplase should be considered in patients
IIa B
≥75 years of age.
Co-therapies
ACUTE
Aspirin (IB), Clopidogrel (IA), Enoxaparin (IA)
MAINTENANCE
DAPT 1 year (IC). After 48hr, switch to potent P2Y12 inh may be considered (IIbC)
Fibrinolysis Strategy = Pharmacoinvasive
Strategy clock
ECG:
STEMI
0 diagnosis When time to PCI >120 min
Fibrinolysis strategy
10 min Bolus of
fibrinolytic
60-90 min
Routine angio Transfer to PCI centre
±PCI
≥120 min
90 min
Summary Cards
Essential Messages
Antiplatelet therapy
Lipid lowering therapy
Beta-blockers
ACE inhibitors/ARBs
MRA
Maintenance antithrombotic strategy after STEMI
Routine therapies: lipid lowering
Routine complete revascularization
Acute Heart Failure and Cardiogenic shock
IC Opiates to relief dyspnea and anxiety IIbB
routine IIIB
IIbB IABP Mechanical complications IIaC
Reperfusion Strategy selection in Cardiogenic
shock: a super “LOE C zone”
Strategy guided as in other STEMI patients (if time from STEMI
diagnosis to
wire crossing is >120min Immediate fibrinolysis & transfer to PCI center)
Urgent angiography upon arrival regardless time from lytics
Management of atrial fibrillation
Recommendations Class Level
Acute rate control of AF
Intravenous beta-blockers are indicated for rate control if necessary
I C
and there are no clinical signs of acute heart failure or hypotension.
Intravenous amiodarone is indicated for rate control if necessary in
I C
the presence of concomitant acute heart failure and no hypotension.
Intravenous digitalis should be considered for rate control if necessary
Ila B
in the presence of concomitant acute heart failure and hypotension.
Cardioversion
Immediate electrical cardioversion is indicated when adequate rate
control cannot be achieved promptly with pharmacological agents
I C
in patients with AF and ongoing ischaemia, severe haemodynamic
compromise or heart failure.
14
Management of atrial fibrillation
Not focused into specific treatments,
rather encouraging pursuing etiology!
Aligned with dedicated ESC position papers
Quality indicators: New Chapter!
There is a wide practice gap between optimal and actual care
for patients with STEMI across the world.
Quality indicators
• Structural measures
• Performance measures
- for reperfusion therapy
- for risk assessment
- for antithrombotic treatment
- for discharge medication and counseling
• Patient-related outcomes
• Outcome measures
• Opportunity-based composite QIs
17
Full 90 min session on
2017 STEMI Guidelines
DREAM STEAMI
PART I
Chronic Mesenteric
Mesenteric artery Ischaemia (CMI)
disease Acute Mesenteric
Ischaemia (AMI)
Peripheral Renal Artery Disease Hypertension,
Arterial (RAD) renal failure
Diseases NEW!
(PADs) Typical claudication,
Lower-Extremity
Artery Disease
atypical symptoms,
Chronic Limb-Threatening
Cardiac
(LEAD) Ischaemia (CLTI),
Acute Limb Ischaemia (ALI) Conditions
www.escardio.org/guidelines 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with ESVS 3
(European Heart Journal 2017; doi:10.1093/eurheartj/ehx095)
General Aspects
General prevention
PADs patients
management
• Smoking cessation
Non • Healthy diet
pharmacological
therapy • Weight loss
• Regular physical exercise
Best
Medical
Therapy
• Anti-HTN drugs
• Statins
Pharmacological
measures • Optimal glucose control
in diabetic pts
• Antithrombotic drugs
www.escardio.org/guidelines 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with ESVS
(European Heart Journal 2017; doi:10.1093/eurheartj/ehx095)
Lower extremities artery disease
(LEAD)
Clinical stages of LEAD (I)
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Interpretation of the WIFI classification
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Management of Chronic Limb-Threatening
Ischaemia (CLTI)
Recommendations Class Level
Early recognition of tissue loss and/or infection and referral to the
vascular team is mandatory to improve limb salvage. I C
In patients with CLTI, assessment of the risk of amputation is
indicated. I C
In patients with CLTI and diabetes, optimal glycaemic control
isrecommended. I C
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(European Heart Journal 2017; doi:10.1093/eurheartj/ehx095)
Antiplatelet therapy in patients
with lower extremity artery disease
Management of antiplatelet therapy in patients with LEAD
not requiring anticoagulation
Asymptomatic Symptomatic Revascularization
Percutaneous Surgery
A
0
DAPT SAPT Aspirin
A+C
No SAPT SAPT Class IIa C A or C 75-100 mg/day
1 mo.
Class IIb B
Time delay
A or C SAPT C
Clopidogrel
Class III A Class I A
A or C VKA 75 mg/day
O
Class IIa C
Class IIb B O
1 year
Oral
Long term Anticoagulation
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Multisite Artery Disease
Screening of associated atherosclerotic
disease in additional vascular territories
• Heart Failure
• Atrial Fibrillation
Interrelations between heart failure and
lower extremity artery disease
Smoking
Inflammation
Atherosclerosis
Dyslipidaemia
CAD Aorta
Diabetes stiffness
Heart LEAD
failure
Hypertension Ageing
Physical impairment
and deconditioning
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Management of HF associated with PADs
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Management of AF associated with PADs
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Antithrombotic therapy in patients
with LEAD requiring oral anticoagulation
LEAD in patients requiring long-term oral anticoagulation
0 DAT A
O A or C
OAC Class IIa OAC Aspirin
1 mo. Monotherapy Monotherapy 75-100 mg/day
Time delay
DAT
O
O A+C O C
Class IIb O Clopidogrel
Class I Class IIa 75 mg/day
OAC
Monotherapy
Class IIb
1 year O
Long term Oral
Anticoagulation
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PART II
• RAD is a strong independent predictor
of mortality and increasing severity of
RAD has an incremental effect on
survival probability
CORAL trial
The rate of ipsilateral stroke was 2.3% in studies before 2000 and decreases to less than 1% Abbott AL et al. Int J Stroke 2007
in studies completing recruitment between 2000 and 2010 Naylor A R Semin Vasc Surg 2008
Clinical/imaging features associated with increased risk of stroke
in patients with asymptomatic carotid stenosis treated medically
Clinical • Contralateral TIA/stroke
Cerebral imaging • Ipsilateral silent infarction
Ultrasound • Stenosis progression (> 20%)
T
M
B
imaging • Spontaneous embolization on transcranial Doppler (HITS)
TE
PI
ES
• Large plaques
ST
R
• Echolucent plaques
FO
ISK
Life expectancy >5 yrs?
BMT
No
Favourable anatomy?
Class I A
≥1 feature suggesting
higher stroke risk on BMT?
CEA + BMT
should be considered
Class IIa B
CAS + BMT
may be considered
Class IIb B
MANAGEMENT OF ASYMPTOMATIC CAROTID DISEASE
In “average surgical risk” patients with an asymptomatic 60-99%
stenosis in the presence of clinical and/or imaging characteristics d
that may be associated with an increased risk of late ipsilateral
IIb B
stroke, CAS may be an alternative to CEA provided documented
perioperative stroke/death rates are <3% and the patient’s life
expectancy is >5 years.
REVASCULARIZATION IN PATIENTS WITH
SYMPTOMATIC CAROTID DISEASE
CEA is recommended in symptomatic patients with 70-99% carotid
I A
stenoses, provided the documented procedural death/stroke rate is <6%.
In recently symptomatic patients with a 50–99% stenosis who present
with adverse anatomical features or medical comorbidities that are
IIa B
considered to make them “high-risk for CEA”, CAS should be considered,
provided the documented procedural death/stroke rate is <6%.
REVASCULARIZATION IN PATIENTS WITH
SYMPTOMATIC CAROTID DISEASE
Meta-analyses from RCT’s have shown that patients over 70 yrs should receive CEA rather than CAS
REVASCULARIZATION IN PATIENTS WITH
SYMPTOMATIC CAROTID DISEASE
Timing of interventions after onset of symptoms
Recommendations
When decided, it is recommended to
perform revascularization of
symptomatic 50–99% carotid stenoses I A
as soon as possible, preferably within 14
days of symptom onset.
Meta-analyses from RCT’s have shown that patients
revascularized within 2 weeks do better with CEA rather than
with CAS
MANAGEMENT OF EXTRACRANIAL CAROTID ARTERY DISEASE
SYMPTOMATIC
Occlusion Carotid Carotid Carotid
or near stenosis stenosis stenosis
occlusion <50% 50-69% 70-99%
CEA + BMT CEA + BMT
BMT recommended
should be
Class I A considered
Class I A
Class IIa B
CAS + BMT
should be
CAS + BMT considered if
may be “high-risk” for
considered CEA
Class IIa B
Class IIb B
otherwise
may be
considered
Algorithm of management strategies Class IIb B
In patients with symptomatic carotid stenosis
Management of antithrombotic treatment in patients
with carotid stenosis
Management of antiplatelet therapy in carotid artery stenosis
0
DAPT
A + C
SAPT Class I A SAPT
1 mo.
Time delay
A or C A or C A
SAPT
Aspirin
A or C Class I A
Class IIa C 75-100 mg/day
Class I A
C
1 year Clopidogrel
75 mg/day
Long term
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(European Heart Journal 2017; doi:10.1093/eurheartj/ehx095) 17
SAPT: single antiplatelet therapy, DAPT: dual antiplatelet therapy
Should we screen for CAD, patients undergoing
carotid revascularization?
Recommendations
In patients undergoing elective
CEA, preoperative CAD screening,
P=0.01 IIb B
including coronary angiography,
may be considered.
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How to deal with a symptomatic carotid stenosis
in a patient undergoing CABG?
Recommendations Class Level
It is recommended that the indication (and if so the method and
timing) for carotid revascularization be individualized after I C
discussion within a multidisciplinary team, including a neurologist.
In patients scheduled for CABG, with recent (<6 months) history of TIA/stroke:
• Carotid revascularization should be considered in patients with 50
IIa B
–99% carotid stenosis,
• Carotid revascularization with CEA should be considered as first
IIa B
choice in patients with 50–99% carotid stenosis,
• Carotid revascularization is not recommended in patients with
III C
carotid stenosis <50%.
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How to deal with an asymptomatic carotid
stenosis in a patient undergoing CABG?
Recommendations Class Level
In neurologically asymptomatic patients scheduled for CABG:
• Routine prophylactic carotid revascularization in patients with a 70-
III B
99% carotid stenosis is not recommended.
• Carotid revascularization may be considered in patients with
bilateral 70-99% carotid stenoses or 70-99% carotid stenosis + IIb B
contralateral occlusion.
• Carotid revascularization may be considered in patients with a 70–
99% carotid stenosis, in the presence of one or more characteristics
IIb C
that may be associated with an increased risk of ipsilateral stroke,
in order to reduce stroke risk beyond the perioperative period.
www.escardio.org/guidelines 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with ESVS
(European Heart Journal 2017; doi:10.1093/eurheartj/ehx095) 21
Want more details?
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2017 ESC Focused Update on Dual
Antiplatelet Therapy in Coronary Artery
Disease developed in collaboration with
the EACTS*
The Task Force for the Management of Dual Antiplatelet Therapy in Coronary
Artery Disease of the European Society of Cardiology (ESC) and of the European
Association for Cardio-Thoracic Surgery (EACTS)
ESC Chairperson: Marco Valgimigli (Switzerland).
Authors/Task Force Members: Héctor Bueno (Spain), Robert Byrne (Germany),
Jean-Philippe Collet (France), Francesco Costa (Italy), Anders Jeppsson (Sweden),
Peter Jüni (Canada), Adnan Kastrati (Germany), Philippe Kolh (Belgium),
Laura Mauri (USA), Gilles Montalescot (France), Franz-Josef Neumann (Germany),
Mate Petricevic (Croatia), Marco Roffi (Switzerland), Philippe Gabriel Steg (France),
Stephan Windecker (Switzerland), Jose Luis Zamorano (Spain).
Additional Contributor: Glenn Levine (USA).
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 2
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
History of dual antiplatelet therapy (DAPT) in patients
with coronary artery disease
ASPIRIN
TICLOPIDINE
CLOPIDOGREL
PRASUGREL
TICAGRELOR
<1 m STARMATTIS ACCOAST ATLANTIC
(1998) (1998) (2013) ISAR PRAGUE
CURRENT (2014) TRIPLE
OASIS 7 (2016)
Investigated DAPT Duration
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 4
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Use of risk scores as guidance for the
duration of dual antiplatelet therapy
The use of risk scores designed to evaluate the benefits and
IIb A
risks of different DAPT durations may be considered.
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 5
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Risk scores validated for dual antiplatelet
therapy duration decision-making
PRECISE-DAPT score DAPT score
Time of use At the time of coronary stenting After 12 months of uneventful DAPT
DAPT duration Short DAPT (3–6 months) vs. Standard DAPT (12 months) vs.
strategies assessed Standard/long DAPT (12–24 months) Long DAPT (30 months)
Score calculation HB ≥2 11-5 11 10-5 ≤10 Age
≥75 –2 pt
WBC ≤5 8 1012141618 ≥20 65 to <75 –1 pt
<65 0 pt
Age ≤50 60 70 80 ≥90 Cigarette smoking +1 pt
Diabetes mellitus +1 pt
CrCI ≥100 80 60 40 20 0
MI at presentation +1 pt
Prior PCI or prior MI +1 pt
Prior No Yes
Paclitaxel-eluting stent +1 pt
Bleeding
Stent diameter <3 mm +1 pt
Score 0 2 4 6 8 1012141618202224262830 CHF or LVEF <30% +2 pt
Points
Vein graft stent +2 pt
Score range 0 to 100 points –2 to 10 points
Decision making Score ≥25 � Short DAPT Score ≥2 � Long DAPT
cut-off suggested Score <25 � Standard/long DAPT Score <2 � Standard DAPT
Calculator www.precisedaptscore.com www.daptstudy.org
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 6
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Algorithm for dual
antiplatelet therapy (DAPT)
in patients treated with
percutaneous coronary
intervention
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 7
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Dual antiplatelet therapy duration in high bleeding
risk patients with stable coronary artery disease
treated with percutaneous coronary intervention
Recommendations Class Level
In patients with stable CAD considered at high bleeding risk
(e.g. PRECISE-DAPT ≥25), DAPT for 3 months should be IIa B
considered1.
In patients with stable CAD in whom 3-month DAPT poses
IIb C
safety concerns, DAPT for 1 month may be considered2.
1:Theevidence supporting this recommendation comes from two studies where zotarolimus-eluting
Endeavour sprint stent has been investigated in conjunction with a 3-month DAPT regimen.
2:1-month DAPT after implantation of zotarolimus-eluting Endeavour sprint stent or drug coated
Biofreedom stent reduced risks of reintervention, myocardial infarction and inconsistently of stent
thrombosis compared to bare-metal stent under similar DAPT duration.
It is unclear if this evidence applies to other contemporary DES.
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 8
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Algorithm for dual
antiplatelet therapy
(DAPT) in patients
with acute coronary
syndrome undergoing
coronary artery bypass
grafting
No indication
for DAPT in
stable CAD
pts unless
concomitant
or prior
indication
overrides
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 9
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Algorithm for dual
antiplatelet therapy
(DAPT) in patients with
acute coronary
syndrome undergoing
medical management
No indication
for DAPT in
stable CAD
pts unless
concomitant
or prior
indication
overrides
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 10
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Algorithm for switching between oral P2Y12 inhibitors
in the acute setting
CLOPIDOGREL
Ti spe tim
l
in id )
irr
re
os p g
ca cti in
d Clo m
g og
gr ve g a
d g)
Cl h a
nd ior 60
el of nd
el m
e
24
op fte
g a pr (
os
or pr d
gr 0
in of LD
id r la
LD ior si
su 0
og st
ra (6
tim ive rel
(1 Clo ng
re Ti
t P D
ec ug
as l L
80 pid
l L cag
p s
r l e
a
D re
m ogr
o
t
r
ACUTE
Pr
te g
(6 lo
g) el
af o
es
h id
00 r d
SETTING
irr
24 op
m ose
Cl
g)
ALWAYS RELOAD
Ticagrelor LD (180 mg)
24h after last Prasugrel dose
PRASUGREL TICAGRELOR
Prasugrel LD (60 mg)
24h after last Ticagrelor dose
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 12
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Algorithm for switching between oral P2Y12 inhibitors in
the chronic setting
CLOPIDOGREL
os .)
Ti h
d d
ca af
el .
e
gr g q
24
gr te
os .)
d .d
Cl h a
el r la
pi m
24
el q
or st
op fte
lo 10
gr g
M Cl
do
su m
id r la
t C D (
D pi
og st
ra 75
M
(9 do
re Ti
t P (
0 gr
as D
o
l
l L cag
as
re
r l l M
m el
r l
D re
ug
g b do
CHRONIC
fte
fte re
(6 lo
as
.i. se
a g
a
00 r d
o
Pr
d.
h
SETTING
4h id
24
m ose
)
2 op
g)
Cl
Ticagrelor MD (90 mg b.i.d.)
24h after last Clopidogrel dose
PRASUGREL TICAGRELOR
Prasugrel LD (60 mg)
24h after last Ticagrelor dose
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 13
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Algorithm for dual
antiplatelet therapy
(DAPT) in patients
with an indication for
oral anticoagulation
undergoing
percutaneous
coronary
intervention (PCI)
Clopidogrel is
the only
option to
establish a
DAPT
regimen
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 14
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Timing for elective non-cardiac surgery in patients treated
with dual antiplatelet therapy (DAPT) after percutaneous
coronary intervention (PCI)
P2Y12 inhibitor interruption after PCI for elective non-cardiac surgery
ASA continued throughout the perioperative period
ACS at index PCI or other high ischaemic risk features?
Time from DAPT No Yes
initiation
Class III B Class III B
1 mo.
Class IIa B Class IIb C
6 mo.
Class I B Class I B
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 15
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Dual antiplatelet therapy in patients
undergoing elective non-cardiac surgery
(continued)
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 16
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Minimal discontinuation and re-implementation time
frames of dual antiplatelet therapy (DAPT) for patients
undergoing elective surgery
ASPIRIN1
//….9…….8….…7…….6….…5…….4….…..3……..2…… ….0……………………………… 1-4
Minimal delay for P2Y12 interruption Days after surgery
= Expected average platelet function recovery
1 Decision to stop aspirin throughout surgery should be made on a single case basis taking into
account the surgical bleeding risk.
2 In patients not requiring OAC.
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 17
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Gender considerations and those for special
populations
Recommendations Class Level
Similar type and duration of DAPT are recommended in male
and female patients. I A
It is recommended to reassess the type, dose and duration of
DAPT in patients with actionable bleeding complication while I C
on treatment.
Similar type and duration of DAPT should be considered in
patients with and without diabetes mellitus. IIa B
Prolonged (i.e. >12 months) DAPT duration should be
considered in patients with prior stent thrombosis, especially IIa C
in the absence of correctable causes (e.g. lack of adherence or
correctable mechanical stent-related issues).
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 18
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Gender considerations and those for special
Populations (continued)
Recommendations Class Level
Prolonged (i.e. >12 months) DAPT duration may be considered IIb B
in CAD patients with LEAD.
Prolonged (i.e. >6 months) DAPT duration may be considered IIb B
in patients who underwent complex PCI.
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 19
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Bleeding during treatment with dual antiplatelet therapy ± OAC
• Continue DAPT.
TRIVIAL BLEEDING
Any bleeding not requiring medical • Consider OAC continuation or skip one single next pill.
intervention or further evaluation
• Reassure the patient.
e.g. skin bruising or ecchimosis, • Identify and discuss with the patient possible preventive
self-resolving epistaxis, minimal strategies.
conjunctival bleeding
• Counsel patient on the importance of drug-adherence.
Legend
DAPT management
OAC management
General recommendations
20
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Bleeding during treatment with dual antiplatelet therapy ± OAC
MILD BLEEDING • Continue DAPT.
Any bleeding that requires medical • Consider shortening DAPT duration or switching to less potent
attention without requiring P2Y12 inhibitor (i.e.from ticagrelor/ prasugrel to clopidogrel),
hospitalization especially if recurrent bleeding occurs.
e.g. not self resolving epistaxis, • In case of triple therapy consider downgrading to dual
moderate conjunctival bleeding, therapy, preferably with clopidogrel and OAC.
genitourinary or upper/lower
gastrointestinal bleeding without • Identify and possibly treat concomitant conditions associated
significant blood loss, with bleeding (e.g. peptic ulcer, haemorrhoidal plexus,
mild haemoptysis neoplasm).
• Add PPI if not previously implemented.
Legend • Counsel patient on the importance of drug-adherence.
DAPT management
OAC management
General recommendations
21
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Bleeding during treatment with dual antiplatelet therapy ± OAC
• SAPT, preferably with the P2Y12 inhibitor especially in case of upper GI
MODERATE BLEEDING bleeding.
Any bleeding associated with • Reinitiate DAPT as soon as deemed safe.
blood loss (>3 g/dL HB) and/or • Consider shortening DAPT duration or switching to less potent P2Y12,
requiring hospitalization, which especially if recurrence occurs.
is haemodynamically stable • Consider OAC dis. or reversal until bleeding is controlled, unless very high
and not rapidly evolving thrombotic risk
• Reinitiate treatment within one week if clinically indicated. For VKA
e.g. genitourinary, target INR of 2.0–2.5 unless overriding indication (i.e. mechanical heart
respiratory or upper/lower gastro- valves or cardiac assist device) for NOAC consider the lowest effective
intestinal bleeding with significant dose.
blood loss or requiring transfusion • In case of triple therapy consider downgrading to dual therapy,
Legend preferably with clopidogrel and OAC.
• If patients on dual therapy, consider stopping antiplatelet Tx.
DAPT management
• Consider i.v. PPI if GI bleeding occurred.
OAC management • Identify and possibly treat concomitant conditions associated with
General recommendations bleeding (e.g. peptic ulcer, haemorrhoidal plexus, neoplasm).
• Counsel patient on the importance of drug-adherence. 22
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Bleeding during treatment with dual antiplatelet therapy ± OAC
• Consider stopping DAPT and continue with SAPT, preferably with the P2Y 12 inhibitor
SEVERE BLEEDING especially in case of upper GI bleeding.
Any bleeding requiring • If bleeding persists despite treatment or treatment is not possible, consider stopping
hospitalisation, associated with a all antithrombotic medications.
• Once bleeding has ceased, re-evaluate the need for DAPT or SAPT, preferably with the
severe blood loss P2Y12 inhibitor especially in case of upper GI bleeding.
(>5 g/dL HB) which is haemo- • If DAPT is re-started, consider shortening DAPT duration or switching to less potent
dynamically stable and not rapidly P2Y12 inhibitor (i.e. from ticagrelor/prasugrel to clopidogrel), especially if recurrent
evolving bleeding occurs.
e.g. severe genitourinary, • Consider stopping and reversing OAC until bleeding is controlled unless prohibitive
respiratory thrombotic risk (i.e. mechanical heart valve in mitral position, cardiac assist device).
or upper/lower • Reinitiate treatment within one week if clinically indicated. For vitamin-K antagonists
gastrointestinal bleeding consider a target INR of 2.0-2.5 unless overriding indication (i.e. mechanical heart
valves or cardiac assist device) for NOAC consider the lowest effective dose.
Legend • If patient on triple therapy consider downgrading to dual therapy with clopidogrel and
OAC. If patients on dual therapy, consider stopping antiplatelet therapy if deemed
DAPT management safe.
• Consider i.v. PPI if GI bleeding occurred.
OAC management • RBC transfusion if HB <7-8 g/Dl.
• Consider platelet transfusion.
General recommendations • Urgent surgical or endoscopic treatment of bleeding source if deemed possible.. 23
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Bleeding during treatment with dual antiplatelet therapy ± OAC
LIFE-THREATENING BLEEDING • Immediately discontinue all antithrombotic medications.
Any severe active bleeding putting • Once bleeding has ceased, re-evaluate the need for DAPT
patient’s life immediately at risk
or SAPT, preferably with the P2Y12 inhibitor especially in
e.g. massive overt genitourinary, case of upper GI bleeding.
respiratory or upper/lower
gastrointestinal bleeding,
active intracranial, • Stop and reverse OAC.
spinal or intraocular haemorrhage,
or any bleeding causing • Fluid replacement if hypotension.
haemodynamic instability.
• Consider RBC transfusion irrespective of HB values.
Legend • Platelet transfusion.
DAPT management • Consider i.v. PPI if GI bleeding occurred.
OAC management
• Urgent surgical or endoscopic treatment of bleeding
source if deemed possible.
General recommendations
24
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
www.escardio.org/guidelines 2017 ESC Focused Update on DAPT in Coronary Artery Disease, developed in collaboration with EACTS 26
(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx419)
Guidelines team - Names and roles
Veronica Dean Head of Guidelines Department
Scientific Research Analyst & Senior Project Manager,
Catherine Despres
responsible for Quality Assurance
Nathalie Cameron Senior Guidelines Development Coordinator
Laetitia Flouret Guidelines Development Officer
Maike Binet Guidelines Development Officer
1
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
2
Reperfusion therapy
3
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
No stenosis ???
4
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
5
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Diagnostic criteria for myocardial infarction
with non-obstructive coronary arteries
The diagnosis of MINOCA is made immediately upon coronary
angiography in a patient presenting with features consistent with an
AMI, as detailed by the following criteria:
(1) Universal AMI criteria.
(2) Non-obstructive coronary arteries on angiography, defined as no
coronary artery stenosis ≥50% in any potential IRA.
(3) No clinically overt specific cause for the acute presentation.
6
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Flow-chart
• Working diagnosis
10
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
MINOCA
12
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Possibly Causes
13
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Pasupathy et al Circulation 2015
Quantitative
assessment of 28
publications.
The prevalence of
MINOCA was 6%
18
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Diagnostic test flow chart in MINOCA
SUSPECTED STEMI
ACUTE INVESTIGATION
No Coronary stenosis
Coronary stenosis ≥50% Urgent angiography ≥50% + Fulfilment
universal AMI criteria
Treat as STEMI
MINOCA
Acute LV wall motion assessment (angiogram/echo)
19
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Diagnostic test flow chart in MINOCA (continued)
20
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Diagnostic test flow chart in MINOCA (continued)
TTE Echo
Myocardial
CMR
disease
(Takotsubo, others)
D-dimer(Pulmonary embolism)
Pulmonary
CT scan (Pulmonary embolism)
Embolism
Thrombophilia screen
21
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Conclusion I
•
Thank you for the attention
Quality indicators in STEMI:
measure to improve.
Héctor Bueno, MD, PhD, FESC
Centro Nacional de Investigaciones Cardiovasculares (CNIC)
Cardiology Department. Hospital Universitario 12 de Octubre, Madrid, Spain
Aug 28, 2017
Disclosure
2012 2017
Performance measures Quality indicators
• Structural measures
• Performance measures
- for reperfusion therapy
- for risk assessment
- for antithrombotic treatment
- for discharge medication and counseling
• Patient-related outcomes
• Outcome measures
• Opportunity-based composite QIs
Rationale: Why new quality indicators?
Dimensions Focus of the analysis Point of view
Technical competence
Security & personal relations
Structure Community
Effectiveness
Type of problem Patient
Patient-centered Process
HC Providers
Timeliness
Results HC system
Uderuse of Overuse of
Efficiency
approriate services
unncessary services Administration
Equity
Financier
Rationale: Why new quality indicators?
Focus of the analysis
Human
Material Resources Structure Structural conditions
Financial
Interaction HC Process Adequacy with standards
professionals - patients
Health outcomes Results Outcome improvement
Definition of Quality indicators
Definition of Quality indicators
FMC: EMS
<10’
Primary <90’ Reperfusion
≤120 min PCI (Wire crossing)
strategy
STEMI
diagnosis Time
to PCI?
<10’
>120 min Fibrinolysis <10’ Reperfusion
FMC: strategy (Lytic bolus)
Non-PCI centre
12
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
“Do not forget”
interventions in STEMI
patients undergoing a
primary PCI strategy
13
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Quality indicators (continued)
Type of indicator Quality indicator
and process
Performance 1) Proportion of STEMI patients arriving in the first 12 h receiving reperfusion
measures therapy
for reperfusion 2) Proportion of patients with timely reperfusion therapy, defined as:
therapy • For patients attended to in the pre-hospital setting:
‒ 90 min from STEMI diagnosis to IRA wire crossing for reperfusion with PCI,
‒ <10 min from STEMI diagnosis to lytic bolus for reperfusion with fibrinolysis
• For patients admitted to PCI centres:
‒ <60 min from STEMI diagnosis to IRA wire crossing for reperfusion with PCI,
• For transferred patients:
‒ <120 min from STEMI diagnosis to IRA wire crossing for reperfusion with PCI
‒ <30 min door-in-door-out for patients presenting in a non-PCI centre (en
route to a PCI centre)
14
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Quality indicators (continued)
Type of indicator Quality indicator
and process
Performance 1) Proportion of patients having LVEF assessed before discharge.
measures for risk
assessment in
hospital
Performance 1) Proportion of patients without a clear and documented contra-indication for
measures for aspirin and/or a P2Y12 inhibitor, discharged on DAPT.
antithrombotic
treatment in
hospital
15
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Quality indicators (continued)
Type of indicator Quality indicator
and process
Performance 1) Proportion of patients without contra-indications with a statin (high-
measures for intensity) prescribed at discharge.
discharge 2) Proportion of patients with LVEF ≤40% or clinical evidence of heart failure
medication and without contra-indications with a beta-blocker prescribed at
and counseling discharge.
3) Proportion of patients with LVEF ≤40% or clinical evidence of heart failure
without contra-indications with an ACE inhibitor(or ARB if not tolerated)
prescribed at discharge.
4) Proportion of patients with smoking cessation advice/counsellng at
discharge.
5) Proportion of patients without contra-indications enrolled in a secondary
prevention/cardiac rehabilitation programme at discharge.
16
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Validity of the Quality Indicators
Distribution of hospitals’ performance Distribution of the opportunity-based
in the ACCA QIs for AMI ACCA composite QI for AMI
(MINAP –UK) (FAST-MI – France, 2005 & 2010)
Bebb O, et al. Eur Heart J 2017 Schiele F, et al. Circ Cardiovasc Qual Outcomes. 2017
Validity of the Quality Indicators
Scatter correlation matrix of ACCA QIs for AMI (MINAP –UK)
20
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Validity of the Quality Indicators
Association between ACCA QIs for AMI and Association between ACCA QIs for AMI
crude 30-day mortality (MINAP –UK) and 3-year adjusted survival (FAST-MI – FR)
Bebb O, et al. Eur Heart J 2017 Schiele F, et al. Circ Cardiovasc Qual Outcomes. 2017
Validity of the Quality Indicators
Survival according to quartiles of the opportunity- 3-Year adjusted* mortality risk for each category of
based composite QI (FAST-MI - France) the ACCA composite QI (FAST-MI – France)
* Adjusted for deciles of GRACE risk score, DM, prior HF, prior stroke, prior
COPD, type of MI, cohort (2005 vs 2010), glycemia, and Hb at admission
23
www.escardio.org/guidelines 2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)
Quality indicators in STEMI:
measure to improve.
Héctor Bueno, MD, PhD, FESC
Centro Nacional de Investigaciones Cardiovasculares (CNIC)
Cardiology Department. Hospital Universitario 12 de Octubre, Madrid, Spain
Aug 28, 2017
2017 ESC/EACTS Guidelines
for the management of
valvular heart disease
Indications for intervention
(low gradient AS, asymptomatic AS)
Choice of intervention modality
(SAVR vs. TAVI vs. BAV)
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS
ASSESSMENT OF AS SEVERITY
Classification by
Gradient (high/low) Severe AS: Vpeak ≥ 4m/s / ∆Pmean ≥ 40mmHg
EF (normal/low) and/or
Flow (normal/low) AVA < 1.0cm2
LOW GRADIENT
AS
∆Pm < 40 mmHg
AVA < 1.0 cm2
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS
LOW GRADIENT AS
Heterogenous population including patients with severe as
well as moderate AS
Measurement errors, small patient stature and
inconsistency of AVA and gradient cut-offs remain major
sources of misclassification of moderate as severe AS
raising concerns of overtreatment
Assessment of severe AS remains challenging
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Stepwise integrated approach for the assessment of aortic
stenosis severity (Modified from Baumgartner et al. Eur Heart J CVI
2017;18:254)
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Stepwise integrated approach for the assessment of aortic
stenosis severity (Modified from Baumgartner et al. Eur Heart J CVI
2017;18:254)
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Criteria that increase the likelihood of severe
aortic stenosis in patients with AVA <1.0 cm2,
mean gradient < 40 mmHg and preserved EF
(Baumgartner et al)
Criteria(continued)
Quantitative imaging • Low flow (SVi <35 mL/m2) confirmed by techniques
data (continued) other than standard Doppler technique (LVOT
measurement by 3D TOE or MSCT; CMR, invasive data).
• Calcium score by MSCT:
‒ Severe aortic stenosis very likely:
men ≥3000; women ≥1600,
‒ Severe aortic stenosis likely:
men ≥2000; women ≥1200,
‒ Severe aortic stenosis unlikely:
men <1600; women<800.
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS
Changes in recommendations
2012 2017
Indications for intervention in symptomatic aortic stenosis
IIb C IIa C
Intervention may be considered in Intervention should be considered in
symptomatic patients with low-flow, low- symptomatic patients with low-flow, low-
gradient aortic stenosis and reduced ejection gradient aortic stenosis and reduced ejection
fraction without flow (contractile) reserve. fraction without flow (contractile) reserve,
particularly when CT calcium scoring
confirms severe aortic stenosis.
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode
Recommendations Class Level
a) Symptomatic aortic stenosis
Intervention is indicated in symptomatic patients with severe, high-
gradient aortic stenosis (mean gradient ≥40 mmHg or peak velocity I B
≥4.0 m/s).
Intervention is indicated in symptomatic patients with severe low-
flow,
low-gradient (<40 mmHg) aortic stenosis with reduced ejection I C
fraction, and evidence of flow (contractile) reserve excluding pseudo-
severe aortic stenosis.
Intervention should be considered in symptomatic patients with low
flow, low-gradient (<40 mmHg) aortic stenosis with normal ejection IIa C
fraction after careful confirmation of severe aortic stenosis.
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode (continued)
Recommendations Class Level
Intervention should be considered in symptomatic patients with low-
flow, low-gradient aortic stenosis and reduced ejection fraction
IIa C
without flow (contractile) reserve, particularly when CT calcium
scoring confirms severe aortic stenosis.
Intervention should not be performed in patients with severe
comorbidities when the intervention is unlikely to improve quality of III C
life or survival.
b) Choice of intervention in symptomatic aortic stenosis
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS
Indications for surgery in asymptomatic aortic stenosis
2012 2017
IIb C IIa C
Markedly elevated BNP levels. Markedly elevated BNP levels (>threefold
age- and sex-corrected normal range)
confirmed by repeated measurements
without other explanations.
IIb C
Increase of mean pressure gradient with Taken out
exercise by >20 mmHg.
IIb C
Excessive LV hypertrophy in the absence of Taken out
hypertension.
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode (continued)
Recommendations Class Level
SAVR should be considered in asymptomatic patients with severe aortic
stenosis and abnormal exercise test showing fall in blood pressure below IIa C
baseline.
SAVR should be considered in asymptomatic patients with normal ejection
fraction and none of the above-mentioned exercise test abnormalities if
the surgical risk is low and one of the following findings is present:
‒ very severe aortic stenosis defined by a Vmax>5.5 m/s,
‒ severe valve calcification and a rate of Vmax progression ≥0.3m/s/year,
‒ markedly elevated BNP levels (>threefold age- and sex-corrected IIa C
normalrange) confirmed by repeated measurements without other
explanations,
‒ severe pulmonary hypertension (systolic pulmonary artery pressure at
rest >60 mmHg confirmed by invasive measurement) without other
explanation.
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode (continued)
Recommendations Class Level
d) Concomitant aortic valve surgery at the time of other cardiac/ascending aorta
surgery
SAVR is indicated in patients with severe aortic stenosis undergoing
I C
CABG, or surgery of the ascending aorta or of another valve.
SAVR should be considered in patients with moderate aortic stenosis*
undergoing CABG, or surgery of the ascending aorta or of another IIa C
valve after Heart Team decision.
* Moderate aortic stenosis is defined by a valve area of 1.0-1.5 cm2 or a mean gradient of 25-40 mmHg
in the presence of normal flow conditions. However, clinical judgement is required.
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS: TAVI vs. SAVR
5 randomized trials
1 meta-analysis
Large registries
Vahl T et al J Am Coll Cardiol 2016;67:1472-87
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS: TAVI vs. SAVR
High risk
High/Interm. risk
Intermediate risk
Intermediate risk
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS: TAVI vs. SAVR
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC STENOSIS: TAVI vs. SAVR
Consideration of TAVI as an alternative to SAVR in a wide range of patients with
increased surgical risk („intermediate“ or „high risk“)
Risk scores alone are insufficient to guide decision between TAVI and SAVR
Avaliable data for TAVI mostly in population > 75 years !
- Bicuspid valves more frequent in younger patients (few experience,
worse results?)
- Missing longterm durability data
- Higher PM and PVL rates become more relevant in younger patients
When patients are theoretically eligible for both, TAVI and surgery, a number
of patient characteristics affect the individual risk / benefit ratio for both
modalities (complex decision process)
Local outcome data for both modalities require consideration
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Aspects to be considered by the Heart Team
for the decision between SAVR and TAVI
in patients at increased surgical risk
Favours Favours
TAVI SAVR
Clinical characteristics
STS/EuroSCORE II <4% (logistic EuroSCORE I<10%) +
STS/EuroSCORE II ≥4% (logistic EuroSCORE I ≥10%) +
Presence of severe comorbidity (not adequately reflected by
scores)
+
Age <75 years +
Age ≥75 years +
Previous cardiac surgery +
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Aspects to be considered by the Heart Team
for the decision between SAVR and TAVI
in patients at increased surgical risk (continued)
Favours Favours
TAVI SAVR
Clinical characteristics (continued)
Frailty +
Restricted mobility and conditions that may affect the
rehabilitation process after the procedure
+
Suspicion of endocarditis +
Anatomical and technical aspects
Favourable access for transfemoral TAVI +
Unfavourable access (any) for TAVI +
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Aspects to be considered by the Heart Team
for the decision between SAVR and TAVI
in patients at increased surgical risk (continued)
Favours Favours
TAVI SAVR
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode (continued)
Recommendations Class Level
b) Choice of intervention in symptomatic aortic stenosis
Aortic valve interventions should only be performed in centres with
both departments of cardiology and cardiac surgery on-site, and with
I C
structured collaboration between the two, including a Heart Team
(heart valve centres).
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode (continued)
Recommendations Class Level
The choice for intervention must be based on careful individual evalu-
ation of technical suitability and weighing of risks and benefits of each
modality (aspects to be considered are listed in the according table). I C
In addition, the local expertise and outcomes data for the given
intervention must be taken into account.
SAVR is recommended in patients at low surgical risk (STS or
EuroSCORE II <4% or logistic EuroSCORE I <10% and no other risk
I B
factors not included in these scores, such as frailty, porcelain aorta,
sequelae of chest radiation).
TAVI is recommended in patients who are not suitable for SAVR as
I B
assessed by the Heart Team.
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode (continued)
Recommendations Class Level
In patients who are at increased surgical risk (STS or EuroSCORE II ≥4%
or logistic EuroSCORE I ≥10% or other risk factors not included in
these scores such as frailty, porcelain aorta, sequelae of chest
radiation), the decision between SAVR and TAVI should be made by I B
the Heart Team according to the individual patient characteristics (see
according table), with TAVI being favoured in elderly patients suitable
for transfemoral access.
Balloon aortic valvotomy may be considered as a bridge to SAVR or
TAVI in haemodynamically unstable patients or in patients with
IIb C
symptomatic severe aortic stenosis who require urgent major non-
cardiac surgery.
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Indications for intervention in aortic
stenosis and recommendations for the
choice of intervention mode (continued)
Recommendations Class Level
Balloon aortic valvotomy may be considered as a diagnostic means
in patients with severe aortic stenosis and other potential cause for
symptoms (i.e. lung disease) and in patients with severe myocardial IIb C
dysfunction, pre-renal insufficiency or other organ dysfunction that
maybe reversible with balloon aortic valvotomy when performed in
centres that can escalate to TAVI.
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Management of aortic regurgitation
Significant enlargement of ascending aortaa
No Yes
Severe aortic regurgitation
No Yes
Symptoms
No Yes
LVEF ≤50% or LVEDD >70 mm
or LVESD >50 mm (or >25 mm/m2 BSA)
No Yes
Follow-up Surgeryb
a See table of recommendations for definitions of aortic diameter
b Surgery should also be considered if significant changes in LV and aortic size occur during FU (see table)
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC REGURGITATION
EVALUATION
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2017 ESC/EACTS Valvular Heart Disease GL
AORTIC REGURGITATION
EVALUATION
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What is new in the 2017 Valvular Heart
Disease Guidelines?
2017 New recommendations
Indications for surgery in severe aortic regurgitation and aortic root disease
New I C recommendations:
* Patients with pliable non-calcified tricuspid or bicuspid valves who have a type I (enlargement
• Heart Team discussion is recommended in selected patients in whom aortic valve repair
of the aortic root with normal cusp motion) or type II (cusp prolapse) mechanism of AR.
may be a feasible alternative to valve replacement.
• Aortic valve repair, using the reimplantation or remodelling with aortic annuloplasty
technique, is recommended in young patients with aortic root dilationand tricuspid
aortic valves, when performed by experienced surgeons.
New IIa C recommendation:
Surgery should be considered in patients who have aortic root disease with maximal
ascending aortic diameter: ≥45 mmin patients with a TGFBR1 orTGFBR2 mutation
(including Loeys-Dietz syndrome)*.
* A lower threshold of 40 mm may be considered in women with low BSA, in patients with a TGFBR2
mutation, or in patients with severe extra-aortic features.
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Full Text and ESC Textbook chapter VHD
www.escardio.org/guidelines
2017 ESC/EACTS Guidelines
for the management of
valvular heart disease
Mitral Valve Disease
Raphael Rosenhek
Department of Cardiology
Medical University of Vienna
2
Experience and Outcome of Mitral
Surgery in Mitral Regurgitation
Proportion repaired
Bolling S et al.
Ann Thorac Surg 2010;90:1904-11
# of isolated mitral cases per surgeon and year
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Concept of Heart Valve Centres
• Multidisciplinary Teams
Heart • Volume
Interventional
Cardiology Surgery • Quality Assessment (robust audit)
• Excellence in
Imaging
Intervention
PAT Surgery
Non-interventional
Cardiology
Imaging
NYHA I-II
Survival (%) 80
60
40 NYHA III-IV
20
0
0 1 2 3 4 5 6 7 8 9 10
Years
Tribouilloy C et al. Circulation 1999;99:400
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Indications for intervention in severe
primary mitral regurgitation
100
60 EF 50-60%
40
20
EF <50%
0
0 2 4 6 8 10
Enriquez-Sarano et al. Circulation 1994;90:830-837.
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Indications for intervention in severe
primary mitral regurgitation
Atrial Fibrillation & Pulmonary Hypertension
Postoperative survival
Survival (%)
Years
Badhwar et al. Ann Thor Surg 2012;94:1870-1877 Le Tourneau et al. Heart 2010;96:1311-1317
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Indications for intervention in severe
primary mitral regurgitation
Recommendations Class Level
Mitral valve repair should be the preferred technique when the results
I C
are expected to be durable.
Surgery is indicated in symptomatic patients with LVEF >30%. I B
Surgery is indicated in asymptomatic patients with LV dysfunction
I B
(LVESD ≥45 mm* and/or LVEF ≤60%).
Surgery should be considered in asymptomatic patients with
preserved LV function (LVESD <45 mm and LVEF >60%) and atrial
IIa B
fibrillation secondary to mitral regurgitation or pulmonary hyper-
tension (systolic pulmonary pressure at rest >50 mmHg**).
* Cut-offs refer to average-size adults and may require adaptation in patients with unusually small or large stature
** If an elevated SPAP is the only indication for surgery, the value should be confirmed by invasive
measurement
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Indications for intervention in severe
primary mitral regurgitation (continued)
Left Ventricular and Left Atrial Size
In patients with flail leaflets
Tribouilloy C et al.
Le Tourneau T. et al.
J Am Coll Cardiol 2009;54:1961-1968
J Am Coll Cardiol 2010;56:570-8
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Indications for intervention in severe
primary mitral regurgitation (continued)
Recommendations Class Level
Surgery should be considered in asymptomatic patients with
preserved LVEF (>60%) and LVESD 40–44 mm* when a durable repair
is likely, surgical risk is low, the repair is performed in heart valve
centres, and at least one of the following findings is present: IIa C
- flail leaflet or,
- presence of significant LA dilatation (volume index ≥60 mL/m²
BSA) in sinus rhythm.
Mitral valve repair should be considered in symptomatic patients with
severe LV dysfunction (LVEF <30% and/or LVESD >55 mm) refractory
IIa C
to medical therapy when likelihood of successful repair is high and
comorbidity low.
* Cut-offs refer to average-size adults and may require adaptation in patients with unusually small or large stature
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What is new in the 2017 Valvular Heart
Disease Guidelines?
Changes in recommendations
2012 2017
Indications for intervention in asymptomatic severe primary mitral regurgitation
Pulmonary hypertension on exercise (SPAP
Taken out
≥60 mmHg at exercise).
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Indications for intervention in severe
primary mitral regurgitation (continued)
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Management of severe chronic primary mitral regurgitation
Symptoms
No Yes
LVEF ≤60% or LVESD ≥45 mm LVEF >30%
No Yes No Yes
New onset of AF or Refractory to medical therapy
SPAP >50 mmHg
No Yes No Yes
High likelihood of durable Medical therapy
repair, low surgical risk, and Durable valve repair is likely
presence of risk factorsa and low comorbidity
No Yes No Yes
Extended HF
Follow-up treatment/percutaneous
edge-to-edge repair
Surgery (repair whenever possible)
a LVESD ≥40 mm and one of the following present: flail leaflet or LA volume ≥60 mL/m² BSA at sinus rhythm
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Echocardiographic criteria for the
definition of severe valve regurgitation:
an integrative approach (continued)
(Adapted from Lancellotti et al.)
Mitral regurgitation
Quantitative Primary Secondary
EROA (mm²) ≥40 ≥20
Regurgitant volume
≥60 ≥30
(mL/beat)
+ enlargement of cardiac LV, LA
chambers/vessels
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What is new in the 2017 Valvular Heart
Disease Guidelines?
Changes in recommendations
2012 2017
Indications for mitral valve intervention in secondary mitral regurgitation (continued)
Additional statement:
The lower thresholds defining severe MR
compared to primary MR are based on their
association with prognosis. However, it is
unclear if prognosis is independently
affected by MR compared to LV dysfunction.
For isolated mitral valve treatment in
secondary MR, thresholds of severity of MR
for intervention still need to be validated in
clinical trials. So far, no survival benefit has
been confirmed for reduction of secondary
MR.
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Indications for mitral valve
intervention in chronic secondary
mitral regurgitation
Recommendations Class Level
Surgery is indicated in patients with severe secondary mitral
I C
regurgitation undergoing CABG and LVEF >30%.
Surgery should be considered in symptomatic patients with severe
secondary mitral regurgitation, LVEF <30% but with an option for IIa C
revascularization, and evidence of myocardial viability.
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What is new in the 2017 Valvular Heart
Disease Guidelines?
Changes in recommendations
2012 2017
Indications for mitral valve intervention in secondary mitral regurgitation
IIa C
Surgery should be considered in patients
with moderate secondary mitral Taken out
regurgitation undergoing CABG
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Indications for mitral valve intervention
in chronic secondary mitral regurgitation
(continued)
Recommendations Class Level
When revascularization is not indicated, surgery may be considered in
patients with severe secondary mitral regurgitation and LVEF >30%,
IIb C
who remain symptomatic despite optimal medical management
(including CRT if indicated) and have a low surgical risk.
In patients with severe secondary mitral regurgitation and LVEF <30%
who remain symptomatic despite optimal medical management
(including CRT if indicated) and who have no option for revascularis-
ation, the Heart Team may consider percutaneous edge-to-edge IIb c
procedure or valve surgery after careful evaluation for ventricular
assist device or heart transplant according to individual patient
characteristics.
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Indications for PMC and mitral valve
Surgery in clinically significant mitral
stenosis (≤1.5cm2)
Recommendations Class Level
PMC is indicated in symptomatic patients without unfavourable
I B
characteristics for PMC.
PMC is indicated in any symptomatic patients with a contra-
I C
indication or at high-risk for surgery.
Mitral valve surgery is indicated in symptomatic patients who
I C
are not suitable for PMC.
PMC should be considered as initial treatment in symptomatic
patients with suboptimal anatomy but no unfavourable clinical IIa C
characteristics* for PMC.
* Several of the following: old age, history of commissurotomy, NYHA class IV, Afib., pulm. hypertension
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Indications for PMC and mitral valve
surgery (continued)
PMC should be considered in asymptomatic patients without
unfavourable clinical and anatomical characteristics for PMC
and
• high thromboembolic risk (history of systemic embolism,
dense spontaneous contrast in the LA, new-onset or IIa C
paroxysmal atrial fibrillation); and/or
• high-risk of haemodynamic decompensation (systolic
pulmonary pressure >50 mmHg at rest, need for major non
-cardiac surgery, desire for pregnancy).
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Contra-indications for percutaneous
mitral commissurotomy (PMC)
Contra-indications
Mitral valve area >1.5 cm²
Left atrial thrombus
More than mild mitral regurgitation
Severe or bi-commissural calcification
Absence of commissural fusion
Severe concomitant aortic valve disease, or severe combined tricuspid
stenosis andregurgitation requiring surgery
Concomitant CAD requiring bypass surgery
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Echo scores: Wilkins score, Cormier
score, and Echo Score “Revisited” for
immediate outcome prediction
Assessment of mitral valve anatomy according to the Wilkins score
Grade Mobility Thickening
Highly mobile valve with only Leaflets near normal in
1
leaflettips restricted thickness(4−5 mm)
Leaflet mid and base portions Mid leaflets normal, considerable
2
havenormal mobility thickeningof margins (5−8 mm)
Valve continues to move forward Thickening extending through the
3
indiastole, mainly from the base entireleaflet(5−8 mm)
No or minimalforwardmovementof Considerable thickening of all leaflet
4
the leaflets in diastole tissue(>8−10 mm)
The total score is the sum of the four items and ranges between 4 and 16
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Echo scores: Wilkins score, Cormier score,
and Echo Score “Revisited” for immediate
outcome prediction (continued)
Assessment of mitral valve anatomy according to the Wilkins score
Grade Calcification Subvalvular thickening
A single area of increased Minimal thickening just below the mitral
1
echobrightness leaflets
Scattered areas of brightness Thickening of chordal structures extending
2
confined to leaflet margins to one thirdof the chordal length
Brightness extending into the Thickening extended to distal third of the
3
midportions of the leaflets chords
Extensive brightness through- Extensive thickening and shortening of all
4 outmuch of the leaflet tissue chordalstructures extending down to the
papillary muscles
Unfavourable anatomy: score >8
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Echo scores: Wilkins score, Cormier score,
and Echo Score “Revisited” for immediate
outcome prediction (continued)
Assessment of mitral valve anatomy according to the Cormier score
Echocardiographic group Mitral valve anatomy
Pliable non-calcified anterior mitral leaflet and
Group1 mild subvalvular disease (i.e., thin chordae
≥10 mm long)
Pliable non-calcified anterior mitral leaflet and
Group 2 severe subvalvular disease (i.e., thickened
chordae <10 mm long)
Calcification of mitral valve of any extent, as
Group 3 assessed by fluoroscopy, whatever the state
ofsubvalvular apparatus
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Management of clinically significant mitral stenosis (MVA <1.5 cm 2)
Symptoms
No Yes
High-risk of embolism or haemodynamic decompensation CI to PMC
No Yes No Yes
Exercice testing CI or high-risk for surgery Surgery
No Yes
Symptoms
No Yes PMC
Follow-up CI to or unfavourable Favourable anatomical
characteristics for PMC characteristics
No Yes No Yes
Favourable clinical
characteristics*
No Yes
Tricuspid valve
disease
What is new in the 2017 Valvular Heart
Disease Guidelines?
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What is new in the 2017 Valvular Heart
Disease Guidelines?
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Requirements of a heart valve centre
(Modified from Chambers et al.)
Requirements
Multidisciplinary teams with competencies in valve replacement, aortic
root surgery, mitral, tricuspid and aortic valve repair, as well as trans-
catheter aortic and mitral valve techniques including reoperations and
reinterventions. The Heart Teams must meet on a regular basis and work
with standard operating procedures.
Imaging, including 3D and stress echocardiographic techniques, peri-
operative TOE,cardiac CT, MRI, and positron emission tomography-CT.
Regular consultation with community, other hospitals, and extracardiac
departments,and between non-invasive cardiologists and surgeons and
interventional cardiologists.
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Patient evaluation
Essential questions in the evaluation of
patients for valvular intervention
Questions
• How severe is VHD?
• What is the aetiology of VHD?
• Does the patient have symptoms?
• Are symptoms related to valvular disease?
• Are any signs present in asymptomatic patients that indicate a worse
outcome if the intervention is delayed?
• What are the patient’s life expectancy and expected quality of life?
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Essential questions in the evaluation of
patients for valvular intervention
(continued)
Questions (continued)
• Do the expected benefits of intervention (versus spontaneous
outcome)outweigh its risks?
• What is the optimal treatment modality? Surgical valve replacement
(mechanicalor biological), surgical valve repair, or catheter intervention?
• Are local resources (local experience and outcome data for a given
intervention)optimal for the planned intervention?
• What are the patient’s wishes?
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Essential questions in the evaluation of
patients for valvular intervention
Questions
• How severe is VHD?
• What is the aetiology of VHD?
• Does the patient have symptoms?
• Are symptoms related to valvular disease?
• Are any signs present in asymptomatic patients that indicate a worse
outcome if the intervention is delayed?
• What are the patient’s life expectancy and expected quality of life?
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Essential questions in the evaluation of
patients for valvular intervention
(continued)
Questions (continued)
• Do the expected benefits of intervention (versus spontaneous outcome)
outweigh its risks?
• What is the optimal treatment modality? Surgical valve replacement
(mechanical or biological), surgical valve repair, or catheter
intervention?
• Are local resources (local experience and outcome data for a given
intervention) optimal for the planned intervention?
• What are the patient’s wishes?
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Tricuspid regurgitation
Etiology
• Secondary TR
– RV dysfunction following pressure and/or volume overload
– structurally normal leaflets
• Primary TR
– infective endocarditis (especially in intravenous drug addicts)
– rheumatic heart disease
– carcinoid syndrome
– myxomatous disease
– endomyocardial fibrosis
– Ebstein’s anomaly
– congenitally dysplastic valves
– drug-induced valve diseases
– thoracic trauma
– iatrogenic valve damage
Evaluation
• Echocardiography
– abnormalities of the valve structure (primary TR)
– degree of dilatation of the annulus/degree of TV deformation (secondary TR)
– RV dimension and function
– TR severity (integration of multiple qualitative and quantitative parameters) and pulmonary
systolic pressure
– associated valve lesions (particularly on the left side) and LV function
– In experienced laboratories, 3D measurements of RV volumes can be considered
• CMR
– gold standard for assessing RV volumes and function
• Cardiac catheterization
– to evaluate haemodynamics (in particular pulmonary vascular resistance) in patients in whom
isolated tricuspid valve surgery is contemplated for secondary tricuspid regurgitation
TR severity (integration of multiple qualitative and
quantitative parameters)
Echocardiographic criteria for the
definition of severe valve regurgitation:
an integrative approach (continued)
(Adapted from Lancellotti et al.)
Tricuspid regurgitation
Qualitative
Valve morphology Abnormal/flail/large coaptation defect
Colour flow regurgitant jet Very large central jet or eccentric wall
impinging jet
Dense/triangular with early peaking
CW signal of regurgitant jet
(peak <2 m/s in massive TR)
Other –
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Echocardiographic criteria for the
definition of severe valve regurgitation:
an integrative approach (continued)
(Adapted from Lancellotti et al.)
Tricuspid regurgitation
Semiquantitative
Vena contracta width (mm) ≥7
Upstream vein flow Systolic hepatic vein flow reversal
Inflow E-wave dominant ≥1 m/s
Other PISA radius >9 mm
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Echocardiographic criteria for the
definition of severe valve regurgitation:
an integrative approach (continued)
(Adapted from Lancellotti et al.)
Tricuspid regurgitation
Quantitative Primary
EROA (mm²) ≥40
Regurgitant volume ≥45
(mL/beat)
+ enlargement of cardiac RV, RA, inferior vena cava
chambers/vessels
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Indications for Tricuspid Valve Surgery
Timing
– controversial (limited/heterogeneous data available)
– surgery should be carried out sufficiently early to avoid
irreversible RV dysfunction.
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in patients with severe primary tricuspid
I C
regurgitation undergoing left-sided valve surgery.
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery should be considered in patients with moderate primary IIa C
tricuspid regurgitation undergoing left-sided valve surgery.
Surgery should be considered in asymptomatic or mildly symptomatic
patients with severe isolated primary tricuspid regurgitation and IIa C
progressive right-ventricular dilatation or deterioration of right
ventricular function.
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Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in patients with severe primary tricuspid
I C
regurgitation undergoing left-sided valve surgery.
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery should be considered in patients with moderate primary IIa C
tricuspid regurgitation undergoing left-sided valve surgery.
Surgery should be considered in asymptomatic or mildly symptomatic
patients with severe isolated primary tricuspid regurgitation and IIa C
progressive right-ventricular dilatation or deterioration of right
ventricular function.
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)
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in patients with severe primary tricuspid
I C
regurgitation undergoing left-sided valve surgery.
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery should be considered in patients with moderate primary IIa C
tricuspid regurgitation undergoing left-sided valve surgery.
Surgery should be considered in asymptomatic or mildly symptomatic
patients with severe isolated primary tricuspid regurgitation and IIa C
progressive right-ventricular dilatation or deterioration of right
ventricular function.
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)
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in patients with severe primary tricuspid
I C
regurgitation undergoing left-sided valve surgery.
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery should be considered in patients with moderate primary IIa C
tricuspid regurgitation undergoing left-sided valve surgery.
Surgery should be considered in asymptomatic or mildly symptomatic
patients with severe isolated primary tricuspid regurgitation and IIa C
progressive right-ventricular dilatation or deterioration of right
ventricular function.
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)
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in patients with severe primary tricuspid
I C
regurgitation undergoing left-sided valve surgery.
Surgery should be considered in patients with moderate primary IIa C
tricuspid regurgitation undergoing left-sided valve surgery.
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)
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in patients with severe primary tricuspid
I C
regurgitation undergoing left-sided valve surgery.
Surgery should be considered in patients with moderate primary IIa C
tricuspid regurgitation undergoing left-sided valve surgery.
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)
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in patients with severe primary tricuspid
I C
regurgitation undergoing left-sided valve surgery.
Surgery should be considered in patients with moderate primary IIa C
tricuspid regurgitation undergoing left-sided valve surgery.
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)
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery should be considered in asymptomatic or mildly symptomatic
patients with severe isolated primary tricuspid regurgitation and IIa C
progressive right-ventricular dilatation or deterioration of right
ventricular function.
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Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery should be considered in asymptomatic or mildly symptomatic
patients with severe isolated primary tricuspid regurgitation and IIa C
progressive right-ventricular dilatation or deterioration of right
ventricular function.
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)
Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery should be considered in asymptomatic or mildly symptomatic
patients with severe isolated primary tricuspid regurgitation and IIa C
progressive right-ventricular dilatation or deterioration of right
ventricular function.
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Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
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Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
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Indications for tricuspid valve surgery
Recommendations Class Level
Primary tricuspid regurgitation
Surgery is indicated in symptomatic patients with severe isolated
primary tricuspid regurgitation without severe right-ventricular I C
dysfunction.
Surgery may be considered in patients undergoing left-sided valve
surgery with mild or moderate secondary tricuspid regurgitation IIb C
even in the absence of annular dilatation when previous recent right heart failure has
been documented.
After previous left-sided valve surgery and in the absence of recurrent left-sided
valve dysfunction, surgery should be considered in patients with severe tricuspid
regurgitation who are symptomatic or have progressive right-ventricular IIa C
dilatation/dysfunction, in the absence of severe right or LV dysfunction,and severe
34
pulmonary vascular disease/hypertension.
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Indications for tricuspid valve surgery
Recommendations Class Level
Secondary tricuspid regurgitation
Surgery is indicated in patients with severe secondary tricuspid I C
regurgitation undergoing left-sided valve surgery.
Surgery should be considered in patients with mild or moderate
secondary tricuspid regurgitation with dilated annulus (≥40 mm or IIa C
>21 mm/m² by 2D echocardiography) undergoing left-sided valve surgery.
Surgery may be considered in patients undergoing left-sided valve
surgery with mild or moderate secondary tricuspid regurgitation IIb C
even in the absence of annular dilatation when previous recent right heart failure has
been documented.
After previous left-sided valve surgery and in theabsence of recurrent left-sided valve
dysfunction, surgery should be considered in patients with severe tricuspid
regurgitation who are symptomatic or have progressive right-ventricular IIa C
dilatation/dysfunction, in the absence of severe right or LV dysfunction,and severe
35
pulmonary vascular disease/hypertension.
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Indications for tricuspid valve surgery
Recommendations Class Level
Secondary tricuspid regurgitation
Surgery is indicated in patients with severe secondary tricuspid I C
regurgitation undergoing left-sided valve surgery.
Surgery should be considered in patients with mild or moderate
secondary tricuspid regurgitation with dilated annulus (≥40 mm or IIa C
>21 mm/m² by 2D echocardiography) undergoing left-sided valve surgery.
After previous left-sided valve surgery and in theabsence of recurrent left-sided valve
dysfunction, surgery should be considered in patients with severe tricuspid
regurgitation who are symptomatic or have progressive right-ventricular IIa C
dilatation/dysfunction, in the absence of severe right or LV dysfunction,and severe
36
pulmonary vascular disease/hypertension.
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Indications for tricuspid valve surgery
Recommendations Class Level
Secondary tricuspid regurgitation
Surgery is indicated in patients with severe secondary tricuspid I C
regurgitation undergoing left-sided valve surgery.
Surgery should be considered in patients with mild or moderate
secondary tricuspid regurgitation with dilated annulus (≥40 mm or IIa C
>21 mm/m² by 2D echocardiography) undergoing left-sided valve surgery.
Surgery may be considered in patients undergoing left-sided valve
surgery with mild or moderate secondary tricuspid regurgitation IIb C
even in the absence of annular dilatation when previous recent right heart failure has
been documented.
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Indications for surgery in secondary TR
during left sided valve surgery
• Tricuspid repair during left-sided surgery should be
performed liberally when annulus dilatation is present
because:
– It does not increase operative risk
– It provides RV reverse remodeling
– It improves the functional status
Indications for tricuspid valve surgery
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Indications for tricuspid valve surgery
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Indications for tricuspid valve surgery
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Indications for tricuspid valve surgery
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Indications for tricuspid valve surgery
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Indications for surgery in secondary TR after
previous left sided valve surgery
• Reoperation in late TR following mitral valve surgery carries a
high risk, mostly due to the late referral and the consequently
poor clinical condition of the patients.
• To improve the prognosis of these patients surgery should be
considered earlier, even in asymptomatic patients, if there are
signs of progressive RV dilatation or decline in RV function.
Surgical timing
- a key issue -
The problem of late surgical referral is emphasized in
the 2014 AHA Guidelines :
Tricuspid Regurgitation: Intervention
Recommendations COR LOE
Reoperation for isolated tricuspid valve repair or
replacement may be considered for persistent
symptoms due to severe TR (stage D) in patients
who have undergone previous left-sided valve IIb C
surgery and who do not have severe pulmonary
hypertension or significant RV systolic dysfunction
….waiting for persistent
symptoms, as recommended,
is not going to make it any
better!
According to the 2012
ESC/EACTS VHD guidelines
Since severe TR will certainly lead to RV
failure, progressive RV dilatation/initial
dysfunction should trigger TV surgery
regardless of symptoms
Indications for tricuspid valve surgery in
ESC/EACTS VHD Guidelines
Recommendations Class Level
Secondary tricuspid regurgitation
After previous left-sided valve surgery and in the absence of recurrent left-sided
valve dysfunction, surgery should be considered in patients with severe tricuspid
regurgitation who are symptomatic or have progressive right-ventricular IIa C
dilatation/dysfunction, in the absence of severe right or LV dysfunction, and severe
pulmonary vascular disease/hypertension.
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Indications for tricuspid valve surgery in
ESC/EACTS VHD Guidelines
Recommendations Class Level
Secondary tricuspid regurgitation
After previous left-sided valve surgery and in the absence of recurrent left-sided
valve dysfunction, surgery should be considered in patients with severe tricuspid
regurgitation who are symptomatic or have progressive right-ventricular IIa C
dilatation/dysfunction, in the absence of severe right or LV dysfunction, and severe
pulmonary vascular disease/hypertension.
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Indications for tricuspid valve surgery in
ESC/EACTS VHD Guidelines
Recommendations Class Level
Secondary tricuspid regurgitation
After previous left-sided valve surgery and in the absence of recurrent left-sided
valve dysfunction, surgery should be considered in patients with severe tricuspid
regurgitation who are symptomatic or have progressive right-ventricular IIa C
dilatation/dysfunction, in the absence of severe right or LV dysfunction, and severe
pulmonary vascular disease/hypertension.
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Contra-indications for tricuspid valve surgery in
isolated secondary TR after previous left-sided
valve surgery
Recommendations Class Level
Secondary tricuspid regurgitation
After previous left-sided valve surgery and in the absence of recurrent left-sided
valve dysfunction, surgery should be considered in patients with severe tricuspid
regurgitation who are symptomatic or have progressive right-ventricular IIa C
dilatation/dysfunction, in the absence of severe right or LV dysfunction, and severe
pulmonary vascular disease/hypertension.
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Type of intervention in TR
• Valve repair is preferable to valve replacement (ring annuloplasty)
• Valve replacement should be considered if:
– leaflets are significantly tethered
– annulus is severely dilated
• Percutaneous repair techniques must be further evaluated before
any recommendations can be made.
Management of tricuspid regurgitation (TR)
Need for left-sided valve surgery?
No Yes
Kind of tricuspid regurgitation Kind of tricuspid regurgitation
Severe secondary TR Severe primary TR Mild to moderate Severe primary or
secondary TR secondary TR
Absence of severe RV or LV TA dilatation* or recent signs of
dysfunction and of severe right-heart failure?
pulmonary hypertension?
No Yes No Yes
Markedly symptomatic? No TV surgery
No Yes
No or mild symptoms
but progressive RV
dilatation/dysfunction?
No Yes
Conservative TV repair (TVR when repair not feasible)
treatment
* Tricuspid annulus ≥ 40 mm or 21 mm/m2
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Tricuspid stenosis
Etiology
• Rheumatic (often combined with TR in pts with left-
sided valve lesions, particularly mitral stenosis)
• Other causes are rare:
– congenital
– drug-induced valve
– Whipple's disease
– Endocarditis
– large right atrial tumour.
Evaluation
• Echocardiography
– anatomy of the valve and its subvalvular
apparatus
– mean gradient ≥5 mmHg at normal heart rate is
considered indicative of clinically significant
tricuspid stenosis.
Indications for tricuspid valve surgery
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Indications for tricuspid valve surgery
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Indications for tricuspid valve surgery
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Indications for tricuspid valve surgery
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Type of intervention
• Intervention on the tricuspid valve is usually carried out at the time of intervention
on the other valves
• Balloon commissurotomy can be considered in the rare cases with anatomically
suitable valves when tricuspid stenosis is isolated or additional mitral stenosis can
also be treated interventionally.
– limited number of cases
– frequently induces significant regurgitation
– lack of data on long-term results
• The choice between surgical repair or replacement depends on valve anatomy and
surgical expertise.
• The choice of the prosthesis is still a matter of debate
– biological prostheses usually preferred (less thrombotic risk and satisfactory long-term
durability)
Key points
• Tricuspid stenosis is rare, whereas tricuspid regurgitation is more
frequent, (especially secondary TR).
• For appropriate management, secondary TR has to be clearly
distinguished from primary TR.
• Primary TR requires intervention sufficiently early to avoid
secondary RV damage, which is associated with poor outcome.
• Secondary TR should be liberally treated at the time of left-sided
valve surgery.
• Isolated TR surgery after previous left-sided valve surgery requires
comprehensive assessment of the underlying disease, pulmonary
haemodynamics, and RV function.
Gaps in evidence
• Criteria for optimal timing of surgery in primary TR require
refinement.
• Criteria for concomitant tricuspid valve surgery at the time of
left-sided surgery in patients without severe TR require
refinement.
• The potential role of transcatheter tricuspid valve treatment
in high-risk patients needs to be determined.
Thank you!
ESC Guidelines 2017
Valvular Heart Disease
Prosthetic Valves
Bernard Iung
Bichat Hospital, Paris Diderot University, France
on behalf of the Task Force
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Choice of the aortic/mitral prosthesis in
favour of a mechanical prosthesis
Recommendations Class Level
A mechanical prosthesis is recommended according to the
desire of the informed patient and if there are no contra- I C
indications to long-term anticoagulation*.
A mechanical prosthesis is recommended in patients at risk of
I C
accelerated structural valve deterioration**.
A mechanical prosthesis should be considered in patients
already on anticoagulation because of a mechanical prosthesis IIa C
in another valve position.
* Increased bleeding risk because of comorbidities, compliance concerns or geographic, lifestyle or
occupational conditions
** Young age (<40 years), hyperparathyroidism
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Choice of the aortic/mitral prosthesis
in favour of a mechanical prosthesis
(continued)
Recommendations Class Level
A mechanical prosthesis should be considered in patients aged
<60 years for prostheses in the aortic position and <65 years IIa C
for prostheses in the mitral position*.
A mechanical prosthesis should be considered in patients with
a reasonable life expectancy, for whom future redo valve IIa C
surgery would be at high-risk.
A mechanical prosthesis may be considered in patients already
on long-term anticoagulation due to high-risk for thrombo- IIb C
embolism.
* Between 60 and 65 (aortic prosthesis) / 65 and 70 years (mitral prosthesis), both valves are acceptable
and the choice requires careful analysis of factors other than age
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Choice of the aortic/mitral prosthesis
in favour of a bioprosthesis
Recommendations Class Level
A bioprosthesis is recommended according to the desire of the
I C
informed patient.
A bioprosthesis is recommended when good-quality
anticoagulation is unlikely (compliance problems, not readily
available) or contra-indicated because of high bleeding risk I C
(previous major bleed, comorbidities, unwillingness,
compliance problems, lifestyle, occupation).
A bioprosthesis is recommended for reoperation for
mechanical valve thrombosis despite good long-term anti- I C
coagulant control.
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Choice of the aortic/mitral prosthesis
in favour of a bioprosthesis (continued)
Recommendations Class Level
A bioprosthesis should be considered in patients for whom
there is a low likelihood and/or a low operative risk of future IIa C
redo valve surgery.
A bioprosthesis should be considered in young women
IIa C
contemplating pregnancy.
A bioprosthesis should be considered in patients aged
>65 years for a prosthesis in the aortic position, or age
IIa C
>70 years in a mitral position*, or those with life expectancy
lower than the presumed durability of the bioprosthesis.
* Between 60 and 65 (aortic prosthesis) / 65 and 70 years (mitral prosthesis), both valves are acceptable
and the choice requires careful analysis of factors other than age
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Age thresholds and choice of the
type of prosthesis
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Long-term survival and type of
prosthesis
Observational series in pts aged 50-69 yrs with mechanical
or biological aortic prostheses.
Comparison of survival in propensity-matched groups.
2 groups of 1001 pts 2 groups of 1099 pts
No difference for 50-59 and 60-69 yrs
(Chiang et al. JAMA 2014;312:1323-29) (Glaser et al. Eur Heart 2016;37:2658-67)
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Indications for antithrombotic therapy
for mechanical prostheses
Recommendations Class Level
Mechanical prosthesis
Oral anticoagulation using a VKA is recommended lifelong for all
I B
patients.
Bridging using therapeutic doses of UFH or LMWH is recommended
I C
when VKA treatment should be interrupted.
The addition of low-dose aspirin (75-100 mg/day) to VKA should be
IIa C
considered after thromboembolism despite an adequate INR.
The addition of low-dose aspirin (75-100 mg/day) to VKA may be
IIb C New
considered in the case of concomitant atherosclerotic disease.
INR self-management is recommended provided appropriate training
I B New
and quality control are performed.
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Target INR for mechanical prostheses
Prosthesis Patient-related riskfactorsa
thrombogenicity None ≥1 risk factor
Lowb 2.5 3.0
Mediumc 3.0 3.5
Highd 3.5 4.0
a Mitral or tricuspid valve replacement, previous thromboembolism, atrial fibrillation,
mitral stenosis of any degree, LVEF <35%
b Carbomedics, Medtronic Hall, ATS, Medtronic Open-Pivot, St. Jude Medical, On-X, Sorin Bicarbon
c Other bileaflet valves with insufficient data
d Lillehei-Kaster, Omniscience, Starr-Edwards (ball-cage), Björk-Shiley and other tilting-disc valves
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Lower target INR for mechanical
aortic prostheses ?
(Nishimura et al.
J Am Coll Cardiol 2017;70:252-89)
PROACT trial
• 375 pts randomized after AVR (ON-X valve): INR [1.5-2.0] vs. [2.0-3.0] (+ASA 81 mg/j).
Decrease of major (1.5% vs. 3.3%, p=0.047) and minor bleeding (1.3% vs. 3.4%, p=0.021) with
no difference in thromboembolic events (3.0% vs. 1.8%, p=0.18).
• Limitations
− Single type of prosthesis
− Lack of statistical power for thromboembolic risk
− Weekly INR self-monitoring (Puskas et al. J Thorac Cardiovasc Surg 2014;147:1202-11)
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Systematic association of aspririn
for mechanical prostheses ?
(Nishimura et al.
J Am Coll Cardiol 2017;70:252-89)
Thromboembolism Major Bleeding
(Massel and Little Cochrane Database Syst Rev 2013:CD003464)
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
INR self-monitoring
Meta-analysis of 11
randomized trials
(6417 pts)
•Significant benefit for the
prevention of
thromboembolic events
•Particularly marked benefit
in patients with mechanical
prostheses
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Indications for antithrombotic therapy
for mechanical prostheses (continued)
Recommendations Class Level
Mechanical prosthesis
In patients treated with coronary stent implantation, triple therapy
with aspirin (75-100 mg/day), clopidogrel (75 mg/day), and VKA New
IIa B
should be considered for 1 month, irrespective of the type of stent
used and the clinical presentation (i.e. ACS or stable CAD).
Triple therapy comprising aspirin (75-100 mg/day), clopidogrel
(75 mg/day), and VKA for longer than 1 month and up to 6 months
should be considered in patients with high ischaemic risk due to ACS IIa B New
or other anatomical/procedural characteristics that outweigh the
bleeding risk.
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Indications for antithrombotic therapy
for mechanical prostheses (continued)
Recommendations Class Level
Mechanical prosthesis (continued)
Dual therapy comprising VKA and clopidogrel (75 mg/day) should be
considered as an alternative to 1-month triple antithrombotic therapy IIa A New
in patients in whom the bleeding risk outweighs the ischaemic risk.
In patients who have undergone PCI, discontinuation of antiplatelet New
IIa B
treatment should be considered at 12 months.
In patients requiring aspirin and/or clopidogrel in addition to VKA, the
dose intensity of VKA should be carefully regulated with a target INR New
IIa B
in the lower part of the recommended target range and a time in
therapeutic range >65-70%.
The use of NOACs is contra-indicated. III B New
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Antithrombotic therapy in patients with mechanical
valve prosthesis after undergoing PCI
(Adapted from the 2017 ESC Focused Update on Dual Antiplatelet Therapy)
Patients with a mechanical valve undergoing PCI
Concerns about
ischaemic risk Concerns about
prevailing bleeding risk prevailing
Time from
treatment
initiation A C O A C O C O
1 mo. Triple Therapy 1 mo. Triple Therapy Dual Therapy
Class IIa B Class IIa B up to 12 mo.
1 mo. Class IIa A
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Antithrombotic therapy in patients with mechanical
valve prosthesis after undergoing PCI (continued)
(Adapted from the 2017 ESC Focused Update on Dual Antiplatelet Therapy)
A C O C O OR A O C O
3 mo.
Triple Therapy Dual Therapy Dual Therapy
up to 6 mo. up to 12 mo.
Dual Therapy up to 12 mo.
Class IIa B Class IIa A Class IIa A
up to 12 mo.
6 mo. Class IIa A
C O A O
Dual Therapy up to 12 mo.
Class IIa A
12mo.
O
Beyond OAC alone
12 mo. Class IIa B
(www.societechirorale.com
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Main bridging steps for an intervention requiring
interruption of oral anticoagulation in a patient with
a mechanical prosthesis
(Reproduced with permission from Iung and Rodes-Cabau)
Intervention
Days -6 -5 -4 -3 -2 -1 0 +1 +2 +3 +4 +5 +6
Stop VKA Restart VKA
Begin LMWH Switch LMWH Restart LMWH Stop heparin when
or UFH for IV UFH or continue INR > 2.0 (aortic)
UFH INR > 2.5 (mitral)
Stop IV LMWH Restart IV UFH
6 hours before 12 to 24 hours
intervention After intervention
Timing should be individualized according to patient characteristics, actual INR, and the type of intervention
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Indications for antithrombotic therapy
for bioprostheses
Recommendations Class Level
Bioprostheses
Oral anticoagulation is recommended lifelong for patients with
surgical
I C
or transcatheter implanted bioprostheses who have other indications
for anticoagulation.
Oral anticoagulation using a VKA should be considered for the first
3 months after surgical implantation of a mitral or tricuspid IIa C
bioprosthesis.
Oral anticoagulation using a VKA should be considered for the first
IIa C
3 months after surgical mitral or tricuspid valve repair.
Low-dose aspirin (75-100 mg/day) should be considered for the first
3 months after surgical implantation of an aortic bioprosthesis or valve IIa C
-sparing aortic surgery.
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Early antithrombotic therapy after
AVR using a bioprosthesis
4075 patients undergoing AVR (1997-2009).
Of 881 pts without post-op warfarin, 181 received ASA
(Merie et al.
JAMA
2012;308:2118-25)
26 656 patients ≥ 65 yrs undergoing AVR (1997-2009)
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Indications for antithrombotic therapy
for bioprostheses (continued)
Recommendations Class Level
Bioprostheses (continued)
Dual antiplatelet therapy should be considered for the first 3-
6 months after TAVI, followed by lifelong single antiplatelet therapy in IIa C New
patients who do not need oral anticoagulation for other reasons.
Single antiplatelet therapy may be considered after TAVI in the case of
IIb C New
high bleeding risk.
Oral anticoagulation may be considered for the first 3 months after
IIb C
surgical implantation of an aortic bioprosthesis.
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Antithrombotic therapy after TAVI
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TAVI thrombosis diagnosed by CT scan
• 16/156 pts (10%)
Small but significant increase in gradients
(Pache et al. Eur Heart J 2016; 37, 2263–71)
• 23/405 pts (7%)
Increased gradients
(Hansson et al. J Am Coll Cardiol 2016;68:2059-69)
• 10/752 (13%)
(4% for surgical bioprosthesis)
Increased incidence of TIA
(Chakravarty et al. Lancet 2017;389:2383-92)
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Management of left-sided obstructive mechanical prosthetic thrombosis
Suspicion of thrombosis
Echo (TTE + TOE/fluoroscopy)
Obstructive thrombus
Critically ill?
No Yes
Recent inadequate anticoagulation? Surgery immediately available?
No Yes No Yes
Fibrinolysis* Surgery*
IV UFH ± aspirin
Success/failure?
Failure Success
High-risk for surgery?
No Yes
* Risk and benefits of both treatments should be individualized. The presence of a first-generation prosthesis
is an incentive to surgery.
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Obstructive mechanical prosthetic
thrombosis:
Fibrinolysis vs. surgery
Meta-anaysis of 7 studies (690 pts with obstructive thrombosis)
Restoration of normal valve function
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Management of prosthetic valve
dysfunction (continued)
Recommendations Class Level
Bioprosthetic thrombosis
Anticoagulation using a VKA and/or UFH is recommended in
bioprosthetic valve thrombosis before considering I C New
reintervention.
Haemolysis and paravalvular leak
Reoperation is recommended if paravalvular leak is related to
endocarditis or causes haemolysis requiring repeated blood I C
transfusions or leading to severe symptoms.
Transcatheter closure may be considered for paravalvular
leaks with clinically significant regurgitation in surgical high- IIb C New
risk patients (Heart Team decision).
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Management of prosthetic valve
dysfunction (continued)
Recommendations Class Level
Bioprosthetic failure
Reoperation is recommended in symptomatic patients with a
significant increase in transprosthetic gradient (after exclusion I C
of valve thrombosis) or severe regurgitation.
Reoperation should be considered in asymptomatic patients
with significant prosthetic dysfunction, if reoperation is at low- IIa C
risk.
Transcatheter valve-in-valve implantation in aortic position
should be considered by the Heart Team depending on the risk IIa C New
of reoperation and the type and size of prosthesis.
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(European Heart Journal 2017 - doi:10.1093/eurheartj/ehx391)
Conclusion
The choice between a mechanical prosthesis and
a bioprosthesis should not overstress age but
fully take into account patient’s wishes.
Patients with a mechanical prosthesis require
lifelong VKA with a target INR adapted to the
prosthesis and patient characteristics.
The addition of low-dose aspirin to VKA is
restricted to selected patients.
After ACS or PCI in a patient with mechanical
prosthesis, antithrombotic therapy should be
individualized according to ischaemic and
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