PROTECT-AF

COLEGIO ARGENTINO DE
CARDIOLOGOS INTERVENCIONISTAS
Left atrial appendange closure
Indications and results
Pierre Aubry, Eric Brochet, Jean-Michel Juliard,
Dominique Himbert, Alec Vahanian
Bichat Hospital
Department of Cardiology
Paris
France
COLEGIO ARGENTINO DE
CARDIOLOGOS INTERVENCIONISTAS
The speaker has no conflicts of interest to declare
Prevention of stroke in patients with AF
Left atrial appendage closure
Alternative strategy to oral anticoagulation
(OAC)
In place of OAC in non eligible patients?
In place of OAC in eligible patients?
LAA closure in patients with AF
Evidence-based medicine
Eligible population to warfarin therapy
LAA percutaneous closure concept
LA
LV
PROTECT-AF Study
707 patients with AF eligible to warfarin
Warfarin treatment
Watchman device
 Randomized study
 Non inferiority study
 Composite primary efficacy end point:
stroke + cerebral bleeding + death + systemic embolism
 Mean CHADS2 score = 2.2
 Mean follow-up = 18 months
Holmes D et al. Lancet 2009
PROTECT-AF Study
Composite primary efficacy end point:
stroke + cerebral bleeding + death + systemic embolism
Primary efficacy end point
Reddy V et al. Circulation 2013
Stroke
Use of OAC in France
ANSM French data
2013 people treated with OAC
1.49 million
Patients with AF ~ 750.000
Key points
 OAC should be proposed for most patients with AF
 CHA2DS2-VASc score is recommended to assess stroke risk
 HAS-BLED score allows assessment of bleeding risk
 NOAC should be considered for most patients
 Antiplatelet therapy should be limited
 Percutaneous LAA closure may be considered
Eur Heart J 2012:33;2719–2747
CHA2DS2-VASc Score
HAS-BLED Score
OAC bleeding risks
OAC bleeding-related deaths
~ 5000/year in France
 Gastrointestinal bleeds
 Urologic bleeds
 Pulmonary bleeds
 Articular bleeds
 Soft tissues bleeds
 Post traumatic bleeds
 Cerebral bleeds
Cerebral amyloid angiopathy
Amyloid deposits
Lobar bleeds
2014 AHA/ACC/HRS AF guideline
2014 AHA/ACC/HRS AF guideline
No recommendation
PREFER in AF
Clinical characteristics







Population
Age (years) ( mean)
CHA2DS2 VASc score (mean)
Prior stroke (%)
Concomitant antiplatelet therapy (%)
HAS-BLED score (mean)
Prior bleeding (%)
Europace 2014
7243
71.5
3.4
8.2
22.1
2.0
7.3
PREFER in AF
Antithrombotic therapy
 No antithromotic therapy (%)
 Oral anticoogulant therapy (%)
 Antiplatelet as monotherapy (%)
6.5
82.3
11.2
 New oral anticoagulants (%)
 Combination of OAC and APA (%)
6.1
10.9
APA: antiplatelet agents
OAC: oral anticoagulants
Europace 2014
Discontinuation rates of OAC
Feldman T. EuroPCR 2014
Non rare situation in patients with AF
High Risk Stroke
High Risk Bleeds
Population candidate but non eligible to OAC: ≥10%?
Preventing Stroke
Avoiding Bleeds
Percutaneous LAA closure devices
Watchman®
Amplatzer® Cardiac Plug
Interventional procedures
Curative treatment
PCI
HCM
TAVI
PFO
ASD
MITRA CLIP
LAA
Preventive treatment
LAA closure in patients with AF
Stroke prevention
Primary stroke prevention:
Secondary stroke prevention:
~ 70%
~ 30%
Percutaneous LAA closure
Major adverse events
Cardiac
perforation
requiring
surgical repair
Pericardial
tamponade
requiring
drainage
1%
1.5%
Stroke/
Cerebral bleed
<1%
Embolization
device
1%
 Life threatening complications
 Learning curve impact
Thrombus
device
4%
Percutaneous LAA closure with Watchman
Feldman T. EuroPCR 2014
Percutaneous LAA closure with Watchman
Feldman T. EuroPCR 2014
Percutaneous LAA closure
When to discuss?
 Definitive contraindication to OAC
- history of cerebral bleeding
- history of major bleeding with no curable cause
 Relative contraindication to OAC
- poor compliance to OAC
- high risk of bleeding with OAC
 Eligitibiliy to OAC
- recurrence of stroke under optimal treatment
Percutaneous LAA closure
Contraindications
 LA or LAA thrombus
 Unfavorable anatomy for transeptal access
 Unfavorable anatomy for LAA closure
 High risk of thrombus device after implantation
Four-Year Follow-up of PROTECT AF
Efficacy and Safety
of Left Atrial Appendage Closure
with WATCHMAN® Device
PROTECT-AF: Primary safety endpoint
4 year data
Reddy V. HRS 2013
PROTECT-AF: Primary efficacy endpoint
4 year data
Reddy V. HRS 2013
PROTECT-AF: Primary efficacy endpoint
4 year data
Reddy V. HRS 2013
LAA percutaneous closure
Challenges
 Long-term follow-up after LAA closure
 Randomized study in non eligible population to OAC
 Optimal antithrombotic regimen after LAA closure
 Limitation of traumatic bleeding risks
 Identification of thrombus device risk factors
 Improvement of LAA closure device design
Muchas gracias
Antithrombotic regimen after LAA closure
Device thrombus risk ~ 4%
 Type?: ASA/Clopidogrel/VKA/NOAC
 Duration?
 PROTECT-AF: patients eligible to OAC
- coumadine 6 weeks
- DAPT 6 months
- ASA long life
 Risk factors of thrombus: to identify
 Personalized treatment: adapted to risks

Download Report