Atrial fibrillation in the context of cryptogenic strokes and - - PowerPoint PPT Presentation

Atrial fibrillation in the context of cryptogenic strokes and transcatheter PFO closure

Ignacio Inglessis, MD

Director Structural Heart Disease Program Massachusetts General Hospital Harvard Medical School

Disclosures

Proctor and Consultant for:

• Gore Medical
• St Jude Medical

• Importance of afib as a risk factor for cryptogenic strokes
• Ideal methodology for afib detection in cryptogenic strokes
• Incidence, time course, and clinical consequences of afib

in patients that undergo transcatheter PFO closure

• Treatment recommendations for post-PFO closure afib

Lecture Objectives

• Importance of afib as a risk factor for cryptogenic strokes
• Ideal methodology for afib detection in cryptogenic strokes
• Incidence, time course, and clinical consequences of afib

in patients that undergo transcatheter PFO closure

• Treatment recommendations for post-PFO closure afib

Lecture Objectives

Cryptogenic Stroke

• CS is a stroke in which no cause is identified during initial standard

evaluation

• CS account for 10-40% of all ischemic causes
• Atrial fibrillation is now increasingly recognized as a cause of

cryptogenic strokes

Workup for a Cryptogenic Stroke in the early 2000’s

RESPECT Trial Initiated

(Second US Randomized, Prospective Trial)

Stroke patients only, randomized 1:1 to medical therapy alone or to PFO closure with Amplatzer device plus medical therapy First patient enrolled 2003

Workup for afib in PFO closure clinical trials

2002

Workup for afib in RESPECT Trial

REDUCE Trial Initiated

(Third Randomized, Prospective US/OUS Trial)

Stroke patients only, randomized 2:1 to PFO closure plus medical therapy or to medical therapy alone.

First patient enrolled 2008 HELEX transitioned to Cardioform

2008

Workup for afib in PFO closure clinical trials

Workup for afib in REDUCE Trial

Impact of long-term monitoring technology

Detection of Afib at 6 months

Randomized trial evaluating Implantable cardiac monitoring versus EKG/Holter for detection of afib in patients with CS

Detection of Afib at 12 months

15%

2014

What afib duration impacts the stroke risk?

Duration of detected afib

Do all afib episodes have the same risk? Afib > 1 hour is clinically significant

• Importance of afib as a risk factor for cryptogenic strokes
• Ideal methodology for afib detection in cryptogenic strokes
• Incidence, time course, and clinical consequences of afib

in patients that undergo transcatheter PFO closure

• Treatment recommendations for post-PFO closure afib

Lecture objectives

Factors that increase risk for afib detection in CS

• Older age (>40)
• Higher CHADS-VASC score (Hypertension, diabetes, CHF, PVD)
• MRI consistent with embolic stroke (i.e. multiple vascular territories)
• LA atrial cardiopathy

➢LA dilation ➢Reduced LA emptying fraction ➢LAA size and single lobe-morphology

• Frequent atrial premature beats

The presence of at least one risk factor indicates the need for prolonged monitoring

The strategy for afib detection depends on the risk

Current strategies for the detection of afib

REDUCE Post Approval Study adopted this strategy to rule out afib before enrollment

Current strategies for the detection of afib

• Importance of afib as a risk factor for cryptogenic strokes
• Ideal methodology for afib detection in cryptogenic strokes
• Incidence, time course, and clinical consequences of afib

in patients that undergo transcatheter PFO closure

• Treatment recommendations for post-PFO closure afib

Lecture objectives

Ra Randomized con

• ntroll

lled PFO tria trials: : Atr trial l Fib Fibril illa lation an and Atria ial Flu Flutter Clin linic ical l Outcomes

Gore REDUCE Clinical Study 1 Closure (N= 441) Amplatzer RESPECT Study 2 Closure (N = 499) Any atrial fibrillation 29 (6.6%) 20 (4.0%) Any atrial flutter 2 (0.5%) 2 (0.4%) Serious atrial fibrillation 10 (2.3%) 6 (1.2%) Serious atrial flutter 1 (0.2%) 1 (0.2%)

1 Søndergaard L, Kasner SE, Rhodes JF, et al; Gore REDUCE Study Investigators. New England Journal of Medicine 2017;377(11):1033-1042.

• 2. Saver JL, Carroll JD, Thaler DE, et al; RESPECT Investigators.. New England Journal of Medicine 2017;377(11):1022-1032.

All PFO RCTS found an increase in afib after PFO closure – regardless of device

Incidence of afib post PFO closure

Gore REDUCE Clinical Study 1 Closure (N= 441)

Non-Serious atrial fibrillation or atrial flutter 19/29 (66%) Atrial fibrillation detected within 45 days post-procedure 24 / 29 (83%) Cases that resolved within 2 weeks of onset 17 / 29 (59%)

The REDUCE Study found:

Severity and time course of afib post PFO closure

1 Søndergaard L, Kasner SE, Rhodes JF, et al; Gore REDUCE Study Investigators. New England Journal of Medicine 2017;377(11):1033-1042.

Gore REDUCE Clinical Study 1 Closure (N= 441) Amplatzer RESPECT Study 2 Closure (N = 499)

Subjects with post-implant atrial fibrillation

• r flutter who had a recurrent stroke

1 (0.2%) 1 (0.2%)

1 1. Søndergaard L, Kasner SE, Rhodes JF, et al; Gore REDUCE Study Investigators. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. New England Journal of Medicine 2017;377(11):1033-1042.

• 2. Saver JL, Carroll JD, Thaler DE, et al; RESPECT Investigators. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. New England Journal of Medicine 2017;377(11):1022-1032.
• Both REDUCE and RESPECT showed low risk of recurrent stroke due to post-

implant atrial fibrillation

Clinical consequences of afib post PFO closure

Afib post PFO closure

Key Points

AFIB is more common with an implant but is typically transient and

• nset within 45 days

post implant Serious AFIB is rare Risk of recurrent stroke in patients with AFIB post implant is low The relative risk of recurrent stroke is still reduced by 77% with PFO closure even when including the additional risk of AFIB

Key Points

AFIB is more common with an implant but is typically transient and

• nset within 45 days

post implant Serious AFIB is rare Risk of recurrent stroke in patients with AFIB post implant is low The relative risk of recurrent stroke is still reduced by 77% with PFO closure even when including the additional risk of AFIB

Key Points

AFIB is more common with an implant but is typically transient and

• nset within 45 days

post implant Serious AFIB is rare Risk of recurrent stroke in patients with AFIB post implant is low The relative risk of recurrent stroke is still reduced by 77% with PFO closure even when including the additional risk of AFIB

Key Points

AFIB is more common with an implant but is typically transient and

• nset within 45 days

post implant Serious AFIB is rare Risk of recurrent stroke in patients with AFIB post implant is low The relative risk of recurrent stroke is still reduced by 77% with PFO closure even when including the additional risk of AFIB

Balance between stroke reduction and risk for afib post PFO closure

Kuijpers T, Spencer FA2, Siemieniuk RAC, et al.. BMJ 2018;362:k2515.

British Medical Journal

• Importance of afib as a risk factor for cryptogenic strokes
• Ideal methodology for afib detection in cryptogenic strokes
• Incidence, time course, and clinical consequences of afib

in patients that undergo transcatheter PFO closure

• Treatment recommendations for post-PFO closure afib

Lecture objectives

• Start anticoagulation
• Implant a cardiac monitor
• Monitor patient for duration of monitor’s battery (3 years)
• Consider discontinuation of anticoagulation if no recurrent

significant events (> 1 hour) for at least 1 year

Strategies for management of post PFO closure afib

Thank you…